Category: United States

NIST’s Proposed Changes to Bayh-Dole Would Create Additional Burdens for Tech Transfer Offices

March 26, 2021

On January 4, 2021, the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) announced that they are seeking comments on proposed changes to the regulations entitled, “Rights to Federally Funded Inventions and Licensing of Government Owned Inventions” that support the University and Small Business Patent Procedures Act of 1980, commonly known as the “Bayh-Dole Act”.  Comments on the proposed regulations can be submitted via the Federal e-Rulemaking Portal using the docket identification number 201207-0327 and must be received no later than April 5, 2021. NIST held a public webinar on February 25, 2021, on the Notice of Proposed Rulemaking.  The proposed changes are intended to further the Return on Investment (ROI) Initiative for Unleashing American Innovation, which was published in April 2019. 

As provided in the Federal Register, these proposed changes would:

  • make technical corrections;
  • reorganize certain subsections;
  • remove outdated and/or unnecessary sections;
  • institute a reporting requirement on Federal agencies; and
  • provide clarifications on definitions, communications, scope of march-in rights, filing of provisional patent applications, electronic filing, the purpose of royalties on government licenses, and the processes for granting exclusive, co-exclusive and partially exclusive licenses and for appeals.

The proposed changes related to the scope of march-in rights have received the most attention to date, and have been the subject of commentary in trade journals, blog posts, law firm alerts, and from AUTM CEO Stephen Susalka.  Briefly, these proposed changes would clarify 37 CFR § 401.6 to include a provision that march-in rights would not be exercised by an agency exclusively on the basis of business decisions of a contractor regarding the pricing of commercial goods and services arising from the practical application of an invention.

This post, however, will focus on changes related to the filing of provisional patent applications.  The proposed revisions to 37 CFR § 401 will, in part:

  • update the definitions of a patent application and initial patent application in § 401.2(m) and (n) to encompass U.S. provisional and nonprovisional applications, applications filed in a foreign country or international patent office directly, PCT applications, and applications for Plant Variety Protection certificates; and
  • revise § 401.14(c)(3) to clarify the procedures for filing more than one provisional patent application on a disclosed subject invention

More particularly, 37 CFR § 401(m) and (n) would be revised to read as follows (changes from the previous version are shown with additions underlined and deletions in brackets):

(m) The term patent application or ‘‘application for patent’’ [includes a provisional or nonprovisional U.S. national application for patent as defined in 37 CFR 1.9 (a)(2) and (a)(3), respectively,]  may be the following: (1) A United States provisional application as defined in 37 CFR 1.9(a)(2) and filed under 35 U.S.C. 111(b); or (2) A United States nonprovisional application as defined in 37 CFR 1.9(a)(3) and filed under 35 U.S.C. 111(a); or (3) A[n] patent application [for patent] filed in a foreign country or an international patent office; or (4) A patent application filed under the Patent Cooperation Treaty as defined in 37 CFR 1.9(b) which designates the United States; or (5) An application for a Plant Variety Protection certificate.

(n) The term initial patent application means, as to a given subject invention[,]: (1) T[t]he first United States provisional [or non-provisional U.S. national] application as defined in 37 CFR 1.9(a)(2) [and (3), respectively,] and filed under 35 U.S.C. 111(b); or (2) The first United States nonprovisional application as defined in 37 CFR 1.9(a)(3) and filed under 35 U.S.C. 111(a); or (3) The first patent application filed in a foreign country or an international patent office; or (4) The first [international] patent application filed under the Patent Cooperation Treaty as defined in 37 CFR 1.9(b) which designates the United States[;], or (5) The first application for a Plant Variety Protection certificate [, as applicable].

The changes to 37 CFR § 401.14, however, would have the most potential impact on operating procedures for technology transfer offices and in-house and outside counsel.  The revisions to 37 CFR § 401.14(3) include (changes from the previous version are shown with additions underlined and deletions in brackets):

(i) The contractor will file its initial patent application on a subject invention to which it elects to retain title within one year after election of title or, if earlier, prior to the end of any statutory period wherein valid patent protection can be obtained in the United States after a publication, on sale, or public use. Subject to the grant of an extension by an agency under paragraph (c)(5) of this clause, if the contractor files a provisional application as its initial patent application, it shall file a non-provisional application within 10 months of the filing of the provisional application.   (ii) Each provisional application filed following the initial patent application must contain additional written description of the subject invention not previously disclosed in a patent application. The contractor shall file or notify the government that they do not intend to file a non-provisional application within 10 months of the last filed provisional application that is consistent with this section. (iii) The contractor will file patent applications in additional countries or international patent offices within either ten months of the first filed patent application or six months from the date permission is granted by the Commissioner of Patents to file foreign patent applications where such filing has been prohibited by a Secrecy Order. (iv) If required by the Federal agency, the contractor will provide the filing date, patent application number and title; a copy of the patent application; and patent number and issue date for any subject invention in any country in which the contractor has applied for a patent.

Of particular concern are the proposed revisions under 37 CFR § 401.14(3)(ii), which provide that “each provisional application filed following the initial patent application must contain additional written description of the subject invention not previously disclosed in a patent application.” (emphasis added).  The proposed revision does not define what is meant by “additional written description” or what, at a minimum ,would be sufficient to satisfy this requirement.  Does “additional written description” require inclusion of additional features and/or embodiments not previously disclosed in the initial patent application or would merely revising a paragraph disclosed in the initial patent application to add further clarifications or discussion about the invention be sufficient?

In practice, it is not uncommon to abandon a first filed provisional application, either expressly or naturally by not filing a non-provisional application on or before the one-year anniversary of the priority date.  This strategy often is adopted when sufficient progress has not been made on the invention to merit the filing of a non-provisional application and no public disclosure has occurred or to delay the expense of preparing and filing a non-provisional application or the start of potential patent term.  In these circumstances, the first filed provisional application is often refiled “as is” one day after abandonment.    

Under the proposed changes, however, any provisional applications filed after the initial patent application would need to contain additional written description of the invention that was not contained in the previously filed application.  In practice, however, this is often not the case and would create additional burdens on technology transfer offices and their counsel regarding what would be sufficient to constitute “additional written description.”   For example, if sufficient progress has not been made on an invention during the provisional filing year, the inventor, technology transfer office and their counsel will need to spend precious time and resources determining what additional written description would or could be needed to be added to the application.  This begs the question of whether the time and resources being expended on trying to find additional (and sufficient) written description for refiling a provisional might be better spent on assisting an inventor on making progress with his or her invention and developing a patent filing strategy consistent with the current state of the research and potential licensing opportunities.  

Also of concern is the provision under 37 CFR § 401.14(3)(ii) that “[t]he contractor shall file or notify the government that they do not intend to file a non-provisional application within 10 months of the last filed provisional application that is consistent with this section.” (emphasis added).  This provision seems to be inconsistent with 37 CFR § 401.14(3)(i), which provides that “if the contractor files a provisional application as its initial patent application, it shall file a non-provisional application within 10 months of the filing of the provisional application.”

In practice, it is not uncommon to file more than one provisional application during the one-year pendency of the initial patent application, e.g., the first filed provisional application.  This strategy often is referred to as “rolling provisionals,” or “serial provisionals” in which new data, additional description, and potentially new claims, are added to the first filed provisional application as the inventor(s) generate new experimental results.  Under this strategy, a non-provisional application is filed on or before the one-year anniversary of the filing date of the first filed provisional application, including all of the subject matter included in any subsequently filed provisional application in this series. 

Under the proposed changes, however, the contractor would need to file a non-provisional application or notify the government that they do not intend to file a non-provisional application within 10 months of the last filed provisional application.  In practice, this most likely would never be the case as the decision to file a non-provisional application is based on the filing date of the first filed provisional application not the last.  Further, filing a non-provisional application based on the filing date of the last provisional application would run counter to the definition of the “first application” as provided Article 4(c)(4) of the Paris Convention.  This inconsistency should be addressed by the rulemaking body.

Finally, in the public webinar conducted by NIST, slide 21 provides that revisions to 37 CFR § 401.14(c)(3) include that “the filing of serial provisional applications on the same subject invention – must be approved by agency, ….”  (emphasis added).  This language, however, is not mentioned in the materials published in the Federal Register.  To our knowledge, agency approval to file a patent application has not been required by previous regulations and the filing of a patent application has been at the discretion of the contractor, e.g., the tech transfer office.  If adopted, this language would place additional burdens on technology transfer offices and would be impractical as provisional filings typically must be made in a timely manner, for example, prior to a public disclosure.  It is unlikely that approval from the funding agency could be received before the provisional application would need to be filed prior to such disclosure, which could result in the forfeiture of foreign patent rights and negatively impact the commercial value of the invention.  This approach would run counter to the express goals of the Bayh-Dole Act.

Please continue to watch BRICS & Beyond for updates on the proposed changes to the Bayh-Doyle Act.

This post was written by Lisa Mueller & Jeff Childers.

Filing a Divisional Application in the United States – Part 14

February 24, 2021

This is the fourteenth post in our 16-part series examining divisional practice in Argentina, Brazil, Canada, China, Europe, India, Indonesia, Malaysia, Mexico, Pakistan, Russia, Thailand, Saudi Arabia, Singapore, the United States, and Vietnam (in no particular order).  Our first thirteen posts examining divisional practice in Brazil, Mexico, China, India, Argentina, Canada, Thailand, Pakistan, Malaysia, Singapore, Russia, Saudi Arabia and Vietnam and can be found here:  Divisional Practice – Brazil, Divisional Practice – Mexico, Divisional Practice – China, Divisional Practice – India, Divisional Practice – Argentina, Divisional Practice – Canada, Divisional Practice -Thailand,  Divisional Practice – Pakistan, Divisional Practice – Malaysia, Divisional Practice – Singapore, Divisional Practice in Russia, Divisional Practice in Saudi Arabia and Divisional Practice in Vietnam.

Divisional Practice in the United States

Continuing Applications

In the U.S., a pending application may serve as the basis for a continuing application.  Three types of continuing applications exist under U.S. practice, namely divisional, continuation, and continuation-in-part applications.  A continuing application may itself serve as the basis for another continuing application.

Time Period for Filing a Continuing Application 

One or more divisional, continuation, and/or continuation-in-part applications may be filed any time prior to grant of a U.S. patent application.

Requirements for Filing a Continuing Application 

When filing a continuing application, the following documents must be submitted:

  1. A copy of the specification, drawings, and abstract;
  2. A set of claims to be pursued;
  3. An oath or declaration (for continuation-in-part applications) or a copy of a previously submitted oath or declaration (for divisional and continuation applications); and
  4. Basic filing, search, and examination fees.

Additional fees will be required for more than three independent claims, more than 20 total claims, and for each additional 50 sheets that exceeds 100 sheets.

Claims of a Continuing Application 

Divisional Application:   U.S. law provides that if an application contains claims directed to two or more independent and distinct inventions, an Applicant may be required to elect a single invention for examination on the merits.  Each non-elected invention may be pursued in what is referred to as a “divisional” application(s).  Because restriction was required in the parent (original) application, the parent application cannot serve as the basis of a double patenting rejection as long as the claims of the divisional application are directed to a non-elected invention.  In another words, in a properly filed divisional application, a double patenting rejection cannot be made.

Continuation Application:   A continuation application contains the originally disclosed subject matter.  A continuation application may be filed with the originally filed claims and/or new claims (provided that there is support for the claims in the specification as originally filed).  The parent application (or another continuation application that claims priority back to the parent application) may serve as the basis of a double patenting rejection during examination of any continuation application. 

Continuation-in-part Application:   A continuation-in-part application contains the originally disclosed subject matter, plus additional, new subject matter.  Accordingly, the claims of a continuation-in-part application may be directed to the originally disclosed subject matter, the newly disclosed subject matter, or a combination thereof.  The parent application (or a continuation application that claims priority back to the parent application) may serve as the basis of a double patenting rejection during examination of a continuation-in-part application.

Double Patenting 

Under U.S. practice, the doctrine of double patenting prevents an Applicant from extending patent exclusivity beyond the term of a patent.  This doctrine assumes that the public will be free to use the claimed invention, plus modifications and variants that would have been obvious to one of ordinary skill in the art upon expiration of a patent.  Double patenting may be raised when an issued patent and one or more pending applications (referred to as “non-provisional” double patenting) or two or more pending applications (referred to as “provisional” double patenting because neither application has yet issued as a patent) meet one of the following requirements: (1) have the same inventors; (2) have at least one common inventor; (3) are commonly assigned or owned; or (4) are non-commonly owned or assigned, but subject to a joint research agreement.

Generally, two types of double patenting exist in U.S. practice: 

  1. Statutory Double Patenting:  Based on 35 U.S.C. § 101, refers to the fact that an Applicant may obtain only a single patent per invention.  Accordingly, if the claims of an application being examined and an issued patent or pending application are directed to the same invention, a statutory double patenting rejection will be issued by the United States Patent and Trademark Office (USPTO).  The phrase “same invention” means identical subject matter.  The test of whether or not the same invention is being claimed twice is whether the claim in an application being examined can be infringed without literally infringing a corresponding claim in a patent or pending application.  An example is provided below.

Example

  • Claim in a pending application undergoing examination:  A compound of Formula I wherein X is chlorine.
  • Claim in issued patent:  A compound of Formula I wherein X is chlorine.
  • Test:  Can the claim in the examined application be infringed without literally infringing the claim in the issued patent?  Answer:  No.  The claim in the application being examined will be rejected by the Examiner for statutory double patenting.
  1. Non-statutory Obviousness-type Double Patenting:  This type of double patenting is the result of a judicially created doctrine.  Non-statutory obviousness-type double patenting intends to prevent an Applicant from extending patent exclusivity by obtaining claims in a second patent that are patentably indistinguishable (in other words, not patentably distinct) from the claims in another patent or pending application.  Accordingly, if the claimed invention in an application that is being examined (such as in a continuation or continuation-in-part application) is an obvious variant or modification of a claimed invention in an issued patent or pending application, a non-statutory obviousness-type double patenting rejection will be issued by the USPTO.  Essentially, a non-statutory obviousness-type double patenting rejection is considered to be “analogous” to a failure to meet the obviousness requirement of 35 U.S.C. Section 103 except the patent or pending application underlining the double patenting rejection does not have to be prior art.

The key inquiry in a non-statutory obviousness-type double patenting rejection is the differences between the inventions defined by the conflicting claims.  The specification can only be used to construe the meaning of the claims (namely, as a dictionary to learn the meaning of the term in the claims).

Overcoming a Double Patenting Rejection 

  1. Statutory Double Patenting: A statutory double patenting rejection may be overcome by:  (a) amending the claims in the application being examined so as not to be coextensive in scope with the claims of the issued patent or pending application that form the basis of the rejection; (b) arguing the rejection; (c) canceling the conflicting claims in the application being examined; (d) if a “provisional” statutory double patenting rejection is the only rejection remaining in both applications, asking the Examiner to withdraw the rejection in the application with the earlier filing date and permitting that application to issue as a patent (if both applications were filed on the same date, Applicant will need to elect which of the two applications is to be allowed); or (e) abandoning the application in which the rejection is raised.  A terminal disclaimer cannot be used to overcome a statutory double patenting rejection.
  2. Non-statutory Obviousness-type Double Patenting: A non-statutory obviousness-type double patenting rejection may be overcome by:  (a) amending the claims in the application being examined to be patentably distinct over the claims of the issued patent or pending application that form the basis of the rejection; (b) arguing the rejection; (c) canceling the claims at issue in the pending application being examined; (d) if a “provisional” non-statutory obviousness-type double patenting rejection is the only rejection remaining in both applications, asking the Examiner to withdraw the rejection in the application with the earlier filing date and permitting that application to issue as a patent (if both applications were filed on the same date, Applicant will need to elect which of the two applications is to be allowed); (e) if the rejection is a “provisional” rejection, abandoning one of the pending applications; or (f) filing a terminal disclaimer.

Terminal Disclaimers 

A terminal disclaimer is a legal document that ensures that the term of a patent granted on an examined application will not extend past the expiration of the term of the conflicting patent or a patent granted on a conflicting application.  A terminal disclaimer is effective only if there is common ownership between the conflicting claims at issue.  If there is no common ownership, a terminal disclaimer cannot be filed.  Additionally, it is important to remember when conducting due diligence that a patent granted in which a terminal disclaimer is filed is enforceable only as long as the patent issuing and the prior patent that formed the basis of the non-statutory obviousness-type double patenting rejection are commonly owned.

A terminal disclaimer must: (1) specify the portion of the term of the patent being disclaimed; (2) state the present extent of Applicant’s or Assignee’s ownership interest in the patent to be granted; and (3) indicate that the terminal disclaimer fee is enclosed (Presently, $170.00 per terminal disclaimer filed for a large, small or micro entity).  The terminal disclaimer may be signed by the Applicant or an attorney or agent of record.

A terminal disclaimer operates with respect to all claims in a patent.  A terminal disclaimer is only effective with respect to the application identified in the disclaimer, unless an Applicant specifically recites that the disclaimer applies to one or more continuation applications.

A certificate of correction cannot be used to remove a terminal disclaimer mistakenly filed during prosecution or which is no longer believed to be necessary.  However, an Applicant can file a petition to withdraw a terminal disclaimer during prosecution before an application issues if grounds are provided explaining why the terminal disclaimer(s) is no longer believed to be necessary.  A reissue proceeding cannot be used to withdraw a terminal disclaimer that is in effect at the time a patent issues.

This post was written by Lisa Mueller.

Zombie Patents? USPTO Issuing Notices of Abandonment in U.S. National Stage PCT Applications After Filing of an RCE where no Inventor Oath or Declaration or Substitute Statement has been Filed

July 22, 2020

Back on April 2, 2015, the U.S. Patent and Trademark Office (USPTO) published final rules for implementing the Geneva Act of the Hague Agreement Concerning the International Registration of Industrial Designs July 2, 1999 (Final Rules).  Implementation of the Hague Agreement was significant because it allowed Applicants to (1) file a single international design application with the USPTO as the “office of indirect filing”; (2) designate multiple Hague Agreement member countries and pay filing fees for each designated country; and (3) benefit from the resulting registration becoming effective and enforceable in each of the designed countries. 

Also included in the Final Rules, however, was a change that impacted U.S. utility patent practice, specifically, the filing of a Request for Continued Examination (RCE).  Most importantly, the Final Rules clarified that the filing of an RCE under 37 CFR. § 1.114 was not applicable in international design applications and excluded U.S. National Stage Patent Cooperation Treaty (PCT) applications that did not comply with 35 U.S.C. § 371.  On page 17930 of its summary of the Final Rules, the USPTO explained that this change to Section § 1.114 was made to “clarify that the request for continued examination practice set forth in § 1.114 added in section 4403 of the AIPA [American Inventors Protection Act of 1999] does not apply to an international application until the international application complies with 35 U.S.C. § 371 (which requires the filing of an inventor’s oath or declaration (or substitute statement) in the international application, as well, as for example, the basic national fee and an English language translation of the international application if filed in another language)”.  As a result, the USPTO amended § 1.114 by revising paragraphs (e)(3)-(5) and adding paragraph (e)(6) to currently read as shown below:

§  1.114    REQUEST FOR CONTINUED EXAMINATION.
(a) If prosecution in an application is closed, an applicant may request continued examination of the application by filing a submission and the fee set forth in § 1.17(e) ….
*****
(e) The provisions of this section do not apply to:
(1) A provisional application
(2) An application for a utility or plant patent filed under 35 U.S.C. § 111(a) before June 8, 1995;
(3) An international application filed under 35 U.S.C. 363 before June 8, 1995 or an international application that does not comply with 35 U.S.C. § 371;
(4) An application for a design patent;
(5) An international design application; or
(6) A patent under reexamination.

The Final Rules became effective on May 13, 2015.  Thus, beginning on this date, a U.S. National Stage PCT application for which an inventor’s oath or declaration (or substitute statement) had not been filed was not eligible for an RCE filing.

Last week, Applicants who filed an RCE in a U.S. National Stage PCT application in which an inventor oath or declaration had not been filed began receiving Notices of Abandonment which stated:

“The Office acknowledges the filing off the Request for Continued Examination (RCE) on January 1, XXXX.  However, the RCE provisions of 37 CFR 1.114 do not apply to an international application that does not comply with 35 U.S.C. 371.  See 37 CFR 1.114(e)(3).  An inventor’s oath or declaration for each named inventor is required for an international application to comply with 35 U.S.C. 371, notwithstanding the changes permitting applicants to postpone filing the inventor’s oath or declaration until the date on which the issue fee is paid.  See 37 CFR 1.495(c)(3)(ii).  See also Changes To Implement the Hague Agreement Concerning International Registration of Industrial Designs, Final Rule, 80 Fed. Reg. 17918, 17930 (April 2, 2015).  The present application, which is a national stage entry of an international application, has not met the requirement of 35 U.S.C. 371(c)(4) in that a compliant inventor’s oath or declaration has not been filed for each named inventor.  Accordingly, as a proper reply to the Office Action mailed on June 1, XXXX, has not been timely filed, the application is abandoned.”

The receipt of these Notices of Abandonment came as a complete surprise to many Applicants and has led to the question as to “What do you do if you find yourself in this predicament?” 

For abandoned applications:

  1.  Obtain executed inventor oaths or declarations or substitute statements as quickly as possible;
  2. File an RCE form along with the executed inventor oaths or declarations or substitute statements; and
  3. File a Petition for Revival of an Application for Patent Abandoned Unintentionally under 37 CFR § 1.137(a) and the petition fee as soon as possible.

For pending U.S. National Stage PCT applications:

  1. Conduct an audit of your currently pending application and obtain executed inventor oaths or declarations or substitute statements and file them in the USPTO as soon as possible; or
  2. If the application is under final rejection and executed inventor oaths or declarations cannot be readily obtained or the conditions for filing a substitute statement have not been met, file a continuation application.

Patents issued from U.S. National Stage PCT applications in which an RCE was filed without an inventor oath or declaration:

Consider filing an RCE form with the executed inventor oaths or declarations or substitute statements and a Petition for Revival of an Application for Patent Abandoned Unintentionally under 37 CFR § 1.137(a) (Petition to Revive) and petition fee as soon as possible. 

Although it may appear odd to be filing a Petition to Revive on an issued patent, the USPTO has previously granted such petitions.  For example, a Petition to Revive was granted in U.S. Patent No. 6,872,198 (the ‘198 patent).  U.S. Application No. 10/231,748 (Application), which issued as the ‘198 patent, was filed with a nonpublication request under 35 U.S.C. § 122(b)(2)(B)(i).  A PCT application was later filed claiming priority to the Application.  During litigation, it was alleged that the Application should have been abandoned under 35 U.S.C. § 122(b)(2)(B)(iii) for failure to notify the U.S. Patent Office of the PCT filing.  The Patent Owner filed a Rescission of Previous Nonpublication Request and a Petition to Revive on March 23, 2006.  The USPTO granted the petition on August 17, 2006.  In its Decision Granting Petition Under 37 CFR § 1.137(b) (Decision), the USPTO noted that “[T]his application matured into Patent No. 6,872,198 on March 29, 2005.  Therefore, no further action being required, this patented file is being referred to Files Repository.”  Copies of the Petition to Revive and Decision are provided here:  

petition_to_revive_6872198-2Download
decisiononpetition-1Download

The ‘198 patent was the subject of litigation in Arrow Intern. v. Spire Biomedical, Inc., 443 F.Supp.2d 182 (D. Mass. 2006) and Arrow Intern. v. Spire Biomedical, Inc., 635 F.Supp.2d 46 (D. Mass. 2009).

Additionally from a policy perspective, perhaps a technical correction to the statute should be considered that (1) would be retroactive; and (2) would make RCEs in these applications proper provided that all the requirements under 35 U.S.C. § 371 were satisfied by the time the issue fee is paid.  Such a revision of the statute would be consistent with 35 U.S.C. 115(f), which requires the oath or declaration to be filed no later than the date on which the issue fee for the patent is paid.

Considerations for future U.S. National Stage PCT Application filings

One option when filing a U.S. National Stage PCT application is to file the application as a 35 U.S.C. § 120 continuation application, which is also known as a “pass through” or “bypass” continuation.  Filing a bypass continuation avoids the need to submit an oath or declaration before the filing of an RCE.    Another option is to include inventor signatures as part of the PCT Request (Form PCT/RO/101) by utilizing Box VIII(iv).  Alternatively, signatures of the inventors can be included on Form PTO/AIA/01 using the PCT international application number to identify the application to which the declaration is directed and submit the form upon entering the national phase.

We will continue to monitor this situation and provide further updates as they become available.

This post was written by Lisa Mueller and Jeff Childers.

Patentability of Diagnostic Inventions in the United States, Europe and Canada – Part 2

July 21, 2020

This 3-part series will provide an overview of the patentability of diagnostic inventions in the United States (U.S.), Europe and Canada.  Part 1 examined the patentability of diagnostic inventions in the U.S. and can be found here.  Part 2 will examine the patentability of diagnostic inventions in Europe.

Europe

Despite the challenges of obtaining patent protection for diagnostic inventions in the U.S., patent protection for diagnostic inventions is available in a number of jurisdictions outside of the U.S.  Europe remains a pro-patentee jurisdiction as far as diagnostic inventions are concerned.  At the European Patent Office (EPO), Article 53(c) of the European Patent Convention (EPC) does state that:  “European patents shall not be granted in respect of … methods of treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body…” (emphasis added).  However, the EPO applies this exclusion narrowly.  To be excluded, the method must be both diagnostic in nature and practiced on the human or animal body. 

In G 1/04, the Enlarged Board stated that because neither the EPC nor the preparatory documents to the EPC provided a definition for the term “diagnostic methods”, according to established jurisprudence of the EPO, a diagnostic method must include at least the following steps: 

(i)   the examination phase involving the collection of data;

(ii)  the comparison of these data with standard values;

(iii) the finding of any significant deviation, i.e., a symptom, during the comparison; and

(iv) the decision phase (attribution of the deviation to a particular clinical picture).

Thus, presenting claims lacking some of steps (i) to (iv) may avoid the exclusion.

Additionally, in G 1/04, the Enlarged Board further stated that for a claimed method to be considered a diagnostic method excluded from patentability under Article 53(c) EPC, the claim must contain the following features:

(a) the diagnosis for curative purposes stricto sensu representing the deductive medical or veterinary decision phase as purely intellectual exercise (i.e., decision step (iv), above);

(b) the preceding steps which are constitutive for making that diagnosis (i.e., examination, comparison and finding of significant deviation steps (i) to (iii) above); and

(c) the specific interactions with the human or animal body which occur when carrying those out among these preceding steps which are of a technical nature.

What is meant by feature c) above is that when determining whether or not the method is “practiced on the human or animal body”, only the recited steps that are a) preceding steps necessary for making a diagnosis, and, b) technical in nature, should be considered.   The EPO has a consistent but very broad interpretation of what is meant by the term “practiced on the human or animal body”.  If the performance of the respective step implies any interaction with the human or animal body, then the requirement is met.  The interaction does not need to be invasive, involve any risk to patient safety or require a medical professional to be considered a step “practiced on” the body. Furthermore, a direct physical interaction on the body is not required; it is sufficient that the body is present and an interaction occurs.  Moreover, a diagnostic method claim may be objected to as encompassing steps practiced on the human or animal body even if the practice is not positively recited.  For example, EPO Examiners will consider the content of the description and dependent claims and, if it is considered that a step practiced on the human or animal body is encompassed by the claim, then an objection will likely be raised. 

It is important to note that the exclusion of Article 53(c) EPC does not apply to in vitro diagnostic methods, such as for the testing or processing of samples derived from a subject.  Even simple in vitro diagnostic method claims, straightforwardly based on the discovery of a correlation between a biomarker/ analyte and a disease state/clinical picture, are patent patentable at the EPO.  In this regard, the subject-matter eligibility situation for diagnostics is much more positive at the EPO than at the U.S. Patent and Trademark Office.

To learn more on the patenting of diagnostic inventions in the U.S., Europe and Canada, please join Lisa Mueller of Casimir Jones, Phillip Price of Dehns, and Noel Courage of Bereskin & Parr LLP for a webinar on July 23, 2020 that will explore in more detail the patentability of diagnostic inventions and provide practical tips on how to overcome objections commonly raised with respect to these inventions in each of these jurisdictions.  You can register for the webinar at the following link:  Link to webinar.

This post was written by Lisa Mueller, Phillip Price of Dehns, and Noel Courage and Ainslie Parsons of Bereskin & Parr LLP.

Patentability of Diagnostic Inventions in the United States, Europe and Canada – Part 1

July 20, 2020

This 3-part series will provide a brief overview of the patentability of diagnostic inventions in the United States (U.S.), Europe and Canada.  Part 1 will examine the patentability of diagnostic inventions in the U.S.

United States

As many readers are aware, beginning in 2012, the U.S. Supreme Court issued the first of a series of three decisions over three consecutive years that had a tremendous impact on the patenting of inventions in the life science industry.  These decisions were Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Int’l, 575 U.S. 208 (2014).  For diagnostic companies, the Mayo decision was particularly problematic.  The patents in Mayo, namely, U.S. Patent Nos. 6,355,623 (the ‘623 patent) and 6,680,302, were directed to methods for optimizing drug dosages for the treatment of autoimmune diseases in humans.  Specifically, the inventions involved the discovery of the relationship between the concentration of a metabolite in the blood following administration of a drug and the likelihood that the dosage administered would be ineffective or cause harmful side effects.  Claim 1 of the ‘623 patent was considered representative and recited:

  1.  A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8 x 108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject, and

wherein the level of 6-thioguanine greater than about 400 pmol per 8 x 108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The Court in Mayo held that the claims of the ‘623 patent were invalid as directed to a law of nature and thus encompassing patent ineligible subject matter pursuant to 35 U.S.C. § 101 (§ 101).  Additionally, the Court introduced a two-step test or framework for distinguishing patent ineligible concepts from patent-eligible applications of those concepts.  The first step involves determining whether the claims are directed to a judicially recognized exception to patentability, such as a law of nature, natural phenomena or abstract idea. If the answer to the first question is “yes”, the claim is considered to be directed to a judicially recognized exception and the analysis moves to the second question.  The second question involves determining whether the claims “do significantly more than simply describe those natural relations,” when considered separately and in an ordered combination.  If the answer to this question is “no”, then the claims are considered to be directed to ineligible subject matter, and not patentable.

The patents involved in the Myriad decision related to isolated human genes, namely, the BRCA1 and BRCA2 genes and mutations thereof, that were associated with a predisposition to breast and ovarian cancer.  In its decision, the Supreme Court unanimously held that genes (e.g., DNA) and the information they encode (e.g., proteins) were not patent eligible simply because they had been isolated from surrounding genetic material since such DNA and proteins did not exhibit any “markedly different characteristics” than those products found in nature.

The final decision in Alice, which was issued about one year after Myriad, involved a series of patents directed to a computer-implemented scheme for mitigating “settlement risk” (e.g., the risk that only one party to a financial transaction will pay what it owes) by using a third-party intermediary.  In Alice, the Court reaffirmed the Mayo two-step test, applying it to claims directed to a computer-implemented process, a computer system, and computer-readable medium for mitigating the settlement risk.  With respect to the second step of the Mayo test, the Court referred to this step as a “search for an inventive concept – i.e., an element or combination of elements that is sufficient to ensure that the patent in practice amounted to significantly more than a patent upon the ineligible concept itself”. 

Since these three decisions, the Mayo/Alice 2-step framework has been used by the U.S. Patent and Trademark Office (USPTO) and courts in determining the patent eligibility of claimed subject matter under § 101. Unfortunately, since the Court’s decisions in Mayo, Myriad, and Alice, the United States Court of Appeals for the Federal Circuit (Federal Circuit) has found all eight cases involving patents claiming diagnostic methods to be invalid as being directed to patent ineligible subject matter. 

Despite the challenges of the Mayo decision as well as the subsequent decisions at the Federal Circuit, it is still possible to obtain claims to diagnostic inventions in the U.S.  While the types of claims currently being granted by the USPTO tend not to be as broad as the claims granted before the Mayo decision, patent protection is still possible.  The ability to obtain patent protection for diagnostic inventions is important, particularly during times of significant public health crisis, such as that currently being experienced with COVID-19, in order to provide an incentive for diagnostic manufacturers to invest the time and resources to pursue the research and commercialization of new diagnostic tests. 

To learn more on the patenting of diagnostic inventions in the U.S., Europe and Canada, please join Lisa Mueller of Casimir Jones, Phillip Price of Dehns, and Noel Courage of Bereskin & Parr LLP for a webinar on July 23, 2020 that will explore in more detail the patentability of diagnostic inventions and provide practical tips on how to overcome objections commonly raised with respect to these inventions in each of these jurisdictions.  You can register for the webinar at the following link:  Link to webinar.

This post was written by Lisa Mueller, Phillip Price of Dehns, and Noel Courage and Ainslie Parsons of Bereskin & Parr LLP.

A Study of Post-Grant Reviews in U.S. PTO Tech Center 1600

September 28, 2018

Post grant review (PGR) is a trial proceeding conducted at the Patent Trial and Appeal Board (PTAB or Board) to review the patentability of one or more claims in a patent on any ground that could be raised under 35 U.S.C. §282(b)(2) or (3) (e.g., §§101, 102, 103 or 112). The procedure for conducting post grant review took effect on September 16, 2012, and generally applies to patents issuing from applications subject to first-inventor-to-file provisions of the American Invents Act.

The PGR process begins with a third party filing a petition on or prior to the date that is 9 months after the grant of the patent or issuance of a reissue patent. The patent owner may file a preliminary response to the petition. A PGR may be instituted upon a showing that, it is more likely than not that at least one claim challenged is unpatentable. If the proceeding is instituted and not dismissed, a final determination by the PTAB will be issued within 1 year (extendable for good cause by 6 months).

We have been monitoring the PGRs filed in U.S. PTO Tech Center (TC) 1600 and a summary of the PGRs filed to date is shown in the attached table: PGRCHARTTC1600_09_28_2018.  We will continue to update this table in future posts as new PGRs are filed against patents issued from this TC.

As of September 27, 2018, 39 PGRs have been filed in TC 1600.  Twenty-three of these PGRs have involved transitional applications.  Five different drugs listed in the electronic Orange Book have been the subject of one or more PGRs (namely, Aloxi®, phenylephrine hydrochloride, Copaxone®, Jakafi® and Qbrelis®).

A summary of the grounds alleged in the 39 PGRs is provided in the below table.

§101
§101* (Other)
§112 (Written Description)
§112 (Enablement)
§112 (Indefiniteness)
§102
§103

4

 2 28 25 15 27

27

*Other grounds raised under §101 included lack of inventorship and practical utility.

A summary of the status of the 39 PGRs is provided in the below table.

Terminated
Institution Denied
Trial Instituted
Final Written Decision
Pending
7
13
4
4
11

The four written decisions issued thus far have been in Altaire Pharmaceuticals, Inc. v. Paragon BioTeck, Inc. (PGR2015-00011), Grünenthal GmBH v. Antecip Bioventures II LLC (PGR2017-0008), L’Oréal USA, Inc. v. Liqwd, Inc. (PGR2017-00012) and KVK-Tech, Inc. v. Silvergate Pharmaceuticals, Inc. (PGR2017-00039).   A brief summary of each of the final written decisions is provided in the attached table.  Particularly noteworthy is the decision in Grünenthal which is the first final written decision involving a patent in TC 1600 that focuses solely on written description.  This decision is helpful in that it provides insight on how the PTAB analyzes written description in such proceedings.  Given its importance, Grünenthal is discussed in more detail below.

Grünenthal GmBH v. Antecip Bioventures II LLC

Grünenthal requested post-grant review of claims 1-17 of U.S. Patent No. 9,283,239 (the ‘239 patent) owned by Antecip.  In a final written decision entered on June 22, 2018, the PTAB held that Grünenthal had demonstrated by a preponderance of the evidence that claims 1-17 of the ‘239 patent were unpatentable for a lack of written description.

Background

The ‘239 patent is directed to oral dosage forms of bisphosphonate compounds, such as zoledronic acid, that can be used to alleviate pain or related conditions.  One such condition, complex regional pain syndrome (CRPS), is a debilitating pain syndrome that is characterized by severe pain in a limb that is accompanied by edema, and autonomic, motor and sensory changes.  Because bisphosphonates generally have low oral bioavailability, the ‘239 patent describes enhancing oral bioavailability of zoledronic acid by administering the compound in its disodium salt form.

Claims of the ‘293 patent

The ‘293 patent issued with 17 claims.  Claim 1, the only independent claim, is reproduced below:

  1. A method of treating complex regional pain syndrome comprising orally administering zoledronic acid to a human being in need thereof, wherein the human being receives about 80 to about 500 mg of zoledronic acid within a period of six months.

Dependent claim 17, which also discussed in the PTAB’s decision, is reproduced below:

  1. The method of claim 1, wherein the zoledronic acid is orally administered in a dosage form containing at least 10% zoledronic acid.

Written Description of the ‘293 patent

According to the specification, the monthly dose of zoledronic acid:

. . . is about 5000 mg or less, about 4000 mg or less, about 3000 mg or less, about 2000 mg or less, about 1000 mg or less, about 700 mg or less, about 600 mg or less, about 1 mg to about 4,000 mg, about 1 mg to about 1,000 mg, about 10 mg to about 1000 mg, about 50 mg to about 1000 mg, about 10 mg to about 600 mg, about 40 mg to about 600 mg, about 50 mg to about 600 mg, or about 100 mg to about 600 mg, about 40 mg to about 2000 mg, about 40 mg to about 800 mg, about 50 mg to about 800 mg, or about 100 mg to about 800 mg, about 40 mg to about 1000 mg, about 50 mg to about 1000 mg, or about 100 mg to about 1000 mg, or any monthly dose in a range bounded by, or between, any of these values.  Column 11, lines 33-48.

…may be administered for only 1 month, or may be repeatedly administered for 2 or more months.  Column 12, lines 2-3.

Additionally, the specification, in column 10, lines 40-63, provides following guidance with regard to dosing regimens:

Any suitable amount of zoledronic acid may be used. Some solid or liquid oral dosage forms, or units of oral dosage forms (referred to collectively herein as ‘oral dosage form(s)’) may contain about 0.005 mg to about 20 mg, about 0.1 mg to about 10 mg, about 0.5 mg to about 10 mg, about 0.2 mg to about 5 mg, about 1 mg to about 500 mg, about 1 mg to about 50 mg, about 10 mg to about 250 mg, about 100 mg to about 300 mg, about 20 mg to about 200 mg, about 20 mg to about 150 mg, about 30 mg to about 100 mg, about 1 mg to about 1,000 mg, about 10 mg to about 50 mg, about 10 mg to about 300 mg, about 10 mg to about 150 mg, about 10 mg to about 100 mg, about 40 mg to about 150 mg, about 10 mg to about 600 mg, about 40 mg to about 600 mg, about 40 mg to about 2000 mg, about 40 mg to about 800 mg, about 25 mg to about 800 mg, about 30 mg to about 800 mg, about 10 mg to about 500 mg, about 50 mg to about 150 mg, about 50 mg, about 100 mg, about 50 mg to about 500 mg, about 100 mg to about 2000 mg, about 300 mg to about 1500 mg, about 200 mg to about 1000 mg, about 100 mg to about 500 mg, or about 150 mg of zoledronic acid, or any amount of zoledronic in a range bounded by, or between, any of these values. In some embodiments, the oral zoledronic acid is administered daily, weekly, monthly, every two or three months, once a year, or twice a year. (Emphasis added).

Moreover, the specification in column 13, lines 34-40, provides the following guidance with regard to dosing regimens:

In some embodiments, an oral dosage form comprises about 10 mg to about 150 mg or about 10 mg to about 100 mg of zoledronic acid, and is administered daily for about 5 to about 10 consecutive days. This regimen may be repeated once monthly, once every two months, once every three months, once every four months, once every five months, once every six months, once yearly, or once every two years. (Emphasis added).

With respect to the examples, example 3 describes treatment of CRPS with orally administered zoledronic acid in a rat tibia fracture model. According to this example, CRPS was induced by fracturing the right distal tibias of the animals, then casting the fractured hindpaws for four weeks. The animals were orally administered either a vehicle (control) or 18 mg/m2/day of zoledronic acid for 28 days. After 28 days, the casts were removed and the animals tested for hindpaw pain, edema, and warmth.  Additionally, Figures 3–6 depict the results of the treatment. The ’239 patent states that “a daily dose of 18 mg/m2 corresponds to a monthly dose of about 500–560 mg/m2 or a human dose of about 800–900 mg”.

PTAB’s Analysis and Decision

Claim 1 – “about 80 to about 500 mg of zoledronic acid within a period of six months”

The PTAB first considered whether the specification provided written description support for the range of “about 80 to about 500 mg of zoledronic acid” as recited in the claims.  The PTAB acknowledged the Antecip’s argument that column 10 of the ’239 patent specification disclosed ranges that would encompass the claimed range.   Specifically, the PTAB noted that this portion of the specification disclosed the range of “about 50 mg to about 500 mg,” thereby giving literal support to the range and to the endpoint of “about 500 mg.”  The Board also noted that although the endpoint of “about 80 mg” was not expressly disclosed in combination with the 500 mg endpoint, that the Federal Circuit had explained

If lack of literal support alone were enough to support a rejection under § 112, then the statement of In re Lukach . . . that ‘the invention claimed does not have to be described in ipsis verbis in order to satisfy the description requirement of § 112,’ is empty verbiage.

Thus, according to the PTAB, the issue was whether the description “clearly allowed persons of ordinary skill in the art to recognize” the claimed invention.  The PTAB stated that in this case, the ’239 patent specification clearly did not allow persons of ordinary skill in the art to recognize the “about 80 mg” endpoint as part of invention described in the ’239 patent.  Specifically, the Board noted that there was no disclosure of “about 80 mg” as a preferred endpoint, no disclosure of a specific embodiment including a dose of 80 mg, nor any other description suggesting the importance or criticality of the “about 80 mg” endpoint.

As a result, the Board concluded:

In view of the lack of any explicit disclosure for ‘about 80 mg’ endpoint, Patent Owner suggests that the ‘about 80 mg’ endpoint may be derived from the specification in numerous ways. PO Resp. 13–33; Ex. 2015 ¶¶ 26, 28. For example, Patent Owner argues that the endpoint of 80 mg finds support in column 13 of the specification, which discloses a range of ‘about 10 mg to about 100 mg’ administered over the course of 5 to 10 consecutive days, thereby essentially disclosing a list six different ranges that includes the ranges of about 50 mg to about 500 mg and about 80 mg to about 800 mg. PO Resp. 14 (citing Ex. 2015 ¶¶ 18, 26–29); Tr. 24:8–25:7, 30:16–33:11, 45:3–46:22.

We are aware of cases indicating that the written description analysis requires consideration as to whether one of skill in the art could derive the claimed ranges from the specification. See e.g., Purdue Pharma L.P. v. Faulding Inc., 230 F.3d at 1327; Vas–Cath Inc. v. Mahurkar, 935 F.2d at 1563–64; Ralston Purina Co. v. Far–Mar–Co, Inc., 772 F.2d at 1575; In re Wertheim, 541 F.2d at 264–65. For example, we note that ‘ranges found in applicant’s claims need not correspond exactly to those disclosed in [the specification, so long as] one skilled in the art could derive the claimed ranges from the  [ ] disclosure’. Vas–Cath, 935 F.2d at 1566. However, none of the cases concluding that sufficient written description existed such that a person of ordinary skill in the art could derive a claimed range from a specification are factually equivalent to the present case, where, as here, a non-original claim recites a dosage regimen range with endpoints derived from an inordinate amount of picking and choosing from disparate disclosures of various embodiments reciting broader ranges. For example, in Ralston, the Federal Circuit held that the disclosure of 25%–27% water in a soybean mixture did not support broader claims to ‘at least 20%’, ‘between 20% and 40%’, or ‘in the range of 20%–30%’ moisture levels, but did support moisture levels of ‘at least about 25% by weight’ and ‘at least 25% by weight’, reasoning that the open-ended claims would be limited by what a person skilled in the art would understand to be workable. 772 F.2d at 1576; see also, In re Wertheim, 541 F.2d at 264–65 (discussed hereinabove).

Furthermore, we note that the disparate disclosures of the ’239 patent specification upon which Patent Owner relies may very well render the ‘about 80 mg’ endpoint of the claimed ranges obvious to a person having ordinary skill in the art. Obviousness, however, is an inappropriate standard to measure a claim’s compliance with the description requirement. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (‘One shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious’.) Moreover, we note that the claims do not merely require administration of a dose of about 80 mg to about 500 mg of zoledronic acid, they also require that dose to be administered ‘within a six month period’.  The ’239 patent specification does not use the phrase ‘within a six month period’, but rather discloses that the various described dosage amounts may be administered, for example, ‘monthly, every two or three months, once a year, or twice a year’ or may be ‘repeated . . . once every six months’.  Ex. 1003, 10:40–63, 13:27–33. To the extent the specification does describe periods of six months, it also does not specify the administration of the recited doses over six months. Thus, a person of ordinary skill in the art must further derive from the language of the ’239 patent specification the time frame of ‘within a period of six months’ to administer the recited dose of ‘about 80 to about 500 mg of zoledronic acid’, thereby further complicating the process necessary to derive the recited dosing regimen from the ’239 patent specification. We thus, conclude that the ’239 patent specification does not clearly allow persons of ordinary skill in the art to recognize nor derive the recited dosing regimen of ‘about 80 to about 500 mg of zoledronic acid within a period of six months’.  (Emphasis added).

Claim 17 – “orally administered in a dosage form containing at least 10% zoledronic acid”

With respect to claim 17, Grünenthal acknowledged that the ’239 patent described liquid compositions containing from 0.0001 % to about 50% (w/v) zoledronic acid, and solid compositions containing from 5% up to about 90% (w/w) zoledronic acid.  However, Grünenthal argued that because formulations containing more than 90% zoledronic acid were not described in the specification but would be within the scope of claim 17, the written description requirement was not satisfied.  Interestingly, Antecip did not specifically address Grünenthal’s arguments regarding claim 17. Nonetheless, the PTAB was not persuaded by Grünenthal’s contentions. Instead, it found that the ’239 patent contained a sufficient written description of an oral dosage form containing “at least 10% zoledronic acid”.  Specifically, according to the PTAB, the specification described a “full panoply of zoledronic acid concentrations” citing to column 10, lines 17-28 which recited that the liquid compositions may contain:

…about 10% (w/v) to about 15% (w/v), about 15% (w/v) to about 20% (w/v), about 20% (w/v) to about 30% (w/v), about 30% (w/v) to about 40% (w/v), or about 40% (w/v) to about 50% (w/v) of zoledronic acid.

Additionally, with respect to solid dosage forms, the PTAB referred to column 10, lines 29-32 which recited that such solid forms “may contain at least about 10% (w/w), at least about 20% (w/w) . . .” up to “at least about 80% [w/w]” zoledronic acid.  Moreover, solid dosage forms were also described in this same section of the specification as containing zoledronic acid in ranges beginning from “about 10% (w/w) to about 30% (w/w), about 10% (w/w) to about 20% (w/w) . . .” all the way up to a range of “about 80% (w/w) to about 90% (w/w)” (See, column 10, lines 32-39).  Therefore, according to the PTAB, the breadth of zoledronic acid concentration ranges disclosed in the specification was more comprehensive than, and therefore distinguishable from, the more limited concentration ranges disclosed in Wertheim (where the claimed range of “at least 35%” was not supported by disclosure of 25% to 60% range disclosed in priority application). In short, the PTAB determined that a person of ordinary skill in the art, namely, a medical doctor with experience treating CRPS, would have recognized that the “inventor invented what is claimed” and did not overreach in claiming “at least 10% zoledronic acid” in an orally administered dosage form for treating CRPS.

This post was written by Lisa Mueller.