Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The present application claims priority to the applications, 63/174,415 and PCT/US2022/024684, with effective filing dates of 13 April 2021 and 13 April 2022, respectively.
Claim Status
This Office Action is in response to Applicant’s Amendment filed, 15 April 2026, wherein
the Applicant amended claims 9, 15, and 19. Claim 21 was previously canceled.
Claims 1-20 are pending.
Information Disclosure Statement
The Information Disclosure Statement filed on 15 April 2026 and the references cited therein have been considered, unless indicated otherwise.
Rejections Withdrawn
Claim Rejections – 35 USC § 112
1. Claims 9, 15, and 19 were rejected for failing to comply with the written description requirement for referring to immunomodulatory agents by binding affinity to their antigen. Claims 9, 15, and 19 were amended to remove the references to immunomodulatory agents by their binding affinity for a certain antigen. Applicant’s amendment, see page 6, with respect to claims 9, 15, and 19 has been fully considered. The rejection of claims 9, 15, and 19 has been withdrawn.
Claim Rejections – 35 USC § 102/103
2. Claims 1-20 were rejected as being anticipated under 35 U.S.C. 102(a)(2) by, or in the alternative, under 35 U.S.C. 103 as obvious over Baccei (Wo 2021/071843, filed 6 Oct 2020, of record, see PTO-892 16 Jan 2026).
Applicant’s arguments, see page 6, with respect to the rejection(s) of claims 1-20 under 102(a)(2)/103 have been fully considered and is persuasive. The 102(a)(2)/103 rejection of claims 1-20 has been withdrawn.
Rejections: Modified/New or Maintained
Claim Rejections – Double Patenting
3. (Modified/Maintained) Claims 1-20 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-38 of copending Application No. 17/762,683 (now U.S. Patent No. 12,565,501). Claims 23-24 correspond to claims 12-16 and 23-26 of U.S. Patent No. 12,565,501, and claims 26-38 of copending Application No. 17/762,683 were withdrawn. Accordingly, the rejection is modified to reflect the issuance of U.S. Patent No. 12,565,501. Thus, claims 1-20 are rejected as being unpatentable over claims 12-16 and 23-26 of U.S. Patent No. 12,565,501.
Applicant’s arguments, see pages 8-13, with respect to the rejection of claims 1-20 under nonstatutory double patenting have been fully considered, but they are not persuasive.
Applicant argues that the Office imported limitations of the reference application as if it were prior art by relying on the description of
PNG
media_image1.png
115
297
media_image1.png
Greyscale
being a white solid. Applicant argues that the Examiner has not established the threshold predicate for In re Best burden-shifting. Applicant states that the Examiner cannot determine whether or not ‘501 possesses the properties which would anticipate or render obvious the claimed invention and that because the Examiner cannot determine if ‘501 possesses the aforementioned properties suggests that In re Best does not apply. Applicant argues that the Examiner’s reasoning is impermissible under MPEP § 2112 to establish inherency. Applicant states that the Examiner relies on the language of possibility not necessity and that one or ordinary skill in the art “would reasonably infer” the claimed polymorph. Applicant argues that even if inherency and In re Best burden-shifting requirements were met, Gardner does not support the Examiner’s position. Applicant states that the Examiner improperly implies that Gardner suggests crystal formation in every instance of small molecule synthesis. Applicant argues that the Examiner has not established the compound of ‘501 is the claimed polymorph. Applicant states that the mere fact that the specification identifies freebase Type A under a certain set of conditions does not establish that conditions outside that set would yield the same polymorphic form. Applicant argues that the rejection also fails under obviousness and further states that the Examiner engaged in impermissible hindsight analysis.
In response to Applicant’s arguments that Applicant argues that the Office improperly imported limitations of the reference application, the MPEP states that to avoid improperly treating what is disclosed in a reference patent or copending app as if it were prior art in the context of a NSDP analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. See MPEP 804(II)(B)(1). The Examiner relies upon the reference patent specification to assess if the claimed compound,
PNG
media_image1.png
115
297
media_image1.png
Greyscale
, is a solid or not, which is relevant to the scope of the claims. Accordingly, it is proper.
In response to Applicant’s arguments that the Examiner has not established the threshold predicate for In re Best burden-shifting, the Office does not have any method to investigate the full scope of the claims of ‘501 regarding the crystalline nature of
PNG
media_image1.png
115
297
media_image1.png
Greyscale
or if the compound of ‘501 is amorphous, which is ambiguous. Accordingly, the burden is properly shifted to Applicant to ascertain if the compound of ‘501 (
PNG
media_image1.png
115
297
media_image1.png
Greyscale
) is crystalline or amorphous, which is relevant to assessing nonstatutory double patenting.
In response to Applicant’s arguments that that the Examiner has not established inherency, the Office does not have the ability to determine if the compound of ‘501 (
PNG
media_image1.png
115
297
media_image1.png
Greyscale
) is amorphous due to the silence of the conflicting claims with respect to whether the compound as claimed and the written description of the claims in the conflicting patent (‘501). The Office is not in possession of the evidence showing how the compound of ‘501 was isolated and its characterization aside from the written description of ‘501, and the Office does not possess the facilities to further determine the crystalline nature of the compound of ‘501 (
PNG
media_image1.png
115
297
media_image1.png
Greyscale
). Accordingly, the Office has established inherency with the relevant information available.
In response to Applicant's arguments against the references individually (i.e. Gardner), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to Applicant’s arguments that the Examiner has not established the compound of ‘501 is the claimed polymorph, Applicant demonstrates multiple methods to make a crystalline solid of
PNG
media_image1.png
115
297
media_image1.png
Greyscale
, all having one polymorph (Form A). To the best of the Examiner’s interpretation, the claimed compound of the copending patent, ‘501, was isolated as a crystalline solid, which is a fair inference, absent objective evidence to the contrary. Applicant is in the best position to provide unambiguous evidence that the compound of ‘501 (
PNG
media_image1.png
115
297
media_image1.png
Greyscale
) is or is not the crystalline solid of the instant application. Additionally, attorney argument absent objective evidence is unpersuasive.
In response to Applicant's argument that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the Applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
As such, the rejection of claims 1-20 as being unpatentable on the ground of nonstatutory double patenting over U.S. Patent No. 12,565,501 is maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Madeline M Dekarske whose telephone number is (571)272-1789. The examiner can normally be reached Monday - Thursday 10am - 4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MADELINE M. DEKARSKE/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
Prosecution Insights