DETAILED ACTION
Applicant’s amendment and remarks filed July 17, 2025 are acknowledged and entered. New claims 31-50 are pending.
Newly submitted claims 31-46 are directed to an invention that is independent or distinct from the invention originally claimed. Claims 31-46 are directed to method of manufacturing a vaccine comprising obtaining a first polypeptide comprising a first peptide tag, wherein the polypeptide is a particle-forming polypeptide, obtaining a second polypeptide comprising an antigen fused to a second peptide tag, and subjecting the first polypeptide to conditions which enable formation of an isopeptide bond between the first peptide tag and the second peptide tag.
The invention originally claimed (represented in claims 47-50) and the invention of claims 31-46 are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the method is capable of yielding not only VLPs, as claimed in claim 47, but also outer membrane vesicles, a materially different product, though reasonably considered a type of particle. Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 31-46 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Claims 47-50 are directed to embodiments encompassing HER-2. Claim 48 recites various species of disease, including cancer, cardiovascular disease, immune-inflammatory disease, a chronic disease, a neurological disease and/or infectious disease. Given that HER-2 is a cancer antigen, the species of cancer disease will be examined. The other diseases are withdrawn from consideration.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Specification
The amendment filed July17, 2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows [emphasis added]: a particle-forming polypeptide, illustratively the AP205 capsid protein. This amendment broadens the original disclosure from VLPs, to any particles. Applicant is required to cancel the new matter in the reply to this Office Action.
Claims Summary
New claim 47 is directed to a composition comprising:
a particle-forming polypeptide comprising AP205 capsid protein and a first peptide tag;
A HER-2 antigen or antigenic fragment thereof used to a second peptide tag;
wherein the HER-2 antigen or antigenic fragment thereof and the AP205 capsid protein are linked via an isopeptide bond between the first and second tag, forming a particles displaying the HER-2 antigen or antigenic fragment thereof. The composition has an intended use, i.e., in the prophylaxis and/or treatment cancer (new claim 48), specifically breast cancer, gastric cancer, ovarian cancer, and/or uterine serous carcinoma (new claim 49).
New claim 50 is directed to a vaccine comprising:
A virus capsid protein comprising a first peptide tag; and
HER-2 or an antigenic fragment thereof fused to a second peptide tag,
wherein the HER-2 antigen or antigenic fragment thereof and the virus capsid protein are linked via an isopeptide bond between the first and second tag, forming VLPs displaying the HER-2 antigen or antigenic fragment thereof.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 121 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/691,897, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, Application No. 16/691,897 does not disclose a “particle-forming polypeptide” and a “particle”. That specification does not provide support for these generic terms in this application. Rather, that specification is directed to VLPs and virus capsid proteins, a species of the genus “particle-forming polypeptide” and a “particle”. The species does not provide support for the broader genus.
Applicant’s remarks filed July 17, 2025 have been considered but fail to persuade. Applicant points to PCT/DK/2016/050011, filed January 15, 2016, which claims priority to January 15, 2015. Applicant note that on pages 13-14 of the PCT application, VLPs are defined as proteins that spontaneously assemble into particle structure. Applicant argues that VLPs are exemplary, not limiting. Applicant also argues that the reference to “pre-existing components” on page 14, lines 4-5 (of the PCT application) refers to any polypeptide, but in the next lines of the same paragraph, lines 6-7, the application states “[I]n the present context, self-assembly refers to the intrinsic capacity of an AP205 capsid protein and/or a phage fr capsid protein to self assemble into virus-like particles” etc. Thus, it does not appear that a generic polypeptide or generic particle was contemplated, rather, capsid proteins of viruses and VLPs.
The earliest effective filing date for claims 47-49 is the date of the preliminary amendment filed April 12, 2023. Claims 47-49 are directed to embodiments wherein the particle-forming polypeptide comprises/encompasses an AP205 capsid protein. While the embodiment of the AP205 capsid protein has support in the specification and the parent application, the claims recite “particle-forming polypeptide” and “particle”, rather than “virus capsid protein” and “virus-like particle”.
The earliest effective filing date for claim 50 is the filing date of PCT/DK/2016/050011, filed January 15, 2016.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 47-49 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The claims are directed to embodiments of a “particle-forming polypeptide” and a “particle”. The specification does not provide support for these terms. Rather, the specification is directed to VLPs and virus capsid proteins. While the embodiment of the AP205 capsid protein has support in the specification, the claims recite “particle” rather than “virus-like particle”. Applicant’s remarks filed July 17, 2025 have been addressed above as regards the disclosure in application PCT/DK/2016/050011.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 47-50 are rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of Liu et al. (Scientific Reports, 2014, 4, 7266, 8 pages, of record) and Bachmann (US 20040076611, of record). The claims are summarized above and correlated with the teachings of the prior art in bold font below.
Liu describes a synthetic vaccine employing the SpyTag/SpyCatcher technique as rapid and efficient method of conjugation of proteins via an isopeptide bond (see abstract and page 1) (claims 47 and 50, aspects of tags and isopeptide bond). Liu describes, as proof-of-principle, the SpyTag/SpyCatcher system in assembling vaccines composed of a single-chain antibody against DEC205 and model antigens, including OVA8 and TBEV ED3, making use of fusion proteins (see page 2, left column, and page 6, “Methods”) (claims 47 and 50, aspect of fusions). Liu teaches that the method is useful for protein-engineering, noting recombinant proteins for prevention/therapy of various cancers and infectious diseases (see pages 5-6, bridging paragraph, and Figure 6 on page 6) (claims 47-50, aspects of antigens, and breast cancer therapy).
Bachmann describes a composition comprising an AP205 VLP and an antigen, such as HER2, for inducing immune responses useful for the prevention or treatment of breast cancer (see abstract and paragraph [0112]) (claims 47 and 50, aspects of AP205, HER2 and VLPs). Bachmann describes the VLP as useful for the attachment and display of antigens, including allergens, cancer antigens and infectious disease antigens, for the stimulation of an immune response in a subject (see paragraph [0012]).
It would have been obvious to combine the teachings above and employ the SpyTag/SpyCatcher system and supporting methods taught by Liu in attaching an antigen to the AP205 coat protein taught by Bachmann with a reasonable expectation of success (claims 47 and 50). One would have been motivated to do so in order to rapidly and efficiently assemble AP205 VLPs for cancer vaccine/therapy development. Therefore, the claimed invention would have been obvious to one of ordinary skill in the art the time before the effective filing date of the claimed invention.
In Applicant’s remarks filed July 17, 2025, Applicant attempts to incorporate by reference the declaration of Dr. Adam Frederik Sander Bertelsen from parent applications USSNs 15/542,623 and 16/691,897, filed under 37 C.F.R. 1.132. A copy of the declaration must be filed in this application and may not be incorporated by reference. Until such time, the merits of the declaration and any impact thereof on the rejection of record cannot be addressed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 47-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,086,056 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are directed to a species (particular sequences of AP205 and HER2) of the instantly claimed genus (generic AP205 and HER2). A species anticipates a genus.
Claims 47-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,526,376 B2 in view of Bachmann (US 20040076611, of record). Although the claims at issue are not identical, they are not patentably distinct from each other. The patented claims do not specify the cancer antigen HER2. However, it would have been obvious to have claimed HER2 since patented claims 10 and 11 are directed to prophylaxis and/or treatment of cancer with a cancer-specific polypeptide. Given Bachmann’s disclosure of VLPs comprising HER2, it would have been obvious to have claimed HER2 in the patented claims, with a reasonable expectation of success.
Claims 47-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,497,800 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The patented claims do not specify the cancer antigen HER2. However, it would have been obvious to have claimed HER2 since patented claims 10 and 11 are directed to prophylaxis and/or treatment of cancer with a cancer-specific polypeptide. Given Bachmann’s disclosure of VLPs comprising HER2, it would have been obvious to have claimed HER2 in the patented claims, with a reasonable expectation of success.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1671
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