DETAILED ACTION
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
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. This application is a continuation of PCT/GB2021/50940 filed April 19, 2021. All claims have been given an effective filing date of April 19, 2021.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in United Kingdom 20170255.0 on April 17, 2020. It is noted, however, that Applicant has not filed a certified copy of the 20170255.0 application in the instant application as is required by 37 CFR 1.55. An attempt by the Office to electronically retrieve, under the priority document exchange program, the foreign application 20170255.0 failed (see document filed on 07/14/2023). Failure to provide a certified copy may result in no benefit being accorded for the 20170255.0 application.
Election/Restriction
Applicant's election without traverse of Group I (Claims 1-2, 4, 6-7, and 9-10) and species:
Antigens in the form of polypeptides
Antigens that are separate polypeptides
SEQ ID NOs: 1 and 2
in the reply filed on November 20, 2025 is acknowledged.
Claims 2, 4, 6-7, 13-21, 23, and 25-27 are withdrawn from further consideration pursuant
to 37 CFR 1.142(b), as being drawn to a nonelected inventions or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 20, 2025.
Upon further consideration, Examiner withdraws the species election requirement A-C as set forth in the Office action mailed on 08/20/2025. Claims 2, 4, and 6-7 are hereby rejoined and fully examined for patentability. In view of the withdrawal of the species election requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Claim Status
Claim listing filed on November 20, 2025 is pending. Claims 3, 5, 8, 11-12, 22, and 24 are cancelled. Claims 13-21, 23, and 25-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions. Claims 1-2, 4, 6-7, and 9-10 are examined upon their merits.
Information Disclosure Statement
The information disclosure statement filed on 03/09/2023 fails to fully comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Multiple copies of both the foreign patent documents and the non-patent literature documents are missing. The IDS filed on 03/09/2023 has been considered with the exception of the lined-through references (see attached).
All the other information disclosure statements (IDSs) submitted on 11/20/2025, 10/21/2022, and 11/02/2022 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
Page 10, line 2 recites “Each of Figures 1-38” wherein “Figures 1-37” is correct.
Table S1 is referenced on page 60, last paragraph, but no “Table S1” exists in the disclosure.
Table 10 on page 82 should be labeled “Table 7.”
Appropriate correction is required.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Specifically, there are four hyperlinks on page 57, one hyperlink on page 61, one hyperlink on page 63, one hyperlink on page 66, two hyperlinks on page 67, one hyperlink on page 71, one hyperlink on page 32, and one hyperlink on page 89. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Applicant is urged to carefully review the specification for additional informalities.
Sequence Compliance in Drawings
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 C.F.R. § 1.821 (a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 C.F.R. § 1.821 through 1.825. Specifically, no sequence identification has been provided for the amino acid sequences presented in Figures 55A-D of the drawings. MPEP § 2412.04 states that where a sequence is presented in a drawing, reference must be made to the sequence by use of the sequence identifier (§ 1.832(a)), either in the drawing or in the Brief Description of the Drawings, where the correlation between multiple sequences in the drawing and their sequence identifiers (§ 1.832(a)) in the Brief Description is clear. The Brief Description of the Drawings for Fig. 55 (page 13 of specification) lists SEQ ID NOs: 11, 13-15, 19-29, 33-35, and 40-42, but the correlation between the SEQ ID NOs and the multiple sequences in Figs. 55A-D is unclear.
Should Applicant choose to correct the drawings, corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Applicant is reminded to comply with sequence rules as stated in MPEP§ 2422 and review the specification to ensure the application is in full sequence compliance in response to this action.
Claim Objections
Claims 1 and 6 are objected to because of the following informalities:
Claim 1(b) recites “SEQ ID NO: 2 or a variant thereof or an immunogenic fragment” and should recite “SEQ ID NO: 2 or a variant thereof, or an immunogenic fragment” with a comma after “thereof” as recited in Claims 1(a) and 1(c)-1(h).
Claim 6 recites “The antigen pool according to claim 1 which is an antigen pool…” and should recite “The antigen pool according to claim 1, which is an antigen pool…” with a comma after “claim 1” to distinguish the claim preamble.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-2, 4, 6-7, and 9-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a variant thereof” and “an immunogenic fragment.” Claims 2, 4, 6-7, and 9-10 are dependent on Claim 1 and do not further define the claimed variants and fragments. The specification defines that variants of the antigenic polypeptide sequences include sequences having “a high degree of sequence identity thereto” and gives a non-limiting example of a suitable variant having at least about 80% identity to the reference sequence (page 21, paragraph 3). “A high degree of sequence identity” is indefinite because it is non-limiting in structure. The metes and bounds of what is considered a variant cannot be determined. Further, the specification defines an immunogenic variant as a variant that elicits a response which is at least 20% of the activity of the reference sequence (page 21, paragraph 4).
This definition of immunogenic variant/fragment is considered functional language because the feature (the immunogenic fragment) is defined by what it does (elicits a response at least 20% of the activity of the reference sequence) rather than by what it is (MPEP § 2173.05(g)). The definition also includes indefinite relative terminology by requiring at least 20% of the activity of the reference sequence when it is unclear what the base activity of the reference sequence is (MPEP § 2173.05(b)). Due to the indefinite functional language and relative terminology, the metes and bounds of “immunogenic fragment” cannot be determined. Claims 1-2, 4, 6-7, and 9-10 are rejected as being indefinite, because it is unclear what is encompassed by “variant thereof” and “immunogenic fragment.”
Claim 6 recites “wherein the nucleic acid is RNA, e.g. messenger RNA.” The phrase "e.g." renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purpose of compact prosecution, Claim 6 is interpreted as “wherein the nucleic acid is RNA” wherein mRNA is not a required claim limitation.
Note, in Claim 9, “immunogenic” is interpreted as an inherent property of a pharmaceutical composition comprising the antigen pool according to claim 1 and a pharmaceutically acceptable carrier (MPEP § 2112.01). Note, Claim 10 recites “immunostimulants” which the specification defines using functional language (any substance that enhances or potentiates an immune response to an exogenous antigen – page 47, paragraph 2); however, “immunostimulants” is not indefinite because it was understood in the art prior to the time of filing as evidenced by Shahbazi et al. J Med Microbiol Infec Dis 2016 (whole document).
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 1-2, 4, 6-7, and 9-10 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 claims contain 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.
Claims 1-2, 4, 6-7, and 9-10 are directed to an antigen pool comprising two or more different antigens selected from SEQ ID NOs: 1-8, a variant thereof, an immunogenic fragment thereof, or a variant of the immunogenic fragment. The specification defines that variants of the antigenic polypeptide sequences include sequences having “a high degree of sequence identity thereto” (page 21, paragraph 3). The broadest reasonable interpretation of “variant” is a polypeptide comprising at least two consecutive amino acids from the reference sequence. The specification defines an immunogenic variant as a variant that elicits a response which is at least 20% of the activity of the reference sequence (page 21, paragraph 4). The broadest reasonable interpretation of “immunogenic fragment” is a polypeptide comprising any structure as long as it has at least 20% functional activity of the reference sequence. Therefore, the claims are directed to a genus of antigens comprising substantial structural variation.
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant has possession of and what Applicant is claiming. In order to provide adequate written description and evidence of possession of this claimed genus of antigens, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
In the instant case, the specification teaches eight antigens comprising SEQ ID NOs: 1-8, respectively (page 15). The specification further teaches example immunogenic fragments of antigen SEQ ID NOs: 1-8 that comprise SEQ ID NOs: 9-55 (page 25, paragraph 3). Specifically, SEQ ID NOs: 9-17 are peptide sequences derived from SEQ ID NO: 1; SEQ ID NOs: 18-30 are peptide sequences derived from SEQ ID NO: 2; SEQ ID NOs: 31-35 are peptide sequences derived from SEQ ID NO: 3; SEQ ID NOs: 36-44 are peptide sequences derived from SEQ ID NO: 4; SEQ ID NOs: 45-47 are peptide sequences derived from SEQ ID NO: 5; SEQ ID NOs: 48-51 are peptide sequences derived from SEQ ID NO: 6; SEQ ID NO: 52 is a peptide sequence derived from SEQ ID NO: 7; and SEQ ID NOs: 53-55 are peptide sequences derived from SEQ ID NO: 8 (page 15). Considering that the claimed variants can comprise any combination of substitutions, deletions, and insertions that can alter immunogenicity and function (specification page 23, paragraph 3), and the claimed immunogenic fragments can comprise any structure as long as 20% functional activity is retained, the example variants/immunogenic fragments comprising SEQ ID NOs: 9-55 do not adequately describe the variation in antigens claimed. The genus of antigen variants and immunogenic fragments encompasses well over thousands of structural variations for each of SEQ ID NOs: 1-8. Only 1 to 4 example variants are taught individually for SEQ ID NOs: 5, 6, 7, and 8. Thirteen example variants are taught for SEQ ID NO: 2, but even these variants do not provide adequate written description for the genus of SEQ ID NO: 2 variants that can comprise any structure as long as two consecutive amino acids of the 70 amino acid residue are conserved or for the genus of SEQ ID NO: 2 immunogenic fragments that can comprise any structure as long as function is conserved.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (MPEP § 2163.05.Ib). In the absence of sufficient recitation of distinguishing identifying characteristics or structure-to-function attributes for the entire genus of antigens, the specification does not provide adequate written description of the claimed genus. Therefore, in view of the case law directed to an appropriate number of representative species, claims 1-2, 4, 6-7, and 9-10 are rejected for insufficient written description.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. § 112 is severable from its enablement provision (see page 1115).
Claims 1-2, 4, 6-7, and 9-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for an antigen pool comprising two or more different antigens selected from SEQ ID NOs: 1-8, does not reasonably provide enablement for an antigen pool comprising two or more antigens selected from variants of SEQ ID NOs: 1-8, immunogenic fragments of SEQ ID NOs: 1-8, and variants of the immunogenic fragments of SEQ ID NOs: 1-8. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
MPEP § 2164.01(a) states that there are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure
does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors include, but are not limited to:
A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01.
The breadth of the claims and nature of the invention:
The nature of the invention is complex. As understood with the broadest reasonable interpretation, the claims encompass an antigen pool comprising two or more different antigens selected from SEQ ID NOs: 1-8, a variant thereof, an immunogenic fragment thereof, or a variant of the immunogenic fragment. Based on the definitions of variant and immunogenic fragment in the specification (see written description rejection above), a “variant” is interpreted as a polypeptide comprising at least two consecutive amino acids from the reference sequence, and an “immunogenic fragment” is a polypeptide comprising any structure as long as it has at least 20% functional activity of the reference sequence. Therefore, the claims are directed to a genus of antigens with substantial structural variation.
When analyzing the scope of enablement, the claims are analyzed with respect to the teachings of the specification and are to be "given their broadest reasonable interpretation consistent with the specification." See MPEP 2111 [R-5]; Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005); and In re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550- 51 (CCPA 1969).
The state of the prior art and level of predictability in the art:
The level of predictability in the art depends, most importantly, on whether the claimed invention can be practiced by one of ordinary skill in the art. In AMGEN INC. ET AL. v. SANOFI ET AL. (No. 21-757, decided May 18, 2023), the Supreme Court held that Amgen was not enabled for “the entire genus” of antibodies that (1) “bind to specific amino acid residues on PCSK9,” and (2) “block PCSK9 from binding to [LDL receptors]” (872 F. 3d 1367, 1372) even though Amgen identified the amino acid sequences of 26 antibodies that perform these two functions. The case law applies to the instant claims which encompass a genus of antigens with substantial structural variation, yet the inventors have only disclosed 1 to 13 example variants for each antigen sequence (specification page 15).
In Amgen, the Supreme Court has stated that despite recent advances, aspects of antibody science remain unpredictable. For example, scientists understand that changing even one amino acid in the sequence can alter an antibody's structure and function. See id., at 14. But scientists cannot always accurately predict exactly how trading one amino acid for another will affect an antibody's structure and function. Ibid. The unpredictability of polypeptide structure and function extends to the antigen polypeptides in the instant application. It is unclear how any combination of amino acid deletions, insertions, or substitutions affects the immunogenicity of the antigens (as supported by specification page 23, paragraph 3).
The case law shows a continued lack of predictability in amino acid alterations even after the effective filing date of the instant invention, and there is no support in the Applicant’s disclosure leading one of ordinary skill to overcome the lack of predictability in the genus of antigens claimed. The specification provides no guidance or direction for structure that must be maintained such that the functional properties of the invention are preserved (antigens that induce an anti-melanoma immune response).
Level of skill in the art:
The level of skill would be high encompassing protein science, immunology, oncology, etc.
Amount of direction provided by inventor and the existence of working examples:
In the instant case, the specification teaches eight antigens comprising SEQ ID NOs: 1-8, respectively (page 15). The specification further teaches example immunogenic fragments of antigen SEQ ID NOs: 1-8 that comprise SEQ ID NOs: 9-55 (page 25, paragraph 3). Specifically, SEQ ID NOs: 9-17 are peptide sequences derived from SEQ ID NO: 1; SEQ ID NOs: 18-30 are peptide sequences derived from SEQ ID NO: 2; SEQ ID NOs: 31-35 are peptide sequences derived from SEQ ID NO: 3; SEQ ID NOs: 36-44 are peptide sequences derived from SEQ ID NO: 4; SEQ ID NOs: 45-47 are peptide sequences derived from SEQ ID NO: 5; SEQ ID NOs: 48-51 are peptide sequences derived from SEQ ID NO: 6; SEQ ID NO: 52 is a peptide sequence derived from SEQ ID NO: 7; and SEQ ID NOs: 53-55 are peptide sequences derived from SEQ ID NO: 8 (page 15).
However, the example antigen variants do not adequately represent the scope of antigen variants and immunogenic fragments that could encompass well over thousands of structural variations. A person having ordinary skill in the art would have to make a substantial inventive contribution in order to make and characterize a representative number of antigen variants and immunogenic fragments and test their immunogenicity to encompass the claimed genus.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
In light of the unpredictability surrounding the claimed subject matter, the undue breadth of the claimed invention’s intended use, and the lack of adequate guidance, one wishing to make and use the presently claimed invention would be unable to do so without engaging in undue experimentation. Given that structure is essential to function, a person having ordinary skill in the art would have to perform further experimentation to make a representative number of antigen variants and immunogenic fragments and screen their characteristics in order to practice the invention commensurate with the scope of the claims.
The instant specification does not enable the invention to make and use the entire genus of antigens claimed; therefore, Claims 1-2, 4, 6-7, and 9-10 are rejected.
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.
1. Claims 1-2, 4, 6, and 9-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 9-10, 14-15, and 25-26 of copending U.S. App. No. 18/046,675.
The instant claims recite an antigen pool comprising two or more different antigens as separate polypeptides, separate nucleic acids, a fusion protein, or a nucleic acid encoding a fusion protein wherein the two or more different antigens are selected from SEQ ID NOs: 1-8, variants thereof, immunogenic fragments thereof, or variants of the immunogenic fragments (Claim 1); the antigens are joined together by one or more peptide linkers positioned between the antigen polypeptide sequences (Claim 2); the antigen pool comprises SEQ ID NOs: 1-2, 4, and 6-8 (Claim 4); wherein the nucleic acid is RNA (Claim 6); an immunogenic pharmaceutical composition comprising the antigen pool and a pharmaceutically acceptable carrier (Claim 9); and wherein the pharmaceutical composition further comprises one or more immunostimulants (Claim 10).
The copending claims recite a fusion protein comprising SEQ ID NOs: 1-2, 4, and 6-8 (Claim 1); a fusion protein further comprising SEQ ID NOs: 3 and/or 5 (Claim 2); wherein the antigenic polypeptides are separated by peptide linkers (Claims 9-10); an isolated nucleic acid encoding the fusion protein (Claim 14); wherein the nucleic acid is RNA (Claim 15); an immunogenic pharmaceutical composition comprising the fusion protein and a pharmaceutically acceptable carrier (Claim 25); and a vaccine composition comprising the fusion protein, a pharmaceutically acceptable carrier, and an immunostimulant (Claim 26). Note, copending SEQ ID NOs: 1-8 are 100% identical to instant SEQ ID NOs: 1-8, respectively.
Because the copending claims recite the same elements of the instant claims, the instant claims are either anticipated and/or rendered obvious by the copending claims. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2. Claims 1-2, 4, 6, and 9-10 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 77, 81, 83, 93-94, and 96-97 of copending U.S. App. No. 19/062,913 in view of Chen et al. Advanced Drug Delivery Reviews 2013.
The instant claims are recited above.
The copending claims recite: a vector comprising a nucleic acid sequence encoding an isolated polypeptide comprising a sequence selected from any one of SEQ ID NOs: 1-10 (Claim 77); a composition comprising the vector and a pharmaceutically acceptable carrier (Claim 81); a vaccine comprising the vector, one or more immunostimulants, and a pharmaceutically acceptable carrier (Claim 83); a vector comprising a nucleic acid encoding a fusion protein comprising two or more sequences selected from SEQ ID NOs: 1-4, a variant thereof, or an immunogenic fragment thereof (Claims 93-94); a vector comprising a nucleic acid encoding a fusion protein wherein the fusion protein comprises any one of SEQ ID NOs: 1-10 and one or more additional polypeptides selected from any one of SEQ ID NOs: 1-10 (Claim 96); and the fusion protein of claim 96 further comprising two or more of SEQ ID NOs: 1-4 (Claim 97). Note, copending SEQ ID NOs: 1-4 are 100% identical to instant SEQ ID NOs: 1-4, respectively. Copending SEQ ID NOs: 5-8 read on the instant variants of SEQ ID NOs: 5-8, respectively.
The copending claims fail to teach wherein the polypeptides of the fusion protein are separated by peptide linkers (instant claim 2). Chen teaches that the successful construction of a recombinant fusion protein requires two indispensable elements: the component proteins and the linkers (section 1, paragraph 2). Chen teaches example peptide linkers and their functionalities in Table 3. It would have been obvious to one of ordinary skill prior to the effective filing date of the claimed invention to separate the polypeptides of the fusion protein with peptide linkers as this is common practice in fusion protein formation as taught by Chen. The motivation to add peptide linkers is because Chen teaches that peptide linkers are an “indispensable element” of a fusion protein. Further, instant claim 6 is obvious over the nucleic acid taught by the copending claims as there are only two primary forms of nucleic acid, RNA and DNA. Thus, the instant claims are either anticipated and/or rendered obvious by the copending claims in view of Chen. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
3. Note, no double patenting rejection is made in view of US Patent No. 12,263,216. The patented claims are directed to SEQ ID NO: 1 and variants thereof comprising SEQ ID NOs: 11-14, 55-57, and 73-74 wherein patented SEQ ID NO: 1 is 100% identical to instant SEQ ID NO: 1. However, the patented claims do not teach antigens comprising SEQ ID NOs: 2-8 or the combination of two or more different antigens.
Conclusion
No claim is allowed.
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/SARAH COOPER PATTERSON/Examiner, Art Unit 1675
/STACEY N MACFARLANE/Examiner, Art Unit 1675