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/US2021/028029 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 20170174.5 on April 17, 2020. It is noted, however, that Applicant has not filed a certified copy of the 20170174.5 application in the instant application or in the parent application (PCT/US2021/028029) as is required by 37 CFR 1.55.
Election/Restriction
Applicant's election without traverse of Group I (Claims 1-2, 4-5, 7-10, 12-13, 25-26, and 28) in the reply filed on November 4, 2025 is acknowledged.
Claims 14-15, 19, 31, 35, 37, and 39 are withdrawn from further consideration pursuant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 4, 2025.
Claim Status
Claim listing filed on November 4, 2025 is pending. Claims 3, 6, 11, 16-18, 20-24, 27, 29-30, 32-34, 36, and 38 are canceled. Claims 13 and 28 are amended. Claims 14-15, 19, 31, 35, 37, and 39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions or species. Claims 1-2, 4-5, 7-10, 12-13, 25-26, and 28 are examined upon their merits.
Information Disclosure Statement
The information disclosure statements filed on 10/21/2022, 11/02/2022, 02/21/2023, and 11/04/2025 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:
The title recites “Fusion Proteins of CTL Antigens for Treating Melanoma.” However, based on the contents of the specification (e.g. page 14, lines 10-30), Examiner believes the title was intended to recite “CLT Antigens.”
Page 9, line 2 recites “Each of Figures 1-38” wherein “Figures 1-37” is correct.
Table 10 on page 69 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 is one hyperlink on page 34, four hyperlinks on page 46, one hyperlink on page 49, one hyperlink on page 50, two hyperlinks on page 53, one hyperlink on page 58, and one hyperlink on page 75. 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.
Claim Objections
Claims 13 and 26 are objected to because of the following informalities:
Claim 13 lists subclaims (i), (ii), and (iii) wherein all other claims list subclaims alphabetically as (a), (b), (c), etc. Please correct Claim 13 to list subclaims alphabetically ((a), (b), (c)) for consistency.
Claim 26 recites “optionally wherein vaccine further comprises” and should be corrected to “optionally wherein the vaccine further comprises.”
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, 4-5, 7-10, 13, 25-26, and 28 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.
Claims 1-2, 4-5, and 7-8 recite “a variant thereof” and “an immunogenic fragment.” Claims 9-10, 13, 25-26, and 28 are dependent on Claim 1 and do not further define the claimed variants and fragments. The specification defines that variants of polypeptide sequences of the fusion proteins 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 22, lines 18-22). “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 22, lines 23-26).
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, 4-5, 7-10, 13, 25-26, and 28 are rejected as being indefinite, because it is unclear what is encompassed by “variant thereof” and “immunogenic fragment.”
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Claim 10 recites “wherein the fusion protein comprises a peptide linker positioned immediately C-terminal to each antigenic polypeptide.” This claim language encompasses a fusion peptide that ends a with a peptide linker after the last antigenic polypeptide (as demonstrated in the screenshot of Fig. 67 below with a blue bracket on the C-terminal of the fusion protein). All of the fusion proteins taught by the specification (SEQ ID NOs: 76-79 as shown in Figs. 67-70, respectively) have an antigenic polypeptide at the C-terminal, not a peptide linker. Therefore, the language of Claim 10 is indefinite because it fails to distinctly claim the subject matter. Possible claim language to overcome the discrepancy is “wherein the fusion protein comprises a peptide linker positioned immediately C-terminal to each antigenic polypeptide except the C-terminal antigenic polypeptide, resulting in a fusion protein comprising peptide linkers between each antigenic polypeptide.”
Claim 13 recites “(ii) polypeptide sequences which are capable of enhancing an immune response.” This phrase is considered indefinite functional language because the features (the polypeptide sequences) are defined by what they do (capable of enhancing an immune response) rather than by what it is (MPEP § 2173.05(g)). The functional language recites a result obtained without any required structure. Further, Claim 13 recites “(iii) polypeptide sequences which are capable of providing strong CD4+ help to increase CD8+ T cell responses to antigen epitopes.” This phrase is also considered indefinite functional language because the features (the polypeptide sequences) are defined by what they do (capable of providing strong CD4+ help) rather than by what it is (MPEP § 2173.05(g)). “CD4+ help” is not defined in the specification in such a way that one of ordinary skill would understand its meaning. Additionally, “to increase CD8+ T cell responses to antigen epitopes” includes indefinite relative terminology, specifically the term “increase” (MPEP § 2173.05(b)). What is the threshold of “increase” (e.g. a 10% increase)? What is the increase relative to (e.g. T cell responses in the absence of the fusion protein)? Due to the indefinite functional language and relative terminology, the metes and bounds of the polypeptide sequences are indefinite, and Claim 13 is rejected.
Claim 28 recites “derivatives thereof.” There is no definition of “derivative” in the specification such that one of ordinary skill would understand clear boundaries of what is encompassed by derivatives of the listed immunostimulants. Further, Claim 28 recites “TLR4,” “TLR7,” and “TLR9” without defining the abbreviation. For the purpose of compact prosecution, “TLR” is interpreted as “toll-like receptor,” but appropriate correction is required. Claim 28 is rejected for the indefinite terms “derivatives” and “TLR.”
Note, “melanoma associated antigens” in Claim 13 is not indefinite because melanoma associated antigens were understood in the art prior to the time of filing as evidenced by Xiao et al. World J Gastroenterol 2004. Note, in Claim 25, “immunogenic” is interpreted as an inherent property of a pharmaceutical composition comprising the fusion protein according to claim 1 and a pharmaceutically acceptable carrier (MPEP § 2112.01). Note, Claim 26 recites “immunostimulants” which the specification defines using functional language (any substance that enhances or potentiates an immune response to an exogenous antigen – page 41, lines 16-17); 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. Similarly, “immunostimulatory oligonucleotides” in Claim 28 is not indefinite functional language because immunostimulatory oligonucleotides were understood in the art prior to filing (Shahbazi Table 1 and page 48).
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, 4-5, 7-10, 13, 25-26, and 28 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, 4-5, 7-10, 13, 25-26, and 28 are directed to a fusion protein comprising 6-8 antigenic polypeptides wherein the antigenic polypeptides can comprise a variant of a recited sequence, an immunogenic fragment of a recited sequence, or a variant of the immunogenic fragment. The specification defines that variants of polypeptide sequences of the fusion proteins include sequences having “a high degree of sequence identity thereto” (page 22, lines 18-22). 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 22, lines 23-26). 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 fusion proteins comprising antigenic polypeptides with 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 fusion proteins, 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 antigenic polypeptides comprising SEQ ID NOs: 1-8, respectively (page 14, lines 9-16). The specification further teaches four fusion proteins (SEQ ID NOs: 76-79) that comprise six to eight of the antigenic polypeptides or variants thereof (Figs. 67-70 and corresponding figure captions on pages 13-14). The fusion proteins comprise the full-length antigenic polypeptides comprising SEQ ID NOs: 1-8 with the following exceptions: SEQ ID NOs: 76, 77, 78, and 79 comprise a variant form of SEQ ID NO: 2 that lacks the first methionine residue (as evidenced by the sequence alignment below wherein SEQ ID NO: 2 is on the top line and SEQ ID NO: 76 is on the bottom line); and SEQ ID NO: 78 comprises a variant form of SEQ ID NO: 6 that lacks the first methionine residue. Other than these two variants of SEQ ID NOs: 2 and 6, the specification does not evaluate any other antigenic polypeptide variants or immunogenic fragments. Considering that the claimed variants and fragments can comprise any combination of substitutions, deletions, and insertions that can alter immunogenicity and function (specification page 24, lines 20-24), two variants each comprising one amino acid deletion do not adequately describe the variation of antigenic polypeptides claimed.
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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 fusion proteins comprising antigenic polypeptide variants and/or immunogenic fragments, 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, 4-5, 7-10, 13, 25-26, and 28 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, 4-5, 7-10, 13, 25-26, and 28 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 a fusion protein comprising antigenic polypeptides comprising SEQ ID NOs: 1-2, 4, and 6-8 (Claim 1), a fusion protein further comprising antigenic polypeptides comprising SEQ ID NOs: 3 and/or 5 (Claim 2), and fusion proteins comprising SEQ ID NOs: 76, 77, 78, or 79 (Claim 12); does not reasonably provide enablement for the genus of fusion proteins comprising antigenic polypeptides comprising variants and/or immunogenic fragments of the sequences thereof (Claims 1-2, 4-5, 7-10, 13, 25-26, and 28). 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 a genus of fusion proteins comprising 6-8 antigenic polypeptides wherein the antigenic polypeptides can comprise a variant of a recited sequence, an immunogenic fragment of a recited sequence, 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 fusion proteins comprising antigenic polypeptides 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 fusion proteins comprising antigenic polypeptides with substantial variation, yet the inventors have only disclosed eight antigenic polypeptides (SEQ ID NOs: 1-8) and two variants thereof (SEQ ID NOs: 2 and 6 with a deletion at residue 1 as evidenced in fusion proteins comprising SEQ ID NOs: 76-79).
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 antigenic polypeptides.
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 fusion proteins claimed. The specification provides no guidance or direction for structure that must be maintained such that the functional properties of the invention are preserved (antigenic polypeptides 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 antigenic polypeptides comprising SEQ ID NOs: 1-8, respectively (page 14, lines 9-16). The specification further teaches four fusion proteins (SEQ ID NOs: 76-79) that comprise six to eight of the antigenic polypeptides or variants thereof (Figs. 67-70 and corresponding figure captions on pages 13-14). The fusion proteins comprise the full-length antigenic polypeptides comprising SEQ ID NOs: 1-8 with the following exceptions: SEQ ID NOs: 76, 77, 78, and 79 comprise a variant form of SEQ ID NO: 2 that lacks the first methionine residue and SEQ ID NO: 78 comprises a variant form of SEQ ID NO: 6 that lacks the first methionine residue. Other than these two variants of SEQ ID NOs: 2 and 6, the specification does not evaluate any other antigenic polypeptide variants or immunogenic fragments.
Two antigenic polypeptide variants do not adequately represent the scope of antigenic polypeptide variants and immunogenic fragments that could encompass thousands of 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 antigenic polypeptides 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 fusion proteins comprising a representative number of antigenic polypeptide 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 fusion proteins claimed; therefore, Claims 1-2, 4-5, 7-10, 13, 25-26, and 28 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, 4-5, 7-8, 9-10, 25-26, and 28 are provisionally rejected on the ground of nonstatutory obvious-type double patenting as being unpatentable over claims 1-2, 4, and 9-10 of copending U.S. App. No. 18/046,670 in view of Shahbazi et al. J Med Microbiol Infec Dis 2016.
The instant 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 sequences have a specific orientation (Claims 4-5 and 7-8), wherein the antigenic polypeptides are separated by peptide linkers (Claims 9-10); an immunogenic pharmaceutical composition comprising the fusion protein and a pharmaceutically acceptable carrier (Claim 25); a vaccine composition comprising the fusion protein, a pharmaceutically acceptable carrier, and an immunostimulant (Claim 26); wherein the immunostimulant is an interferon (Claim 28).
The copending claims recite: an antigen pool wherein the different antigens are present as part of a fusion protein comprising two or more different antigens selected from SEQ ID NOs: 1-8 (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); 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). Note, copending SEQ ID NOs: 1-8 are 100% identical to instant SEQ ID NOs: 1-8, respectively.
The copending claims do not teach wherein the immunostimulant is specifically an interferon, but Shahbazi teaches that interferons are known to be immunostimulants (introduction paragraph 1). It would have been obvious to one of ordinary skill prior to the effective filing date of the claimed invention that an interferon could be used as a specific type of immunostimulant with a reasonable expectation of success. Further, changing the N- to C- terminal orientation of the recited antigens is an obvious variation of the same fusion protein. 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 in view of Shahbazi. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2. Claims 1-2, 4-5, 7-8, 13, 25-26, and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 77, 81, 83-84, and 93-97 of copending U.S. App. No. 19/062,913.
Instant claims 1-2, 4-5, 7-8, 25-26, and 28 are recited above. Claim 13 recites wherein the fusion protein is fused to a second polypeptide selected from a melanoma associated antigen (Claim 13).
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) wherein the immunostimulant is an interferon (Claim 84); a vector comprising a nucleic acid encoding a fusion protein comprising SEQ ID NOs: 1-4 (Claims 93-95); 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 and a melanoma associated antigen (Claim 96); 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.
A nucleic acid vector encoding a fusion protein reads on the fusion protein of the instant claims. The copending claims also teach that four or more antigens can be combined on one fusion protein. 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.
Allowable Subject Matter
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Further, a fusion protein comprising SEQ ID NOs: 1-2, 4, and 6-8 is free of the prior art.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH COOPER PATTERSON whose telephone number is (703)756-1991. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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/SARAH COOPER PATTERSON/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675