DETAILED ACTION
Claims 111-130 are pending in the instant application and being examined on the merit.
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 .
Information Disclosure Statement
The information disclosure statement filed 11/2/2023 fails to 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. Specifically, reference B58 (WO2020227515A1, Voyager Therapeutics, Inc.) is missing a legible copy of the cited foreign patent document. Furthermore, reference C14 (Jansen et al, 2019) is missing a legible copy of the cited non-patent literature publication. The Examiner would also like to note that the following references have duplicate copies uploaded: B35, B47, B40 and C23. It has been placed in the application file, but the information referred to therein has not been considered.
Drawings
The drawings are objected to because Figures 127A and B are missing legends that depict which symbol represents which group/clone in the graph. 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.
Specification
The disclosure is objected to because of the following informalities:
“engineered” should read “engineer” (page 249, paragraph [01556]).
Appropriate correction is required.
Claim Objections
Claim 111 is objected to because of the following informalities: Claim 111, part a) is followed by a period. Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See MPEP §608.01(m).
Claim 112 is objected to because of the following informalities: “PD-L3” should read “PD-L1”.
Appropriate correction is required.
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 111-119 and 122-130 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..
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or it may be satisfied by the disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. “Functional” terminology may be used “when the art has established a correlation between structure and function” but “merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing one has invented a genus and not just a species. Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 598 F3d 1336, 94 USPQ2d 1161, 1171 (Fed Cir. 2010).
Claimed Invention
Instant claims 111-119 and 122-127, are drawn to a multispecific antibody comprising:
A CD28 antigen binding domain comprising a first variable heavy domain (VH1) having at least 90% identity to the amino acid sequence SEQ ID NO:3380 and a first variable light domain (VL1) having at least 90% identity to the amino acid sequence SEQ ID NO:2452;
A PD-L2 antigen binding domain comprising a second variable heavy domain (VH2) having at least 90% identity to the amino acid sequence SEQ ID NO:3319 and a second variable light domain (VL2) having at least 90% identity to the amino acid sequence SEQ ID NO:2452; and
A PD-L1 antigen binding domain comprising a third variable heavy domain (VH3) having at least 90% identity to the amino acid sequence SEQ ID NO:3251 and a third variable light domain (VL3) having at least 90% identity to the amino acid sequence SEQ ID NO:2452.
Instant claim 128 is drawn to a composition comprising a CD28 antigen binding domain, wherein the CD28 binding domain comprises 1) a variable heavy domain having at least 90% sequence identity to a variable heavy domain sequence listed in figure 163, and 2) a variable light domain having at least 90% sequence identity to a variable light domain sequence listed in figures 35 and 37, or SEQ ID NO:3239.
Instant claim 129 is drawn to a composition comprising a PD-L1 antigen binding domain, wherein the PD-L1 binding domain comprises 1) a variable heavy domain having at least 90% sequence identity to a variable heavy domain sequence listed in figure 161, and 2) a variable light domain having at least 90% sequence identity to a variable light domain comprising amino acid sequence SEQ ID NO:3239.
Instant claim 130 is drawn to a composition comprising a PD-L2 antigen binding domain, wherein the PD-L2 binding domain comprises 1) a variable heavy domain having at least 90% sequence identity to a variable heavy domain sequence listed in figure 162, and 2) a variable light domain having at least 90% sequence identity to a variable light domain comprising amino acid sequence SEQ ID NO:3239.
Breadth of Claims
The invention as disclosed in claims 111-119 and 122-127 recite a multispecific antibody that binds to CD28 comprising amino acid sequences SEQ ID NO:3380 and 2452, PD-L2 comprising amino acid sequences SEQ ID NO:3319 and 2452, and PD-L1 comprising amino acid sequences SEQ ID NO:3251 and 2452. The claims encompass a genus of heavy and light chain variable regions comprising variability (e.g., 90% identical) in both the heavy and light chain variable regions which are claimed as having the function of specifically binding to CD28, PD-L2 or PD-L1 antigen. This means that the variability in sequence identity can also occur in the CDRs, the domains that are critical for the antibody binding to its target, which one of ordinary skill in the art would understand to result in unpredictable binding characteristics with no reasonable expectation of maintaining CD28, PD-L2, or PD-L1 antigen binding. Additionally, the instant disclosure does not provide an adequate number of species of the claimed genus nor does the disclosure provide a structure-function correlation that would allow for a person of ordinary skill in the art to envision what variation can occur to the light and heavy chains, particularly in the CDR regions, such that the obtained structure would result in the claimed functions.
The invention as disclosed in claims 128-130 recite a composition comprising an antigen binding domain wherein the antigen is CD28, PD-L2, or PD-L1. The claims encompass a genus of heavy and light chain variable regions comprising variability (e.g., 90% identical) in both the heavy and light chain variable regions which are claimed as having the function of specifically binding to CD28, PD-L2 or PD-L1 antigen. This means that the variability in sequence identity can also occur in the CDRs, the domains that are critical for the antibody binding to its target, which one of ordinary skill in the art would understand to result in unpredictable binding characteristics with no reasonable expectation of maintaining CD28, PD-L2, or PD-L1 antigen binding. Additionally, the instant disclosure does not provide an adequate number of species of the claimed genus nor does the disclosure provide a structure-function correlation that would allow for a person of ordinary skill in the art to envision what variation can occur to the light and heavy chains, particularly in the CDR regions, such that the obtained structure would result in the claimed functions.
Scope of Disclosed Species
The anti-CD28, PD-L1 and PD-L2 multispecific antibodies or compositions in the Applicant disclosure (e.g. see figures 156-160) represent the anti-CD28, anti-PD-L1 and anti-PD-L2 multispecific antibodies or compositions that the applicant was in possession of at the time of filing. Instant claims 112-119 and 122-127 incorporate the entire scope of instant claim 111, and the added limitation disclosed in these claims do not cure the underlying lack of support for the variation that can occur in the light and heavy chains, particularly in the CDR regions.
State of the Prior Art
At the time of filing, antibody functionality were known to depend on the entire structure, particularly a full complement of six CDRs. It is understood by one of ordinary skill in the art that mutation to CDRs is unpredictable and that each construct requires function testing (Sela-Culang et al, Fron. Immuno., 2013, 4(302): 1-13; hereinafter Sela-Culang). Sela-Culang reviews the structural basis of antibody-antigen recognition in the state of the art. Naturally occurring antibodies have six hypervariable loops are commonly termed complementary determining regions (CDRs) and are widely assumed to be responsible for antigen recognition (page 1, Abstract; page 3, “The Role of CDRs and their Definition” section). A person of ordinary skill in the art would understand that although the above basics of antibody-antigen binding are known, the specifics of antibody structure (e.g., within the CDRs) that underlie the antigen recognition are not well characterized (page 1, “The Motivations for, and Applications of, the Study of Ab-Ag Recognition” Section).
Further, Herold (Herold et al, Nature Scientific Reports, 2017, 7(12276):1-17; hereinafter Herold) teaches that it should be emphasized that there is no correlation between experimentally determined change in antibody binding affinity and a given mutation and additionally that no such correlation is expected, because antigen binding is affected by each CDR loop differently and changes thereto can, in principle, affect antigen binding affinity in an unpredictable way (page 14, paragraph 2). Further, Herold asserts that multiple determinants regulate antigen affinity and the interactions with CDRs are complex ( page 14, paragraph 3).
At the time of filing, Hui teaches that programmed cell death-1 (PD-1) is a coinhibitory receptor wherein PD-1 binds to two ligands, PD-L1 and PD-L2, is expressed by a variety of immune and nonimmune cells, and suppresses T cell activation, which make it an important cancer immunotherapy target (page 1428, Abstract; Hui et al, Science, 2017, 355:1428-1433, IDS entered 11/2/2023; hereinafter Hui). Hui additionally teaches that CD28 is the most sensitive target of PD-1-activated Shp2 compared to TCRs (page 1430, left panel, second paragraph; Fig. 2). Kamphorst teaches that CD28 is required for PD-1 targeted therapies to kill cancer cells efficiently and eliminate chronic viral infections in mouse models (page 1423, right column, second paragraph; Fig. 1; Kamphorst et al, Science, 2017, 355: 1423-1427, IDS entered on 11/2/2023; hereinafter Kamphorst). Furthermore, Kamphorst teaches that lung cancer patients who responded to PD-1 therapy had more CD28+ T cells, demonstrating that CD28 costimulation is required for CD8 T cell rescue and suggests an important role for the CD28/B7 pathway in PD-1 therapy of cancer patients (page 1423, Abstract).
Antibodies targeting PD-L1, PD-L2 and/or CD28 were disclosed in various studies at the time of filing. Zeng teaches a PD-L1 x CD28 bispecific antibody that conditionally costimulate CD28 only in the presence of PD-L1 and TCR engagement, wherein since PD-1/PD-L1 signaling has been shown to directly inhibit CD28 costimulation, this bispecific antibody can promote CD28 costimulation while simultaneously preventing suppression of the same signal (“Background” section; Zeng et al, Journal for ImmunoTherapy of Cancer, 2021, “Abstract 698 PD-L1 targeted CD28 costimulatory bispecific antibodies enhance T cell activation in solid tumors”; hereinafter Zeng). Zeng further teaches that the PD-L1 x CD28 bispecific antibody 1) enhanced T cell degranulation, cytokine secretion, and cancer cell cytotoxicity in concert with CD3 stimulation only in the presence of PD-L1; 2) enhanced proliferation of CMV+ T cells recognizing cancer cells loaded CMV-pp65-derived peptide; and 3) inhibited tumor growth significantly greater than an anti-PD-L1 antibody alone in hCD28 mice inoculated with MC38 tumors expressing hPD-L1 (“Results” section). Ghiotto teaches differential molecular mechanisms of interaction of PD-L1 and PD-L2 with PD-1, and suggests possible new approach for the therapy of chronic infection, cancer and transplantation by generating PD-1, PD-L1, and PD-L2 monoclonal antibodies for flow cytometry and functional analysis (page 651, Abstract; page 652, left column, fifth paragraph; Ghiotto et al, International Immunology, 2010, 22(8):651-660). Therefore, the prior art demonstrates that the binding of CD28, PD-L1, and PD-L2 is possible by various anti-CD28, anti-PD-L1, and/or anti-PD-L2 antibodies. However, the prior art does not teach a PD-L2 x CD28 bispecific antibody or a PD-L1, PD-L2, and CD28 trispecific or multispecific antibody at the time of filing. Furthermore, the prior art does not teach a known structure activity relationship for HCDR1-3 and LCDR1-3 in anti-CD28, anti-PD-L1, and anti-PD-L2 multispecific antibody that would allow prediction of CDR residues that specifically bind to CD28, PD-L1 and PD-L2 antigens.
Thus, making changes to the CDR sequence of an antibody sequence is a highly unpredictable process and one skilled in the art could not a priori make any predications regarding such mutations with any reasonable expectation of success nor envisage the breadth of structurally unrelated CDR combinations that would still possess the required function(s).
Conclusion
As indicated by the art, a full complement of 6 CDRs are required for antigen binding and one cannot predict which CDR residues may be changed and still result in a multispecific antibody or a composition that binds CD28, PD-L1, and/or PD-L2. Written description can be met if the claims recite the minimal structure that is needed to perform the function recited in the claims. Above, the art indicates that the 6 CDRs in an antibody antigen-binding domain are the minimal structure that binds to a target antigen. Specifically, Applicant claims 111, and 128-130 would need to recite the 6 CDRs in the antibody that bind antigens CD28, PD-L1, and/or PD-L2, without variability in the sequences thereof.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 122 is 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.
Instant claim 122 recites the limitation "a second polynucleotide encoding the second monomer of claim 2" in part b) and “a third polynucleotide encoding the first, second, and third common light chains of claim 2” in part c). There is insufficient antecedent basis for this limitation in the claim, since claim 2 is a cancelled claim. Therefore, claim 2 is indefinite as being incomplete by its dependence on cancelled claim 2. See MPEP 608.01(n).
Claims 128-130 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, because 35 U.S.C. 112(b) and 35 U.S.C. 112 (pre-AIA ), second paragraph, require claims to particularly point-out and distinctly claim subject matter. The instant claims attempt to incorporate by reference to a specific table or figure; however, such incorporation is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. In the instant case, there is a practical way to define the invention in words. Incorporation by reference is a necessity doctrine, not for applicant' s convenience. See MPEP 2173.05(s).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 122 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Because claim 122 depends from a cancelled claim, the claim fails to incorporate by reference all the limitations of the claim to which it refers. Similarly, because of the dependency upon cancelled claim 2, claim 122 fails to specify further limitation. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
For the purpose of expedited prosecution, claim 122 is interpreted to depend from claim 112.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 128 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Desjarlais et al (US Patent No. 11,919,958B2, IDS entered 11/2/2023; hereinafter Desjarlais).
Regarding instant claim 128, Desjarlais teaches novel anti-CD28 compositions, including anti-CD28 x anti-TAA (e.g. anti-CD28 x anti-B7H3) antibodies and methods of using such antibodies, for the treatment of cancers (page 127, column 1, fifth paragraph). Desjarlais additionally teaches a synthetic polypeptide comprising the CD28 binding domain (described as “1A7[CD28])” (page 151, column 49, third and fourth paragraphs), SEQ ID NO:1199, wherein SEQ ID NO:1199 is a variable heavy domain (1A7 [CD28]_H1.42) and is identical to instant SEQ ID NO:3373 described in instant application as 1A7[CD28]_H1.122 (page 153, column 53, second paragraph; Claim 2; Described in “Sequence Listing”). Furthermore, Desjarlais teaches a synthetic polypeptide comprising SEQ ID NO:932 (described as the 2E4A3.189[B7H3]_H1L1 Variable light (vl) domain), wherein SEQ ID NO:932 is identical to instant SEQ ID NO:3239 (page 132, column 12, second paragraph; page 165, column 78, first paragraph; Described in “Sequence Listing”).
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.
Claim 128 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 16 of US Patent No. 11,919,958 B2 (Desjarlais et al; hereinafter Desjarlais ‘958).
Regarding instant claim 128, Desjarlais ‘958 teaches a heterodimeric antibody comprising a CD28 binding domain, wherein the CD28 binding domain comprises amino acid sequence SEQ ID NO:1199 (claims 2 and 16), wherein SEQ ID NO:1199 is identical to instant SEQ ID NO:3373 of instant claim 128. Desjarlais ‘958 additionally teaches novel anti-CD28 compositions, including anti-CD28 x anti-TAA (e.g. anti-CD28 x anti-B7H3) antibodies and methods of using such antibodies, for the treatment of cancers (Specification page 127, column 1, fifth paragraph). Desjarlais ‘958 further teaches a synthetic polypeptide comprising SEQ ID NO:932, wherein SEQ ID NO:932 is identical to instant SEQ ID NO:3239 of instant claim 128 (Specification page 132, column 12, second paragraph; page 165, column 78, first paragraph). Therefore, although the claims at issue are not identical, the instant claims are not patentably distinct from the issued claims.
Claim 128 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-14, 16, 28, 44, and 57 of US PGPUB No. 20220098306 A1 (Desjarlais et al, Priority to 8/19/2020; hereinafter Desjarlais ‘306). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim 128, Desjarlais ‘306 claims 1-3 teach a heterodimeric antibody comprising two monomers and a common light chain wherein one of the antigen binding domains binds to human CD28. Claims 5-14 of Desjarlais ‘306 teach the VH2 domain of the heterodimeric antibody comprising amino acid sequence SEQ ID NO:1199 (identical to instant SEQ ID NO:3373 of instant claim 128), and describe the variant Fc domains that comprise the first and second Fc domains of the heterodimeric antibody. Claims 16, 28, 44, and 57 of Desjarlais ‘306 teach the structural features of the heterodimeric antibody comprising two antigen binding domains, one of which binds human CD28. Desjarlais ‘306 additionally teaches novel anti-CD28 compositions, including anti-CD28 x anti-TAA (e.g. anti-CD28 x anti-B7H3) antibodies and methods of using such antibodies, for the treatment of cancers (Specification page 112, paragraph [0005]). Furthermore, Desjarlais ‘306 teaches a synthetic polypeptide comprising SEQ ID NO:932, wherein SEQ ID NO:932 is identical to instant SEQ ID NO:3239 of instant claim 128 (Specification page 118, paragraph [0061]; page 152, paragraph [0414]). Therefore, although the claims at issue are not identical, the instant claims are not patentably distinct from the issued claims.
Allowable Subject Matter
Claims 120 and 121 are 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.
Conclusion
No claims are allowed.
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/J.H./Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643