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 .
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
Elect 5 of ABP structures recited in claim 12 and 24 a)-ii).
Applicant is required, in reply to this action, to elect five species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claim(s) are generic: 12, 24, 120, and 122-133.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
The species of ABP lack unity of invention because the groups do not share the same or corresponding technical feature. Specifically, there is no shared combination of CDRs as demonstrated by the alignment of VH sequences below.
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During a telephone conversation with Jennifer Bachorik (Applicant’s representative) on November 3, 2025 a provisional election was made without traverse to prosecute the species of antigen-binding protein recited in claim 12 a), e), i), bb), and gg) (corresponding to 24 a), e), i), bb), and gg) of claim 24, respectively). No claims stand withdrawn. Affirmation of this election must be made by applicant in replying to this Office action. Previously elected Species B (see Restriction Requirement mailed May 28, 2024) relates to claim 12 a) and is free of the prior art. Searching and examination has been expanded to encompass the presently elected species of claim 12 e), i), bb), and gg).
Status of Claims
Claims 12, 24, 120, and 122-133 are currently pending.
WITHDRAWN OBJECTIONS and/or REJECTIONS
Applicant’s arguments filed September 8, 2025, with respect to:
Objection to claims 18 and 19,
Rejection of claims 12, 24, and 120 under 35 U.S.C. § 112(a) for lacking a written description (see Remarks on pg. 24 through the penultimate ¶ on pg. 26),
Rejection of claim 12 under 35 U.S.C. § 101 (pg. 27 in the last ¶ spanning pg. 28), and
All grounds of rejection under 35 U.S.C. § 102 (pgs. 28-31; Note well, although Jooss in US 2021/0147440 A1 discloses the sequences of the antigen binding protein of instant claim 12 in Table 3 on pg. 78, the provisional applications on which Jooss relies, ‘146 and ‘368, do not support said sequences. Therefore, the contents of Jooss relating to the instantly claimed antigen binding protein sequences are not available as prior art under 102(a)(2)).
have been fully considered and are persuasive. The aforementioned grounds of objection and/or rejection have been withdrawn.
Claim Interpretation
Claim 132 recites a YTE mutation that extends half-life. The art refers to YTE as a mutation with the amino acid substitutions M252Y, S254T, and T256E according to the EU index.1 The only isotype of antibody Fc containing the indicated native residues is IgG.2 Therefore, the broadest reasonable interpretation of an Fc comprising a YTE mutation, to those ordinarily skilled in the art, is an IgG Fc comprising the mutations M252Y, S254T, and T256E according to the EU numbering system.
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.
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.
Claims 12, 24, and 120 stand and newly added claims 122-133 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.
Applicant's arguments filed September 8, 2025 have been fully considered but they are not persuasive.
Applicant argues that claims 12 and 24 are not indefinite because 37 CFR § 1.821 (d) requires sequences to be accompanied by a SEQ ID NO. Applicant alleges that the rejection was on the basis that parentheses are used “to recite the term SEQ ID NO: 72” (see pg. 23 in the last ¶). However, the rejection was on the grounds that the limitations of SEQ ID NO: 72 are recited in parentheses which makes it unclear whether said sequence is an optional embodiment of HLA A*01:01 or whether HLA A*01:01 as claimed is limited to SEQ ID NO: 72. In no way was it explicitly or implicitly stated that claim 12 is indefinite for reciting the term “SEQ ID NO: 72” with the amino acids that it represents (see Office Action mailed March 7, 2025 at pg. 4 in the first ¶).
Claim 12 in lines 6-11 recites:
“the HLA Class I molecule is HLA subtype A*01:01 (reference sequence: MGSHSM… (SEQ ID NO: 72))”
For clarity, the rejection refers to the highlighted and underlined parentheses above. Examiner maintains the positions that claim 12 is indefinite because it is not clear whether the limitations of SEQ ID NO: 72 are optional or required of the claimed invention.
Suggested claim language to overcome the foregoing rejection under 112(b):
“the HLA Class I molecule is HLA subtype A*01:01 according to SEQ ID NO: 72”
Additionally, newly filed claims 122-133 are rejected by virtue of their dependency on claim 12.
The antigen-binding protein of claim 12 is recited as comprising a VH and a VL region. No known single-domain antibodies, as recited in claim 122, contain both a VH and VL. The metes and bounds of claim 122 are thus indefinite because it is unclear whether the antigen-binding protein (ABP) is limited to an ABP comprising VH and VL region, or whether each domain (VH or VL) may individually constitute a single-domain antibody binding to the HLA-peptide target in the absence of the other.
Furthermore, the metes and bounds of claim 122 are unclear regarding the alternative embodiments. Specifically, in line 3, claim 122 recites “and/or a single domain antibody or antigen binding fragment thereof”; it would be unclear to the skilled artisan whether “thereof” refers to the ABP, i.e. an antigen binding fragment of the ABP, or the single domain antibody. The different interpretations that a skilled artisan may arrive at are represented below.
The ABP comprises:
1) an Fv fragment,
2) a Fab fragment,
3) a Fa(ab’)2 fragment,
4) a Fab’ fragment,
5) an scFv fragment,
6) an scFv-Fc fragment, and/or
7) a single-domain antibody;
or
an antigen binding fragment thereof.
The ABP comprises:
1) an Fv fragment,
2) a Fab fragment,
3) a Fa(ab’)2 fragment,
4) a Fab’ fragment,
5) an scFv fragment,
6) an scFv-Fc fragment, and/or
7) a single-domain antibody or an antigen binding fragment thereof.
Claim 126 encompasses a “humanized” embodiment of the ABP of claim 12. “Humanized” antibodies are antibodies having CDRs of a species other than a human which are grafted into human framework regions. The VH and VL CDR sequences of claim 12 relate to G2 series antibody clones, which were generated using a SuperHuman 2.0 synthetic naïve scFv library (see specification in Example 19, particularly ¶’s [00957] through [00959]). The metes and bounds of a “humanized” ABP of claim 12 would be unclear to a person of ordinary skill because the CDRs of the ABP of claim 12 are human sequences. Some skilled artisans would argue that the scope of a “humanized” antibody having human CDR sequences encompasses grafting human CDRs into non-native human frameworks regions. Other skilled artisan would interpret a “humanized” antibody obtained using human CDR sequences as having the same scope as a “human” antibody. Still other skilled artisans would argue that the process of humanization is incompatible with CDRs that were obtained from human antibodies because human CDR sequences cannot become any more human. Therefore, claim 126 is indefinite.
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.
Claims 124 and 126 are 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.
Claim 12 requires that the ABP comprise a heavy chain variable region and light chain variable region, indicating that the minimum structure is an antigen-binding fragment of an immunoglobulin molecule. An “antibody” according to specification pg. 43 in ¶ [0020] includes a full immunoglobulin molecule and antigen-binding fragments. Since the VH and VL as required by claim 12 form the minimal structure of an antigen-binding fragment, the broadest reasonable interpretation of claim 12 is that the antigen binding protein comprises an “antibody,” i.e. full immunoglobulin or an antigen-binding fragment thereof. Therefore, claim 124 does not further limit the scope of claim 12 because it does no more than recite “antibody” and “antigen-binding fragment” which requires no further structures features beyond those inherent to the ABP of claim 12.
Claim 126 recites a “human” ABP of claim 12. The broadest reasonable interpretation of a “human antibody” is an “antibody originally obtained using human sequences and having the same binding properties.” In other words, the metes and bounds of a “human antibody” is an antibody having at least human CDR sequences. However, the sequences of the ABP according to claim 12 are necessarily human and result in the same binding property as the antibody from which they were obtained (see specification in Example 19, particularly ¶’s [00957] through [00959]). Therefore, a “human” ABP does not further narrow the scope of ABPs according to claim 12.
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.
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.
Claim 120 stands 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 alleviation / diminishing pathological consequences / decreasing the rate of progression / palliation of Kita Kyushu lung cancer antigen-1 (KK-LC-1) positive cervical cancer by administering an antibody with the VH and VL CDR1-3 sequences of clones listed in Tables 33 and Table 34, does not reasonably provide enablement for:
Prevention / prophylaxis of cancer by administering an antigen binding protein of claim 12.
Prevention / prophylaxis / alleviation / diminishing pathological consequences / decreasing the rate of progression / palliation of any cancer by administering any antigen binding protein of claim 12.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims complies with the enablement requirement of 35 U.S.C. § 112(a).
Applicant acknowledges Examiner’s findings that the art and specification only provides direction to treat patients having cervical cancer with HLA-A*01:01 complexed with NTDNNLAVY (Remarks pg. 26 in the last ¶ spanning pg. 27). Applicant states that they “respectfully disagree” without distinctly and specifically pointing out the supposed errors. Furthermore, Applicant has amended the claim without limiting to cervical cancer, rather the amendment limits claim 120 to treating a subject having a cancer “that expresses or is predicted to express the HLA-PEPTIDE target” (Remarks on pg. 27 in the first full ¶). Again, without explaining how the amendments render the claimed invention enabled in view of the Examiner’s Wands analysis, Applicant states that they believe “the amendments to claim 120 obviate the rejection.”
To predict whether a particular patient with cancer has the HLA-PEPTIDE target, the skilled artisan practicing the claimed invention would have to determine at least a) whether the subject has a HLA*01:01 haplotype and b) whether the cancer expresses KK-LC-1. As laid forth in the prima facie case, at the time of instant filing lung adenocarcinoma, gastric cancer, non-small cell lung cancer, papillomavirus induced cervical cancer, and triple negative breast cancer were known to express KK-LC-1 (see pg. 286 of the Office Action mailed on May 7, 2025). The full scope of cancers that express KK-LC-1 were not known at the time of instant filing (see Id. at pg. 27 in the last ¶ spanning pg. 28). Given that cancer treatment is highly unpredictable, the skilled artisan would not have had reasonable expectation that a particular cancer outside of those explicitly known in the art to express KK-LC-1 would express the HLA-PEPTIDE target. The instant specification fails to cure the deficits of the art (see Id. at pg. 28 in the last ¶ spanning pg. 29). Thus, the skilled artisan would not have been able to anticipate which cancer types, besides those known in the art, e.g. cervical cancer, could be tested for KK-LC-1 expression with any reasonable expectation of finding said expression. The amount of experimentation required to determine which cancers, besides those known in the art, express KK-LC-1 would have required a considerable amount of experimentation. Thus, even with the amendments to claim 120, it would have taken undue experimentation to practice the full scope of the claimed invention. The enabled scope for which support is provided in the specification has been determined to be treating a cervical cancer that expresses or is predicted to express the HLA-PEPTIDE target in a subject that has cervical cancer that expresses or is predicted to express the HLA-PEPTIDE target.
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 12, 24, and 120 stand and claims 122-128 and 130 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 15, 23, 24, 28, 31, 44, 70, 72, 75, 78, 79, 80, 84, 87, 90, 103, 106, 111, 197, 204, 207, and 212 of copending Application No. 18/018,400 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claims 122, 124, and 126 are taught by ‘440 on the same grounds previously stated. Particularly, the VH and VL sequences necessarily form at least an antigen-binding fragment, Fv and the sequences are inherently human. In line with In re Vogel G2 clones, including 1H11 clone sequences, were formatted into IgG or scFv for analysis ¶ [001151] on pg. 268, teaching the limitations of a monoclonal antibody as in instant claims 123 and 125. Table 47 on pg. 337 discloses a construct having clone 1H11 VH and VL sequences as well as a modified IgG1 Fc, as in instant claims 127, 128, and 130.
Claims 12 and 24 stand and claims 122-124, 126 and 130 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 15, and 325-348 of copending Application No. 17/426,627 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
‘627 claim 326 (i) recites an ABP comprising a VH of SEQ ID NO: 109723 and a VL of SEQ ID NO: 109758, relating to clone 1H11, in scFv format and CH2-CH3, i.e. Fc, as in instant claims 12, 24, 122-124, and, inherently, claim 126. Claim 342 teaches the Fc region is a variant, i.e. modified, Fc region as in instant claim 130.
Claims 12, 24, 120, 122-124, 125, 126, 129, 130, 131 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 15, and 325-348 of copending Application No. 17/426,627; as applied to claims 12, 24, 122-124, 126, and 130 above and further in view of Galluzi et al. 2012. OncoImmunology. 1(1):28-37.
See discussion above on ‘627 as applied to claims 12, 24, 122-124, 126, and 130.
While ‘627 teaches an ABP comprising modified Fc and a VL and VH in scFv format that binds to the HLA A*01:01-NTDNNLAVY comprising the sequences of clone 1H11, ‘627 does not teach a monoclonal antibody, a method of treating cancer, IgG1, or modified Fc with one or more mutations that extend half-life.
However, Galluzi teaches that monoclonal antibodies are an industry boon for treating cancer (see Abstract). Particularly, monoclonal antibodies are advantageous over polyclonal antibodies because they are more specific and less prone to contamination (see pg. 28 in the second col.). Monoclonal antibodies may also be altered to increase serum half-life “by favoring the binding to neonatal Fc receptor, which prevents IgG degradation.” (see pg. 29 in the first col.).
It would have been prima facie obvious to a person of ordinary skill to formulate the ABP of ‘627 as a monoclonal antibody, modify Fc to increase serum half-life, and use the antibodies for their intended purpose of treating cancer. Regarding formatting as a monoclonal and modifying to increase half-life, the skilled artisan would have been motivated because Galluzi teaches an advantage. See MPEP 2144 (II). Regarding using the antibody for treating cancer, the skilled artisan would have been motivated because of the art-recognized use of monoclonal antibodies for treating cancers when the antibody is directed to a tumor target as in the invention of ‘627. See MPEP 2144.07. In view of the level of skill and explicit teachings of the art the skilled artisan would have had a reasonable expectation of success in doing so. In combining the teachings of ‘627 and Galluzi, one would have arrived at the instantly claimed invention.
Claims 12, 24, 122-124, 126-128, and 129-132 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 15, and 325-348 of copending Application No. 17/426,627; as applied to claims 12, 24, 122-124, 126, and 130 above and further in view of Robbie et al. 2013. Antimicrobial Agents Chemother. 57(12):6147-6153.
See discussion above on ‘627 as applied to claims 12, 24, 122-124, 126, and 130.
While ‘627 teaches an ABP comprising modified Fc and a VL and VH in scFv format that binds to the HLA A*01:01-NTDNNLAVY comprising the sequences of clone 1H11, ‘627 does not teach a YTE mutation.
However, Robbie teaches a YTE mutation in IgG1 Fc extends serum half-life of antibodies, which is advantageous because “extending half-life would reduce the required dosing frequency” for antibodies. (see, e.g., Abstract, pg. 6147 in the first ¶ of the first col., and Table 2 on pg. 6150).
It would have been prima facie obvious to the skilled artisan to introduce a YTE mutation to an IgG1 Fc region to the antigen binding protein of ‘627. The person having ordinary skill would have been motivated by the advantage that YTE-induced half-life extension taught by Robbie. See MPEP 2144 (II). In view of the level of skill in the art and explicit teachings one would have had a reasonable expectation of success in doing so. In combining the teachings of ‘627 on an antigen binding protein and Robbie on extending half-life with a YTE mutation in IgG1, one would have arrived at the instantly claimed invention.
Claims 12 and 24 stand and claims 122, 124, and 126 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 97, 98, 100, 103, 104, 105, 111,112, 113, 116, 119, 151, 163, 164, 165, 167, 168, 173, 175, 179, and 180 of copending Application No. 18/065,223 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 122, 124, and 126 are taught by the previously cited VH and VL sequences (see Office Action mailed on March 7, 2025 at pg. 51).
Claim 12, 24, 122-124, 126-128, and 130 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 10-15, 17, 32, 37, 45, and 47-51 of copending Application No. 17/820,434 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
‘434 claim 10 and 13 recite an antigen binding protein that binds HLA-A*01:01-NTDNNLAVY having the CDRs or VH and VL of clone 2C06, teaching the limitations of instant claims 12e) and 24e). ‘434 claim17 teaches an antigen binding fragment scFv-Fc as in instant claims 122, 123, and 124. Instant claim 126 in inherently taught by ‘434’s 2C06 sequences. Claim 49 of ‘434 teaches IgG1 as in instant claims 127 and 128. Claim 50 of ‘434 teaches a variant, i.e. modified, Fc as in instant claim 130.
This is a provisional nonstatutory double patenting rejection.
Claims 12, 24, and 122-130 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 10-15, 17, 32, 37, 45, and 47-51 of copending Application No. 17/820,434; as applied to claims 12, 24, 122-124, 126-128, and 130 above and further in view of Galluzi et al. 2012. OncoImmunology. 1(1):28-37.
See discussion above on ‘434 as applied to claims 12, 24, 122-124, 126-128, and 130.
While ‘434 teaches an ABP comprising modified Fc and a VL and VH in scFv format that binds to the HLA A*01:01-NTDNNLAVY comprising the sequences of clone 2C06, ‘434 does not teach a monoclonal antibody, a method of treating cancer, IgG1, or modified Fc with one or more mutations that extend half-life.
However, Galluzi teaches that monoclonal antibodies are an industry boon for treating cancer (see Abstract). Particularly, monoclonal antibodies are advantageous over polyclonal antibodies because they are more specific and less prone to contamination (see pg. 28 in the second col.). Monoclonal antibodies may also be altered to increase serum half-life “by favoring the binding to neonatal Fc receptor, which prevents IgG degradation.” (see pg. 29 in the first col.).
It would have been prima facie obvious to a person of ordinary skill to formulate the ABP of ‘434 as a monoclonal antibody, modify Fc to increase serum half-life, and use the antibodies for their intended purpose of treating cancer. Regarding formatting as a monoclonal and modifying to increase half-life, the skilled artisan would have been motivated because Galluzi teaches an advantage. See MPEP 2144 (II). Regarding using the antibody for treating cancer, the skilled artisan would have been motivated because of the art-recognized use of monoclonal antibodies for treating cancers when the antibody is directed to a tumor target as in the invention of ‘434. See MPEP 2144.07. In view of the level of skill and explicit teachings of the art the skilled artisan would have had a reasonable expectation of success in doing so. In combining the teachings of ‘434 and Galluzi, one would have arrived at the instantly claimed invention.
Claims 12, 24, 122-124, 126-132 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 10-15, 17, 32, 37, 45, and 47-51 of copending Application No. 17/820,434; as applied to claims 12, 24, 122-124, 126-128, and 130 above and further in view of Robbie et al. 2013. Antimicrobial Agents Chemother. 57(12):6147-6153.
See discussion above on ‘434 as applied to claims 12, 24, 122-124, 126-128, and 130.
While ‘434 teaches an ABP comprising modified Fc and a VL and VH in scFv format that binds to the HLA A*01:01-NTDNNLAVY comprising the sequences of clone 1H11, ‘434 does not teach a YTE mutation.
However, Robbie teaches a YTE mutation in IgG1 Fc extends serum half-life of antibodies, which is advantageous because “extending half-life would reduce the required dosing frequency” for antibodies. (see, e.g., Abstract, pg. 6147 in the first ¶ of the first col., and Table 2 on pg. 6150).
It would have been prima facie obvious to the skilled artisan to introduce a YTE mutation to an IgG1 Fc region to the antigen binding protein of ‘434. The person having ordinary skill would have been motivated by the advantage that YTE-induced half-life extension taught by Robbie. See MPEP 2144 (II). In view of the level of skill in the art and explicit teachings one would have had a reasonable expectation of success in doing so. In combining the teachings of ‘434 on an antigen binding protein and Robbie on extending half-life with a YTE mutation in IgG1, one would have arrived at the instantly claimed invention.
Applicant's arguments filed September 8, 2025 have been fully considered but they are not persuasive.
Applicant’s request that the provisional ODP rejection be held in abeyance until allowable subject matter is indicated is acknowledged, but cannot be granted. Obviousness type double patenting rejections, whether provisional or not, cannot be held in abeyance. A double patenting rejection can be overcome, e.g., by a convincing rebuttal of the merits of the rejection, by amending the claims such that they are no longer anticipated and/or rendered obvious by the reference claims or by filing a proper terminal disclaimer.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANNA K SWARTWOUT whose telephone number is (703)756-4672. The examiner can normally be reached Monday-Friday 8-5.
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/B.K.S./Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644
1 Robbie et al. 2013. Antimicrobial Agents Chemother. 57(12): 6147-6153. See Abstract.
2 Kabat et al. 1991. Sequences of Proteins of Immunological Interest Vol. I. 5th Edition. pp. 670-699.