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
Applicant’s election of Species A (a single and specific anti-B7-H4 antibody, PR002408, comprising the LCDR1-3 of SEQ ID NOs: 47, 54, and 67; HCDR1-3 of SEQ ID NOs: 9, 24, and 35; VH of SEQ ID NOs: 81; VL of SEQ ID NO: 90; light chain of SEQ ID NO: 114; heavy chain of SEQ ID NO: 100) and Species B (a single and specific anti-CD3 binding domain, PR000627, comprising the LCDR1-3 of SEQ ID NOs: 46, 53, and 63; HCDR1-3 of SEQ ID NOs: 8, 20, and 34; VL of SEQ ID NO: 86; and VH of SEQ ID NO: 76) in the reply filed on October 14, 2025 is acknowledged. The examined species of first, second, and third polypeptide pertaining to the elected species is that of SEQ ID NO: 114, 121, and 119, respectively. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). In an explicit statement stating whether the election was made with or without traverse, it is unclear whether the description of certain non-elected species relating to the elected species is intended to traverse the grounds of the restriction requirement.
The argument is moot because, in light of Examiner’s search, examination has been extended to encompass all non-elected species.
The elected species is free of the prior art insofar as the claims are interpreted as set forth in Claim Rejections under 35 U.S.C. 112(b) below. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement among Species A, as set forth in the Office action mailed on 8/14/2025, is hereby withdrawn and all nonelected species are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Status of Claims
Claims 1, 3-7, and 23-36 are currently pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 1, 3-7, and 23-36 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, 3, 4, and 5 recite a B7H4-targeting antibody or “variant thereof.” The term “variant” is not defined in the specification and the person having ordinary skill would have had no direction as to the degree of amino acid similarity to which an antibody variant has with the recited sequences. Moreover, it would be unclear whether the scope of a “variant” encompasses only antibodies with proteinogenic amino acids, or whether the scope encompasses unnatural, synthetic, or non-proteinogenic amino acids. Moreover, some skilled artisans would argue that a variant as claimed still requires all 6 of one of the sets of amino acid CDR sequence, while other skilled artisans would argue that the scope of a “variant” includes substitutions or other alterations to the recited CDR sequences. Under the latter interpretations, i.e. insofar as one may interpret the variant as encompassing antibodies with unnatural, synthetic, or non-proteinogenic amino acids and/or having substations or alterations in the recited CDR sequences, the claimed would be rejectable under a written description and/or enablement rejection under 35 U.S.C. 112(a). Note well, insofar as claim 6 recites “the antibody according to claim 5”, claim 6 is interpreted as further limiting to only an antibody and excludes an antibody variant.
Additionally, the sequences of CDRs, VH / VL, heavy chain / light chain, and first / second / third polypeptide are recited in claims 1, 3, 6, 24, 25, 26, 27, and 28 as, e.g., “a [CDR] with amino acid sequences as set forth in SEQ ID NO: [X].” Some skilled artisan would argue that the minimum required boundaries from each recited SEQ ID NO: are at least two adjacent peptides within each SEQ ID NO:. However, other skilled artisan would argue that the scope of the antibodies requires all amino acids of each SEQ ID NO: in addition to any amino acids joined at the N- and/or C-terminus. Suggested language includes, e.g., “the light chain variable region comprises a LCDR1, LCDR2, and LCDR3 comprising SEQ ID NO: 47, 54, and 64, respectively…” Such language is suggested for each sequence description of all VH / VL, heavy chain / light chain, and first / second / third polypeptide including the heavy chain CDRs, not just recited in claims 1, 3, 6, 24, 25, 26, 27, and 28.
Moreover, the use of semicolons and new paragraphs in the Markush group listing of light and heavy chain elements in claims 1, 3, 4, 6, 24, and 25, the listing of protein functional region B and A in claims 26 and 27, and the listing of first, second, and third polypeptides of claim 28 renders interpretation of the claims unclear. For example, in claim 1 some skilled artisan would argue that each new paragraph indicates a group of 6 CDRs which should be interpreted as required altogether. However, other skilled artisan would argue that the use of the semicolon within the paragraph in addition to at the end of the paragraph separating sets of 6 CDRs in combination with the coordinating conjugation of “or” in line 23 indicates that the interpretation of the claim should encompass each set of three (either light or heavy chain CDRs) as an individual member of the group, thus the anti-B7H4 does not require all 6 heavy chain CDRs of each paragraph section.
A similar diversity of interpretations applies to the Markush groups of claims 3, 4, 6, 24, 25, 26, 27, and 28 which all use semicolons between elements which some skilled artisan would interpret as being required together while other would interpret as being alliterative / optional embodiments.
Semicolons are used to either indicate a) a separation between members of list wherein each member of the list comprises multiple commas or b) to express an independent clause within the same sentence without the use of coordinating conjunction.
The scope could, thus, be clarified by use a comma and the phrase “and” in place of a semicolon within each paragraph of the list. For example:
Lines 4-7 of claim 1 could be expressed as “the light chain variable region…. 67, respectively, and the heavy chain…. 35, respectively;”
Lines 3-5 of claim 3 could be expressed as “the light chain variable region…. SEQ ID NO: 90, and the heavy chain variable region… 81;”
Lines 3-4 of claim 6 could be expressed as “the heavy chain…. SEQ ID NO: 100, and the light chain…. 114;”
Lines 3-6 of claim 24 could be expressed as “wherein the light chain…. 46, 53 and 63, respectively, and the heavy chain variable…. 8, 20 and 34, respectively;”
Note well, this is not an all-encompassing listing of each instance of the issue.
To advance prosecution on the merits, the claims are examined with the scope of an anti-B7H4 antibody requiring all amino acid sequences recited in a set of 6 SEQ ID NOs: for the 6 CDRs. Additionally, the claims are examined as requiring all elements recited within a single paragraph of each Markush grouping.
The alternative embodiments of claims 24 are examined as a) a LCDR1-3 comprising SEQ ID NOs: 46, 53 and 63 AND a HCDR1-3 comprising SEQ ID NOs: 8, 20 and 34; OR b) a LCDR1-3 comprising SEQ ID NOs: 46, 53 and 63 AND a HCDR1-3 comprising SEQ ID NOs: 10, 20 and 34.
The alternative embodiments of claim 25 are examined as a) a light chain comprising SEQ ID NO: 86 AND a heavy chain comprising SEQ ID NO: 76; OR b) a light chain comprising SEQ ID NO: 86 AND a heavy chain comprising SEQ ID NO: 78; OR c) a light chain comprising SEQ ID NO: 86 AND a heavy chain comprising SEQ ID NO: 84.
Claims 7, 23 and 29-36 are additionally rejected by virtue of their dependency on claim 1.
Claim 5 recites “a monoclonal or polyclonal antibody prepared from an antibody as above.” The use of “prepared from” indicates a product-by-process limitation, wherein the structure of the monoclonal or polyclonal antibody requires a structure “from an antibody as above.” However, the use of “as above” renders the limitations of the claim indefinite because different skilled artisan would arrive at different interpretations of the claim scope. Some skilled artisan would interpret “as above” as referring to the preamble, i.e. the product-by-process limitations further limits the preamble to an antibody according to claim 1 and excludes variants. Other skilled artisans would argue that “as above” refers to any of the preceding claims, in which case it would be unclear to the skilled artisan whether the claim is intended to be in multiple dependent form.
For the purpose of applying art, the claim is examined as an antibody according to claim 1 which is monoclonal or polyclonal.
Claim 35 recites “treatment and/or prevention” of a cancer. The scope of treating and preventing cancer is unclear because some skilled artisan would argue that if cancer truly has been prevented, then there would nothing to treat. Other skilled artisan would argue that “treating and preventing cancer” is limited to treating a patient for cancer (i.e. inducing remission) and preventing relapse.
To apply art, the latter interpretation is adopted.
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 34 is 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 34 recites that the pharmaceutically acceptable carrier of the claimed composition is an optional element. Without the carrier being required, the claim fails to further limit the scope of the antibody of claim 1 because the antibody is a pharmaceutical and a composition of matter. Therefore, the preamble, without more, does not place further limitations upon the structures recited in claim 1.
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.
Claims 35 and 36 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 method for the treatment of a cancer wherein the cancer is a B7H4 positive tumor, does not reasonably provide enablement for a method for the prevention of a cancer wherein the cancer is a B7H4 positive tumor. 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.
“A specification may call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of the invention and the underlying art. Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023) (citing Minerals Separation Ltd. v. Hyde, 242 U.S. 261, 270-71 (1916)).” (MPEP 2164.01). In the instant case, the nature of preventing cancer with an anti-B7H4 antibody in subjects who may acquire cancer requires the ability to anticipate which subjects will ultimately develop cancer.
Cancer is a highly heterogenous disease and no one person’s cancer is the same as another’s. The etiology of each cancer is complicated and poorly understood, and as a consequence the skilled artisan is generally unable to say in advance who will eventually develop cancer. Many potential factors have been hypothesized to cause a person to be at risk of, e.g., a brain tumor, only to be shown to have no predictive value in subsequent work (see, e.g., McKinney. J Neurol Neurosurg Psychiatry. 2004. 75(Suppl II):ii12–ii17, at pages ii15-16, cited herewith).
Hippisley-Cox and Coupland developed algorithms for predicting the risk of developing future cancer over a 10-year period with 11 different types of cancer using data on risk factors reported in patient’s electronic records (Hippisley-Cox and Coupland. 2015. BMJ Open. 5:e007825, cited herewith; see Introduction on pg. 2). Risk factors included general factors such as BMI, smoking status, alcohol use, as well as cancer-type specific factors including family history (pg. 3, left col). Even in the top 10% of women at the highest risk of cancer, the best performing algorithm, which compared to the literature had a “very good” performance, only had a sensitivity of 67% (Abstract, pg. 15, left col., and pg. 21, left col.).
While cancer prediction and prevention have been a long-sought after goal, the aforementioned art indicates a high level of unpredictability with respect to identifying whether an individual will develop cancer. Moreover, the use of anti-B7H4 in prevention of cancer has not been investigated.
As long as the specification discloses at least one method for making and using the claimed invention that bears a reasonable correlation to the entire scope of the claim, then the enablement requirement of 35 U.S.C. 112 is satisfied. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). (MPEP 2164.01(b)).
In Examples 3 and 16, the anti-B7H4 antibody was shown to kill tumor cells in vitro. In Examples 12 and 17, Applicant shows that the anti-B7H4 administered to mice already having an established tumor reduces said tumor’s volume and therapeutically treats the cancer. Notably, the instant specification does not provide any working examples on preventing B7H4 positive tumors, nor does it provide any further direction on how to identify whether a subject would develop a B7H4 positive tumor and benefit from preventive administration of anti-B7H4.
In turning to experimentation to determine which subjects would develop B7H4 positive tumors and benefit from preventive administration of anti-B7H4 prior to developing cancer, the skilled artisan would have to practice the full translation spectrum of research (i.e. basic mechanistic research, pre-clinical animals, and clinical trials) for a vast number of diseases. "‘The test [for undue experimentation] is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed.’" In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) (citing In re Angstadt, 537 F.2d 498, 502-04, 190 USPQ 214, 217-19 (CCPA 1976)). Clearly, this would go beyond what is considered routine experimentation in the art. Indeed, although the ordinarily skilled artisan is presumed to be highly skilled in the art, the quantity of experimentation that is not routine needed to determine which subjects would develop B7H4 positive tumors and benefit from prevention administration of anti-B7H4 imposes an undue burden given the lack of guidance in the specification for using the invention commensurate in scope with the instant claims. Thus, the person of ordinary skill would have to practice undue experimentation to prevent a B7H4 positive tumor from developing in a subject using the anti-B7H4 antibodies. Indeed, the guidance in the art does not extend beyond the use of anti-B7H4 to therapeutically treat patients with cancer, and the specification provides insubstantial direction on how to determine which subjects would benefit from preventive administration of anti-B7H4.
Thus, the instant specification fails to remedy the deficiencies in the art with respect to predicting which subject would acquire B7H4 positive cancer and the efficacy of anti-B7H4 in stopping cancer from ever developing. Rather, given the nature of the invention and underdevelopment of the art, one of ordinary skill would have to practice undue experimentation to practice preventing cancer with an anti-B7H4 antibody.
“Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” Genentech Inc. v. Novo Nordisk A/S, 42 USPQ2d 1001, 1005 (CA FC 1997).
Thus, in view of the foregoing Wands analysis, claims 35 and 36 are rejected on the grounds that one of ordinary skill in the art would not be able to practice the preventing B7H4 positive cancer in a subject administered the antibody of instant claims. The scope of enabled matter recited in the claim is restricted to therapeutically treating cancer in a subject comprising administering to the subject the anti-B7H4 antibody.
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 1, 3-7, 23-27, 31-32, and 34-36 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 13-15, and 17-20 of copending Application No. 18/571,174 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
‘174 teaches a bispecific antibody combination comprising a bispecific antibody I targeting CD3 and B7-H4 in claim 1. In claim 4 i), ‘174 teaches that the bispecific antibody I comprises a B7-H4 binding domain comprising SEQ ID NO: 65 and 71, which are the variable domains of clone PR002408, teaching instant claims 1, 3, 7, and 23. Claim 4 i) also teaches that the CD3 binding site comprises a VH of SEQ ID NO: 67 and a VL of SEQ ID NO: 70, teaching the instantly claimed CD3 binding site having a VH of SEQ ID NO: 84 and a VL of SEQ ID NO: 86, which comprise HCDR1-3 of SEQ ID NOs: 10, 20, and 34 and LCDR1-3 of SEQ ID NOs: 46, 53 and 63 as in instant claims 24, 25, 26, and 27.
In claim 5 i), ‘174 recites an anti-B7-H4 having a heavy chain set forth in SEQ ID NO: 76 and a light chain set forth in SEQ ID NO: 82, which teach the heavy and light chain of instant SEQ ID NO:100 and 114, as in instant claim 4, 5, and 6.
‘174 claim 7 teaches a nucleic acid as in instant claim 31; ‘174 claim 8 teaches an expression vector as in instant claim 32; ‘174 claim 10 teaches a pharmaceutical composition as in instant claim 34; and ‘174 claim 20 teaches a method of treating cancer as in instant claims 35 and 36.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-7, and 29-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 26-47 of copending Application No. 18/002,499 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 28 of ‘499 teaches ana nti-B7-H4 with heavy chain according to SEQ ID NO: 192 and a light chain according to SEQ ID NO: 200, which is PR002408, teaching instant claims 1 and 3-6. ‘499 claim 43 teaches a chimeric antigen receptor, teaching instant claim 29. While ‘499 does not explicitly teach the chimeric antigen receptor as part of an immune cell, the skilled artisan would at least have at once envisaged a “CAR T-cell” upon reading “chimeric antigen receptor”, teaching instant claim 30. ‘499 claim 41 teaches a nucleic acid as in instant claims 31 and 32. ‘499 claims 44-45 teach an antibody-drug conjugate, as in instant claim 33. ‘499 claim 34 teaches a pharmaceutical composition as instant claim 34. ‘499 claims 46-47 teach treating cancer as in instant claims 35-36. Moreover, ‘499 claim 1 teaches that the antibody is a bispecific antibody that also binds 4-1BB, teaching the limitations of instant claim 7.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-7, 23, and 32-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 18/013,523 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
‘523 in claim 19 teaches an anti-B7H4 with a heavy chain of SEQ ID NO: 194 and light chain of SEQ ID NO: 208, which pertain to clone PR002408, teachings instant claims 1 and 3-6. Claim 4 teaches that the antibody has a function region targeting CD3, as in instant claims 7 and 23. ‘523 claim 7 teaches a nucleic acid relating to instant claim 31; ‘523 claim 8 teaches a vector, relating to instant claim 32; ‘523 claim 11 teaches a pharmaceutical composition as in instant claim 34; ‘523 claim 17 teaches treating cancer pertaining to instant claims 35-36.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-7, and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-22 of copending Application No. 18/013,530 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 5 of ‘530 teaches a binding protein with two functional regions, one of which is a B7H4 binding domain having a VH and VL according to SEQ ID NOs: 113 and 121, respectively, which are the variable regions of PR002408, thus teaching instant claims 1, 3, and 7. The binding protein has an Fc homodimer, see claim 1 of ‘530, as in instant claims 4 and 5. SEQ ID NO: 139 teaches instant SEQ ID NO: 114 and SEQ ID NO: 150 comprises instant SEQ ID NO: 100, with an additional binding domain appended to the C-terminal end (specification pg. 52). While the claims of ‘530 do not recite SEQ ID NO: 139 and 150, they fall within the scope of, e.g., ‘530 claim 5. “The court in Vogel recognized ‘that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,’ but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first ‘determine how much of the patent disclosure pertains to the invention claimed in the patent’ because only ‘[t]his portion of the specification supports the patent claims and may be considered.’” In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). See MPEP 804 II B. 1. Accordingly, instant claim 6 is an obvious variation of the invention of ‘530. ‘530 claim 10 teaches an isolated nucleic acid, relating to instant claim 31. ‘530 claim 11 teaches an expression vector, relating to instant claim 32. ‘530 claim 34 teaches a pharmaceutical composition, relating to instant claim 34. ‘530 claim 21 teaches treating cancer relating to instant claims 35 and 36.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 5, 7, 23, and 31-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2-18 and 21-22 of copending Application No. 19/114,651 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
‘651 claim 12 describes a bispecific antibody that binds CD3 and B7H4, wherein the B7H4 binding site comprises a VL according to SEQ ID NO: 134 and a VH of SEQ ID NO: 103, corresponding to the sequences of clone PR003366. PR003366 relates to instant SEQ ID NOs: 79 and 91, thus ‘651 claim 12 anticipates instant claims 1, 3, 5, 7, and 23. Claim 13 of ‘651 teaches the bispecific antibody comprises SEQ ID NO: 178, an scFv-Fc fusion protein comprising the B7H4 binding site of PR00366, teaching instant claim 4. Claim 14 of ‘651 teaches an isolated nucleic acid, relating to instant claim 31. Claim 15 of ‘651 teaches a vector, relating to instant claim 32. ‘651 claim 18 teaches a pharmaceutical composition relating to instant claim 34. ‘651 claims 21-22 teach treating cancer, relating to instant claims 35 and 36.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 1, 3-7, and 23-36 have been determined as free of the prior art, insofar as they have been interpreted as set forth in Claim Rejections under 35 U.S.C. 112(b), supra, and require the limitations of the anti-B7H4 antibody of claim 1. The closest prior art made of record is Eckelman in WO 2020/023553 A1 published on January 30, 2020. Eckelman teaches a multispecific antibody that binds CD3 and B7-H4 (see claim 150). Eckelman teaches a CD3 binding domain having the CDRs of SEQ ID NOs: 46, 53, 63, 8, 20, and 34 (see Sequence Table on pg. 189 to 192). However, no prior art teaches a B7H4 binding domain having the instantly claimed combination of CDRs.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Shi in US 2023/0295324 effectively filed June 30, 2020 discloses the anti-B7H4 antibody of clone PR002408 and claims sequence pertaining thereto. ‘324’s application would otherwise qualify as a nonstatutory double patenting reference except it does not appear to have a shared inventor or assignee. The instant Applicant, Nona Biosciences, is a wholly owned subsidiary of Harbour Biomed.
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/B.K.S./Examiner, Art Unit 1644
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683