DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
1. The Elections filed April 29, 2026 and July 22, 2026 in response to the Office Action of March 3, 2026 are acknowledged. Applicant elected with traverse Group I, and the species of:
A. VH CDR1-3 SEQ ID NOs:9, 46, and 3;
B. VH SEQ ID NO:185;
C. VH formula SEQ ID NO:234; and
D. VH CDR1-3 formulas: SEQ ID NOs:136, 137, and 138.
2. Applicant argues that the search and examination of the entire application would not place serious burden on the examiner and the claims are overlapping. Applicant argues the restriction does not provide full analysis of how the art is applicable to the claims as presented and does not meet the burden of establishing that a special technical feature does not contribute over the known art. Applicants disagree it would be obvious to modify the Brown reference to arrive at the claimed invention. Applicants request rejoinder of Groups II, III, and all species.
3. The arguments have been considered but are not persuasive. Search burden does not constitute grounds for restriction when considering lack of unity for applications filed as a National Stage entry under 35 U.S.C. 371. Contrary to arguments, Examiner did specifically point out the technical feature shared among the Groups and how and where the prior art disclosed this technical feature. As stated in the restriction, the inventions listed as Groups I-III 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:
“Groups I-III lack unity of invention because even though the inventions of these groups require the technical feature of an isolated antigen binding protein binding to a same or overlapping PD-1 epitope with a reference antibody, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Brown et al (PLoS ONE, March 2020, 15(3): e0229206). Brown teaches and demonstrates antibodies binding to overlapping epitopes on PD-1 with a reference antibody (p. 8-9; Table 3).”
Thus, “special technical feature” does not define a contribution over the prior art. For these reasons, the restriction requirement is deemed to be proper and is therefore made FINAL.
4. Examiner notes Applicant’s request for rejoinder of Groups II and III and the species of antibody, however, no generic claim of Group I is allowed nor is the product invention of Group I allowed, therefore the restriction of inventions and species is maintained.
5. Claims 1-80 are pending. Claims 61 and 66-78 have been withdrawn from further consideration by the examiner under 35 CFR 1.142(b) as being drawn to non-elected inventions. Claims 11, 19, 22, 25, 28, and 37 are withdrawn as being drawn to non-elected species. Claims 1-10, 12-18, 20, 21, 23, 24, 26, 27, 29-36, 38-60, 62-65, 79 and 80 are currently under prosecution as drawn to the elected species.
Claim Interpretation
6. The phrase: “comprises an amino acid sequence as shown in SEQ ID NO:#” is used throughout several claims. This phrase is reasonably interpreted to encompasses any (“an”) amino acid sequence found in (“as shown in”) the SEQ ID NO, including amino acid sequences as short as two consecutive amino acids long that are shown in the claimed SEQ ID NOs. Therefore, the phrase broadly encompasses any fragment sequences found in the claimed SEQ ID NOs.
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.
7. Claim 65 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. Claim 65 recites a method comprising “preparing” the isolated antigen binding protein according to claim 1 or a polypeptide “into a drug”. The claim is unclear with regards to what steps are encompassed by “preparing” the protein or polypeptide “into a drug”. The plain definition of “prepare” is to make or get something or someone ready for a future event, use, or purpose (see Cambridge Dictionary printed October 2026). The claim is grammatically unclear how the protein or polypeptide can be “prepared” “into a drug” or made ready into a drug and no specific steps to accomplish the method are recited. The metes and bounds of the claimed invention cannot be determined.
Examiner Suggests amending the claim to recite: A method of making a drug to treat a disease or a disorder, the method comprising combining the isolated antigen binding protein of claim 1 with a pharmaceutically acceptable carrier.
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.
8. Claims 1-10, 12-18, 20, 21, 23, 24, 26, 27, 29, 31-36, 38-60, 62-65, 79, and 80 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 claim(s) contains 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a WRITTEN DESCRIPTION rejection.
The claims are drawn to an isolated antigen binding protein that functions to:
Bind to a same or overlapping PD-1 epitope with a reference antibody (claim 1);
Compete with the reference antibody for binding to PD-1 (claim 2);
Have a binding affinity for PD-1 substantially the same as the binding affinity of the reference antibody for PD-1 (claim 3);
Bind to PD-1 with an EC50 of about 11 ug/ml of less n an ELISA assay or inhibit the binding of human OPD-L1 to human PD-1 with an EC50 of about 2ug/ml or less in competitive ELISA assay (claim 4);
Bind to PD-1 derived from primates, wherein the primates comprise human and/or monkeys (claims 5 and 6); and
Be suitable for inhibiting the interaction between PD-1 and PD-L1 (claim 79 and 80).
Thus, the claims identify the antibody by function only as listed above. No antigen binding protein or antibody structure is recited.
Dependent claims 7-18, 20, 21, 23, 24, and 26 further define sequences comprised by the reference antibody that the claimed antigen binding protein competes with for binding to PD-1. Dependent claims 7-18, 20, 21, 23, 24, and 26 do not recite any sequence structure of the claimed antigen binding protein critical to performing the claimed functions.
Dependent claims 27, 29, 36, and 38 recite a vast genus of isolated antigen binding proteins comprising any sequence or fragment found in the recited VH CDR1-3 SEQ ID NOs or VH SEQ ID NOs (see the Claim Interpretation section above). Claims 27, 29, 36, and 38 do not require the complete VH CDR1-3 sequences critical to performing the claimed functions and critical to recognizing members of the antigen binding protein genus that function as claimed.
Dependent claims 31-35 recite framework sequences, but do not recite and require the complete VH CDR1-3 sequences critical to performing the claimed functions and critical to recognizing members of the antigen binding protein genus that function as claimed.
The instant specification discloses producing single domain (VHH) antibodies in alpaca by immunizing alpaca with PD-1 protein, screening for VHH that inhibit PD-L1 binding to PD-1, and isolating parental antibody MHPD1-A (Table 1; Examples 1-5). The instant specification discloses mutating MHPD1-A at amino acid sites “based on structural prediction and experience” to make variants, then purifying VHH variants named MHPD1-A -4, -7, -8, -13, -15, -24, -25, -30, -32, -39, -42, -44, and -45. (Example 13). The specification discloses humanizing the VHH antibody to produce more VHH variants listed in Table 6, Example 17. The specification discloses further producing affinity-matured variants of the VHH antibodies as listed in Table 8, Example 19. Thus, the specification discloses isolating a parental MHPD1-A anti-PD-1 VHH that inhibits PD-L1 binding to PD-1, and utilizing its sequence to produce homologous mutant variants and affinity matured variants. The specification discloses the VHH CDR1-3 SEQ ID NOs for the parental MHPD1-A antibody as SEQ ID NOs:1-3 (p. 36), and lists the CDR1-3 SEQ ID NOs for the derived variants MHPD1-A-1 to MHPD1-A-49 on p. 36-46.
Thus, the instant specification describes a genus of highly homologous VHH antibody derivatives that bind to PD-1 at the same or similar epitope and inhibit PD-L1/PD-1 interaction as claimed. The specification fails to disclose the structural sequence required of any other antigen binding proteins, VHH, or antibodies to possess the functions listed above.
To provide adequate written description and evidence of possession of the claimed antigen binding protein genus, the instant specification can structurally describe representative antigen binding proteins that function as listed above, or describe structural features common to the members of the genus, which features constitute a substantial portion of the genus. Alternatively, the specification can show that the claimed invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics (see University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) and Enzo Biochem, Inc. V. Gen-Probe Inc.). A disclosure that does not adequately describe a product itself logically cannot adequately describe a method of using or making that product.
In this case, the only factor present in the claims is a recitation of the antigen binding protein functions listed above. Other than for VHH MHPD1-A and its homologous derivatives, the instant specification fails to describe structural features common to the members of the genus, which features constitute a substantial portion of the genus. A definition by function does not suffice to define the genus because it is only an indication of what the antigen binding protein does, rather than what it is. Other than for VHH MHPD1-A and its homologous derivatives, the specification fails to provide the structural features coupled to the claimed functional characteristics. The instant specification fails to describe a representative number of antigen binding protein sequences for the vast genus of antigen binding proteins that function as claimed. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus required to perform the claimed methods.
The claims broadly encompass any antigen binding protein or antibody that functions as claimed. Applicants have not established any reasonable structure-function correlation with regards to the sequences in the variable domains or CDRs that can be altered from those disclosed and still maintain the antigen binding protein function as claimed. The instant claims attempt to claim every antigen binding protein that would achieve a desired result/function as listed above, wherein the instant specification does not describe representative examples to support the full scope of the claims because the instant specification discloses a highly homologous population of VHH sequences. Given the well-known high level of polymorphism of antibody CDR sequences and structure, the skilled artisan would not have been in possession of the vast repertoire of antigen binding proteins, VHH, or antibodies encompassed by the claimed invention. One could not reasonably or predictably extrapolate the structure of a parental VHH sequence and its highly homologous variants to the structure of any and all antigen binding proteins, VHH, or antibodies as broadly claimed. Therefore, one could not readily envision members of the broadly claimed genus.
It is also noted claim 42 encompasses a genus of fully human antibodies. The specification discloses producing VHH antibodies in alpacas that are fully alpaca sequences, and fails to disclose the sequence structure representative of any fully human antibodies that function as claimed and contemplated.
Although Applicants may argue that it is possible to screen for antigen binding proteins, VHH, or antibodies that bind PD-1 and function as claimed, the court found in (Rochester v. Searle, 358 F.3d 916, Fed Cir., 2004) that screening assays are not sufficient to provide adequate written description for an invention because they are merely a wish or plan for obtaining the claimed chemical invention. “As we held in Lilly, “[a]n adequate written description of a DNA … ‘requires a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” 119 F.3d at 1566 (quoting Fiers, 984 F.2d at 1171). For reasons stated above, that requirement applies just as well to non-DNA (or RNA) chemical inventions.” Knowledge of screening methods provides no information about the structure of any future antigen binding proteins, VHH, or antibodies yet to be discovered that may function as claimed. The PD-1 antigen provides no information about the structure of an antigen binding protein, VHH, or antibody that binds to it.
Given the lack of representative examples to support the full scope of the claimed antigen binding proteins and those used in the claimed methods, and lack of reasonable structure-function correlation with regards to the unknown sequences in the variable domains or CDRs that provide PD-1 epitope-binding function and functions listed above, the present claims lack adequate written description. Thus, the specification does not provide an adequate written description of antigen binding proteins, VHH, or antibodies that bind PD-1 and function as listed above that is required to practice the claimed invention. Since the specification fails to adequately describe the product to which the claimed methods use or make, it also fails to adequately describe the methods.
Examiner Suggestions:
(1) Amend the limitations of claim 30 into claim 1; and
(2) Amend claim 42 to delete “fully human antibody”.
Claim Rejections - 35 USC § 102
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.
9. Claim(s) 1-3, 5, 6, 17, 39, 44-46, 48-51, 54, 65, 79, and 80 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brown et al (PLoS ONE, March 5, 2020, 15(3): e0229206) and Supplementary Table S1.
Regarding claims 1, 2, 5, 6, 39, 54: Brown teaches and demonstrates antibodies binding to overlapping epitopes on human PD-1 with a reference antibody (p. 8-9; Table 3). For example, Figure 5 states: “mAb03 and mAb13 each target epitopes that are closely adjacent to or minimally overlapping with that of mAb26.” It is noted that mAb13 is pembrolizumab (Table 3), therefore mAb26 binds to an overlapping PD-1 epitope with reference antibody pembrolizumab (mAb13).
Regarding claim 3: mAbs26, 27, and 32 all have similar affinities to PD-1 (Table 3).
Regarding claim 17: Table 3 also demonstrates mAb27 and mAb32 were displaced by pembrolizumab, therefore bind overlapping epitopes.
Regarding claims 44-46, 48-51: The mAbs are full length IgG antibodies comprising heavy chain with VH region linked to Fc through hinge (flexible linker) in the order of N-C term: VH – hinge linker - Fc. The mAbs of Brown are polypeptides comprising the antigen binding VH and VL domains binding to PD-1.
Regarding claim 65: The mAbs of Brown are polypeptides and are prepared in compositions/solutions for testing and are known to be therapeutically applied as drugs to treat cancer, therefore Brown teaches methods of preparing the antibody or polypeptide into a drug (Introduction; see all figures and Tables).
Regarding claims 79 and 80: Brown teaches mAb26, mAb32, mAb03, and mAb32 all block PD-L1 binding to PD-1 (Table 3).
Brown teaches these antibodies are publicly available and their sources (see Supplementary Table S1)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
10. Claim(s) 4, 41, 42, 52, 55-60, 62-64 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al (PLoS ONE, March 5, 2020, 15(3): e0229206) and Supplementary Table S1 as applied to claims 1-3, 5, 6, 17, 39, 44-46, 48-51, 54, 65, 79, and 80 above, and further in view of US Patent Application Publication 2014/0356363, Zhou et al.
Brown teaches IgG mAbs that bind to overlapping epitopes on PD-1 with a reference antibody, including mAb26, as set forth above. Brown further teaches the sequence of mAb26 is known in the prior art and discloses the source of the antibody is from US Patent Application Publication 2014/0356363, Zhou, as antibody RG1H10 (see Supplemental Table S1). Brown teaches the PD-1 antibodies are therapeutic for treating cancer (Introduction).
Brown does not teach:
antibody binding to PD-1 of EC50 less than 11ug/ml in ELISA (claim 4);
humanizing the antibody (claim 42);
antibody fragments (claim 41);
the antibody comprises an IgG1 or IgG4 Fc region (claim 52);
an immunoconjugate comprising the antibody (claim 55)
a nucleic acid encoding the antibody (claim 56);
a vector comprising the nucleic acid encoding the antibody (claim 57);
a cell comprising or expressing the antibody (claim 58);
a pharmaceutical composition comprising the antibody (claim 60);
method of preparing the antibody by culturing a cell to express the antibody (claim 59); and
kit comprising the antibody and making the kit to include the antibody (claims 62-64).
Zhou teaches antibody RG1H10 (mAb26 of Brown), that it binds to human PD-1, and discloses its sequences ([6-12]; [24-25]).
Zhou teaches:
RG1H10 binds to PD-1 at EC50 less than 11ug/ml in ELISA (Table 1; Example 2; Table 3; Example 5);
humanizing the antibody or making a chimeric antibody ([43-45]);
antibody fragments of the antibody ([6-12]; [132]);
the antibody comprises an IgG1 or IgG4 Fc region ([20-22]; Figs. 6-8; Example 4; Table 2);
an immunoconjugate comprising the antibody ([113-114]);
a nucleic acid encoding the antibody ([57]; [60-66]);
a vector comprising the nucleic acid encoding the antibody ([56]; [63-65]);
a cell comprising or expressing the antibody ([58]; [64-66]);
a pharmaceutical composition comprising the antibody with pharmaceutically acceptable carrier ([95-100]); and
method of preparing the antibody by culturing a cell to express the antibody ([60-68]).
With regards to kits, Zhou teaches methods of making the RG1H10 and producing pharmaceutical compositions including the antibody for treatment of cancer or detection of PD-1 protein ([8]; [27]; [32]; [103-116]), therefore renders obvious the instantly claimed antibody of the kit. It is noted that textural instructions (as recited in claim 63) are viewed as a recitation of intended use and therefore do not differentiate the claims from the prior art (see MPEP 2112.01).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was effectively filed to produce the instantly claimed forms of the RG1H10 (mAb26) antibody, compositions, nucleic acid, vector, cell and methods of preparing the antibody, a kit, and compositions. One would have been motivated to
and have a reasonable expectation of success to, because: (1) Brown teaches the RG1H10 (mAb26) antibody is publicly known and that PD-1 antibody are utilized for cancer therapy; and (2) Zhou teaches RG1H10 (mAb26) antibody is a therapeutic PD-1 antibody, discloses the sequences to make the antibody, and summarizes known, routine methods of producing humanized antibody, antibody fragments, nucleic acids and vectors encoding the antibody, host cells expressing the antibody for production, preparing pharmaceutical compositions, and making conjugates, thereby rendering obvious manipulations and production of the RG1H10 (mAb26) antibody and its compositions as instantly claimed.
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.
11. Claims 1-10, 17, 18, 20, 21, 23, 24, 26, 27, 29, 30, 36, 38-52, 55-60, 62-65, 79, and 80 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-39 of copending Application No. 18/996,343 (reference application). Claims 55, 59, and 62-64 are further rejected in view of US Patent Application Publication 2014/0356363, Zhou et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claims an antibody comprising VHH (single domain) SEQ ID NO:1 that is 100% identical to instant SEQ ID NO:185, and comprises 100% of instant VH CDR1-3 SEQ ID NOs:9, 46, and 3 (comprised by instant CDR formula SEQ ID NOs:126, 127, and 128 and VH formula SEQ ID NO:234) (see copending claim 20 and sequence alignment below). Given the antibody of the copending application comprises the same sequences as the instantly claimed reference antibody or isolated antigen binding protein, the antibody claimed by the copending application is reasonably expected to comprise the same functions instantly claimed.
The copending application further claims and renders obvious the VH attached to a peptide linker and Fc; comprising an IgG Fc, an isolated nucleic acid encoding the antibody, vector, host cell, and pharmaceutical compositions comprising the antibody with a pharmaceutically acceptable carrier/excipient (copending claims 26-37).
The copending application claims methods of treating a tumor comprising administering the antibody to a mammal (copending claims 38-39), therefore renders obvious preparing the antibody as a drug.
With regards to claims 55, 59, and 62-64, the copending application does not claim the PD-1 VHH is an immunoconjugate, methods of producing the antibody by culturing a cell comprising nucleic acid or vector encoding the antibody; and methods of preparing a kit comprising the antibody to detect PD-1.
Zhou teaches PD-1 antibodies are therapeutically effective to treat cancer, and reviews routine methods of making conjugates of PD-1 antibodies, compositions comprising labeled PD-1 antibodies for detecting PD-1 protein, and methods of producing PD-1 antibodies by culturing cells expressing the antibodies, as set forth above.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was effectively filed to manipulate the therapeutic PD-1 antibody of the copending application by the methods and compositions taught by Zhou for therapeutic use and production of PD-1 antibodies using cell culture and for a kit. One would have been motivated to and have a reasonable expectation of success to, because the copending application claims the PD-1 VHH is to be applied therapeutically, and Zhou teaches routine methods of producing therapeutic PD- antibodies through cell culture, and making conjugates of the antibodies for PD-1 detection. Given the known sequences of the PD-1 VHH claimed by the copending application and the known methods of conjugating PD-1 antibodies to detectable labels for PD-1 detection as taught by Zhou, it is well within the level of the ordinary skilled artisan to make and include the antibody of the copending application into a kit for the detection of PD-1 protein.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant SEQ ID NO:185 aligned with Application No. 18/996,343 SEQ ID NO:1:
US-18-996-343-1
Filing date in PALM: 2025-01-17
Sequence 1, US/18996343
Publication No. US20260035463A1
GENERAL INFORMATION
APPLICANT: MINGHUI PHARMACEUTICAL (HANGZHOU) LIMITED (en)
TITLE OF INVENTION: Multispecific antibody and use thereof (en)
FILE REFERENCE: IEC226046PCT
CURRENT APPLICATION NUMBER: US/18/996,343
CURRENT FILING DATE: 2025-01-17
NUMBER OF SEQ ID NOS: 35
SEQ ID NO 1
LENGTH: 118
TYPE: PRT
FEATURE:
NAME/KEY: source
LOCATION: 1..118
QUALIFIERS: mol_type = protein
organism = synthetic construct
ALIGNMENT:
Query Match 100.0%; Score 623; Length 118;
Best Local Similarity 100.0%;
Matches 118; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGLVQPGGSLRLSCATSGSRRSIYAMGWFRQAPGKGLEFVAGIGWAYATTYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVESGGGLVQPGGSLRLSCATSGSRRSIYAMGWFRQAPGKGLEFVAGIGWAYATTYY 60
Qy 61 ADSVKGRFTISRDNTKNTLYLQMNSLRAEDTAVYYCAADLDHSGFDYWGQGTLVTVSS 118
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTISRDNTKNTLYLQMNSLRAEDTAVYYCAADLDHSGFDYWGQGTLVTVSS 118
12. Conclusion: No claim is allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA B GODDARD whose telephone number is (571)272-8788. The examiner can normally be reached Mon-Fri, 7am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Laura B Goddard/Primary Examiner, Art Unit 1642
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