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 .
Election/Restrictions
Applicant's election with traverse of Group I, Claims 1-7, 9-10, 12-14, 16-17, 19, 22-26, 29, and the CL7 antibody with HCDRs 1-3 of SEQ ID NOs: 79, 80, and 81, respectively, LCDRs 1-3 of SEQ ID NOs: 82, 83, and 84, respectively, and a VH and VL of SEQ ID NOs: 327 and 328, respectively, in the reply filed on 04/13/2026 is acknowledged. The traversal is on the ground(s) that both Group 1 and Group 2 share the technical feature over the prior art of a novel anti-CD300c antibody per se, and that the method for providing information also utilizes the anti-CD300c antibody and therefore shares the same improved technical feature. This is not found persuasive because Group II does not require the technical feature of the anti-CD300c antibody. The independent claim of group II, claim 32, recites a method comprising the step of determining the expression level of a marker. The markers recited in claim 32 do not include CD300c, and the specification does not provide support that the recited anti-CD300c antibodies can also detect one of these markers. Therefore, the steps of claim 32 does not require the antibody of CD300c, and is a separate invention from group I.
The requirement is still deemed proper and is therefore made FINAL.
Claims 32 and 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/13/2026.
Status of Claims
Claims 8, 11, 15, 18, 20-21, 27-28, 30-31, 33, and 35-38 were previously cancelled, in the amendment filed 11/13/2023. Claims 1-7, 9-10, 12-14, 16-17, 19, 22-26, 29, 32, and 34 are pending. Claims 32 and 34 are withdrawn. Claims 1-7, 9-10, 12-14, 16-17, 19, 22-26, and 29 will be examined on the merits.
Information Disclosure Statement
The Information Disclosure Statements filed on 11/13/2023, 12/12/2024, 6/23/2025, 9/05/2025, and 1/12/2026 have been considered. Signed copies are enclosed.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on applications filed in Korea on 5/13/2021, 8/27/2021, and 4/06/2022. It is noted, however, that applicant has not filed a certified copy of the KR10-2021-0062312, KR10-2021-0062313, KR10-2021-0062311, KR10-2021-0114297, or KR10-2022-0042680 applications as required by 37 CFR 1.55.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
As there is no translated copy of the foreign priority applications, it cannot be determined if they disclose the claimed invention. Therefore, the effective filing date of the claimed invention is considered to be 5/13/2022, the date of filing for PCT/KR2022/006938, for the purposes of applying prior art.
Specification
The disclosure is objected to because of the following informalities: The examples in the specification are numbered in a. For example, prefacing the examples with an explanation of the difference between the roman numeral, “Example” and “Experimental Example” or renumbering the examples in a clearer manner.
Appropriate correction is required.
Drawings
The replacement drawings were received on 11/13/2023. These drawings are acceptable.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 112
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 19 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 19 recites "the method of claim 1, comprising inhibiting the proliferation, survival, metastasis, recurrence, or cancer agent resistance of cancer." This claim does not further limit claim 1, but merely recites the result of the step "administering" 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 1-4, 9-14, 16, 17, 19, 22-26 and 29 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are drawn to a method for the prevention or treatment of cancer comprising administering to a subject any anti-CD300c antibody. Claims 3-7 and 9 further define the antibody by the CDRs, with claim 3 reciting lists of possible CDRs for HCDR1-3 and LCDR1-3, claim 4 narrowing the list of claim 3, and claim 5-7 reciting specific antibodies with 3 specific HCDRs and 3 specific LCDRs, or defined VH and VL regions. Claim 9 recites an antibody with HCDR1-3 defined by formulas 1-3, and LCDR1-3 defined by formulas 4-6.
The specification teaches 25 anti-CD300c antibodies, defined by six CDRs in Table 6 and by VH and VL region in Tables 4-5. These 25 antibodies meet the written description provision of 35 U.S.C. 112(a). However, the claims encompass many more antibodies than just these 25 anti-CD300c antibodies. As written, any of the HCDR1 sequences listed in claim 3 (i) can be combined with any of the HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 sequences in claim 3 (ii)-(vi), resulting in hundreds of millions of antibody combinations. CDRs are known in the art to define the binding capabilities of an antibody (See Herold et al. (2017) Scientific reports, 7(1), 12276), and there is no support in the art that these hundreds of millions of antibodies would still bind to and inhibit activity of CD300c. Similarly, claim 9 recites nearly infinite possibilities for antibodies. Moreover, there is no existing body of anti-CD300c antibodies in the art outside of these 25. Therefore, the specification does not provide sufficient support for claim 1 as written, or claims 3, 4, or 9.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
To fulfill the written description requirements set forth under 35 U.S.C. 112(a), the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession of the claimed invention. To adequately describe the genus of antibodies, Applicant must adequately describe which combination of variable regions and framework regions that give rise to an antibody with the claimed immunological function. The instant specification, however, does not disclose distinguishing and identifying features of a representative number of members of the genus of antibodies to which the claims are drawn, such as a correlation between the structure of the antibody and its recited function (CD300c antagonism), so that the skilled artisan could immediately envision, or recognize, at least a substantial number of members of the claimed genus of antibodies. The specification fails to disclose which amino acids might be added, replaced or deleted so that the resultant antibody retains the binding specificity of its parent, or by which other amino acids the essential amino acids might be replaced so that the resultant antibody retains the binding specificity of its parent. Beyond the 25 antibodies listed in Tables 4-6, the specification does not any limitations on which CDR combinations or residues must be maintained in order to preserve the antibody’s function. Therefore, the specification fails to adequately describe at least a substantial number of members of the genus of antibodies to which the claims refer; and accordingly, the specification fails to adequately describe at least a substantial number of members of the claimed genus of antibodies.
As evidenced by the teachings below, the art is unpredictable. Skolnick et al. (Trends in Biotechnology (2000) 18:34-39) discloses the skilled artisan is well aware that assigning functional activities for any particular protein or protein family based upon sequence homology is inaccurate, in part because of the multifunctional nature of proteins (see, e.g., the abstract; and page 34, Sequence-based approaches to function prediction). Even in situations where there is some confidence of a similar overall structure between two proteins, only experimental research can confirm the artisan's best guess as to the function of the structurally related protein (see, in particular, the abstract and Box 2). Thus, one skilled in the art would not accept the assertion, which is based only upon an observed similarity in amino acid sequence that a variant of a given polypeptide would necessarily bind to a given antibody.
As stated above, the CDRs are vital for antigen binding, as evidenced by Kapingidza et al. (Vertebrate and invertebrate respiratory proteins, lipoproteins and other body fluid proteins, 2020, 465-497) (see page 468, lines 1-4, and pages 476-482). Sela-Culang et al. (Frontiers in immunology, 2016, 4:302.) expands on the importance of antibody sequence and function, explaining that amino acid residues outside of the CDRs can influence antigen binding (abstract, whole document). Additionally, Clark et al. (Journal of Structural Biology, 2014, 185(2), 223-227) show that mutational effects on interfaces are often unpredictable (see pg. 223, 2nd col. 1st full para), and that it is easy to damage an interface and decrease binding affinity. Therefore, a person of ordinary skill in the art at the time of filling would understand residues within the CDRs are integral to antigen binding or maintaining the structure of the region that binds to the antigen and substitutions in these regions would affect one or both these attributes. As there is no art-recognized correlation between structure and function, it would be impossible for one of ordinary skill in the art to predict which variable CDRs, combinations of CDRs, or combinations of particular substitutions, would result in a structure that antagonizes CD300c.
Overall, based on the disclosure, the state of the art at the time of filing, a skilled artesian would have recognized that the applicant was not in possession of the claimed invention at the time of filing. Consequently, in accordance with the MPEP, only the antibodies claimed in tables 4-6 of the instant specification, not the full breadth of claims 1, 3, 4, or 9, regarding any anti-CD300c antibody or any antibody with any combination of possible CDRs, meets the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. Claims 2, 10, 12-14, 16-17, 19, 22-26, and 29 inherit this rejection, as they are dependent on claim 1 and do not rectify the issues laid out above.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is severable from its enablement provision. (See page 1115).
Claims 1-7, 9-10, 12-14, 16-17, 19, 22-26, and 29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for treating cancer, does not reasonably provide enablement for a method for preventing cancer. 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.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized in In re Wands (858 Fed 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, limited working examples, and the unpredictability in the art.
The instant claims are drawn to a method for the prevention or treatment of cancer comprising administering to a subject an anti-CD300c antibody. The specification defines “treatment” as obtaining a desired pharmacological and/or physiological effect, and “prevention” as a prophylactic treatment, which completely or partially prevents a disease or symptom thereof (see instant specification page 11). The specification further defines “cancer” as a physiological condition that is typically characterized by unregulated cell growth in mammals (see page 28) and provides many examples of cancers that this method may be applied to. Therefore, the instant claims are broadly drawn to a method of treating or preventing any condition termed a ‘cancer’ that is characterized by unregulated cell growth in mammals.
The specification provides several working examples, including in vitro experiments in a variety of cancer cell lines, and in vivo examples in mouse models, that demonstrate the effectiveness of the CL7 antibody in affecting CD-300c signaling processes and even cancer outcomes. However, there is no data to support the prevention of cancer developing. Additionally, the disclosure does not discuss, or demonstrate through working examples, a method that could be used to determine that tumors were prevented using claimed anti-CD300c antibody, as there is no disclosed method to determine that primary tumor(s) would have predictably occurred in the models.
The state of the art teaches that to date, universal prevention of and treatment of cancer has not been achieved (Gu et al. (2020) Journal of cancer prevention, 25(3), 127). There is also no known method of identifying subjects who would have predictably developed cancer in order to determine that cancer was prevented using any methods, much less the claimed method. One of ordinary skill in the art would know that there are risk factors associated with cancers (see Meyskens et al., J Natl Cancer Inst (2016) 108(2)), but that prevention with medication has yet to be achieved (See Gu et al.). It is noted that the broadest cancer treatment at current are immune checkpoint inhibitors, such as anti-PD-1 antibodies. Cui et al. ((2018) Frontiers in immunology, 9, 2657) note that CD300c is in the same family as PD-1 and PD-L-1, which supports that CD300c antibodies may have a similarly broad effect. Therefore, while the state of the art might support a broad claim for treating cancers with an anti-CD300c antibody, there is no support in the art for preventing cancer using the claimed method.
Therefore, while being enabling for a method of treating cancer, the specification is does not support a method of preventing cancer. One of ordinary skill in the art would have to engage in undue experimentation to practice the full scope of the instant claimed invention. As such, claim 1 does not meet the enablement requirement set forth in 35 USC § 112(a). As no subsequent claim rectifying the problem, claims 2-7, 9-10, 12-14, 16-17, 19, 22-26, and 29 are included in this rejection.
Enablement can be met by amending claim 1 to remove "prevention or". Dependent claims 2-7, 9-10, 12-14, 16-17, 19, 22-26, and 29 can overcome this rejection by amending claim 1 in this manner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 13-14, 16-17, 19, and 22-23 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO 2019/231188, Jeon et al., hereinafter Jeon '188, (published 12/05/2019; EFD 05/27/2019). (Note: WO document is in Korean; EP 3 808 375 A1 will be used as English translation, and paragraph or page numbers will refer to the EP document)
The instant claims are drawn to a method for the prevention or treatment of cancer comprising administering to a subject an anti-CD300c antibody and at least one additional anticancer agent. Dependent claims further define the additional anticancer agent, the cancer, and the administration of the two agents.
Jeon ‘188 discloses a method of treating cancer comprising administering to an individual a composition comprising a CD300c activity inhibitor, or an antibody (see claims 9, 1). Jeon’188 further discloses administration of an additional anticancer agent (claim 5), thereby anticipating instant claim 1. Paragraph [0011] of the specification recites that the anticancer agent may be doxorubicin, cisplatin, oxaliplatin, 5-fluorouracil, and the like, thereby anticipating instant claims 2, 13, and 14. Paragraph [0011] also recites that the anticancer agents are coadministered, anticipating instant claim 22. Jeon ‘188 discloses that the cancer may be selected from a list which encompasses that of instant claim 16, in claim 4 and paragraph [0010], thereby anticipating instant claim 16. The examples of Jeon ‘188 recite tumors, which are solid masses of cancer cells, anticipating claim 17. Claim 6 and paragraph [0012] of Jeon ‘188 recite that the pharmaceutical composition inhibits the proliferation, survival, metastasis, and recurrence of cancer, or resistance to an anticancer agent, anticipating instant claim 19. Finally, paragraph [0015] recites identifying the expression level of CD300c, anticipating claim 23. Therefore, Jeon ‘188 anticipates claims 1-2, 13-14, 16-17, 19, and 22-23.
Claim(s) 1-7, 9-10, 12-14, 16-17, 19, and 22 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO 2021/101244, Jeon et al., hereinafter Jeon '244 (published 5/27/2021; EFD 11/18/2020) (Note: WO document is in Korean; EP 4062934A1 will be used as an English translation, and page and paragraph numbers will refer to EP document).
The instant claims are drawn to a method for the prevention or treatment of cancer comprising administering to a subject an anti-CD300c antibody and at least one additional anticancer agent. Dependent claims further define the anti-CD300c antibody, the additional anticancer agent, the cancer, and the administration of the two agents.
Jeon ’244 discloses a method for preventing or treating cancer, comprising administering to an individual a composition that comprises an anti-CD300c monoclonal antibody in claim 17, and the composition further comprising a cancer immunotherapy in claim 7. Jeon ‘244 also discloses an antibody with HCDRs 1-3 of SEQ ID NOs: 79, 80, and 81, respectively, and LCDRs 1-3 of SEQ ID NOs: 82, 83, and 84, respectively, and a VH and VL of SEQ ID NOs: 327 and 328, respectively, in Jeon ‘244 SEQ ID NO: 14, thereby anticipating instant claims 3-7 and 9. Claim 8 of Jeon ‘244 recites possible cancer immunotherapies that can be co-administered with the anti-CD300c antibody, including those in instant claim 10, anticipating instant claims 2, 10, and 22. Moreover, paragraph [0065] of Jeon ‘244 recites pembrolizumab (Keytruda), thereby anticipating instant claim 12. Paragraph [0010] of Jeon ‘244 recites that a co-administered chemotherapy may be doxorubicin, cisplatin, and more, thereby anticipating instant claims 13 and 14. Claim 6 of Jeon ‘244 recites a list of cancers that overlaps with the list of instant claim 16, thereby anticipating instant claim 16. The examples of Jeon ‘244 recite tumors, which are solid masses of cancer cells, anticipating claim 17. Claim 9 of Jeon ‘244 recites that the pharmaceutical composition inhibits the proliferation, survival, metastasis, and recurrence, or therapy resistance of cancer, anticipating instant claim 19. Therefore, claims 1-7, 9-10, 12-14, 16-17, 19, and 22 are anticipated by Jeon ‘244.
Claim(s) 1-7, 9-10, 16-17, and 22-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shin et al., 2021, Annals of Oncology, 32, S572.
The instant claims are drawn to a method for the prevention or treatment of cancer comprising administering to a subject an anti-CD300c antibody and at least one additional anticancer agent. Dependent claims further define the anti-CD300c antibody, the additional anticancer agent, the cancer, and the administration of the two agents, as well as identifying expression levels of various markers to inform the method.
Shin et al. teaches a method of treating cancer comprising administering an anti-CD300c antibody, referred to as CL7, the same name given to the claimed antibody in the instant specification. The antibody of Shin is assumed to be the same as the claimed antibody. Therefore, Shin et al. anticipates claims 3-7 and 9. Shin et al. teach that treatment with the CL7 antibody results in changes in the expression of PD-1 and CTLA-4, and that, subsequently, CL7 was co-administered with a PD-1 blockade. Therefore, Shin et al. teach the method of claim 1, 2, 10, and 22, and the method further comprising measuring the expression of PD-1 and selecting the additional anti-cancer agent based on the expression level of the marker, teaching instant claims 24 and 25. Moreover, as the study of Shin et al. performs immune profiling with comparisons before and after treatment, Shin et al. teach a method of measuring the level of CD300c before administration, teaching instant claim 23. Shin et al. also teach measuring the effectiveness of the treatment based on the immune profile data, including the change in expression of PD-1 and CTLA-4, thereby teaching instant claim 26. Shin teaches administering the method to a mouse model of colon cancer, anticipating claim 16, comprising a tumor, anticipating claim 17.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7, 9-10, 12-14, 16-17, 19, and 22-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jeon '244 in view of Shin et al., 2021, Annals of Oncology, 32, S572, or, alternately, over Jeon '188 in view of Shin et al.
The instant claims are drawn to a method for the prevention or treatment of cancer comprising administering to a subject an anti-CD300c antibody and at least one additional anticancer agent. Dependent claims further define the anti-CD300c antibody, the additional anticancer agent, the cancer, and the administration of the two agents. The teachings of Jeon ‘188 and Jeon ‘244 are outlined above, under paragraphs 19 and 20, and the teachings of Shin et al. are outlined in paragraph 21.
Neither Jeon ‘244 or Jeon ‘188 disclose a method for the prevention or treatment of cancer comprising administering to a subject an anti-CD300c antibody and at least one additional anticancer agent and further comprising identifying the expression of a marker and selecting the additional anti-cancer agent based on the expression level of the marker, as recited in instant claims 24 and 25, or identifying the therapeutic responsiveness of the anti-CD300c antibody based on the expression level of the marker, as in instant claims 26 and 29. Jeon ‘244 and Jeon ‘188 also do not disclose measuring the level of CD300c before administration, as in instant claim 23.
However, Shin et al. do teach a method of treating cancer comprising administering an anti-CD300c antibody, referred to as CL7, the same name given to the claimed antibody in the instant specification. The antibody of Shin et al. is assumed to be the same as the claimed antibody. Shin et al. teach that treatment with the CL7 antibody results in changes in the expression of PD-1 and CTLA-4, and that, subsequently, CL7 was co-administered with a PD-1 blockade. Therefore, Shin et al. teach the method of claim 1, 2, 10, and 22, and the method further comprising measuring the expression of PD-1 and selecting the additional anti-cancer agent based on the expression level of the marker, teaching instant claims 24 and 25. Moreover, as the study of Shin et al. performs immune profiling with comparisons before and after treatment, Shin et al. teach a method of measuring the level of CD300c before administration, teaching instant claim 23. Shin et al. also teach measuring the effectiveness of the treatment based on the immune profile data, including the change in expression of PD-1 and CTLA-4, thereby teaching instant claim 26.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Jeon ‘244 or Jeon ‘188 with the immune profiling analysis of Shin et al. One would be motivated to do so in order to gain more information about the tumor microenvironment, as recited under ‘Results’ in Shin et al. One would have a reasonable expectation of success, as Shin et al. show this method of immune profiling provides useful data, such as the expression levels of PD-1. One would be motivated to select an antibody, such as an anti-PD-1 antibody, based on this data, as done in the ‘Results’ section of Shin et al., with the expectation of an enhanced anti-tumor responses, such as stronger suppression of tumor growth and longer overall survival, as seen in ‘Results’ of Shin et al. One would also be able to evaluate the data gathered from the immune profiling to determine if treatment was successful, as was done in Shin et al.
Additionally, it would be obvious to one of ordinary skill in the art to replace the polyclonal antibody of Jeon ‘188 with the CL7 anti-CD300c antibody of Shin et al. One would have a reasonable expectation of success because the antibodies target the same molecule, and one would be motivated to do so because the antibody of Shin et al., as recited under ‘Background’ of Shin et al., has a potent anti-tumor immune response and helps to enhance PD-1 activity in colon cancer.
Therefore, Jeon ’224 and/or Jeon ‘188 in view of Shin et al. teaches instant claims 1-7, 9-10, 12-14, 16-17, 19, and 22-26.
Claim(s) 1-7, 9-10, 12-14, 16-17, 19, 22, 24-26, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jeon '244 in view of Appiah-Kubi et al., 2016, Tumor Biol. 37, 10053–10066 (2016), or, alternately, claims 1-2, 13-14, 16-17, 19, 22-26, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Jeon '188 in view of Appiah-Kubi et al.
The instant claims are drawn to a method for the prevention or treatment of cancer comprising administering to a subject an anti-CD300c antibody and at least one additional anticancer agent. Dependent claims further define the anti-CD300c antibody, the additional anticancer agent, the cancer, and the administration of the two agents. The teachings of Jeon ‘188 and Jeon ‘244 are outlined above, under paragraphs 17 and 18.
Neither Jeon ‘244 or Jeon ‘188 disclose a method for the prevention or treatment of cancer comprising administering to a subject an anti-CD300c antibody and at least one additional anticancer agent and further comprising identifying the expression of a marker and selecting the additional anti-cancer agent based on the expression level of the marker, as recited in instant claims 24 and 25, or identifying the therapeutic responsiveness of the anti-CD300c antibody based on the expression level of the marker, as in instant claims 26 and 29. Jeon ‘244 and Jeon ‘188 also do not disclose measuring the level of CD300c before administration, as in instant claim 23.
Appiah-Kubi et al. teach that PDGFR-B is a biomarker of treatment response in several cancers. Moreover, Appiah-Kubi teach that PDGFR-B expression levels can indicate better response to treatment with several anti-cancer agents, including bevacizumab and imatinib, which are immunotherapies (as in instant claim 2) and/or chemotherapies (as in instant claims 2 and 13), respectively (see page 10056, left column, first paragraph). Therefore, Appiah-Kubi et al. teach identifying the expression level of PDGFR-B, as in instant claim 24, as well as selecting an anti-cancer agent based on this expression level, as in instant claim 25, and predicting the responsiveness to treatment anti-cancer treatment based on the expression of this marker, as in instant claims 26 and 29.
While Appiah-Kubi et al. does not directly teach this method of detecting PDGFR-B expression in the context of an anti-CD300c antibody, it does teach that PDGFR is implicated in several cancers, including breast, ovarian, prostate, colon, and NSCLC (see page 10055, left column, second paragraph, and table 1), which are implicated in the cancers listed at treated by the method of both Jeon ‘188 and ‘244. It would be obvious to one of ordinary skill in the art to augment the method of Jeon ‘188 or Jeon ‘244 with the measurement of a known cancer marker, such as PDGFR-B, to determine if treatment is successful. One would have a reasonable expectation of success as both CD300c and PDGFR-B are implicated in the same cancers. It is also obvious to use a known cancer marker like PDGFR-B to determine an additional cancer agent to be used, as PDGFR-B is known in the art to be a marker for increased efficacy of certain treatments. Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the methods of Jeon ‘188 or Jeon ‘244 by measuring levels of a marker to monitor effectiveness and determine additional treatments.
Therefore, taken together, claims 1-7, 9-10, 12-14, 16-17, 19, 22, 24-26, and 29 are obvious over Jeon ‘244 in view of Appiah-Kubi et al., and claims 1-2, 13-14, 16-17, 19, 22-26, and 29 are obvious over Jeon ‘188 in view of Appiah-Kubi et al.
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 1-7, 9-10, 12-14, 16-17, 19, 22-26, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 8-11, 13-18, and 35-37 of copending Application No. 17/746,569 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘569 claim 1(vii) and claim 5 are drawn to the same antibody as elected in the current application, and are the same as the antibody of instant claims 6 and 7. Claims 13-18 disclose a pharmaceutical composition comprising this antibody and another immunotherapy, similar to instant claims 2, 10, and 12. As this pharmaceutical composition is similar to that of the instant claims, and includes known anti-cancer immunotherapies, a method of using the composition to treat cancer is not patentably distinct from the claims of ‘569.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7, 9-10, 12-14, 16-17, 19, 22-26, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 14-16 of copending Application No. 18/862,251 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of '251 is drawn to a method for treating a degenerative brain disease comprising an anti-CD300c antibody to the subject, and claim 9 recites the same antibody as elected in the instant application and recited in instant claims 6 and 7. As the methods consist of essentially the same steps, and the instant method can be drawn to brain cancer, the two methods are patentably indistinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/AMELIA STEPHENS/Examiner, Art Unit 1645
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
Prosecution Insights