DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The preliminary amendment of 3/13/26 has been entered in full. Claims 1, 4-8, 10, 12-14, 17-18, 20-21 and 25 are amended. Claims 3, 11, 19 and 23-24 are canceled. Claims 1-2, 4-10, 12-18, 20-22 and 25 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because of the following informalities:
---The title of the invention is not descriptive because it is directed, in part, to “Uses Thereof” of the claimed antibody, the claimed methods that are directed to uses are limited to treatment of cancer. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: “An Antibody Against P-Cadherin and Uses Thereof in Treating Cancer”.
---The disclosure is objected to because it contains embedded hyperlinks at (browser-executable code) at page 11, line 23, and page 23, line 7. Applicants are required to delete the embedded hyperlinks; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01 (VII).
Appropriate correction is required.
Claim Objections
Claims 10 and 22 are objected to because of the following informalities:
In claim 10, lines 3 and 6, “bind” should be “binds”; lines 9, 10 and 11, “have” should be “has”; line 12, “inhibit” should be “inhibits”; line 13, “show” should be “shows”; and line 14, “being stable” should be “is stable”.
In claim 10, line 5, the shorthand term “EC50” should be accompanied by the full terminology the first time it is used; e.g., “half maximal effective concentration (EC50)”; see page 13 of the specification.
In claim 10, line 5, the acronym “FACS” should be accompanied by the full terminology the first time it is used; e.g., “fluorescence-activated cell sorting (FACs)”; see page 16 of the specification.
In claim 10, line 6, the shorthand term “KD” should be written as “KD”, and should be accompanied by the full terminology the first time it is used; e.g., “dissociation constant (KD)”; see page 13 of the specification.
In claim 10, line 11, the acronym “ADCC” should be accompanied by the full terminology the first time it is used; e.g., “antibody-dependent cellular cytotoxicity (ADCC)”; see page 56 of the specification.
In claim 22, the acronym “NSCLC” should be accompanied by the full terminology the first time it is used; e.g., “non-small cell lung cancer (NSCLC)”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 9-10, 12 and 14-16 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 pre-AIA the applicant regards as the invention.
In claim 9, the terms “preferably” (line 2) and “such as” (line 3) each render the claim indefinite because it is unclear whether the limitations following each term are part of the claimed invention. See MPEP § 2173.05(d). With respect to “preferably” and “such as”, it is unclear whether the claim requires that the constant domain is a human IgG1 constant domain or not, or whether the claim requires that the variants is one comprising L234A or L235A or not.
In claim 10, lines 3 and 12, the meaning of the term “nM grade” is unclear. If an EC50 range with a unit of nM is intended, this range should be enumerated.
In claim 10, lines 10 and 11, the term "benchmark" is a relative term which renders the claim indefinite. The term "benchmark" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “antibodies” is rendered indefinite by use of the term “benchmark”, as it is unclear what specific antibodies are encompassed.
In claim 12, the term “preferably” (line 3) renders the claim indefinite because it is unclear whether the limitations following each term are part of the claimed invention. See claim 9 above.
Claim 14 recites the limitations “the heavy chain variable region” and “the light chain variable region” in line 2. There is insufficient antecedent basis for this limitation in the claim. Specifically, claim 14 refers to “the heavy chain variable region and/or the light chain variable region of the isolated antibody as defined in claim 1”, but the antibody of claim 1 does not refer to a heavy or light chain variable region; as such, the recitations in claim 14 lack antecedent basis.
The remaining claim(s) included in the rejection are dependent claims that depend from one of the claims rejected above, and encompass the same indefinite subject matter.
Double Patenting
The nonstatutory double (NSDP) 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 NSDP 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 (TD) in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on NSDP 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 TD must be signed in compliance with 37 CFR 1.321(b).
The filing of a TD by itself is not a complete reply to a NSDP rejection. A complete reply requires that the TD 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 TD 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 (eTD) may be filled out completely online using web-screens. An eTD that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTDs, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4-10, 12-18, 20-22 and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27- of co-pending application 18/560,285, filed 11/10/23, and which shares the same applicant and inventors with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Instant claims 1 and 2 each encompass an isolated antibody that binds P-cadherin and comprising an HCDR1 comprising SEQ ID NO: 2; an HCDR2 comprising SEQ ID NO: 4; an HCDR3 comprising SEQ ID NO: 6; an LCDR1 comprising SEQ ID NO: 13; an LCDR2 comprising SEQ ID NO: 15; and an LCDR3 comprising SEQ ID NO: 17. Claim 27 of ‘285 encompasses an antibody-drug conjugate (ADC) comprising an antibody conjugated to a drug moiety, wherein the antibody binds P-cadherin and comprising six CDRs of SEQ ID NO: 1-6 that corresponds with 100% identity to the six CDRs recited in instant claim 1. As such, the portion of the ADC of ‘285 directed to the antibody encompasses an antibody of instant claim 1 or 2, and thus instant claims 1 and 2 are not patentably distinct from the claims of ‘285.
Instant claims 4 and 7 each encompass an antibody of claim 1 wherein the heavy chain variable region (VH) encompasses an amino acid sequence of SEQ ID NO: 21 and the light chain variable region (VL) encompasses an amino acid sequence of SEQ ID NO: 27. Claim 36 of ‘285 encompasses an antibody of claim 27 of ‘285 wherein the VH and VL are SEQ ID NO: 7 and 8, which are 100% identical to instant SEQ ID NO: 21 and 27. As such, claims 4 and 7 are not patentably distinct from the claims of ‘285.
Instant claims 5 and 6 each encompass an antibody of claim 1 wherein the antibody comprises a VH region comprising a HFRW1 of SEQ ID NO: 1 and a VL region comprising a LFRW1 region of SEQ ID NO: 19. As shown in the specification in Table B, the LFRW1 region of SEQ ID NO: 19 includes an amino acid substitution with respect to the LFRW1 region of SEQ ID NO: 12 of the parental antibody, and thus meets the limitation of claim 5 with respect to one or more substitutions of amino acids in FRW1 of the VL region. Furthermore, the sequence of SEQ ID NO: 19 is found within SEQ ID NO: 27 as shown in Table C. As such, the limitations of claims 5 and 6 are also met by claim 36 of ‘285, which encompasses an antibody of claim 27 of ‘285 wherein the VL and VL are SEQ ID NO: 7 and 8, which are 100% identical to instant SEQ ID NO: 21 and 27. As such, claims 5 and 6 are not patentably distinct from the claims of ‘285.
Instant claims 8 and 9 each encompass an antibody of claim 1 wherein the antibody further comprises a human IgG1 constant claim. This corresponds to the further limitations of claim 37 of ‘285. As such, claims 8 and 9 are not patentably distinct from the claims of ‘285.
Instant claim 10 encompasses an antibody of claim 1 that binds to cell surface human P-cadherin with an EC50 in nM grade as measured by FACs. The portion of the specification that informs the claimed antibody of independent claim 27 of ‘285 is properly construed as encompassing an antibody with this property (page 28); as such, claim 10 is not patentably distinct from the claims of ‘285.
Instant claim 12 encompasses an antibody of claim 1 that is humanized. The portion of the specification that informs the claimed antibody of independent claim 27 of ‘285 is properly construed as encompassing humanized antibodies (page 4); as such, claim 12 is not patentably distinct from the claims of ‘285.
Instant claim 13 encompasses an antibody of claim 1 wherein the heavy chain comprises a VH of SEQ ID NO: 21 and a constant region of SEQ ID NO: 29, and the light chain comprises a VL of SEQ ID NO: 27 and a constant region of SEQ ID NO: 30. This corresponds to dependent claim 39 of ‘285, which recites a heavy chain comprises a VH of SEQ ID NO: 7 and a constant region of SEQ ID NO: 9, and the light chain comprises a VL of SEQ ID NO: 8 and a constant region of SEQ ID NO: 10. As such, claim 13 is not patentably distinct from the claims of ‘285.
Instant claims 14-16 are directed to a nucleic acid (claim 14), vector (claim 15), or host cell (claim 16) encoding the antibody of claim 1. Such a nucleic acid, vector and host cell are used in the method of producing the antibody of claim 41 of ‘285, and as such claims 14-16 are not patentably distinct from the claims of ‘285.
Instant claim 17 encompasses a pharmaceutical composition comprising an antibody of claim 1 and a pharmaceutically acceptable carrier. Claim 40 of ‘285 is directed to a pharmaceutical composition comprising an ADC of claim 27 and a pharmaceutically acceptable carrier. As such, claim 17 is not patentably distinct from the claims of ‘285.
Instant claim 18 encompasses a method for producing the antibody of claim 1 comprising two steps that correspond to the first two steps of the method of dependent claim 41 of ‘285, and as such claim 18 is not patentably distinct from the claims of ‘285.
Instant claims 20-22 encompass a method of treating P-cadherin positive cancer in a subject comprising administering an antibody of claim 1 to the subject (claim 20), and wherein the cancer is breast cancer (claims 21 and 22). These claims correspond to the method of treatment of claims 43-45 of ‘285. As such, claims 20-22 are not patentably distinct from the claims of ‘285.
Instant claim 25 encompasses a kit for treating cancer comprising a container comprising the antibody of claim 1. This claim corresponds to the kit of claim 46 of ‘285, which comprises a container comprising the ADC of claim 27 of ‘285. As such, claim 25 is not patentably distinct from the claims of ‘285.
Notes on Patentability
(1) No prior art has been identified that teaches or suggests an anti-P-cadherin antibody or antigen-binding portion thereof that comprising the specific CDR sequences required by the claims; specifically, the combination of an HCDR1 comprising SEQ ID NO: 2; an HCDR2 comprising SEQ ID NO: 4; an HCDR3 comprising SEQ ID NO: 6, 8, 9, 10 or 11; an LCDR1 comprising SEQ ID NO: 13; an LCDR2 comprising SEQ ID NO: 15; and an LCDR3 comprising SEQ ID NO: 17.
(2) The relevant prior art recognized that P-cadherin was overexpressed in a variety of cancers. Kudo et al (2017. Scientific Reports. 7(39518):1-15) teaches, “P-cadherin is a cell adhesion protein expressed in squamous epithelium … but whose overexpression is strongly associated with a poor prognosis in lethal cancers including lung, pancreatic, and breast cancers … In particular, overexpression of P-cadherin has been linked to cancer, cell metastatic dissemination, and aberrant growth” (page 1). Kudo further demonstrates that an anti-P-cadherin antibody can abolish the cell adhesion mediated by the protein (see Abstract). Imai et al (2018. Lung Cancer. 118: 13-19) teaches that “Placental (P)-cadherin expression is associated with malignant phenotype of cancer cell” (see Abstract); “[u]pregulated P-cadherin expression is reportedly associated with tumor progression and poor patient survival in some invasive epithelial tumors, including breast … and pancreatic cancer” (page 14); and “high P-cadherin expression [in NSCLC samples] was associated with malignant phenotype and poor prognosis” (page 18).
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674
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