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 .
Status of Claims
Claims 28-48 are pending.
Claims 30-48 are new.
Claims 28 and 29 are amended.
Claims 28-48 are currently under examination on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The U.S. effective filing date of all claims under examination is set at 12/18/2020 based on the foreign provisional application EP20215766 (filed 12/18/2020).
Information Disclosure Statement
The information disclosure statement (IDS) submitted are being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on Pg. 33 Paragraph [00127]: http://www.uniprot.org. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http://, www., or other browser-executable code. See MPEP § 608.01.
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 43 and 46-48 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 43, 46 and 48, and dependent claim 47, are rejected because claims 43, 46 and 48 recite “….wherein the first bispecific antibody molecule…..”. There is insufficient antecedent basis for “the first bispecific antibody molecule” in the claims.
Claim 48 is rejected because the claim recites in line 2 the phrase “of the CEAMCAM5 x CD3 bispecific antibody” is unclear. It appears that the bispecific antibody molecule should be a CEACAM5 x CD47 bispecific antibody. There is insufficient antecedent basis for “the CEAMCAM5 x CD3 bispecific antibody” in the claim.
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.
First NSDP U.S. Patent No. US11753481B2
Claims 28-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. US11753481B2 in view of Fletcher et al. (WO2018098384A1 (Date Published 2018-05-31).
The patent claims are drawn to the same CEACAM5 X CD47 bispecific antibodies as the CEACAM5 X CD47 bispecific antibodies of the instant claims. However, the patent does not specifically also recite a method of treating a solid cancer comprising administering to a subject in need thereof a therapeutically effective amount of the said bispecific antibodies. However, these deficiencies are rendered obvious by Fletcher et al.
Fletcher et al. teaches a bispecific protein comprising a first binding domain that targets human CD47 protein and a second binding domain that targets CEACAM5, a human colon cancer antigen (paragraph [037]). They teach that a bispecific protein that can bind to both CD47 and CEACAM5, wherein both are present on cancer cell surfaces, can overcome the ability of cancer cells expressing CD47 to evade recognition by macrophages, thereby causing a macrophage to phagocytose a tumor cell that it otherwise would, making it a protein used in a method for immunotherapy or in a method to enhance the effectiveness of an immunotherapy (paragraphs [015], [017] and [037]).
Therefore, it would be obvious to administer the patented bispecific antibody which binds to human CEACAM5 and human CD47 to a subject to treat cancer because Fletcher et al. teaches that using such a bispecific protein can facilitate exposure of cancer cells to phagocytosing macrophages for cancer immunotherapy or to enhance the effectiveness of an immunotherapy to treat cancer (paragraphs [015], [017] and [037]).
It is noted instant claims 35 and 41-48 passively state reagents “is administered” or “are administered” and do not require one performing the claimed method to actively administer recited products.
Second NSDP Application No. 18/875,477
Claims 28-43 and 45-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-20, 22 and-31 of copending Application No. 18/875,477.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and copending claims are both drawn to methods of treating a patient having a CEACAM5-expressing cancer comprising administering to the patient a therapeutically effective amount of a first bispecific antibody in recited doses and in combination with a second bispecific antibody comprising a human CEACAM5 binding part and a human CD3ɛ binding part. The first bispecific antibody of the copending claims is identical to the instant bispecific antibody comprising a first binding part that binds specifically to human CEACAM5 comprising CDRH1 is SEQ ID NO:1, CDRH2 is SEQ ID NO:2 and CDRH3 is SEQ ID NO:3 and CDRL1 is SEQ ID NO:23, CDRL2 is SEQ ID NO:24, and CDRL3 is SEQ ID NO:25 and a second binding part that binds specifically to human CD47 comprising CDRH1 is SEQ ID NO:1, CDRH2 is SEQ ID NO:2 and CDRH3 is SEQ ID NO:3 and CDRL1 is SEQ ID NO:7, CDRL2 is SEQ ID NO:8, and CDRL3 is SEQ ID NO:9.
Regarding instant claim 32, SEQ ID NO:27 of copending claim 22 is comprised in instant SEQ ID NO:6. In addition, copending specification discloses that the common heavy chain HC of the bispecific antibody is SEQ ID NO:27 (VH-CH1) and further defines that the common heavy chain cHC of the bispecific antibody is of SEQ ID NO:28 (VH-CH1-CH2-CH3) (Pg. 24 lines 3-6 of the copending specification, in particular). Alignment of copending SEQ ID NO:28 with instant SEQ ID NO: 6 shows that they are an exact match (alignment not shown).
Regarding instant claim 33, the copending specification discloses copending claimed bispecific antibody CEACAM5 x CD47 re-directs and activates macrophages against CEACAM5-expressing solid tumors in combination therapy with CEACAM5 x CD3 bispecific antibodies to increase the tumor cell killing effect of the CEACAM 5 x CD3 bispecific antibodies and to avoid increased risk of Cytokine Release (Pg. 4 lines 11-16 of the copending specification, in particular).
Regarding instant claim 34, the CEACAM5 expressing cancer of copending claim 16 abnormally expresses CEACAM5 as compared to normal tissue of the same type lacking CEACAM5 expression.
Regarding instant claim 36, the copending specification discloses copending claimed bispecific antibody of CEACAM5 x CD47 is characterized in being monovalent for the first binding part and monovalent for the second binding part (Pg. 9 lines 5-6 of the copending specification, in particular).
Regarding instant claim 37, the copending specification discloses copending claimed bispecific antibodies both comprise constant and variable framework region sequences that are human (Pg. 8 lines 34-35 of the copending specification, in particular).
Regarding instant claim 38, the copending specification discloses copending claimed bispecific antibody where the light chain of one binding part comprises a lambda light chain and a light chain of the other binding part comprises kappa light chain (Pg. 24 lines 20-23 of the copending specification, in particular).
Regarding instant claim 39, the copending specification discloses copending claimed bispecific antibodies both are human IgG1 type (Pg. 9 lines 1-4 of the copending specification, in particular).
Regarding instant claim 40, the copending specification discloses copending claimed bispecific antibody CEACAM5 x CD47 is characterized in comprising a Fc region that has been glycoengineered to have a reduced number of fucose residues as compared to the same bispecific antibody that has not been glycoengineered (Pg. 9 lines 8-11 of the copending specification, in particular).
Regarding instant claim 41, the copending specification discloses copending claimed bispecific antibody combination can be administered in combination with chemotherapy or radiation therapy to a human subject (Pg. 11 lines 21-24 of the copending specification, in particular).
Regarding instant claim 43, the CEACAM5 binding parts of the two bispecific antibodies of copending claim 16 appear to bind different epitopes due to differences in the VH and VL domain CDR sequences of the two CEACAM5 binding parts.
Regarding instant claim 47, the copending specification discloses copending claimed first bispecific antibody and the second bispecific antibody are administered to said subject simultaneously in 2 to 15 day intervals (Pg. 12 lines 9-12 of the copending specification, in particular).
Therefore, the copending claims anticipate the instant claims and are so rejected.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yie-Chia Lee (Tonya) whose telephone number is (571)272-0123. The examiner can normally be reached Monday - Friday 7.30a - 3.30p Eastern Time Zone.
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/YIE-CHIA LEE (TONYA)/Examiner, Art Unit 1642
/SEAN E AEDER/Primary Examiner, Art Unit 1642