DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1, 2, 5 and 7-15 are pending upon entry of amendment filed on 5/11/23.
Claims 1, 2, 5 and 7-15 are under consideration in the instant application.
3. Applicant’s claim for the foreign priority under 35 U.S.C. 119(a)-(d) is acknowledged.
4. Applicant’s IDS filed on 8/2/23, 9/7/23 and 7/2/24 have been acknowledged.
5. The oath filed on 10/3/23 has been acknowledged.
6. 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. Claims 1, 2, 5 and 7-15 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.
The claims recite “α4β7 antibody”. It is not clear whether this antibody must bind α4β7 or the antibody needs to be conjugated to α4β7. It is recommended that Applicant amend the claims to read “anti- α4β7 antibody” or antibody that binds α4β7.
Further, claim 10 recites “main peak” that is a relative term which renders the claim indefinite. The term main peak is not defined by the claim and the specification does not provide standard ascertaining the requisite degree and one of ordinary skill in the art would not reasonably apprised of the scope of the invention.
8. 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 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.
9. 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.
10. Claim(s) 1, 2 and 8 is/are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by U.S. Pub. 2005/0053598.
The ‘598 publication teaches anti-α4β7 antibody formulation comprising phosphate buffer at pH 6.5 in the presence of NaCl and 0.02% of polysorbate and histidine (claims 1-39). Given that the further addition of histidine reads on addition of free amino acid as in claim 1, it meets the claimed limitation. Also, claim 2 is included in this rejection as the preferred embodiments is silent of the addition of PEG or antioxidant in formulation (note claims).
In addition, claim 9 is included in this rejection as the products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. Therefore, the reference teachings anticipate the claimed invention.
11. 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 of this title, 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.
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.
12. Claims 1, 2, 5 and 7-15 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pat. 9,764,033 (IDS reference) in view of U.S. Pub. 2005/0053598.
The ‘033 patent teaches vedolizumab (anti-α4β7 antibody) compositions comprising arginine, histidine buffer, polysorbate at about pH 6.5 (claims 1-33). Note the ‘033 patent teaches the concentration of antibody ranges greater than 120mg/ml and dose of 300mg that is inclusive of 160mg/ml-175mg/ml as in claims 7, 13 and 15. In addition, the ‘033 patent teaches methods of reducing aggregates after storage at room temperature or 40oC after addition of arginine, histidine buffer and polysorbate (Examples, Tables 1-40).
Further, the ‘033 patent teaches reducing particles sizes of aggregates (col. 19-20) readable upon controlling antibody aggregate formation with SEC-HPLC, IEX as in tables, meets the limitations of claims 9-15.
The disclosure of the ‘033 patent differs from the instant claimed invention in that it does not teach the use of NaCl as in claim 1 of the instant application.
The teachings of the ‘598 publication have been discussed, supra.
The ‘598 publication further teaches NaCl improves purity during purification and yield (p. 5) and help maintains sterility ([0051], p. 6). NaCl also works as tonicity modifier in antibody formulation ([0030]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize NaCl as taught by ‘598 publications the antibody compositions taught by the ‘033 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of NaCl may be helpful in improving purity and yield during the purification and enhances sterility during the packaging.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
13. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
14. Claims 1, 2, 5 and 7-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims U.S. Application No. 17/045,405.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘405 application recites a pharmaceutical composition comprising anti-α4β7 antibody, buffer, NaCl and surfactant.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
15. Claims 1, 2, 5 and 7-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims U.S. Application No. 17/045,336.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘336 application recites a pharmaceutical composition comprising anti-α4β7 antibody, buffer, NaCl and surfactant.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
16. Claims 1, 2, 5 and 7-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims U.S. Application No. 17/766,823.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘823 application recites a pharmaceutical composition comprising anti-α4β7 antibody, buffer, NaCl and surfactant.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
17. Claims 1, 2, 5 and 7-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims U.S. Application No. 18/265,812.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘812 application recites a pharmaceutical composition comprising anti-α4β7 antibody, buffer, NaCl and surfactant.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18. No claim is allowed.
19. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
December 3, 2025
/YUNSOO KIM/Primary Examiner, Art Unit 1641