DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to filed provisions of the AIA .
2. Claims 16-17 and 22-39 are pending upon entry of amendment filed on 2/16/24.
Claims 16, 17 and 22-39 are under consideration in the instant application.
3. Applicant’s IDS filed on 5/1/24 (two entries) and 6/2/26 have been acknowledged.
Copies of non-patent literatures are found in U.S.S.N. 16/715,580. The supplemental IDS filed on 5/1/24 has been considered and treated as PTO-1449.
4. The oath filed on 2/16/24 has been acknowledged.
5. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
6. 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.
7. 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.
8. Claim(s) 16-17 and 22-35 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by U.S. Pub. 2016/0340420 (IDS reference).
The ‘420 publication teaches treatment of ocular disease mediated by VEGF antibody in aqueous pharmaceutical compositions for VEGF antibody at least 50mg/ml, about 6.75% sucrose, 0.01% sodium citrate, 0.05% polysorbate at pH about 6.8-7.3 (claims 1, 19-24) including delivery device for the antibody composition. The prior art SEQ ID NO:1-4 are identical to the claimed SEQ ID NO:1-4. The ocular disease includes neovascular diseases and the particulate matters of greater than 10microns are not increased after 3 days of shaking stress (Table 10)/
The ’420 publication further teaches treatment dosage of 3mg or 6 mg antibody for ocular administration ([0052]), 10mM citrate buffer, sucrose concentrations of 5.8% and 6.5% and the polysorbate ranges from 0.001-0.01% in Tables 7-11 at various pH including 7.2, claims 32-36 are included in this rejection. Therefore, the reference teachings anticipate the claimed invention.
9. 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.
10. Claims 16 and 36-39 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pub. 2016/0340420 (IDS reference) in view of WO2009/155724.
The teachings of the ‘420 publication have been discussed, supra.
The disclosure of the ‘420 publication differs from the instant claimed invention in that it does not teach treatment of ocular disorders set forth in 36-39 of the instant application.
The ‘724 publication teaches the use of VEGF antibody in treatment of nAMD, DME or PDR (note claim 59, p.43-38).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to expand VEGF antibody in treatment of AMD, DME or PDR as taught by the ‘724 publication in treatment of vascular/ocular disorder treatment taught by the ‘420 publication.
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 known stable VEGF antibody formulation adds stability in VEGF antibody and expand therapeutic applicability to other species of VEGF antibody treatable ocular disorders.
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.
11. 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.
12. Claims 16-17 and 22-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-18 of U.S. Pat. 10,689,438.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘438 patent recite treatment of vascular disorder comprising a pharmaceutical composition comprising VEGF antibody set forth in SEQ ID NO:1-4 at 60-120mg/ml, citric acid 0.01%, 5-10% of sucrose and 0.001-0.1% polysorbate 80 at pH about 6.8.
13. Claims 16 and 36-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-18 of U.S. Pat. 10,689,438 in view of WO2009/155724.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘438 patent recite treatment of vascular disorder comprising a pharmaceutical composition comprising VEGF antibody set forth in SEQ ID NO:1-4 at 60-120mg/ml, citric acid 0.01%, 5-10% of sucrose and 0.001-0.1% polysorbate 80 at pH about 6.8.
The claims of the ‘438 patent differ from the instant claimed invention in that it does not recite treatment of ocular disorders set forth in 36-39 of the instant application.
The ‘724 publication teaches the use of VEGF antibody in treatment of nAMD, DME or PDR (note claim 59, p.43-38).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to expand VEGF antibody in treatment of AMD, DME or PDR as taught by the ‘724 publication in treatment of vascular/ocular disorder treatment taught by the ‘438 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 known stable VEGF antibody formulation adds stability in VEGF antibody and expand therapeutic applicability to other species of VEGF antibody treatable ocular disorders.
14. No claims are allowable.
15. 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
September 3, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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