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 1-9, 15-17 and 19-23 are pending upon entry of amendment filed on 8/18/25
Applicant’s election of group I, claims 1-9, 15-17 and 19-21 without traverse in the reply filed on 8/18/25 has been acknowledged.
Accordingly, claims 22-23 are withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention. Claim 1-9, 15-17 and 19-21 are under consideration in the instant application.
3. Applicant’s IDS filed on 9/13/22, 6/20/24 and 11/21/24 have been acknowledged.
4. 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.
5. Claims 17 is 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 use of the term “optionally” in claim 17 and, renders the claim indefinite because it is unclear whether the limitations following such terms or phrases are part of the claimed invention. See MPEP 2173.05 (h).
6. 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.
7. Claim 1-9, 15-17 and 19-21 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a New Matter rejection.
The specification or the original claims as filed does not provide a written description the phrases “about 0.2wt% to 0.75% polysorbate, glycerol or combination thereof” as in claims 1 and 19. Applicants has not pointed out where the support comes from. The specification does not support ranges of surfactant and combination with glycerol at specific concentration as currently amended. In addition, no exemplary formulations that are encompassed by the currently amended claims including the polysorbate concentration and any concentration in the context with amended claims are present in the specification.
The currently amended range is not supported by the original claims or instant specification.
The instant claims now recite a limitation which was not clearly disclosed in the specification as filed, and now changes the scope of instant disclosure as filed.
Such limitations recited in the present claims, which did not appear in the specification as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C.112.
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 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 1-9, 15-17 and 19-21 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pub. 2016/0331815 (IDS reference) in view of WO2013/126799 (IDS reference) and U.S. Pub 2006/0088523.
The ‘815 publication teaches the use of silk-derived protein formulation comprising fibroin-derived protein having molecular weight of less than 60Kda including about 25Ka (Fig3) and the protein comprising at least 4% of glycine, serine and alanine and fibroin light protein chain is reduced by greater than 25% compared to the native ([0008-0009]). Further, the ‘815 publication teaches addition of 0.01% to about 2% (w/v) of buffer and MgCl2 ([0100-0101]) and the formulation comprising fibroin-derived protein treats ophthalmic disorders ([0112]).
Moreover, the ‘815 publication teaches the fibroin-derived protein comprises greater than 46% of glycine, serine content is being reduced greater than 40% and less than 8% of serine compared to native fibroin derived protein ([0063-0065]).
The disclosure of the ‘815 publication differs from the instant claimed invention in that it does not teach the use of 10-50mM of acetate buffer at pH 4-6.5, addition of osmotic agent and about 0.2-0.75% polysorbate as in claims 1 and 19 and addition of dextrose as in claim 15, specific osmolarity of formulation being 170-300 mOsm/kg as in claim 9 and 19 of the instant application, and storage container of glass as in claim 17 of the instant application, respectively.
The ’799 publication teaches use of silk derived protein (interchangeably use with fibroin-derived protein) in the composition comprising treatment of ophthalmic disorders (p.4-5, 15-20). Further, the ‘799 publication uses VEGF antibodies and silk-derived protein stabilizes antibody and allows addition of other therapeutic agents.
Likewise, the ‘523 publication teaches VEGF antibody formulations in the presence of histidine, acetate buffer at 10-50mM, polysorbate of 0.01-0.1% at pH 5.5 in the presence of various sugars (p.7, claims). The ‘523 publication includes glucose and the claimed dextrose is D-glucose, it reads on the claimed invention ([102]). In addition, the ‘523 publication teaches use of isotonic formulation having 250-350mOsm that is same as osmotic pressure of human blood ([0099]). Moreover, the ‘523 publication teaches the antibody formulation comprising acetate, polysorbate and sugar improve stability by reducing aggregates and the formulation is stable at least 3 months at 5oC ([0092, 379]) and the formulation is being packaged in glass ([0399]).
Given the teachings of the prior art, the prior art teacher FDO that read on the claimed protein. 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. Claimed limitation of having diameter of 10um of aggregate particulates in claim 1 is met.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize excipients taught by the ‘799 publication and ‘523 publication into the fibroin-derived protein compositions taught by the ‘815 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 specific excipient and buffer concentration adds stability by reducing aggregate, provides similar osmolarity as human blood and there is reasonable expectation of success as the ‘815 publication already taught excipients that are suitable for fibroin-derived protein.
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 1-9, 15-17 and 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Pat 9,394,355 in view of U.S. Pub 2016/00331815 and U.S. Pub 2006/0088523.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘355 patent teach fibroin derived protein at 30-60KDa and about 30KDa is overlapping in the claimed range.
The claims of the ‘355 patent differ from the claimed invention in that it does not teach use of acetate buffer, MgCl2, polysorbate and dextrose at pH about 6 and stable after greater than 12 weeks at 4-40oC as in claims 1, 9 and 19 of the instant application.
The teachings of the ‘815 and ‘523 publications have been discussed, supra.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize excipients taught by the ‘799 publication and ‘523 publication into the fibroin-derived protein compositions taught by the ‘355 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 specific excipient and buffer concentration adds stability by reducing aggregate, provides similar osmolarity as human blood and there is reasonable expectation of success as the ‘815 publication already taught excipients that are suitable for fibroin-derived protein.
13. Claims 1-9, 15-17 and 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Pat. 9,907,836 in view of U.S. Pub 2016/00331815 and U.S. Pub 2006/0088523.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘836 patent teach fibroin derived protein about 35-45 KDa and about 35KDa is overlapping in the claimed range.
The claims of the ‘836 patent differ from the claimed invention in that it does not teach use of acetate buffer, MgCl2, polysorbate and dextrose at pH about 6 and stable after greater than 12 weeks at 4-40oC as in claims 1, 9 and 19 of the instant application.
The teachings of the ‘815 and ‘523 publications have been discussed, supra.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize excipients taught by the ‘799 publication and ‘523 publication into the fibroin-derived protein compositions taught by the ‘836 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 specific excipient and buffer concentration adds stability by reducing aggregate, provides similar osmolarity as human blood and there is reasonable expectation of success as the ‘815 publication already taught excipients that are suitable for fibroin-derived protein.
14. Claims 1-9, 15-17 and 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Pat. 10,471,128 in view of U.S. Pub 2016/00331815 and U.S. Pub 2006/0088523.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘128 patent teach fibroin derived protein about 18.75-100 KDa and about 18.75 KDa is overlapping in the claimed range.
The claims of the ‘128 patent differ from the claimed invention in that it does not teach use of acetate buffer, MgCl2, polysorbate and dextrose at pH about 6 and stable after greater than 12 weeks at 4-40oC as in claims 1, 9 and 19 of the instant application.
The teachings of the ‘815 and ‘523 publications have been discussed, supra.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize excipients taught by the ‘799 publication and ‘523 publication into the fibroin-derived protein compositions taught by the ‘128 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 specific excipient and buffer concentration adds stability by reducing aggregate, provides similar osmolarity as human blood and there is reasonable expectation of success as the ‘815 publication already taught excipients that are suitable for fibroin-derived protein.
15. Claims 1-9, 15-17 and 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Pat. 11,045,524 in view of U.S. Pub 2016/00331815 and U.S. Pub 2006/0088523.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘524 patent teach fibroin derived protein about less than 100 KDa and about less than 100KDa is overlapping in the claimed range.
The claims of the ‘524 patent differ from the claimed invention in that it does not teach use of acetate buffer, MgCl2, polysorbate and dextrose at pH about 6 and stable after greater than 12 weeks at 4-40oC as in claims 1, 9 and 19 of the instant application.
The teachings of the ‘815 and ‘523 publications have been discussed, supra.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize excipients taught by the ‘799 publication and ‘523 publication into the fibroin-derived protein compositions taught by the ‘524 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 specific excipient and buffer concentration adds stability by reducing aggregate, provides similar osmolarity as human blood and there is reasonable expectation of success as the ‘815 publication already taught excipients that are suitable for fibroin-derived protein.
16. Claims 1-9, 15-17 and 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Pat. 11,242,367 in view of U.S. Pub 2016/00331815 and U.S. Pub 2006/0088523.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘367 patent teach fibroin derived protein about 25-50 KDa and about 25 KDa is overlapping in the claimed range.
The claims of the ‘367 patent differ from the claimed invention in that it does not teach use of acetate buffer, MgCl2, polysorbate and dextrose at pH about 6 and stable after greater than 12 weeks at 4-40oC as in claims 1, 9 and 19 of the instant application.
The teachings of the ‘815 and ‘523 publications have been discussed, supra.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize excipients taught by the ‘799 publication and ‘523 publication into the fibroin-derived protein compositions taught by the ‘367 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 specific excipient and buffer concentration adds stability by reducing aggregate, provides similar osmolarity as human blood and there is reasonable expectation of success as the ‘815 publication already taught excipients that are suitable for fibroin-derived protein.
17. Claims 1-9, 15-17 and 19-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S application 17/668,268 in view of U.S. Pub 2016/00331815 and U.S. Pub 2006/0088523.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘268 application teach fibroin derived protein about 25-60 KDa and about 25 KDa is overlapping in the claimed range.
The claims of the ‘268 application differ from the claimed invention in that it does not teach use of acetate buffer, MgCl2, polysorbate and dextrose at pH about 6 and stable after greater than 12 weeks at 4-40oC as in claims 1, 9 and 19 of the instant application.
The teachings of the ‘815 and ‘523 publications have been discussed, supra.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize excipients taught by the ‘799 publication and ‘523 publication into the fibroin-derived protein compositions taught by the ‘268 application.
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 specific excipient and buffer concentration adds stability by reducing aggregate, provides similar osmolarity as human blood and there is reasonable expectation of success as the ‘815 publication already taught excipients that are suitable for fibroin-derived protein.
18. Claims 1-9, 15-17 and 19-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Application 18/431596 in view of U.S. Pub 2016/00331815 and U.S. Pub 2006/0088523.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘128 patent teach fibroin derived protein about less than100 KDa and less than KDa is overlapping in the claimed range.
The claims of the ‘596 application differ from the claimed invention in that it does not teach use of acetate buffer, MgCl2, polysorbate and dextrose at pH about 6 and stable after greater than 12 weeks at 4-40oC as in claims 1, 9 and 19 of the instant application.
The teachings of the ‘815 and ‘523 publications have been discussed, supra.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize excipients taught by the ‘799 publication and ‘523 publication into the fibroin-derived protein compositions taught by the ‘596 application.
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 specific excipient and buffer concentration adds stability by reducing aggregate, provides similar osmolarity as human blood and there is reasonable expectation of success as the ‘815 publication already taught excipients that are suitable for fibroin-derived protein.
19. No claims are allowable.
20. 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 11, 2025
/YUNSOO KIM/Primary Examiner, Art Unit 1641