DETAILED ACTION
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 the Claims
Claims 1-15 and 17 are pending.
Information Disclosure Statement
The information disclosure statement submitted on 13 February 2026 filed after the mailing date of the non-final Office action on 29 December 2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Withdrawn Rejections
Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn.
Response to Arguments
Applicant’s arguments, see pg. 6-7, filed 18 March 2026, with respect to the rejections of claims 1-15 and 17 under 35 U.S.C. 102(a)(1) and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made below.
Claim Rejections - 35 USC § 103
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Sheha et al. (Clinical Ophthalmology, 2019) in view of Lacoste et al. (US 2022/0257809 A1), BormedTM SB815MO by Borealis (Product Data Sheet, 2020) and BormedTM SC876CF by Borealis (Product Data Sheet, 2014).
Regarding claims 1-15 and 17, Sheha et al. teach recombinant human nerve growth factor (rhNGF; cenegermin) as an ophthalmic solution for eye drops packaged in a carton of 7 multi-dose vials. The inactive ingredients in the product include disodium hydrogen phosphate anhydrous, hydroxypropyl methylcellulose, L-methionine, mannitol, polyethylene glycol 6000, sodium dihydrogen phosphate dihydrate, trehalose dihydrate, water, and hydrochloric acid and/or sodium hydroxide to adjust pH to 7.1–7.3 (pg. 1975-1976).
Sheha et al. do not explicitly disclose that the vials are a plastic container having an inner contact surface comprising greater than 80% by weight of a propylene-ethylene copolymer having a melting enthalpy of 35-95 J/g, a melting temperature of 130-160 °C, and an ethylene monomer content of between 5% and 40%, as instantly claimed.
Lacoste et al. teach packaging for preserving a sterile aqueous pharmaceutical composition comprising at least one inner layer of polypropylene, wherein the packaging is a bottle or a vial (Claims 1, 11 and 14). Lacoste et al. teach that commercially available polypropylenes are for example the polypropylene BORMED SB815MO by Borealis ([0029]). Also, Lacoste et al. teach that the active ingredients include proteins ([0074]).
Borealis teach that BormedTM SB815MO is a polypropylene random-heterophasic copolymer intended for evaluation for use in Healthcare applications. This grade is designed for production of bottles & ampoules for use in Pharmaceutical & Diagnostic applications (Description).
Borealis teach that BormedTM SC876CF is a random heterophasic copolymer for Medical devices or Pharmaceutical & Diagnostic packaging (Description).
The instant specification teaches that BormedTM SB815MO and BormedTM SC876CF are within the scope of the claimed propylene-ethylene copolymer package.
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to use the ampoules according to Lacoste et al. and BormedTM SB815MO by Borealis and BormedTM SC876CF by borealis for storage and delivery of the rhNGF according to Sheha et al. It would have been obvious for a person of ordinary skill in the art to use known and commercially available propylene-ethylene copolymers for the preparation of the vials according to Sheha et al., and Lacoste et al., BormedTM SB815MO and BormedTM SC876CF teach that their copolymers are intended for use in the production of bottles and ampoules for use in pharmaceutical and diagnostic applications.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nathan W Schlientz whose telephone number is (571)272-9924. The examiner can normally be reached 10:00 AM to 6:00 PM, Monday through Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571) 272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.W.S/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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