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 .
Priority
This application is a 371 of PCT/US2021/045963 (08/13/2021)
PCT/US2021/045963 has PRO 63/065,118 (08/13/2020).
Status
Claims 1-2, 4-6, 8, 11-18, 23, 28, 30, 34, 41, 81, 94 are pending.
Rejections not reiterated in this action are withdrawn.
Claim Rejections - 35 USC § 102
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.
Claim 41 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Limjeerajarus et al. (Key Engineering Materials, 2020-08-03, 856(11): p. 391-398).
Limjeerajarus teaches “a Thermo-Sensitive Injectable Hydrogel as an Iloprost Delivery System for Dental Use” (Title) “that prolonged the release of iloprost for up to 5 days in vitro” (p. 396). Limjeerajarus teaches the composition also comprises PF-127 hydrogel (also known as poloxamer 407) (p. 392). The prior art product has substantially the same structure as the product of the claim and in its normal use would result in the same concentration and time range. As per MPEP 2112.01: Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Response to Remarks - 35 USC § 102
Applicant amended claim 1 adding the language “wherein the composition is a phospholipid gel” and argues that claim 1 is thus novel.
Regarding claims depending from claim 1 the rejection is withdrawn. Applicant does not argue claim 41 which is independent. This rejection is maintained.
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.
Claims 1-2, 4-6, 8, 11-18, 23, 28, 30, 34, 41, 81 are rejected under 35 U.S.C. 103 as being unpatentable over Limjeerajarus et al. (Key Engineering Materials, 2020-08-03, 856(11): p. 391-398) in view of Chen et al. (US20120316108).
Regarding amended claim 1, Limjeerajarus teaches iloprost formulated in a sustained release biocompatible polymer, hydrogel depot (Title: “a Thermo-Sensitive Injectable Hydrogel as an Iloprost Delivery System for Dental Use”; p. 396: “that prolonged the release of iloprost for up to 5 days in vitro”). Limjeerajarus does not teach a phospholipid gel.
Chen teaches phospholipid gel compositions for sustained release of pharmaceuticals (Abstract, claim 1, [0097]-[0104]). Chen teaches phospholipid gels for formulation have advantages over polymer-based depots, including smaller diameter needle size for injection ([0005]). Chen teaches the gel compositions are applicable to a wide range of pharmaceutical agents ([0097]-[0104]).
One of ordinary skill in the art would have reasonably considered improving Limjeerajarus’ injectable hydrogel by utilizing the phospholipid gel of Chen and arrive at the claimed invention. Once of ordinary skill in the art would have been motivated by the combined teaching of the prior art to create a controlled release formulation with the beneficial aspects of the phospholipid gel. One of ordinary skill in the art had a reasonable expectation of success because both prior art references are to injectable controlled release formulations in the same field of endeavor. Such a modification of Limjeerajarus’ injectable composition with an improved equivalent for the same purpose is prima facie obvious. MPEP 2144.06.
Regarding claims 2 and 4, Chen teaches optimized plasma drug concentration profiles and dose adjustment ([0201]-[0202], [0326]-[0355]) as does Limjeerajarus (p. 395-396) that one of ordinary skill in the art would have considered the optimization as a well-known results-effective variable and arrive at the claimed invention.
Regarding claim 5, both Limjeerajarus and Chen teach formulation for subcutaneous administration.
Regarding claim 6, Limjeerajarus teaches varying the weight percent to optimize the iloprost delivery (p. 391-92) that one of ordinary skill in the art would have considered routine optimization of a results-effective variable.
Regarding claim 8, Chen teaches the composition comprises phospholipids including lecithin (claim 12).
Regarding claims 11-12, Chen teaches the composition comprises oil, including vitamin E (claim 13).
Regarding claim 13, Chen teaches the composition comprises sucrose (claim 14).
Regarding claim 14, Chen teaches the composition comprises an acidifying agent (claim 16).
Regarding claim 15, Chen teaches the composition comprises an ethanol (claim 15).
Regarding claim 16, Chen teaches the composition is injectable (claim 18).
Regarding claim 17, Chen teaches the composition is nanoemulsion (claim 1, [0063]).
Regarding claim 18, Chen teaches the composition comprises a peptide ([0097]).
Regarding claim 23, Chen teaches the composition comprises a liposome ([0007]-[0008]).
Regarding claim 28, Chen teaches the composition comprises average particle sizes of 30 -200 nm ([0030]).
Regarding claims 30, 34, Chen teaches the composition comprises micro particles ([0071]: “phospholipid particles or oil droplets of size greater than 500 nm in diameter”) that one of ordinary skill in the art would optimize for utility in being injectable.
Regarding claim 41, Limjeerajarus teaches the same composition as detailed in the 35 USC 102 rejection.
Regarding claim 81, Limjeerajarus teaches a pH which is “about” the same as defined in the instant specification ([0056]) and one of ordinary skill in the art would have considered optimization of the pH to improve efficacy and arrive at the claimed invention.
Claim 94 is rejected under 35 U.S.C. 103 as being unpatentable over Limjeerajarus et al. (Key Engineering Materials, 2020-08-03, 856(11): p. 391-398) in view of Chen et al. (US20120316108) as applied to claims 1-2, 4-6, 8, 11-18, 23, 28, 30, 34, 41, 81 above and further in view of Visalli et al. (J Rare Dis Res Treat. (2017) 2(4): 6-13).
Regarding claim 94, Visalli teaches injection of the iloprost to treat infection including digital ulcer and gangrene in systemic sclerosis patients (p. 6, Table 1) and one of ordinary skill in the art would have considered utilizing the composition in the same manner including those recited in the claim.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
Response to Remarks - 35 USC § 103
Applicant amended claim 1 adding the language “wherein the composition is a phospholipid gel” and argues that claim 1 is thus novel. Applicant argues that one of ordinary skill in the art would not be motivated to develop a phospholipid gel composition as claimed because Limjeerajarus does not teach such a gel.
This argument is not persuasive because as detailed in the 35 USC 103 rejection above, one of ordinary skill in the art would have considered known alternative injectable formulations that provide controlled release and arrive at the claimed invention with a reasonable expectation of success.
Conclusion
No claims allowed. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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