DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/26/2025 has been entered.
Amendments
Applicants’ amendments to the claims filed 8/26/2025 have been entered. Any objection\rejections from the previous office action filed 3/28/2025 not addressed below has been withdrawn.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 2,4-5,16-18,22,23,27,30-32,34 and 113 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fu et al. (WO 2016/118001), cited previously, in view of Grinblat et al. (WO 02/051426).
Fu teaches a nanocarrier delivery system comprising ascorbic palmitate, cholesterol (meeting lipid in claims 5,27), PEG-DSPE (meeting polymer comprising PEG recited in claim 16-17) and γ-tocotrienol (GT3), the nanocarriers carried a negative charge for zeta potential. See entire disclosure, especially abstract, Ex 3 and claims 1,4,7-11 and 22. Regarding the mol% recited in claims 4,18,22, 27, on percent GT3, lipid, PEG-DSPE and cholesterol, from table 1 the examiner calculated the mol % of GT3 is 11.6, PEG-DSPE is 2-6 %, lipid is 87% and cholesterol 29%, within the claimed ranges. See Ex 1 and table 1. Regarding claim 23, the size of the nanocarrier was less than 150 nm, the data point of 150 nm is within the claimed range. Regarding claims 30-32, which recite physical properties or functional limitations on the particle’s zeta potential, radiolabeling efficiency over time and diameter variance over time, it follows that since the nanocarrier is within the scope of the pending claims it will feature these same properties. Note that no radiolabel is recited in claim 2, thus the recitation of radiolabeling efficiency is considered to be a property of the composition if a radiolabel is added. Such properties would be the natural result of following the teachings of Fu and producing a liposome within the claimed scope.
Fu does not teach the claimed active agents including androstenedione recited in claim 2.
Grinblat is used for its disclosure that liposome type of delivery vehicles were already well known to be capable of delivering androstenediol, which was used to improve muscle strength and mass and/or treat sexual dysfunction. See entire disclosure, especially abstract and claims 1 and 14.
Since Fu teaches delivery of a number of active agents one of ordinary skill in the art could reason numerous agents such as the androstenediol of Grinblat could be added/substituted into the liposomes of the primary reference with a high expectation of success. Reason to make such a substitution would be to provide liposomal delivery of androstenediol to one in need of improved muscle strength or for treatment of sexual dysfunction. Thus, the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claim(s) 2,4-5,16-18,22,23,27,30-32,34 and 113 is/are rejected under 35 U.S.C. 103 as being unpatentable over over Garcia et al. “Neutral and Anionic Liposome-Encapsulated Hemoglobin: Effect of Postinserted Poly(ethylene glycol)-distearoylphosphatidyl ethanolamine on Distribution and Circulation Kinetics”, Journal of Pharmacology and Experimental Therapeutics April 2004, 309 (1) 241-248, cited IDS, in view of Ghosh et al. “Gamma-tocotrienol, a tocol antioxidant as a potent radioprotector”, International Journal of Radiation Biology, Volume 85, 2009 - Issue 7, cited IDS, in view of Grinblat et al. (WO 02/051426).
Garcia teaches neutral and anionic liposome-encapsulated hemoglobin, containing Pegylated DSPC (reading on polymer containing PEG), cholesterol and a tocopherol, in amounts of 51/46/2.2 or 46/42/2.2 respectfully, these amounts are within the ranges claimed for total lipids, cholesterol and active. See entire disclosure, especially abstract and page 242 rt col 1st full ¶. The liposomes were further radiolabeled with 99mTc for imaging studies. Regarding claim 23, the size of the liposomes of Garcia was 210-240 nm. See page 246 left col. 1st ¶. Regarding claim 113, hemoglobin is a biological. Garcia suggests that numerous drugs could be delivered using the liposomal delivery system See page 247 last two ¶.
Garcia while teaching tocopherol, an isomer of GT3, is silent on the use of the claimed isomer.
Ghosh is used primarily for the disclosure within that GT3 was well known before the time of the claimed invention to be a potent radioprotector. See entire disclosure, especially abstract.
Since Garcia teaches use of tocopherol, an isomer of GT3, one of ordinary skill in in the art would have a high expectation of success in substituting GT3 for tocopherol with a high expectation of success. The artisan would recognize that, based on their close structural similarity, GT3 could be substituted for Tocopherol with similar results. Reason to make such a substation would be to provide a potent radioprotectant to the radiolabeled liposome of Gracia.
Fu does not teach the claimed active agents including androstenedione recited in claim 2.
Grinblat is used for its disclosure that liposome type of delivery vehicles were already well known to be capable of delivering androstenediol, which was used to improve muscle strength and mass and treat sexual dysfunction. See entire disclosure, especially abstract and claims 1 and 14.
Since Garcia teaches delivery of a number of active agents one of ordinary skill in the art could reason numerous agents such as the androstenediol of Grinblat could be added/substituted into the liposomes of the primary reference with a high expectation of success. Reason to make such a substitution would be to provide liposomal delivery of androstenediol to one in need of improved muscle strength or for treatment of sexual dysfunction.
Thus, the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Response to Arguments
Applicant's arguments filed 8/26/2025 have been fully considered but they are not persuasive. Applicants assert the amendment to the claims which cancels SOD mimetics is no longer obvious over the previously presented obviousness rejections. While the previous obviousness rejections in view of Shaazeeb are withdrawn applicants new Markush group is obvious when the secondary reference Grinblat is considered.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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/JAMES W ROGERS/Primary Examiner, Art Unit 1618