DETAILED ACTION
Previous Rejections
Applicants' arguments, filed 22 May 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
Claims 1 and 3-10 are rejected under 35 U.S.C. 103 as being unpatentable over Yoo et al. (US Patent Application Publication 2018/0327554) in view of Gagnon et al. (US Patent Application Publication 2005/0101632).
Yoo et al. teaches preparing nanoparticles by irradiation of an aqueous solution of a polysaccharide and a polyethylene glycol (abstract). The result is inter- or intra-molecular crosslinking of these ingredients (id.). The nanoparticles can further comprise a drug (id.). Yoo et al. further clarifies that the term nanoparticle includes nanohydrogels, as the nanoparticles have hydrogel characteristics (paragraph [23 and 29]). And the polysaccharide can be hyaluronic acid (paragraph [31] & example 2).
Yoo further teaches that the nanoparticle can further have a drug encapsulated therein (paragraph [80]), and these can include anti-inflammatory agents (paragraph [81]).
Yoo et al. does not teach the inclusion of a silicone in the nanoparticles. However, this deficiency is remedied by Gagnon et al. Gagnon et al. discloses the use dimethicone as an agent to treat inflammation (abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have included dimethicone (as taught by Gagnon et al.) as the anti-inflammatory agent in the composition disclosed by Yoo et al. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
Instant claim 1 recites that the polyethylene glycol used in the formation step has a molecular weight of from 20 to 35 kDa. The claim is drawn to the product itself, and thus the product suggested by the prior art has the same structural features and components as required by the instant claims. And the patent-ability of a product does not depend on its method of production, and if the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113. Also, it is noted that Yoo teaches that the polyethylene glycol has a molecular weight of from 0.1 to 150 kDa (paragraph [33]). This range overlaps the instantly recited range, and in cases involving overlapping ranges, where the instantly claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. See MPEP 2144.05.
Instant claim 1 further recites that the crosslinking occurs via irradiation or radiation. Yoo et al. suggests using an electron beam irradiation at a dose of 5-250 kGy (claim 7), which also is embodied (example 1).
Instant claims 3-4 and 9 further limit the steps for forming the crosslinking. Yoo et al. suggests using an electron beam irradiation at a dose of 5-250 kGy (claim 7), which also is embodied (example 1). These claims also recite a limitation to when the silicone is incorporated. The references do not expressly state this step. However, the agents are taught as included in the hydrogel nanoparticles, and the claims include the silicone in the hydrogel. Thus, structurally there does not appear to be a difference between the claimed product and the taught product. And the patent-ability of a product does not depend on its method of production, and if the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113.
Instant claim 10 also recites a limitation to the process of preparing the product. And while the energy intensity is not taught by Yoo et al., the result (irradiation with an electron beam in order to crosslink) is the same as instantly recited.
Instant claims 5, 6, and 10 limit the process steps for preparing the hydrogel (such as the concentration). These claims are also drawn to the product itself, and thus the product suggested by the prior art has the same structural features and components as required by the instant claims. And the patent-ability of a product does not depend on its method of production, and if the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113.
Instant claim 7 recites a limitation to the silicone, and the dimethicone reads upon the limitation.
Response to Arguments
The Applicant argues the rejection is not proper. The Applicant argues that Yoo does not provide any experimental evidence in the working examples that the crosslinking of the materials actually occurs. The Applicant also argues that the invention disclosed by Yoo (nanoparticle technology) and the present invention (bulk hydrogel) are fundamentally different. The Applicant further argues that the molecular weight limitation added to now amended claim 1 is not taught by the references.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. With respect to the crosslinking, Yoo et al. teaches preparing nanoparticles by irradiation of an aqueous solution of a polysaccharide and a polyethylene glycol (abstract). The result is inter- or intra-molecular crosslinking of these ingredients (id.). Thus, based on the teaching of Yoo there is crosslinking present. The argument that there is no additional experimental evidence is not persuasive, as Yoo clearly teaches this crosslinking.
As for the two forms being fundamentally different, Yoo et al. further clarifies that the term nanoparticle includes nanohydrogels, as the nanoparticles have hydrogel characteristics (paragraph [23 and 29]). Thus, both the teachings of Yoo and the claimed invention relate to hydrogels.
As for the molecular weight limitation regarding the polyethylene glycol, it is noted that Yoo teaches that the polyethylene glycol has a molecular weight of from 0.1 to 150 kDa (paragraph [33]). This range overlaps the instantly recited range.
Conclusion
THIS ACTION IS MADE FINAL. 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 Brian Gulledge whose telephone number is (571) 270-5756. The examiner can normally be reached Monday - Friday 7am - 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Brian Gulledge/Primary Examiner, Art Unit 1699
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