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 .
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 1. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
This application does not contain an abstract of the disclosure as required by 37 CFR 1.72(b). An abstract on a separate sheet is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-3 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims recite percentages, but do not include if they are on a weight, volume, or weight per volume basis.
Claim 1 recites “the silicone oil droplet”, but there is a lack of antecedent basis for the recitation since there is no previous recitation in the claim of silicone oil droplets being present. The droplets in the emulsion are not implicitly silicone oil droplets due to the recited proportion of components that potentially permit 78.5% of the composition to be unrecited components that could be other oil components. Thus it is not clear if the recitation is a limitation excluding other oils from the droplets of the emulsion or just constraining the size of oil droplets that contain silicone oil.
Claims not explicitly elaborated upon are also indefinite because they depend from an indefinite claim and do not add clarity.
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 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Loria (US Patent No. 9,993,578) in view of Gale (CA 1164749).
Loria teaches an injectable silicone-in-water composition as a tissue filler composed of 1 to 80% silicone oil having a viscosity from 1500 to 30,000 centistokes, 20 to 99% water, and 0.005 to 10% of a thickening agent, where the silicone oil forms droplets having a size from 30 to 2000 microns (see title, column 1 lines 15-24, and column 4 lines 15-26). The thickener is envisioned and exemplified as carboxymethyl cellulose (CMC), a biodegradable polymer (see column 4 lines 37-46 and column 15 lines 49-56). The composition stimulates collagen production and provides a temporary scaffold for collagen growth between silicone oil droplets (see column 4 lines 23-26 and column 16 lines 29-33). Loria teaches that silicone oils improved their clinical results with increasing viscosity from 1000 to 12,500 cSt (see column 15 lines 40-48). They detail shifting from high levels of undesired biological response at 1000 cSt to a response that is low to moderate at 5000 cSt to a response that is very low at 12,500 cSt (see table 3). This indicates that silicon oil viscosity is result effective at least within the taught/tested range. The higher two silicone oil viscosity preparations also included CMC. The CMC is preferably and exemplified as being crosslinked by 1,4-butanediol diglycidyl ether present at 0.05 to 7 wt% (see column 5 lines 32-35, column 15 lines 54-56, and table 1). Loria teaches the thickener and composition made with a sterile solvent envisioned as water as well as lactated Ringer ‘s solution (see column 5 liens 18-28). A 10,000 cSt silicone oil is not explicitly exemplified.
Gale teaches a composition for administering a drug (see abstract). The composition includes a fluid that is preferably a silicone fluids as a reservoir for the drug (see page 8 line 30-page 9 line 11). The silicone oil is exemplified as having a 10,000 cSt viscosity (see example 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ a silicone oil known to be employed for medical applications with a viscosity to yield a lessened negative reaction in the composition of Loria. Since this parameter is result effective and the 10,000 cSt is close to the 12,5000 cSt that performed best, the choice of the 10,000 cSt of Gale would have been obvious as a matter of routine optimization. Therefore claims 1 and 3 are obvious over Loria in view of Gale.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Loria in view of Gale as applied to claims 1 and 3 above, and further in view of Loria (US PGPub No. 2023/0414828 – henceforth Loria B) and Linko et al. (US PGPub No. 2017/0143870).
Loria in view of Gale render obvious the limitations of instant claim 1 and 3, where CMC along with 1,4-butanediol diglycidyl ether are present and where sterile water and lactated Ringer‘s solution are envisioned components as well. Gale additionally teach that a rheological agent is preferably present when silicone oil is the fluid in the composition (see page 8 lines 33-36). Gale teaches and exemplifies silica as a rheological agent in the silicone oil, generally at 0.1 to 10 wt% (see page 9 lines 20-30 and example 8).
Loria B teaches an injectable silicone-in-water emulsion tissue filler similar to that of Loria, where silicone oil with a viscosity less than 30,000 cSt is present at 1 to 80 %, 15 to 98% water, 1 to 3 % transport medium, as well as 0.05 to 10% surfactant (see title and paragraphs 14 and 16). A silicone with a viscosity of about 12,500 cSt is noted to have a lessened foreign body reaction (see paragraph 57). CMC is detailed as the transport medium and may be crosslinked (see paragraph 25). Lidocaine and polysorbate are both named as surfactants, where the former also serves as an anesthetic (see paragraphs 26 and 80-81). They envision additional components such as the preservative methyl paraben at up to about 1% (see paragraph 88). Vitamin C is not detailed as present.
Linko et al. teach vitamin C as a desired component in tissue fillers to promote collagen production (see abstract and paragraph 104). Envisioned concentrations span from 0.1 to 10 mg/ml (about 0.01 to 1%) (see paragraph 104).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include 1,4-butanediol diglycidyl ether at a taught concentration as the exemplified crosslinker of CMC in the composition of Loria in view of Gale because it is preferred. It additionally would have been obvious to include lidocaine and polysorbate at a proportion within the taught range as surfactants in light of Loria B to support the emulsion and provide separately controllable anesthesia. This modification is obvious as the application of the same technique to a similar product in order to yield the same improvement. Similarly, the inclusion of methyl paraben for is preservative properties in light of Loria B as well as water and lactated Ringer‘s solution for the thickener solvent at taught proportions in light of Loria would have been obvious based upon the same rationale. Further supplementation of the composition with vitamin C to enhance the desired collagen formation and silica to modify its rheology as desired would have been obvious in light of Gale and Linko et al. These modifications are also obvious as the application of the same technique to a similar product in order to yield the same improvement. The ranges of proportions for the silica, 1,4-butanediol diglycidyl ether, lactated Ringer’s solution, sterile water, lidocaine, polysorbate, methyl paraben and ascorbic acid overlap or embrace the instantly claimed amounts, thereby rendering the claimed values obvious. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). In the absence of evidence of the criticality of the claimed amounts, the overlapping teachings of the prior art are sufficient to render them obvious. Therefore claims 1-3 are obvious of Loria in view of Gale, Loria B, and Linko et al.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/Examiner, Art Unit 1615