DETAILED CORRESPONDENCE
Claims 1-5, and 22-27 are pending and under consideration on the merits.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/04/2025 has been entered.
Status of the Rejections
The 103 rejections of record are revised in view of the amendment.
The double patenting rejection is withdrawn in view of the filing and approval of a terminal disclaimer.
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-3, 22-26 are rejected under 35 U.S.C. 103 as unpatentable over Kluge et al. (US Pat. Pub. 2016/0046679) in view of DiBenedetto et al. (US Pat. Pub. 2003/0099630) and Mougin (US Pat. Pub. 2004/0191199).
As to claims 1-3 and 22-26, Kluge discloses a composition in the form of a gel (claim 1) or film (claim 22) and comprising silk fibroin or fragments thereof having a molecular weight of 5-125 kDa, which is within the ranges of claims 1 and 3 (paragraphs 4, 8, and 24). Kluge teaches the use of buffering agents to adjust the pH of the composition to 7.2 (paragraphs 43 and 263), which is slightly below the less than 7.0 recited by claim 1. Kluge further teaches that the silk fibroin composition can be incorporated into an aqueous solution which is stable for a period of time under a variety of conditions not only at ambient temperature but even at elevated temperatures such as 60 degrees Celsius (paragraph 7).
Regarding claims 23-24, Kluge expressly teaches that the silk fibroin composition may be flexible, and teaches a specific embodiment wherein the silk fibroin may be used to form a medical article that is, for example, a flexible Swanson prosthesis for use on the hands and wrists, and teaches that the composition is flexible enough to be manufactured into a variety of shapes (paragraphs 241, 340, 348, 350) and used on various locations of the body (paragraphs 351-353). Therefore, the composition is flexible enough to conform to an anatomical portion of the body as recited by claim 23, and additionally it would have been prima facie obvious to form the composition into whatever shape is necessary in order to apply it to a given part of the body such as any of the body portions recited by claim 24 in light of Kluge’s teaching that the composition can be formed into different shapes and be applied to different areas of the body.
Regarding claims 25-26, Kluge further teaches that the film may comprise a therapeutic agent such as hyaluronic acid or a wound healing agent, which the skilled artisan would recognize as an agent suitable for the treatment of a skin disorder (i.e., the elected species of therapeutic agent) such as a cut in the case of a wound healing agent or dry skin in the case of hyaluronic acid due to its humectant properties (paragraphs 369, 389-390, 399).
As to claims 1-3 and 22-26, Kluge does not further expressly disclose that the polydispersity is of about 1-5 to about 3.0 as recited by claims 1 and 22, nor that the silk fibroin fragments when in a solution do not spontaneously or gradually gelate for at least 4 weeks at room temperature as recited by claims 1 and 22, nor a range for the pH of less than 7.0 as recited by claim 1. Nor does Kluge teach the presence of a nucleating agent such as lactic acid or ascorbic acid as recited by claim 2. Nor does Kluge expressly teach the bacterial count property recited by claim 1.
Mougin discloses a cosmetic or dermatological composition comprising a polymer, the polymer having a polydispersity of 2.5 or less (paragraphs 2 and 9), which overlaps the about 1.5-3.0 range recited by claim 3. Mougin teaches that cosmetic compositions typically call for a variety of characteristics such as good retentiveness and long lasting deposit, as well as good adhesion to the substrate, which commonly requires the use of multiple polymers in the composition which may lead to undesirable de-mixing of the polymers, but that this problem can be overcome by using polymers having sufficiently narrow polydispersity values (paragraphs 5-9).
DiBenedetto discloses an aqueous composition comprising fibroin protein and which may be in the form of a gel (paragraphs 7 and 31), the fibroin having a weight average molecular weight of most preferably 0.5-20 KDa (paragraph 32). DiBenedetto further teaches that the composition can be formed as a solution or a suspension by selecting an appropriate pH for the composition, wherein reducing the pH of a fibroin solution below its isoelectric point of 3.8 using an acid such as ascorbic acid or lactic acid will promote suspension formation (paragraph 33).
As to claims 1-3 and 22-26, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the present invention to modify the composition of Kluge by selecting a sufficiently narrow range of molecular weight fibroin polymers to allow for a polydispersity within the range recited by the claims, in view of Mougin’s teaching that such polydispersity values are known in the prior art for polymers that are found in cosmetic compositions and are considered advantageous in that increase the compatibility of the polymer in the presence of other polymers in the composition, since mixing of polymers in a cosmetic composition may lead to demixing in the composition if the polymers possess high polydispersity. Additionally, discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 105 USPQ233.
Regarding the pH value of the gel as recited by claim 1, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of Amer. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium). Here, due to the closeness of 7.0 and 7.2, the skilled artisan reasonably would have expected the composition of Kluge possessing a pH of 7.2 to have the same properties as the claimed composition. Additionally, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Kluge silk fibroin composition by incorporating ascorbic acid or lactic acid as recited by claim 2 to reduce the pH of the composition to below 3.8 which is within the range of claim 1, because DiBenedetto teaches that this will advantageously promote formation of the silk fibroin gel.
Regarding the limitation of claims 1 and 22 that the silk fibroin fragments when in a solution do not spontaneously or gradually gelate for at least 4 weeks at room temperature, although Kluge does not expressly teach that a solution comprising its silk fibroin fragments would be stable for at least 4 weeks, Kluge does teach that an aspect of its invention is the fact that its compositions are stable in solution for an extended period of time even at elevated temperatures such as 60 degrees Celsius as discussed above. Therefore, since Kluge expressly teaches that its compositions have high stability in solution, and because the composition of Kluge and Mougin as combined supra comprises the same ingredients recited by claim 1, it will possess the ability to not spontaneously gelate for at least 4 weeks at room temperature when incorporated into a solution as recited by claim 1 based upon the evidence currently of record. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
The composition of Kluge and Mougin as combined supra also will have a fungal count within the range recited by claim 1, because it comprises the same ingredients in the same amounts that are recited by the claims. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
Claims 4-5 are rejected under 35 U.S.C. 103 as unpatentable over Kluge et al. (US Pat. Pub. 2016/0046679) in view of DiBenedetto et al. (US Pat. Pub. 2003/0099630) and Mougin (US Pat. Pub. 2004/0191199) as applied to claims 1-3 and 22-26 above, and further in view of Mathur et al. (US Pat. Pub. 2016/0120803).
The teachings of Kluge, Mougin, and DiBenedetto are relied upon as discussed above, and Kluge further teaches that the composition may comprise a preservative (paragraph 409) and may comprise cosmetics (paragraph 369), and that the composition may comprise the silk fibroin in an amount of 0.1-5 wt% which encompasses the range of claim 5 (paragraph 127) but Kluge does not further expressly disclose that the preservative is sodium anisate and which is present in the amount recited by claim 4.
Mathur discloses personal care compositions such as cosmetic or therapeutic compositions (paragraphs 2-3), and teaches that the composition comprises a preservative such as sodium anisate in the amount of 0.02-2.5%, which overlaps the range of claim 4 (paragraphs 68-69).
As to claims 4-5, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the present invention to modify the composition of Kluge, Mougin, and DiBenedetto as combined supra by incorporating sodium anisate as the preservative, since Kluge expressly teaches that the composition may comprise a preservative and does not limit the identity of the preservative, which would have motivated to the skilled artisan to search the prior art for preservatives that would be suitable for inclusion, which would have led to Mathur, which teaches that sodium anisate is a preservative that is suitable for use in a cosmetic, such a modification being merely the combining of prior art elements according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
Claim 27 is rejected under 35 U.S.C. 103 as unpatentable over Kluge et al. (US Pat. Pub. 2016/0046679) in view of DiBenedetto et al. (US Pat. Pub. 2003/0099630) and Mougin (US Pat. Pub. 2004/0191199) as applied to claims 1-3 and 22-26 above, and further in view of Gilbert (US Pat. No. 4,867,150).
The teachings of Kluge, DiBenedetto, and Mougin are relied upon as discussed above, but they do not, however, expressly disclose that the film comprises a plurality of perforations as recited by claim 27.
Gilbert discloses a wound dressing in the form of a film (column 1, 1st paragraph), and teaches that wound dressings in the form of a film are perforated in order to provide adequate ventilation of the wound bed (paragraph bridging column 3-4).
As to claim 27, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the present invention to modify the composition of Kluge, DiBenedetto, and Mougin as combined supra by providing the film with perforations, because Gilbert teaches that wound dressings in the form of a film benefit from being perforated because the perforations provide ventilation of the wound bed.
Response to Applicant’s Arguments
Applicant asserts that the cited art, separately or in combination, does not teach or suggest all limitations of the claimed compositions, but did not provide any argumentation in support of this position, or explain which limitations of the claims allegedly are not taught or suggested by the cited art.
In response, Applicant’s argument has been considered carefully, but the cited art is viewed as rendering prima facie obvious all limitations of the present claims for the reasons discussed above in the revised grounds of rejection.
Examiner discussed during a telephone call with Applicant (see attached Interview Summary) that Kluge did not appear to teach that a solution comprising its silk fibroin fragments would be stable for at least 4 weeks as recited by the amendment to claim 1 dated 8/0402025. Upon further review of Kluge, however, Examiner noted that Kluge does teach that an aspect of its invention is the fact that its compositions are stable in solution for an extended period of time even at elevated temperatures such as 60 degrees Celsius as discussed above in the revised grounds of rejection. Therefore, since Kluge expressly teaches that its compositions have high stability in solution, and because the composition of Kluge and Mougin as combined supra comprises the same ingredients recited by claim 1, it is Examiner’s position that it will possess the ability to not spontaneously gelate for at least 4 weeks at room temperature when incorporated into a solution as recited by claim 1 based upon the evidence currently of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/ Primary Examiner, Art Unit 1600