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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06 January 2026 has been entered.
Claim Status
Applicant’s claim amendments and arguments filed on 08 December 2025, are acknowledged.
Claims 1 & 5 are pending.
Claim 1 is amended.
Claims 2-4 & 6-12 are cancelled.
No claims are withdrawn.
Claims 1 & 5 are under consideration.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 and constitute the complete set presently being applied to the instant application.
Maintained Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 & 5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 recites the cosmetic composition comprises a cationic surfactant. Applicant does not state where support for this amendment may be found (reply, pg. 3). Cationic surfactants are a large genus made of many different types of substances including amine oxides. However, Table 1 contemplated as a “Class of Ingredients” quaternary ammonium salt compounds or fatty amine salts. Table 1 discloses quaternary ammonium salt compounds or fatty amine salts “Function” as a “Cationic Surfactant”. As such, Applicant has possession of quaternary ammonium salt compounds or fatty amine salts which function as cationic surfactants but does not have possession of the genus of cationic surfactants. Amended claim 1 changes the scope of the disclosure; thereby constituting new matter.
Claim 5 is rejected under 35 USC 112(a)-New Matter because it depends from rejected claim 1.
Response to Arguments
Applicant argues no new matter is present because the specification need not disclose what the already skilled possess (reply, pg. 3). Applicant argues the specification provides the written description required for the genus of cationic surfactants because they are well known in the art (reply, pg. 4). Applicant argues the ordinary skilled artisan would understand by Applicant’s teaching of a cationic formulation at paragraphs [101] and [103] and hair conditioning base at paragraph [110] of the specification would require a cationic surfactant (reply, pg. 4).
This is not persuasive. With regard to Applicant’s argument that Applicant is not required to disclose what is well known, the examiner notes “newly added claims or claim limitations must be supported in the specification through express, implicit, or inherent disclosure” (MPEP 2163.I.B.). “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).")” (MPEP 2163.II.3.ii). In the instant case, Applicant has only described cationic surfactants which are quaternary ammonium salt compounds or fatty amine salts. A representative number of species representative of the genus of cationic surfactants is not disclosed. As such, no support is present for the broader recitation of “cationic surfactants”. The NEW MATTER rejection is maintained.
With regard to Applicant’s argument pertaining to support being present for the genera of cationic surfactants because the specification teaches “cationic formulation” and “hair conditioning base”, the examiner notes that “cationic formulations” and “hair conditioning bases” do not necessarily encompass cationic surfactants; cationic formulations and hair conditioning bases may receive their cationic and conditioning features from cationic polymers, not cationic surfactants. Given this rationale, and the lack of disclosure of the broader genus of “cationic surfactant”, no support is present for the claimed limitation of the genus of cationic surfactants. The NEW MATTER 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 & 5 are rejected under 35 U.S.C. 103 as being unpatentable over Scheibel (US 2009/0123967; X-reference-previously cited; IDS filed 04/23/2021) and Lee (KR 101172733; Published: 08/14/2012; previously cited).
With regard to claim 5, Scheibel in their claim 42 teaches a gel or foam comprising a protein of claims 20 or 21. With regard to claims 1 & 5, Scheibel in claims 21, 38, & 42 teaches a hydrogel and gel comprising ADF-4/spider silk protein of Seq ID No. 10. More broadly, with regard to claim 1, Scheibel teaches spider silk proteins, including ADF-4, which are recombinant proteins for use in their invention ([0042] & [0080]). With regard to claim 1, more broadly, to assess the aggregation of the spider silk protein from an admixture of protein aggregate/precipitate and soluble protein in a buffer (a cosmetically acceptable vehicle comprising water) of TRIS HCl, protein concentrations of 0.174 mg/ml were used (i.e. about 0.0174 % ADF-4/spider silk protein; [0113]- [0114]; Table 2) which is close to the amount of 0.01 % recited by instant 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 America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). In the instant case, 0.01% ADF-4 and 0.0174 ADF-4 are expected to have the qualities of coupling substances such as drugs, metals, polypeptides, polysaccharides, marker molecules, quantum dots, nucleic acids, lipids, and etc. (Scheibel-[0013]). This assertion is supported by paragraph [0046] of the instant specification which discloses ”ADF-4 recombinant is used in the selected range of about 0.06 to about 0.008%, preferably about 0.01%, based on the total weight of the composition”; indicating that 0.01 % and 0.0174 % are both suitable. Scheibel teaches the composition of their invention may be incorporated into a haircare product to show improved characteristics such as improved tensile strength or tear strength [0092]. With regard to claim 5, Scheibel claims a gel for the modified proteins of their invention (Scheibel’s clam 42).
Scheibel does not teach inclusion of a cationic surfactant.
In the same field of invention, Lee teaches a transparent gel (title). Lee teaches the transparent gel of their invention may comprise “proteins” (pg. 5). Lee teaches the tensile strength of hair is increased (pg. 9). Lee teaches the transparent gel comprise 0.5-10% surfactants and purified water (i.e. cosmetically acceptable vehicle; pg. 10). Lee teaches inclusion of quaternary ammonium salts which are cationic surfactants in the transparent gel to provide a wool effect (pg. 3). Lee teaches the cationic surfactants include stearyltrimethylammonium chloride and cetyltrimethylammonium chloride (pg. 3 & 4). Lee teaches the transparent gel of their invention comprise stearyltrimethylammonium chloride in an amount of 0.5 to 10% by weight (pg. 4).
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Here, at least rationale (A) may be employed by adding Scheibel’s ADF-4 protein in an amount of 0.0174% to Lee’s transparent gel comprising 0.5 to 10 % stearyl trimethyl ammonium chloride (i.e. cationic surfactant) because both Scheibel and Lee are directed to the same purpose of improving the tensile strength of hair. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to improve the tensile strength of hair by combining a protein for improving hair tensile strength and a gel for improving hair tensile strength that has the added benefit of providing a wool effect through inclusion of cationic surfactants including stearyl trimethyl ammonium chloride.
With regard to the recitation “wherein the ADF-4 recombinant protein is dispersed in water as a gel comprising (a) a water soluble fraction that contains the recombinant protein in hydrogel form, and (b) a water dispersed fraction that contains the protein as protein aggregates which form a gel”, as evidenced by pg. 11-12 of the instant specification, ADF-4 recombinant protein contains water soluble fraction which is in the form of a hydrogel and water-dispersed fraction which aggregates and disperses as a gel. This is inherent to the ADF-4 recombinant protein. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). Nonetheless, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant’s own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Response to Arguments
Applicant points to Test 3 of the instant specification at paragraphs [93]-[99] that describes treating hair with compositions comprising 0.01% or 0.1% ADF-4 recombinant protein (reply, pg. 6). Applicant argues that damaged hair treated with 0.1% ADF-4 recombinant protein had a texture close to damaged hair but at a concentration of 0.01% the hair returned to a healthy condition (reply, pg. 6). Applicant argues there is no reason to expect, based upon Scheibel, that a lower concentration would be able to exhibit a comparable effect as a concentration ten times as high, let alone a superior effect (reply, pg. 6).
This is not persuasive. Applicant appears to be arguing the criticality of lower concentrations. However, Scheibel teaches a concentration of 0.0174% which is close to 0.01%. 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 America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). Applicant has not shown that a concentration of 0.01% recombinant ADF-4 is superior to a concentration of 0.0174% ADF-4 in a practical and significant way. The evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). This is important because paragraph [0046] of the instant specification discloses ”ADF-4 recombinant is used in the selected range of about 0.06 to about 0.008%, preferably about 0.01%, based on the total weight of the composition”; indicating that 0.01 % and 0.0174 % are both suitable.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORI K MATTISON whose telephone number is (571)270-5866. The examiner can normally be reached 9-7 (M-F).
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/LORI K MATTISON/ Examiner, Art Unit 1619
/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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