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 .
Status of the Claims
Claims 15 and 17 have been canceled. New claims 18-22 have been added. Accordingly, claims 1-14, 16, and 18-22 are pending and under current examination.
Withdrawn Objection and Rejections
The objection to the abstract is withdrawn upon entry of the abstract filed 6/24/2025. Applicant’s argument to this effect is persuasive.
All rejections of claims 15 and 17 are withdrawn in view of Applicant’s cancelation of these claims.
The rejections of claims 1-17 under 35 U.S.C. 112(b) are withdrawn in view of Applicant’s amendments to the claims.
Response to Arguments
Applicant’s arguments filed 6/24/2025 (hereafter, “Remarks”) have been fully considered and are addressed as follows.
Regarding the rejections under 35 U.S.C. 103 over Savaides, Applicant argues that claim 1 as amended is a method for treating or repairing alkaline-damaged hair of a subject after the subject receives an alkaline hair treatment, wherein the keratin fiber is administered after the alkaline treatment. Applicant’s argument is not persuasive because the initial recitation in claim 1 of the “after the subject receives an alkaline hair treatment” is in the preamble and constitutes an intended use of the method claim and does not actually recite a step in a method of use. Additionally, the wherein clause at the end of claim 1, “wherein the keratin fiber treatment is administered after the alkaline treatment, thereby treating or repairing the alkaline-damaged hair of the subject” lacks antecedent, referencing an intended use and not an actual method step antecedent of administration of an alkaline treatment. In effect, the specific claim language presented for examination does not encompass a second step but rather alludes to a prior alkaline step. Upon further review since the telephonic interview (dated 5/7/2025 in the file wrapper), it is ascertained that Savaides does actually teach this same allusion to a prior alkaline treatment step by its teaching of treatment of [previously] bleached hair wherein bleached hair is considered to have been alkaline treated. See Savaides Examples 5 and 8
As to new claim 18, Applicant argues that a new step is included here. In reply, this step constitutes new matter as detailed below. In the remarks filed 6/24/2025, Applicant asserts that there is no new matter, however it is not clear where Applicant finds support for the new claim language. Applicant is kindly requested to point out where in the original claims or specification as filed is considered to constitute support for a stepwise alkaline hair treatment or administration of alkaline treatment.
As to new claim 19, Applicant cites paragraph [0084] of the pre-grant publication and not the specification as filed. It appears that paragraph [0084] of the pre-grant publication is an example of a composition comprising various amino acids in each of virgin hair, hair treated with conventional bleach, and hair treated with conventional bleach plus an inventive composition. It is noted that this disclosure pertains to the effects of performing a method step and not an actual administration of an alkaline hair treatment as claimed.
Applicant characterizes on page 11 of Remarks the Savaides reference as a 1-step process for permanent hair treatment and a subsequent heat treatment and argues that Savaides’ method does not teach a method for treating or repairing alkaline-damaged hair of a subject after the subject receives an alkaline hair treatment and argues that Savaides does not restore amino acids as in new claim 19. In reply, Applicant’s arguments are noted but are not persuasive in view of the specific claim language structure which alludes to but does not specify a method step supported by the specification as filed. Savaides’ relevance is maintained since Savaides’ method is used for the very same purpose as the method instantly claimed: treating bleached hair (see Savaides’ Example 5 at paragraph [0105], the title of which is “Hair softening composition for bleached or delicate hair”) and, since upon review, Savaides does appear to teach treatment of alkaline-damaged hair in an example. Savaides’ Example 5 for bleached hair recites an intended use the same as instantly claimed wherein Savaides’ process is applied to a bleached hair population in particular to provided hair softening benefits.
Otherwise, new ground of rejection necessitated by amendments as presented below address the new claims.
Claim Objections
Claim 20 is objected to because of the following informalities: claim 20 recites “bis-PG Propyl Silanetriol”, however common chemical names are not capitalized typically. It appears that “propyl” and “silanetriol” should be recited using lowercase letters. Appropriate correction is required.
New Grounds of Rejection Necessitated by Amendments filed 6/24/2025
Claim Rejections - 35 USC § 112, New Matter
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.
Claim 18 is 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.
Claim 18 recites a stepwise administration of an alkaline hair treatment to the subject in line 2 of the claim; this constitutes new matter. While the specification as filed references a composition which is a keratin treatment comprising a cosmetic concentrate composition intended to be applied after an alkaline treatment, the specification as filed does not actually teach any stepwise administration of an alkaline hair treatment to a subject wherein said alkaline hair treatment is followed with a keratin fiber treatment as in the claims. The specification as filed (currently entered with a TRNA file code in the file wrapper, dated 7/15/2023) teaches a composition as well as the administration of a composition which is a concentrate comprising specified ingredients (thiol, cystine polymer, peptide) and states that the concentrate composition may be used directly after treatments causing deposits (see page 1, “Field of the Invention” section of specification as filed) and describes that the concentrate composition may be used in an alternative embodiment wherein the concentrate is combined with another treatment regime or after a damaging alkaline treatment (page 4,first full paragraph), however this disclosure never teaches any method step of administration of an alkaline treatment. See also specification as filed at page 9, last paragraph and Example 2a for instance. Accordingly, while an intended use recited in the preamble does not constitute a stepwise administration of an alkaline hair treatment to a subject, step a as in claim 18 itself constitutes new matter which was not present upon the filing date of the application in the specification, claims, or drawings and was added after the application fling.
Claim Rejections - 35 USC § 112(b)
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 1-14, 16, and 19-22 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.
Claim 1 recites the limitation "wherein the keratin fiber treatment is administered after the alkaline treatment, thereby treating or repairing the alkaline-damaged hair of the subject" in the last two lines of the claim as amended. There is insufficient antecedent basis for this limitation in the claim since both “the alkaline treatment” and “the alkaline-damaged hair of the subject” are only previously recited in the claim in terms of an intended use in the preamble and not an actual structural and required component of the claimed method. Claim 19 recites limitations in kind. Claims 2-14, 16, and 18-22 as well as claim 20 are rejected since they depend from a rejected base claim.
Additionally, claim 19 recites “the original amino acids in the subject hair” for comparison with restored amino acids after the method of treatment is performed. However, “the original amino acids” lacks antecedent basis, so it is unclear to what the restoration process is being compared. Claim 20 is additionally rejected since it depends from a rejected base claim.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 recites a thiol compound to be present “from a lower concentration by weight of the concentrate composition of 1.0% to an upper concentration by weight of the concentrate composition of up to 5.0%”. Claim 12 depends from claim 1. Claim 1 recites the thiol component to be present between 0.01 to 4% by weight of the concentrate. Accordingly, claim 1 does not further limit claim 12 since claim 12’s upper limit is 5%, however claim 1’s upper limit is now 4% as amended. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Modified Rejections Necessitated by Amendments of 6/24/2025 and New Rejections of New Claims
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 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.
Claims 1-14, 16, and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Savaides et al. (US 2014/0261518 A1, previously cited) as evidenced by Skopp (“On cosmetically treated hair- aspects and pitfalls of interpretation; Forensic Science International; 84 (1997) 43-52; newly cited).
Claim 1 is drawn to method comprising administering to a subject a keratin fiber treatment composition comprising a cosmetic concentrate composition, the components of which are further specified in the claims, and wherein the keratin fiber treatment is administered after the alkaline treatment thereby treating or repairing alkaline-damaged hair of the subject. Said concentrate composition comprises a thiol, a polymer or copolymer comprising at least one cystine unit, one or more peptides as further specified in the claims as elected (see election dated 11/6/2024 in the file wrapper). It is noted that the language “wherein the keratin fiber treatment composition treats or repairs damaged hair of the subject” as recited in the last two lines of claim 1 recites functional effects of performing the claimed method step. Since the structural components are otherwise addressed below, the resulting claimed effects are considered to be met by the prior art since a process and its effects are inseparable. As to the amount of thiol, polymer or copolymer, and one or more peptide components recited in claim 1, claim 1 is interpreted to pertain to a method comprising a keratin fiber treatment composition wherein the keratin fiber treatment composition comprises a cosmetic concentrate composition. It is noted that claim 1 and similarly claim 19 recite a single step which is administering a keratin fiber treatment composition to a subject; the claim preamble and wherein clause at the end of the claim refers to a prior alkaline treatment before the only step recited in the method claim, and, in the case of claim 19, the additional wherein clause at the end of the claim describes the effects of performing the aforementioned method step.
Accordingly, the preambles of claims 1 and 19 are interpreted as outlined above and in accordance with MPEP 2111.02 such that the preamble provides a claim context and an intended method’s use but does not recite a second method step. No structural distinction resulting from the preamble’s intended use is noted, particularly since Savaides actually teaches the very same intended use which is treatment of hair previously bleached in order to provide restoration and/or cosmetic benefit to bleached hair, as detailed below.
Savaides teaches formulations and methods for straightening and revitalizing hair upon treatment of keratin fibers (see abstract in particular) by way of application to the hair from a single application and treatment (see [0014]). Savaides’ formulations may be in the form of a concentrate which is stepwise blended with a sealer composition to form a keratin mixture (see [0035]) in a weight ratio of 1:3 to form a ready-to-use formulation (see [0066]). As such, Savaides’ amounts of each thiol, copolymer, and peptide component equivalents are slightly larger than those amounts recited in the instant claims, however Savaides’ amounts overlap in range when Savaides’ dilution or combination with a sealer composition to form a total keratin mixture composition is performed, as detailed below. Savaides teaches an exemplary embodiment including in the concentrate component of the final formulation an at least one reducing agent which is thioglycolic acid, thiolactic acid, 3-mercaptopropionic acid, thioglycerol(3-mercaptopropane-1,2-diol), cysteine, cysteamine, etc., or esters thereof (see [0025] and [0059]) in an amount of 6 to 16% by weight (see [0026]); as noted above, performing a 1:3 dilution of this range as suggested by Savaides teaches a range overlapping and including values instantly recited. Understanding that this percentage of cysteine or equivalent component is essentially diluted in a 1:3 ratio upon combination with the sealer component, Savaides teaches the cysteine component to be present in an amount within a range overlapping the instantly claimed range of 0.01 to 5% by weight. Regarding the polymer or copolymer component comprising at least one cystine unit, which Applicant has elected to be cystine bis-PG-propyl silanetriol, Savaides too teaches this component (see [0043]); in kind, this component is included in about 1 to 6% by weight of Savaides’ concentrate equivalent which is diluted in a 1:3 ratio thereby providing an amount within the range overlapping the instantly claimed range of 0.1 to 3% in the keratin fiber treatment composition. Regarding the one or more peptide component further recited in claim 1, Savaides demonstrates a hydrolyzed wheat protein present in an amount of 0.01 to 0.6% by weight in a total hair softening composition which is analogous to the instantly claimed keratin fiber treatment composition (see Table 1B for instance), a range overlapping the instantly claimed range of 0.1 to 1.5% after dilution from a concentrate equivalent to a total formulation equivalent in a ratio of 1:3 as Savaides suggests.
Accordingly, Savaides teaches all claimed components in a method of administering a keratin fiber treatment the same or substantially the same as instantly claimed. Additionally, in at least Example 5, Savaides teaches a hair softening composition for bleached hair in the stepwise administration of Example formulation 8 to bleached hair, thereby reasonably suggesting administration “after the subject receives an alkaline hair treatment” and thereby reasonably suggesting “wherein the keratin fiber treatment is administered after the alkaline treatment, thereby treating or repairing the alkaline-damaged hair of the subject” as recited in the preamble and final wherein clause of claim 1 as amended. Because Savaides teaches the administration of the claimed components to bleached hair in separate embodiments, this rejection is made using obviousness rationale. However, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine these elements based on Savaides as a whole which reasonably suggests its formulas to be used in methods of treating hair in need of revitalization and further specifies bleached hair (alkaline-treated hair) among hair in need of revitalization in Example 5 for instance. Skopp provides evidence that “All bleaching methods are oxidative-alkaline treatments” (see second line on page 44).
Because the rationale for adjusting amounts of requisite components as outlined above relies on the skill of the ordinary artisan to perform combined steps in a method of making to arrive at the instant invention drawn to a method of using, this rejection is made using obviousness rationale. Regarding claim 1 and further regarding claims 12, 13, and 16, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to adjust the relative amounts of Savaides’ keratin mixture comprising a keratin concentrate composition and a keratin sealer composition to arrive at a total formulation which is the same or substantially the same as the composition encompassed in the instant method of use where Savaides already teaches the application [administration] of the total formulation to the hair for softening effects. One would have been motivated to do so to achieve a total formulation for application directly to the hair for the desired softening effects (see [0066]) and moreover would have been motivated to adjust the relative formulation components in order to achieve the desired product properties such as stability and efficacy (i.e., softening efficacy) upon application to the keratin fibers, as is customary and routine in the art.
Regarding claim 2, Savaides teaches application to the hair which constitutes a ready-to-use lotion comprising all requisite components thereby capable of performing the claimed intended effects further recited in claim 2.
Regarding claims 3 and 5 and the product-by-process encompassed in the claimed method, Savaides teaches mixing immediately before treating to arrive at a ready-to-use formulation (see [0066]) considered capable of having any of the intended effects of bleaching, coloring, or waving as further specified in claims 3 and 5.
Further regarding claim 1 as amended and also regarding claim 4, Savaides teaches application of a hair softening composition then rinsing then application of a keratin mixture (see Savaides claims 10 and 11) and further regarding claims 6 and 7 also teaches rinsing after application (see [0023]) as well as additional steps of shampooing(see [0022]) and conditioning may be added (see [0070] for instance]). Savaides teaches application of a hair softening composition for bleached hair in Example 5, indicating treatment with the composition would have occurred after a prior hair bleaching process, which necessarily would have been alkaline as would have been reasonable recognized by the ordinary artisan upon reading Savaides’ Example 5 in particular.
Regarding claims 8 and 9, Savaides teaches cysteine and its acylated derivative for instance (see [0062]).
Regarding claim 10, Savaides teaches cystine bis-PG-proyl silane triol (see Table 2 and [0068] for instance).
Regarding claim 11, Savaides specifies the pH of the concentrate composition may be 4-7 (see [[0068]).
Regarding claim 14, Savaides teaches alkali metal sulfite components (see [0062]).
Regarding claim 19, the claimed effect of “wherein the method restores amino acids in the subject’s hair to a greater than 95% of the original amino acids in the subject hair” is considered an effect inseperable from the method step of treatment with the claimed components addressed above.
Regarding claims 21 and 22, Savaides teaches that the formulations containing the active compoudns react on the keratin fibers at ambient conditions for a sufficient time (see [0061]). Savaides’ method includes a treatment step at ambient temperature for instance 10-30 minutes at ambient temperature (see [0061]), which is noted to be less than 400 degrees Fahrenheit.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 AUDREA B CONIGLIO whose telephone number is (571)270-1336. The examiner can normally be reached Monday - Thursday 7:00 a.m. - 5:30 p.m..
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/AUDREA B CONIGLIO/Primary Examiner, Art Unit 1617