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 .
Claim Status
Applicant’s declaration, claim amendments, and arguments, filed 20 April 2026, are acknowledged.
Claims 6 & 24-31 are pending.
Claims 1-5 & 7-23 are cancelled.
Claims 24-31 are new.
Claim 6 is amended.
Claim 6 is withdrawn.
Claims 24-31 are under consideration.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file. The effective filing date is 08 April 2021 is based upon the English language disclosure of EP 21167441.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 20 April 2026 and 04 May 2026 have been fully considered by the examiner. A signed and initialed copy of each IDS is included with the instant Office Action.
Declaration Filed Under § 1.132
The declaration filed on 20 April 2026 by Applicant is acknowledged. The declaration is addressed in the response to Applicant’s traverse below.
Terminal Disclaimer Proper
The terminal disclaimer filed on 20 April 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No. 12/447,118 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Objections/Rejections
The objection to claims 15-22 are withdrawn due to cancellation of the claims.
The rejection of claims 16-23 under 35 U.S.C. 112(a) is withdrawn due to cancellation of the claims.
The rejection of claim 16 under 35 U.S.C. 112(b) is withdrawn due to cancellation of the claim.
The rejection of claim 15 under 35 U.S.C. 103 over Cosmetic Technical Sheet in view of Mueller, Iman and Bender is withdrawn due to cancellation of the claims.
The rejection of claims 15-23 under 35 U.S.C. 103 over Reed in view of Feng is withdrawn due to cancellation of the claims.
The rejection of claims 15-23 on the ground of nonstatutory double patenting over claims 1-7, 10 & 11 of U.S. Patent No. 12,447,118 (Patented: 10/21/2025) in view of Reed is withdrawn due to filing an approved terminal disclaimer and cancellation of the claims.
New Rejections
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 24-31 are rejected under 35 U.S.C. 103 as being unpatentable over Reed (US 2018/0369102; Published: 12/27/2018; previously cited) in view of Feng (US 2022/0241179; Published: 08/04/2022; Provisional Filing Date: 01/29/2021; previously cited).
With regard to claim 24, Reed teaches an exemplary embodiment of a personal care composition consisting essentially of a surfactant system consisting essentially of an anionic surfactant and a zwitterionic surfactant (i.e. co-surfactant); a preservative; a pH modifier; and a rheology modifier (i.e. viscosity modifier; [0010]-[0014]). With regard to claims 24 & 31, Reed teaches the pH of the composition be “about 4.2-4.8” ([0052] & [0094]). With regard to claims 24 ii) & 27, Reed teaches the pH modifier may be citric acid and in Table 1 teaches 0.5% of a pH modifier ([0026]; Table 1-[0119]). With regard to claim 24 iii), Reed teaches anionic surfactant may be sodium laureth ether sulfate, sodium lauryl sulfate and ammonium lauryl sulfate and in Table 1 teaches sodium laureth sulfate in an amount of 7.9% (i.e. sodium lauryl ether sulfate; [0103]; Table 1-[0119]). With regard to claims 24 iv), 29, & 30, Reed teaches inclusion of a preservative which may be sodium benzoate in an amount of 0.01 wt % to 2.5 wt % and in Table 1 teaches inclusion of 0.4% sodium benzoate ([0031] & [0108]; Table 1-[0119]) With regard to claim 24 v), Reed teaches the surfactant system is present in an amount of about 5 wt% to about 15 wt% of the composition and the ratio of about 1.2:1 to about 2.1:1 anionic surfactant to zwitterionic surfactant ([0020] & [0032]). As such, Reed teaches the amount of zwitterionic co-surfactant is 1.6-6.7% ([Math: 0.32* 0.05 = 1.6%; 0.45 * 0.15= 6.7%]; [0020] & [0032]). With regard to claim 24 x), Reed in Table 1 teaches the composition comprises 72.5% water. More broadly, with regard to claim 24 x), Reed teaches the composition further comprises water [0051]. With regard to claim 24, Reed teaches the composition may be a shampoo [0033]. With regard to claim 24 i), Reed teaches inclusion of a chelating agent [0035].
Reed does not teach inclusion of sodium gluconate or the amount of citric acid is 0.2 wt%.
With regard to claims 24 i), 25 & 26, Feng teaches a shampoo comprising a chelating agent which may be sodium gluconate in an amount of about 1 to about 2 wt. % including ranges and subranges therebetween (abstract; [0216]; [0217]). With regard to claim 28, Feng teaches inclusion of pH adjusters which may be citric acid in an amount of about 0.12 to about 5 wt. %, including ranges and sub-ranges therebetween ([0212] & [0214]).
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 (G) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date of the invention to have modified Reed’s shampoo by adding about 1 to about 2 wt. % sodium gluconate and adjusting the amount of citric acid to be about 0.12 to about 5 wt. % as taught by Feng because Reed and Feng are both drawn to shampoos comprising chelating agents and citric acid and it is obvious to modify similar compositions in the same way. The ordinary skilled would have been motivated to add about 1 to about 2 wt. % sodium gluconate because Reed teaches inclusion of chelating agents and sodium gluconate is suitably used in shampoos in an amount of about 1 to about 2 wt. %. The ordinary skilled artisan would have been motivated to adjust the amount of citric acid to be about 0.12 to about 5 wt. % because Reed teaches inclusion of citric acid to adjust the pH and an amount of about 0.12 to about 5 wt. % citric acid is suitably used in shampoos to adjust the pH.
With regard to the recited amounts of sodium gluconate, citric acid, anionic surfactant/sodium laureth sulfate/sodium lauryl sulfate/ammonium lauryl sulphate, sodium benzoate and co-surfactant and the recited pH range, the combined teachings of Reed and Feng teach these parameters with values which fall within or overlap with the claimed ranges. 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). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant requests rejoinder of a withdrawn process claim (reply, pg. 11).
The request is acknowledged but is premature as no product claims are in conditions for allowance at this time for the reasons presented above in the 35 USC 103(a) and response to Applicant’s traverse.
Applicant argues new claims 24-31 are nonobvious over Reed in view of Feng because impermissible hindsight has been used to select sodium gluconate and the specifically claimed narrow amount of sodium gluconate from numerous optional chelating agents (reply, pg. 7-8).
This is not persuasive. In response to Applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, Reed teaches a shampoo comprising citric acid and directs the ordinary skilled artisan to put a chelating agent into the shampoo. Feng teaches sodium gluconate as a suitable chelating agent for use in shampoos containing citric acid and teaches sodium gluconate in an amount of about 1 to about 2 wt. % including ranges and subranges therebetween (abstract; [0216]; [0217]). The amount of sodium gluconate taught by Feng is more narrow than Applicant’s claimed range. Applicant is using a known reagent suitable for inclusion in shampoos in amounts that are art recognized as suitable for shampoos. Notably, Applicant has not shown that sodium gluconate performs better than any other chelating agent taught by Feng.
Applicant argues neither Reed nor Feng teach the combination of sodium gluconate and citric acid in shampoo compositions for the purpose of repairing internal hair proteins (reply, pg. 7 & 10).
This is not persuasive. A rationale different from Applicant’s is permissible. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). In the instant case, Reed teaches the shampoo of their invention may comprise a pH modifier which may be citric acid and in Table 1 teaches inclusion of a pH modifier in an amount of 0.5% ([0026]; Table 1-[0119]). Reed teaches inclusion of a chelating agent and Feng teaches inclusion of sodium gluconate in shampoos which may comprise citric acid.
Applicant argues the claimed shampoos has an unexpected and surprising level of hair repair that is statistically and practically significant (reply, pg. 8). Applicant discusses their inventive composition 6 in the specification (which comprises 1.0% sodium gluconate and 0.2% citric acid) and states composition 6 shows sodium gluconate is required at a level of about 1% or greater in order to achieve the high level of protein repair observed with composition 6 and that composition 6 is commensurate with the scope of the claims (reply, pg. 9; Declaration-pg. 3-4). Declarant argues their inventive composition 6 has a mean higher denaturation temperature than Comparative Composition 1 (147.54 °C versus 144.78 °C) which is similar to that of virgin hair (Declaration-pg. 4). Declarant argues there is a significant difference between Inventive Composition 6 and Comparative 1 as shown by the Tukey-Kramer HSD test (reply, pg. 9; Declaration-pg. 4).
This is not persuasive. First, comparison of Inventive Composition 6 to Comparative Example 1 is an apples to oranges comparison in that Comparative Example 1 lacks both citric acid and sodium gluconate. Notably, Reed teaches inclusion of citric acid as a pH modifier and embodies a pH modifier in the amount of 0.5% in their examples. A more fair comparison would be Comparative Composition 2 which at least comprises 0.2% citric acid, but lacks any chelating agent.
Secondly, it is noted that Comparative Composition 2 and Inventive Composition 6 differ by just about one degree in mean denaturing temperature (Declaration-Table 2, pg. 5). Applicant fails to describe why this one degree difference is of practical significance (reply, pg. 9; Declaration-pg. 5). 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) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength “are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration.”); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992).
Thirdly, Declarant has used a Tukey-Kramer HSD test to compare groups and found Comparative Example 2 is not grouped with Inventive Composition 6 which suggests statistical significance (reply, pg. 9; Declaration-pg. 5). However, the Tukey-Kramer HSD test assumes homogeneity of variance between groups. It is noted that Declarant has not supplied variance data or has showed that the variance between the two groups are similar. Notably, the standard deviation of Composition 6 is 1.25 while the standard deviation of Comparative Composition 2 is 0.24 suggesting a lack of homogeneity of variance. If one group’s data is tightly clustered while another’s is widely scattered, that pooled estimate becomes misleading (Specification-pg. 17).
Also, with just one degree of difference between the mean denaturing temperature of Comparative Example 2 and Inventive Composition 6 (which displays a standard deviation of +/- 1.25 °C, overlapping with the spread of data achieved for Comparison Composition 2), is this property different to such an extent that the difference is really unexpected? Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (differences in sedative and anticholinergic effects between prior art and claimed antidepressants were not unexpected). In In re Waymouth, 499 F.2d 1273, 1276, 182 USPQ 290, 293 (CCPA 1974), the court held that unexpected results for a claimed range as compared with the range disclosed in the prior art had been shown by a demonstration of "a marked improvement, over the results achieved under other ratios, as to be classified as a difference in kind, rather than one of degree." Compare In re Wagner, 371 F.2d 877, 884, 152 USPQ 552, 560 (CCPA 1967) (differences in properties cannot be disregarded on the ground they are differences in degree rather than in kind); Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) ("we generally consider a discussion of results in terms of ‘differences in degree’ as compared to ‘differences in kind’ . . . to have very little meaning in a relevant legal sense"). The mean difference in denaturing temperature between the two groups is just one degree Celsius suggesting it is a difference in degree rather than a difference in kind.
It is also noted that Reed also teaches inclusion of a chelating agent and Declarant has failed to show that sodium gluconate performs better than any other chelator used in conjunction with citric acid in shampoos.
With regard to Applicant’s argument that their Inventive Composition 6 data is commensurate in scope with the claimed range. Applicant’s representative appears to be confusing amounts that fall within a recited range with commensurate with recited range. While Inventive Composition 6 falls within the recited ranges for the recited reagents, it is ONE composition having SINGULAR values for each reagent and does not support the entirety of amounts recited for each reagent. "[O]bjective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).
Declarant supplies additional data in their declaration in which the amounts of citric acid, sodium benzoate and sodium gluconate were varied (Declaration-pg. 5). The Examiner notes that Compositions A-D, F & H fall within the ranges claimed by instant claim 24 and Compositions E, G, I, & J fall outside the claimed ranges (Declaration-pg. 5). Declarant states “No results were provided for Compositions G and H-J because they were determined to have one or more undesirable parameter. The examiner queries Applicant’s representative in claiming compositions (i.e. Composition H) which has “undesirable parameters” (Declaration-pg. 6).
Declarant argues Tables 4, 5 and Figure 1 “provide a statistically significant increase in mean denaturation temperature relative to bleached hair and a non-conditioning shampoo (a control) with several compositions exhibiting denaturation temperatures comparable to that of virgin hair. (Id., 119.) These results show that shampoo compositions containing sodium gluconate and citric acid in select amounts produce a high level of repair to damaged hair that is statistically and practically significant.” (reply, pg. 9).
This is not persuasive. The Examiner notes that shampoo E (which falls outside of the claimed composition) performed as well as shampoos A, F, and D (which fall inside the claimed ranges), with the four compositions being labeled as Group “B” by Declarant’s Tukey-Kramer test (Declaration-Table 5, pg. 8). Further, that shampoo E (which falls outside of the claimed composition) performed as well as shampoos F, D, C, and B (which fall inside the claimed ranges), with the five compositions being labeled as Group “C” by Declarants Tukey-Kramer test (Declaration-Table 5, pg. 8). Notably, Shampoo H (which falls within the claimed ranges) which is determined to have an undesirable parameter by Declarant had a higher denaturing temperature than virgin hair (Declaration- pg. 6. Table 4, pg. 7). Declarant did not evaluate Inventive Composition H in the Tukey Kramer HSD test (see Table-5, pg. 8). Declarant does not explain these conflicting results. "[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness." Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992).
Declarant argues that Figure 1 shows “several composition exhibiting denaturing temperatures comparable to that of virgin hair” (Declaration-pg. 9). The examiner notes that Composition E, which falls outside the claimed range, has a denaturing temperature which overlaps with that of virgin hair. This is not explained by Declarant (See Declaration-Fig 1, pg. 9).
Next, the Tukey-Kramer HSD test assumes homogeneity of variance between groups. It is noted that Declarant has not supplied variance data. However, the dispersion of temperature denaturing temperatures suggests the variance between groups is high (Declaration-Figure 1, pg. 9). For example, the dispersion of data for Shampoos B and D appear great while the dispersion of data for Shampoo A appears smaller. This suggests a lack of homogeneity of variance. If one group’s data is tightly clustered while another’s is widely scattered, that pooled estimate becomes misleading.
The Examiner notes that inventive Shampoos A and F are grouped with virgin hair. However, Shampoo E (which falls outside of the claimed ranges) only has a difference in the mean denaturing temperature of 1.4 °C as compared to virgin hair. Applicant has not described why this difference is practically significant. This important as other inventive shampoos which fall within the claimed range overlap with/are grouped with Shampoo E (see Shampoos F, D, C & B). Applicant fails to disclose which compositions achieved surprising results versus just different results. This is important in light of Shampoo E (which falls outside of the claimed ranges) overlapping with inventive Shampoos F, D, C & B.
The inventive shampoos are also not commensurate with the scope of the claims (i.e. Shampoos A-D, F & H). In particular, instant claim 24 recites inclusion of 0.1 to 2 wt% citric acid but only the lower end of the range was examined (i.e. 0.2 -0.4%). Instant claim 24 recites inclusion of 0.01 to 2 wt% of sodium benzoate but only the mid to upper ends of the range were examined (0.3-2 wt.%) with inventive Shampoos A-D, F & H.
Declarant argues their inventive Shampoos K-O provide a statistically significant increase in denaturation temperature after 5 and 10 washes as compared to the non-conditioning shampoo P (Declaration-pg. 11; reply, pg. 10). Applicant argues that significant internal repair can be consistently evidenced regardless of the surfactant used (reply, pg. 10).
This is not persuasive. Shampoos K-O are not commensurate with the scope of the claims in that instant claim 24 recites inclusion of an anionic surfactant in an amount of 5 to 20 wt%, yet only the middle of the range was examined (i.e. 8-14 wt% anionic surfactant). Applicant has not shown unexpected results for the ends of the claimed range.
Next, the claims recite the co-surfactant may be a nonionic surfactant. No non-ionic surfactants were examined. The results are not commensurate with the scope of claim 24.
The amount of co-surfactant is not commensurate with the range recited by instant claim 24. Instant claim 24 recites inclusion of a co-surfactant in an amount of 0.5 to 8 wt%. However, only the middle of the range was examined using only the amphoteric/zwitterionic surfactant cocamidopropyl betaine in an amount of 1.6 to 2.5 %. The ends of the claimed range were not examined.
Declarant argues the Tukey-Kramer analysis show no statistical differences between Shampoos K-O after 5 washes indicating that the variation in shampoo chassis does not impact the magnitude of internal repair delivered by Shampoos K-O after 5 wash cycles (Declaration-pg. 11, reply, pg. 10). After 10 washes, all shampoo delivered a significant increase in denaturing temperature when compared to the non-conditioning shampoo (Declaration-pg. 11).
This is not persuasive, The Examiner notes variance values were not given between groups. The analysis of Tukey-Kramer HSD test with regard to Declarant’s 5 and 10 wash cycles is the same as presented above regarding the results pertaining to inventive composition 6, and Shampoos A-D, F & H. For the Tukey-Kramer HSD test to be applicable, homogeneity of variance must be present. Further Declarant has not described the practical significance between the denaturing temperature of the control shampoo to inventive shampoos (i.e. a mean denaturing degree difference ranging from about 3.67-8.09 °C). Declarant does not disclose how this difference in mean denaturing temperatures lead to a difference in kind versus a difference in degree.
Conclusion
No claims are 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 LORI K MATTISON whose telephone number is (571)270-5866. The examiner can normally be reached 9-7 (M-F).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David J Blanchard can be reached at 5712720827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LORI K MATTISON/ Examiner, Art Unit 1619
/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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