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 .
This office action is in response to the reply filed 11/5/2025.
Election/Restriction
Claim 20 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Terminal Disclaimer
The terminal disclaimer filed on 10/18/2024 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Application 17/044264 has been reviewed and is NOT accepted due to the reference application date.
Response to Arguments
All of Applicant’s arguments filed 11/5/2025 have been fully considered.
In view of the amendments to the claims, the 112(b) issues identified by the examiner in the previous office action have been resolved, as such the rejection is withdrawn.
Applicant remarks that in the claims as amended the scope has been substantially limited and argues that that all the essential ingredients for the claimed compositions are already present in the claims and it’s not necessary to have one or more additional additives such as salicylic acid to formulate the microemulsion according to the instant invention. Compositions A and B as described in the specification show that formulation of the microemulsion is possible without any additional additives. As such the claims are commensurate in scope with the filed declaration.
This is not persuasive. While Applicant has limited the claims, the declaration is still not persuasive. As previously explained Applicant provides a single inventive example comprising very specific ingredients in specific amounts. One data point is insufficient to “to ascertain a trend in the exemplified data which would allow [one having ordinary skill in the art] to reasonably extend the probative value thereof.” In re Kollman, 595 F.2d 48, 56 (Fed. Cir. 1979). Furthermore, the example presented in the declaration use both PG-4 laurate and PG-5 laurate; and glycerin and propanediol. As stated by Applicant the slightest change in the nature of the ingredients or their content can impact stability and lead to the loss of the microemulsion form as such the data presented by Applicant is not sufficient to cover the scope of the entire claims. Applicant’s remarks regarding salicylic acid and Examples A and B of the instant specification are not persuasive as its unsupported by factual evidence. Applicants reliance on Examples A and B to show that additives are not necessary to form the microemulsion are not persuasive as the instant specification does not indicate that Compositions A and B are microemulsions. While specification generically teaches that microemulsions are preferred, compositions A and B are not taught to be microemulsions.
Applicant argues that a skilled artisan would not be able to predict the unexpected results of the instant invention based on the teachings of the prior art.
This is not persuasive as the data presented is not persuasive as this time.
Applicant’s request for rejoinder is not persuasive at this time as claim 1 is not allowable over the prior art.
Applicant’s arguments regarding the double patenting rejection are not persuasive. While US’264 does not comprise a cationic polysaccharide the DP rejection is based on obviousness and the prior art makes obvious adding a cationic polysaccharide into the composition of US’264 and only a one way determination of obviousness is needed.
Modified 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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1-4, 15, 17, 22 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Derrips (US2016/0317416), KR 20170062899 and Manfred (EP 0806200).
Derrips discloses a cosmetic composition in the form of a nanoemulsion or microemulsion, comprising: (a) at least one oil; (b) at least one nonionic surfactant with an HLB value from 8.0 to 14.0; (c) at least one C-glycoside compound; and (d) water (Abs).
Regarding claims 1 and 22: Derrips teaches that the oil is preferably chosen from fatty esters. The fatty esters are preferably liquid esters of liquid esters of linear or branched, saturated or unsaturated C1-C26 aliphatic monoacids or polyacids and of linear or branched, saturated or unsaturated C-C aliphatic monoalcohols, the total number of carbon atoms in the fatty esters being greater than or equal to 10 [0028]. A preferred fatty ester are those containing one or more C1-C12 hydrocarbon-based chain, for example, isopropyl myristate (i.e. monoester of monoalcohol and of monoacids) and the oil can be used in amounts ranging from 1-40%, which overlaps with the claimed ranges and overlapping ranges are prima facie obvious absent evidence of criticality in the claimed range ([0052-0053] and working example), reading on liquid fatty substance.
Regarding claim 1: Derrips teaches the non-ionic surfactant to be a polyglycerol monolaurate comprising 3-6 glycerol units, the non-ionic surfactant can be used in amounts ranging from 0.1-30%, which overlaps with the claimed ranges and overlapping ranges are prima facie obvious absent evidence of criticality in the claimed range (Derrips – claims 7 and 9). Preferred surfactants include PG-4 laurate [0119 and 0126].
Regarding claim 1: Derrips teaches the composition to comprise at least one polyol, in amounts of 0.01-30% and suitable polyols for use those having 2-5 hydroxyl groups, such as butylene glycol, glycerol, 1,3-propanediol, etc. [0348-0353], thus the use of two polyols, including at least one diol is prima facie obvious. Derrips teaches amounts that overlap with the claimed ranges of polyol and diol and overlapping ranges are prima facie obvious absent evidenced showing the claimed ranges to be critical.
The working example in table 1 discloses a composition comprising: oil (isopropyl myristate and octyldodecanol); PG-2 caprate and PG-5 laurate; butylene glycol and water among other ingredients.
Derrips does not teach a specific embodiment having all the claimed elements.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. AG. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is... a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected various combinations of various disclosed ingredients including Pg-4 laurate, liquid fatty substance, polyols, cationic agents, as discussed above, for preparation of a cosmetic composition from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Regarding the ratio of claims 1-4 and 15: Derrips teaches the non-ionic surfactant (i.e. PG-4 laurate, the claimed monoester) to be used in amounts of 0.1-30% and teaches that polyols, such as 1,3-propanediol, can be used in amounts of 0.01-30% which provides a ratio of monoester to diol/polyol .0033-3000 and the working example exemplifies a ratio of 6.5. and overlapping amounts are prima facie obvious absent evidence of criticality.
However, Derrips does not teach the amount of water used to be 1-20% or between 2-10% as recited by instant claims 1 and 24.
KR’899 teaches micro- or nano-emulsions, in particular W/O emulsions (Abs) and teaches these emulsions to comprise water in amounts of 5-20%, preferably 8-15%; oil in amounts ranging from 10-70%.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Derrips with those of KR’899. One of skill in the art would have been motivated to formulate the composition of Derrips as a W/O emulsion comprising amounts of water between 5-20% as KR’899 teaches that these amounts of water are suitable for use when formulating W/O nanoemulsion and its prima facie obvious to combine prior art elements according to known methods to achieve a predictable result. There is a reasonable expectation of success as Derrips teaches that preferred formulations are O/W and W/O emulsions, thus the selection of either type of emulsion is obvious and both Derrips and KR’899 teaches W/O nanoemulsions.
Regarding the ratio of claim 17: The prior art makes obvious to use of water in amounts of 5-20%, and teaches the oil to be used in amounts of 1-40%, which provides a ratio of 0.167-4. The prior art teaches ratios which overlap with the claimed amounts and overlapping ratios are prima facie obvious absent evidence of criticality.
However, the above references do not teach the composition to further comprise a cationic polysaccharide as recited by the instant claims.
It is noted that Derrips teaches that thickening agents chosen from polysaccharides, such as starches and xanthan gum, can be effectively added in amounts of 0.1-5% [0360 and 0357] and teaches the composition to be applied to treat skin and/or hair [0384].
Manfred teaches hair dyeing compositions (i.e. cosmetics) and teaches these to comprise thickening agents such as xanthan gum and celluloses (methyl cellulose, ethyl cellulose, hydroxyethylcellulose, etc.) and their cationic derivatives (Pg. 2).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Derrips and KR’899 with those of Manfred. It would have been prima facie obvious to add a polysaccharide such as a cationic derivative of the celluloses of Manfred to the formulation of Derrips with a reasonable expectation of success as the presence of polysaccharide thickening agents are specifically contemplated by Derrips and both xanthan gum, cellulose of Manfred and their cationic derivative are taught by the prior art to be equivalent polysaccharide thickening agents for use in hair cosmetics. One of skill in the art would have a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
As recognized by MPEP §2144.06, it is prima facie obvious to substitute art-recognized equivalents, and an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).
New Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-4, 15, 17, 21 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2, 9 and 11-13 of copending Application No. 17/044264 (reference application), Derrips and Manfred (EP 0806200). Although the claims at issue are not identical, they are not patentably distinct from each other because both teach cosmetic composition comprising polyglycerl-4 laurate, liquid fatty substances such as monoester of monoacids and of monoalcohols, polyols, cationic agents such as cationic polysaccharides and water, all in overlapping amounts. Both teach overlapping weight ratios between monoester and diol; water and liquid fatty substance; etc.
However, US’264 does not teach the presence of a cationic polysaccharides.
The teaching of Derrips and Manfred discussed above are incorporated into this rejection. It would have been prima facie obvious to add a thickening agent to the composition such as cationic cellulose derivatives taught by Manfred as these are taught by the prior art to be suitable for cosmetic composition and its prima facie obvious to pursue the known options within the technical grasp of a skilled artisan to achieve the predictable results of formulating a cosmetic composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowable.
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 Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on (571) 272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613