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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/30/2026 has been entered.
Status of the Claims
This action is in response to papers filed 03/23/2026 in which claim 20 was withdrawn; and claims 1 and 11 were amended. All the amendments have been thoroughly reviewed and entered.
Claims 1-19 are under examination.
Withdrawn Rejection
The rejection of claim(s) 1-19 under 35 U.S.C. 103 as being unpatentable over Montoya et al (US 2020/0345596 A1) in view of Yang (US 2021/0077373 A1) and Faig et al (US 2021/0401715 A1), is withdrawn, in view of Applicant’s amendments to claims 1 and 11, which had necessitated the New Matter rejection below. Thus, Applicant’s arguments in the Remarks filed 03/23/2026 are hereby moot. However, in the event the new matter material was to be removed in response to the new matter rejection as set forth below, this 103 rejection may be reinstated.
New Objection
Claim Objections
Claims 1 and 11 are objected to because of the following informalities: please remove the “s” in “compositions” in the second to last line of said claims because the preamble of said claims is to “composition” in singularity. Appropriate correction is required.
Modified Rejection
Necessitated by Applicant’s Claim Amendments
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.
Claims 1-19 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.
Claims 1 and 11 introduce new matter as the claims recite the limitation: “the compositions is free of any clay present in an amount greater than about 0.8%, by weight, based on the total weight of the cosmetic composition.” There is no support in the specification for this limitation.
Applicant asserted that the support for the amendments can be found in paragraph [0043] of the specification. However, after a thorough review of said paragraph [0043], as well as, throughout the specification, there appeared to be no support for the negative limitation of “the compositions is free of any clay present in an amount greater than about 0.8%, by weight, based on the total weight of the cosmetic composition” as claimed.
It is noted that paragraph [0043] of the specification discloses “each one of the polymers and clay in the cosmetic composition is present by weight, based on the total weight of the cosmetic composition, as disclosed above [disclosed in paragraph [0042]], from about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, to about 2.5 percent, including increments and ranges therein and there between.” There is no support anywhere in paragraph [0043] (as disclosed above) for the cosmetic composition to be “free of any clay present in an amount greater than about 0.8%, by weight.” Paragraph [0043] of specification only provide for each one of the clay in the cosmetic composition to be present from a range of “about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, to about 2.5 percent.” There is no indication in said paragraph [0043] that “an amount greater than about 0.8% by weight” of any clay can be excluded.
It is noted that [a]ny negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) ("[the] specification, having described the whole, necessarily described the part remaining."). See also Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983), aff’d mem., 738 F.2d 453 (Fed. Cir. 1984). The mere absence of a positive recitation is not basis for an exclusion.
The disclosure of ““each one of the polymers and clay in the cosmetic composition is present by weight, based on the total weight of the cosmetic composition, as disclosed above [disclosed in paragraph [0042]], from about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, to about 2.5 percent, including increments and ranges therein and there between” from paragraph [0043] is not an alternative element positively recited in the specification that provide support for exclusion of “any clay present in an amount greater than about 0.8%, by weight,” because “an amount of greater than about 0.8%, by weight” is a broad range that set a minimum starting point of “about 0.8%” but puts no limit on how high the value can go and thus, would include a broad range of from about 0.8% to as high as 100%. Paragraph [0043] of the specification is merely a disclosure of a weight % range for the content of clay or in other words, weight% range of from about 0.1 to about 2.5 % by weight, where the maximum point is 2.5% by weight. Given that individual weight % point is disclosed (i.e., 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5), the exclusion of sub-ranges (i.e., about 0.8% to about 2.5% or 1.0% to 2.5%, etc.) are supported, but not the exclusion of the claimed broad range of “an amount greater than about 0.8%, by weight.” It is noted that the claimed broad range of “an amount greater than about 0.8%, by weight “ includes a range of about 0.8% to about 100% by weight, where the upper limit such as 20%, 40%, 60% or even 100% by weight is clearly not supported by paragraph [0043]. Thus, Applicant does not have possession of excluding any clay present in an amount in the broad range of “greater than about 0.8%, by weight.”
Claims 2-10 and 12-19 are also rejected, as they dependent directly or indirectly from claims 1 and 11, respectively, thereby also containing the conflicting new matter limitation.
As such, the disclosure does not reasonably convey that the inventor had possession of the subject matter of amended claims 1 and 11 at the time of filing of the instant application.
Response to Arguments
Applicant's arguments filed 03/23/2026 have been fully considered but they are not persuasive.
Applicant argues:
“[P]aragraph [0043] of the Specification discloses that "each one of the polymer and clay in the cosmetic composition is present, by weight based on the total weight of the cosmetic composition, as disclosed above, from about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, to about 2.5 percent, including increments and ranges therein and there between." Pursuant to MPEP § 2173.05(i), "[i]f alternative elements are positively recited in the specification, they may be explicitly excluded in the claims." Therefore, because paragraph [0043] specifically and positively recites that each clay in the cosmetic composition may be present from about 0.8% as an alternative range, that range may be excluded for each clay present.” (Remarks, bottom of page 7 to page 8).
In response, the Examiner disagrees. As discussed above in the pending New Matter rejection, the disclosure of ““each one of the polymers and clay in the cosmetic composition is present by weight, based on the total weight of the cosmetic composition, as disclosed above [disclosed in paragraph [0042]], from about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, to about 2.5 percent, including increments and ranges therein and there between” from paragraph [0043] is not an alternative element positively recited in the specification that provide support for exclusion of “any clay present in an amount greater than about 0.8%, by weight,” because “an amount of greater than about 0.8%, by weight” is a broad range that set a minimum starting point of “about 0.8%” but puts no limit on how high the value can go and thus, would include a broad range of from about 0.8% to as high as 100%. Paragraph [0043] of the specification is merely a disclosure of a weight % range for the content of clay or in other words, weight% range of from about 0.1 to about 2.5 % by weight, where the maximum point is 2.5% by weight. Given that individual weight % point is disclosed (i.e., 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5), the exclusion of sub-ranges (i.e., about 0.8% to about 2.5% or 1.0% to 2.5%, etc.) are supported, but not the exclusion of the claimed broad range of “an amount greater than about 0.8%, by weight.” It is noted that the claimed broad range of “an amount greater than about 0.8%, by weight “ includes a range of about 0.8% to about 100% by weight, where the upper limit such as 20%, 40%, 60% or even 100% by weight is clearly not supported by paragraph [0043]. Thus, Applicant does not have possession of excluding any clay present in an amount in the broad range of “greater than about 0.8%, by weight.”
As a result, for at least the reason discussed above, it is maintained that the disclosure does not reasonably convey that the inventor had possession of the subject matter of amended claims 1 and 11 at the time of filing of the instant application.
Maintained Rejection
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.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12036304 in view of Yang (US 2021/0077373 A1) and Faig et al (US 2021/0401715 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the U.S. Patent No. 12036304 significant overlap with the subject matter of the instant claims i.e. salt-stable cosmetic compositions in the form of an oil in water emulsion, comprising: a water phase including: (i) a salt-stable polymeric system comprising a polymer blend comprising polyacrylate crosspolymer-6 and one or more gum such as xanthan gum; (ii) at least one acidic skin active present in the form of a cosmetically acceptable acid; and (iii) one or more neutralizing agents to provide a pH in a range from about 4.5 to about 7.5; and an oil phase, wherein: the total amount of polymer present in the salt-stable cosmetic composition is not more than about 1.5%, by weight, based on the total weight of the salt-stable cosmetic composition; the salt stable cosmetic composition includes greater than 2% salt; and the salt-stable cosmetic composition resists phase separation, pilling and gellifying.
While the claims in the Patent ‘304 further contains acrylamide/sodium acryloyldimethyltaurate copolymer in the polymer blend, it would have been obvious to include acrylamide/sodium acryloyldimethyltaurate copolymer in the polymer blend of the instant claims in view of the guidance from Yang (Abstract; [0012]-[0014], [0035]-[0063], [0065]-[0077], [0099]; Example 1, Table 1; claims 1-12).
While the claims in the Patent ‘304 does not contain one or more clay in a range from about 0.1% to about 0.8% by weight, it would have been obvious to include clay in the composition of the Patent ‘304, as well as, optimize the amount of clay included in the composition to an amount as claimed, in view of the guidance from Faig (Abstract; [0006]-[0011], [0013]-[0016], [0019]-[0024], [0028]-[0030], [0078]-[0165], [0181]-[0202]; claims 1-18).
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the U.S. Patent No. 12036304 in view of Yang and Faig.
Response to Arguments
Applicant's arguments filed 03/23/2026 have been fully considered but they are not persuasive.
Applicant argues that “[t]able 3 and paragraph [0205] of the present Specification demonstrates that the introduction of the clay component provides the unexpected result of forming an emulsion that does not contract, and which lacks liquid pooling. Therefore, even if the combinations of references were proper, any obviousness-type double patenting is overcome by the showing of unexpected results.” Applicant then alleges that “[o]n pages 23-25 of the Office Action, the Patent Office suggests claims 1 and 11 are not adequately commensurate in scope with the Inventive 1 composition which was used for showing the unexpectedly improved results or a property not taught by the prior art, and yet the Patent Office's rejection of the dependent claims, particularly claims 7 and 18, without comment or analysis, do not support the Patent Office's contention that lack of commensurate scope is the basis of the Patent Office's rejection of all claims. Further, the Patent Office's comment on page 20 of the Office Action suggesting that the result may not actually be unexpected in light of art that is not applied in the double-patenting rejection is contrary to the Patent Office's mandate for compact prosecution. Either art is applied in a rejection or it is not applied in a rejection.” (Remarks, page 13).
In response, the Examiner disagrees. Because Applicant is arguing “unexpected results,” MPEP 716.02(d) had made clear that any objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support. As previously discussed, Independent claims 1 and 11 are not commensurate in scope with Applicant’s alleged evidence of unexpected results. Claim 7 and 18 of the instant invention is dependent from rejected base claims 1 and 11 and thus, the rejected base claims 1 and 11 remained not commensurate in scope with the Inventive 1 composition used for showing the alleged unexpected results.
Thus, as previously discussed, the Examiner maintains the position that Applicant’s alleged evidence of unexpected emulsion stability as shown in Table 3 and paragraph [0205] of the specification are considered, but are found not persuasive because Inventive 1 composition is drawn to particularly 0.5% polyacrylate crosspolymer-6, 0.3% xanthan gum and 0.5% hectorite, yet the salt-stable polymeric system of claims 1 and 11 are much broader than Inventive 1 composition, particularly claim 1 is drawn generically to any clay, as well as, both claims 1 and 11 are drawn to broad ranges for polyacrylate crosspolymer-6, xanthan gum, and hectorite. Thus, claims 1 and 11 are not adequately commensurate in scope with Inventive 1 composition that was used for showing the alleged unexpected emulsion stability. It is noted that [w]hether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective 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). In re Grasselli, 713 F.2d 731, 741, 218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.). See MPEP 716.02(d).
Furthermore, it is noted that the alleged evidence of unexpected emulsion stability shown in Example 3 of the Specification may not be truly unexpected because Yang established that the presence of a combination of polyacrylate crosspolymer-6, xanthan gum in an oil-in-water emulsion provides a stable emulsion, as this combination functions as a stabilizing thickener for the emulsion (cosmetic composition) (Yang: [0099]; claims 1-11).
Accordingly, for at least the reason discussed above, the alleged evidence of unexpected results were not persuasive and thereby, the obviousness-type double patenting as set forth in this office action have not been overcome, pending filing of a terminal disclaimer.
As a result, it is maintained that the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the U.S. Patent No. 12036304 in view of Yang and Faig.
Conclusion
No claim is allowed.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
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