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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/11/2026 has been entered.
Status of Claims
Amendment filed on 05/11/2026 is acknowledged.
Claims 1-11 remain cancelled. Clams 19-30 remain withdrawn for being drawn to nonelected group. Claim 12 is amended.
Claims 12-18 are pending and being examined on the merits herein.
Priority
This instant application 18247527, filed on 03/31/2023, is a 371 of PCT/EP2021077176, filed on 10/01/2021, which claims foreign priority to Germany 10 2020 125 874.7, filed on 10/02/2020.
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.
Claims 12-14 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Gassenmeier et al. (WO2004026295, 04/01/2004, IDS of 11/03/2023, translation replied upon below; attached, PTO-892), in view of Liu (CN106333874, 01/18/2017, IDS of 11/03/2023, translation relied upon below; attached, PTO-892) and Lambers et al. (Int J Cosmet Sci. 2006 Oct; 28(5): 359-70, Abstract attached, PTO-892).
Gassenmeier throughout the reference teaches the use of at least one substance which can form a zwitterion and/or the derivatives thereof for protecting the skin and/or skin appendages (e.g., Claim 1; Abstract).
For Claims 12 and 16, Gassenmeier specifies that the specific substance is selected from glycine, alanine, glutamic acid, praline, taurine (corresponding to instant claim 16), betaine, sarcosine, creatine, N, N-dimethylglycine (corresponding to instant claim 12), lysine and their derivatives (e.g., Claims 5, 17, and 21), and the substances are particularly suitable for dermatological use by topical application, such as pharmaceutical preparations include powders, ointments, oils, creams, pastes, suspensions (e.g., Pg. 20, 2nd paragraph), and cosmetic preparations including toothpastes, gels, mouthwashes, mouthwashes, skin care creams, after-sun products, surfactant products such as shower baths and I or shampoos, hair treatment agents such as treatments or rinses, or hair dyes (e.g., Claims 23-25). Gassenmeier indicates the composition is characterized that the substance can form a zwitterion at pH values between 3 and 11 (e.g., Claim 2).
For Claim 13, Gassenmeier specifies that the specific substance, e.g., dimethylglycine, characterized in the preparations between 0.005 to 15 wt.% (e.g., Claim 22), falling within the amount range of 0.00001% to 25.0% in claim 13.
For Claims 14 and 17, Gassenmeier teaches many suitable additives, including surfactants, oil additives, pearlescent waxes, thickeners, stabilizers, antioxidants, preservatives, solubilizers, dyes and the like (e.g., Pg. 8, middle). Gassenmeier exemplifies in a “leave-on” formulation, with the active ingredient incorporated in a concentration of 2.5% in the base cream, comprising glyceryl stearate 4.0% and PEG-20 glyceryl stearate 7.0%, cetearyl alcohol 6.0 (as moisturizer, thickener, or stabilizer), petrolatum 25.5% , propylene glycol 10.0%, aqua (as solvents, corresponding to instant claim 17) 20.0% (Pg. 27, middle, Table 4), among which surfactants glyceryl stearate and PEG-glyceryl stearate present in total 11.0%, falling within the amount range of 2% to 40% in claim 14.
For Claim 18, Gassenmeier teaches the composition as cosmetic or pharmaceutical preparation selected from hair and or skin or body and /or mouth or dental care products, toothpastes, gels, mouthwashes, skin care creams, shower baths and/ or shampoos, hair treatments, rinses, or hair dyes (e.g., Claims 23-25). Gassenmeier teaches that skin is the surface of the human body and an organ that is built up in different layers. The outermost of these layers is formed by the epidermis. The top layer of the epidermis, in turn, is the stratum corneum, which consists of dead cells. The epidermis protects the underlying tissue from external physical influences, such as heat or UV radiation, and from chemical and biological influences, such as microorganisms. Dry, brittle, flaky, sensitive or irritated skin is often rough or cracked and cannot fully fulfill the protective function of the intact skin. An increased trans epidermal water loss of the cracked or rough skin can, in addition to the loss of moisture and the associated lower elasticity, also lead to an increase in the osmolarity in the extracellular region of the epidermis (e.g., Pg. 2, middle). Gassenmeier states that the object of the invention is to find active substances for protecting the skin which can remedy the negative consequences of UV stress and/or osmotic stress in the skin, and the object is achieved by using at least one substance that can form a zwitterion and/or its derivatives to protect the skin and /or skin appendages from apoptosis (e.g., Claims 18-20; Pg. 2, middle), indicating the composition is a care composition able to promote metabolism of skin and hair, corresponding to claim 18.
Gassenmeier does not specify the final composition pH is in the range of 3.0 to 5.4 as recited in instant claim 12, although Gassenmeier teaches pH values between 3 and 11 allow the form zwitterion (e.g., Claim 2).
Liu throughout the reference teaches hydrating moisturizing sleeping facial mask comprising 10 parts of dimethylglycine with the pH value of the facial mask approximate to that of human body skins (e.g., Abstract; [0023]). Liu indicates that with the pH value close to that of human skin, it is non-irritating to the skin; after use, the skin feels noticeably comfortable and soft without any greasiness, and has obvious firming, moisturizing, and skin nourishing effects [0023].
Lambers reports skin pH values reported in literature are all in the acidic range but with a broad range from pH 4.0 to 7.0; Lambers provides a multicenter study that the natural skin surface pH is on average 4.7, i.e. below 5.0 (Abstract; Conclusions). Lambers indicates that an acidic skin pH (4-4.5) keeps the resident bacterial flora attached to the skin (Abstract; Conclusions), overlapping with pH range of 3.0 to 5.4 in instant claim 12.
It would have been prima facie obvious for a person with ordinary skills in the art prior to filing date to incorporate the teachings from Liu and Lambers to modify the pH value into the composition of Gassenmeier to arrive at current invention, because the pH value of the composition close to human skin constitutes the benefit of comfortable feelings with no irritation on the skin, especially Lambers teaches that human natural skin pH is acidic on average 4.7 and pH (4-4.5) keeps resident bacterial flora attached to the skin, artisans would have the motivation to implement such pH range for the composition for reasonable expectation of success. This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D). Moreover, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Selecting the suitable components taught by prior art renders obviousness.
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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, the component weight amounts, pH values overlap with those taught by prior art. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gassenmeier et al. (WO2004026295, 04/01/2004, IDS of 11/03/2023, translation replied upon below; attached, PTO-892), in view of Liu (CN106333874, 01/18/2017, IDS of 11/03/2023, translation relied upon below; attached, PTO-892) and Lambers et al. (Int J Cosmet Sci. 2006 Oct; 28(5): 359-70, Abstract attached, PTO-892) as applied to claims 12-14 and 16-18 above, further in view of Brooks et al. (EP1417956, 05/12/2004, IDS of 11/03/2023).
Combined teachings of Gassenmeier, Liu and Lambers teach the topical composition comprising dimethylglycine with pH range close to skin pH, e.g., 4.7, below 5.0, or 4-4.5 so that the composition would provide the skin comfortable care without irritation to promote skin health, as discussed and applied to claims 12-14 and 16-18 above, and incorporated herein.
Gassenmeier exemplifies using suitable silicic acid polishing agents such as precipitated silicas with various viscosity (e.g., 30-60 Pa.s in an amount 10-20 wt. %; 10-100 Pa.s, Pg. 17, middle paragraphs) to adjust the product viscosity to make products into forms like toothpastes or liquid cleaning agents (Pg. 17, 1st paragraph), strongly suggesting the viscosity of the product depends on adjustors and any form of products can be anticipated based upon adjustments, corresponding to viscosity in instant claim 15.
Combined teachings of Gassenmeier, Liu and Lambers do not explicitly teach the composition has a viscosity of 800 to 6000 mPa.s.
Brooks throughout the reference teaches skin care composition comprising zwitterionic bulking agent (Claim 5), trimethylglycine, proline, bicine, dimethylglycine, or mixtures thereof (Claim 6). Brooks indicates that the compositions preferably have a viscosity of from 1 Pa.s to 50 Pa.s, more preferably from 2 Pa.s to 25 Pa.s, more preferably still from 3 Pa.s to 10 Pa.s [0068] (overlapping with the viscosity range of 800 to 6000 mPa.s, or 0.8 to 6 Pa.s in instant claim 15).
It would have been prima facie obvious for a person with ordinary skills in the art prior to filing date to incorporate the teaching from Brooks of viscosity ranges into the composition taught by Gassenmeier, Liu and Lambers to arrive at current invention. Because Brooks topical composition comprising same components, e.g., methylglycine and zwitterionic agent, as the skin care composition taught by Gassenmeier, Liu, and Lambers, while Gassenmeier indicates using variable viscous materials to adjust the viscosity, it would be convenient and advantageous for artisans to adopt the viscosity values taught by Brooks for reasonable expectations of success, to achieve the desirable skin feel attributes (e.g., [0064]) of forming dimensionally thick and robust films once dry [0005] with improved moisturization and elasticity [0006], easy removal and improved skin feel [0052]. Therefore, the claimed invention is a simple combination of reagents known to be obvious materials that all already taught in prior art and discussed above. The idea for combining them flows logically from them having been individually taught in the prior art. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, the viscosity overlaps with that taught by prior art. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
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 12-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 11-14 and 18-23 of copending Application No. 18247524 (reference application, hereafter US’524). Although the claims at issue are not identical, they are not patentably distinct from each other.
US’524 directs to a method for treating hair and scalp by administering a composition comprising dimethylglycine and/or a salt of dimethylglycine (Claim 11) (corresponding to instant claim 12), wherein the composition is topically administered to the hair or scalp of the subject (Claims 12-13), able to promote metabolism of the scalp and hair (Claim 14) (corresponding to instant claim 18). US’524 recites the composition has a pH in the range from 3.0 to 5.9 (Claim 18)(overlapping with pH range as in instant claim 12), 0.00001% to 25.0% of dimethylglycine and/or a salt of dimethylglycine (Claim 19) (identical to instant claim 13), surfactants in an amount of from 2% to 40% by weight (Claim 20)(identical to instant claim 14), at least one other active ingredient species (Claim 21) (identical to species in instant claim 16), at least one additive species (Claim 22) (identical to instant claim 17). US’524 recites the method by administering the composition comprising a) 0.00001% to 25.0% dimethylglycine and/or salt of dimethylglycine, b)surfactants in an amount of from 2% to 40% by weight, c) at least one other active ingredient selected from caffeine, menthol, biotin, zinc PCA, niacinamide, panthenol, and others, and wherein the composition has a pH in the range of from 3.0 to 5.9 (Claim 23) (corresponding to instant claims 12-14 and 16-18). Even though US’524 does not recite the composition having a viscosity of 800 to 6000 mPa.s as recited in instant claim 15, viscosity is interpreted as a property of the composition because it does not materially contribute to the composition subject matter, and capable of being achieved at any claimed value by routine practice in the field.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 12-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 11, 13, 15-16, 18-21 and 24 of copending Application No. 18247542 (reference application, hereafter US’542) in view of Gassenmeier et al. (WO2004026295, 04/01/2004, IDS of 11/03/2023, translation replied upon below; attached, PTO-892), Liu (CN106333874, 01/18/2017, IDS of 11/03/2023, translation relied upon below; attached, PTO-892), Lambers et al. (Int J Cosmet Sci. 2006 Oct; 28(5): 359-70, Abstract attached, PTO-892) and Brooks et al. (EP1417956, 05/12/2004, in record of IDS 11/03/2023). Although the claims at issue are not identical, they are not patentably distinct from each other.
US’542 directs to a topical composition (Claim 11) comprising a) dimethylglycine and /or a salt of dimethylglycine, and b) caffeine (Claim 11) (corresponding to instant claims 12 and 16), wherein dimethylglycine and/or a salt of dimethylglycine is 0.001% to 10.0% by weight (Claim 13) (falling within weight range in instant claim 13), at least one other active ingredient selected from menthol, biotin, and other species (Claim 15) (corresponding to instant claim 16), at least one additive species (Claim 16) (identical to instant claim 17), able to promote metabolism of skin and hair (Claim 18) (corresponding to instant claim 18). US’542 further recites a method by administering the composition comprising dimethylglycine and /or salt of dimethylglycine and at least claims 19-21 and 24 are also relevant to the instantly claim composition.
US’542 does not recite the composition pH in instant claim 12, or surfactant in the composition as recited in instant claim 14, or composition has a viscosity of 800 to 6000 mPa.s as recited in instant claim 15.
Combined teachings of Gassenmeier, Liu, Lambers and Brooks teach topical composition comprising dimethylglycine with surfactant amount 11%, pH at 4.7, or below 5.0, or 4.0-4.5, with viscosity of the composition overlapping with instantly claim range, as discussed above in great detail and incorporated herein.
It would have been prima facie obvious for one with ordinary skill in the art to incorporate surfactant and pH, and viscosity taught by Gassenmeier, Liu, Lambers, and Brooks into the topical composition recited in US’542 to arrive at current invention. Because they share most common components for the same intended use, it would motivate scientists in the field to combine these teachings to experiment and optimize a composition. Therefore, the claimed invention is a simple combination of reagents known to be obvious materials that all already taught in prior art and discussed above. The idea for combining them flows logically from them having been individually taught in the prior art. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, the component weight, pH, viscosity overlaps with those recited in US’542 or taught by prior art. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 12-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 11, 13, and 15-23 of copending Application No. 18854001 (reference application, hereafter US’001) in view Gassenmeier et al. (WO2004026295, 04/01/2004, IDS of 11/03/2023, translation replied upon below; attached, PTO-892), Liu (CN106333874, 01/18/2017, IDS of 11/03/2023, translation relied upon below; attached, PTO-892), Lambers et al. (Int J Cosmet Sci. 2006 Oct; 28(5): 359-70, Abstract attached, PTO-892) and Brooks et al. (EP1417956, 05/12/2004, in record of IDS 11/03/2023). Although the claims at issue are not identical, they are not patentably distinct from each other.
US’001 directs to a topical composition (Claim 11) comprising a) dimethylglycine and /or a salt of dimethylglycine, and b) at least one carboxylic acid (corresponding to instant claim 12), wherein dimethylglycine and/or a salt of dimethylglycine is 0.0001% to 25.0% by weight (Claim 13) (same range as in instant claim 13), and further comprising surfactants in an amount of 2 to 40 wt% (Claim 15) (corresponding to instant claim 14), at least one other active ingredient selected from the group consisting of caffeine, menthol, biotin, zinc PCA, etc. (Claim 16) (corresponding to instant claim 16), at least one additive species as listed (Claim 17)(many identical species to instant claim 17), being a care composition (claim 18) able to promote metabolism of skin (Claim 19) (corresponding to instant claim 18). US’001 further recites a method as a cosmetic or medicinal use of the composition to obtain benefit on treated skin (claims 21-23) that are also relevant to the instantly claim composition.
US’001 does not recite the composition pH in instant claim 12, or has a viscosity of 800 to 6000 mPa.s as recited in instant claim 15.
Combined teachings of Gassenmeier, Liu, Lambers and Brooks teach topical composition comprising dimethylglycine with surfactant amount 11%, pH at 4.7, or below 5.0, or 4.0-4.5, with viscosity of the composition overlapping with instantly claim range, as discussed above in great detail and incorporated herein.
It would have been prima facie obvious for one with ordinary skill in the art to incorporate pH and viscosity taught by Gassenmeier, Liu, Lambers, and Brooks into the topical composition recited in US’001 to arrive at current invention. Because they share most common components for the same intended use, it would motivate scientists in the field to combine these teachings to experiment and optimize a composition. Therefore, the claimed invention is a simple combination of reagents known to be obvious materials that all already taught in prior art and discussed above. The idea for combining them flows logically from them having been individually taught in the prior art. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, the component weight, pH, viscosity overlaps with those recited in US’001 or taught by prior art. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s remarks/arguments filed on 05/11/2026 have been fully considered.
35 USC 102 Rejections
Applicant asserts that Brooks does not suggest the use of dimethylglycine as an active treatment of skin, hair or hair loss, and does not provide teaching of pH range as instantly claimed.
In light of applicant’s remarks and amendments, 35 USC 102 rejections have been withdrawn, and new combined prior art Gassenmeier, Liu, Lambers are used to teach the use of dimethylglycine as active treatment of skin, and pH range. Please refer to the entire office action as presented above as a complete response to the arguments.
35 USC 103 Rejections
Applicant asserts that Abou-Nemeh does not provide specific teaching directed to dimethylglycine and does not disclose pH as recited; Combination of Abou-Nemeh and Brooks could not have successfully arrive at current claims.
This argument is moot because the new ground of rejections do not rely on Abou-Nemeh. Further, one cannot show nonobviousness by attacking references individually where the rejections are
based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck
& Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Because "[T]he test for obviousness is what
the combined teachings of the references would have suggested to [a PHOSITA]." In re Mouttet, 686
F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012).
Nonstatutory double patenting rejections
Applicant asserts that the presently amended claims are patentably distinct from the claims pending from the claims cited in co-pending applications in non-statutory double patenting rejections.
As presented above in detail in this office action, these copending applications read on the instant claims as amended with or without in view of the secondary references. Therefore, the nonstatutory provisional double patenting rejections remain.
Conclusion
No claims are allowed.
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/DX.Z./ Examiner, Art Unit 1616
/MONICA A SHIN/ Primary Examiner, Art Unit 1616
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