DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Amendment filed on 11/07/2025 is acknowledged.
Claims 1-11 remain cancelled. Clams 19-30 remain withdrawn for being drawn to nonelected group. Claims 12 and 16 are amended.
Claims 12-18 are pending and being examined herein on merits.
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. No English translated copy was provided.
New Claim Rejections
The following rejections are necessitated by applicant’s amendment filed on 11/07/2025.
Claim Interpretation
Claims 12, 15 and 18 are interpreted as following.
Claim 12 is interpreted as a composition comprising dimethylglycine and/or a salt of dimethylglycine, wherein the composition has a pH in the range of 3.0 to 5.9.
The recitations of “topical” and “wherein the composition is in the form of a leave-on formulation” are interpreted as property or “intended use” of the composition, because they do not contribute structural limitations to the composition.
Claim 15, the viscosity is interpreted as a property of the composition since it does not contribute structural limitations to the composition.
Claim 18 is interpreted as the property or “intended use” of the composition. The phrases “care” and “able to promote metabolism of skin and hair” do not provide structural limitation to the composition.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 12-18 are rejected under 35 U.S.C. 102 as being unpatentable over Brooks et al. (EP1417956, 05/12/2004, IDS of 11/03/2023).
Brooks throughout the reference teaches a topical composition comprising a film-forming polymer and zwitterionic bulking agent (Claim 1) to deliver decreased dry-down times, increased moisturization and improved application and removal characteristics (Abstract).
Regarding instant claims 12-13, Brooks specifies that the composition comprises 3% to 30% zwitterionic bulking agent (Claim 5) comprising trimethylglycine, proline, bicine, dimethylglycine, or mixtures thereof (Claim 6) (corresponding to instant claims 12-13, end point 3% falling within range 0.00001% to 25.0% as recited in instant claim 13). Brooks specifies that the compositions comprise a pH modifiers in an amount that is sufficiently effective to adjust the pH of the composition to fall within a range from 5.5 to 9 [0049] (pH end point 5.5 falling within range of 3.0 to 5.9 in instant claim 12). MPEP 2131.03.I states that "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023).
Brooks teaches the composition subsequently adheres to the surface of the skin and delivers the actives contained therein over a sustained period (e.g., [0002]), and the composition can be left on the skin surface for a time until it is dry, preferably for at least 15 minutes, following which the dried-down film is removed from the skin (e.g., [0070]). As evidenced by instant specification, “leave-on” is characterized in that it remains in contact with the skin after application over a longer period of time (Pg. 12, Lines 23-25). Therefore, Brooks composition reads into the instant leave-on composition.
Moreover, in light of claim interpretation, the composition in the form of a leave-on formulation in the property of intended use of the composition. Since Brooks teaches the same compound dimethylglycine, as the only compound in the instant composition, with the same pH as instantly claimed as shown above, Brooks composition would have the leave-on formulation properties as instantly claimed. As MPEP 2112.01.II states "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable, as indicated in MPEP 2112.01.II. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada' s polymer latexes for lack of novelty.").
Regarding instant claims 14-15, Brooks teaches that the compositions may further comprise a surfactant, preferred for use as non-ionic surfactants, typically be present in an amount ranging from 0.01% to 2% [0063] (the end point falling within 2% to 40% in instant claim 14). 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] (the end point 3 Pa.s falling within the viscosity range of 800 to 6000 mPa.s, equal to 0.8 to 6 Pa.s, as recited in instant claim 15). MPEP 2131.03.I states that "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). Moreover, in light of claim interpretation, viscosity is inherent composition property of the composition Brooks has already taught.
Regarding instant claims 16-17, Brooks states that preferred skin active agents for use include vitamins, panthenol (Claim 17), caffeine, niacinamide, and many others [0043-0044] (corresponding to instant claim 16). Brooks also specifies that the composition can comprise thickening agent [0061], conditioning agent [0064], and humectants [0037], and ethanol [0036]; Claim 18) (corresponding to instant claim 17).
Regarding instant claim 18, Brooks points out that the composition is to deliver desired skin care benefit [0013], suitable for use in contact with the skin or hair of humans and lower animals without undue toxicity, incompatibility, instability, irritation, allergic response and the like [0014]. Brooks teaches that incorporation of a skin active in the present compositions enhances the skin benefit properties by providing reduced water loss and/or providing a desquamatory, keratolytic and rejuvenating effect when topically applied [0043], indicating its enhancement of skin and keratin health and rejuvenation. Moreover, in light of claim interpretation, that the composition is able to promote metabolism of skin and hair is inherent property of the composition already taught by Brook as presented above.
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.
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 12-18 are rejected under 35 U.S.C. 103 as obvious over Abou-Nemeh (US20070231377, 10/04/2007, IDS of 11/03/2023) in view of Brooks et al. (EP1417956, 05/12/2004, IDS of 11/03/2023).
Abou-Nemeh throughout the reference teaches compositions for treating hair loss, nail brittleness and skin conditions, and for promoting or enhancing hair growth (e.g., Abstract).
Regarding instant claims 12-13, Abou-Nemeh teaches that the composition can comprise agents effective for treating alopecia, skin, or nail brittleness can be used for the composition including dimethylglycine (e.g., [0092], and Abou-Nemeh specifies that the composition can be leave-on hair conditioners, milks, cleansers, moisturizers, and skin patches, and the like (e.g., [0061]). Abou-Nemeh further indicates that as would be apparent to one of ordinary skill, all of the parameters including pH, concentration of components for the composition can be varied [0082].
Regarding instant claims 14-18, Abou-Nemeh teaches various surfactants (e.g., [0065]) (corresponding to instant claim 14), antioxidants and vitamins including biotin (B7) (e.g., [0086]) (corresponding to instant claim 16), with other additional solvents, fragrances, and thickeners (e.g., [0064] (corresponding to instant claim 17) to adjust viscosity (e.g., [0069]) (corresponding to instant claim 15). Abou-Nemeh teaches the compositions for treating hair loss, nail brittleness and skin conditions, and for promoting or enhancing hair growth (e.g., Abstract) (corresponding to instant claim 18).
Abou-Nemeh does not teach the composition pH as recited in instant claim 12, or dimethylglycine amount, or surfactant amount, or viscosity in the composition as recited in instant claims 13-15 respectively.
Brooks throughout the reference teaches hair care compositions comprising trimethylglycine, and specifies that the composition comprises 3% to 30% zwitterionic bulking agent (Claim 5) comprising trimethylglycine, proline, bicine, dimethylglycine, or mixtures thereof (Claim 6) (overlapping with range 0.00001% to 25.0% as recited in instant claim 13). Brooks specifies that the compositions comprise a pH modifiers in an amount that is sufficiently effective to adjust the pH of the composition to fall within a range from 5.5 to 9 [0049] (overlapping with range 3.0 to 5.9 in instant claim 12).
Brooks teaches that the compositions may further comprise a surfactant, preferred for use as non-ionic surfactants, typically be present in an amount ranging from 0.01% to 2% [0063] (overlapping with range of 2% to 40% in instant claim 14). 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 range 800 to 6000 mPa.s, equal to 0.8 to 6 Pa.s, as recited in instant claim 15).
It would have been prima facie obvious for one person with ordinary skills of art prior to filing date to incorporate the teaching of Brooks and adjust pH and other parameters of the composition in Abou-Nemeth to arrive at the current leave-on composition. 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), as both Brooks and Abou-Nemeth teach the compositions comprising shared ingredients. Because Abou-Nemeth teaches that it is routine practice for artisans in the field to adjust pH, concentrations, and viscosity, while Brooks teaches the parameters, it would have provided reasonable expectation of success for artisans to adjust the parameters to reach current invention. Moreover, in light of claim interpretation, the viscosity is inherent property of the composition that Abou-Nemeth and Brooks already taught.
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, pH value, dimethylglycine amount range, and viscosity range 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).
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) in view of Brooks et al. (EP1417956, 05/12/20224, IDS of 11/03/2023) and Abou-Nemeh (US20070231377, 10/04/2007, IDS of 11/03/2023). 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)(same 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 405 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).
US’524 does not recite the composition is leave-on as recited in instant claim 12, or having a viscosity of 800 to 6000 mPa.s as recited in instant claim 15.
As discussed above in great detail and incorporated herein, Brooks and Abou-Nemeh teaches a composition that can be leave on composition comprising dimethylglycine with overlapping viscosity ranges as instantly claimed range.
It would have been prima facie obvious to incorporate the viscosity taught by Brooks and Abo-Nemeh into the method comprising the composition recited by US’524 to arrive at current invention. Because all inventions share most components for the same intended use and administering method as topical application, one would expect reasonable success to select an additional component and property for the composition improvement. 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).
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 Brooks et al. (EP1417956, 05/12/20224, IDS of 11/03/2023) and Abou-Nemeh (US20070231377, 10/04/2007, IDS of 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 19) 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) (overlapping with 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 is leave-on as recited 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.
Brooks and Abou-Nemeh teaches a composition that can be leave-on composition comprising dimethylglycine with surfactant amount 2%, and viscosity of the composition overlaps with the instant claimed 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 viscosity taught by Brooks and Abou-Nemeh into the topical composition recited in US’542 to arrive at current invention. Because all inventions 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).
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 of Brooks et al. (EP1417956, 05/12/20224, IDS of 11/03/2023) and Abou-Nemeh (US20070231377, 10/04/2007, IDS of 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 is leave-on as recited in instant claim 12, or has a viscosity of 800 to 6000 mPa.s as recited in instant claim 15.
Brooks and Abou-Nemeh teaches a composition that can be leave-on composition with overlapping viscosity range with instantly claimed 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 viscosity taught by Brooks and Abou-Nemeh into the topical composition recited in US’001 to arrive at current invention. Because all inventions 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).
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 11/07/2025 have been fully considered.
Art rejections
Applicant asserts that the one skilled in the art would not have predicted that Brooks could have been modified to successfully arrive at every limitation of the presently amended claims.
As presented above in this office action, the rejections have been made under 35 USC 102 over Brooks, or in the alternative, under 35 USC 103 over Abou-Nemeh in view of Brooks. Every limitation as instantly claimed is addressed in detail. Because the composition in instant claim 1 comprises only one compound with pH, and the leave-on feature is interpreted as property or intended use of the composition, for artisans in the field, it is routine practice to adjust pH, and other parameters, including viscosity, ingredient amounts, or adding other excipients or additives. Please refer to the complete office action for detailed new rejections, with the most relevant paragraph copied below regarding differences in claimed concentrations or pH ranges:
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, pH value, dimethylglycine amount range, and viscosity range 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).
Applicant asserts particularly the topical composition is in the form of a leave-on formulation, because Brooks states their formulations are “removed from the skin, preferably by peeling off in one piece”, in contrast, instant compositions are designed to remain on the skin or hair for prolonged periods that creates a kind of active-ingredient depot over a longer period of time, and a pH range of 3.0-5.9 fulfill the requirements of a leave-on formulation.
As presented in office action above, Brooks teaches the composition can be left on skin for long period of time till the film dries, since the claim language does not provide any period for the remains in contact, Brooks composition reads into the claim, and resonates with the description of “leave-on” formulation in instant specification, as “remains in contact with skin … after application” and “for prolonged periods”, same as applicant points out above.
Also applicants in the remark stated the pH level of their invention renders the composition “fulfill the requirements of a leave-on formulation…” which pH your reference teaches 5.5. Therefore, by applicant’s assertion, the reference’s composition would be capable of performing the intended use “leave-on” for however long the application calls for.
Moreover, Abou-Nemeh teaches the composition that can comprise active ingredient dimethylglycine can be leave-on. Furthermore, in light of claim interpretation, the leave-on is property or intended use of the composition which is already taught by Brooks and Abou-Nemeh. The most relevant paragraphs are copied below for reference.
Brooks teaches the composition subsequently adheres to the surface of the skin and delivers the actives contained therein over a sustained period (e.g., [0002]), and the composition can be left on the skin surface for a time until it is dry, preferably for at least 15 minutes, following which the dried-down film is removed from the skin (e.g., [0070]). As evidenced by instant specification, “leave-on” is characterized in that it remains in contact with the skin after application over a longer period of time (Pg. 12, Lines 23-25). Therefore, Brooks composition reads into the instant leave-on composition.
Moreover, in light of claim interpretation, the composition in the form of a leave-on formulation in the property of intended use of the composition. Since Brooks teaches the same compound dimethylglycine, as the only compound in the instant composition, with the same pH as instantly claimed as shown above, Brooks composition would have the leave-on formulation properties as instantly claimed. As MPEP 2112.01.II states "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable, as indicated in MPEP 2112.01.II. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada' s polymer latexes for lack of novelty.").
Regarding instant claims 12-13, Abou-Nemeh teaches that the composition can comprise agents effective for treating alopecia, skin, or nail brittleness can be used for the composition including dimethylglycine (e.g., [0092], and Abou-Nemeh specifies that the composition can be leave-on hair conditioners, milks, cleansers, moisturizers, and skin patches, and the like (e.g., [0061]). Abou-Nemeh further indicates that as would be apparent to one of ordinary skill, all of the parameters including pH, concentration of components for the composition can be varied [0082].
C Applicant asserts the claimed composition with pH 3.0-5.9 demonstrates a clear prolonged effect using the leave-on formulation, e.g., the ability to close wounds, between cell viability and proliferation, and surprising growth of human epidermal keratinocyte cells and increased expression of the growth factor, etc., and accordingly Brooks would not have been successfully modified to arrive at current invention.
It is noted that the features upon which applicant mentions as shown above are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Obviousness-type Double Patenting
D 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 discussed above in the updated NSDP rejections, these copending applications read on the instant claims as amended in view of the cited references. Therefore, the nonstatutory provisional double patenting rejections remains.
In conclusion, the argument is not persuasive. Please refer to the entire office action presented above as complete response to arguments.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DONGXIU ZHANG SPIERING whose telephone number is (703)756-4796. The examiner can normally be reached 7:30am-5:00pm (Except for Fridays).
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/DX.Z./ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616