DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Status of Claims
The amendment, filed on 8 January 2026, is acknowledged.
Claims 1-7, 10-11, 13-14, and 16 have been amended.
Claims 16-20 were previously withdrawn from consideration, pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention in the non-final Office Action mailed on 8 August 2025.
Claims 1-15 are pending and under consideration in the instant Office Action, to the extent of the following previously elected species:
the specific reducing agents are glutaric acid and a-ketoglutaric acid;
the specific amino acid is arginine;
the specific amine compound is ethanolamine;
and the specific solvent is water.
Objections Withdrawn
Objections to Claims
Applicant’s amendment to claims 2, 4, 6, 11, and 13, submitted on 8 January 2026, have overcome the objections to the claims set forth in the Office Action mailed on 8 August 2025. Accordingly, the relevant objections are withdrawn.
Rejections Withdrawn
Rejections pursuant to 35 U.S.C. § 112
The rejections of claims 3, 5, 7, and 14 under 35 U.S.C. § 112 are withdrawn in view of Applicant’s amendments to the claims.
Rejections pursuant to 35 U.S.C. § 103
The rejection of claims 1-15 under 35 U.S.C. § 103 is withdrawn in view of Applicant’s amendments to claims 1 and 10 and in favor of the new grounds of rejection below.
Maintained Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites “the reducing agent (a)” in lines 1-2, which lacks antecedent basis because base claim 10 recites “(a) at least one reducing agent”, which encompasses multiple reducing agents. Thus, it is unclear if “the reducing agent (a)” refers to just one, more than one, or all of the reducing agents. Amending claim 12 to recite “the at least one reducing agent (a)” consistent with the base claim would overcome this rejection.
Response to Amendments
The Applicant’s amendment to claim 3, filed on 8 January 2026, has overcome the rejection of the claim under 35 U.S.C. § 112(b) for lacking antecedent basis, but a similar amendment was not made to claim 12, which was also rejected for lacking antecedent basis.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
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.
Claims 1-15 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 claims 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 10 were amended to recite “wherein the hair-color removing composition is free of oxidizing agents”. In the first para. of pg. 6 of the remarks filed on 8 January 2026, Applicant states that support for the amendments may be found in paragraphs [0079] and [0084] of the specification. Neither paragraph discloses “oxidizing agents” and para. [0079] discloses that “the compositions may be free…[or] essentially free of sulfites, bisulfites, metabisulfites, persulfates, peroxides, and/or ammonia”. While persulfates and peroxides are two genera of known oxidizing agents, sulfites, bisulfites, metabisulfites, and ammonia are not oxidizing agents and there is insufficient written support in the original disclosure for the exclusion of all oxidizing agents.
Claims 1 and 10 are therefore rejected for containing subject matter which was not described in the specification at the time the application was filed. Claims 2-9 depend from claim 1, claims 11-15 depend from claim 10, therefore claims 2-9 and 11-15 are also rejected for introducing new matter.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Henry (U.S. Patent Application Publication No. US 2022/0062142 A1, published on 3 March 2022) in view of Dixon et al. (U.S. Patent No. 8,513,200 B2, published on 20 August 2013, hereafter referred to as Dixon), Seo et al. (J. Dermat. Sci. 2012, 66 (1), 12., hereafter referred to as Seo), Morel et al. (Chem. Rev. 2011, 111 (4), 2537., hereafter referred to as Morel).
Henry teaches hair treatment and hair lightening compositions and methods of their use (Abstract). Compositions that alter hair color are taught to frequently irritate or damage the hair and/or scalp, demonstrating a clear need for compositions that “protect hair fibers during bleaching, thereby reducing damage or further damage to the hair” while also imparting improved aesthetics (para. [0004-0009]). The compositions taught by Henry are directed to lightening and/or bleaching, and bleaching is interpreted as removing the existing color from hair, so it is therefore determined to be equivalent to a hair-color removing composition as recited in the instant application.
The compositions are taught to comprise one or more polycarboxylic acids, one or more amino acids, one or more antioxidants, and one or more color altering components (claims 1-2). One example of a useful polycarboxylic acid that may be included in the composition is taught to be the dicarboxylic acid glutaric acid (para. [0019] and [0027], claim 9). Henry teaches a range of ~0.1-5.0% by weight of polycarboxylic acids to be in the compositions, which falls within the ranges recited in instant claims 2 and 11 (para. [0028] and claim 22).
Compositions used to lighten or lift color are additionally taught to typically be alkaline, having a pH above 7, which requires the presence of one or more alkalizing agents (para. [0004]). Henry teaches a preferred alkalizing agent to be monoethanolamine (MEA) and alkalizing agents to be present in an amount from 1-40% by weight, a range that significantly overlaps with the ranges recited in instant claims 6-7 and 15 (para. [0067-0068] and claim 22).
Finally, Henry teaches that the hair lightening compositions of their invention may be combined with a bleaching agent and/or developer composition prior to application (para. [0133-135] and claims 2-3). Examples of bleaching agents are taught to be peroxides, redox enzymes, or oxygen (para. [0133]) and examples of developer compositions comprise peroxides, sources of peroxymonocarbonate ions, or ammonia (para. [0135-0137]). In one embodiment, the source of peroxymonocarbonate ions is taught to be arginine (para. [0137]). In the embodiment that the peroxymonocarbonate ion source is arginine, the amino acid is taught to be present in the developer composition in an amount from 0.1-40.0% by weight (para. [0137]). The developer composition is taught to comprise 0.1-5% of the total composition in some embodiments, resulting in arginine being present in an amount of 0.01-2.0% w/w of the total composition, falling within the ranges recited in instant claims 4 and 13 (para. [0094]).
Henry does not teach the glutaric acid derivative a-ketoglutaric acid to be in their composition, the pH of their composition to be acidic, nor motivate the selection of oxygen as the bleaching agent. These deficiencies are offset by the teachings Dixon, Seo, and Morel.
Dixon teaches a method of treating hair via application of a composition that comprises at least one weak acid in a cosmetically acceptable medium that produces straightened or relaxed hair (Abstract). Dixon teaches that commonly used commercial products applied to hair often contain strong bases, such as alkaline metal hydroxides, which can cause damage to the hair and chemical burns to the scalp and skin surrounding the hair (col. 1, lines 24-35). To overcome these issues, Dixon teaches the use of weak acids in their composition, which are safer for both the skin and hair (col. 2, lines 52-57). Examples of weak acids that are suitable for safe use on hair include those with a pKa value of 0.5-8.0, such as carboxylic acids including glutaric acid and alpha-ketoglutaric acid (col. 4, lines 48-52 and claim 8).
Seo teaches the impact of repeated use of hair dye products on the skin and hair, in particular the components ammonia, hydrogen peroxide, and monoethanolamine (Title and Introduction). Using mice models, Seo found that all compositions containing hydrogen peroxide and all compositions containing a neutralized dye mixture caused hair loss and dermatitis following application to the models (pg. 15, Identification of causative ingredients for hair dye-induced hair loss, para. 1). Conversely, compositions comprising only monoethanolamine (MEA) and a hair dye or lacking the combination of H2O2 and the neutralized hair dye did not cause hair loss and dermatitis (pg. 15, Identification of causative ingredients for hair dye-induced hair loss, para. 1-2). Further tests demonstrated that MEA and H2O2 in combination lead to hair loss and dermatitis (pg. 18, Mechanism underlying hair-dye induced dermatitis and hair loss), and Seo concluded that repeated application of hair dye products containing this combination can lead to unwanted results via production of reactive oxygen species (pg. 18, right col., final para.).
Morel teaches current trends in hair dyeing from the perspective of chemistry (Title and Introduction). Despite the popularity of hair dying, Morel teaches that the chemistry used in the mid-19th century is still common in hair dyeing despite the recognized risks and issues that arise from the procedure (pg. 2537, right col., final para.). Oxidative hair dyeing is the most popular mechanism of dyeing and typically requires hydrogen peroxide as an oxidizing agent (pg. 2542, Permanent Hair Coloration: An Oxidative Process, para. 1). However, hydrogen peroxide is well known to damage hair and irritate skin, urging researchers and inventors to pursue alternatives (pg. 2547, right col., final para. and pg. 2552, right col., final para.).
One alternative to H2O2 is taught to be oxygen, which is readily available in the atmosphere, and is taught to be capable of performing “auto-oxidation” (pg. 2545, left col., penultimate para.). Morel further teaches that alkaline conditions can damage hair and irritate skin (pg. 2547, right col., final para.) and that compositions may reduce pH values to avoid damage and/or irritation (pg. 2549, left col, para. 1). Morel teaches that the impact of pH values may be due to human hair having an isoionic point, the pH at which hair has an equivalent number of positive and negative charges, of ~pH 5.8 and an isoelectric point, the pH at which a protein does not migrate in an electric field, of ~pH 3.67, while alkaline pH conditions are required to facilitate the affinity of cationic dyes to hair (pg. 2541, right col., final para.).
Guidelines on the obviousness of similar and overlapping ranges, amounts, and proportions are provided in MPEP § 2144.05. With respect to claimed ranges which “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). These guidelines apply to the amounts of reducing agent, amino acid, and amine compound in the composition and the pH of the composition. In each case, the ranges/values taught by Henry and Morel either fall within, significantly overlap with, or completely encompass the ranges recited in the instant application.
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to modify the invention of Henry with the teachings of Dixon, Seo, and Morel to arrive at the claimed invention because the use of techniques known in the prior art to improve similar inventions yields predictable results. Henry teaches a composition for lightening or removing color from hair comprising one or more polycarboxylic acids, one or more amino acids, one or more antioxidants, and one or more color altering components. Among the preferred embodiments, the composition of Henry may include glutaric acid and ethanolamine, and is preferred to be used in combination with a “developer” composition which in some embodiments comprises arginine and a bleaching agent in water.
One of ordinary skill would be motivated to use alpha-ketoglutaric acid alongside glutaric acid in the composition of Henry in view of the teachings of Dixon because Dixon teaches both of the weak acids to be safer for users’ skin and hair than strongly alkaline components that are commonly used in hair compositions. The ordinary artisan would desire their composition to be safe for users and therefore be motivated to use the taught components. In view of the teachings of Seo, a person of ordinary skill would be motivated to not choose peroxides as the bleaching agent from the options taught in the invention of Henry because Seo teaches that, when used in conjunction with MEA, H2O2 can induce hair loss and irritate the skin of users, which a person of ordinary skill would recognize as undesirable.
Finally, the teachings of Morel would motivate one of ordinary skill in the art to select oxygen as a bleaching agent from the options taught by Henry because it is taught by Morel to be readily abundant in the atmosphere and to not possess the drawbacks associated with H2O2, such as skin irritation and hair damage, which a person of ordinary skill would recognize as objectionable in a hair composition. The ordinary artisan would further be motivated by the teachings of Morel to make the composition of Henry acidic because Morel teaches that alkaline conditions are damaging to the hair of users, which the ordinary artisan would also recognize as undesirable. Morel further teaches that human hair has characteristics that naturally reside at acidic pH values of ~4 and 6, which would further motivate an artisan to make their composition acidic to better suit the natural conditions of hair. As a result, there is a reasonable expectation of success in arriving at the invention of instant claims 1-15 in view of the teachings of Henry, Dixon, Seo, and Morel.
Response to Arguments
The Applicant’s arguments, filed on 8 January 2026, have been fully considered but are not persuasive.
In the section titled “The Prior Art Does Not Teach or Suggest All Claim Elements” that spans pg. 8-9, Applicant argues that the Henry, Chan, and Dixon references contain oxidizing agents and therefore do not render obvious the amended claims. These arguments are considered moot in view of the new grounds of rejection above.
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 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-9 of copending Application No. 18/084,403 in view of Oshimura et al. (J. Cosmet. Sci. 2007, 58, 347., hereafter referred to as Oshimura).
This is a provisional nonstatutory double patenting rejection.
Copending Application No. 18/084,403 recites a hair composition comprising at least one reducing agent chosen from glutaric acid, glyoxylic acid, thiolactic acid, thioglycolic acid, and/or glycolic acid in addition to a-ketoglutaric acid, optionally one or more amine compounds, and at least one solvent, which in one embodiment may be water (claims 1, 3, and 9). The total amount of reducing agents is recited to be 1-20% by weight and the total amount of amine compounds, if present, is recited to be 0.1-20.0% by weight (claims 2 and 5). The amine compound in one embodiment is monoethanolamine (claim 6). Application ‘403 recites an embodiment in which the composition is free of any reducing agent other than glutaric acid (claim 8) and wherein the pH is from 1-6 (claim 9). Finally, ‘403 recites the composition to comprise one or more thickening agents, amino acids, clay compounds, and surfactants, the latter genus including anionic, non-ionic, and amphoteric/zwitterionic surfactants (claim 7).
Copending Application No. 18/084,403 does not recite the specific amino acid in the composition to be arginine nor the quantity of arginine. These deficiencies are offset by the teachings of Oshimura.
Oshimura teaches the interaction of various amino acids with human hair when applied in an aqueous solution (Abstract). Arginine, which contains a guanidinium functional group, is taught to be known in the art as having a high affinity for hair protein (pg. 352, Use of arginine as an “anchor”). Oshimura teaches this ability to motivate the use of arginine as an “anchor” for human hair, allowing improved deposition of other cosmetics onto hair which may otherwise have weak affinity for the hair (pg. 352, Use of arginine as an “anchor”). As an example, Oshimura teaches the use of arginine to increase the uptake of pyrrolidone carboxylic acid (PCA) by hair, which increases at pH values below 5 (pg. 352, Use of arginine as an “anchor” and Fig. 7-8). Oshimura further teaches that this ability of arginine to increase uptake could be useful for increasing hair uptake of moisturizers and conditioners from cosmetics (pg. 352, Use of arginine as an “anchor”). The quantity of arginine used in the experiments is taught to be 5% w/w (Figures 7-8).
It would have been prima facie obvious to a person of ordinary skill in the art, in view of the teachings of Oshimura, to choose arginine as the amino acid in the invention recited by copending Application No. 18/084,403 because combining elements known in the art in similar inventions produces predictable results. Copending Application ‘403 recites a hair composition comprising glutaric acid, specifically a-ketoglutaric acid, the amine compound monoethanolamine, and at least one solvent, which in one embodiment may be water. The total amount of reducing agents is recited to be 1-20% by weight, the total amount of amine compounds, is recited to be 0.1-20.0% by weight, an embodiment in which the composition is free of any reducing agent other than glutaric acid and wherein the pH is from 1-6 is also recited. Finally, ‘403 recites the composition to comprise one or more thickening agents, amino acids, clay compounds, and surfactants, the latter genus including anionic, non-ionic, and amphoteric/zwitterionic surfactants. The ordinary artisan would find it obvious to select arginine as the amino acid in view of the teachings of Oshimura because Application ‘403 recites the genus of amino acids but does not specify a species. The Oshimura reference teaches arginine as a user-safe component of hair compositions that can improve uptake of other hair cosmetic components at acidic pH values, which is important in copending Application ‘403. Further, Oshimura teaches the use of arginine in an amount of ~5.0% by weight, which a person of ordinary skill would be motivated to use because ‘403 does not recite a quantity of amino acid to be used. As a result, there is a reasonable expectation of success in arriving at the invention of instant claims 1-15 in view of the invention recited in claims 1-3 and 5-9 of copending Application No. 18/804,403 and in view of the teachings of Oshimura.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-15 and 17 of copending Application No. 18/626,306 in view of Oshimura (J. Cosmet. Sci. 2007, 58, 347.) and Dreher et al. (U.S. Patent Application Publication No. US 2017/0246094 A1, published on 31 August 2017, hereafter referred to as Dreher).
This is a provisional nonstatutory double patenting rejection.
Copending Application No. 18/626,306 recites a hair-color altering composition comprising at least one organic acid, at least one solvent, and at least one surfactant, thickening agent, organic amine compound, and/or amino acid, wherein the total amount of organic acids is about 10-80% by weight (claim 14). The organic acid may be keto-glutaric acid and Application ‘306 does not require more than one organic acid, therefore an embodiment is recited which contains no organic acids that are not keto-glutaric acid (claim 15). Finally, the pH of the composition is recited as being 1-5 (claim 17).
Copending Application No. 18/626,306 does not recite the specific amino acid arginine, the amount of arginine, the specific organic amine compound monoethanolamine (MEA), the amount of monoethanolamine, nor the specific solvent water. These deficiencies are offset by the teachings of Oshimura and Dreher.
Oshimura has been described above.
Dreher teaches compositions and a method for altering the color of hair, said composition comprising monoethanolamine and at least one amino acid (Abstract). One specific objective of the invention of Dreher is to provide compositions that can strengthen hair fibers and protect them from damage or further damage (para. [0012]). In a study on Strength and Tactile Substance, Dreher teaches application of various compositions, each comprising MEA and a different carboxylic acid, at a pH of 3 (para. [0282] and Tables 5A-F). Dreher concludes that the “best combination of tactile substance and strength resulted from compositions including MEA and at least one carboxylic acid” (para. [0284]).
It would have been prima facie obvious to a person of ordinary skill in the art to use the components and ranges of the hair composition taught by Oshimura and Dreher in the invention recited by copending Application No. 18/626,306 because combining elements known in the art in similar inventions produces predictable results. Copending Application ‘306 recites a hair composition comprising an organic acid, which may be keto-glutaric acid, present in an amount of 10-80% by weight, at least one solvent, at least one organic amine compound, and at least one amino acid at a pH of 1-5. In view of the teachings of Oshimura, the ordinary artisan would be motivated to select the solvent water and the amino acid arginine because Oshimura reference teaches arginine in water as a user-safe solution that can improve uptake of other hair cosmetic components at acidic pH values, which is important in copending Application ‘306. Further, Oshimura teaches the use of arginine in an amount of ~5.0% by weight, which a person of ordinary skill would be motivated to use because ‘306 does not recite a quantity of amino acid to be used.
One of ordinary skill would further be motivated to select monoethanolamine as the organic amine in the invention recited by Application ‘306 in view of the teachings of Dreher because Dreher teaches the amine, alongside carboxylic acids, to provide an optimal combination of hair tactile substance and strength. The invention recited in ‘306 contains carboxylic acids and the ordinary artisan would desire a composition that imparts strength and pleasant aesthetics to the hair of users, which Dreher teaches is achievable with the use of MEA. As a result, there is a reasonable expectation of success in arriving at the invention of instant claims 1-15 in view of the invention recited in claims 14-15 and 17 of copending Application No. 18/626,306 and in view of the teachings of Oshimura and Dreher.
Claims 1-15 are directed to an invention not patentably distinct from claims 14-15 and 17 of commonly assigned copending Application No. 18/626,306 in view of the teachings of Oshimura and Dreher. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned copending Application No. 18/626,306, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Arguments
In para. 2 of the “Double Patenting Rejections” section on pg. 6 of the remarks filed on 8 January 2026, Applicant requested that the double patenting rejections “be held in abeyance until allowable subject matter is indicated”. A complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by the Applicant showing that the claims subject to the restriction are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sean J. Steinke, Ph.D., whose telephone number is (571) 272-3396. The examiner can normally be reached Mon. - Fri., 09:00 - 17:00 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard, can be reached at (571) 272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at (866) 217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call (800) 786-9199 (IN USA OR CANADA) or (571) 272-1000.
/S.J.S./
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619