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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-5 and 7-10 in the reply filed on 30 June 2026 is acknowledged.
Claims 11-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 30 June 2026.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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 5 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 5 recites the phrase “wherein the treatment is” in claim 1. However, claim 1 does not recite the term “treatment.” As such, it appears that there is no antecedent basis for the phrase “wherein the treatment is” in claim 1.
Additionally, the examiner notes that the term “treatment” generally refers to a method. However, claim 5 is a composition claim. A single claim which claims both an apparatus (or in this case, chemical composition) and the method steps of using the apparatus (e.g. treatment) is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p)(II).
For the purposes of examination under prior art, the examiner has examined claim 5 with the understanding that it depends from claim 2 rather than from claim 1, and that it is drawn to a composition rather than a method.
Claim Interpretation
The instant claims recite the abbreviation “TRPM5.” This refers to “transient receptor potential cation channel subfamily M member 5.” See the instant specification as of the paragraph bridging pages 3-4.
Claim 1 recites an active agent for use in the treatment of skin pigmentation, wherein the active agent activates, enhances, inactivates, blocks or dampens the cellular response of the transient receptor potential ion channel TRPM5 or interferes with the expression of the ion channel. For the purposes of examination, the examiner understands that claim requires that the active agent be capable of being used for the above-indicated purposes. Prior art which teaches the required active agent being used for a different purpose than that indicated above is understood to meet the claimed requirements provided that the active agent in the prior art could have been used for the above-indicated purpose. This is because something which is old does not become patentable upon the discovery of a new property, and this feature need not have been recognized at the time of filing. See MPEP 2112(I & II). Also see MPEP 2112.01(I & II) and MPEP 2114(II).
Claim 1, last line, recites the phrase “the ion channel.” As best understood by the examiner, it is clear from the context that the ion channel being referred to here is the TRPM5 ion channel.
Claim 5 recites “pigmented nevi (moles)” and “post-birth hypopigmented stretch marks [striae distensae]”. As best understood by the examiner, “pigmented nevi” and “moles” have the same meaning. Also, as best understood by the examiner, “post-birth hypopigmented stretch marks” and “striae distensae” have the same meaning. As such, the claim appears to recite synonyms. This is not understood to render the claim indefinite because it appears that the recited synonyms have the same meaning.
Note Regarding CAS Numbers in Claims
Claim 5 specifies the CAS number of a particular recited ingredient. The examiner notes that CAS numbers refer to numbers assigned by Chemical Abstracts Services to all chemicals to identify said chemicals. As such, CAS numbers can be used to identify particular chemicals.
The examiner notes that according to MPEP 2173.05(u), trade names and trademarks in claims can render claims indefinite. However, the examiner notes that CAS numbers are not trademarks or trade names. As such, the provisions of MPEP 2173.05(u) are not understood to render claim 5 to be indefinite.
Claim Rejections - 35 USC § 102 – Anticipation
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.
Claim(s) 1-5, 7-8, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Woo et al. (WO 02/060404 A1).
Woo et al. (hereafter referred to as Woo) is drawn to a composition for skin whitening that comprises miconazole, as of Woo, title and abstract. Woo teaches miconazole in the form of a skin whitening cream, as of Woo, page 13, Table 1, reproduced below.
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As to claim 1, the claim requires that the active agent be used for the treatment of skin pigmentation. Woo teaches using miconazole for this purpose, as of Woo, title, abstract, and above-reproduced table.
As to claim 1, the claim requires that the active agent activates, enhances, inactivates, blocks or dampens the cellular response of the transient receptor potential ion channel TRPM5 or interferes with the expression of the ion channel. While Woo teaches the same active agent as required by the instant claims (the miconazole of Woo is the same active agent as recited by instant claim 4), and also for the purpose of skin whitening, Woo is silent as to the active agent enhancing, inactivating, blocking or dampening the cellular response of the transient receptor potential ion channel TRPM5 or interferes with the expression of the ion channel. Nevertheless, the discovery of a scientific explanation for the prior art’s functioning does not render the composition of the prior art patentable to the discoverer. See MPEP 2112(I).
Additionally as to claim 1, when the structure in the prior art reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. See MPEP 2112.01(I). In this case, the structure of the miconazole in the prior art is the same as in the claimed invention; as such, its properties can be presumed to be inherent. Once a reference teaching a product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to applicant. See MPEP 2112(V). In this case, the evidence to show inherency is that the chemical structure of miconazole in the prior art appears to be the same as the chemical structure of miconazole in claim 4. This is sufficient to shift the burden to applicant in accordance with MPEP 2112(V).
As to claims 2-3, the arguments presented above relying upon MPEP 2112 are applicable to claims 2-3 for the same reason that they are applicable to claim 1.
As to claim 4, the miconazole of Woo reads on the miconazole recited by the second line of part (b) of instant claim 4.
As to claim 5, the arguments presented above relying upon MPEP 2112 are applicable to claims 2-3 for the same reason that they are applicable to claim 1.
As to claim 7, the composition of Table 1 of Woo, which is reproduced above, is understood to read on the cosmetic composition required by the claim. The agents other than miconazole in the composition are understood to read on the required auxiliary agents.
As to claim 8, the glycerin in the composition of Table 1 of Woo is understood to read on the required auxiliary agent.
As to claim 10, Woo teaches a skin cream, as of the above-reproduced Table 1.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (US 2005/0137185 A1).
Lee et al. (hereafter referred to as Lee) is drawn to chlorpromazine, as of Lee, title and abstract. Lee teaches chlorpromazine in a topical formulation, as of paragraph 0113.
As to claim 1, the claim requires that the active agent enhances, inactivates, blocks, or dampens the cellular response to TRPM5. While Lee teaches the same active agent as required by the instant claims (the chlorpromazine of Lee is recited by instant claim 4), and also for the purpose of skin whitening, Lee is silent as to the active agent enhancing, inactivating, blocking or dampening the cellular response of the transient receptor potential ion channel TRPM5 or interferes with the expression of the ion channel. Nevertheless, the discovery of a scientific explanation for the prior art’s functioning does not render the composition of the prior art patentable to the discoverer. See MPEP 2112(I).
Additionally as to claim 1, when the structure in the prior art reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. See MPEP 2112.01(I). In this case, the structure of the chlorpromazine in the prior art is the same as in the claimed invention; as such, its properties can be presumed to be inherent. Once a reference teaching a product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to applicant. See MPEP 2112(V). In this case, the evidence to show inherency is that the chemical structure of chlorpromazine in the prior art appears to be the same as the chemical structure of chlorpromazine in claim 4. This is sufficient to shift the burden to applicant in accordance with MPEP 2112(V).
As to claim 1, the claim recites that the active agent is for use in treating skin pigmentation. Lee does not appear to teach that chlorpromazine is used for this purpose. Nevertheless, composition claims cover what a composition is, not what a composition does. See MPEP 2114(II), wherein the rationale in that section of the MPEP regarding apparatus claims is also understood to be relevant for composition claims. The skilled artisan would have understood that the topical chlorpromazine composition of Lee could have been used to treat skin pigmentation even if it was not specifically taught for this purpose. As all of the structural elements of Lee are the same as that of the claimed invention (e.g. that the chlorpromazine of Lee is the same as the recited chlorpromazine), the composition of Lee is understood to meet the claimed requirements.
As to claims 2-3, the rationale in the above paragraph is understood by the examiner to be applicable to claims 2-3.
As to claim 4, the chlorpromazine of Lee is understood to read on the chlorpromazine required by part (b) of claim 4.
As to claim 5, this claim is rejected for essentially the same reason that claims 2-3 are rejected.
Claim Rejections - 35 USC § 103 – Obviousness
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5 and 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woo et al. (WO 02/060404 A1).
Woo et al. (hereafter referred to as Woo) is drawn to a composition for skin whitening that comprises miconazole, as of Woo, title and abstract. Woo teaches miconazole in the form of a skin whitening cream, as of Woo, page 13, Table 1, reproduced below.
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As to claim 1, the claim requires that the active agent be used for the treatment of skin pigmentation. Woo teaches using miconazole for this purpose, as of Woo, title, abstract, and above-reproduced table.
As to claim 1, the claim requires that the active agent activates, enhances, inactivates, blocks or dampens the cellular response of the transient receptor potential ion channel TRPM5 or interferes with the expression of the ion channel. While Woo teaches the same active agent as required by the instant claims (the miconazole of Woo is recited by instant claim 4), and also for the purpose of skin whitening, Woo is silent as to the active agent enhancing, inactivating, blocking or dampening the cellular response of the transient receptor potential ion channel TRPM5 or interferes with the expression of the ion channel. Woo is silent as to this. Nevertheless, the discovery of a scientific explanation for the prior art’s functioning does not render the composition of the prior art patentable to the discoverer. See MPEP 2112(I).
Additionally as to claim 1, when the structure in the prior art reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. See MPEP 2112.01(I). In this case, the structure of the miconazole in the prior art is the same as in the claimed invention; as such, its properties can be presumed to be inherent. Once a reference teaching a product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to applicant. See MPEP 2112(V). In this case, the evidence to show inherency is that the chemical structure of miconazole in the prior art appears to be the same as the chemical structure of miconazole in claim 4. This is sufficient to shift the burden to applicant in accordance with MPEP 2112(V).
As to claim 1, purely en arguendo and for the purposes of this ground of rejection only, the examiner understands that the prior art teaches all of the claimed requirements, but not in the same embodiment. As such, while the prior art teaches all of the claimed components, the prior art is not anticipatory insofar as these components must be selected from various lists/locations in the prior art reference. It would have been prima facie obvious; however, to have selected the recited components from various lists/locations in the prior art reference and to have combined them together. This is because such a modification would have represented nothing more than the predictable use of prior art components according to their established functions. Combining separate prior art components (from a single prior art reference) according to known methods to yield predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claims 2-3, the arguments presented above relying upon MPEP 2112 are applicable to claims 2-3 for the same reason that they are applicable to claim 1.
As to claim 4, the miconazole of Woo reads on the miconazole recited by the second line of part (b) of instant claim 4.
As to claim 5, the arguments presented above relying upon MPEP 2112 are applicable to claims 2-3 for the same reason that they are applicable to claim 1.
As to claim 7, the composition of Table 1 of Woo, which is reproduced above, is understood to read on the cosmetic composition required by the claim. The agents other than miconazole in the composition are understood to read on the required auxiliary agents.
As to claim 8, the glycerin in the composition of Table 1 of Woo is understood to read on the required auxiliary agent.
As to claim 9, Woo teaches additional depigmenting agents including ascorbic acid, kojic acid, and hydroquinone, as of Woo, page 2, starting on line 12. As such, the skilled artisan would have been motivated to have combined these with miconazole to have predictably whitened the skin with a reasonable expectation of success. See MPEP 2143, Exemplary Rationale A. While Woo teaches undesirable properties of ascorbic acid, kojic acid, and hydroquinone, these are not understood by the examiner to be examples of teaching away because all of ascorbic acid, kojic acid, and hydroquinone have been used as skin whitening agents. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use. See MPEP 2145(X)(D)(1) and 2123(II).
As to claim 10, Woo teaches a skin cream, as of the above-reproduced Table 1.
Claim(s) 1-5, 7-8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2005/0137185 A1).
Lee et al. (hereafter referred to as Lee) is drawn to chlorpromazine, as of Lee, title and abstract. Lee teaches chlorpromazine in a topical formulation, as of paragraph 0113.
As to claim 1, the claim requires that the active agent enhances, inactivates, blocks, or dampens the cellular response to TRPM5. While Lee teaches the same active agent as required by the instant claims (the chlorpromazine of Lee is recited by instant claim 4), and also for the purpose of skin whitening, Lee is silent as to the active agent enhancing, inactivating, blocking or dampening the cellular response of the transient receptor potential ion channel TRPM5 or interferes with the expression of the ion channel. Nevertheless, the discovery of a scientific explanation for the prior art’s functioning does not render the composition of the prior art patentable to the discoverer. See MPEP 2112(I).
Additionally as to claim 1, when the structure in the prior art reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. See MPEP 2112.01(I). In this case, the structure of the chlorpromazine in the prior art is the same as in the claimed invention; as such, its properties can be presumed to be inherent. Once a reference teaching a product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to applicant. See MPEP 2112(V). In this case, the evidence to show inherency is that the chemical structure of chlorpromazine in the prior art appears to be the same as the chemical structure of chlorpromazine in claim 4. This is sufficient to shift the burden to applicant in accordance with MPEP 2112(V).
As to claim 1, the claim recites that the active agent is for use in treating skin pigmentation. Lee does not appear to teach that chlorpromazine is used for this purpose. Nevertheless, composition claims cover what a composition is, not what a composition does. See MPEP 2114(II), wherein the rationale in that section of the MPEP regarding apparatus claims is also understood to be relevant for composition claims. The skilled artisan would have understood that the topical chlorpromazine composition of Lee could have been used to treat skin pigmentation even if it was not specifically taught for this purpose. As all of the structural elements of Lee are the same as that of the claimed invention (e.g. that the chlorpromazine of Lee is the same as the recited chlorpromazine), the composition of Lee is understood to meet the claimed requirements.
As to claim 1, purely en arguendo and for the purposes of this ground of rejection only, the examiner understands that Lee teaches all of the claimed requirements but not in the same embodiment. As such, while the prior art teaches all of the claimed components, the prior art is not anticipatory insofar as these components must be selected from various lists/locations in the prior art reference. It would have been prima facie obvious; however, to have selected the recited components from various lists/locations in the prior art reference and to have combined them together. This is because such a modification would have represented nothing more than the predictable use of prior art components according to their established functions. Combining separate prior art components (from a single prior art reference) according to known methods to yield predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claims 2-3, the rationale in the above paragraph is understood by the examiner to be applicable to claims 2-3.
As to claim 4, the chlorpromazine of Lee is understood to read on the chlorpromazine required by part (b) of claim 4.
As to claim 5, this claim is rejected for essentially the same reason that claims 2-3 are rejected.
As to claim 7, the composition of Lee appears to be a medical composition. Lee teaches various drug delivery forms including creams and ointments, which are known for topical administration in paragraph 0098. Lee teaches a pharmaceutically acceptable excipient in at least paragraphs 0029 and 0101.
As to claim 8, Lee teaches nanoparticles and liposomes in paragraph 0101.
As to claim 10, Lee teaches various drug delivery forms including creams and ointments, which are known for topical administration in paragraph 0098.
Non-Statutory 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 1-4 and 7-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/838,817 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to an active agent for use in treating skin pigmentation and a composition comprising said active agent. Said active agent may be one of various agents including dimethylpyrazine, as of instant claim 4. The instant claims recite various drug formulations such as a gel or cream in claim 10, and various excipient such as glycerin in claim 8.
The copending claims are drawn to an active agent for use in treating skin anti-aging and a composition comprising said active agent. Said active agent may be one of various agents including dimethylpyrazine, as of copending claim 3. The instant claims recite various drug formulations such as a gel or cream in copending claim 9, and various excipient such as glycerin in copending claim 7.
The instant and copending claims differ because the instant claims are drawn to a composition for the treatment of skin pigmentation, whereas the copending claims are drawn to an anti-aging composition. Nevertheless, the active agents in the copending claims appear to be the same as those in the instant claims. As such, the subject matter of the copending claims appears to effectively anticipate that of the instant claims, resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4 and 7-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-34 of copending Application No. 18/043,263 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to an active agent for use in treating skin pigmentation and a composition comprising said active agent. Said active agent may be one of various agents including dimethylpyrazine, as of instant claim 4. The instant claims recite various drug formulations such as a gel or cream in claim 10, and various excipient such as glycerin in claim 8.
The copending claims are drawn to a composition comprising an active agent for regulating hair growth, along with an auxiliary agent. Said active agent may be one of various agents including dimethylpyrazine, as of copending claim 18. The instant claims recite various drug formulations such as a gel or cream in copending claim 24, and various excipient such as glycerin in copending claim 22.
The instant and copending claims differ because the instant claims are drawn to a composition for the treatment of skin pigmentation, whereas the copending claims are drawn to a composition for regulating hair growth. Nevertheless, the active agents in the copending claims appear to be the same as those in the instant claims; e.g. dimethylpyrazine is recited by copending claim 18 as well as instant claim 4. As such, the subject matter of the copending claims appears to effectively anticipate that of the instant claims, resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Additional Cited Prior Art
As an additional relevant prior art reference, the examiner cites Morariu (US 2006/0216251 A1). Morariu is drawn to topical formulations for treatment of skin, as of Morariu, title and abstract. Morariu teaches isopimpinellin in a long list of active agents in paragraph 0108. The examiner notes that isopimpinellin is the same active agent as recited by instant claim 4.
In selecting the references to be used in rejecting the claims, the examiner should carefully compare the references with one another and with the applicant’s disclosure to avoid an unnecessary number of rejections over similar references. The examiner is not called upon to cite all references that may be available, but only the "best." (See 37 CFR 1.104(c).) Multiplying references, any one of which is as good as, but no better than, the others, adds to the burden and cost of prosecution and should therefore be avoided. See MPEP 904.03. As best understood by the examiner, Morariu is just as good as, but no better than the Lee reference over which the instant claims were rejected above. As such, in view of the provisions of MPEP 904.03, the examiner has not written a separate rejection over Morariu.
As another additional relevant reference, the examiner cites Maeda et al. (Oncotarget, 2017, Vol. 8, (No. 45), pp: 78312-78326). Maeda et al. (hereafter referred to as Maeda) is drawn to TRPM5 siRNA, as of Maeda, page 78312, abstract. With that being said, Maeda does not teach treating skin pigmentation.
In selecting the references to be used in rejecting the claims, the examiner should carefully compare the references with one another and with the applicant’s disclosure to avoid an unnecessary number of rejections over similar references. The examiner is not called upon to cite all references that may be available, but only the "best." (See 37 CFR 1.104(c).) Multiplying references, any one of which is as good as, but no better than, the others, adds to the burden and cost of prosecution and should therefore be avoided. See MPEP 904.03. As best understood by the examiner, Maeda is just as good as Lee et al. (US 2005/0137185 A1), over which the claims have been rejected above, but no better than this reference. This is because Maeda, like Lee, is drawn to a composition comprising a compound explicitly recited by instant claim 4, but not intended for use in the treatment of skin pigmentation. As such, the teachings of Maeda are similar to those of Lee. As such, the examiner has not written an additional rejection over Maeda in view of the provisions of MPEP 904.03.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612