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 .
The claims dated 4/6/2026 are under consideration.
The amendments and arguments presented in the papers filed 4/6/2026 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 1/5/2026 listed below have been reconsidered as indicated.
a) The objections to the specification are withdrawn in view of the amendments and the Remarks (p. 7).
b) The rejections of claims 1-3 and 5 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of the amendments to the claims.
c) The rejections of claim(s) 1-3 and 5 under 35 U.S.C. 102(a)(1) as being anticipated by Mittelbrunn (J Invest Dermatol. 2005. 125:334-342) are withdrawn in view of the amendments to the new claims which do not include CCR7 as one of the genes subjected to expression level determination.
The Examiner’s responses to the Remarks regarding issues not listed above are detailed below in this Office action.
New and modified grounds of rejection necessitated by amendment are detailed below and this action is made FINAL.
Priority
The present application is a 371 national stage entry of PCT/JP2022/008772 (filed 3/2/2022), and claims benefit of JAPAN 2021-037357 (filed 3/9/2021).
An English translation of the certified foreign priority document has not been received.
Information Disclosure Statement
The listing of references in the specification or the citation of references throughout the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or cited on a submitted IDS, they have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. The embedding hyperlink appears in paragraph 42 on p. 14.
Claim Objections
Claim 9 is objected to because of the following informalities: the claim recites “determining an mRNA level that is a transcription product of the gene”. The language is inconsistent. An “mRNA level” is a value and not a transcription product of the gene. The “mRNA” itself is “a transcription product of the gene”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: the claim recites “determining a protein level that is a transcription product of the gene”. The language is inconsistent. An “protein level” is a value and not a transcription product of the gene. The “protein” itself is “a transcription product of the gene”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: the claim recites “comparable to that in cells that has not” rather than “comparable to that in cells that have not”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 6, 7, 8, 9, 10, 11, 13, 14, 15, 16, 17, 18, 19, 20 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions without significantly more.
The claims are drawn to methods, one of the four statutory categories.
The claim(s) recite(s):
“determining an expression level of at least one gene selected from the group consisting of GPR17, GABRR1, OR2AG2, CMKLR1, CDH19, AVPR2, and OXGR1 in cells” (claim 6);
“identifying cells in which the expression of at least one gene selected from the group consisting of GPR17, GABRR1, CMKLR1, AVPR2, and OXGR1 is detected” (claim 6);
“identifying cells in which the expression level of at least one gene selected from the group consisting of OR2AG2, and CDH19 is increased compared to the expression level in cells that are not exposed to UV light” (claim 6);
“detecting the identified cells as the photoaged cells” (claim 6);
“quantifying the photoaged cells in the cells” (claim 6);
“sorting out cells detected as photoaged cells” (claim 11);
“determining an expression level of at least one gene selected from the group consisting of GPR17, GABRR1, OR2AG2, CMKLR1, CDH19, AVPR2, and OXGR1 in the cells” (claim 13);
“identifying, as a substance that suppresses proliferation or development of photoaged cells or a substance that reduces photoaged cells, a substance that has been brought into contact with cells in which expression of at least one gene selected from the group consisting of GPR17, GABRR1, CMKLR1, AVPR2, and OXGR1 is not detected after irradiation with the light” (claim 13);
“identifying, as a substance that suppresses proliferation or development of photoaged cells or a substance that reduces photoaged cells, a substance that has been brought into contact with cells in which expression level of at least one gene selected from the group consisting of OR2AG2, and CDH19 after irradiation with the light is comparable to that in cells that has not been irradiated with the light” (claim 13);
“determining an expression level of at least one gene selected from the group consisting of GPR17, GABRR1, OR2AG2, CMKLR1, CDH19, AVPR2, and OXGR1 in the cells” (claim 16);
“identifying cells in which the expression of at least one gene selected from the group consisting of GPR17, GABRR1, CMKLR1, AVPR2, and OXGR1 is detected” (claim 16);
“identifying cells in which the expression level of at least one gene selected from the group consisting of OR2AG2, and CDH19 is increased compared to the expression level in cells that are not exposed to UV light” (claim 16); and
“obtaining the identified cells as the photoaged cells” (claim 16).
The steps of “determining an expression level” broadly encompasses an abstract idea such as normalizing of raw data as described in para. 81 of the instant specification. This data manipulation for a limited number of genes may be done in a purely mental manner or with the aid of a pen and paper.
The steps of “identifying” broadly encompasses an abstract idea as it encompasses making a mental determination or conclusion regarding cells and their expression level of a gene.
The step of “detecting the identified cells as the photoaged cells” broadly encompasses making a conclusion regarding identified cells. This process broadly encompasses an abstract idea in the form of mentally “detecting” or identifying cells as photoaged cells.
The step of “quantifying the photoaged cells in the cells” broadly encompasses an abstract idea in the form of counting cells or extrapolating expression levels to cell counts.
The step of “obtaining the identified cells as the photoaged cells” broadly encompasses simply identifying cells as photoaged cells or receiving cells.
The step of “sorting out cells detected as photoaged cells” broadly encompasses abstractly separating out cells, such as annotating cells from other cells.
The judicial exceptions are not integrated into a practical application because the claims do not involve:
improvements to the functioning of a computer or to any other technology or technical field;
applying or using the judicial exceptions to effect a particular treatment or prophylaxis for a disease or medical condition;
applying the judicial exception with, or by use of, a particular machine; or
effecting a transformation or reduction of a particular article to a different state or thing.
The claimed limitations add insignificant extra-solution activity to the judicial exceptions as they are data gathering steps.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims encompass the use of commercially available materials that are well-known and used in a conventional manner as described in paragraph 81, 84 and 85 of the instant specification.
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.
Claims 6-21 are 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.
Regarding claim 6, the claim recites “is detected” in line 2 of (ii)(a). The recitation lacks proper antecedent basis as the claim does not require “detecting” expression and rather “determines” an “expression level”.
Claims 7-12 depend from claim 6 and are rejected for the same reason.
Regarding claim 13, the claim recites “expression…is not detected after irradiation with the light” starting in line 3 of (iv)(a). The recitation lacks proper antecedent basis as the claim does not require “detecting” expression and rather “determines” an “expression level”.
Claims 14-15 depend from claim 13 and are rejected for the same reason.
Regarding claim 16, the claim recites “is detected” in line 2 of (Iii)(a). The recitation lacks proper antecedent basis as the claim does not require “detecting” expression and rather “determines” an “expression level”.
Claims 17-21 depend from claim 16 and are rejected for the same reason.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 6-9, 11, 13-14 and 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tock (Pigment Cell Melanoma Res. 2011. 24(5):972-974 and Supplementary Materials).
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Regarding claim 6, Tock teaches determining the expression level of at least GPR17 and GABRR1 using the Affymetrix Human Genome U133A Array. The array includes the following probes that determine the expression of GPR17 and GABRR1:
The expression data of Tock is available as GSE22083.
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The data of Tock demonstrates Tock identified cells in which an expression level of GPR17 (215225_s_at and 206190_at) and GABRR1 (206525_at) is detected relative to a “No Irradiation Control” as demonstrated below:
The cells of Tock having expression of GPR17 and GABRR1 detected were “detected” as having been photoaged through the exposure to 0.1 MED ssR dose (Table S1).
Regarding claim 7, Tock teaches the cells are skin cells (Supplementary Materials, p. S2).
Regarding claim 8, Tock teaches the cells were “cultured” for 24 hours after ssR irradiation, after which the cells were removed from the subject (Supplementary Materials, p. S2).
Regarding claim 9, the Affymetrix Human Genome U133A Array used by Tock determines expression level at the RNA level as demonstrated by Tock extracting RNA from samples (Supplementary Materials, p. S2).
Regarding claim 11, as noted above, Tock teaches the method of claim 6. Tock further sorts cells photoaged through the exposure to 0.1 MED ssR dose from other cell samples (Table S1).
Regarding claim 13, Tock teaches bringing sunscreen as “at least one candidate substance” in contact with skin cells that have not been irradiated (Supplementary Materials, p. S2).
Tock teaches irradiating the cells using ssR including Ultraviolet B (Supplementary Materials, p. S1), which has an emission peak wavelength of 315 nm.
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Tock teaches determining the expression level of at least GPR17 and GABRR1 using the Affymetrix Human Genome U133A Array. The array includes the following probes that determine the expression of GPR17 and GABRR1:
The expression data of Tock is available as GSE22083.
The data of Tock demonstrates Tock identified sunscreen as a substance that causes expression level of GPR17 (215225_s_at and 206190_at) and GABRR1 (206525_at) to not be detected at the same level as when the cells were not contacted
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with the sunscreen as demonstrated below:
Regarding claim 14, Tock teaches irradiation doses include 100, 150, 200, 250, 300 J/m2 or 10, 15, 20, 25, 30 mJ/cm2 (Supplementary Materials, p. S1).
Regarding claim 16, Tock teaches irradiating the cells using ssR including Ultraviolet B (Supplementary Materials, p. S1), which has an emission peak wavelength of 315 nm.
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Tock teaches determining the expression level of at least GPR17 and GABRR1 using the Affymetrix Human Genome U133A Array. The array includes the following probes that determine the expression of GPR17 and GABRR1:
The expression data of Tock is available as GSE22083.
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The data of Tock demonstrates Tock identified cells in which an expression level of GPR17 (215225_s_at and 206190_at) and GABRR1 (206525_at) is detected relative to a “No Irradiation Control” as demonstrated below:
The cells of Tock having expression of GPR17 and GABRR1 detected were “obtained” photoaged cells through the exposure to 0.1 MED ssR dose (Table S1).
Regarding claims 17-18, Tock teaches the cells were “cultured” for 24 hours after ssR irradiation, after which the cells were removed from the subject (Supplementary Materials, p. S2).
Regarding claim 19, Tock further sorts cells photoaged through the exposure to 0.1 MED ssR dose from other cell samples (Table S1).
Regarding claim 20, Tock teaches irradiation doses include 100, 150, 200, 250 or 300 J/m2 or 10, 15, 20, 25, 30 mJ/cm2 (Supplementary Materials, p. S1).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 10, 15 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tock (Pigment Cell Melanoma Res. 2011. 24(5):972-974 and Supplementary Materials).
Regarding claims 10, 15 and 21, Tock teaches the elements of claims 6, 13, 14 and 16 as described in the above rejections.
Regarding claim 10, it would have been prima facie obvious to the ordinary artisan at the time of filing to have modified the method of Tock to have been based on measuring protein expression levels.
Regarding claims 15 and 21, it would have been prima facie obvious that the amount of time required by Tock could be varied based on the power of the irradiation source and the irradiation device itself. Thus, the amount of time as claimed may be arrived upon based on routine optimization.
Conclusion
No claims 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 JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH G. DAUNER/ Primary Examiner, Art Unit 1682
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