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 10/19/2023 are under consideration.
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 of the following informalities: the specification recites “Cerabeam T” in paragraph 76. It appears it may have been intended to recite “CerabeamTM”.
On page 27, the specification recites “LONZAKK” rather than “LONZA”, as was done on page 26.
On page 28, the specification recites “TRIzol TM” rather than “TRIzolTM”.
Appropriate correction is required.
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 1-3 and 5 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 1, it is not clear how the recited preamble is intended to breathe life and meaning into the claims. The preamble of the claim recites a “method for detecting or quantifying a photoaged cell”. However, the method steps in the body of the claim only require a single step of detecting or quantifying expression of at least one gene selected from the group consisting of GPR17, CD34, GABRR1, OR2AG2, CMKLR1, CDH19, CD93, AVPR2, CCR7, and OXGR1 in a cell. Thus, it is unclear if applicant intends to cover any method of detecting or quantifying expression of at least one gene selected from the group consisting of GPR17, CD34, GABRR1, OR2AG2, CMKLR1, CDH19, CD93, AVPR2, CCR7, and OXGR1 in a cell, or if the method is intended to somehow require more to accomplish the goal set forth in the preamble. If it is the later, then it appears that the claims are incomplete, as they fail to provide any active steps that clearly accomplish the goal of detecting or quantifying a photoaged cell as set forth by the preamble of the claim. Amending the claim to include an active process step directed towards detecting or quantifying photoaged cells based on the detected or quantified expression of the at least one gene may overcome this objection. Claim 2 similarly is indefinite because it requires performing the method of claim 1.
Regarding claim 1, the claim has the intended use of “quantifying a photoaged cell”, but the claim requires detecting or quantifying expression “in a cell”. It is unclear how to quantify a cell when only a single cell is analyzed.
Claim 2 is similarly indefinite because it requires performing the method of claim 1.
Regarding claim 3, the claim has the recited intended use of screening a substance that “reduces a photoaged cell” and “selecting” such a substance. It is unclear what is intended by or encompassed by a substance that “reduces” a photoaged cell or any type of cell, for that matter. For example, to what is the cell to be “reduced”?
Regarding claim 5, the claim recites “a cell that has been irradiated with light having an emission peak within a wavelength range of 300 to 315 nm”. Based on the use of the passive voice, it is unclear if the claim is intended to include an active method step of “irradiating a cell with light having an emission peak within a wavelength range of 300 to 315 nm” or if the claim broadly encompasses any cell having the structure resulting from being irradiated by such light.
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.
Claim(s) 1-3 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mittelbrunn (J Invest Dermatol. 2005. 125:334-342).
Claim 1 is drawn to a “method for detecting or quantifying a photoaged cell”; however, the active method steps do not explicitly require an active method step of detecting or quantifying any type of cell. MPEP 2111.02 states:
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
Accordingly, the claim language of "method for detecting or quantifying a photoaged cell" merely sets forth the intended use or purpose of the claimed methods, but does not limit the scope of the claims. The claims are given the broadest reasonable interpretation as requiring a single step of:
detecting or quantifying expression of at least one gene selected from the group consisting of GPR17, CD34, GABRR1, OR2AG2, CMKLR1, CDH19, CD93, AVPR2, CCR7, and OXGR1 in a cell.
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Regarding claim 1, Mittelbrunn teaches detecting the expression of CCR7 in a cell as depicted in Figure 9, reproduced below:
Mittelbrunn anticipates claim 1 because it teaches all of the active method steps required by the claim.
Claim 2 recites an active method step of “performing the detecting or quantifying according to claim 1”. The method of claim 1 is interpreted as described above. The first active method step of claim 2 is interpreted as requiring a single step of:
detecting or quantifying expression of at least one gene selected from the group consisting of GPR17, CD34, GABRR1, OR2AG2, CMKLR1, CDH19, CD93, AVPR2, CCR7, and OXGR1 in a cell.
Regarding claim 2, Mittelbrunn teaches detecting the expression of CCR7 in a cell as depicted in Figure 9, reproduced above.
Mittelbrunn further teaches using a Flow cytometry analysis in which cells are analyzed and “sorted” based on fluorescence intensity (p. 341, Flow cytometry analysis).
Mittelbrunn anticipates claim 2 because it teaches all of the active method steps required by the claim.
Regarding claim 3, Mittelbrunn teaches bringing cells into contact with LPS as a “candidate substance” (Figure 9; and p. 341, Preparation of monocyte-derived DC).
Mittelbrunn teaches detecting the expression of CCR7 in a cell contacted with LPS as depicted in Figure 9, reproduced above.
Mittelbrunn identifies or “selects” LPS as a substance that suppresses development of a photoaged cell because LPS induces CCR7 expression, which irradiation suppressed as depicted in Fig. 9 reproduced above.
Claim 5 is drawn to a “method for preparing a photoaged cell”; however, the active method steps do not explicitly require an active method step of preparing, treating or manipulating any type of cell. MPEP 2111.02 states:
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
Accordingly, the claim language of "method for preparing a photoaged cell" merely sets forth the intended use or purpose of the claimed methods, but does not limit the scope of the claims. The claims are given the broadest reasonable interpretation as requiring a single step of:
detecting or quantifying expression of at least one gene selected from the group consisting of GPR17, CD34, GABRR1, OR2AG2, CMKLR1, CDH19, CD93, AVPR2, CCR7, and OXGR1 in a cell that has been irradiated with light having an emission peak within a wavelength range of 300 to 315 nm.
The type of cell analyzed in the step is limited to those that have the structure resulting from irradiation with the specified type of light; however, the claim does not require an active method step of irradiating the cell.
Regarding claim 5, Mittelbrunn teaches detecting the expression of CCR7 in a cell as depicted in Figure 9, reproduced above, in cells that have been irradiated with UVB (p. 341, Solar-simulated UV radiation) having a peak wavelength of 290-320 nm (p. 334). The claimed wavelengths of light are encompassed by those used by Mittelbrunn.
Conclusion
No claims allowed.
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