DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election without traverse of Group I, claims 1-10 in the reply filed on 4 May 2026 is acknowledged. Claims 11-20 have been withdrawn. Claims 1-10 are currently pending and under examination.
This application claims priority to Japanese Patent Application No. 2023-104916, filed June 27, 2023.
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 1-10 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.
With regard to claim 1, this claim recites in relevant part: “a preparation step of placing an object cell sample of a measurement object containing a plurality of cells cultured on a culture dish on a sample stage”; this step is indefinite, because it is unclear what an “object cell sample of a measurement object” is intended to include or exclude. It is unclear if “of a measurement object” is intended to limit the object cell sample. For the purpose of examination, this step is interpreted to include placing a cell sample that includes a plurality of cultured cells on a sample stage.
Further regarding claim 1, use of parentheses renders the claim indefinite because it is unclear whether the limitation(s) within the parentheses are part of the claimed invention. Here, it is unclear if the N integer is required to be 2 or more, or if this is merely exemplary. For the purposes of examination, N may be any number, including 1.
The term “mid-infrared region” in claim 1 is a relative term which renders the claim indefinite. The term “mid-infrared” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The mid-infrared range does not have a consistent definition in the art, and the specification does not provide a specific definition. For the purposes of examination, any wavelength within the infrared range is deemed to be encompassed by this term.
Also regarding claim 1, the limitation “irradiation amounts different from each other” in the evaluation light irradiation step is indefinite, because it is unclear what is meant by irradiation amounts. It is noted that “amounts” can include, for example, irradiation time, irradiation wavelength, or number of irradiation sessions. As such, it is unclear what is intended to be encompassed by “amounts.”
With regard to claim 2, the limitation of irradiating a plurality of points “in each of the N irradiation regions” is indefinite, because as discussed with regard to claim 1, the limitation within parenthesis, that N is 2 or more, is not interpreted as a required limitation. Thus, it is similarly unclear here if N is required to be more than one or not.
Claims 3-10 are included in this rejection, as these claims depend from above rejected claims and fail to remedy the noted deficiencies.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 7, 8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gu et al. (Discrimination of viable and dead microbial materials with Fourier transform infrared spectroscopy in 3–5 micrometers, Optics Express, Vol. 26, No. 12, (2018), pp. 1-9).
With regard to claim 1, Gu et al. teach a method for discrimination between viable and dead microbes (Abs.), which is a cell sample measurement method.
A plurality of fungal spores and mycelia are cultured, and then prepared by being pressed into a tablet and placed on the staging of an IR spectrometer coupled to a Continuum microscope for evaluation (p. 3, 2. Preparation of material samples to 3.1, Measurement of reflection spectra), which is a preparation step of placing an object cell sample of a measurement object containing a plurality of cells cultured on a culture dish on a sample stage.
Three sampling points from each sample tablet are selected to determine reflection spectra, and evaluated at wavelengths including each point of 3-15 µm and 3-5 µm (Fig. 1; Fig. 4), which is an evaluation light irradiation step of irradiating N = 3 irradiation regions, by dividing a culture region of the plurality of cells in the object cell sample with evaluation light having a wavelength in a mid-infrared region supplied from an irradiation light source with irradiation amounts different from each other.
A dead and viable number of the spores and mycelia are measured according to the different wavelengths for each sampling point (Fig. 1, 4; p. 3-4, 3.1 Measurement of reflection spectra), which is a dead cell number measurement step of measuring a dead cell number generated according to the irradiation amount of the evaluation light in each of the N irradiation regions of the object cell sample.
An amount of dead spores and mycelia are correlated with the wavelengths (Fig. 1, 4), which is a culture state analysis step of obtaining, for the object cell sample, an object correlation between the irradiation amount of the evaluation light and the dead cell number for the N irradiation regions serving as an index of evaluation of a culture state of the object cell sample
With regard to claim 2, Gu et al. teach that three sampling points from each sample tablet are selected to determine reflection spectra, and evaluated at wavelengths including each point of 3-15 µm and 3-5 µm (Fig. 1; Fig. 4), which is in the evaluation light irradiation step, a plurality of irradiation points are set for irradiating with the evaluation light in each of the N irradiation regions, and in the dead cell number measurement step, the dead cell number is measured at each of the plurality of irradiation points in each of the N irradiation regions.
With regard to claim 3, Gu et al. teach that three sampling points from each sample tablet are selected to determine reflection spectra, and evaluated at wavelengths including each point of 3-15 µm and 3-5 µm (Fig. 1; Fig. 4). Wherein the three sampling points per sample tablet are deemed to be a “grid pattern.” Further, as radiation wavelengths from 3-15 µm and 3-5 µm are utilized (see Fig. 1, 4), the irradiation points are deemed to be “sequentially irradiated” with the evaluation light.
With regard to claim 4, Gu et al. teach that the object correlation between the irradiation amount of the evaluation light in each irradiation region and an average value of the dead cell numbers at the plurality of irradiation points in each irradiation region for the N irradiation regions is obtained (Fig. 1 – correlation between dead spores/mycelia at each wavelength point; see also Fig. 3-6).
With regard to claim 7, Gu et al. teach that the three sampling points from each sample tablet are selected to determine reflection spectra, and evaluated at wavelengths including each point of 3-15 µm and 3-5 µm (Fig. 1; Fig. 4), which includes that the irradiation amount of the evaluation light is set by an irradiation condition including an irradiation power. Further, irradiation time and a focusing condition for the irradiation region are also utilized (see Fig. 3-6).
With regard to claim 8, Gu et al. teach that the wavelengths of the evaluation light include from 3-15 µm and 3-5 µm (Fig. 1; Fig. 4), which are fully encompassed within 3 µm or more and 20 µm or less.
With regard to claim 10, Gu et al. teach that an irradiation position of the evaluation light in the culture region is set by driving the sample stage on which the object cell sample is placed in a plane intersecting with an irradiation optical axis of the evaluation light (p. 3-4, 3.1. Measurement of reflective spectra; see also Fig. 2).
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.
Claims 1, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Gu et al.
The teachings of Gu et al. as applied to claim 1 have been set forth above.
With regard to claims 5 and 6, Gu et al. do not specifically teach the use of a staining agent, including a fluorescent dye, for selectively staining dead cells. However, Gu et al. do further teach that discrimination of viable and dead Vibrio vulnificus can be carried out using fluorescent dye, including propidium monoazide (PMA), which selectively stains dead cells (p. 2, 1. Introduction, para. 2 to p. 2, para. 1), and thus the dead cells are measurable by capturing a fluorescent image after exciting the PMA. As such, it would have been obvious to one of ordinary skill in the art from the teachings of Gu et al. to utilize a fluorescent dye that selectively stains dead cells in the taught method, such as when the cells being analyzed are from Vibrio vulnificus.
Claims 1 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Gu et al., and further in view of Takebe et al. (US 2018/0236257; Published 2018).
The teachings of Gu et al. as applied to claim 1 have been set forth above.
With regard to claim 9, while Gu et al. teach an irradiation light source for providing wavelengths in the mid-infrared light spectrum (see Fig. 1, 3-6), it is not specifically taught that the light source is a quantum cascade laser.
Takebe et al. teach a cell stimulation method that emits mid-infrared light to a cell sample, wherein the mid-infrared light source is a quantum cascade laser (Abs. Para. 37).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Gu et al. with Takebe et al., because both utilize mid-infrared light to irradiate a cell sample. It is known in the art from the teachings of Takebe et al. that a quantum cascade laser is usable as a mid-infrared light source. The use of a quantum cascade laser as taught by Takebe et al. in the method of Gu et al. amounts to the simple substitution of one known mid-infrared light source for another, wherein the quantum cascade laser of Takebe et al. would have been expected to predictably and successfully provide a light source capable of providing wavelengths from 3-15 µm as desired by Gu et al.
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 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18/739573 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both encompass a cell sample measurement method comprising: a preparation step of placing an object cell sample of a measurement object containing a plurality of cells cultured on a culture dish on a sample stage; an evaluation light irradiation step of irradiating N irradiation regions set by dividing a culture region of the plurality of cells in the object cell sample with evaluation light having a wavelength in a mid-infrared region supplied from an irradiation light source with irradiation amounts different from each other; a dead cell number measurement step of measuring a dead cell number generated according to the irradiation amount of the evaluation light in each of the N irradiation regions of the object cell sample; and a culture state analysis step of obtaining, for the object cell sample, an object correlation between the irradiation amount of the evaluation light and the dead cell number for the N irradiation regions serving as an index of evaluation of a culture state of the object cell sample (Instant claim 1; Cited reference claim 1-2).
In the evaluation light irradiation step: a plurality of irradiation points are set for irradiating with the evaluation light in each of the N irradiation regions, and in the dead cell number measurement step, the dead cell number is measured at each of the plurality of irradiation points in each of the N irradiation regions; all the irradiation points set in the N irradiation regions are arranged in a grid pattern in the culture region, and the irradiation points are sequentially irradiated with the evaluation light; the irradiation amount of the evaluation light is set by an irradiation condition including at least one of an irradiation time, an irradiation power, and a focusing condition of the evaluation light for the irradiation region; the wavelength of the evaluation light is set in a wavelength region of 3 µm or more and 20 µm or less; the irradiation light source for supplying the evaluation light includes a quantum cascade laser; and an irradiation position of the evaluation light in the culture region is set by driving the sample stage on which the object cell sample is placed in a plane intersecting with an irradiation optical axis of the evaluation light (Instant claim 2, 3, 7-10; Cited reference claim 3, 4, 7-10). In the culture state analysis step, the object correlation between the irradiation amount of the evaluation light in each irradiation region and an average value of the dead cell numbers at the plurality of irradiation points in each irradiation region for the N irradiation regions is obtained; in the dead cell number measurement step, the dead cell number is measured by capturing an optical image of the object cell sample stained with a staining agent for selectively staining dead cells; and wherein the staining agent is a fluorescent dye, and in the dead cell number measurement step, the dead cell number is measured by capturing a fluorescent image generated by irradiating the object cell sample stained with the fluorescent dye with excitation light (Instant claim 4-6; Cited reference claim 5, 6).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm 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, Sharmila G. Landau can be reached at (571)272-0614. 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.
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
Prosecution Insights