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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement submitted on 12/13/2024 and 7/11/2025 have been considered by the examiner.
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12 recites the limitation "the absorption coefficient value" in line 12. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 11-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for an embodiment in which a blood glucose level is obtained and determined to be a normal level, does not reasonably provide enablement for any other determinations related to human health or disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
Claim 11 recites “a control unit configured to determine whether the subject is normal by comparing a detection signal of the ultrasonic wave with the reference signal” in lines 5-6. The broadest reasonable interpretation of a subject, based on the specification, includes a human subject. The broadest reasonable interpretation of “normal” human, based on the specification, includes a human free of any and all diseases. Thus, the scope of the claim includes an embodiment in which any and all human diseases can be detected by the control unit (because a human with a disease might not be “normal”). However, neither the specification nor the prior art (i.e., the prior art of record of this application and of the parent application) discloses how to detect all possible diseases using photoacoustic measurements. Since the breadth of the claim includes an embodiment in which any and all human diseases can be detected by the control unit, but neither the specification nor the prior art discloses how to detect all possible diseases using photoacoustic measurements, the examiner has determined that the specification, at the time the application was filed, would not have taught one skilled in the art to make and/or use the full scope of the claimed invention without undue experimentation.
Claim 12 has a similar limitation and is rejected for the same reason.
Claims 13-17 depend on claim 12 and are rejected for inheriting the same problem.
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 1-17 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.
Claim 1 recites that “the absorption coefficient value is obtained by removing the second noise value subtracted from the first noise value” in lines 12-13. However, the specification discloses that the absorption coefficient value is obtained by removing noise value from the measurement value, where the noise value corresponds to a first ultrasonic wave generated from the first light source and the measurement value corresponds to a second ultrasonic wave generated from the second light source. See paragraphs [0013], [0040] and [0049]. Thus, there is a contradiction between the claim and the specification. It has been held that a claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. In re Moore, 439 F.2d 1232, 1235-36, 169 USPQ 236, 239 (CCPA 1971); In re Cohn, 438 F.2d 989, 169 USPQ 95 (CCPA 1971); In re Hammack, 427 F.2d 1378, 166 USPQ 204 (CCPA 1970). The examiner respectfully suggests replacing “the absorption coefficient value is obtained by removing the second noise value subtracted from the first noise value” with -- the absorption coefficient value is obtained by removing the first noise value second noise value --.
Claims 2-10 depend on claim 1 and are rejected for inheriting the same problem.
The term “normal” in claim 11 is a relative term which renders the claim indefinite. The term “normal” 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 term “normal” in claim 12 is a relative term which renders the claim indefinite. The term “normal” 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.
Claim 12 recites that “the control unit obtains the absorption coefficient value by removing the second noise value subtracted from the first noise value” in lines 14-15. However, the specification discloses that the absorption coefficient value is obtained by removing noise value from the measurement value, where the noise value corresponds to a first ultrasonic wave generated from the first light source and the measurement value corresponds to a second ultrasonic wave generated from the second light source. See paragraphs [0013], [0040] and [0049]. Thus, there is a contradiction between the claim and the specification. It has been held that a claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. In re Moore, 439 F.2d 1232, 1235-36, 169 USPQ 236, 239 (CCPA 1971); In re Cohn, 438 F.2d 989, 169 USPQ 95 (CCPA 1971); In re Hammack, 427 F.2d 1378, 166 USPQ 204 (CCPA 1970). The examiner respectfully suggests replacing “the control unit obtains the absorption coefficient value by removing the second noise value subtracted from the first noise value” with -- the control unit obtains the absorption coefficient value by removing the first noise value second noise value --.
Claims 13-17 depend on claim 12 and are rejected for inheriting the same problems.
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, 2, 4, 7, 9-13, 15 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,203,844. Although the claims at issue are not identical, they are not patentably distinct from each other as shown below.
As for claim 1, U.S. Patent 12,203,844 claims a photo-acoustic sensing method comprising:
providing a source light in a subject (claim 1);
detecting an ultrasonic wave generated in the subject by the source light (claim 1); and
obtaining an absorption coefficient value of the substrate (claim 1)
wherein the source light comprises:
a first source light having a first wavelength band and generating a reference signal that includes a first noise value of the ultrasonic wave (claim 1)
a second source light having a second wavelength band narrower than the first wavelength band and generating a measurement signal that includes a second noise value corresponding to the first noise value and the absorption coefficient value of the subject (claim 1),
wherein the absorption coefficient value is obtained by removing the second noise value subtracted from the first noise value (claim 1).
As for claim 2, U.S. Patent 12,203,844 claims the photo-acoustic sensing method of claim 1, wherein the first wavelength band is 1800 nm to 2500 nm (claim 1).
As for claim 4, U.S. Patent 12,203,844 claims the photo-acoustic sensing method of claim 1, wherein the second wavelength band is 1500 nm to 1800 nm (claim 1).
As for claim 7, U.S. Patent 12,203,844 claims the photo-acoustic sensing method of claim 1, wherein the ultrasonic wave includes:
a first ultrasonic wave generated by the first source light (claim 2); and
a second ultrasonic wave generated by the second source light (claim 2).
As for claim 9, U.S. Patent 12,203,844 claims the photo-acoustic sensing method of claim 1, wherein the source light includes near-infrared light having a wavelength of 900 nm to 3000 nm (claim 1).
As for claim 10, U.S. Patent 12,203,844 claims the photo-acoustic sensing method of claim 1, further comprising obtaining a blood glucose value by comparing the absorption coefficient value with a reference value (claim 3).
As for claim 11, U.S. Patent 12,203,844 claims a photo-acoustic sensor device, comprising:
a photo-acoustic sensor device comprising:
a light source configured to provide a source light to a subject (claim 4);
a detector configured to receive an ultrasonic wave generated in the subject by the source light (claim 4); and
a control unit configured to determine whether the subject is normal by comparing a detection signal of the ultrasonic wave with a reference signal (claim 4),
wherein the light source generates the source light having a wavelength of 900 nm to 3000 nm in a near-infrared band (claim 4).
As for claim 12, U.S. Patent 12,203,844 claims a photo-acoustic sensor device, comprising:
a light source configured to provide a source light to a subject (claim 4);
a detector configured to receive an ultrasonic wave generated in the subject by the source light (claim 4); and
a control unit configured to determine whether the subject is normal by comparing a detection signal of the ultrasonic wave with a reference signal (claim 4),
wherein the source light comprises:
a first source light having a first wavelength band and generating a reference signal that includes a first noise value of the ultrasonic wave (claim 4); and
a second source light having a second wavelength band narrower than the first wavelength band and generating a measurement signal that includes a second noise value corresponding to the first noise value and the absorption coefficient value of the subject (claim 4),
wherein the control unit obtains the absorption coefficient value by removing the second noise value subtracted from the first noise value (claim 4).
As for claim 13, U.S. Patent 12,203,844 claims the photo-acoustic sensor device of claim 12, wherein the source light includes near-infrared light having a wavelength of 900 nm to 3000 nm (claim 4).
As for claim 15, U.S. Patent 12,203,844 claims the photo-acoustic sensor device of claim 12, wherein the first wavelength band is 1800 nm to 2500 nm (claim 4).
As for claim 16, U.S. Patent 12,203,844 claims the photo-acoustic sensor device of claim 12, wherein the second wavelength band is 1500 nm to 1800 nm (claim 4).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent 8,332,006 issued to Naganuma et al. (“Naganuma”) is cited for all that it discloses including a photo-acoustic sensor device that has two light sources and a detector that detects ultrasonic waves to determine a blood glucose value.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN N OLAMIT whose telephone number is (571)270-1969. The examiner can normally be reached M-F, 8 am - 5 pm (Pacific).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Stephen Meier can be reached at (571) 272-2149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JUSTIN N OLAMIT/ Primary Examiner, Art Unit 2853
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