DETAILED ACTION
Applicant’s arguments, filed 11/16/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Applicant canceled claims 2 and 4.
Claims 1, 3, and 5 are pending and hereby under examination.
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 .
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5, line 2, “a photoacoustic diagnostic device” should read “the photoacoustic diagnostic device”.
Appropriate correction is required.
Claim Interpretation
The “measuring unit” continues to be interpreted as laid out in the Office Action filed 08/25/2025.
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.
Claim 1 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 limitation “measuring unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that performs the function in the claim, the structure described in the specification does not perform the entire function in the claim, and no association between the structure and the function can be found in the specification. For example, the measuring unit is described as “may use an optical method of measuring the change in the shape of the membrane by measuring capacitance, and measuring and analyzing light reflected by irradiating the light to the sound receiver 200 to measure the change in the shape of the membrane” (Paragraph 0040). However, no structure is given to the measuring unit. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
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.
Claims 1, 3, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (WO 2009076427 – cited by Applicant) and Zheng (US 10624543 – previously cited).
Regarding claim 1, Chen discloses a photoacoustic diagnosis apparatus, comprising:
a light source radiating sound by radiating light to a subject (Figs. 1A-2B, optical fiber 106 shining light on tissue 190);
a plurality of sound receivers (Figs. 1A, array 102 of ultrasonic transducers 104) provided with a membrane whose shape is changed by the sound (Paragraph 0009, “Recently, capacitive micromachined ultrasonic transducers (CMUTs) emerged as a promising alternative for piezoelectric transducers for medical imaging. In the ultrasound transmission process, the membrane of a CMUT is generally biased with a d.c. voltage. An a.c. signal is superimposed on this d.c. bias to cause a time-varying deformation of the membrane. This membrane deformation stirs the ambient media and transmits ultrasound”; Paragraph 0057); and
a measuring unit measuring a change in shape of the membrane (Paragraph 0057-0058), wherein the membranes of the plurality of sound receivers have different sizes (Fig. 6, CMUT devices with different radii).
While Chen recognizes the usefulness of using photoacoustic analysis for various means (Paragraphs 0003-0007), Chen fails to disclose wherein the resonance frequency is matched to blood sugar.
However, Zheng teaches a photo-acoustic sensing apparatus for deriving blood glucose from the sensed photoacoustic signals, wherein a resonance frequency of the sound receiver is matched to a peak of blood sugar (Col 22, line 55 – Col 23, line 8). One of ordinary skill in the art would have been capable of applying this known technique of measuring glucose of Zheng to the device of Chen that was ready for improvement and the results would have been predictable to one of ordinary skill in the art.
Chen and Zheng are considered analogous to the claimed invention because they are in the same field of photoacoustic devices. One of ordinary skill in the art would have been capable of applying this known technique of measuring glucose of Zheng to the device of Chen that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teachings of Zheng.
Regarding claim 3, Chen discloses a photoacoustic diagnosis method for measuring blood sugar using a photoacoustic diagnosis apparatus, the photoacoustic diagnosis method comprising:
radiating light to a subject using a light source (Figs. 1A-2B, optical fiber 106 shining light on tissue 190);
collecting sound emitted from the subject through a plurality of sound receivers (Figs. 1A, array 102 of ultrasonic transducers 104) provided with a membrane (Paragraph 0009, “Recently, capacitive micromachined ultrasonic transducers (CMUTs) emerged as a promising alternative for piezoelectric transducers for medical imaging. In the ultrasound transmission process, the membrane of a CMUT is generally biased with a d.c. voltage. An a.c. signal is superimposed on this d.c. bias to cause a time-varying deformation of the membrane. This membrane deformation stirs the ambient media and transmits ultrasound”; Paragraph 0057);
measuring a change in shape of the membrane (Paragraph 0057-0058).
While Chen recognizes the usefulness of using photoacoustic analysis for various means (Paragraphs 0003-0007), Chen fails to disclose wherein the resonance frequency is matched to blood sugar.
However, Zheng teaches a photo-acoustic sensing apparatus for deriving blood glucose from the sensed photoacoustic signals, wherein a resonance frequency of the sound receiver is matched to a peak of blood sugar to measure the concentration of blood sugar (Col 22, line 55 – Col 23, line 8). One of ordinary skill in the art would have been capable of applying this known technique of measuring glucose of Zheng to the device of Chen that was ready for improvement and the results would have been predictable to one of ordinary skill in the art.
Regarding claim 5, Chen and Zheng fail to explicitly disclose a computer-readable recording medium on which a program for realizing the method according to claim 3 is recorded. However, Zheng discloses a central control unit / processing module for coordinating the laser, data measurement, display, and other needed functionalities (Col 12, lines 50-54). Thus, one of ordinary skill in the art would recognize that a computer-readable medium would be used to perform the method disclosed above.
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 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of co-pending Application No. 18/852207 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader than those of the co-pending application. For example, the co-pending application claims 1-4 and 9 are directed to the analysis of “resonance peaks” related to “blood sugar” using a “light source”, using similar language to the instant application. The co-pending application claims “one or more transducers” with a “membrane element” while the instant application claims related elements of “a plurality of sound receivers provided with a membrane”.
As such, one in possession of an apparatus or method consistent with the claims of the co-pending application would necessarily be in possession of the claims of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments, see page 6, filed 11/19/2025, with respect to the drawings objections have been fully considered and are persuasive. Applicant has amended the specification to incorporate the missing reference characters. The objection of the drawings has been withdrawn.
Applicant’s arguments, see page 7, filed 11/19/2025, with respect to the 35 U.S.C. §112(b) rejections have been fully considered and are persuasive. Applicant has amended the language to clarify each sound receiver has its own members and that each sound receiver has its own resonance frequency. The rejection of the claims has been withdrawn.
Applicant's arguments filed 11/19/2025, with respect to the 112(b) rejection regarding the “measuring unit” have been fully considered but they are not persuasive. Applicant argues that the “measuring unit” does not invoke 35 U.S.C. 112(f) because it is not a generic placeholder. However, “unit” is identified as a generic placeholder (see MPEP §2181 subsection I), and a “measuring unit” does not impart any structure to the claimed device. Within the specification, there is no specific structure linked to the claimed function of “measuring a change in shape of the membrane”. Thus, the rejection of claim 1 is maintained.
Applicant’s arguments, see page 8, filed 11/19/2025, with respect to the 35 U.S.C. §101 rejection have been fully considered and are persuasive. Applicant has amended the claim to clarify that the computer-readable recording medium is non-transitory. The rejection of claim 5 has been withdrawn.
Applicant’s arguments, see page 8, filed 11/19/2025, with respect to the provisional non-statutory double patenting rejection have been fully considered but are not persuasive. The rejection is maintained as the claims still fall under double patenting with co-pending Application No. 18/852207.
Applicant's arguments, see page 9, filed 11/19/2025, with respect to the 35 U.S.C. §102(a)(1) and §103 rejections have been fully considered but they are not persuasive.
Applicant argues that the references fail to teach or suggest a “a resonance frequency of each of the sound receivers is matched to a photoacoustic peak of blood sugar”. Examiner disagrees. Chen teaches a device with multiple receivers with membranes of various sizes. Chen also teaches measuring components in blood using photo-acoustics. Zheng teaches a way to do so by extracting resonance frequencies specific to blood sugar. In combination, the references read on claims 1 and 3.
Applicant further argues that the instant application uses multiple sound receivers, each configured to operate in its own distinct, non-overlapping frequency band. However, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that these features upon which applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
While Chen may teach multiple receivers such that their frequency bands overlap, the measured frequencies cover the peaks of blood glucose. Additionally, since Chen teaches a system of receivers with multiple membranes of various sizes, the membranes inherently have differing resonance frequencies. Thus, these resonance frequencies may be matched to blood sugar.
Lastly, Applicant argues that there is no motivation to modify Chen. Examiner disagrees. Zheng discloses measuring a resonance frequency of blood sugar. While Chen encompasses a broader range of frequencies measured (which overlaps with blood sugar resonance frequencies), Zheng modifies Chen such that a sound receiver is matched to a peak of blood sugar. As such, the references in combination read on the claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kruger (5713356) teaches an apparatus for measuring electromagnetic wave absorption properties of biologic tissues using multiple acoustic transducers.
Lilienfeld-Toal (US 6484044) teaches an apparatus for measuring glucose in body tissue at different peaks in the absorption spectrum. See Fig. 3.
Balberg (US 7515948) teaches an apparatus for non-invasively monitoring a body region using a photoacoustic effect with acoustic elements of various sizes. See Fig. 3A.
THIS ACTION IS MADE FINAL. 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 NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOAH M HEALY/Examiner, Art Unit 3791
/RENE T TOWA/Primary Examiner, Art Unit 3791