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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 6th, 2025 has been entered. Claims 7-9 remain pending in the application.
Response to Arguments
Applicant's arguments filed November 6th, 2025 which respect to the claim objections have been fully considered. The claim objections are withdrawn.
Applicant's arguments filed November 6th, 2025 which respect to the rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive. the rejections under 35 U.S.C. 101 are maintained.
At pages 9-10, Applicant argues that the claim does not recite a mental process because the steps (directing precise laser pulses into biological tissue at different wavelengths, measuring resulting photoacoustic soundwaves, and performing fluence correction using a reference pulse) are not practically performed in the human mind, specifically the components directed to a plurality of laser sources and a photoacoustic detector. Examiner respectfully disagrees. Page 7 of the previous office action clearly identified the limitations that are considered abstract. “It is essential that the broadest reasonable interpretation (BRI) of the claim be established prior to examining a claim for eligibility.” MPEP 2106 II. In light of Applicant’s specification, the claim encompasses measured amplitudes of photoacoustic soundwaves. See, for example, pages 14-20. “The courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea.” MPEP 2106.04(a)(2) III. The claimed steps can be performed using the measured amplitudes in the human mind or by using a pen and paper. Furthermore, the addition of the “plurality of laser sources” and the “photoacoustic detector” does not add meaningful limitations to the system/steps as it merely adds data-gathering to provide data for performing the abstract ideas. With or without the claimed abstract idea, the plurality of laser sources and photoacoustic detector gathers data the same. Thus, the plurality of laser sources and photoacoustic detector gathers data in a pre-solution activity for the abstract process.
At pages 10-11, Applicant argues that the judicial exception is integrated into a practical application because claim 7 applies the mathematical relationship with a concrete technological context, photoacoustic microscopy for measuring blood oxygen saturation. Examiner respectfully disagrees. This judicial exception (abstract idea) in Claims 7-9 is not integrated into a practical application because the abstract idea amounts to simply implementing the abstract idea on a computer/processor. For example, the recitations regarding the generic computing components for calculating merely invoke a computer/processor as a tool. Furthermore, the data-gathering step (direct[ing], measur[ing]) and the data-output step do not add a meaningful limitation to the system/steps as they are insignificant extra-solution activity. The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to calculate a blood oxygen saturation. The claims do not apply the abstract idea to a particular machine. "Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more." MPEP 2106.05(b) III. The pending claims utilize a computer/processor for calculating. The claims do not apply the calculated blood oxygen saturation to a particular machine. Rather, the data is merely output in a post-solution step.
At page 11-12, Applicant argues that the steps of directing lasers and measuring soundwaves are not directed to mere data-gathering steps because they are essential to achieving the improved result. Examiner respectfully disagrees. The addition of the plurality of laser sources and photoacoustic detector does not add a meaningful limitation to the system as it merely adds data-gathering to perform the abstract ideas. With or without the claimed abstract idea, the plurality of laser sources and photoacoustic detector gathers data the same. Therefore, it is unclear how there can be an improvement to the technology. Under step 2B, the claim utilizes a plurality of laser sources and a photoacoustic detector, which are generic and well-known in the industry – as evidenced by: Wang (US 20170065182 A1), in para. [0107], discloses a conventional photoacoustic imaging system 400 comprising a processor 416, data storage 418, PA laser source 402, PA transducer(s) 412; Ohta (US 5936982 A), in column 1 lines 26-49, discloses conventional variable wavelength laser light sources; Watanabe (US 20200301174 A1), in para. [0061], discloses the conventional method to irradiate the imaging object with irradiation light including a plurality of light pulses having different wavelengths from each other and having a time difference; Muller (US 5963575 A), in col. 2 lines 7-11, discloses conventional laser-active media … such as neodymium-doped laser crystals; The Non-Patent Literature of record: Li M, Tang Y, Yao J. Photoacoustic tomography of blood oxygenation: A mini review. Photoacoustics. 2018 May 31;10:65-73. doi: 10.1016/j.pacs.2018.05.001; Kuniyil Ajith Singh, M.; Xia, W. Portable and Affordable Light Source-Based Photoacoustic Tomography. Sensors 2020, 20, 6173. https://doi.org/10.3390/s20216173
At page 12, Applicant argues that the specific combination and arrangement of elements is novel and unconventional. Examiner respectfully disagrees. The claim utilizes a plurality of laser sources, a photoacoustic detector, a memory, and a processor which are generic and well-known in the industry – as evidenced by the prior art of record: Wang (US 20170065182 A1), in para. [0107], discloses a conventional photoacoustic imaging system 400 comprising a processor 416, data storage 418, PA laser source 402, PA transducer(s) 412; Ohta (US 5936982 A), in column 1 lines 26-49, discloses conventional variable wavelength laser light sources; Watanabe (US 20200301174 A1), in para. [0061], discloses the conventional method to irradiate the imaging object with irradiation light including a plurality of light pulses having different wavelengths from each other and having a time difference; Muller (US 5963575 A), in col. 2 lines 7-11, discloses conventional laser-active media … such as neodymium-doped laser crystals; Li M, Tang Y, Yao J. Photoacoustic tomography of blood oxygenation: A mini review. Photoacoustics. 2018 May 31;10:65-73. doi: 10.1016/j.pacs.2018.05.001; Kuniyil Ajith Singh, M.; Xia, W. Portable and Affordable Light Source-Based Photoacoustic Tomography. Sensors 2020, 20, 6173. https://doi.org/10.3390/s20216173.
Applicant's arguments and amendments filed November 6th, 2025 which respect to the rejections under 35 U.S.C. 112(b) have been fully considered and are withdrawn. However, additional rejections are added in view of the amendment.
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9 lines 1-2 should recite “wherein the processor is further configured to adjust a quantity of a component”.
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 7-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 7 (claims 8-9 by virtue of dependency) recites the limitations “a memory configured to store absorption coefficients of oxyhemoglobin and deoxyhemoglobin for each of the wavelength λ1, λ2, λ0; and a processor operatively coupled to the photoacoustic detector and the memory”. The specification as originally filed at the time of the effective filing date does not explicitly disclose “a processor” and “a memory”. The specification does disclose on page 23 that “the system can be configured to output and process signals from 3 or more wavelengths”, however the specification does not recite a processor or a memory and does not recite a processor operatively coupled to the photoacoustic detector and memory. Therefore, the limitations “a memory configured to store absorption coefficients of oxyhemoglobin and deoxyhemoglobin for each of the wavelength λ1, λ2, λ0; and a processor operatively coupled to the photoacoustic detector and the memory” in Claim 7 (claims 8-9 by virtue of dependency) fail to comply with the written description requirement.
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 7-9 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 7 recites the limitation “repeating above step a) to step g) …” and “repeating step h) for a second plane” in lines 49 & 52. It is unclear what structure is configured to repeat the steps of a) to g) and h). Furthermore, step a) to step c) are directed to system limitations with respect to a first laser, a second laser, and a third laser. It is unclear how it is possible to repeat system limitations, with respect to the first laser, the second laser, and the third laser, as method steps as recited in claim 1.
The limitations are suggested to recite “wherein the photoacoustic detector is configured to repeat above steps d) to f) and the processor is configured to repeat above step g) by directing the first laser, the second laser, and the third laser for every point in a first plane through the biological sample” and “wherein the photoacoustic detector is configured to repeat above steps d) to f) and the processor is configured to repeat above step g) for a second plane”.
Claims 8-9 are rejected by virtue of depending from rejected claim 1.
Claim 9 recites the limitation “a laser source”. It is unclear if this is referring to the plurality of laser sources as recited in claim 7 or if the laser source is in addition to the plurality of laser sources as recited in claim 7. The limitation is suggested to recite “the plurality of laser sources”.
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 7-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 7-9 are all within at least one of the four categories.
Independent Claim 7 recites:
a plurality of laser sources comprising:
a) a first laser configured to direct a first light pulse at a first wavelength λ1 into a point of a biological sample to trigger a first photoacoustic soundwave;
b) a second laser configured to direct, at a different time, a second light pulse at a second wavelength λ2 into the point in the biological sample to trigger a second photoacoustic soundwave;
c) a third laser configured to direct, at another different time, a third light pulse in a reference wavelength λ0 into each point in a plan of the biological sample to trigger a reference photoacoustic soundwave;
a photoacoustic detector operatively coupled to the plurality of laser sources and configured to:
d) measure a first amplitude of the first photoacoustic soundwave;
e) measure a second amplitude of the second photoacoustic soundwave; and
f) measure a third amplitude of the third photoacoustic soundwave;
a memory configured to store absorption coefficients of oxyhemoglobin and deoxyhemoglobin for each of the each of the wavelength λ1, λ2, λ0;
a processor operatively coupled to the photoacoustic detector and the memory, wherein the processor is configured to g) calculate a blood oxygen saturation based on a following relationship
PNG
media_image1.png
66
458
media_image1.png
Greyscale
Where
Pλ1 is an amplitude of photoacoustic soundwave in the first wavelength λ1;
Pλ2 is an amplitude of photoacoustic soundwave in the second wavelength λ2;
Pλ0 is an amplitude of photoacoustic soundwave in the reference wavelength λ0;
ε
o
x
y
λ
1
is a molar extinction coefficient of oxyhemoglobin (HbO2) in the first wavelength λ1;
ε
d
e
λ
1
is a molar extinction coefficient of deoxyhemoglobin (HbR) in the first wavelength λ1;
ε
o
x
y
λ
2
is a molar extinction coefficient of oxyhemoglobin (HbO2) in the second wavelength λ2;
ε
d
e
λ
2
is a molar extinction coefficient of deoxyhemoglobin (HbR) in the second wavelength λ2;
ε
o
x
y
λ
0
is a molar extinction coefficient of oxyhemoglobin (HbO2) in a reference wavelength λ0;
ε
d
e
λ
0
is the molar extinction coefficient of deoxyhemoglobin (HbR) in the reference wavelength λ0;
h) repeating above step a) to step g) by the first laser, the second laser, and the third laser for every point in a first plane through the biological sample;
i) repeating step h) for a second plane; wherein the second plane is parallel and adjacent to the aforementioned plane.
The above claim limitations (calculating) constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
“A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018).
The claimed steps of calculating recite a mathematical concept (i.e., mathematical relationships, mathematical formulas or equations, and mathematical calculations).
The step of “calculating the blood oxygen saturation” in independent Claim 7 is a mathematical relationship between wavelengths, amplitudes, and molar extinction coefficients.
Referring to pages 13-14 of the specification, calculating the blood oxygen saturation can be computed from photoacoustic data, most notably wavelengths, amplitudes, molar extinction coefficients.
The claimed steps of calculating can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
“[T]he ‘mental processes’ abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.” MPEP 2106.04(a)(2) III. The pending claims merely recite steps for calculating blood oxygen saturation that include observations, evaluations, and judgments.
Examples of ineligible claims that recite mental processes include:
a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.A.;
claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics Corp.
a claim to collecting and comparing known information, which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
Claim 8 is directed to a photoacoustic monitoring device which is well-understood, routine, and conventional, and previously known to the pertinent industry and is directed to more abstract ideas and further limitations on abstract ideas is already recited.
Claim 9 is directed to a laser source which is well-understood, routine, and conventional, and previously known to the pertinent industry and is directed to more abstract ideas and further limitations on abstract ideas is already recited.
This judicial exception (abstract idea) in 7-9 is not integrated into a practical application because:
The abstract idea amounts to simply implementing the abstract idea on a photoacoustic microscopy system. For example, the recitations regarding the generic computing components for calculating merely invoke a photoacoustic microscopy system as a tool.
The data-gathering step (direct[ing], measur[ing], repeat[ing]) and the data-output step do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a photoacoustic microscopy system that is used as a tool for calculating.
The claims do not apply the abstract idea to affect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to calculate a blood oxygen saturation.
The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a photoacoustic microscopy system for calculating. The claims do not apply the obtained calculation to a particular machine. Rather, the data is merely output in a post-solution step.
The additional elements are identified as follows: plurality of laser sources; photoacoustic detector; memory; processor; photoacoustic monitoring device.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
Applicant’s specification (e.g., page 9 lines 5-16 & page 23 lines 5-9 & page 24 lines 1-24) which discloses that the photoacoustic microscopy system comprises generic computer components that are configured to perform the generic computer functions (e.g., calculating) that are well-understood, routine, and conventional activities previously known to the pertinent industry.
Applicant’s Background in the specification; and
The prior art of record: Wang (US 20170065182 A1), in para. [0107], discloses a conventional photoacoustic imaging system 400 comprising a processor 416, data storage 418, PA laser source 402, PA transducer(s) 412
The prior art of record: Ohta (US 5936982 A), in column 1 lines 26-49, discloses conventional variable wavelength laser light sources;
The prior art of record: Watanabe (US 20200301174 A1), in para. [0061], discloses the conventional method to irradiate the imaging object with irradiation light including a plurality of light pulses having different wavelengths from each other and having a time difference;
The prior art of record: Muller (US 5963575 A), in col. 2 lines 7-11, discloses conventional laser-active media … such as neodymium-doped laser crystals;
The Non-Patent Literature of record: Li M, Tang Y, Yao J. Photoacoustic tomography of blood oxygenation: A mini review. Photoacoustics. 2018 May 31;10:65-73. doi: 10.1016/j.pacs.2018.05.001;
Kuniyil Ajith Singh, M.; Xia, W. Portable and Affordable Light Source-Based Photoacoustic Tomography. Sensors 2020, 20, 6173.
https://doi.org/10.3390/s20216173
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional generic computer components as those claimed. See option III. A. 2. in the Berkheimer memorandum.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the units associated with the steps do not add meaningful limitation to the abstract idea. A photoacoustic microscopy system or equivalent hardware is merely used as a tool for executing the abstract idea(s). The process claimed does not reflect an improvement in the functioning of the computer.
When considered in combination, the additional elements (i.e., the generic photoacoustic microscopy system functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Conclusion
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791