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 .
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Objections
Claim 1 is objected to because of the following informalities: the positive recitation of “the the” in line 7 should apparently read “the”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: the positive recitation of “the the” in line 4 should apparently read “the”. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: the positive recitation of “the the” in line 5 should apparently read “the”. 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 1-20 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.
The term “soft” patch in independent claims 1, 11, and 19 is a relative term which renders the claim indefinite. The term “soft” 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 requisite degree of “softness” is unclear. The scope of the claims is indeterminate with respect to what may explicitly, implicitly, inherently, or inferentially be required and/or excluded as considered “soft” enough. Depending claims 2-10, 12-18 and 20 inherit and do not remedy the indefiniteness.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 11-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more, wherein the abstract idea may be considered a mental process of receiving data and determining vasoconstriction.
For independent claim 11, the claim(s) recite(s) a process of receiving a PPG signal data set and determinizing vasoconstriction based on the PPG signal data. As broadly as structurally and/or functionally claimed these steps may be reasonably considered as the judicial exception of a mental process performable within the human mind, including by observation, evaluation, judgement and opinion forming, or by a human using pen and paper (see MPEP 2106.04(a)(2) subsection III). For example, at least, these limitations are nothing more than a medical professional capturing data, printing it out, and using the data to mentally extract, classify or learn from data features to determine a vasoconstriction.
This judicial exception is not integrated into a practical application because the process steps as broadly as claimed are not tied to nor required to be performed, executed, or programmed on a special purpose computer. Further, the judicial exception is not even required to be performed on or tied to a mere generic processing device, controller, or the like.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the preliminary steps of data gathering via a soft patch compressed into a chest with a PPG/vasoconstriction sensor are well-known, routine and conventional amounting to insignificant data gathering as pre-solution activity.
Depending claims 12-18 inherit and do not remedy the non-statutory deficiency noted above. For claims 12-16 and 18, despite further specifying steps relating to output, additional sensors and/or locations, communications, or reporting, the claims do not integrate into a practical application nor include additional elements amounting to significantly more. Similarly, claim 17 suffers the same, however the recitation of a trained machine learning model may further be considered abstract as a mental process executable by the mind of a trained medical professional, particularly in the absence of structural recitations to the contrary.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zavanelli et al. (US 11,464,451 B1, hereinafter Zavanelli).
For claim 1, Zavanelli discloses a system (Fig 2) (Cols 9-17), comprising inter alia:
a processor (203,230) (Fig 2) (Cols 9-17); and
a memory (215,236) (Fig 2) (Cols 9-17) having instructions stored thereon, wherein the instructions when executed by the processor causes the processor to:
receive a photoplethysmogram (PPG) signal data set acquired by a soft patch (103) comprising a vasoconstriction sensor (PPG sensor 221) placed on a chest of a subject (Fig 2) (Cols 9-17); and
determine if the subject is experiencing vasoconstriction using the PPG signal data set (Fig 2) (Cols 9-17);
wherein the soft patch compresses the vasoconstriction sensor into the chest of the subject (Fig 2) (Cols 9-17).
For claim 2, Zavanelli discloses the system of claim 1, wherein the instructions, when executed by the processor, further cause the processor to output if the subject is experiencing vasoconstriction in a graphical user interface or a report to be used for an evaluation of cardiovascular health in the subject (Fig 2) (Cols 9-17).
For claim 3, Zavanelli discloses the system of claim 1, wherein the soft patch further comprises an electrocardiography sensor (ECG sensor 221) (Fig 2) (Cols 9-17) and/or a seismocardiography sensor (SCG sensor 221) (Fig 2) (Cols 9-17).
For claim 4, Zavanelli discloses the system of claim 1, wherein the soft patch is placed on a sternum of the subject (Fig 2) (Cols 9-17).
For claim 5, Zavanelli discloses the system of claim 1, wherein the soft patch further comprises an elastomer (222) (Fig 2) (Cols 9-17) disposed over the vasoconstriction sensor (Fig 2) (Cols 9-17); and wherein the elastomer dampens motion artifacts in the PPG signal data caused by movement of the chest of the subject (Fig 2) (Cols 9-17).
For claim 6, Zavanelli discloses the system of claim 1, wherein the soft patch includes wireless communication circuitry (218) (Fig 2) (Cols 9-17).
For claim 7, Zavanelli discloses the system of claim 1, wherein the instructions, when executed by the processor, further cause the processor to determine via a trained machine learning model (233) if the subject is experiencing sleep apnea (Fig 2) (Cols 9-17).
For claim 8, Zavanelli discloses the system of claim 7, wherein the instructions, when executed by the processor, further cause the processor to output if the subject is experiencing sleep apnea in a graphical user interface or a report to be used for an evaluation of sleep apnea in the subject (Fig 2) (Cols 9-17).
For claim 9, Zavanelli discloses the system of claim 1, wherein the system is configured as a smartwatch or smartphone (Fig 2) (Cols 9-17).
For claim 10, Zavanelli discloses the system of claim 1, wherein the system is implemented in cloud infrastructure (206) (Fig 2) (Cols 9-17).
For claim 11, Zavanelli discloses a method, comprising inter alia:
receiving a PPG signal dataset (from PPG sensor 221) acquired by a soft patch (103) comprising a vasoconstriction sensor (PPG sensor 221) placed on a chest of a subject (Fig 2) (Cols 9-17); and
determining if the subject is experiencing vasoconstriction using the PPG signal data set (Fig 2) (Cols 9-17);
wherein the soft patch compresses the vasoconstriction sensor into the chest of the subject (Fig 2) (Cols 9-17).
For claim 12, Zavanelli discloses the method of claim 11, further comprising outputting if the subject is experiencing vasoconstriction in a graphical user interface or a report to be used for an evaluation of cardiovascular health in the subject (Fig 2) (Cols 9-17).
For claim 13, Zavanelli discloses the method of claim 11, wherein the soft patch further comprises an electrocardiography sensor (ECG sensor 221) (Fig 2) (Cols 9-17) and/or a seismocardiography sensor (SCG sensor 221) (Fig 2) (Cols 9-17).
For claim 14, Zavanelli discloses the method of claim 11, wherein the soft patch is placed on a sternum of the subject (Fig 2) (Cols 9-17).
For claim 15, Zavanelli discloses the method of claim 11, wherein the soft patch further comprises an elastomer (222) (Fig 2) (Cols 9-17) disposed over the vasoconstriction sensor (Fig 2) (Cols 9-17); and wherein the elastomer dampens motion artifacts in the PPG signal data caused by movement of the chest of the subject (Fig 2) (Cols 9-17).
For claim 16, Zavanelli discloses the method of claim 11, wherein the soft patch includes wireless communication circuitry (218) (Fig 2) (Cols 9-17).
For claim 17, Zavanelli discloses the method of claim 11, further comprising determining via a trained machine learning model (233) if the subject is experiencing sleep apnea (Fig 2) (Cols 9-17).
For claim 18, Zavanelli discloses the method of claim 17, further comprising outputting if the subject is experiencing sleep apnea in a graphical user interface or a report to be used for an evaluation of sleep apnea in the subject (Fig 2) (Cols 9-17).
For claim 19, Zavanelli discloses a non-transitory computer readable medium having instructions stored thereon (Fig 2) (Cols 9-17), wherein the instructions when executed by a processor causes the processor to:
receive a photoplethysmogram (PPG) signal data set acquired by a soft patch (103) comprising a vasoconstriction sensor (221) placed on a chest of a subject (Fig 2) (Cols 9-17); and
determine if the subject is experiencing vasoconstriction using the the PPG signal data set (Fig 2) (Cols 9-17);
wherein the soft patch compresses the vasoconstriction sensor into the chest of the subject (Fig 2) (Cols 9-17).
For claim 20, Zavanelli discloses the computer readable medium of claim 19, wherein the instructions, when executed by the processor, further cause the processor to output if the subject is experiencing vasoconstriction in a graphical user interface or a report to be used for an evaluation of cardiovascular health in the subject (Fig 2) (Cols 9-17).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means and methods for evaluating sleep apnea via PPG.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791