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 .
Claim Objections
Claims 1, 4, 5, 19, and 20 are objected to because of the following informalities:
The preamble of claim 1 recites “estimating values associated with a disease state, medical condition, or indication of either”; subsequent clauses in the claim recite “an estimated value for a/the metric” – if not a value of the metric, it is unclear what the value represents relative to the metric (that is, a value for the metric).
Further, the later clauses in the claim define the metric being “associated with the disease state, medical condition, or either” – that is, the metric is A, B, or A or B? It is unclear why “or either” has been retained in each of these. Still further, the preamble, though having no patentable weight, does not match the clauses of the claim by also referring to “indication of either”.
Similar issues are also found in claims 19 and 20.
Claim 1 recites “heart rate variability-associated properties”; claim 6 recites “heart-rate variability associated properties” and also “heart rate variability-associated properties”. Punctuation usage should be consistent throughout the claims.
Claim 4 recites that “the one or more biophysical signals comprise photoplethysmographic signals acquired from optical sensors”; as claim 1 already defines that “the second biophysical signals are photoplethysmographic signals”, it appears claim 4 should define “wherein the photoplethysmographic signals are acquired from optical sensors”. The same is true of claim 5.
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 3, 5-8, 15-17 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 3 defines that “the one or more first biophysical signals comprise biopotential signals acquired for three channels of measurements”; claim 1 now defines that “the first biophysical signals are cardiac signals”. It is unclear if claim 3 is further defining the cardiac signals as defined in claim 1, or if these are to be acquired in addition to cardiac signals, or if this is an attempt to redefine the cardiac signals into some other signals. Clarification is required. A similar issue is found in claim 5.
Claim 6 now calls for the heart-rate variability associated properties to be determined by generating a modulation data set from the biophysical-signal data set, and determining values of features extracted from that modulation data set; per claim 1, the determination of values that describe heart rate variability-associated properties is “based on the synthetic waveform”; it is unclear how this modulation data set relates to the synthetic waveform, if the intent is to somehow use both, or if the modulation data set is used to find some other unrelated properties. Clarification is required. A similar issue involving use of another modulation data set is also recited in claim 8.
Claim 15 recites “the disease state, medical condition or indication of either”; there is no longer antecedent basis for this limitation in the claim, as claim 1 defines a “disease state, medical condition, or either”.
Claims 16 and 17 each refer to “the obtained biophysical data set”; there is no antecedent basis for this limitation in the claim as claim 1 now defines only “receiving… a biophysical-signal data set”. Clarification is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 recites only that “the one or more biophysical signals comprise photoplethysmographic signals acquired from optical sensors”. Claim 1 already defines the second signals as being photoplethysmographic signals, and optical sensors are inherently the source as the use of optical sensing gives the photo of photoplethysmographic, where no other sensors are used for this type of sensing. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-8 and 13-18 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 1 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “receiving… a biophysical data set”, “generating… a synthetic respiration waveform”, “determining… values of respiration rate-related features”, “determining… an estimated value for a metric… based on an estimation model”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams), and also subject matter directed to a mathematical calculation, which has also been found to represent abstract ideas (a mathematical concept need not be expressed in mathematical symbols, because “[w]ords used in a claim operating on data to solve a problem can serve the same purpose as a formula.” In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989). See, e.g., SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163, 127 USPQ2d 1597, 1599 (Fed. Cir. 2018) holding that claims to a ‘‘series of mathematical calculations based on selected information’’ are directed to abstract ideas; Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) holding that claims to a ‘‘process of organizing information through mathematical correlations’’ are directed to an abstract idea).
The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. This judicial exception is not integrated into a practical application because the receipt of data, generation of a waveform, identification of features, and use of an “estimation model” to estimate a value
does not present any improvement to the functioning of a computer or to any other technology, as it is merely the manipulation of data
does not apply or use a judicial exception to effect a particular treatment or as a prophylaxis for a disease or medical condition, as the only output is some indication of “presence” which might be used to “direct treatment” in a wholly nonspecific fashion without use of any particular element for this purpose
does not apply the judicial exception with, or by use of, a particular machine, as it is merely embodied on a well-understood, routine, and conventional “processor” for its execution (see MPEP 2106.05(d), Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims."), showing that these computer functions are well-understood, routine, and conventional functions)
does not effect a transformation or reduction of a particular article to a different state or thing, as the determination of the value is merely the processing of acquired data
does not apply or use the judicial exception in some other meaningful way, as no other use beyond providing an estimation is recited
That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are one or more processors used perform the abstract idea. However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by Alice v. CLS Bank and Bilksi v. Kappos, which held that generic computer structure does not otherwise transform a patent-ineligible claim into a patent-eligible one. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 2-8, 13-18 fail to cure the deficiencies of independent claim 1 by merely reciting additional abstract ideas or further limitations on abstract ideas already recited. Claims 2 and 12 are directed to the insignificant postsolution activity of outputting a result (see MPEP 2106.05 - Presenting data, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93 - another type of activity that the courts have found to be well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity); claims 3-5 describes aspects of the data used in the determinations; claims 4 and 5 refer to the data as having been obtained from well-understood, routine, and conventional “optical sensors” but generic use of such sensors be more than the insignificant extrasolution activity of data gathering; claims 6-8, 13-15 are directed to aspects of the abstract idea itself; claims 16 and 17 are directed to the insignificant extrasolution activity of data gathering (See MPEP 2106.05(d), where determining the level of a biomarker by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968, the data gathering being performed entirely via nonspecific circuitry; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional), and claim 18 is directed to aspects of the generic computing device used to provide a technological environment for execution of the abstract idea itself.
Thus, claim(s) 1-8 and 13-18 is/are rejected under 35 U.S.C. 101.
Claim(s) 19 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 19 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 19 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “receive… a biophysical data set”, “generate… a synthetic respiration waveform”, “determine… values of respiration rate-related features”, “determine… an estimated value for a metric… based on an estimation model”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams), and also subject matter directed to a mathematical calculation, which has also been found to represent abstract ideas (a mathematical concept need not be expressed in mathematical symbols, because “[w]ords used in a claim operating on data to solve a problem can serve the same purpose as a formula.” In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989). See, e.g., SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163, 127 USPQ2d 1597, 1599 (Fed. Cir. 2018) holding that claims to a ‘‘series of mathematical calculations based on selected information’’ are directed to abstract ideas; Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) holding that claims to a ‘‘process of organizing information through mathematical correlations’’ are directed to an abstract idea).
The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. This judicial exception is not integrated into a practical application because the receipt of data, generation of a waveform, identification of features, and use of an “estimation model” to estimate a value
does not present any improvement to the functioning of a computer or to any other technology, as it is merely the manipulation of data
does not apply or use a judicial exception to effect a particular treatment or as a prophylaxis for a disease or medical condition, as the only output is some indication of “presence” which might be used to “direct treatment” in a wholly nonspecific fashion without use of any particular element for this purpose
does not apply the judicial exception with, or by use of, a particular machine, as it is merely embodied on a well-understood, routine, and conventional “processor” for its execution (see MPEP 2106.05(d), Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims."), showing that these computer functions are well-understood, routine, and conventional functions)
does not effect a transformation or reduction of a particular article to a different state or thing, as the determination of the value is merely the processing of acquired data
does not apply or use the judicial exception in some other meaningful way, as no other use beyond providing an estimation is recited
That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are a memory storing the abstract idea and a processor for its execution. However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by Alice v. CLS Bank and Bilksi v. Kappos, which held that generic computer structure does not otherwise transform a patent-ineligible claim into a patent-eligible one. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 19 fails to recite patent-eligible subject matter under 35 U.S.C. 101.
Claim(s) 20 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 20 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 20 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “receive… a biophysical data set”, “generate… a synthetic respiration waveform”, “determine… values of respiration rate-related features”, “determine… an estimated value for a metric… based on an estimation model”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams), and also subject matter directed to a mathematical calculation, which has also been found to represent abstract ideas (a mathematical concept need not be expressed in mathematical symbols, because “[w]ords used in a claim operating on data to solve a problem can serve the same purpose as a formula.” In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989). See, e.g., SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163, 127 USPQ2d 1597, 1599 (Fed. Cir. 2018) holding that claims to a ‘‘series of mathematical calculations based on selected information’’ are directed to abstract ideas; Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) holding that claims to a ‘‘process of organizing information through mathematical correlations’’ are directed to an abstract idea).
The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. This judicial exception is not integrated into a practical application because the receipt of data, generation of a waveform, identification of features, and use of an “estimation model” to estimate a value
does not present any improvement to the functioning of a computer or to any other technology, as it is merely the manipulation of data
does not apply or use a judicial exception to effect a particular treatment or as a prophylaxis for a disease or medical condition, as the only output is some indication of “presence” which might be used to “direct treatment” in a wholly nonspecific fashion without use of any particular element for this purpose
does not apply the judicial exception with, or by use of, a particular machine, as it is merely embodied on a well-understood, routine, and conventional “processor” for its execution (see MPEP 2106.05(d), Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims."), showing that these computer functions are well-understood, routine, and conventional functions)
does not effect a transformation or reduction of a particular article to a different state or thing, as the determination of the value is merely the processing of acquired data
does not apply or use the judicial exception in some other meaningful way, as no other use beyond providing an estimation is recited
That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are a computer-readable medium storing the abstract idea. However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by Alice v. CLS Bank and Bilksi v. Kappos, which held that generic computer structure does not otherwise transform a patent-ineligible claim into a patent-eligible one. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 20 fails to recite patent-eligible subject matter under 35 U.S.C. 101.
Response to Arguments
Applicant's arguments filed 2 January 2026 have been fully considered but they are not persuasive.
Regarding the rejections under 112, Applicant’s remarks merely assert that the amendments to the claims have resolved all issues; this is not the case, as set forth above.
Regarding the rejections under 101, Applicant’s remarks merely assert that the claims have been amended to overcome the rejections and “clearly integrate the alleged abstract idea into a practical application” without identifying what this application might be or what aspect of the claimed invention provides this integration; this is not the case, as set forth above.
Regarding the art rejections, the Examiner notes that no art has been applied against the claims at this time such that these remarks will not be further addressed here but will be revisited if still applicable in the future.
Conclusion
No art has been applied against the claims at this time; however, as all the pending claims have been rejected under 101 and/or 112, they are not presently allowable and the question of prior art will be revisited if applicable in the future.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KAREN E TOTH whose telephone number is (571)272-6824. The examiner can normally be reached Mon - Fri 9a-6p.
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, Jennifer Robertson can be reached at 571-272-5001. 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.
/KAREN E TOTH/ Examiner, Art Unit 3791