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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Objections
Claim 4 is objected to because of the following informalities: “is a not candidate” (line 22) appears that it should be “is not a candidate.”
Claim 16 is objected to because of the following informalities: “is a not candidate” (line 10) appears that it should be “is not a candidate.”
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.
Claim(s) 1-20 is/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.
For claim 1, the claim terms “a candidate” (line 11), “a candidate” (line 13), and “a candidate” (line 14) are ambiguous. It is unclear whether the same candidate is being referred to or whether these are different candidates. The claim is examined under the former interpretation.
For claim 2, the claim language “the first blood pressure values” lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 2, the claim language “the second blood pressure values” lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 3, the claim terms “a candidate” (line 7) and “a candidate” (line 10) are ambiguous. Claim 1, from which claim 3 depends, already recites “a candidate.” It is unclear whether the same candidate is being referred to or whether these are different candidates. The claim is examined under the former interpretation.
For claim 4, the claim term “the circadian pattern difference threshold” (line 4) lacks antecedent basis. The claim is examined as depending from claim 3.
For claim 4, the claim terms “a candidate” (line 17) and “a candidate” (line 22) are ambiguous. Claim 1, from which claim 3 depends, already recites “a candidate.” It is unclear whether the same candidate is being referred to or whether these are different candidates. The claim is examined under the former interpretation.
For claim 9, the claim language “the first blood pressure values” lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 9, the claim language “the second blood pressure values” lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 11, the claim terms “a candidate” (lines 16-17), “a candidate” (line 18), and “a candidate” (line 19) are ambiguous. It is unclear whether the same candidate is being referred to or whether these are different candidates. The claim is examined under the former interpretation.
For claim 12, the claim terms “a candidate” (line 9), “a candidate” (line 11), and “a candidate” (line 12) are ambiguous. It is unclear whether the same candidate is being referred to or whether these are different candidates. The claim is examined under the former interpretation.
For claim 13, the claim language “the first blood pressure values” lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 13, the claim language “the second blood pressure values” lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 14, the claim terms “a candidate” (line 7) and “a candidate” (line 10) are ambiguous. Claim 12, from which claim 14 depends, already recites “a candidate.” It is unclear whether the same candidate is being referred to or whether these are different candidates. The claim is examined under the former interpretation.
For claim 15, the claim term “the circadian pattern difference threshold” (line 4) lacks antecedent basis. The claim is examined as depending from claim 14.
For claim 16, the claim terms “a candidate” (line 5) and “a candidate” (line 10) are ambiguous. Claim 12, from which claim 16 depends, already recites “a candidate.” It is unclear whether the same candidate is being referred to or whether these are different candidates. The claim is examined under the former interpretation.
Dependent claim(s) 2-10 and 13-20 fail to cure the ambiguity of independent claim(s) 1 and 11-12, thus claim(s) 1-20 is/are rejected under 35 U.S.C. 112(b).
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) 1-20 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 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 “determine a baseline circadian pattern of blood pressure for a patient over a first period of time,” “determine a subsequent circadian pattern of blood pressure for the patient over a second period of time, the second period of time being after the first period of time,” “determine one or more differences between the subsequent circadian pattern and the baseline circadian pattern,” “determine, based on the one or more differences between the subsequent circadian pattern and the baseline circadian pattern, whether the patient is a candidate for denervation therapy,” and “output, responsive to determining whether the patient is a candidate for the denervation therapy, an indication of whether the patient is or is not a candidate for the denervation therapy.” 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). 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. 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,” and “one or more processors coupled to the memory.” However, these elements are not “significantly more” because it has been held in Bilski and Alice that generic computer structures (such as memories and processors) do not other transform a patent-ineligible claim into an 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. Independent claim(s) 11 and 12 fail to recite patent-eligible subject matter for similar, if not the exact same, reasoning as that of independent claim 1. Claim 11 differs in that is recites “a wearable device configured to sense and collect data indicative of blood pressure of a patient,” and “wherein the computing device is communicatively coupled to the wearable device.” However, this additional element is not significantly more because it is well-known, routine, and/or conventional as evidenced by para [0041] of U.S. Patent Application Publication No. 2022/0201080 to Exner. Dependent claim(s) 2-9 and 13-20 fail to cure the deficiencies of independent claim(s) 1 and 12 by merely reciting additional abstract ideas and/or further limitation(s) on abstract idea(s) already recited. Thus, claim(s) 1-20 is/are rejected under 35 U.S.C. 101.
Allowable Subject Matter
Claim(s) 1-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) and 35 U.S.C. 101, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
“Predictors of blood pressure response to ultrasound renal denervation in the RADIANCE-HTN SOLO Study,” by Saxena et al. (hereinafter “Saxena”) discloses a method (Abstract) comprising: determining a baseline circadian pattern of blood pressure for a patient over a first period of time (page 630, section entitled “Ambulatory BP measurements”); determining a subsequent circadian pattern of blood pressure for the patient over a second period of time, the second period of time being after the first period of time (page 630, section entitled “Ambulatory BP measurements”); and determining whether the patient is a candidate for denervation therapy (page 631, section entitled “Univariate analysis).
U.S. Patent Application Publication No. 2021/0383908 to Foin et al. (hereinafter “Foin”) discloses a method (Abstract) comprising: determining a baseline (i.e., “V1,” para [0012]) blood pressure (“blood pressure,” para [0018]) for a patient over a first period of time (“time scales,” para [0140]); determining a subsequent (“V2,” para [0012]) blood pressure (“blood pressure,” para [0018]) for the patient over a second period of time (“time scales,” para [0140]), the second period of time being after the first period of time (para [0074]); determining one or more differences between the subsequent blood pressure and the baseline blood pressure (“difference,” para [0013]); determining, based on the one or more differences between the subsequent blood pressure and the baseline blood pressure, whether the patient is a candidate for denervation therapy (para [0005]); and outputting, responsive to determining whether the patient is a candidate for the denervation therapy, an indication of whether the patient is or is not a candidate for the denervation therapy (para [0005]).
However, the prior art of record does not disclose and would not have rendered obvious the ordered combination of elements recited in the claim(s).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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.
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
Prosecution Insights