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 information disclosure statement (IDS) submitted on 02/27/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase “a load-dependent stiffness” in lines 11-12 should be amended to read –the load-dependent stiffness--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “an elasticity” in line 13 should be amended to read –the elasticity. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: the phrase “a total stiffness in line 2 should be amended to read –the total stiffness--. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the phrase “an arterial blood pressure” in line 1 should be amended to read –the arterial blood pressure--. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: the phrase “a load-dependent stiffness” in line 11 should be amended to read –the load-dependent stiffness--. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: the phrase “a structural stiffness” in line 12 should be amended to read –the structural stiffness--. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: the phrase “a total stiffness in line 2 should be amended to read –the total stiffness--. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: the phrase “an arterial blood pressure” in line 1 should be amended to read –the arterial blood pressure--. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: the phrase “a structural stiffness” in line 1 should be amended to read –the structural stiffness--. Appropriate correction is required.
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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
STEP 1: claim 1 recite an apparatus to determine arterial stiffness, and claim 10 recites a series of steps or acts to determine arterial stiffness. Thus, the claims are directed to a process and a product. which are ones of the statutory categories of invention.
STEP 2A PRONG ONE: The claim(s) recite(s) specific limitations/method steps of: an arterial pulse wave velocity monitor adapted to provide a measure of total arterial stiffness; and an electronic processor communicating with the pressure monitor and arterial pulse wave velocity monitor and executing a stored program to: collect total arterial stiffness values and arterial blood pressures; and provide outputs, based on the fit nonlinear model, indicating a load-dependent stiffness representing a change in elasticity with arterial distention and a structural stiffness representing an elasticity at a predetermined arterial blood pressure. This limitation recites a mental process, because the claimed limitation describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A PRONG TWO: This judicial exception is not integrated into a practical application because the claim(s) recite the combination of additional elements/method steps of: the processor configured to fit the collected arterial stiffness values and arterial blood pressures to a nonlinear model of arterial elasticity. Accordingly, this additional element/step does not integrate the abstract idea into a practical application because the claim limitations fail to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception.
STEP 2B: The claim(s) does/do not include additional structural elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements, such as, the processor configured to fit the collected arterial stiffness values and arterial blood pressures to a nonlinear model of arterial elasticity, but do(es) not include additional elements that are sufficient to amount to significantly more than the judicial exception because these structural elements are generically claimed to enable the collection of data by performing the basic functions of: (i) receiving, processing, and providing/displaying data, and (ii) automating mental tasks. The courts have recognized these functions to be well‐understood, routine, and conventional functions when claimed in a merely generic manner. Merely adding hardware that performs “‘well understood, routine, conventional activities’ previously known to the industry” will not make claims patent-eligible (In re TLI Communications LLC). As such, the recitation of these additional limitations in claims 2-9 and 11-19 does not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment and represent insignificant extra-solution activity. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as a sensor and use of a processor does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)). Thus, the claimed invention does not amount to significantly more than the Abstract Idea.
When viewed alone or in combination, the limitations of claims 1-19 merely instruct the practitioner to implement the concept of collecting data with routine, conventional activity specified at a high level of generality in a particular technological environment. The inventive concept cannot be furnished by the abstract idea; instead, the application must provide something inventive, beyond mere “well-understood, routine, conventional activity” (Genetic Technologies Limited v. Merial L.L.C.). The additional elements of independent claims when viewed alone or as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea and does not amount to significantly more than the abstract idea itself. In other words, this claim merely applies an abstract idea to a computer and does not (i) improve the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
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 18 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 18 recite the limitation “the load-dependent stiffness is the difference of” this limitation is not defined by the claims, which renders the claims indefinite. One with ordinary skill in the art would not be able to know the load-dependent stiffness is the difference of which parameters. The scope of the claim is indetermined because of the claimed limitation “difference of”.
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.
Claim(s) 1-3, 10-12, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pewowaruk et al (Carotid Artery Stiffness Mechanisms Associated with Cardiovascular Disease Events and Incident Hypertension: NPL# 1 in IDS mailed on 02/27/2024).
As to claims 1 and 10, Pewowaruk teaches an apparatus and method for determination of load-dependent arterial stiffening (abstract) comprising:
a pressure monitor adapted to provide a measure of arterial blood pressure in a human patient (inherently the pressure monitor that measures subjects blood pressure to make sure the blood pressure is at the standard value 120/80 mmHg, method, page 2 and first par. In fig.3, fig.1);
an arterial pulse wave velocity monitor adapted to provide a measure of total arterial stiffness (arterial pulse monitor that measures/calculates PWV, equation 2 in page 3, wherein arterial stiffness is calculated from PWV, last par. In page 3; and
an electronic processor (inherently the processor that receives measured data and process and analyzes the data to determine arterial stiffness, pages 2-3) communicating with the pressure monitor and arterial pulse wave velocity monitor and executing a stored program to:
(a) collect total arterial stiffness values and arterial blood pressures (collecting determined stiffness and blood pressure as best seen in fig.1-3, and pages 3-4);
(b) fit the collected arterial stiffness values and arterial blood pressures to a nonlinear model of arterial elasticity (fitting determined stiffness and blood pressure in equation 3, page 3, and on the non-linear stiffness parameter in last par. In page 3); and
(c) provide outputs, based on the fit nonlinear model, indicating a load-dependent stiffness representing a change in elasticity with arterial distention and a structural stiffness representing an elasticity at a predetermined arterial blood pressure (outputting load-dependent arterial stiffness, last par. In page 3, and determining structural arterial stiffness, 1st par. In page 4).
As to claims 2 and 11, Pewowaruk teaches the apparatus and method, wherein the load-dependent stiffness is determined from a difference between a total stiffness and the structural stiffness (end of page 3-1st par. In page 4).
As to claims 3 and 12, Pewowaruk teaches the apparatus and method, wherein the total stiffness is a function of arterial wave velocity at a patient's current blood pressure (equation 2 is used when blood pressure is at a standard/reference level 120/80 mmHg, page 2-3).
As to claim 17, Pewowaruk teaches the method, herein structural stiffness is an elasticity at a predetermined standard pressure determined from the nonlinear model (equation 3, pages 3-4)
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.
Claim(s) 4, 5, 13 and 14 is/are rejected under 35 U.S.C. 103 as being obvious over Pewowaruk et al (Carotid Artery Stiffness Mechanisms Associated with Cardiovascular Disease Events and Incident Hypertension: NPL# 1 in IDS mailed on 02/27/2024) in view of Bikia et al (US 2022/0287640).
As to claims 4, 5, 13 and 14, Pewowaruk teaches the invention substantially above, but failed to explicitly teach the arterial pulse wave velocity monitor is an arterial tonometer measuring an acoustic signal at least one arterial position to determine a velocity of a pressure wave through an artery, wherein the arterial tonometer provides measurement of pulse wave velocity at two positions of a carotid artery to a femoral artery.
However, Bikia teaches an analogous system and method to determine arterial stiffness that leads to CAD (abstract and par.18, fig.1), wherein the arterial pulse wave velocity monitor is an arterial tonometer measuring an acoustic signal at least one arterial position to determine a velocity of a pressure wave through an artery (a measured pulse wave velocity value, obtained using one or more accelerometers, pressure tonometers, par.18, fig.1), wherein the arterial tonometer provides measurement of pulse wave velocity at two positions of a carotid artery to a femoral artery (PWV measuring means are placed adjacent the femoral and carotid arteries of the patient, such that the measured pulse velocity value is obtained by measuring propagation time of an arterial pulse from the proximal site, e.g., in the vicinity of the carotid artery or near the heart, to the distal site, e.g., near the femoral artery or away from the heart, par.18, fig.1).
Since tonometers are well-known in the art to measure PWV, so it would have been obvious to one with ordinary skill in the art before the effective filing fate of the invention to include a tonometer to measure PWV in Pewowaruk’s invention insead of calculating PWV value from an equation, as taught by Bikia’s invention, to provide more accurate and reliable PWV measuerement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791