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 .
Response to Arguments
Applicant’s arguments filed 9/23/2025 with respect to the rejections of claims 2-4 under 35 USC 112(b) have been fully considered and are persuasive. Applicant’s amendments have overcome the previously cited indefiniteness issues. Therefore, the rejection has been withdrawn.
Applicant’s arguments regarding the rejection of Claims 1-7 under 35 USC 101 have been fully considered but are not persuasive. Applicant argues that the Claim 1 limitation “perform biological information acquisition processing that acquires biological information of the user from a blood pressure monitor that is communicably linked via a blood pressure monitor wireless communication unit configured to wirelessly communicate with a user device wireless communication unit of a user device, the user device configured to transmit the biological information to the biological information acquisition device” is sufficient to integrate the recited judicial exception into a practical application. The Examiner respectfully disagrees. Such a blood pressure monitor amounts to mere data gathering, and is well understood, routine and conventional. Applicant’s arguments are therefore not persuasive.
Applicant’s arguments with respect to independent Claim 7 and dependent Claims 2-6 are similar to Applicant’s arguments with respect to Claim 1, and are not persuasive for the same reasons.
Applicant’s arguments with respect to the rejection of Claims 1-7 under 35 USC 102 as being anticipated by U.S. Patent No. 9,883,831 (“Stewart”) have been fully considered and are persuasive. The Examiner agrees that Stewart does not disclose such biological information acquisition from “…a blood pressure monitor that is communicably linked via a blood pressure monitor wireless communication…” in the manner recited by amended Claims 1 and 7. Therefore, the rejection is withdrawn. However, upon further search and consideration, new grounds of rejection is made in view of US 20150359477 A1, S. Waldstein et al., "Stress-induced blood pressure reactivity and cognitive function," Neurology, Volume 64, Number 10, May 24, 2005, Pages: 1746-1749, Q. Zhao et al., "Short-Term Delayed Recall of Auditory Verbal Learning Test Is Equivalent to Long-Term Delayed Recall for Identifying Amnestic Mild Cognitive Impairment," PLOS ONE, Volume 7, Issue 12, e51157, December 2012, and US 2015/0359489 A1.
Applicant’s arguments regarding the rejection of Claims 1-7 under 35 USC 103 as being unpatentable over U.S. Patent No. 9,883,831 (“Stewart”) have been fully considered and are persuasive. The Examiner agrees that Stewart does not disclose such biological information acquisition from “…a blood pressure monitor that is communicably linked via a blood pressure monitor wireless communication…” in the manner recited by amended Claims 1 and 7. Therefore, the rejection is withdrawn. However, upon further search and consideration, new grounds of rejection is made in view of US 20150359477 A1, S. Waldstein et al., "Stress-induced blood pressure reactivity and cognitive function," Neurology, Volume 64, Number 10, May 24, 2005, Pages: 1746-1749, Q. Zhao et al., "Short-Term Delayed Recall of Auditory Verbal Learning Test Is Equivalent to Long-Term Delayed Recall for Identifying Amnestic Mild Cognitive Impairment," PLOS ONE, Volume 7, Issue 12, e51157, December 2012, and US 2015/0359489 A1.
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 1-7 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Subject matter eligibility pursuant to 35 U.S.C. § 101 requires first (“Eligibility Step 1”) that the claimed invention fall within one of the four statutorily authorized categories, and second (“Eligibility Step 2”) that the claim not be improperly directed to a judicial exception. MPEP 2106(III).
Determination as to whether a claim is improperly directed to a judicial exception is a two-part inquiry. Part one (“Eligibility Step 2A”) depends first (“Eligibility Step 2A, Prong One”) on whether the claim recites a judicial exception, and second (“Eligibility Step 2A, Prong Two”) whether the claim contains additional elements sufficient to integrate the judicial exception into a practical application. MPEP 2106(III). If the claim at issue does recite a judicial exception but does contain said such sufficient additional elements, then the claim is not improperly directed to a judicial exception and is not directed to patent ineligible subject matter. See MPEP 2106.04(d).
If the claim at issue does recite a judicial exception and does not contain sufficient additional elements to integrate the judicial exception into a practical application, then assessment must be made as to whether the claim sufficiently furnishes an inventive concept. MPEP 2106.04(d). Part two of the two-part inquiry (“Eligibility Step 2B”) thus looks at any additional claim elements to determine whether “the claim as a whole amounts to significantly more than the judicial exception itself.” MPEP 2106.05(d), (citing Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 227-218 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, at 71-72 (1966))). Claims that do amount to “significantly more” are not directed to patent ineligible subject matter under 35 U.S.C. 101; claims that do not amount to “significantly more” are directed to patent ineligible subject matter. MPEP 2106(III).
Eligibility Step 1 – The Four Categories of Statutory Subject Matter
“35 U.S.C. 101 enumerates four categories of subject matter that Congress deemed to be appropriate subject matter for a patent: processes, machines, manufactures and compositions of matter.” MPEP 2106.03. “If a claim covers material not found in any of the four statutory categories, that claim falls outside the plainly expressed scope of § 101 even if the subject matter is otherwise new and useful.” In re Nuijten, 500 F.3d 1346, 1354 (Fed. Cir. 2007).
Claims 1-7 each fall within one of the four categories of statutory subject matter. Claims 1-6 are drawn to a “biological information acquisition device” (i.e., a machine) and thus fall within one of the four statutory categories. Claim 7 is drawn to a “biological information acquisition method” (i.e., a process), and thus falls within one of the four statutory categories.
Eligibility Step 2A, Prong One
“The mere inclusion of a judicial exception … in a claim means that the claim ‘recites’ a judicial exception under Step 2A Prong One.” MPEP 2106.04(II)(A)(2). “[J]udicial exceptions … are subject matter that the courts have found to be outside of … the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena….” MPEP 2106(I). Though the courts have declined to define abstract ideas, the MPEP enumerates several groupings distilled from relevant case law. See MPEP 2106.04(a). “If the identified limitation(s) falls within at least one of the[se] groupings…, it is reasonable to conclude that the claim recites an abstract idea in Step 2A Prong One.” MPEP 2106.04(a). Mental processes are one such enumerated category, and are defined as concepts that “can be performed in the human mind, or by a human using a pen and paper.” MPEP 2106.04(a)(2)(III) (quoting CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372 (Fed. Cir. 2011)).
Claims 1-7 recite abstract ideas:
Regarding Independent Claim 1:
The limitation “perform test information provision processing that provides a user with test information for testing cognitive function” recites a mental process when the term is afforded its broadest reasonable interpretation. The claimed test information provision processing is broadly recited, and the human mind is capable of practically performing such test information provision processing as claimed. For example, a human could present a series of questions relevant to cognitive function.
The limitation “and after the biological information acquisition processing is ended, perform answer check processing in which the biological information acquisition device prompts the user to answer to the test information, acquires answers from the user to the test information and checks the answers” recites a mental process when the term is afforded its broadest reasonable interpretation. The claimed answer check processing is broadly recited, and the human mind is capable of practically performing such answer check processing as claimed. For example, a human could solicit and subsequently compare answers to verbally presented questions to an answer key indicating correct responses to those questions and exercise judgement regarding the results.
Regarding Claims 2-6, Claims 2-6 depend from and further limit the mental processes recited in Independent Claim 1, and therefore recite mental processes for the same reasons as explained above with respect to Claim 1.
Regarding Independent Claim 7:
The limitation “(a) providing a user with test information for testing cognitive function;” recites a mental process for the same reasons as explained above with respect to the similar limitation of Claim 1.
The limitation “and (c) the biological information acquisition device prompting the user to answer to the test information, acquiring answers from the user to the test information and checking the answers” recites a mental process for the same reasons as explained above with respect to the similar limitation of Claim 1.
Eligibility Step 2A, Prong Two
“[A] claim that recites a judicial exception is not directed to that judicial exception, if the claim as a whole integrates the recited judicial exception into a practical application of that exception.” MPEP 2106.04(II)(A)(2). Thus, “Prong Two asks[:] does the claim recite additional elements that integrate the judicial exception into a practical application?” Id. “If there are no additional elements in the claim, then it cannot be eligible.” Id. Additional elements amounting to “insignificant extra-solution activity” that is “incidental to the primary process or product” are insufficient to integrate a judicial exception into a practical application. MPEP 2106.05(g). Limitations “amount[ing] to necessary data gathering and outputting” have been held to constitute “insignificant extra-solution activity.” Id. “[M]ere physical or tangible implementation of an exception does not guarantee eligibility.” MPEP 2106.04(d) (citing Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 224 (2014)).
Claims 1-7 do not recite additional elements that integrate the judicial exception into a practical application:
Regarding Independent Claim 1:
The additional element “a processor configured to…” amounts to merely reciting the words “apply it.” The recited processor is what allows the recited judicial exceptions to be performed by the system. Accordingly, the recited judicial exceptions are applied by processor. “As the Supreme Court explained in Alice Corp., mere physical or tangible implementation of an exception does not guarantee eligibility. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 224, 110 USPQ2d 1976, 1983-84 (2014) (‘The fact that a computer “necessarily exist[s] in the physical, rather than purely conceptual, realm,” is beside the point’).” MPEP 2106.04(d)(I). Thus, the fact that the physical component “a processor” is used to carry out the recited judicial exception is not sufficient to integrate the judicial exception into a practical application.
The additional element “perform biological information acquisition processing that acquires biological information of the user…” amounts to necessary data gathering in conjunction with implementing the abstract idea, and as such is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
That the “acquiring biological information of the user” is done “from a blood pressure monitor that is communicably linked via a blood pressure monitor wireless communication unit…” does not change the nature of the “acquiring,” and confirms that it is such data gathering as explained above.
Regarding Claims 2-6, Claims 2-6 do not recite an additional elements.
Regarding Independent Claim 7:
The limitation “acquiring biological information of the user” amounts to necessary data gathering in conjunction with implementing the abstract idea, and as such is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
That the “acquiring biological information of the user” is done “from a blood pressure monitor that is communicably linked via a blood pressure monitor wireless communication unit…” does not change the nature of the “acquiring,” and confirms that it is such data gathering as explained above.
Eligibility Step 2B
Often referred to as “a search for an inventive concept,” Step 2B looks at whether a claim amounts to “significantly more” than the judicial exception it recites. MPEP 2106.05(I). This determination should be made “by first identifying whether there are any additional elements … recited in the claim…, and then evaluating those additional elements individually and in combination to determine whether they contribute an inventive concept.” MPEP 2106.05(II). Additional elements which “simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception…” do not amount to significantly more than the exception itself. Id.
Claims 1-7 do not amount to significantly more than the abstract ideas recited therein:
Regarding Independent Claim 1:
The additional element “a processor configured to…” amounts to adding the words “apply it” as explained above, and thus does not contribute an inventive concept. See MPEP 2106.05(I)(A).
The additional element “perform biological information acquisition processing that acquires biological information of the user” does not contribute an inventive concept. The claimed acquiring is recited at a high level of generality, and such acquiring of biological information is well-understood, routine and conventional. For example, previously cited Adelman AM, Daly MP. Initial evaluation of the patient with suspected dementia. Am Fam Physician. 2005 May 1;71(9):1745-50 describes at Pg. 1748, Left Column, Second Paragraph through Pg. 1749, Left Column, First Paragraph a variety of such “acquiring biological information” that the American Academy of Neurology, The Second Canadian Consensus Conference on Dementia (CCCD) and other prominent medical authorities recommend as part of routine testing for such conditions as those to which the present invention is directed.
That the “acquiring biological information of the user” is done “from a blood pressure monitor that is communicably linked via a blood pressure monitor wireless communication unit…” does not contribute an inventive concept. Such a blood pressure monitor is well understood, routine and conventional in the art. For example, Yoo S, Baek H, Doh K, Jeong J, Ahn S, Oh IY, Kim K. Validation of the mobile wireless digital automatic blood pressure monitor using the cuff pressure oscillometric method, for clinical use and self-management, according to international protocols. Biomed Eng Lett. 2018 Sep 21;8(4):399-404 describes such a device as “general and conventional,” and among “the most fundamental clinical measurement[s]” at Pg. 399, Right Column, First and Second Paragraphs.
Regarding Claims 2-6, Claims 2-6 do not recite any additional elements.
Regarding Independent Claim 7:
The limitation “acquiring biological information of the user” does not contribute an inventive concept. The claimed acquiring is recited at a high level of generality, and such acquiring of biological information is well-understood, routine and conventional. For example, previously cited Adelman AM, Daly MP. Initial evaluation of the patient with suspected dementia. Am Fam Physician. 2005 May 1;71(9):1745-50 describes at Pg. 1748, Left Column, Second Paragraph through Pg. 1749, Left Column, First Paragraph a variety of such “acquiring biological information” that the American Academy of Neurology, The Second Canadian Consensus Conference on Dementia (CCCD) and other prominent medical authorities recommend as part of routine testing for such conditions as those to which the present invention is directed.
That the “acquiring biological information of the user” is done “from a blood pressure monitor that is communicably linked via a blood pressure monitor wireless communication unit…” does not contribute an inventive concept. Such a blood pressure monitor is well understood, routine and conventional in the art. For example, Yoo S, Baek H, Doh K, Jeong J, Ahn S, Oh IY, Kim K. Validation of the mobile wireless digital automatic blood pressure monitor using the cuff pressure oscillometric method, for clinical use and self-management, according to international protocols. Biomed Eng Lett. 2018 Sep 21;8(4):399-404 describes such a device as “general and conventional,” and among “the most fundamental clinical measurement[s]” at Pg. 399, Right Column, First and Second Paragraphs.
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150359477 A1 to Ramachandran et al. (“Ramachandran”) in view of S. Waldstein et al., "Stress-induced blood pressure reactivity and cognitive function," Neurology, Volume 64, Number 10, May 24, 2005, Pages: 1746-1749 (“Waldstein”), and Q. Zhao et al., "Short-Term Delayed Recall of Auditory Verbal Learning Test Is Equivalent to Long-Term Delayed Recall for Identifying Amnestic Mild Cognitive Impairment," PLOS ONE, Volume 7, Issue 12, e51157, December 2012 (“Zhao”), and US 2015/0359489 A1 to Baudenbacher et al. (“Baudenbacher”) as evidenced by Medaval, Product Description for "Dinamap 1846-SX," Manufactured by GE Medical Systems Ltd. (Dinamap), Accessed via the Internet on 10/9/2025 at URL https://www.medaval.ie/resources/EN/devices/Dinamap-1846-SX.html.
Regarding Independent Claim 1, Ramachandran teaches:
A biological information acquisition device including a cognitive function test function, the biological information acquisition device comprising: (Title, “SYSTEMS AND METHODS FOR ASSESSING POSSIBLE COGNITIVE IMPAIRMENT”);
a processor configured to: (Para. [0005], “The processor is configured to present one or more assessment tasks to the first user, receive input from the first user in response to the one or more assessment tasks, and score the input received in response to the one or more assessment tasks.”);
perform test information provision processing that provides a user with test information for testing cognitive function; (Fig. 16, “Word Recall Test Screen 1600;” Paras. [0092], [0093], [0096], and [0097]);
perform answer check processing in which the biological information acquisition device prompts the user to answer to the test information, (Fig. 19, “Word Recall Test Instruction Screen 1900;” Paras. [0092], [0093], [0096], and [0097]);
acquires answers from the user to the test information, (Fig. 20, “Word Recall Test Instruction Screen 2000;” Paras. [0092], [0093], [0096], and [0097]);
and checks the answers. (Fig. 23, “Assessment Test Screen 2300;” Paras. [0100] through [0102]).
Ramachandran does not disclose:
performing biological information acquisition processing “after the test information provision processing is ended,”
perform biological information acquisition processing that acquires biological information of the user from a blood pressure monitor that is communicably linked via a blood pressure monitor wireless communication unit configured to wirelessly communicate with a user device wireless communication unit of a user device, the user device configured to transmit the biological information to the biological information acquisition device;
performing answer check processing “after the biological information acquisition processing is ended,”
Waldstein describes “the relation of stress-induced blood pressure (BP) reactivity to cognitive function” (Abstract). Waldstein is analogous art.
Waldstein teaches:
performing biological information acquisition processing “after the test information provision processing is ended,” (Pg. 1747, Left Column, Fourth Paragraph, “BP was measured oscillometrically at 90-second intervals during baseline (rest) periods and at 60-second intervals during task periods with an automated vital signs monitor (Dinamap Model #1846SX, Critikon)”);
perform biological information acquisition processing that acquires biological information of the user from a blood pressure monitor (Pg. 1747, Left Column, Fourth Paragraph, “BP was measured oscillometrically at 90-second intervals during baseline (rest) periods and at 60-second intervals during task periods with an automated vital signs monitor (Dinamap Model #1846SX, Critikon)”);
performing answer check processing “after the biological information acquisition processing is ended,” (Pg. 1747, Right Column, Second Paragraph, “Verbal memory (immediate and 30 minutes delayed recall) was examined by the Logical Memory subtest of the Wechsler Memory Scale–Revised (WMS-R). Nonverbal memory (immediate and 30 minutes delayed recall) was evaluated by the Visual Reproductions subtest of the WMS-R.”).
Waldstein assesses blood pressure in 90 second intervals throughout Waldstein’s “Verbal memory (immediate and 30 minutes delayed recall)” and “Nonverbal memory (immediate and 30 minutes delayed recall)” tests. At least in Waldstein’s “30 minutes delayed recall” variation of both tests, Waldstein measures blood pressure between presentation of Waldstein’s information for recall and Waldstein’s “answer checking,” wherein the information is to be recalled. As the delay is “30 minutes,” blood pressure measured within the noted period is has ended before information is to be recalled. Any single instance of measuring blood pressure during this period is consistent with the timing criteria of Claim 1.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ramachandran with the teachings of Waldstein (i.e., to perform blood pressure testing in 90 second intervals throughout the duration of Ramachandran’s “word recall” testing) in order to assess stress reactivity, which is relevant to the assessment of cognitive function (Waldstein at Pg. 1749, Left Column, First Paragraph).
Ramachandran is silent regarding the time between presentation of Waldstein’s information and solicitation of user response. Accordingly, Ramachandran as modified by Waldstein does not expressly disclose such a timing as Waldstein’s “30 minutes delayed recall.”
Zhao describes “The relative validity of different retention intervals of delayed recall” in the context of cognitive function assessment (Zhao at Abstract). Zhao is analogous art.
Zhao teaches such an interval as Ramachandran as modified by Waldstein is explained above to lack. (Zhao at Abstract, “…we compared the differentiating value of short-term delayed recall (AVL-SR, that is, a 3- to 5-minute delay time) and long-term delayed recall (AVL-LR, that is, a 20-minute delay time) in distinguishing patients with aMCI (n = 897) and mild AD (n = 530) from the healthy elderly (n = 1215). In patients with aMCI, the correlation between AVL-SR and AVL-LR was very high (r = 0.94), and the difference between the two indicators was less than 0.5 points. There was no difference between AVL-SR and AVL-LR in the frequency of zero scores. In the receiver operating characteristic curves analysis, although the area under the curve (AUC) of AVL-SR and AVL-LR for diagnosing aMCI was significantly different, the cut-off scores of the two indicators were identical.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Ramachandran and Waldstein with the teachings of Zhao (i.e., to employ such a 3 to 5 minutes delay as taught by Zhao between Ramachandran’s presentation of information and solicitation of response) because such an interval is useful in differentiating cognitively normal subjects from those suffering cognitive decline (Zhao at Pg. 6, Right Column, First Paragraph).
The combination of Ramachandran, Waldstein and Zhao does not disclose:
a blood pressure monitor “that is communicably linked via a blood pressure monitor wireless communication unit configured to wirelessly communicate with a user device wireless communication unit of a user device, the user device configured to transmit the biological information to the biological information acquisition device;”
Baudenbacher describes “Smart mobile health monitoring system and related methods” (Title). Baudenbacher is analogous art.
Baudenbacher teaches:
a blood pressure monitor that is communicably linked via a blood pressure monitor wireless communication unit configured to wirelessly communicate with a user device wireless communication unit of a user device, the user device configured to transmit the biological information to the biological information acquisition device; (Para. [0048], “At 52, biometric data (e.g., related to an ECG, a heart rate, a hydration status, fluid shift, a respiration, a cardiac output, a fall, an activity, a body position, a diastolic blood pressure, mean blood pressure, a systolic blood pressure, etc.) can be received (e.g., at mobile computing device 14 across a wired or a wireless connection employing a wireless protocol, such as: a Bluetooth protocol, a Bluetooth low energy protocol, a ZigBee protocol, an ANT+ protocol, a WiFi protocol, etc.) from a sensor (e.g., sensor 12) coupled to a patient's body. At 54, the biometric data is processed (e.g., by the mobile computing device 14) to determine a health status of the patient. At 56, therapeutic feedback (e.g., to the patient and/or to an external device) related to the health status can be provided (e.g., by the mobile computing device 14).”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Ramachandran, Waldstein and Zhao with the teachings of Baudenbacher (i.e., to further modify the device of Ramachandran as modified in accordance with Waldstein to measure blood pressure such that it includes a blood pressure monitor configured in the manner of Baudenbacher) in order to facilitate patient monitoring in an at-home setting (Baudenbacher at Paras. [0048], [0003]), particularly because Waldstein’s described blood pressure monitor is now obsolete.1
Regarding Claim 2, the combination of Ramachandran, Waldstein and Zhao with the teachings of Baudenbacher, Waldstein, Zhao and Baudenbacher renders obvious the entirety of Claim 1 as explained above.
Ramachandran additionally teaches:
wherein the processor is further configured to match an amount of time for the biological information acquisition processing is matched with an amount of time that needs to elapse after end of the test information provision processing until initiation of the answer check processing (Para. [0096], “ As explained in screen 1500, screen 1900 appears after screen 1600, and may appear after one or more other questions have been administered to the user. Screen 1900 explains that a user is to answer whether a displayed word was included in an earlier list of words.”).
Ramachandran’s processor is configured to change an amount of time between presenting information for recall and soliciting user response. Ramachandran’s processor is capable of changing this amount of time to any time. Such a change in time to one that in particular matches an amount of time for the biological information acquisition processing is a mere change in proportion, which is a common practice that the court has held normally require only ordinary skill in the art and hence is considered a routine expedient. MPEP 2144.04(IV). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to select from Ramachandran’s unlimited range of times a time that in particular matches an amount of time for the biological information acquisition processing because such a selection is routine optimization within prior art conditions. MPEP 2144.04(II).
Regarding Claim 3, the combination of Ramachandran, Waldstein and Zhao with the teachings of Baudenbacher, Waldstein, Zhao and Baudenbacher renders obvious the entirety of Claim 2 as explained above.
Ramachandran additionally teaches:
wherein the processor is further configured to change contents of the test information such that an amount of time that needs to elapse after the end of the test information provision processing until the initiation of the answer check processing is equal to an amount of time needed for the biological information acquisition processing. (Para. [0096], “ As explained in screen 1500, screen 1900 appears after screen 1600, and may appear after one or more other questions have been administered to the user. Screen 1900 explains that a user is to answer whether a displayed word was included in an earlier list of words.”).
Ramachandran’s processor is configured to change the contents of Ramachandran’s test such that it changes an amount of time between presenting information for recall and soliciting user response. Ramachandran’s processor is capable of changing this amount of time to any time. Such a change in time to one that in particular matches an amount of time for the biological information acquisition processing is a mere change in proportion, which is a common practice that the court has held normally require only ordinary skill in the art and hence is considered a routine expedient. MPEP 2144.04(IV). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to select from Ramachandran’s unlimited range of times a time that in particular matches an amount of time for the biological information acquisition processing because such a selection is routine optimization within prior art conditions. MPEP 2144.04(II).
Regarding Claim 4, the combination of Ramachandran, Waldstein and Zhao with the teachings of Baudenbacher, Waldstein, Zhao and Baudenbacher renders obvious the entirety of Claim 2 as explained above.
Waldstein additionally teaches:
wherein the processor is further configured to determine a length of time for performing the biological information acquisition processing such that the biological information acquisition processing is performed during an amount of time that needs to elapse after the end of the test information provision processing until the initiation of the answer check processing. (Pg. 1747, Left Column, Fourth Paragraph, “BP was measured oscillometrically at 90-second intervals during baseline (rest) periods and at 60-second intervals during task periods with an automated vital signs monitor (Dinamap Model #1846SX, Critikon); see discussion above with respect to Waldstein’s interval).
Regarding Claim 5, the combination of Ramachandran, Waldstein and Zhao with the teachings of Baudenbacher, Waldstein, Zhao and Baudenbacher renders obvious the entirety of Claim 1 as explained above.
Waldstein additionally teaches:
wherein the biological information acquisition processing is processing that acquires the biological information by measurement (Pg. 1747, Left Column, Fourth Paragraph, “BP was measured oscillometrically at 90-second intervals during baseline (rest) periods and at 60-second intervals during task periods with an automated vital signs monitor (Dinamap Model #1846SX, Critikon)”);
Regarding Claim 6, the combination of Ramachandran, Waldstein and Zhao with the teachings of Baudenbacher, Waldstein, Zhao and Baudenbacher renders obvious the entirety of Claim 1 as explained above.
Waldstein additionally teaches:
wherein the biological information acquisition processing is acquisition processing that receives transfer of the biological information measured by a biological information measurement instrument (Pg. 1747, Left Column, Fourth Paragraph, “BP was measured oscillometrically at 90-second intervals during baseline (rest) periods and at 60-second intervals during task periods with an automated vital signs monitor (Dinamap Model #1846SX, Critikon)”);
Regarding Independent Claim 7, Ramachandran teaches:
A biological information acquisition method executed in a biological information acquisition device including a cognitive function test function, (Title, “SYSTEMS AND METHODS FOR ASSESSING POSSIBLE COGNITIVE IMPAIRMENT”);
the biological information acquisition method comprising:(a) providing a user with test information for testing cognitive function; (Fig. 16, “Word Recall Test Screen 1600;” Paras. [0092], [0093], [0096], and [0097]);
(b) acquiring biological information of the user from a blood pressure monitor that is communicably linked via a blood pressure monitor wireless communication unit configured to wirelessly communicate with a user device wireless communication unit of a user device, the user device configured to transmit the biological information to the biological information acquisition device;
and (c) the biological information acquisition device prompting the user to answer to the test information, (Fig. 19, “Word Recall Test Instruction Screen 1900;” Paras. [0092], [0093], [0096], and [0097]);
acquiring answers from the user to the test information (Fig. 20, “Word Recall Test Instruction Screen 2000;” Paras. [0092], [0093], [0096], and [0097]);
and checking the answers, (Fig. 23, “Assessment Test Screen 2300;” Paras. [0100] through [0102]).
Ramachandran does not disclose:
(b) acquiring biological information of the user from a blood pressure monitor that is communicably linked via a blood pressure monitor wireless communication unit configured to wirelessly communicate with a user device wireless communication unit of a user device, the user device configured to transmit the biological information to the biological information acquisition device;
wherein (a) is performed, (b) is performed after (a) is ended and (c) is performed after (b) is ended.
Waldstein describes “the relation of stress-induced blood pressure (BP) reactivity to cognitive function” (Abstract). Waldstein is analogous art.
Waldstein teaches:
(b) acquiring biological information of the user from a blood pressure monitor… (Pg. 1747, Left Column, Fourth Paragraph, “BP was measured oscillometrically at 90-second intervals during baseline (rest) periods and at 60-second intervals during task periods with an automated vital signs monitor (Dinamap Model #1846SX, Critikon)”);
wherein (a) is performed, (b) is performed after (a) is ended and (c) is performed after (b) is ended (Pg. 1747, Left Column, Fourth Paragraph, “BP was measured oscillometrically at 90-second intervals during baseline (rest) periods and at 60-second intervals during task periods with an automated vital signs monitor (Dinamap Model #1846SX, Critikon);” Pg. 1747, Right Column, Second Paragraph, “Verbal memory (immediate and 30 minutes delayed recall) was examined by the Logical Memory subtest of the Wechsler Memory Scale–Revised (WMS-R). Nonverbal memory (immediate and 30 minutes delayed recall) was evaluated by the Visual Reproductions subtest of the WMS-R.”).
Waldstein assesses blood pressure in 90 second intervals throughout Waldstein’s “Verbal memory (immediate and 30 minutes delayed recall)” and “Nonverbal memory (immediate and 30 minutes delayed recall)” tests. At least in Waldstein’s “30 minutes delayed recall” variation of both tests, Waldstein measures blood pressure between presentation of Waldstein’s information for recall and Waldstein’s “answer checking,” wherein the information is to be recalled. As the delay is “30 minutes,” blood pressure measured within the noted period is has ended before information is to be recalled. Any single instance of measuring blood pressure during this period is consistent with the timing criteria of Claim 7.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ramachandran with the teachings of Waldstein (i.e., to perform blood pressure testing in 90 second intervals throughout the duration of Ramachandran’s “word recall” testing) in order to assess stress reactivity, which is relevant to the assessment of cognitive function (Waldstein at Pg. 1749, Left Column, First Paragraph).
Ramachandran is silent regarding the time between presentation of Waldstein’s information and solicitation of user response. Accordingly, Ramachandran as modified by Waldstein does not expressly disclose such a timing as Waldstein’s “30 minutes delayed recall.”
Zhao describes “The relative validity of different retention intervals of delayed recall” in the context of cognitive function assessment (Zhao at Abstract). Zhao is analogous art.
Zhao teaches such an interval as Ramachandran as modified by Waldstein is explained above to lack. (Zhao at Abstract, “…we compared the differentiating value of short-term delayed recall (AVL-SR, that is, a 3- to 5-minute delay time) and long-term delayed recall (AVL-LR, that is, a 20-minute delay time) in distinguishing patients with aMCI (n = 897) and mild AD (n = 530) from the healthy elderly (n = 1215). In patients with aMCI, the correlation between AVL-SR and AVL-LR was very high (r = 0.94), and the difference between the two indicators was less than 0.5 points. There was no difference between AVL-SR and AVL-LR in the frequency of zero scores. In the receiver operating characteristic curves analysis, although the area under the curve (AUC) of AVL-SR and AVL-LR for diagnosing aMCI was significantly different, the cut-off scores of the two indicators were identical.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Ramachandran and Waldstein with the teachings of Zhao (i.e., to employ such a 3 to 5 minutes delay as taught by Zhao between Ramachandran’s presentation of information and solicitation of response) because such an interval is useful in differentiating cognitively normal subjects from those suffering cognitive decline (Zhao at Pg. 6, Right Column, First Paragraph).
The combination of Ramachandran, Waldstein and Zhao does not disclose:
A blood pressure monitor “that is communicably linked via a blood pressure monitor wireless communication unit configured to wirelessly communicate with a user device wireless communication unit of a user device, the user device configured to transmit the biological information to the biological information acquisition device;”
Baudenbacher describes “Smart mobile health monitoring system and related methods” (Title). Baudenbacher is analogous art.
Baudenbacher teaches:
a blood pressure monitor that is communicably linked via a blood pressure monitor wireless communication unit configured to wirelessly communicate with a user device wireless communication unit of a user device, the user device configured to transmit the biological information to the biological information acquisition device; (Para. [0048], “At 52, biometric data (e.g., related to an ECG, a heart rate, a hydration status, fluid shift, a respiration, a cardiac output, a fall, an activity, a body position, a diastolic blood pressure, mean blood pressure, a systolic blood pressure, etc.) can be received (e.g., at mobile computing device 14 across a wired or a wireless connection employing a wireless protocol, such as: a Bluetooth protocol, a Bluetooth low energy protocol, a ZigBee protocol, an ANT+ protocol, a WiFi protocol, etc.) from a sensor (e.g., sensor 12) coupled to a patient's body. At 54, the biometric data is processed (e.g., by the mobile computing device 14) to determine a health status of the patient. At 56, therapeutic feedback (e.g., to the patient and/or to an external device) related to the health status can be provided (e.g., by the mobile computing device 14).”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Ramachandran, Waldstein and Zhao with the teachings of Baudenbacher (i.e., to further modify the device of Ramachandran as modified in accordance with Waldstein to measure blood pressure such that it includes a blood pressure monitor configured in the manner of Baudenbacher) in order to facilitate patient monitoring in an at-home setting (Baudenbacher at Paras. [0048], [0003]), particularly because Waldstein’s described blood pressure monitor is now obsolete.2
Conclusion
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.
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/C.J.M./Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
1 See Medaval, Product Description for "Dinamap 1846-SX," Manufactured by GE Medical Systems Ltd. (Dinamap), Accessed via the Internet on 10/9/2025 at URL https://www.medaval.ie/resources/EN/devices/Dinamap-1846-SX.html.
2 See Medaval, Product Description for "Dinamap 1846-SX," Manufactured by GE Medical Systems Ltd. (Dinamap), Accessed via the Internet on 10/9/2025 at URL https://www.medaval.ie/resources/EN/devices/Dinamap-1846-SX.html.