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 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 – 20 are rejected under 35 U.S.C. 101 because the claimed invention is drawn to an abstract idea without significantly more. The claim(s) recite(s) steps or executable instructions as part of a system or method (both of which are within a statutory category of invention) that “monitors for” and “detects” respiration and oxygenation events, which each fall in the category of a mental process (see MPEP 2106.04(a)(2)III.). This judicial exception is not integrated into a practical application because with regard to Revised step 2A, an exception is present as noted, and with regard to Revised step 2B, the claim does not recite additional elements that integrate the judicial exception into a practical application. In particular, based on the high level of generality/nominal nature of the motion state sensor and oximetry sensor, the alarm module, and the device control logic, one must conclude that these recitations do not impose a meaningful limitation onto the claim scope, as the limitations do not constitute use of the exception in the context of “a particular machine”. Instead, their high level of generality merely points to a generalized data gathering being undertaken. Additionally, the inclusion of a post-solution function where the device “sends a message” is also recited at such a high level of generality to merely encompass insignificant extra-solution activity. Likewise, the claim(s) does/do not include additional elements/steps that are sufficient to amount to significantly more than the judicial exception because the high level and broad renditions regarding the sensors and generic computer elements indicate that no specific sensors are required and the post-solution “sends a message” is also able to be performed by a mere generic element. Further, the dependent claims generally relate to further aspects of the judicial exceptions, and thus also fail to provide details to integrate the exceptions into a practical application.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1 – 20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The amended claims recite the wearable device “consists of a band around an upper arm or upper leg or calf of the user”, thereby improperly claiming the structure in positive relation to a body part. Applicant should indicate that the elements are “configured for” or “adapted to” provide the relation with the body part to avoid requiring the presence of the body part to define the invention.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 – 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. With regard to claim 1, the claim indicates a device both “comprising” (line 1) and “consists of” (line 6) rendering it unclear whether Applicant intends to use an open-ended transition or close-ended transition interpretation of the claim scope. As noted in the prior office action, claim 1 ascribes certain properties (final four lines) to “the wearable medical device” but never indicates which positively claimed element provides the result. With regard to claim 3, it is unclear how a “system” has been defined as only a single element is discussed and a system, by definition, consists of plural elements. Additionally, no positively claimed element of the wearable device would be recognized as being configured for wireless communication and thus it is unclear what structure could perform the indicated function, as the claim does not introduce any telemetry structures.
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, 5, 6, 9 – 12, 14 – 18, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Workman et al. (USPN 9,693,730) for the reasons of record.
Claim(s) 1, 3, 4, 7, 8, 11, 13, 14, 16, 17, 19, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaib et al. (USPGPub 2017/0143977) for the reasons of record.
Claim(s) 1 – 4, 8, 9, 11, 13 – 18, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bogdanovich et al. (USPGPub 2020/0029899) for the reasons of record.
Response to Arguments
Applicant's arguments filed February 2, 2026 have been fully considered but they are not persuasive.
With regard to the rejection under 35 USC 101, Applicant alleges that the amended language concerning sending a message is beyond the judicial exception of a mental process. However, while the claim has been amended in the manner Applicant refers to, the added limitation is merely drawn to a nominal/generic post-solution activity as discussed in the updated statement of the rejection. Applicant is reminded that such a limitation cannot serve to overcome the rejection, since mere nominal/generic pre- or post-solution activities are not sufficient to provide integration of the judicial exception into a practical application (as discussed in MPEP 2106.05(g)).
With regard to the rejection under 35 USC 101 and section 33(a), while Applicant has addressed the issues raised in the Non-final rejection, the amended claim language of the independent claim directly ties the “band” element to a subject in a manner that is not permitted. As such, contrary to Applicant’s assertions, the amened claims do not overcome the rejection.
With regard to the prior art rejections, Applicant relies upon the amended text indicating that the wearable device consists of a band. The claim provides an intended use recitation of the portion of the body part where the band should be placed during use, but Applicant is reminded that such language does not materially affect the structure needed to meet the claim language regarding a band. Further, Examiner notes that none of claim elements (a) – (c) of claim 1 are explicitly required to be present on the band. With this understanding, one would recognize that the disclosure of Workman et al., Figure 2D and the discussion thereof; Kaib et al. paragraphs [0151], [0161], [0183]; and Bogdanovich et al. paragraphs [0047], [0050], [0090] each disclose structures meeting the amended claim requirements. As such, contrary to Applicant’s allegations, the amendments do not define over the prior art.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC FRANK WINAKUR whose telephone number is (571)272-4736. The examiner can normally be reached Mon-Fri 9 am - 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chuck Marmor, II can be reached at 571-272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
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