DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statements (IDSes) submitted on 08 May 2024 are being considered by the examiner. Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular reference in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
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 8-13 and 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.
Regarding claim 8, it is unclear if the claimed “at least one pressure equalization pathway” is part of the “pressure equalization pathways” recited in claim 2. The Examiner suggests amending the phrase in claim 8 to recite “at least one pressure equalization pathway of the pressure equalization pathways”.
Regarding claim 11, it is unclear if the claimed “two pressure equalization pathways” is part of the “pressure equalization pathways” recited in claim 2. The Examiner suggests amending the phrase in claim 11 to recite “two pressure equalization pathways of the pressure equalization pathways”.
Regarding claim 13, it is unclear if the claimed “at least two pressure equalization pathways” is part of the “pressure equalization pathways” recited in claim 2. The Examiner suggests amending the phrase in claim 13 to recite “at least two pressure equalization pathways of the pressure equalization pathways”.
Regarding claim 17, heart sounds, breath sounds, riles, rhonchi, and stridor are not physiological parameter measurements. Furthermore, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
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 16 and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claims 16 and 17 follows.
Regarding claims 16 and 17, the claims recite a series of steps or acts, including detecting acoustic vibrations, converting the vibrations into an electrical signal, and processing the electrical signal to determine or more physiological parameters. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of processing the electrical signal to determine or more of the claimed physiological parameters sets forth a judicial exception. This step 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.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails 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. Neither claim 16 nor 17 recite an application of the determined one or more claimed physiological parameters. The determination of the one or more claimed physiological parameters does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the determined one or more claimed physiological parameters, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claims recite additional steps of detecting acoustic vibrations, and converting the vibrations into an electrical signal, and outputting the electrical signal. The detecting, converting, and outputting steps are each recited at a high level of generality such that they amount to insignificant presolution activity, e.g., mere data gathering steps necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes them from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do 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)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-10 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7 of U.S. Patent No. 9,955,937. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the US Patent are narrower in scope than the claims of the current invention, encompassing the subject matter of the claims of the current invention. Any reference meeting the limitations set forth in claims 1-5 and 7 of US Patent 9,955,937 would also meet the requirements set forth in claims 2-10 and 15 of the current invention.
Claims 2-6 and 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 14-16 of U.S. Patent No. 11,020,084. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the US Patent are narrower in scope than the claims of the current invention, encompassing the subject matter of the claims of the current invention. Any reference meeting the limitations set forth in claims 1-5 and 14-16 of US Patent 11,020,084 would also meet the requirements set forth in claims 2-6 and 15-17 of the current invention.
Claims 2-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,992,361. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the US Patent are narrower in scope than the claims of the current invention, encompassing the subject matter of the claims of the current invention. Any reference meeting the limitations set forth in claims 1-15 of US Patent 11,992,361 would also meet the requirements set forth in claims 2-17 of the current invention.
Allowable Subject Matter
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The closest prior art to Applicant’s claimed invention can be seen in each of Telfort et al.’271 (US Pub No. 2011/0213271 – cited by Applicant), Telfort et al.’272 (US Pub No. 2011/0213272 – cited by Applicant), and Telfort et al.’273 (US Pub No. 2011/0213273 – cited by Applicant). Each of these references discloses an acoustic sensor comprising an acoustic sensing element supported by a frame, and a one piece integral acoustic coupler that at least partially surrounds the frame, the frame further comprising pressure equalization pathways. Ehrlund’523 (US Pub N. 2012/0230523 – cited by Applicant) discloses an acoustic sensor comprising an acoustic sensing element supported by a frame, and an element connected to the frame that comprises air vent holes, and another element connected to the frame that comprises a pressure equalization pathway; the frame of Ehrlund’523 does not comprise both the acoustic sensing element and the pressure equalization pathway.
The following is a statement of reasons for the lack of prior art rejections:
None of the prior art discloses or suggests, either alone or in combination, an acoustic sensor comprising a one piece integral acoustic coupler that covers at least a portion of a frame that supports an acoustic sensing element, wherein the acoustic coupler comprises one or more air vent holes on at least one sidewall of the acoustic coupler that is aligned with corresponding pressure equalization pathways in the frame, in combination with the other claimed elements.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ETSUB D BERHANU whose telephone number is (571)270-5410. The examiner can normally be reached Mon-Fri 9:00am-5:30pm EST.
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.
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791