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 .
Election/Restrictions
Applicant’s election without traverse of group I (claims 1-9, 27) in the reply filed on 06/10/2026 is acknowledged.
Claims 10-16, 28 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/10/2026.
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 1-9, 27 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.
Claim 1 recites the term "a subject" in line 2. It is unclear if this is intended to be the same or different than the previously-recited subject of the preamble. For the purposes of examination, the term "a subject" is deemed to claim "the subject".
Claim 1 recites the term "the blood pressure" in lines 6 - 7. It is unclear if this is intended to be the same or different than the previously-recited blood pressure level. For the purposes of examination, the term "the blood pressure" is deemed to claim "the blood pressure level".
Claim 1 recites the term "an autoregulation function state of the subject" in lines 11 - 12. It is unclear if this is intended to be the same or different than the subject's autoregulation state recited in the preamble. For the purposes of examination, the term "an autoregulation function state of the subject" is deemed to claim "the autoregulation function state of the subject."
Claim 6 (line 1), recite "wherein the step of determining". There is no previously-recited named "step". For the purposes of examination, the term "wherein the step of determining" is deemed to claim "wherein determining."
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 1-9, 27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) continuously sensing a tissue region of a subject with a tissue oximeter during a period of time, the sensing producing first signals representative of at least one tissue oxygenation parameter; continuously measuring a blood pressure level of the subject during the period of time using a blood pressure sensing device, the measuring producing second signals representative of the blood pressure level of the subject; evaluating the at least one tissue oxygenation parameter using the first signals and the blood pressure level of the subject using the second signals, relative to one another; producing a recent profile of autoregulation data representative of the evaluated said at least one tissue oxygenation parameter and said blood pressure level relative to one another using said first signals and said second signals from a recent portion of the period of time; producing a historical profile of autoregulation data representative of the evaluated said at least one tissue oxygenation parameter and said blood pressure level relative to one another using said first signals and said second signals from a historical portion of the period of time, wherein the historical portion of the period of time is longer than the recent portion of the period of time, and the historical profile of autoregulation data is independent of the recent profile of autoregulation data. The above-identified abstract ideas in each of Independent Claim 1 (and their respective Dependent Claims) are not integrated into a practical application under 2019 PEG because the additional elements (identified in Claims 1-9, 27), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, the additional elements of: "tissue oximeter", "blood pressure sensing device", "near infra-red spectroscopy (NIRS) tissue oximeter", "one or more sensors", "at least one light source", "at least one near detector", "at least one far detector". Additional elements recited include "tissue oximeter", "blood pressure sensing device", "near infra-red spectroscopy (NIRS) tissue oximeter", "one or more sensors", "at least one light source", "at least one near detector", and "at least one far detector". These components are recited at a high level of generality, i.e., as a tissue oximeter performing a generic function of measuring an oxygenation parameter (the sensing). These generic hardware component limitations for "tissue oximeter", "blood pressure sensing device", "near infra-red spectroscopy (NIRS) tissue oximeter", "one or more sensors", "at least one light source", "at least one near detector", and "at least one far detector" are no more than mere instructions to apply the exception using generic computer and hardware components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claim recites an abstract idea.
these elements amount no more than mere instructions to apply the exception a using generic computer and hardware components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim(s) is directed to an abstract idea.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using "tissue oximeter", "blood pressure sensing device", "near infra-red spectroscopy (NIRS) tissue oximeter", "one or more sensors", "at least one light source", "at least one near detector", "at least one far detector". Additional elements recited include "tissue oximeter", "blood pressure sensing device", "near infra-red spectroscopy (NIRS) tissue oximeter", "one or more sensors", "at least one light source", "at least one near detector", and "at least one far detector" amount to no more than mere instructions to apply the exception using a generic hardware and a generic computer component. Mere instructions to apply an exception using a generic hardware and a generic computer component cannot provide an inventive concept. The claim(s) is not patent eligible.
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) 1-9, 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Montgomery et al. (USPN 2016/0345913).
Regarding claims 1, 9, Montgomery et al. discloses a method for providing information regarding a subject's autoregulation function state, comprising: continuously sensing a tissue region of a subject with a tissue oximeter during a period of time, the sensing producing first signals representative of at least one tissue oxygenation parameter ([0032]-[0034], oxygen saturation measurements derived from the oxygen saturation values 44, figure 2A); continuously measuring a blood pressure level of the subject during the period of time using a blood pressure sensing device, the measuring producing second signals representative of the blood pressure level of the subject ([0032]-[0034], blood pressure measurements derived from the blood pressure values 48, figure 2B); evaluating the at least one tissue oxygenation parameter using the first signals and the blood pressure level of the subject using the second signals, relative to one another ([0027]-[0028]); producing a recent profile of autoregulation data representative of the evaluated said at least one tissue oxygenation parameter and said blood pressure level relative to one another using said first signals and said second signals from a recent portion of the period of time ([0027]-[0028], [0034], [0037]); producing a historical profile of autoregulation data representative of the evaluated said at least one tissue oxygenation parameter and said blood pressure level relative to one another using said first signals and said second signals from a historical portion of the period of time, wherein the historical portion of the period of time is longer than the recent portion of the period of time, and the historical profile of autoregulation data is independent of the recent profile of autoregulation data ([0027]-[0028], [0034], [0037]).
Regarding claim 2, Montgomery et al. discloses the historical portion of the period of time extends an entirety of the period of time ([0027]-[0028], [0034], [0037], figure 2).
Regarding claim 3, Montgomery et al. discloses the historical portion of the period of time extends less than an entirety of the period of time by an amount substantially equal to the recent portion of the period of time ([0027]-[0028], [0034], [0037], figure 2).
Regarding claim 4, Montgomery et al. discloses the period of time extends between a first point in time T1 and a second point in time T2, wherein the second point in time is later that the first point in time T1;wherein the recent profile of autoregulation data is produced using said first signals and said second signals from the recent portion of the period of time, the recent portion of the period of time extending between the second point in time T2 and a third point in time T3, wherein the third point in time is earlier than second point in time T2 and later than the first point in time T1; and wherein the historical profile of autoregulation data is produced using said first signals and said second signals from the historical portion of the period of time, the historical portion of the period of time extending between the first point in time T1 and the third point in time T3 ([0027]-[0028], [0034], [0037], figure 2).
Regarding claim 5, Montgomery et al. discloses the period of time extends between the first point in time T1 and a new second point in time NT2, and the new second point in time NT2 is later that the second point in time T2; and updating the historical profile using the recent profile of autoregulation data; and producing a new recent profile of autoregulation data representative of the evaluated said at least one tissue oxygenation parameter and said blood pressure level relative to one another using said first signals and said second signals from a new recent portion of the period of time, the new recent portion of the period of time extending between the new second point in time NT2 and the second point in time T2 ([0027]-[0028], [0034], [0037], figure 2).
Regarding claim 6, Montgomery et al. discloses the step of evaluating the at least one tissue oxygenation parameter using the first signals and the blood pressure level of the subject using the second signals, relative to one another includes:determining frequency domain tissue oxygen parameter values by performing a first frequency domain transformation of the first signals; determining frequency domain blood pressure values by performing a second frequency domain transformation of the second signals; and determining coherence (COHZ) values indicative of the subject's autoregulation state using the frequency domain tissue oxygen parameter values and the frequency domain blood pressure values ([0027]-[0028], [0034], [0037], figure 2).
Regarding claim 7, Montgomery et al. discloses both the recent profile of autoregulation data and the historical profile of autoregulation data include the COHZ values as a function of the blood pressure level ([0027]-[0028], [0034], [0037], figure 2).
Regarding claim 8, Montgomery et al. discloses displaying the historical profile and the recent profile together ([0027]-[0028], [0034], [0037], figure 2).
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 1-9, 27 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/513,075 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader than those of the Patent. As, such, any invention meeting the limitations of the claims of the Patent would necessarily meet those of the instant application as well.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN FARDANESH whose telephone number is (571)270-5508. The examiner can normally be reached Monday-Friday 9:00-17:00.
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/MARJAN FARDANESH/Primary Examiner, Art Unit 3791
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