DETAILED ACTION
Acknowledgments
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-12, 14-25 are pending.
This action is Final.
Priority
Excluding any new matter, the claims 1-12, 14-25 are entitled to an effective filing date of 11/2/2017 as addressed prior.
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 1-12, 14-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,129,536. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are broader form of the patented claims forming a genus species relationship. The species or sub-genus claimed in the conflicting patent anticipates the claimed genus in the instant application being examined and, therefore, a patent to the genus would improperly extend the right to exclude granted by a patent to the species or sub-genus.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12, 14-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1 and 14, the claims have been amended to recite the features:
Claim 1:
based on the analyzed signals, calculate a PACU/ICU assessment of the patient; and
compare the PACU/ICU assessment to predetermined PACU/ICU criteria;
initiate a mobilization protocol upon the PACU/ICU assessment exceeding a first PACU/ICU criteria; and
initiate the patient's discharge upon the PACU/ICU assessment exceeding a second PACU/ICU criteria.
Claim 14
based on the analyzed signals, calculating an Intensive Care Unit and/or Postoperative Anesthesia Care Unit (PACU/ICU) assessment; and
comparing the PACU/ICU assessment to predetermined triage PACU/ICU criteria;
initiating a mobilization protocol upon the triage assessment exceeding a first PACU/ICU criteria; and
initiating the patient's discharge upon the PACU/ICU assessment exceeding a second PACU/ICU criteria.
which are rejected for being new matter. Applicant states support can be found in pages 63-64 of the specification as filed. After careful review of the disclosure as filed, the examiner believes the passages of the original specification applicant cites to are PGPub paragraphs 225-229, but it appears that 226 and 229 are the relevant passages.
These passages state:
[0226] In one embodiment, MV, TV and/or RR become part of a triage system (such as the Aldrete scoring system used for discharge criteria from a PACU) to help make decisions regarding patient care, patient medication or patient nutrition. The triage system preferably is similar to the early warning scoring system. In one embodiment, pre-defined criteria and ranges for the triage system are based on (and may be adjusted according to) a combination of a triage criteria (Aldrete score, etc.) and disease state (OSA, CHF, sepsis, renal disease, etc.) either externally entered (manually or automatically (e.g. from an EHR)) or as determined by the device itself.
[0229] In one embodiment, MV, TV and/or RR become part of a PACU/ICU/hospital floor/home/rehab/nursing home mobilization protocol to help make decisions regarding patient care or patient nutrition. The mobilization protocol system preferably is similar to the early waring scoring system. In one embodiment, pre-defined criteria and ranges for the mobilization protocol system are based on (and may be adjusted according to) a combination of PACU/ICU/hospital floor/home/rehab/nursing home mobilization protocol and disease state (OSA, CHF, sepsis, renal disease, etc.) either externally entered (manually or automatically (e.g. from an EHR)) or as determined by the device itself.
However, these passages do not bridge the concepts claimed to being a singular assessment with first and second thresholds as being claimed. While each paragraph states the two embodiment systems are similar to the EWS, there is no indication that the two systems are one in the same to allow for the same assessment criteria to be each used against two thresholds for making the different initiated protocols. For example, the PACU mobilization does not equate to the PACU discharge.
In addition, this creates a new issue in dependent claims 5 and 18. The assessment as claimed in claims 1 and 14 can be based on using disease status, but there is no indication that the assessments itself are indicative of disease states as set forth in the claims, and based on the disclosure as filed this constitutes new matter as well. For example, the claims could state wherein the assessment is based on at least one of status from at least one of…, but as set forth is not supported, or a new assessment could be claimed here for such, such as the EWS.
For these reasons one of skill in the art would not have recognized applicant had possession of the claimed invention at the time the application was filed.
The dependent claims are rejected for depending on a rejected claim.
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 14-25 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 14 recites the limitation “the triage assessment” in line 15. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 19, the limitations “further comprising physiology sensors, wherein the physiology sensors obtain patient data relating to at least one of minute ventilation, tidal volume, respiratory rate, oxygen saturation, temperature, blood pressure, pulse or heart rate, blood oxygen levels, and brain activity” render the claim indefinite. The claim does not appear to further limit any step from the method of claim 14 which makes it unclear what is being further limited in the claimed method as no active steps are being performed in the claim. This makes the metes and bounds of the claim unclear which renders the claim indefinite.
The dependent claims are rejected for depending on a rejected claim.
Claim Rejections - 35 USC § 101
Claims 1-12, 14-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s):
Claim 1:
determine a calibration coefficient based on the bioelectrical impedance signals and demographic information of the patient (mental process, mathematical concepts);
calibrate the bioelectrical impedance signals (mathematical concepts);
analyze the calibrated bioelectrical impedance signals (mental process, mathematical concepts);
based on the analyzed signals, calculate a PACU/ICU assessment of the patient (mental process, mathematical concepts);
compare the PACU/ICU assessment to predetermined PACU/ICU criteria (mental process, mathematical concepts)
Claim 14:
determining a calibration coefficient based on the bioelectrical impedance signals and demographic information of the patient (mental process, mathematical concepts)
calibrating the bioelectrical impedance signals (mathematical concepts)
analyzing the calibrated bioelectrical impedance signals (mental process, mathematical concepts)
based on the analyzed signals, calculating an Intensive Care Unit and/or Postoperative Anesthesia Care Unit (PACU/ICU) assessment (mental process, mathematical concepts)
comparing the PACU/ICU assessment to predetermined PACU/ICU criteria (mental process, mathematical concepts)
These claim limitations fall within the identified groupings of abstract ideas:
Mathematical Concepts:
mathematical relationships
mathematical formulas or equations
mathematical calculations
Mental Processes
concepts performed in the human mind (including an observation, evaluation, judgment, opinion)
This judicial exception is not integrated into a practical application because:
Under the step 2A, analysis is conducted on the additional features of the claim. Under this analysis, the additional features beyond the judicial exception are:
Claim 1:
a computing device having acquisition circuitry (computer features used as a tool and data gathering);
a plurality of bioelectric impedance sensors for acquiring bioelectrical impedance signals from a patient, wherein the plurality of bioelectric impedance sensors are functionally connected to the acquisition circuitry (insignificant extra solution features related to data gathering)
wherein the computing device is configured to:
receive the bioelectrical impedance signals from the plurality of bioelectric impedance sensors (insignificant extra solution features related to data gathering)
initiate a mobilization protocol upon the PACU/ICU assessment exceeding a first PACU/ICU criteria; and initiate the patient's discharge upon the PACU/ICU assessment exceeding a second PACU/ICU criteria (insignificant post solution activities, or alternatives including non-specific/generic reference to initiating “protocol” “discharge” that is not specific to amount to a practical application if claimed in required form as opposed to alternative)
Claim 14:
coupling a plurality of bioelectric impedance sensors for acquiring bioelectrical impedance signals to a patient (insignificant extra solution features related to data gathering)
receiving the bioelectrical impedance signals from the plurality of bioelectric impedance sensors (insignificant extra solution features related to data gathering)
initiating a mobilization protocol upon the triage assessment exceeding a first PACU/ICU criteria; and initiating the patient's discharge upon the PACU/ICU assessment exceeding a second PACU/ICU criteria (contingent limitation for a method which does not bear patentable weight as such contingency is not required, and insignificant post solution activities, or alternatives including non-specific/generic reference to initiating “protocol” “discharge” that is not specific to amount to a practical application if claimed in required form as opposed to alternative contingent feature)
These features in the claim do not integrate the exception into a practical application of the exception as the additional elements in the claim do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is no more than a drafting effort designed to monopolize the exception.
Limitation concepts that are indicative of integration into a practical application:
Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e) and Vanda Memo
Limitation concepts that are not indicative of integration into a practical application:
Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f)
Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)
Generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h)
Under Step 2B, the claim limitations are evaluated for an inventive concept. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and in combination, they do not add significantly more to the exception. Analyzing the additional claim limitations individually, the additional limitation that is not directed to the abstract idea are the same as those identified above in step 2A. Such limitations related to the sensors are recognized by the courts as routine data gathering in order to input data to the mathematical algorithm, and thus, do not add a meaningful limitation to the method as it would be routinely used by those of ordinary skill in the art in order to apply the mathematical algorithm/mental processes. In addition, these sensor structures are generically claimed and well-known in the art, such as for example Al-Ali et al. (Al-Ali, US 2008/0188733), Killen et al. (Killen, US 2012/0136221), and Kurth (US 6,219,408) and Freeman et al. (Freeman, US 2012/0041279). The computer structures cited above are claimed as performing generic computer functions routinely used in computer applications. Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. The additional limitations recited in the dependent claims have all been analyzed under the same analysis as the independent claims, but are directed to further data gathering using well-known/conventional sensors, further details to extra solution activities, the features related to the alarms do not amount to significantly more than the claimed exceptions as has been consistently determined by the courts, Flook, and further details into the judicial exceptions (A more specific abstraction is still an abstraction). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Therefore, analyzing the claims as an ordered combination under the Mayo/Alice analysis the features claimed are directed to patent ineligible limitations.
Response to Arguments
The examiner acknowledges applicant’s submission of amendments to the claims, specification, and drawings filed 11/19/2025; and IDS filed 2/5/2026.
Applicant’s arguments regarding the drawing objections have been fully considered and are persuasive due to the amendments to the drawings; the objections are withdrawn.
Applicant’s arguments regarding the double patenting rejections have been fully considered and request for abeyance is acceptable. The rejection is provisionally maintained pending new matter resolution.
Applicant’s arguments regarding the claim objections have been fully considered and are persuasive due to the amendments to the claims; the objections are withdrawn.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 112(b) have been fully considered and are partially persuasive due to the amendments to the claims; however, the amendments have necessitated new grounds of rejections.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 101 have been fully considered but are not persuasive. Applicant argues that the post solution activities have been removed from the claims, but the examiner respectfully disagrees as the “initiating” contingent steps are post-solution activities. The additional arguments are conclusory that the claims are a practical application of patient mobilization and discharge protocols. However, it is not clear what such initiating entails based on the disclosure as filed and there is no further articulation as to how such steps amount to a practical application or what entails such protocols, and secondly, the method steps have such as contingency clauses which are not required to occur. The rejections are respectfully maintained as presented above to account for the amendments to the claims.
Applicant’s arguments regarding the rejections of the claims in view of prior art have been fully considered and are persuasive due to the form of the claims.
Conclusion
No prior art rejections have been applied, but the claims are not in condition for allowance due to the 112/101 rejections.
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 MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 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, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791