DETAILED ACTION
Acknowledgements
The present application is being examined under the pre-AIA first to invent provisions.
Claims 2-21 are pending.
This action is Non-Final.
Claim Interpretation
The form of the claims requires different interpretations for the method and the system due to the presence of contingent features.
MPEP 2111.04 (II)
II. CONTINGENT LIMITATIONS
The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim. If the claimed invention requires the first condition to occur, then the broadest reasonable interpretation of the claim requires step A. If the claimed invention requires both the first and second conditions to occur, then the broadest reasonable interpretation of the claim requires both steps A and B.
The broadest reasonable interpretation of a system (or apparatus or product) claim having structure that performs a function, which only needs to occur if a condition precedent is met, requires structure for performing the function should the condition occur. The system claim interpretation differs from a method claim interpretation because the claimed structure must be present in the system regardless of whether the condition is met and the function is actually performed.
See Ex parte Schulhauser, Appeal 2013-007847 (PTAB April 28, 2016) for an analysis of contingent claim limitations in the context of both method claims and system claims. In Schulhauser, both method claims and system claims recited the same contingent step. When analyzing the claimed method as a whole, the PTAB determined that giving the claim its broadest reasonable interpretation, “[i]f the condition for performing a contingent step is not satisfied, the performance recited by the step need not be carried out in order for the claimed method to be performed” (quotation omitted). Schulhauser at 10. When analyzing the claimed system as a whole, the PTAB determined that “[t]he broadest reasonable interpretation of a system claim having structure that performs a function, which only needs to occur if a condition precedent is met, still requires structure for performing the function should the condition occur.” Schulhauser at 14. Therefore "[t]he Examiner did not need to present evidence of the obviousness of the [ ] method steps of claim 1 that are not required to be performed under a broadest reasonable interpretation of the claim (e.g., instances in which the electrocardiac signal data is not within the threshold electrocardiac criteria such that the condition precedent for the determining step and the remaining steps of claim 1 has not been met);" however to render the claimed system obvious, the prior art must teach the structure that performs the function of the contingent step along with the other recited claim limitations. Schulhauser at 9, 14.
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.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12109012. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are generic to the patented claims due to the structure of the clauses and the contingency of the instant claims. As such, the species or sub-genus claimed in the conflicting patent anticipates the claimed genus in the 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 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 2-11 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 2, the limitations “a processor in communication with the non-transitory data store, wherein the computer-executable instructions, when executed by the processor, configure the processor to:…wherein a signal processor is configured to perform specific operations when there is sufficient amount of data and when there is insufficient amount of data in the first buffer over time” renders the claim indefinite. It is not clear what is meant by these limitations as to how they relate to each other. Is this a different processor from the one claimed, or further configurations of the claimed structure configurations? For these reasons the metes and bounds of the claim are unclear which renders the claim indefinite.
Regarding claim 2, the limitations “in response to determining that an insufficient amount of data is in the first buffer for a time period, present a same screen with a last calculated median perfusion value index (PVI) value until a buffer criteria is satisfied.” renders the claim indefinite. It is not clear what is meant by the claimed features as the system comprises NT data store and processor, but no structures related to any screen, let alone a same screen. Applicant should amend the claims to make clearer what structures are being further limited or additional structures of the claimed system. This makes the metes and bounds of the claim unclear which renders the claim indefinite.
Regarding claims 4, 6-8, the limitations “on a monitor screen” renders the claim indefinite. The feature is claimed as an output of the process interacting with inferenced structures, but it is not clear if this is the same or different from the claim 2 “a same screen”. This makes the metes and bounds of the claims unclear which renders the claims indefinite.
Regarding claim 5, the limitations “wherein the computer-executable instructions, when executed on the processor, cause the processor to display the last calculated median PVI along with SpO2 and pulse rate” renders the claim indefinite. The system does not include any positively recited element nor inferentially recited element capable of displaying, unlike the presentation of claims 4, 6-8. As such, the metes and bounds of the claim are unclear which renders the claim indefinite.
The dependent claims are rejected for depending on a rejected claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 12-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over De Felice (WO 2005/096922 A1; cited on IDS filed) in view of Shelly et al. (Shelly, US 2007/0032732).
Regarding claim 12, De Felice teaches a method comprises:
accumulating, in a first buffer, a plurality of perfusion values corresponding to a plurality of pulses, the plurality of perfusion values derived based on the plurality of pulses (see at least [0007], [0013] compiling data in storage);
determining if a sufficient amount of physiologically acceptable data is in the first buffer, wherein a signal processor is configured to perform specific operations when there is sufficient amount of data and when there is insufficient amount of data in the first buffer over time (see at least [0013] “The data record length (T) is set by a predetermined storage interval input 222.” where computer has programming to fulfill the required broadly set forth potential actions as analysis is performed when data length is completed, and further data gathering is performed when length is not completed is a potential non-limiting example); and
in response to determining that an insufficient amount of data is in the first buffer for a time period, presenting a last calculated median perfusion value index (PVI) value until a buffer criteria is satisfied (contingent limitations, met by the step where such determination is satisfied and calculations performed, and thus bears no patentable weight on the claimed method, MPEP 2111.04).
However, the limitations of sufficient amount of physiologically acceptable data is in the first buffer based at least on a length of a respiration cycle of a patient is not directly taught.
Shelly teaches a related PPG system (see title, abstract), and teaches that buffer time segments can be adjusted to take into account breathing lengths (see at least [0082] “The amount of new data added is determined by respiratory rate measured up to that point. Specifically, the amount of data associated with the time of one breath is added to buffer. This new data was then analyzed by the method outlined in accordance with the "windowing function" step and the Fourier analysis step described above.”). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine prior art elements according to known methods to yield predictable results of basing oximeter variation data processing window segment length on respiration lengths in order to capture effected changes on oximetry data resulting from breathing changes.
Regarding claims 13-21, the limitations further limit contingent limitation and do not bear patentable weight in view of the rejections of claim 12.
Allowable Subject Matter
Claims 2-11 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: The art of record teaches the process of measuring PVI, but the art of record fails to teach, suggest, or reasonably make obvious the features claimed, considered as a whole, including the determination of sufficiency of data in buffer relations to respiratory cycle to trigger median PVI presentation/display until criterial met and based on such determination, as claimed with the specific and remaining limitations of the claim.
Conclusion
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.
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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
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