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 .
Applicant’s preliminary amendments filed on 11/22/2023 are acknowledged.
Claims 1-20 are pending for examination.
Claim Objections
Claims 1, 15 and 18 are objected to because of the following informalities: In regard to claims 1, 15 and 18, “determine/ determining a trend based analysis of perfusion based on the first signal and in the second signal” should be set forth “determine a trend based analysis of perfusion based on the first signal and [[in]] the second signal”. Appropriate correction is required.
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.
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 1-14 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). Claims that depend directly or indirectly from claim 1 is/are also rejected due to said dependency. In regard to claim 1, the claim recites “A system for monitoring a patient, comprising: a first sensor disposed at a central site…a second sensor disposed at a distal site”. The phrase should be read as “a first sensor configured to be disposed at a central site…a second sensor configured to be disposed at a distal site” to avoid improperly defining the apparatus in relation to a living being.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions of abstract idea without significantly more. Claims 1-20 recite a method and a system, which fall within one of statutory categories (i.e. process/ machine) (Step 1: YES).
Step 2A Prong One analysis: Claims 1, 15 and 18 recite “correlate a first perfusion index based on the first signal from the first sensor and a second perfusion index based on the second signal from the second sensor; and determine a trend based analysis of perfusion based on the first signal and in the second signal”. The claims involve calculation/ determination of parameter(s) constitutes an abstract idea of mathematical relationships/ calculations and/or mental process, which fall within at least one of the groupings of abstract ideas enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance (Mathematical Concepts) (Step 2A Prong One: YES).
Step 2A Prong Two analysis: Claims 1, 15 and 18 recite “a first sensor and a second sensor”. Claims 1 and 15 recite “memory/ non-transitory computer readable storage medium” and “a processor”. This judicial exception is not integrated into a practical application because no improvement or change in the function of the device (see at least MPEP 2106.05(a), (f) and (g)). And the provide signals steps/ functions associated with the first/ second sensor(s) are considered as data gathering steps to be insignificant extra-solution activity using generic sensors . And/ or the abstract idea (mental process) is directed as being performed 1) on a generic computer, or 2) in a computer environment, or 3) is merely using a computer as a tool to perform the concept (see MPEP 2106.04(a)(2).III.C) “(Step 2A Prong Two: YES).
Step 2B: The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional element(s), when considered separately and in combination, are associated with data gathering steps of insignificant extra-solution activity (see MPEP 2106.05(g)) and 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)) and do not improve the functioning of a computer, e.g. an improvement in the application of the mathematical relationship in determining the parameter(s), which is, itself, an abstract idea (see MPEP 2106.05(a)). The claims merely cover the collection of data obtained from known and existing technology and then using the data to make a correlation for parameter(s) (Step 2B: No). Dependent claims do not recite additional elements/ features and do not add significantly more (i.e. an “inventive concept”) to the exception.
For these reasons, there is no inventive concept in the claims, and thus claims 1-20 are ineligible.
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 1-14 and 18-20 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. Claims that depend directly or indirectly from claims 1, 15 and 18 is/are also rejected due to said dependency. In regard to claims 1 and 18, the claims recite “for monitoring a patient…at a central site…at distal site…” The relationship between the patient and the central/ distal sites are not clearly defined in the claims. It is unclear whether the central/ distal sites refers to the central/ distal sites of the patient or central/ distal sites not associated with the patient. If the first, it is suggested that “at central/ distal sites of the patient” or similar language should be set forth. Clarification is requested by amendments.
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 15 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Al-Ali (USPGPUB 2008/0221464). In regard to claim 15, Al-Ali discloses a tangible non-transitory computer readable storage medium that stores instructions, which, when executed by a processor (memory and processor, Fig. 1 and associated descriptions; software, firmware or other form of code or instructions, or logic or other hardware, or a combination of the above, [0020]), cause the processor to: correlate a first perfusion index based on a first signal from a first sensor (PI baseline at time 331, Fig. 3 and associated descriptions; sensor 106, Fig. 1 and associated descriptions) and a second perfusion index based on a second signal from a second sensor (PI values between time 331 to time 332, Fig. 3 and associated descriptions; it is noted that the first sensor and second sensor are interpreted as the same sensor); and determine a trend based analysis of perfusion based on the first signal and [[in]] the second signal (the trends of PI and PI rate Fig. 3 and associated descriptions; [0024]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 7-8, 14-15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Melker et al. (USPGPUB 2003/0236452) in view of Kiani (USPGPUB 2008/0071155). In regard to claims 1, 15 and 18, Melker teaches a system, a tangible non-transitory computer readable storage medium and a method for monitoring a patient (Fig. 1-7 and associated descriptions) comprises a first sensor disposed at a central site (first pulse oximeter at a central site, Fig. 7 and associated descriptions; [0078-0083]), and adapted to provide a first signal (signals for the central source site, Fig. 7 and associated descriptions; [0078-0083]); a second sensor disposed at a distal site, and adapted to provide a second signal (second pulse oximeter at a peripheral/ non-central site, Fig. 7 and associated descriptions; [0078-0083]); a processor ([0079]); a memory that stores instructions ([0079], which when executed by the processor, cause the processor to: correlate a first physiological parameter based on the first signal from the first sensor and a second physiological parameter based on the second signal from the second sensor (oxygen saturation, Fig. 7 and associated descriptions; [0078-0083]); determine a trend based analysis of perfusion based on the first signal and in the second signal (perfusion, [0018]; perfusion and oxygen saturation values, [0020]; perfusion and time-based changes, [0080]).
Melker does not specifically disclose correlate a first perfusion index based on the first signal from the first sensor and a second perfusion index based on the second signal from the second sensor.
Kiani teaches a pulse oximetry system (Figs. 3-9 and associated descriptions) comprises a first, second and/or third pulse oximeter(s) ( Figs. 4-6 and associated descriptions), wherein the first, second and/or third pulse oximeter(s) measures perfusion index (PR, SpO2 and perfusion index (PI), [0015]; [0031]; [0046]) and correlate a first perfusion index based on the first signal from the first sensor and a second perfusion index based on the second signal from the second sensor (comparison/ site difference, Figs. 7A-7B and 9 and associated descriptions; function 930, Fig. 9 and associated descriptions; cross-channel calculator generates cross-channel values, [0046]); and determine a trend based analysis of perfusion based on the first signal and in the second signal (PI in site difference and trend 790, Fig. 7B and associated descriptions; PI trend 940, Fig. 9 and associated descriptions; [0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/ medium/ method (Melker) to incorporate the oximeter function of generating perfusion index at different measurement sites and obtain the site difference of PI as taught by Kiani, since both devices are oximetry systems and one of ordinary skill in the art that pulse oximeter provides perfusion index information in addition to pulse rate/ SpO2 and site difference of PI provides additional perfusion information between different measurement sites (see Kiani). The rationale would have been to obtain more perfusion related information from the patient.
In regard to claims 7 and 14, Melker as modified by Kiani discloses the trend based analysis comprises a plurality of changes in perfusion indices, or changes in cardiac output, or both, over a selected time period (site difference trend, Fig. 7B and 9 and associated descriptions of Kiani).
In regard to claim 8, Melker as modified by Kiani discloses a display ([0018] of Melker; display, Figs. 3 and 7B and associated descriptions).
Claims 2 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Melker and Kiani as applied to claims 1, 7-8, 14-15, and 18 above, and further in view of Sullivan (USPGPUB 2016/0067514). In regard to claims 2 and 9, Melker as modified by Kiani discloses all the claimed limitations except the trend based analysis further comprises a change in a cardiac output.
Sullivan teaches trend analysis of monitored physiological parameters of patient includes cardiac output and perfusion and provide information regarding the condition of the patient ([0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system (Melker as modified by Kiani) to incorporate additional trend based analysis of change(s) in cardiac output as taught by Sullivan, since boto systems measuring physiological parameters of the patient and one of ordinary skill in the art would have recognized that trend based analysis of change(s) in cardiac output facilitates providing health condition of the patient (see Sullivan). The rationale would have been to obtain more health/ physiological condition of the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHU CHUAN LIU whose telephone number is (571)270-5507. The examiner can normally be reached M-Th (6am-6pm).
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791
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