DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 1-19 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,867,701 and claims 1-19 of U.S. Patent 11,990,240 Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to a broader embodiment of the parent patents. Claims 1-19 correspond to claims 1-19 of the prior patents. Newly added claim 21 is an obvious improvement over the prior patents as Boecker discloses wherein the analysis software logic can be configured differently for different individual patients (Boecker [0043]) and Nevins discloses the portable analyzer unit includes an analysis software logic that uses information from a blood analysis cartridge, together with data from additional observations, to provide an output to the user via the user interface which includes information about a subject patient's current health, status and performance indications (Nevins page 2 lines 20-26 see “contextual alert in response to anomalous data or trend” and page 5 lab results). It would have been obvious to provide an output as in Nevins and the configurable software of Boecker to more rapidly allow a physician to diagnose and treat a number of patients.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-19 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by US Patent Application Publication No. 2004/0260204 to Boecker et al.
Boecker discloses a method, system and program product, the method comprising: using a test sample medium, such as a blood analysis cartridge, test strip, or other component for obtaining a patient-origin sample (0021-0023 cartridge); providing a portable analyzer unit, such as a machine or reader, that receives the sample and enables analysis thereon (0037-0039 analyzer); accessing a software application for use in the analysis of the sample, optionally including diagnosis, trend, and intervention evaluation (0057-0062 software); and using a database stored at a central or distributed environment, such as at a cloud computing system that enables sharing of patient sample data as received via the portable analyzer unit for use by the software application in analysis and optimizing patient-specific intervention strategies using point of care diagnostics (0045-0049 database). Examiner notes that the first newly added wherein clause further limits the optional features of diagnosis, trend and intervention evaluation and the second wherein clause describes an intended use of the indications and information. Boecker therefore does not need to teach these elements to anticipate the claim.
As to claim 2, see the discussion of claim 1, additionally Boecker discloses the system wherein the sample associated with the patient is provided via an analysis strip or cartridge which is used to generate data on blood cells (Boecker [0022])
As to claim 3, see the discussion of claim 2, additionally Boecker discloses the system wherein the system includes that:
the portable analyzer unit interfaces with and facilitates the testing by the cartridge on the sample (Boecker [0022]).
As to claim 4, see the discussion of claim 1, additionally Boecker discloses the system wherein the system includes that:
the software application is installed on a separate computational device such as a laptop computer, which can be configured differently for different needs, based on a different understanding of a user’s needs (Boecker [0041]).
As to claims 5-7 and 9-10, Examiner notes that the wherein clause of claims 5-7 suggests but makes optional “the data can be sent and stored on a cloud computing system that creates a database of results, uses artificial intelligence to design and develop algorithms through machine learning, and automatically or regularly synchronizes information with the software application.” “data can be displayed according to the use scenario and includes one or more of results trends and/or custom reference points.”, “a user can input information on medical and training interventions under the categories of medication, nutrition and/or nutraceuticals, and/or exercise”, “wherein a plurality of different types of sample analysis cartridges can be interchangeably used for different animal types, testing requirements, or use cases.” “wherein sampling information can be used as a base reference point or range for subsequent tests on that patient; and wherein information about the patient's physical condition at the time of testing can be included to associate the sampling information with physical or environmental conditions; and wherein when subsequent tests are performed, deviations of sampling information from established reference points can be determined, to help establish changes in the patient's physical status and/or response to changed physical or environmental conditions such as medical interventions.”
They are not patentably distinguishable from the claim from which they depend and are rejected for the same the same reasons. See MPEP 2111.04.
As to claim 8, 12, and 14, see the discussion of claim 1, additionally Nevins discloses wherein the an analysis software or logic includes one or more of a programmed knowledge that
certain particular characteristics or problems are pertinent to the patient type (Nevins page 2 lines 20-26 see “contextual alert in response to anomalous data or trend”),
certain actual blood or other sample analysis information for the current patient are considered indicators of health or performance (Nevins page 2 lines 20-26 see “contextual alert in response to anomalous data or trend”), and
certain physiological data for the current patient are considered indicators of health or performance (Nevins page 2 lines 20-26 see “contextual alert in response to anomalous data or trend”); and
allows for input and consideration of additional subjective or intuitive information that is pertinent to the intended use case and the current patient (Nevins page 4 lines 1-20 see “self reported data”).
With respect to claims 15-19, the claims further limit the optional step of trend and intervention evaluation and are rejected for the same reasons as claim 1.
Claim 21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US Patent Application Publication No. 2004/0260204 to Boecker in view of WO 2009063285 to Nevins.
As to claim 21, see the discussion of claim 1, Boecker discloses wherein the analysis software logic can be configured differently for different individual patients (Boecker [0043]); however, Boecker does not explicitly teach wherein the portable analyzer unit includes an analysis software logic that uses information from a blood analysis cartridge, together with data from additional observations, to provide an output to the user via the user interface which includes information about a subject patient's current health, status and performance indications. Nevins discloses the portable analyzer unit includes an analysis software logic that uses information from a blood analysis cartridge, together with data from additional observations, to provide an output to the user via the user interface which includes information about a subject patient's current health, status and performance indications (Nevins page 2 lines 20-26 see “contextual alert in response to anomalous data or trend” and page 5 lab results).
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide an output as in Nevins with the testing system of Boecker to more rapidly allow a physician to diagnose and treat a patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eliza Lam whose telephone number is (571)270-7052. The examiner can normally be reached Monday-Friday 8-4:30PST.
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/ELIZA A LAM/Primary Examiner, Art Unit 3681