DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 2 – 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
According to Step 1 of the eligibility analysis, the claim(s) are directed to a “method” which is within a statutory category of invention.
According to Revised Step 2A, Prong One of the eligibility analysis, the claims recite(s) details of mental steps: “receiving” data; “determining” a curve based on the received data; and “comparing” the determined curve to a predefined/known curve. According to Revised Step 2A, Prong Two of the eligibility analysis, these judicial exception (abstract ideas: mental process) are not integrated into a practical application because the claims only provide details drawn to generic processing aspects beyond the judicial exception, as the claims merely require “outputting” information from results of the judicial exceptions. Examiner notes that while sensor signals are received, there are no bounds on any particular sensors for implementing the data collection or nature of the signals, nor is a measurement element/step required.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception under the eligibility analysis Step 2B because, as indicated, any additional elements in the claims are merely recited in a generalized/high level manner. In particular, there are no bounds on the manner for “outputting” the information nor does the outputting amount to a practical application as the claim scope is merely directed to well understood, conventional matters. Similarly, any optical/spectral sensor may supply the data for “receiving” thereof.
Further, no details in any dependent claim are sufficient to show integration of the judicial exception, nor do any of those claims recite details that are considered to amount to significantly more under the eligibility analysis Step 2B, since they merely recite aspects of the judicial exception(s) and/or mere generalized details.
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.
Claim(s) 2 and 3 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Benaron et al. (USPN 6,594,518). Benaron et al. teach an optical measurement arrangement (Figure 1) wherein spectral absorption data (tissue profile) is used to determine patient wellness via various classification analyses (per the Examples discussed in columns 9 - 15; see also the discussion of the classifier in column 7, line 33 - column 8, line 31 which highlights analytes of interest and in which at least some analyses are understood to be in relation to a predetermined/standard curve) and output results thereof to a user.
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 2 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 4 of U.S. Patent No. 8,965,471. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are generally commensurate in scope with those of the patent. While the patent claims do not explicitly refer to outputting a result, it would have been within the skill level of the art before the effective filing date of the claimed invention to have implemented the patent claim to include outputting/reporting the result of the analysis, consistent with known practice in the medical arts.
Claims 2 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 15 of U.S. Patent No. 9,848,807. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant invention are generally commensurate in scope with those of the patent. As such, one using the invention of the patent claims in its intended manner would necessarily perform the corresponding steps of the application claims.
Claims 2 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 15 of U.S. Patent No. 10,251,586. 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. Thus, any invention meeting the limitations of the patent claims would necessarily meet those of the instant application as well.
Claims 2 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 16 of U.S. Patent No. 10,980,457. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant invention are generally commensurate in scope with those of the patent. As such, one using the invention of the patent claims in its intended manner would necessarily perform the corresponding steps of the application claims.
Claims 2 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 16 of U.S. Patent No. 11,647,923. 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. Thus, any invention meeting the limitations of the patent claims would necessarily meet those of the instant application as well.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Benaron et al. is discussed above in relation to the prior art rejections. However, the prior art does not normalize a signal to yield a tissue profile at plural wavelengths (consistent with Figures 2 and 5 of the application), nor is there an analysis of "a shape of the tissue profile" (such as in Figure 5, where the tissue profile is compared with predetermined limits) relative to a first portion and a second portion or assessment of trends in movements of plural tissue profiles over time. Further, the other references of record do not suggest such modifications to Benaron et al.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC FRANK WINAKUR whose telephone number is (571)272-4736. The examiner can normally be reached Mon-Fri 9 am - 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chuck Marmor, II can be reached at 571-272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
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