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 § 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) 20, 21, 23 – 27, 29 - 31, 33 – 37, and 39 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Jarman (USPN 5,842,979). Jarman teach an apparatus and method for performing optical measurement of a subject at plural wavelengths to collect data for determining oxy-, deoxy-, carboxy-, and methemoglobin concentrations (Brief Summary of the Invention). Jarman generally indicate use of four wavelengths for assessing the four components of interest. As part of the analysis (Figures 2 and 5 and the descriptions thereof), values indicative of the four concentrations are further processed to yield final values for display, where constraints are imposed to provide a final result with a 100% of the hemoglobin components. The processing with the imposed constraint necessarily includes adjustment (scaling) to the carboxyhemoglobin value responsive to the methemoglobin value, as part of determination of the final values. The computed values are displayed or otherwise represented to the user (Figure 1 - displays).
Claim Rejections - 35 USC § 103
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.
Claims 22, 28, 32, and 38 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jarman as applied to claims 20 and 30 above, and further in view of Huiku et al. (USPN 10,092,226). Jarman teach an optical measuring apparatus and method for determination of hemoglobin component concentrations, as discussed above, including adjustment to the carboxyhemoglobin value and use of plural wavelengths; however, Jarman does not particularly indicate that a predetermined value is substituted or that five or more wavelength values are measured. Huiku et al. teach a similar invention for obtaining concentrations of hemoglobin components. As in Jarman, Huiku et al. perform a computation that includes a constraint, and additionally recognize that measurements at eight wavelengths (more than five wavelengths) yield good results for assessing met- and carboxyhemoglobin levels in addition to oxy- and deoxyhemoglobin (Figure 4; column 7, line 59 – column 9, line 8). As such, it would have been within the skill level of the art before the effective filing date of the claimed invention, to have implemented Jarman to measure at more than five wavelengths, as taught by Huiku et al., since both inventions are interested in measuring the same hemoglobin concentrations, Jarman recognize that at least one wavelength is measured for each component of interest but do not explicitly state that at least five wavelengths are relied upon, and Huiku et al. disclose that measurements at eight wavelengths provide information for determining the desired values. Further, as noted, Jarman discloses two manners of processing the hemoglobin data. One of skill in the art would recognize that alternate processing/assumptions could be followed, including to assign fixed values to some/all of the dyshemoglobin concentrations when certain conditions are met, consistent with known practice. As such, without a showing of criticality or unexpected results it would have been within the skill level of the art to have relied on fixed carboxyhemoglobin values in the processing, since it has generally been held to be within the skill level to substitute alternate equivalent processing expedients.
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 20 – 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 10 of U.S. Patent No. 9,808,188. 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 20 – 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 20 of U.S. Patent No. 10,299,709. 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 20, 21, 23 – 27, 29 – 31, 33 – 37, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 9, 10, 13, 15, and 18 of U.S. Patent No. 11,089,982. 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. Kuenstner (USPN 5,692,503) teaches an optical measurement arrangement in which oxy-, deoxy-, met-, and carboxyhemoglobin concentrations are determined.
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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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
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