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 .
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(s) 7 – 9 and 14 – 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dietiker (USPN 8,271,063). Dietiker teach a non-invasive medical sensor including two detectors with respective spectral response curves (Figures 7, 9 and the descriptions thereof) and a non-monochromatic light source (broad source/white LED – as shown in Figure 13 and discussed in column 11, line 36 – column 12, line 2). Dietiker teaches that a quotient/ratio of the measurements from the two detectors (column 8, lines 18 - 33) provides information on wavelength (this detail is discussed in the instant application in the same manner). Dietiker indicates (in the Figure 13 section highlighted above) that the sensor may collect light emitted from the broad light source with the sensor to determine pulse information, wherein the pulse information is used for controlling timing of the measurements of the oxygen saturation. Further, Examiner notes that the claim uses the open-ended transition term “comprising” indicating that other steps/structures may be included in a prior art teaching and still be within the BRI of the claim scope. Additionally, the claims set forth the step/limitation for “generating” a value. Given this understanding, one of skill in the art would recognize that the teaching of Dietiker is generating an oxygen saturation value “based on” the detected non-monochromatic light, since the data from the broad/white LED is required for “generating” the final measurement result.
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 7 – 10, 13 – 15, 18, and 22 – 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 10,485,463. The claims of the instant application are generally consistent with those of the patent. While the invention of the patent claims indicates use of detectors with different spectral response curves for sensing the emitted non-monochromatic light, the claims do not specify the spectral region of the sensing band, as set forth in the pending claims. However, one would recognize that 1) the detector must necessarily have a spectral sensing bandwidth to meet the claim and properly provide the data for analysis and 2) it would have been within the skill level to perform routine experimentation to determine parameters of the spectral response band, including to use detectors with response curves having a spectral range as claimed, since this covers the region where the measured analyte (hemoglobin) is spectrally responsive and it has generally been held that such considerations are within the skill of the art.
Claims 7 – 10 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 11,350,861. The claims of the instant application are generally consistent with those of the patent. While the invention of the patent claims indicates use of detectors with different spectral response curves for sensing the emitted non-monochromatic light, the claims do not specify the spectral region of the sensing band, as set forth in the pending claims. However, one would recognize that 1) the detector must necessarily have a spectral sensing bandwidth to meet the claim and properly provide the data for analysis and 2) it would have been within the skill level to perform routine experimentation to determine parameters of the spectral response band, including to use detectors with response curves having a spectral range as claimed, since this covers the region where the measured analyte (hemoglobin) is spectrally responsive and it has generally been held that such considerations are within the skill of the art.
Response to Arguments
Applicant's arguments filed February 9, 2026 have been fully considered but they are not persuasive. Applicant asserts that the amended claim scope is not taught by Dietiker. Applicant has amended the claims with regard to the spectral sensitivity/range of the first and second detectors (by incorporating details of previously pending claim 27). As noted in the prior Office action, Dietiker provides information on the response curves of the detectors utilized in their sensor at Figure 9. One of skill in the art reviewing the figure would conclude that the corresponding responses are within the amended claim bounds. As such, Applicant's assertion is not persuasive.
Examiner notes that Applicant has not otherwise addressed the details/discussion of the prior art rejection and thus, it appears that Applicant agrees with Examiner's interpretation of the bounds of the claim with regard to the understanding of the requirements of the "generating... based on...." language. Further, Applicant's claims provide an indication of the breadth of this construction in the independent claim, in that dependent claim 10, provides additional/specific aspects of the processing that are not imposed on the scope of claim 7. Based on the narrower scope encompassed by claim 10, the claim was not rejected with the prior art.
With regard to the Double Patenting rejections, Applicant has acknowledged the rejections and has indicated a willingness to consider filing a Terminal Disclaimer to overcome the rejections. However, without formally arguing the merits of the rejection or filing the TD, the rejections are not overcome. The Double Patenting rejection has been updated to account for the amended claim scope, but is otherwise maintained.
Allowable Subject Matter
Claims 11 and 12 are allowed.
Claims 17, 19 – 21, 25, and 26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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