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 § 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 2 – 19 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. With regard to claim 2, the claim refers to calculating “a hypersaturation index… prior to the oxygen saturation level reaching 100%” (emphasis added) which is contrary to an understanding of ‘hypersaturation’ that would be derived from analysis of the originally filed specification. For example, as generally discussed in paragraph [0006] and also with regard to Figures 3A and 4 of the originally filed disclosure, ‘hypersaturation’ is associated with conditions once the oxygen saturation has reached 100%. As such, given this discrepancy the effect of the term ‘hypersaturation’ on the bounds of the computed “index” is unclear. Similarly, in claim 7, the first timepoint is associated with a normoxic state but also indicates a “hypersaturation index” may be obtained, and thus the bounds of a calculated base ‘hypersaturation’ index is unclear for the reasons discussed with regard to claim 2.
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, 3, 7, 16, and 17 (as best understood in light of the rejections under 35 USC 112, second paragraph above) is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Al-Ali et al. (USPN 6,334,065). Al-Ali et al. teach an optical measurement arrangement (Figures 1A,1B,2) in which measurements at two wavelengths are performed, a ratio is computed therefrom, and information contained in the ratio data is used to compute both an arterial oxygen saturation value and a value different from the arterial oxygen saturation, namely a venous saturation (Figure 9; “Multiple Parameter Processing” beginning in column 15). In view of the issues under 35 USC 112 raised regarding interpretation of the term “hypersaturaiton”, one would recognize the determination of two different parameters from the same ratio to be within the bounds of the claims. Further, Al-Ali et al. indicate that events/alarms may be output responsive to conditions, including conditions relative to baseline measurement values.
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 – 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 11 of U.S. Patent No. 9,775,546. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are generally commensurate in scope. In particular, in view of the issues raised in the rejection under 35 USC 112, second paragraph, one would recognize that the claims of the patent would (at least in some instances) perform the steps of the method of the instant application.
Claims 2 – 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 10,531,819. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are generally commensurate in scope. In particular, in view of the issues raised in the rejection under 35 USC 112, second paragraph, one would recognize that the claims of the patent would (at least in some instances) perform the steps of the method of the instant application.
Claims 2 – 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9 - 17 of U.S. Patent No. 12,167,913. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are generally commensurate in scope. In particular, in view of the issues raised in the rejection under 35 USC 112, second paragraph, one would recognize one using the device of the claims of the patent in its intended manner would (at least in some instances) perform the steps of the method of the instant application.
Conclusion
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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