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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/06/2026 has been entered.
Applicant’s amendments and remarks filed on 02/06/2026 have been fully considered.
Claims 1-4 and 6 are pending for examination. Claim 5 is cancelled.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al. (USPGPUB 2021/0059582 - cited in previous action) in view of Barman et al. (USPGPUB 2012/0035442). In regard to claim 1, Kang discloses a method comprising: irradiating light to a subject (element 102/ patient's skin 108, Fig. 1 and associated descriptions); separating wavelength components of the light that is reflected and scattered from the subject (element 126 and corresponding elements 118/128/120, Fig. 1 and associated descriptions); generating electrical signals based on the separated wavelength components (CCD 122, Fig. 1 and associated descriptions); wherein the electrical signals are representative of a Raman spectrum of the light that is reflected and scattered from the subject (Fig. 1 and associated descriptions; [0063]; [0083]); and analyzing the electrical signals to extract information on a glucose level of the subject based on the Raman spectrum (Fig. 1 and associated descriptions; [0063]; [0083]), wherein the glucose level in an interstitial fluid (ISF, [0007] and [0073]) is measured based on area ratios between three Raman spectrum peaks with respect to one another (band-area ratios, [0083]; band-area ratio/ normalization, [0109]), the three Raman spectrum peaks corresponding to a protein peak (1450 cm⁻¹ for proteins, [0083]), and a glucose peak (1125 cm⁻¹, [0083]), and wherein the Raman spectrum is obtained by using the wavelength components that are changed by Raman scattering at 830 nm (830nm, [0060-0062]); and the Raman spectra in the range of 810 cm⁻¹ to 1650 cm⁻¹ can be used in the band-area ratio calculations ([0083]).
Kang does not specifically the three Raman spectrum peaks includes a fat peak.
Barman teaches a Raman spectroscopy device for glucose monitoring in tissue/ skin (Figs. 1-25 and associated descriptions) comprises the use of 830nm excitation wavelength for generating Raman spectra in 950 to 1800 cm⁻¹ ([0059]; [0106]; [0110]; [0164]) and a peak of 1650 cm⁻¹ is corresponding to a lipid/ fat peak (1650 cm⁻¹ (Amide I protein/lipid), [0070]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method (Kang) to incorporate the additional Raman peak associated with protein/lipid as taught by Barman, since both devices are Raman spectroscopy systems for glucose monitoring and one of ordinary skill in the art would have recognized that the tissue component of protein/lipid has another Raman peak at 1650 cm⁻¹ (see Barman). The rationale would have been to obtain more information between glucose and the tissue component of protein/lipid for the band-area ratio/ normalization calculations.
In regard to claim 2, Kang as modified by Barman discloses an area for the protein peak is obtained in a range between 1415 cm⁻¹ and 1480 cm⁻¹ (1450 cm⁻¹ , [0083] of Kang).
In regard to claim 3, Kang as modified by Barman discloses an area for the fat
peak is obtained in a range between 1630 cm⁻¹ and 1685 cm⁻¹ (1650 cm⁻¹, [0070] of Barman).
In regard to claim 4, Kang as modified by Barman discloses an area for the
glucose peak is obtained in at least one of three ranges (c-i) between 1089 cm⁻¹ and
1160 cm⁻¹, (c-ii) between 1115 cm⁻¹ and 1140 cm⁻¹ or (c-iii) between 1120 cm⁻¹ and
1130 cm⁻¹ (1125 cm⁻¹, [0083] of Kang).
In regard to claim 6, Kang as modified by Barman discloses the light receiver is implemented as a charge coupled device (CCD) (element 122, Fig. 1 and associated descriptions; [0060] and [0062] of Kang).
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,502,105 in view of Kang. In regard to claim 1, Claims 1-3 of ‘105 recite all the claimed limitations except the Raman spectrum is obtained by using the wavelength components that are changed by Raman scattering at 830 nm. Kang teaches a Raman spectroscopy system for monitoring glucose (Fig. 1) comprises the use of excitation wavelength of 830nm ([0060-0062]); and the Raman spectra in the range of 810 cm⁻¹ to 1650 cm⁻¹ can be used in the band-area ratio calculations ([0083]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the NIR light source (claim 2 of ‘105) with the 830nm light source as taught by Kang to yield predictable results, since both device are Raman glucose monitoring systems and one of ordinary skill in the art would have recognized that excitation wavelength of 830nm is an alternative equivalent excitation wavelength in the NIR region for generating suitable Raman spectra of tissue (see Kang). The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
The followings are a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented:
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10-13 of copending Application No. 18/427,873 in view of Kang. In regard to claims 1-4, Claims 1 and 10-13 of ‘873 recite all the claimed limitations except the Raman spectrum is obtained by using the wavelength components that are changed by Raman scattering at 830 nm. Kang teaches a Raman spectroscopy system for monitoring glucose (Fig. 1) comprises the use of excitation wavelength of 830nm ([0060-0062]); and the Raman spectra in the range of 810 cm⁻¹ to 1650 cm⁻¹ can be used in the band-area ratio calculations ([0083]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the NIR light source (claims 1 and 10-13 of ‘873) with the 830nm light source as taught by Kang to yield predictable results, since both device are Raman glucose monitoring systems and one of ordinary skill in the art would have recognized that excitation wavelength of 830nm is an alternative equivalent excitation wavelength in the NIR region for generating suitable Raman spectra of tissue (see Kang). The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7-10 of copending Application No. 18/427,883 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 710 of ‘883 anticipates/ recites similar limitations as claim 1 of present application.
Claims 1-4 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6 of copending Application No. 18/427,907 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1-4 and 6 of ‘907 anticipates/ recites similar limitations as claims 1-4 and 6 of present application.
Response to Arguments
Applicant’s amendment and argument with respect to claim 1 filed on 02/06/2026 have been fully considered but they are deemed to be moot in views of the new grounds of rejection.
In regard to the DP rejections, applicant requested the rejections to be held in abeyance. In response, updated DP rejections are made above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHU CHUAN LIU whose telephone number is (571)270-5507. The examiner can normally be reached M-Th (6am-6pm).
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791
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