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 .
Applicant’s arguments filed on 09/08/2026 have been fully considered.
Claims 1-4 and 6 are pending for examination. Claim 5 is cancelled.
Response to Arguments
Applicant’s arguments, see the Remarks, filed on 09/08/2026, with respect to the rejection(s) of claim(s) 1-4 and 6 under 35 USC 103 rejection have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Pringle et al. (USPGPUB 2018/0042583).
In regard to the double patenting rejections, applicant requested that the rejections to be held. In response, the double patenting rejections are maintained for the reasons of record.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 and 6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In regard to claim 1, the claim recites “the glucose level in an interstitial fluid is measured based on area ratios between three Raman spectrum peaks with respect to one another, the three Raman spectrum peaks corresponding to a protein peak, a fat peak, and a glucose peak, and wherein the Raman spectrum is obtained by using the wavelength components that are changed by Raman scattering at 830 nm”. And claim 3 recites “the fat peak is obtained in a range between 1630 cm-1 to 1685 cm-1 “. However, paragraph [0085] of the PGPUB describes “blood glucose level-specific signals: 911 cm.sup.−1, 1060 cm.sup.−1, 1125 cm.sup.−1, 898 nm, 910 nm, and 915 nm, skin configuring protein-specific Raman signals: 1450 cm.sup.−1 and 943 nm, and the like) that is changed by Raman scattering at 830 nm that is necessary for measuring a target material, and may cause the signals to reach the light receiving part” and paragraph [0100] describes “Meanwhile, in a case of a peak having a central value of 1660 cm.sup.−1, the area is obtained by using a range of 1630 cm.sup.−1 to 1685 cm.sup.−1 as a peak corresponding to fats”. Examiner cannot find the adequate support(s) for the limitations of “the glucose level in an interstitial fluid is measured based on area ratios between three Raman spectrum peaks with respect to one another, the three Raman spectrum peaks corresponding to a protein peak, a fat peak, and a glucose peak, and wherein the Raman spectrum is obtained by using the wavelength components that are changed by Raman scattering at 830 nm”.
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 Pringle et al. (USPGPUB 2018/0042583). 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 and lipids, [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.
Pringle teaches a Raman spectroscopy device (Figs. 1-19 and associated descriptions) comprises the use of 830nm excitation wavelength for generating Raman spectra (“the excitation laser light may have a wavelength of 830 nm”, [0385-0386]) for skin tissue ([0139]; [0384]), and Raman peaks of 1270/1310/1445/1660/2900 cm⁻¹ is/are corresponding to lipids/proteins (1270/1310/1445/1660/2900 cm⁻¹ originate from lipids and proteins, [0471]).
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 at least one of the additional Raman peaks associated with protein/lipid as taught by Pringle, since both devices are Raman spectroscopy systems and one of ordinary skill in the art would have recognized that the tissue component of proteins and lipids have additional Raman peaks at 1270/1310/1445/1660/2900 cm⁻¹ (see Pringle; it is noted that at least 1660 cm⁻¹ is considered as a Raman peak for fat/ lipid according to [0100] of the specification of PGPUB of the present application). 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 Pringle 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 Pringle discloses an area for the fat
peak is obtained in a range between 1630 cm⁻¹ and 1685 cm⁻¹ ([0083] of Kang; 1660 cm⁻¹, [0471] of Pringle).
In regard to claim 4, Kang as modified by Pringle 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 Pringle 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.
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
