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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/08/2025 has been entered.
The amendments and remarks filed on 12/08/2025 have been fully considered.
Claims 1-3 are pending for examination.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “the filter feeding member is configured to rotate…a rotational motion of the rotation member…” in claim 2.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The structures may be found in paragraphs [0078-0079] and [0083] and Figs. 4-6 of the specification.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Kwok et al. (USPN 8,879,060) in view of Chaiken et al. (USPN 6,044,285) and further in view of Gillispie et al. (USPGPUB 2004/0007675 – cited in previous action). In regard to claim 1, Kwok discloses an apparatus for measuring glucose level in a sample (Figs. 1a and 1b and associated descriptions), comprising: a light source configured to irradiate light to a sample (element 28 and sample 20, Figs. 1a and 1b and associated descriptions); a filter wheel that filters the light reflected and scattered by the sample (element 34, Figs. 1a and 1b and associated descriptions; Col 3 lines 13-44) , wherein the filter wheel includes a plurality of optical filters configured to transmit lights of different wavelength components (Figs. 2a-2f and associated descriptions; a plurality of optical filters, Col 1 lines 53-64; optical filters, Col 3 lines 13-44); a light receiver configured to receive the light filtered by the filter wheel and generate electrical signals based on the filtered light (element 24, Figs. 1a and 1b and associated descriptions); a processor configured to extract information on the glucose level of the sample based on a Raman shift of the light (elements 26/40/44, Figs. 1a and 1b and associated descriptions; Figs. 7a-7b and associated descriptions; Col 14 line 7 – Col 15 line 15; claims 1, 5 and 9) and a collection lens disposed before the filter wheel to concentrate the light reflected and scattered by the subject onto one of the plurality of optical filters of the filter wheel (elements 32 or 64, Figs. 1a and 1b and associated descriptions), wherein the filter wheel is rotationally movable and is configured to sequentially dispose each of the plurality of optical filters in front of the light receiver (element 34, Figs. 1a and 1b and associated descriptions; Figs. 2a-2f and associated descriptions; motor, Col 3 lines 13-44) and wherein the processor is configured to extract the information on the blood glucose level based on the electrical signals that are sequentially obtained by the light receiver through the filter wheel (Figs. 7a-7b and associated descriptions; Col 3 line 60 – Col 4 lines 20; Col 14 line 7 – Col 15 line 15; claims 1, 5 and 9).
Kwok does not specifically discloses the sample is a tissue of a subject and the glucose level is a blood glucose level.
Chaiken teaches a Raman spectroscopy system (Figs. 1-2 and associated descriptions) which measuring an analyte in a sample (element 200, Figs. 1-2 and associated descriptions), wherein the sample can be can be a tissue in a subject, including, for example, skin, muscle, capillary beds, blood, breast or brain (Col 8 lines 25-36) and the sample is measured non-invasively (Col 3 lines 1-15), wherein the analyte includes blood glucose concentration (Col 7 lines 13-47).
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 apparatus (Kwok) to incorporate the non-invasive techniques to direct excitation to a subject for measuring blood glucose information as taught by Chaiken, since both devices are glucose Raman spectroscopy systems and one of ordinary skill in the art would have recognized that blood glucose information can be obtained in a non-invasive manner from a tissue site of a subject. The rationale would have been to non-invasively obtain blood glucose information form a subject.
Kwok as modified by Chaiken does not specifically disclose the filter wheel is a filter array which is linearly movable and is configured to sequentially dispose each of the plurality of optical filters in front of the light receiver.
Gillispie teaches an optical/ a spectroscopy apparatus (Figs. 1 and 3-4 and associated descriptions) comprising a filter array (linear variable array 318, Fig. 3 and associated descriptions; [0050]); a rotation member coupled to the filter array (element 322, Fig. 3 and associated descriptions; [0050]); and a filter feeding member coupled to the rotation member (element 324, Fig. 3 and associated descriptions; [0050]), wherein the filter feeding member is configured to rotate the rotation member (Fig. 3 and associated descriptions; [0050]), and wherein a rotational motion of the rotation member is converted to a linear motion of the filter array (Fig. 3 and associated descriptions; [0050]), thereby causing each of the plurality of optical filters to sequentially dispose in front of a light path (linear variable filters 3181-N, Fig. 3 and associated descriptions; sequentially, [0048]; control and repeat, [0050-0051]).
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 configuration of the filter wheel (Kwok as modified by Chaiken) with the configuration of a filter array and associated elements/ function as taught by Gillispie to yield predictable results, since both devices are optical spectroscopy systems and one of ordinary skill in the art would have recognized that the configuration of a linear variable filter is an alternative equivalent configuration as using a filter wheel (see Figs. 3-4 and associated descriptions of Gillispie). 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.
In regard to claim 2, Kwok as modified by Chaiken and Gillispie discloses a rotation member coupled to the filter array (element 322, Fig. 3 and associated descriptions; [0050] of Gillispie); and a filter feeding member coupled to the rotation member (element 324, Fig. 3 and associated descriptions; [0050] Gillispie), wherein the filter feeding member is configured to rotate the rotation member (Fig. 3 and associated descriptions; [0050] Gillispie), and wherein a rotational motion of the rotation member is converted to a linear motion of the filter array (Fig. 3 and associated descriptions; [0050] Gillispie), thereby causing each of the plurality of optical filters to be sequentially disposed in front of the light receiver (linear variable filters 3181-N, Fig. 3 and associated descriptions; sequentially, [0048]; control and repeat, [0050-0051] Gillispie; referring to claim 1 above).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Kwok, Chaiken and Gillispie as applied to claims 1-2 above, and further in view of Rowe et al. (USPGPUB 2004/0240712 – cited in previous action). In regard to claim 3, Kwok as modified by Chaiken and Gillispie discloses all the claimed limitations except a first lens disposed in front of the light source to concentrate the light irradiated by the light source; a first mirror disposed in front of the first lens to deflect the light concentrated by the first lens; a first wavelength plate disposed downstream of the first mirror to adjust a polarization direction of the light deflected by the first mirror; a second wavelength plate that adjusts a polarization direction of the light reflected and scattered from the subject; a second mirror disposed downstream of the second wavelength plate to deflect the light adjusted by the second wavelength plate; a second lens disposed in front of the second mirror to concentrate the light deflected by the second mirror; and an optical filter disposed between the second lens and the filter array to allow light of a predetermined wavelength band to be transmitted to the filter array.
Rowe teaches an optical glucose measuring apparatus (Figs. 1-3 and associated descriptions) comprises a light source (element(s) 103a-b/ 303a-b, Figs. 1 and 3 and associated descriptions) and a light detector (element 115 or 317, Figs. 1 and 3 and associated descriptions), a first lens disposed in front of the light source to concentrate the light irradiated by the light source (element(s) 105a-b/ 303a-b, Figs. 1 and 3 and associated descriptions); a first mirror disposed in front of the first lens to deflect the light concentrated by the first lens (one or more mirrors, [0050]); a first wavelength plate disposed downstream of the first mirror to adjust a polarization direction of the light deflected by the first mirror (element(s) 107a-b/ 307a-b, Figs. 1 and 3 and associated descriptions); a second wavelength plate that adjusts a polarization direction of the light reflected and scattered from the subject (elements 111/311, Figs. 1 and 3 and associated descriptions); a second mirror disposed downstream of the second wavelength plate to deflect the light adjusted by the second wavelength plate (mirrors, [0054]); a second lens disposed in front of the second mirror to concentrate the light deflected by the second mirror (elements 113/319/315, Figs. 1 and 3 and associated descriptions); and an optical filter disposed between the second lens and a dispersive optical element to allow light of a predetermined wavelength band to be transmitted to the dispersive optical element (the function recited after “allow” are considered as intended uses with insufficient patentable weights; filters, [0051-0052], [0057] and [0061]; the filter(s) may be located at any of a variety of points in both the illumination and detection subsystems, [0065]).
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 optical configurations of the system (Kwok as modified by Chaiken and Gillispie) to incorporate the optical elements of lens, mirrors, polarization elements, filters and associated configurations as taught by Rowe, since both devices are optical glucose monitoring systems and one of ordinary skill in the art would have recognized that optical elements of lens, mirrors, and polarization elements facilitate focusing, concentrating, redirecting light from light sources or to light detector and polarizers/ filters facilitate reducing directly reflected/ unwanted light being detected (see at least [0052-0053] of Rowe). The rationale would have been to obtain more accurate optical measurements.
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 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 18/427,880 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-3 of ‘880 anticipated/ recite similar limitations of claims 1-3 of present application. It is noted that paragraphs [0076-0083] of the specification of the PGPUB of the present application indicate that a diffracting grating a prism, optical filters, filter array, or linear variable filter are alternative equivalent monochrome parts(s).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments, see page 4 of Remarks, filed on 12/08/2025, with respect to claims 1-3 have been fully considered and are persuasive. The 35 USC 112(b) rejection of claims 1-3 has been withdrawn.
Applicant’s amendment and argument with respect to claim 1 filed on 12/08/2025 have been fully considered but they are deemed to be moot in views of the new grounds of rejection.
In regard to the double patenting rejections, applicant requests that the rejections be held in abeyance. However, an updated DP rejection is provided (see above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Keenan et al. (USPGPUB 2008/0072663) teaches an alternative to a filter wheel is a linear filter translated by a motor. The linear filter may include an array of separate filters or a single filter with properties that change along a linear dimension ([0141]).
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791