DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/762,420 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the pending claims has been broadened and the claims are therefore anticipated by the co-pending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5, 9-12, 18-19, 21 and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over US Publication 2009/0213370 to Kim et al., in view of US Publication 2023/0375525 to Merritt et al.
Regarding claims 1, 28 and 30, Kim discloses and shows in Figures 4 and 7, a system comprising:
a pump light source (401) configured to produce a pump beam of light at a pump frequency (par. 14-17, 45);
a Stokes light source (402) configured to produce a Stokes beam of light at a Stokes frequency, wherein the pump and Stokes frequencies are offset by a frequency offset Ω (par. 8, 14-17, 45);
one or more optical elements (411-418) configured to:
direct the pump and Stokes beams of light to a sample (S) (par. 45-50; wherein a plurality of beamsplitters, combiners, mirrors and objectives are utilized to direct and receive the light beams);
receive a Raman signal produced by coherent Raman scattering of the pump and Stokes beams of light at the sample (par. 14-17, 45-50; wherein a plurality of beamsplitters, combiners, mirrors and objectives are utilized to direct and receive the light beams); and
direct the Raman signal to an optical receiver (419) (par. 14-17, 45-50; wherein a plurality of beamsplitters, combiners, mirrors and objectives are utilized to direct and receive the light beams); and
the optical receiver, wherein the optical receiver is configured to detect the Raman signal, the optical receiver comprising:
a probe light source (410) configured to produce a probe beam of light at a probe frequency (par. 15, 17, 46, 48; wherein a reference light source provides a beam with a higher and/or lower frequency to generate an interference signal);
an optical detector (419) configured to coherently mix a portion of the Raman signal with at least a portion of the probe beam of light to produce a corresponding photocurrent signal (par. 14-17, 45-50; wherein an interference signal is detected to determine phase differences and analyze an interference signal); and
an electronic circuit (430) configured to produce a digital output signal corresponding to the photocurrent signal (par. 14-17, 45-50; wherein an imaging unit provides analyses, images and outputs a detected signal);
[claim 28] further comprising a processor (430) configured to determine a characteristic of the photocurrent signal based on the digital output signal (par. 45, 50);
[claim 30] further comprising a display configured to display a value, image, or graph associated with the sample (par. 50).
Kim differs from the limitations in that it is silent to the system further comprising: a photonic integrated circuit (PIC) comprising a plurality of optical waveguides.
However, Merritt teaches and shows in Figures 3a-d, 19-23, and 47-52, a spectroscopic optical sensing module (par. 1, 34), comprising a compact wearable device for obtaining a variety of measurements from a patient (par. 3-4, 34-36), wherein a plurality of photonic integrated circuits (PIC) are utilized to provide a plurality of light sources (4903, 4933), a plurality of photodetectors (4902), an optical multiplexer (1905, 4805, 4835), which may be an echelle grating (par. 42, 56, 209), and a plurality of manipulation elements (211-214), which may include one or more lenses, mirrors or splitters (par. 43, 52, 56, 179) (par. 5).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention, to modify Kim to include the PIC and other well-known optical components discussed above for the advantage of utilizing well-known optical components to obtain a compact minimally invasive optical sensor, with a reasonable expectation of success.
Regarding claims 2-5 and 26, Kim discloses the CARS system further comprising a plurality of beamsplitters, combiners, mirrors and objectives (411-418), which are utilized to split, combine, and generally transmit a plurality of light beams (par. 14-17, 45-50).
Kim differs from the limitations in that it is silent to the system further comprising:
[claim 2] wherein the PIC further comprises a waveguide combiner configured to combine the pump and Stokes beams of light to produce a combined pump-Stokes beam of light that is directed to the sample by one of the optical waveguides;
[claim 3] wherein the PIC further comprises a waveguide combiner configured to combine the Raman signal and the probe beam of light to produce a combined probe-Raman signal that is directed to the optical detector by one of the optical waveguides;
[claim 4] wherein the waveguide combiner is further configured to direct at least a portion of the pump beam of light to the sample, wherein the pump beam of light and the Raman signal propagate in opposite directions along one of the optical waveguides;
[claim 5] wherein the pump beam of light and the Stokes beam of light are directed to the sample separately by different optical waveguides;
[claim 26] wherein the PIC is a multi-chip PIC that comprises two or more secondary PICs, each of the secondary PICs comprising one or more of the optical waveguides.
However, Merritt teaches and shows in Figures 3a-d, 19-23, and 47-52, a spectroscopic optical sensing module (par. 1, 34), comprising a compact wearable device for obtaining a variety of measurements from a patient (par. 3-4, 34-36), wherein a plurality of photonic integrated circuits (PIC) are utilized to provide a plurality of light sources (4903, 4933), a plurality of photodetectors (4902), an optical multiplexer (1905, 4805, 4835), which may be an echelle grating (par. 42, 56, 209), and a plurality of manipulation elements (211-214), which may include one or more lenses, mirrors, splitters, (par. 43, 52, 56, 179) (par. 5). Further, Merritt teaches and shows in Figures 51-52, an SRS Raman spectrometer system, wherein a first waveguide (5102, 5202) is utilized to provide the light beams to a sample, and a second waveguide (5152, 5252) is utilized to receive light from a sample and transmit it to a detector (par. 351-357).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention, to modify Kim to include the grating, mirrors and other well-known optical components discussed above for the advantage of utilizing well-known optical components to obtain a compact optical healthcare sensor, with a reasonable expectation of success.
Regarding claims 9-12, Kim differs from the limitations in that it is silent to the system further comprising:
[claim 9] wherein one of the optical waveguides comprises a grating configured to direct the pump and Stokes beams of light to the sample along a direction that is at an angle with respect to a plane of the PIC;
[claim 10] wherein a second optical waveguide comprises a grating configured to receive the Raman signal and direct the Raman signal to propagate along the second waveguide to the optical receiver;
[claim 11] wherein the optical detector is one of a plurality of optical detectors, wherein each detector is configured to receive a portion of the Raman signal produced from a different part of the sample;
[claim 12] further comprising a mirror configured to direct the pump and Stokes beams of light to the sample along a direction that is at an angle with respect to a plane of the PIC.
However, Merritt teaches and shows in Figures 3a-d, 19-23, and 47-52, a spectroscopic optical sensing module (par. 1, 34), comprising a compact wearable device for obtaining a variety of measurements from a patient (par. 3-4, 34-36), wherein a plurality of photonic integrated circuits are utilized to provide a plurality of light sources (4903, 4933), a plurality of photodetectors (4902), an optical multiplexer (1905, 4805, 4835), which may be an echelle grating (par. 42, 56, 209), and a plurality of manipulation elements (211-214), which may include one or more lenses, mirrors, splitters, (par. 43, 52, 56, 179) (par. 5).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention, to modify Kim to include the grating, mirrors and other well-known optical components discussed above for the advantage of utilizing well-known optical components to obtain a compact optical sensor, with a reasonable expectation of success.
Regarding claims 18-19, 21, 27 and 29, Kim differs from the limitations in that it is silent to the system further comprising:
[claim 18] wherein the system is configured to be affixed to a patient’s body;
[claim 19] wherein the sample comprises sweat, skin, interstitial fluid, blood, or saliva;
[claim 21] wherein the system is configured to direct the pump and Stokes beams into the patient’s body;
[claim 27] further comprising a rechargeable battery configured to supply power to the system, wherein the battery is configured to be charged by wired charging or wireless charging;
[claim 29] further comprising a processor configured to communicate with an external computer using a wired connection or a wireless connection.
However, Merritt teaches and shows in Figures 51-52 and 60, a wearable spectroscopy module, which may include: skin contact patches, watches, rings, ear buds, head bands and glasses (par. 1-3); and wherein the module may perform a variety of healthcare measurements from sweat, skin, blood (par. 36, 51, 378). Further, the wearable device includes a battery (par. 190) and may communicate with a hospital’s data system (par. 380) or a cloud data system (par. 390-391). Additionally, wired and wireless charging of wearable or portable devices are well-known to those of ordinary skill in the art.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention, to modify Kim to include the wearable optical sensing module discussed above for the advantage of providing real-time healthcare measurements and diagnostics, with a reasonable expectation of success.
Claim(s) 13-17 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Kim and Merritt, and further in view of US Publication 2024/0041328 to Mannion et al.
Regarding claims 13-17 and 22, Kim differs from the limitations in that it is silent to the system further comprising:
[claim 13] an optical fiber coupled to one of the optical waveguides, wherein the optical fiber is configured to receive the pump and Stokes beams from the optical waveguide and direct the pump and Stokes beams to the sample;
[claim 14] wherein the optical fiber is further configured to receive the Raman signal and direct the Raman signal to the optical waveguide.
[claim 15] wherein the optical fiber is a first optical fiber, and the system further comprises a second optical fiber configured to receive the Raman signal and direct the Raman signal to a second optical waveguide, wherein the second waveguide directs the Raman signal to the optical receiver;
[claim 16] wherein the system is configured to be affixed to a patient’s body, wherein the optical fiber extends into the patient’s body and directs the pump and Stokes beams into the patient’s body;
[claim 17] wherein the optical fiber is coated with a biocompatible coating;
[claim 22] further comprising one or more optical fibers configured to be inserted into the patient’s body, wherein the pump and Stokes beams are directed into the patient’s body and the Raman signal is collected and directed to the system by the one or more optical fibers.
However, Mannion teaches and shows in Figures 1a-2a, a minimally invasive spectrometer system, a wearable device (220) comprising a PIC with a plurality of light sources (118), a photodetector (120), a display (145), a battery (150), a wireless communicator (140) and a controller (135), which is attached to the skin, and an endoscope or needle (205) is inserted into a subject’s skin, the endoscope further containing one or more transmitting fibers (105) and one or more receiving fibers (110) (par. 102-106, 112). Further, the needle or endoscope may include a biocompatibility coating (par. 117).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention, to modify Kim to include the optical fibers and configurations discussed above for the advantage of utilizing well-known optical components to obtain a minimally invasive healthcare sensor, with a reasonable expectation of success.
Claim(s) 6 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Kim and Merritt, and further in view of US Publication 2017/0052015 to Swanson et al.
Regarding claims 6 and 23-25, Kim differs from the limitations in that it is silent to the system further comprising:
[claim 6] further comprising an optical circulator comprising a first port, a second port, and a third port, wherein the optical circulator is configured to: receive the pump and Stokes beams at the first port, and direct the pump and Stokes beams to exit the circulator via the second port, wherein the second port is coupled to an optical waveguide that directs the pump and Stokes beams to the sample; and receive the Raman signal at the second port and direct the Raman signal to exit the circulator via the third port, wherein the third port is coupled to another optical waveguide that directs the Raman signal to the optical receiver;
[claim 23] wherein the PIC is made from a flexible material;
[claim 24] wherein the PIC is attached to a flexible substrate;
[claim 25] wherein the PIC comprises: silica-on-silicon, silicon-on-insulator (SOI), indium phosphide (InP), silicon nitride (SiN), lithium niobate (LiNbO3), lithium tantalate (LiTaO3), graphene, or a polymer.
However, Swanson teaches and shows in Figures 2-8, an optical imaging system (par. 2, 58) which includes a plurality of “90 degree hybrid processors”, integrated onto one or more photonic integrated circuits (PIC) (par. 5-6, 64, 90), wherein the processors include a variety of well-known optical components, such as optical fibers, optical couplers, circulators, beam splitters, detectors, polarization modulators and phase modulators (par. 70-79, 85, 88). Further, Swanson teaches the system wherein the PIC may be comprised of various well-known materials, e.g. Silicon, Indium Phosphide, Germanium (par. 5, 64), which may be flexible; and wherein the PIC is a multi-chip PIC that comprises two or more secondary PICs, each of the secondary PICs comprising one or more of the optical waveguides (par. 5, 64).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention, to modify Kim to include the optical components and configurations discussed above for the advantage of utilizing well-known optical components to obtain a desired system configuration, with a reasonable expectation of success.
Claim(s) 7-8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kim and Merritt, and further in view of US Publication 2024/0206783 to Dubrovsky et al.
Regarding claims 7 and 20, Kim differs from the limitations in that it is silent to the system further comprising:
[claim 7] wherein the PIC further comprises an evanescent waveguide, wherein the Raman signal is produced by evanescent-field portions of the pump and Stokes beams that extend into the sample while the pump and Stokes beams propagate along the evanescent waveguide;
[claim 8] further comprising a hollow waveguide, wherein the sample comprises a fluid or gas that flows into the hollow waveguide, and the Raman signal is produced while the pump and Stokes beams propagate through the hollow waveguide.
[claim 20] wherein the sample comprises a part of the patient’s body, and the pump and Stokes beams interact with the sample via an evanescent waveguide or a hollow waveguide.
However, Dubrovsky teaches and shows in Figures 37a-37b, a wearable biosensor for real-time monitoring of a biological specimen (par. 5), wherein a PIC is utilized to support a plurality of light sources and detectors (par. 71), wherein an evanescent waveguide is inserted into a patient with a hollow needle and is utilized to transmit and receive measurement light (par. 158, 173, 175, 199, 212, 230). Further, hollow waveguides are well-known to those of ordinary skill in the art and the hollow needle may also be viewed as a hollow waveguide.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention, to modify Kim to include the evanescence waveguide and configurations discussed above for the advantage of utilizing well-known optical components to obtain real-time monitoring of a biological specimen, with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HANSEN whose telephone number is (571)270-1736. The examiner can normally be reached Monday to Friday, 8am to 4pm.
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JONATHAN M. HANSEN
Primary Examiner
Art Unit 2877
/JONATHAN M HANSEN/Primary Examiner, Art Unit 2877
