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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/19/2026 has been entered.
Claims 1-13 and 21-27 are pending for examination. Claims 14-20 are cancelled.
Applicant's election with traverse of Invention I, claims 1-9, and Species B, Fig. 22, in the reply filed on 06/25/2025 are acknowledged.
Claims 2 and 10-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claim.
Applicant’s amendments and remarks filed on 02/19/2026 have been fully considered.
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 8 and 27 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.
In regard to claim 8, the claim recite “propagation of emitted light”. Claim 1, which claim 8 depends, recites “emitted light from the first optical emitter propagates… emitted light from the second optical emitter propagates…”. It is unclear which emitted light the limitation refers to or the emitted light is a different emitted light. Clarification is requested by amendments.
In regard to claim 27, “the lung tissue” lacks of sufficient antecedent basis. It is noted that claim 1, which claim 27 depends from, recite “a tissue”. If the tissue comprises a lung tissue or the tissue is a lung tissue, similar limitations should be set forth in the claim(s).
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, 3-9, 21, and 23-27 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuhn (USPGPUB 2012/0108925), and further in view of Shao et al. (USPGPUB 2021/0161444 – cited in previous action). In regard to claim 1, Kuhn discloses an optical monitoring device (elements 12, 20, 30, 34, and/or 40, Fig. 1 and associated descriptions) comprising: a first optical emitter (one of elements 106, 106’ or 124, Figs. 2A and 2C and associated descriptions; “It is further contemplated that one light detector could be positioned to detect light emitted by two light emitters located at two different separation distances from the light detector but emitting light through a single common window. For example, vertical cavity surface emitting lasers (VCSELs) could emit light through a common window and be positioned at two different distances (one nearer and one further) from a photodiode window. When a single light detector is used in combination with two light sources to obtain measurements at two separation distances, the emitted light signals are controlled in a time or frequency multiplexed manner to allow separate light attenuation measurements to be obtained for the two separation distances”, [0043]; it is noted that one of the emitter 124, similar to element 106 or 106’, is interpreted as the first emitter and element 128 may be indicative of the location of the first emitter, Fig. 2C), wherein the first optical emitter is configured to emit light at a first wavelength (any one of the wavelengths, [0035-0036]); and a second optical emitter (the other one of elements 106, 106’ or 124, Fig. 2C and associated descriptions [0043]; it is noted that the other one of the emitter 124, similar to element 106 or 106’, is interpreted as the second emitter and element 132 may be indicative of the location of the second emitter, Fig. 2C), wherein the second optical emitter is configured to emit light at a second wavelength that is different from the first wavelength (any different one of the wavelengths, [0035-0036]); and a first optical detector (one light detector, [0043] or a detector similar to elements 108, 108’, 128, or 132, Figs. 2A and 2C and associated descriptions; it is noted that the one light detector, similar to element 108 or 108’, is interpreted as the light detector and element 124 or 122 may be indicative of the location of the first light detector, Fig. 2C); wherein the first optical emitter is spaced a first distance away from the first optical detector along a planar surface of the optical monitoring device (distance between locations 128 and 124, Fig. 2C and associated descriptions; the defined first light emitter and the first light detector (nearer location), [0043] and Fig. 2C); wherein the second optical emitter is spaced a second distance away from the first optical detector along the planar surface of the optical monitoring device (distance between locations 132 and 124, Fig. 2C and associated descriptions; the defined second light emitter and the first light detector (further location), [0043] and Fig. 2C), wherein the first distance is less than the second distance (Fig. 2C and associated descriptions; [0043]); wherein the first optical emitter is configured so that the emitted light from the first optical emitter propagates through a tissue at a first depth of at least 1 cm into the tissue as measured from a surface of the optical monitoring device (according to the dimensions of elements 12, 20, 30, 34, and/or 40, Fig. 1 and associated descriptions and their associated configurations, e.g. Fig. 2C and [0043], it is inherent that some of the emitted light would propagates through a tissue at a depth of at least 1 cm into the tissue; It is also noted that the claim does not require the emitted light from the optical emitter propagates through a tissue at a depth of at least 1 cm into the tissue to be detected by the first detector); wherein emitted light from the second optical emitter propagates through the tissue to a second depth (different separation distances, Fig. 2C and associated descriptions; [0043]), wherein the first depth is less than the second depth (inherent property of the shorter separation distance between the first emitter and the first light detector, Fig. 2C and associated descriptions; [0043]); wherein the emitted light from the first optical emitter propagates through the tissue simultaneously with the emitted light from the second optical emitter (simultaneously, [0035] and [0052]; frequency multiplexed manner, [0043]); wherein the optical monitoring device is configured to determine a physiological parameter of the tissue using incident light detected by the first optical detector (tissue hemoglobin concentration, THC, and/or tissue oxygen saturation, O2Sat, [0003]; [0018]; [0030]; [0034]; [0050]; [0054]); and wherein the optical monitoring device is configured to be implanted in a tissue of a patient (implanted elements 12, 20 or 30, Fig. 1 and associated descriptions; implanted/ implantable, [0020]; [0025-0026]; [0032]; [0048]).
Kuhn does not specifically disclose the first optical detector is configured to selectively detect incident light with respect to its angle of incidence on the optical monitoring device.
Shao teaches a similar reflection type optical sensor (Figs. 1-10 and associated descriptions) comprises an optical detector (elements 204/304/504, Figs. 1-5 and associated descriptions) is configured to selectively detect incident light with respect to its angle of incidence on the optical monitoring device (Figs. 4A-4F and 5A-5B and associated descriptions).
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 device (Kuhn) to incorporate the optical layers, optical films, lenses, and/or window systems and associated optical elements/ functions/ configurations as taught by Shao to the optical detector, since both devices are reflection type optical sensing systems and one of ordinary skill in the art would have recognized that the light restriction designs selectively allow light having an angle of incidence within one or more acceptance viewing angles and block light with angles of incidence outside of the acceptance viewing angles and reduce unwanted/ crosstalk light signals reflected off the one or more interfaces and/or superficial layers which may lead to an erroneous signal, a low signal-to-noise ratio (SNR), or both (see at least abstract; [0035] of Shao). The rationale would have been to improve the accuracy of the optical detection/ measurement.
In regard to claim 3, Kuhn as modified by Shao discloses the first optical detector comprises an angularly selective filter (Figs. 4A-4F and 5A-5B and associated descriptions of Shao).
In regard to claim 4, Kuhn as modified by Shao discloses the angularly selective filter comprises a plurality of angled members, a grating optical filter, an alternating layer filter, a lens, a mirror, or a collimator (angled members, alternating layer filter, a lens, and/or a collimator, Figs. 4A-4F and 5A-5B and associated descriptions of Shao).
In regard to claim 5, Kuhn as modified by Shao discloses the angularly selective filter is configured to selectively transmit incident light at a first incident angle or a first range of incident angles and selectively block incident light at a second incident angle or second range of incident angles (different acceptance angles, Figs. 4A-4F and 5A-5B and associated descriptions of Shao).
In regard to claim 6, Kuhn as modified by Shao discloses the plurality of angled members comprise an angle of from 5 degrees to 75 degrees relative to a surface normal of the angularly selective filter (Fig. 4C and associated descriptions of Shao).
In regard to claim 7, Kuhn as modified by Shao discloses the first optical detector is configured to detect incident light having a first incident angle of from -75 degrees to +75 degrees relative to the surface normal (different acceptance angles, Figs. 4A-4F and 5A-5B and associated descriptions of Shao).
In regard to claim 8, Kuhn as modified by Shao discloses propagation of emitted light through a lung tissue comprises propagation of emitted light from 1 cm to 5 cm in depth as measured from a surface of the optical monitoring device (lung, [0026]; Fig. 2C and associated descriptions; [0043] of Kuhn ; Similar to claim 1 above, when the device is integrated with a pacemaker/ ICD or implanted near the lung in the patient, it is inherent that some of the emitted light would propagates through a lung tissue at a depth of at least 1 cm to 5 cm; rejected as best understood, see the 35 USC 112(b) rejection above).
In regard to claim 9, Kuhn as modified by Shao discloses the first optical emitter and the first optical detector are spaced along a planar surface of the optical monitoring device of from 1 cm to 10 cm apart (according to the relative dimensions between the separation distances of the optical elements in the implantable sensors 12 and 30 and the relative dimension of the patient and/or the pacemaker/ ICD illustrated in Fig. 1, it is inherent that the separation distance, Fig. 2C and associated descriptions; [0043] of Kuhn, would be recognized in the range of 1cm to 10cm). If not inherent, Kuhn further discloses the sensor 30 can be implanted near the lung for monitor a desired tissue volume, [0026]; and Fig. 2C and [0043] requires proper separations between the first/ second emitters and the light detector ([0043]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try different separation distances and associated sizes of the sensor for lung detection, including between 1cm to 10cm, through investigations/ experiments in order to find the optimal separation distance(s) and associated examining depths for desired lung tissue detections. The rationale would have been “obvious to try”, see KSR International Co. v. Teleflex Inc., 550 USPQ2d 398, 421(2007).
In regard to claim 21, Kuhn as modified by Shao discloses the physiological parameter is selected from the group consisting of an oxygenation status of lung tissue, a pulmonary congestion status, a temperature, and a cardiogenetic airway modulation status (O2Sat, referring to claims 1 and 8-9 above; lung, [0026] of Kuhn).
In regard to claim 23, Kuhn as modified by Shao discloses the optical monitoring device is configured to selectively activate the first optical emitter or the first optical detector during certain time periods according to a preset schedule or in response to a detected event (simultaneously, [0035]; and each activation of the device comprises control signals with a period of no light emission, [0052] of Kuhn).
In regard to claim 24, Kuhn as modified by Shao discloses the optical monitoring device is further configured to deliver or suggest a therapy to a patient in response to a detected physiological parameter ([0020-0021]; [0057-0058] of Kuhn).
In regard to claim 25, Kuhn as modified by Shao discloses an implantable optical monitoring device (referring to claim 1 above) comprising: a first optical emitter, wherein the first optical emitter is configured to emit light at a first wavelength (referring to claim 1 above); and a second optical emitter, wherein the second optical emitter is configured to emit light at a second wavelength that is different from the first wavelength (referring to claim 1 above); and a first optical detector (referring to claim 1 above), wherein the first optical detector is configured to selectively detect incident light with respect to its angle of incidence on the implantable optical monitoring device (referring to claim 1 above); wherein the first optical emitter is spaced a first distance away from the first optical detector along a planar surface of the optical monitoring device (referring to claim 1 above); wherein the second optical emitter is spaced a second distance away from the first optical detector along the planar surface of the optical monitoring device (referring to claim 1 above), wherein the first distance is less than the second distance (referring to claim 1 above); wherein the first optical emitter is configured so that the emitted light from the first optical emitter propagates through a tissue at a first depth of at least 1 cm into the tissue as measured from a surface of the implantable optical monitoring device (referring to claim 1 above); wherein emitted light from the second optical emitter propagates through the tissue to a second depth (referring to claim 1 above), wherein the first depth is less than the second depth (referring to claim 1 above); wherein the emitted light from the first optical emitter propagates through the tissue simultaneously with the emitted light from the second optical emitter (referring to claim 1 above); wherein the optical monitoring device is configured to determine a physiological parameter of the tissue using incident light detected by the first optical detector (referring to claim 1 above); and wherein the first optical emitter and the first optical detector are spaced along a planar surface of the implantable optical monitoring device of from 1 cm to 10 cm apart (referring to claims 1 and 9above).
In regard to claim 26, Kuhn as modified by Shao discloses the first optical emitter is disposed at least 6 cm away from the first optical detector (different separation distances and size of the sensor for lung detection, referring to claims 1 and 9 above)
In regard to claim 27, Kuhn as modified by Shao discloses the emitted light from the first optical emitter propagates through the lung tissue at a depth of at least 3 cm as measured from a surface of the optical monitoring device and back to the first optical detector (referring to claims 1, 9 and 26 above; It is also noted that some of the emitted light (different wavelengths and types of light source of the first emitter) would propagate through the lung tissue at a depth of at least 3 cm as measured from a surface of the optical monitoring device and back to the first optical detector, [0043] and [0045]; lung, [0026] of Kuhn).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Kuhn and Shao as applied to claims 1, 3-9, 21, and 23-27 above, and further in view of Nabutovsky et al. (USPN 8,175,668). In regard to claim 22, Kuhn as modified by Shao discloses the first emitter and the light detector comprises windows (Fig. 2C and associated descriptions; [0043] of Kuhn; referring to claim 1 above) but does not specifically disclose an optical barrier disposed between the first optical emitter and the first optical detector to prevent a direct path for light from the first optical emitter to the first optical detector
Nabutovsky teaches an implantable optical device for oxygen detection (Fig. 1A and associated descriptions) comprises a first light emitter (elements 102/104/106, Fig. 1A and associated descriptions) and a second light emitter (element 108, Fig. 1A and associated descriptions) and a light detector (element 114, Fig. 1A and associated descriptions), wherein an optical barrier is disposed between the first optical emitter and the first optical detector to prevent a direct path for light from the first optical emitter to the first optical detector (element 122, Fig. 1A and associated descriptions; Col 3 line 61 – Col 4 line 10).
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 device (Kuhn as modified by Shao) to incorporate the optical barrier between the emitter and detector as taught by Nabutovsky, since both devices are implantable optical systems for oxygen detection and one of ordinary skill in the art would have recognized that a barrier can be disposed between the emitter and detector to prevent light from traveling directly to the light sensor without interacting with the tissue (see Nabutovsky). The rationale would have been to reduce noise or unwanted signals and improve the 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, 8-9 and 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 12,446,782 in view of Shao. In regard to claims 1, 8-9 and 25 of present application, claims 1 and 3 of ‘782 recites all the claimed limitations except the first optical detector is configured to selectively detect incident light with respect to its angle of incidence on the implantable optical monitoring device. Shao teaches a similar reflection type optical sensor (Figs. 1-10 and associated descriptions) comprises an optical detector (elements 204/304/504, Figs. 1-5 and associated descriptions) is configured to selectively detect incident light with respect to its angle of incidence on the optical monitoring device (Figs. 4A-4F and 5A-5B and associated descriptions). 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 device (claims 1 and 3 of ‘782) to incorporate the optical layers, optical films, lenses, and/or window systems and associated optical elements/ functions/ configurations as taught by Shao to each of the optical detector(s), since both devices are reflection type optical sensing systems and one of ordinary skill in the art would have recognized that the light restriction designs selectively allow light having an angle of incidence within one or more acceptance viewing angles and block light with angles of incidence outside of the acceptance viewing angles and reduce unwanted/ crosstalk light signals reflected off the one or more interfaces and/or superficial layers which may lead to an erroneous signal, a low signal-to-noise ratio (SNR), or both (see at least abstract; [0035] of Shao). The rationale would have been to improve the accuracy of the optical detection/ measurement.
Response to Arguments
Applicant’s amendment and argument with respect to claims 1 and 25 filed on 02/19/2026 have been fully considered but they are deemed to be moot in views of the new grounds of rejection.
In regard to the double patent rejection, applicant traversed the rejection but did not provide any detail arguments and further requested the rejection to be held in abeyance until there is an indication of allowable subject matter. In response, the DP rejection is maintained for the reason of records.
Conclusion
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/CHU CHUAN LIU/ Primary Examiner, Art Unit 3791