DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s preliminary amendments filed on 01/03/2025 are acknowledged.
Claims 29-39 are pending for examination. Claims 1-28 are cancelled.
Claim Objections
Claim 1 is objected to because of the following informalities: In regard to claim 1, the claim recites “capable of” which is not considered as positive claim languages. It is suggested “configured to” should be set forth in order to more positively claim the functions. Appropriate correction is required.
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 30-37 and 39 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. Claims that depend directly or indirectly from claims 30 and 34 is/are also rejected due to said dependency.
In regard to claims 30, 34 and 37, the claims contain conditional/ optional languages, “ if “ which do not positively claim the limitations (“Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation”, see MPEP 2103 C and 2111.04). The conditional/ optional limitations are not given patentable weight. It is suggested that “when” or similar claim languages should be set forth.
In regard to claim 33, the claim contains conditional/ optional languages, “ can “ which do not positively claim the limitations (“Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation”, see MPEP 2103 C and 2111.04). The conditional/ optional limitations are not given patentable weight. It is suggested that “are” or “configured to” or similar claim languages should be set forth.
In regard to claim 34, “the signal quality” lacks of sufficient antecedent basis. In addition, the claim recites “the processor is further configured to adjust by activating…”. It unclear what is being adjusted by activating. Clarification is requested by amendments. It is suggested that limitations such as “adjust the number of the plurality of wavelengths by activating…” recited in claim 30 should be set forth.
In regard to claim 37, “the signal quality” lacks of sufficient antecedent basis
In regard to claim 39, “the perfusion measurement” lacks of sufficient antecedent basis. It is suggested that the dependency should be changed.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 29-30, 33-34 and 37-38 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by McCutcheon et al. (USPGPUB 2009/0247849 – applicant cited). In regard to claim 29, McCutcheon discloses an optical non-invasive physiological measurement system (Figs. 1-9 and associated descriptions), the system comprising: a plurality of light emitting sources capable of emitting light at a plurality of wavelengths, each of the plurality of the light emitting sources being configured to emit light at particular wavelength of a set of wavelengths (RED LED 44 and/or IR LED 46, Fig. 2 and associated descriptions); a sensor capable of detecting the emitted light after attenuation by body tissue and outputting a signal that is useable for measuring at least one physiological parameter of the body tissue (detector 18 and associated detected signals transmitted to elements 62 and/or 14); and a processor (element 48, Fig. 2 and associated descriptions) configured to: determine, based on the signal of the sensor, a measurement of the at least one physiological parameter (blocks 302/304, Fig. 3 and associated descriptions; blocks 502/602/702/802/902, Figs. 5-9 and associated descriptions); determine, based on the signal of the sensor, a confidence indicator associated with the measurement of the at least one physiological parameter (blocks 306/308/310/502/602/702/802/904, Figs. 5-9 and associated descriptions; matching, [0006-0007] [0038]; [0047]; SpO2 threshold, [0053]; pulse amplitude threshold, [0054]; signal strength threshold, [0055]; pulse shape threshold, [0056]; thresholds, [0058]; change of data, [0075] and [0077]) ; and adjust a number of the plurality of light emitting sources that are used in operation based on the confidence indicator (one or more of the light sources may be de-energized to save power; [0028];.switch from a high power mode, i.e. both RED and IR are activated to a fourth low power mode, i.e. only one of RED or IR LEDs is activated, Fig. 3 and associated descriptions; [0065]; or switch from low power mode to high power mode, e.g. from activation of one LED to both LEDs, Figs. 5-9 and associated descriptions; [0038]; [0048]; [0051]; switching from a high power mode to a low power mode and vice versa, [0063]; or switch from a low power mode to the other low power modes, Figs. 3 and 6 and associated descriptions; [0070]).
In regard to claims 30, McCutcheon discloses the processor is further configured to adjust the number of the plurality of wavelengths by activating the plurality of light emitting sources configured to emit light at two wavelengths of the set of wavelengths (switch to high power mode with both RED and IR LEDs are activated, Figs. 3 and 5-7 and associated descriptions or switch from the fourth low power mode to the other low power modes, Figs. 3 and 6 and associated descriptions; [0008]; [0070]) if the confidence indicator is determined to be below a threshold (conditional language not given patentable weight, referring to the 35 USC 112 2nd paragraph rejection above; Figs. 5-9 and associated descriptions; [0051]; [0063]; [0075]; [0077]) .
In regard to claim 33, McCutcheon discloses the two wavelengths can be used to calculate a SpO2 reading (conditional language not given patentable weight, referring to the 35 USC 112 2nd paragraph rejection above; [0026]; [0031]; abstract).
In regard to claim 34, McCutcheon discloses the processor is further configured to adjust by activating the plurality of light emitting sources configured to emit light at the set of wavelengths if the signal quality is determined to be sufficient to support the set of wavelengths (rejected as best understood/ conditional language not given patentable weight, referring to the 35 USC 112 2nd paragraph rejections above; referring to claim 29 above).
In regard to claim 37, McCutcheon discloses the processor is further configured to adjust by activating a number of the plurality of light emitting sources that maximizes the number of physiological parameters measured if the signal quality is determined to be insufficient to support the set of wavelengths (rejected as best understood/ conditional language not given patentable weight, referring to the 35 USC 112 2nd paragraph rejections above; referring to claim 29 above).
In regard to claim 38, McCutcheon discloses the processor is configured to adjust the number of the plurality of light emitting sources that are used in operation based on a perfusion measurement made by the system (pulse amplitude, [0052]; it is commonly known in the art that the pulse amplitude is a measurement of perfusion, see at least Baker, JR, USPGPUB 2005/0197549 – applicant cited).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 31-32 and 35-36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over McCutcheon as applied to claims 29-30, 33-34 and 37-38 above, and further in view of Lamego et al. (USPGPUB 2006/0211925 – applicant cited). In regard to claims 32 and 35-36, McCutcheon discloses the emitter 16 is configured to emit at least two wavelengths of light and the RED wavelength may be between about 600 nm and about 700 nm, and the IR wavelength may be between about 800 nm and about 1000 nm ([0028]) but does not specifically the two wavelengths are 660 nm and 905 nm and the set of wavelengths comprises eight wavelengths and the set of wavelengths comprises twelve wavelengths.
Lamego teaches an oximetry device (Fig. 5 and associated descriptions) comprises the use of two wavelengths of 660 nm and 905 nm ([0028]) and a set of wavelengths comprises eight wavelengths (eight wavelengths (610, 620, 630, 655, 700, 720, 800 and 905 nm), [0008]; eight wavelengths (620, 630, 660, 700, 730, 805, 905 and 960 nm), [0028]) and a set of wavelengths comprises twelve wavelengths (twelve wavelengths of 610, 620, 630, 655, 660, 700, 720, 730, 800, 805, 905, 960 nm, [0008] and [0028]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system (McCutcheon) to incorporate the wavelengths and associated elements/ functions as taught by Lamego, since both systems are oximetry devices and one of ordinary skill in the art would have recognized that the system as taught by Lamego facilitates obtaining more physiological parameters ( [0021] and [0026]) and confidence/ probe off detection (Figs. 5-11 and associated descriptions). The rationale would have been to obtain more physiological, confidence and/or probe off information.
In regard to claim 31, McCutcheon as modified by Lamego discloses to determine patient-specific threshold ranges in which the patient's physiological parameter measurements should fall ([0033] of McCutcheon); the current measurements may be compared to thresholds if the measurements exceed a threshold range, [0045] of McCutcheon); the oxygen saturation of the patient's blood has been within a predetermined range for a predetermined time interval (0070] of McCutcheon) and typical oxygen saturation ranges for a patient is between 70%-100% (Fig. 6 and associated descriptions; [0028] of Lamego) but does not specifically disclose the threshold is 80%. It would have been obvious to one having ordinary skill in the art at the time the invention was made to try different thresholds, including 80%, for a specific patient through investigations/ experiments in order to find the optimal patient-specific threshold(s) of oxygen saturation for power mode switching determination. The rationale would have been “obvious to try”, see KSR International Co. v. Teleflex Inc., 550 USPQ2d 398, 421(2007)
Claims 39 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over McCutcheon as applied to claims 29-30, 33-34 and 37-38 above, and further in view of Neumann et al. (USPGPUB 2008/0188728). In regard to claim 39, McCutcheon discloses a perfusion measurement/ pulse amplitude measurement ( [0052]; referring to claim 38 above) but does not teach or suggest the perfusion measurement is based on a perfusion index.
Neumann teaches that pulse amplitude measurements may be affected by pulse shapes and perfusion index values taking into account the energy content value of the signal pulse. The energy content value corresponds to an area under the pulse curve, thus leading to a perfusion index value that is independent of the specific pulse shape ([0011]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the perfusion measurement/ pulse amplitude measurement (McCutcheon) to incorporate the perfusion index based measurement/ an area under the pulse curve as taught by Neumann, since both devices are oximetry systems and one of ordinary skill in the art would have recognized that the perfusion index based measurement is independent of the specific pulse shape (see Neumann). The rationale would have been to obtain more accurate perfusion 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 29-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 10,750,983. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 7 of ‘983 anticipate or recite similar limitations as claims 29-30 of present application.
Claims 29-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 11,534,087. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 7 of ‘087 anticipate or recite similar limitations as claims 29-30 of present application.
Conclusion
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791
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