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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 29-38 and 42-48, drawn to a system to determine blood pressure using pulse wave velocity and the blood velocity, classified in A61B 2562/0247.
II. Claims 39-41, drawn to a device to determine blood pressure using blood velocity, classified in A61B 5/0075
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the combination does not require a pulse wave detector. The subcombination has separate utility such as being able to determine blood pressure using blood velocity alone.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: The inventions have acquired a separate status in the art in view of their different classification, the inventions have acquired a separate status in the art due to their recognized divergent subject matter and the inventions require a different field of search.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Katherine Mead on 8/6/26 a provisional election was made without traverse to prosecute the invention of Group I, claims 29-38 and 42-48. Affirmation of this election must be made by applicant in replying to this Office action. Claims 39-41 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 7/20/26; 2/20/26; 7/10/25; 4/4/25; 1/13/25; 11/1/24(2) has/have been acknowledged and is/are being considered by the Examiner.
Specification
The disclosure is objected to because of the following informalities: the first paragraph of the specification should be updated to indicate the present status of the priority application.
Appropriate correction is required.
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.
Claim(s) 29, 37-38, 42, 47-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Habu et al. (U.S. Pat. 6,176,832 hereinafter “Habu’) in view of GU (U.S. Pub. 2016/0287095).
Regarding claim 29 and 42, Habu discloses a system and method comprising: an emitter (e.g. 4a) configured to emit light towards blood in a blood vessel (e.g. Col. 4, Il. 13-35); a detector (e.g. 4a) configured to detect scatter of the light caused by an interaction of the light with the blood in the blood vessel (e.g. Col. 4, Il.13-35); a pulse wave velocity detector configured to detect a pulse wave velocity of a pulse traveling along the blood vessel (e.g. 7); and a processor electrically coupled to the emitter, the detector, and the pulse wave velocity detector and configured to: determine, by analyzing the scatter of the light, a blood velocity of the blood in the blood vessel (e.g. 6); and determine a blood pressure using the pulse wave velocity and the blood velocity (e.g. 8). Habu discloses the claimed invention except for the emitter and detector being light based systems. However, GU teaches that it is known to use either light or ultrasonic sensors interchangeably as set forth in Paragraph 6 to provide a known means for determining the same blood values with known sensors that can be used interchangeably. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Habu, with light sensors as taught by GU, since such a modification would provide the predictable results of using a known light sensor that is well known in the art as a substitute for an ultrasonic sensor data as it known in the art that substituting one known sensor for another sensor that provides the same data is obvious to one having ordinary skill the art.
Regarding claim 37, meeting the limitations of claim 29 above, Gu further discloses a display configured to output an indication of the blood pressure (e.g. 61).
Regarding claim 38, meeting the limitations of claims 29 and 37 above, Habu further discloses wherein the processor is further configured to determine, by analyzing the scatter of the light, a characteristic of the blood vessel, wherein the characteristic of the blood vessel comprises a depth of the blood vessel, a diameter of the blood vessel, a wall thickness of the blood vessel, or a wall elasticity of the blood vessel, and wherein the display is further configured to output an indication of the characteristic (e.g. Col. 5, ll. 10-19; Col. 10, ll. 53-59).
Regarding claim 47, meeting the limitations of claim 42 above, Habu further discloses determining, by analyzing the scatter of the light, a characteristic of the blood vessel, the characteristic comprising a depth of the blood vessel, a diameter of the blood vessel, a wall thickness of the blood vessel, or a wall elasticity of the blood vessel (e.g. Col. 5, ll. 10-19; Col. 10, ll. 53-59).
Regarding claim 48, meeting the limitations of claim 42 above, Habu further discloses determining, by analyzing the scatter of the light, a wall elasticity of the blood vessel (e.g. Col. 5, ll. 10-19; Col. 10, ll. 53-59).
Claim(s) 30-32, 35-36 and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Habu in view of Gu as applied to claims 29, 37-38, 42, 47-48 above, and further in view of Eisen et al. (U.S. Pub. 2014/0200423 hereinafter “Eisen”).
Regarding claims 30-32, 35-36 and 45, Habu in view Gu discloses the claimed invention except for explicitly stating that the two emitters have differing intensities, wavelengths or coherency. However, Eisen teaches that it is known to use different frequencies including infrared, and differing diffusers for each light source as set forth in Paragraphs 47, 54, 68-69 and 73 to provide a means for producing various wavelengths for more accurately determining pulse characteristics. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Habu in view of Gu, with diffused coherent and non-coherent lasers in various frequencies including infrared as taught by Eisen, since such a modification would provide the predictable results of substituting one known light source for another known light source for providing light sources of various wavelengths and for more accurately determining pulse characteristics.
Claim(s) 33-34, 43-44 and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Habu in view of Gu as applied to claims 29, 37-38, 42, 47-48 above, and further in view of Satomi et al. (U.S. Pub. 2015/0208933 hereinafter “Satomi”).
Regarding claims 33-34 and 43-44, Habu in view of Gu discloses the claimed invention except for explicitly describing the exact locations of the sensors. However, Satomi teaches that it is known to use sensors that can be located on the same or separate sides of the vessel as set forth in Figure 1 and Paragraphs 98 and 102 to provide a means for accurately sensing the pulse wave in ay configuration on the wrist using forward and/or reverse scattered signals. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Habu in view of Gu, with diffused coherent and non-coherent lasers in various frequencies including infrared as taught by Satomi, since such a modification would provide the predictable results of locating sensors around the wrist to allow for a means for accurately sensing the pulse wave in ay configuration on the wrist using forward and/or reverse scattered signals.
Regarding claim 46, Habu in view of Gu discloses the claimed invention except for the pulse wave velocity coming from an external device. However, Satomi teaches that it is known to use a pulse wave velocity coming from an external device as set forth in Paragraph 63 and 342 to provide a pulse wave signal from an external ear worn sensor. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Habu in view of Gu, with an external pulse wave sensor as taught by Satomi, since such a modification would provide the predictable results of using an external ear worn device for proving a pulse wave signal.
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, 32-33, 38, 42, 44 and 47-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 12, 15 and 20-21 of U.S. Patent No. 11,357,415. Although the claims at issue are not identical, they are not patentably distinct from each other because both are directed toward the same subject matter and the claims of the '415 patent anticipate the corresponding claims in the current application. Regarding claims 29, 32-33, 42 and 44, a sensor comprising: an emitter configured to emit light towards blood flowing through a blood vessel ('415 patent; claim 1, lines 4-5; claim 15, lines 3-4; claim 20, lines 2-3); and a detector configured to detect first scattered light that is scattered from the blood flowing through the blood vessel and second scattered light that is scattered from a wall of the blood vessel ('415 patent; claim 1, lines 7-10; claim 15, lines 5-10; claim 20, lines 4-8), a frequency of the first scattered light being different than a frequency of the light emitted towards the blood flowing through the blood vessel ('415 patent; claim 1, lines 8-10; claim 15, lines 6-10; claim 20, lines 5-9); and a processor configured to: determine a blood velocity of the blood flowing through the blood vessel using the frequency of the first scattered light ('415 patent; claim 1; lines 12-15; claim 15, lines 11-14; claim 20, lines 10-13); determine a pulse wave velocity of the blood vessel using a frequency of the second scattered light ('415 patent; claim 1, lines 16-17; claim 15, lines 15-16; claim 20, lines 14-15); and determine a blood pressure as a function of the blood velocity and the pulse wave velocity ('415 patent, claim 1, lines 18-19; claim 15, lines 17-18; claim 20, lines 16-17). Claims 38 and 47-48 are anticipated by claim 12 of the '415 patent.
Claims 29-32, 34-36, 38, 42-43 and 45-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 3-6, 12, 13 and 15 of U.S. Patent No. 12,161,445. Although the claims at issue are not identical, they are not patentably distinct from each other because both are directed toward the same subject matter and the claims of the '445 patent anticipate the corresponding claims in the current application. Regarding claims 29-32, an emitter configured to emit light towards blood flowing through a blood vessel ('445 patent; claim 1, Column 21, ll. 55-57); and a detector configured to detect first scattered light that is scattered from the blood flowing through the blood vessel and second scattered light that is scattered from a wall of the blood vessel ('445 patent; claim 1, Col. 21, ll. 58-66), a pulse wave detector ('445 patent; Claim 1, Column 22, lines 4-5); and a processor configured to: determine a blood velocity of the blood flowing through the blood vessel using the frequency of the first scattered light ('445 patent; claim 1; Column 22, lines 1-3); determine a blood pressure as a function of the blood velocity and the pulse wave velocity ('445 patent, claim 1, Column 22, lines 6-7). Claim 34 is anticipated by claim 3 of the ‘445 patent. Claim 35 is anticipated by claim 15 of the ‘445 patent. Claims 38 is anticipated by claim 18 of the '445 patent. Claims 42-43 are anticipated by claim 5 of the ‘445 patent. Claim 45 is anticipated by claim 6 of the ‘445 patent. Claim 46 is anticipated by claim 12 of the ‘445 patent. Claims 47-48 are anticipated by claim 13 of the ‘445 patent.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Brodnick et al. (U.S. Pat. 7,305,262) – directed toward a patch sensor for sensing a pulse wave.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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/REX R HOLMES/ Primary Examiner, Art Unit 3796
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