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 .
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 21-23, drawn to an emitter and detector for determining a blood velocity and determining blood pressure, classified in A61B 5/0261.
II. Claims 24-40, drawn to an emitter and detector that determines pulse wave velocity, classified in A61B 5/0285.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus as claimed can be used to practice another and materially different process, such as one that determines blood pressure using pulse wave velocity.
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 9/25/26 a provisional election was made without traverse to prosecute the invention of Group II, claims 24-40. Affirmation of this election must be made by applicant in replying to this Office action. Claims 21-23 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 1/16/25; 4/4/25; 5/14/25; 7/10/25; 2/20/26; 7/20/26; 8/21/26 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 § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 24, 28-29, 31, 33 and 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hatschek (U.S. Pat. 5,309,916).
Regarding claim 24, Hatschek discloses a medical device (e.g. see Fig. 1), comprising: an emitter configured to emit light towards a blood vessel (e.g. 27); a detector configured to detect scatter of the light caused by an interaction of the light with a wall of the blood vessel (e.g. 29); and a processor (e.g. 65) configured to: identify, by analyzing the scatter of the light, motion of the wall of the blood vessel (e.g. Col. 12; ll. 6-19); and determine, by analyzing the motion of the wall of the blood vessel, a velocity of a pulse traveling along the blood vessel (e.g. Col. 12, ll. 20-56).
Regarding claim 28, Hatschek further discloses wherein the processor is configured to identify the motion of the wall of the blood vessel by determining that the scatter of the light has a different frequency than the light emitted by the emitter (e.g. Col. 11, ll. 28-47; [analyze the reflected back signal].
Regarding claim 29, Hatschek further discloses wherein the emitter and the detector are configured to be disposed on a same side of the blood vessel (e.g. 13; see Figs. 1-2).
Regarding claim 31, Hatschek further discloses a display configured to output an indication of the velocity of the pulse traveling along the blood vessel (e.g. 45).
Regarding claim 33, Hatschek discloses a method, comprising: emitting, by an emitter (e.g. 27), light towards a blood vessel (e.g. 29); detecting, by a detector, scatter of the light caused by an interaction of the light with a wall of the blood vessel; identifying, by analyzing the scatter of the light, motion of the wall of the blood vessel (e.g. Col. 12, ll. 6-9); and determining, by analyzing the motion of the wall of the blood vessel, a velocity of a pulse traveling along the blood vessel (e.g. Col. 12, ll. 20-56).
Regarding claim 36, Hatschek further discloses wherein identifying the motion of the wall in the blood vessel comprises determining that the scatter of the light has a different frequency than the light emitted by the emitter (e.g. Col. 11, ll. 28-47; [analyze the reflected back signal].
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) 25-27 and 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hatschek as applied to claims 24, 28-29, 31, 33 and 36 above, and further in view of Eisen et al. (U.S. Pub. 2014/0200423 hereinafter "Eisen").
Regarding claims 30-32, 35-36 and 45, Hatschek 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 Hatschek, 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) 30 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hatschek as applied to claims 24, 28-29, 31, 33 and 36 above, and further in view of Satomi et al. (U.S. Pub. 2015/0208933 hereinafter "Satomi").
Regarding claims 30 and 37, Hatschek 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 any 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 Hatschek, 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.
Claim(s) 32 and 39-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hatschek as applied to claims 24, 28-29, 31, 33 and 36 above, and further in view of Habu et al. (U.S. Pat. 6,176,832 hereinafter "Habu").
Regarding claims 32 and 39, Hatschek discloses the claimed invention except for explicitly stating that the system determines a characteristic and then displays it. However, Habu teaches a similar system that determines non-invasive blood pressure that teaches that it is known 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 as set forth in Column 5, lines 10-19 and Column 10, lines 53-59 to provide a means for accurately determining vessel characteristics and displaying them for a physician to analyze. 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 Hatschek, with characteristic determination and display as taught by Habu, since such a modification would provide the predictable results of accurately determining vessel characteristics and displaying them for a physician to analyze.
Regarding claim 40, meeting the limitations of claim 33 and 39 above, Hatschek further teaches that the determining the characteristic of the blood vessel comprises analyzing an amplitude variation of the scatter of the light (e.g. Col. 13, ll. 21-28; [based on amplitude variations]).
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hatschek as applied to claims 24, 28-29, 31, 33 and 36 above, and further in view of Siedenburg (U.S. Pub. 2019/0125191).
Regarding claim 38, Hatschek discloses the claimed invention except for explicitly describing the system analyzing the DC component of the reflected signal. However, Siedenburg teaches that it is known to use the DC component of the reflected signal as set forth in Paragraph 64 to provide a means for detecting movement of vessel wall surfaces, for example, when a pulse travels through the interrogated portion of the vessel. 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 Hatschek, with the analysis of the DC component of the reflected signal as taught by Siedenburg, since such a modification would provide the predictable results of analyzing the DC portion detect movement of vessel wall surfaces, for example, when a pulse travels through the interrogated portion of the vessel to enhance the blood pressure signal.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REX R HOLMES/Primary Examiner, Art Unit 3796
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