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/Restrictions
Applicant’s election without traverse of Invention II in the reply filed on 4 December 2025 is acknowledged.
The Examiner notes that Applicant has asserted that new claims 21-33 would also fall under the grouping of Invention II; this is untrue. Each of the newly presented claims are directed to the combination identified as Invention I in the requirement for restriction, not the elected subcombination of invention II, and none of the newly presented claims require the particulars as defined in the subcombination of invention II.
PNG
media_image1.png
300
650
media_image1.png
Greyscale
Invention I
Claim 21
Claim 33
A sensor implant device comprising:
A sensor implant device comprising:
A sensor implant device comprising:
A shunt body that forms a fluid conduit, the fluid conduit having an axis;
a shunt body that forms a fluid conduit, the fluid conduit having an axis;
a shunt body that forms a fluid conduit, the fluid conduit having an axis;
A first anchor structure associated with a first end of the shunt body; and
a first anchor arm associated with a first end of the shunt body, the first anchor arm adapted to be, in a deployed configuration, deflected radially away from a channel area of the fluid conduit that is defined by a radial boundary around the axis of the fluid conduit, the radial boundary being defined by the fluid conduit; and
an anchor arm having a sensor-retention means associated with a distal portion thereof, the anchor arm being adapted to project radially outward from a first end of the shunt body in a deployed configuration; and
A first sensor device coupled to the first anchor structure such that a sensor transducer of the first sensor device projects into a channel area defined by a radial boundary around the axis of the fluid conduit, the radial boundary being defined by the fluid conduit.
a first elongate cylindrical sensor device coupled to the first anchor arm such that a sensor transducer at a first end of the first sensor device is disposed in the channel area of the fluid conduit
a sensor device secured to the sensor-retention means of the anchor arm such that a sensor transducer of the sensor device projects into a channel area defined by a radial boundary around the axis of the fluid conduit, the radial boundary being defined by walls of the fluid conduit.
None of these require all of the particulars of the plurality of anchor arms being associated with four different sides and ends of a frame, each of the plurality of anchor arms having a base and a distal end as set forth in Invention II, such that the assertion that newly presented claims would 21-33 fall into the grouping of Invention II rather than the grouping of Invention I is entirely false.
Claims 21-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4 December 2025.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the sensor implant device with two sensors on two of its four arms attached to a frame and configured in a delivery configuration where the sensor end of each sensor is disposed within the frame must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Information Disclosure Statement
The information disclosure statements have been considered. Applicant should note that the extraordinarily large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
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.
Claim 20 is 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.
Claim 20 recites “the sensor end of the second sensor device”; there is no antecedent basis for this limitation in the claim, as claim 20, claim 19, and claim 14 do not define a second sensor device. To provide antecedent basis for this it appears claim 19 should depend from any of claims 16-18; for the purposes of examination the claims will be treated as though claim 19 depends from claim 18 and comprises all the intervening limitations; 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) 14 and 15 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rowe (WO 2020/123338).
Regarding claim 14, Rowe discloses a sensor implant device comprising:
a tubular frame having first and second diametrical sides and first and second axial ends (figures 4, 6);
a first anchor arm associated with the first side and the first end of the tubular frame (figure 6, element 621);
a second anchor arm associated with the second side and the first end of the tubular frame (figure 6);
a third anchor arm associated with the first side and the second end of the tubular frame (figure 6);
a fourth anchor arm associated the second side and the second end of the tubular frame (figure 6),
each of the first, second, third, and fourth anchor arms having a base coupled to the tubular frame and a distal end (figure 6, see annotations below); and
a first sensor device coupled to the first anchor arm (element 610), the first sensor device including a sensor transducer (element 612) associated with a “sensor end” (element 605) of the first sensor device that is opposite a “base end” (element 607) of the first sensor device (paragraph [0085], the sensor element “may be disposed or positioned at or near a proximal portion 605 of the sensor 610”);
wherein the sensor end of the first sensor device is associated with the base of the first anchor arm and the base end of the first sensor device is associated with the distal end of the first anchor arm (figure 6, see annotations).
PNG
media_image2.png
512
964
media_image2.png
Greyscale
Regarding claim 15, Rowe further discloses that the sensor implant device is configured to assume a deployed configuration in which the first, second, third, and fourth anchor arms project radially away from the tubular frame (figures 4, 6, 8B).
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) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowe in view of Levi (US 2015/0039084).
Regarding claim 16, Rowe does not disclose the device further comprising a second sensor device coupled to the fourth anchor arm, wherein a sensor end of the second sensor device is associated with the base of the fourth anchor arm and the base end of the second sensor device is associated with the distal end of the fourth anchor arm. Levi teaches a sensor implant device comprising a plurality of anchor arms (elements 154) associated with a central frame (element 116), and first and second sensor devices coupled to arms on opposing sides of the frame (paragraph [0305], elements 142, 144 – see figure 12 – as per paragraph [0305] the sensors are on different sides of the frame and on different sides of the wall into which it is inserted). Further, the mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.05 and In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). As such, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Rowe and duplicated the sensor device on an additional arm, as taught by Levi, as the mere duplication of parts has no patentable significance unless a new and unexpected result is produced. The Examiner notes that the second sensor would thus also have a base end and sensor end, the sensor end associated with the arm’s base.
Claim(s) 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowe and Levi, as applied above, and further in view of Eigler (US 11234702).
Regarding claims 17 and 18, Rowe, as modified, does not disclose the sensor end of each sensor device projecting radially over the tubular frame with respect to an axis of the tubular frame. Eigler teaches a device with a tubular frame (figure 1A, element 10), an anchor arm (element 55) associated with the frame having a “base” coupled to the tubular frame and a “distal end” (figure 5A), and a sensor device (element 54) coupled to the anchor arm at the distal end of the anchor arm (at element 58, see figure 5A) with the opposing end of the sensor device being “associated with” the base of the anchor arm (figure 5A), the opposing end of the sensor arm being configured to project radially over the tubular frame with respect to an axis of the tubular frame (figures 5A, 5B). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Rowe, as modified, with the sensor end of each sensor device configured to project radially over the tubular frame with respect to an axis of the tubular frame, as taught by Eigler, in order to allow sensing of pressures of fluids traveling along the axis through the frame.
Regarding claim 19, Rowe further discloses that the sensor implant device is configured to assume a delivery configuration in which the first, second, third, and fourth anchor arms project axially away from the tubular frame (figures 8A, 8B).
Regarding claim 20, as the sensor ends of each sensor device are configured to project radially over the tubular frame (claims 17 and 18 above), when the sensor implant device is in the delivery configuration, the sensor end of the first sensor device and the sensor end of the second sensor device are thus inherently disposed within the tubular frame between the first and second axial ends of the tubular frame.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 2023/0371902 to Valdez (inventor of the instant application), US 2022/0151618 to Pool, US 2017/0106176 to Taft, which disclose similar devices with tubular frames and anchor arms
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN E TOTH whose telephone number is (571)272-6824. The examiner can normally be reached Mon - Fri 9a-6p.
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 Robertson can be reached at 571-272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAREN E TOTH/Examiner, Art Unit 3791