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 .
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 9-11 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 claim 9, it is unclear if the release element and delivery system were intended to be positively recited. If so, positive recitation of the release element and delivery system is required prior to any functional reference to the release element. When considering the claim on the merits, the examiner will consider prior art that includes an anchoring body capable of interacting with a release element in the manner recited, to read on the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1, 9 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rowland et al. (Rowland: Pub. No. 2015/0208929).
Regarding claim 1, Rowland discloses an implantable wireless sensor (par. 0008) for deploying within a lumen in a body (par. 0006), comprising: a sensor body 101 (see at least Figs. 1, 2 and 21-23) comprising a proximal end and a distal end (inherent); and a first anchoring element 102 coupled to the proximal end of the sensor body and a second anchoring element 103 coupled to the distal end of the sensor body, at least one of the first and second anchoring elements configured to lodge the sensor body within the lumen (par. 0044), wherein the first and second anchoring elements are asymmetric by i) size with respect to each other prior to releasably retaining the sensor in a fixed relationship with a delivery system or ii) number of elements (see pars. 0040 and 0041).
Regarding claim 9, as already discussed in the rejection of claim 1, Rowland discloses an implantable wireless sensor for deploying within a lumen in a body, comprising: a sensor body comprising a proximal end and a distal end; and a first anchoring element coupled to the proximal end of the sensor body and a second anchoring element coupled to the distal end of the sensor body, at least one of the first and second anchoring elements configured to lodge the sensor body within the lumen.
The first anchoring element 102 comprises an anchoring body (loop) extending in a proximal direction with respect to the proximal end of the sensor body (see Fig. 8, for example), wherein the anchoring body includes at least one integrated attachment feature (e.g., ties 511 or 512, Figs. 5 and 7) configured to retain a release element associated with a delivery system, wherein the release element is configured to releasably retain the sensor in a fixed relationship with a delivery system in advance of deployment of the sensor in a body (par. 0048).
Regarding claim 10, the ties are considered loops as they are wires tied around the anchors.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowland ‘929.
Regarding claim 2, while it is not explicitly stated that the proximal anchoring element is relatively larger than the distal anchoring element, as per pars. 0040 and 0041, Rowland teaches that depending on the application, the proximal and distal anchors may be of different size, shape and material. Those of ordinary skill in the art looking to anchor the implant within a vessel that narrows in the distal direction relative to the proximal direction, and given the teachings of Rowland, would have clearly seen the obviousness of making the proximal anchoring element relatively larger than the distal anchoring element in order to ensure proper compressive force against the vessel walls.
A related comment applies to similarly worded claim 3, where a change in the size of the loop-shaped anchors would obviously result in varying diameters.
Allowable Subject Matter
Claims 4-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 4, the prior art of record fails to disclose the use of distal first and second loops orientated to extend at a non-zero angle with respect to at least one of a horizontal or vertical plane associated with the sensor body and spanning smaller diameters than a first proximal anchoring element. Such a feature is taught to advantageously allow the sensor to be placed securely within tapered and branching vessels.
Regarding claim 5, the prior art of record fails to disclose the recited body anchoring loop with a distal end extending under a distal anchoring loop, wherein the body anchoring loop is configured to engage the lumen proximate opposite first and second side surfaces of the sensor. Such a feature is advantageous in that it allows recapture of the anchoring element by a delivery system (see par. 00124). Related comments apply to claim 6.
Claim 11 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The prior art of record fails to disclose an integrated arrangement feature comprising first, second and third integrated attachment features configured to retain the release element with the recited first and second attachment features positioned to overlap each other when retained by the release element. Said features are disclosed as advantageous in minimizing the amount of force necessary to release the anchoring elements and can simplify the manufacturing process (par. 00170)
Claims 12-17 are allowed.
Regarding claim 12, the prior art of record fails to disclose the use of a first anchoring element configured to alter shape to a second diameter that is less than the first unbiased diameter responsive to a force moving the sensor body in a distal direction within the lumen after the sensor is deployed within the lumen, and configured to alter shape to a third diameter that is greater than the first diameter responsive to the sensor body moving in a proximal direction within the lumen after the sensor is deployed within the lumen. Such a feature is disclosed to better dynamically adjust lodging of the sensor into the lumen (par. 00136).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The various references recited disclose a variety of anchoring solutions for sensor devices. White ‘031 in particular shows asymmetric anchoring elements (Figs. 30-33, for example). Hirsh discloses anchor loops residing in different planes (Fig. 12).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached 2nd Monday of the biweek and W-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E. Hamaoui can be reached at 571 270 5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
February 25, 2026