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 with traverse of Group I, Species A1, B1, and C1 in the reply filed on 12 August 2026 is acknowledged. The traversal is on the grounds that Groups I-III are directed to the same invention and that all species identified by the Examiner are obvious variants. This is not found persuasive.
While all identified groups and species recite overlapping subject matter (an implant including a sensor body, anchors, a detachable cap, and a tether), each group recites varying level of details about the claimed subject matter.
Group I recites a detachable cap that is more narrowly claimed than the detachable cap of Group II, but also recites anchors that are claimed more broadly than the anchors (curved hooks) of Group II. Therefore, Applicant’s argument that “claimed structures are not mutually exclusive if one encompasses the other, as is the case here” is not persuasive as this is not the case regarding Groups I and II. Group I does not encompass Group II, nor does Group II encompass Group I.
Group I recites a detachable cap that is more narrowly claimed than the detachable cap of Group III, but also recites a tether that is claimed more broadly than the tether of Group III. Therefore, Applicant’s argument that “claimed structures are not mutually exclusive if one encompasses the other, as is the case here” is not persuasive as this is not the case regarding Groups I and III. Group I does not encompass Group III, nor does Group III encompass Group I.
Group II recites anchors (curved hooks) that are more narrowly claimed than the anchors of Group III, but also recites a detachable cap and a tether claimed more broadly than the detachable cap and tether of Group II. Therefore, Applicant’s argument that “claimed structures are not mutually exclusive if one encompasses the other, as is the case here” is not persuasive as this is not the case regarding Groups II and III. Group II does not encompass Group III, nor does Group III encompass Group II.
Applicant’s argument that the Restriction Requirement does not assert any reasons why there would be a serious burden is not persuasive as the Restriction Requirement asserted several reasons (e.g., the inventions would require employing different search queries, prior art applicable to one invention would not likely be applicable to another invention). Applicant’s argument that no evidence was provided that prior art applicable to one Group or Species would not be applicable to another Group or Species is not persuasive as this would have required performing a prior art search prior to the examination of the claims. It is noted, however, that a reference disclosing the embodiment shown in Figures 7A-C (proximal anchors having semi-circular shapes that are concentric with the sensor body) would not read on the embodiment shown in Figures 8A-B (proximal anchors having semi-circular shapes that extend along a sensor body towards a distal end of the sensor body). A reference disclosing the embodiment shown in Figures 7A-C (a detachable cap having a pointed end, proximal and midbody anchors) would also not read on the embodiment shown in Figure 9 (a detachable cap having a rounded end, proximal and distal anchors).
It is noted that upon further consideration, the requirement to elect one species from B1, B2, and B3 has been withdrawn as the specification provides support for one embodiment comprising both distal and proximal anchors.
The requirement is still deemed proper and is therefore made FINAL. Claims 4, 8, 10, and 13-20 are hereby withdrawn (claim 8 is withdrawn as it is drawn to non-elected Species C2).
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 11 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. The term “approximately” in claim 11 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
Claims 1-3, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al.’571 (US Pub No. 2018/0021571).
Regarding claim 1, Figures 2A and 4 of Anderson et al.’571 disclose a sensor implant device (sections [0009], [0020]), the device comprising: a sensor body (Figure 2A, sensor body 380) having at least a first sensor component (Figure 2A, first sensor component 320, sections [0018], [0020]); one or more anchors (Figure 2A, anchors 35) coupled to the sensor body for anchoring the sensor body to a tissue wall (section [0019]); a detachable cap (Figures 3D and 4, detachable cap 550) having a tip and a base, the detachable cap decreasing in width from the base to the tip (section [0023]); and a tether (Figure 4, tether 540) connecting the detachable cap to the sensor body (section [0024]).
Anderson et al.’571 discloses all of the elements of the current invention, as discussed above, except for the base being a flat base that is disposed against a distal end of the sensor body. However, according to section [0023], end 551 of base 51 of Figure 3A, which is disposed against a distal end of the sensor body, “may be relatively flat”. With this teaching by Anderson et al.’571, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the base shape of the detachable cap shown in Figures 3A, 3B, 3D, and 4 (base 51) to be flat.
Regarding claim 2, the tether is shape set to provide a clearance between the detachable cap and the sensor body (sections [0026], [0029-0030]).
Regarding claim 3, Figures 3A-4 show that the detachable cap has a conical shape with a pointed end.
Regarding claim 5, the detachable cap provides a leading end for the sensor body during delivery to the tissue wall (section [0023]).
Regarding claim 6, Figures 2A, 3D, and 4 show that the one or more anchors include one or more proximal end anchors extending from a proximal end of the sensor body.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al.’571, as applied to claim 6, in view of Yang et al.’801 (US Pub No. 2019/0083801 – cited by Applicant).
Anderson et al.’571 discloses all of the elements of the current invention, as discussed in paragraph 6 above, except for the one or more proximal anchors having semi-circular shapes that are concentric with the sensor body. Figure 9 of Yang et al.’801 discloses one or more proximal end anchors of an implant device, the one or more anchors having semi-circular shapes that are concentric with a device body, wherein the one or more proximal end anchors are configured to actively fix the implant device to an implant site (Figure 9, anchors 252a,252b, section [0077]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have substituted anchors having semi-circular shapes that are concentric with the sensor body for the anchors of Anderson et al.’571, as it would merely be substituting one known anchoring means (concentric anchors) for another to obtain predictable results.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al.’571, as applied to claim 1, in view of Schwartz’171 (US Pub No. 2006/0161171).
Anderson et al.’571 discloses all of the elements of the current invention, as discussed in paragraph 6 above, except for the one or more anchors including one or more distal end anchors extending from a distal end of the sensor body. Schwartz’171 discloses a method for implanting a medical device wherein both proximal end and distal end anchors are used to secure the medical device to a tissue wall (ABSTRACT). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the sensor implant device of Anderson et al.’571 to also include one or more distal end anchors extending from a distal end of the sensor body as it would merely be combining prior art elements according to known methods to yield predictable results. The modification to Anderson et al.’571 would provide an additional means by which to secure the sensor implant device to the tissue wall.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al.’571, as applied to claim 1, in view of Kveen et al.’532 (US Pub No. 2008/0021532).
Regarding claim 11, Anderson et al.’571 discloses all of the elements of the current invention, as discussed in paragraph 6 above, except for the one or more anchors including one or more side anchors extending from a midsection of the sensor body, wherein each of the one or more side anchors includes a free end arranged to form an approximately 45-degree angle relative to the sensor body. Figures 10, 16, and 17 of Kveen et al.’532 show side anchors 129 extending approximately 45-degrees from a midsection of an implantable sensor body, the side anchors being used to secure the implantable sensor body to a tissue site (section [0070]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the sensor implant device of Anderson et al.’571 to include side anchors extending from a midsection of the sensor body at approximately a 45-degree angle, as taught by Kveen et al.’532, as it would provide an additional means by which to secure the sensor implant device to the tissue wall.
Regarding claim 12, Anderson et al.’571 discloses all of the elements of the current invention, as discussed in paragraph 6 above, except for the sensor body including an inner lumen sized to receive a guidewire, and wherein the detachable cap includes a lumen configured to be aligned with the inner lumen of the sensor body during delivery. It is noted that section [0027] of Anderson et al.’571 discloses that a guidewire tip is coupled to the detachable cap. Figures 16 and 17 of Kveen et al.’532 show that a guidewire extending from the tip of an implant device can be housed within an inner lumen of the tip, wherein the inner lumen of the tip is aligned with an inner lumen of a sensor body connected to the tip. The guidewire of Kveen et al.’532 is used to help properly locate a sensor body at a desired tissue site (sections [0076-0077]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the sensor implant device of Anderson et al.’571 such that its guidewire is received within aligned lumens of the sensor body and detachable cap, as it would merely be combining prior art elements according to known methods to yield predictable results. The modification to Anderson et al.’571 would help in properly locating the sensor implant device within a desired tissue wall.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ETSUB D BERHANU whose telephone number is (571)270-5410. The examiner can normally be reached Mon-Fri 9:00am-5:30pm EST.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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