DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Drawings
3. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
in Fig. 1A: reference characters 132, 134, 136, 138, 140,142, 144;
in Fig. 1B: reference characters 132, 134, 136, 138;
in Fig. 2B: reference character 144;
in Fig. 3A: reference characters 340, 344;
in Fig. 4: reference character 344;
in Fig. 5: reference characters 500, 510.
4. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
5. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: in paragraph 0063, there are three recitations of reference character “190” pointing to ‘needles’. While there is reference to ‘needles 192, 194, 196, 198’, there is no indication of reference character ‘190’ in the drawings.
6. 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. 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.
Claim Rejections - 35 USC § 112
7. 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.
8. Claim 15 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.
9. Claim 15 recites the limitation "the tab" in line 3. There is insufficient antecedent basis for this limitation in the claim. While ‘a/the tab’ is referred to in Claims 13 and 14, Claim 14 depends from Claims 1 and 2. Claims 1 and 2 do not recite any ‘tab’, rendering Claim 15 indefinite. Proper correction is required.
Claim Rejections - 35 USC § 102
10. 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.
11. Claims 1-3, 5, 6, 9-14, and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mackellar U.S. 2018/0317794 (herein referred to as “Mackellar”).
12. Regarding Claim 1, Mackellar teaches a digital suture device (para 0016, “elongated sensor-carrying members (e.g., threads, sutures…)”), comprising:
a. an adapter (Fig. 2, ‘encapsulated electronics module’; Fig. 3, ref num 160) configured to be connected to a data collection and/or stimulus control system (abstract, “the electronics subsystem configured to power the system and facilitate processing of biosignals detected by the system”); and
b. a sensor body electrically and mechanically connected to the adapter (Fig. 3, ref num 110; para 0011, “an electronics subsystem 160 coupled to the biosignal sensor subsystem 110”);
c. the sensor body including one or more sensor members extending from the adapter (Fig. 3, ref nums 120 and ‘wire bundles’);
d. each sensor member including a first section distal to the adapter (see Fig. 3, most distal portion of ‘wire bundles’), a second section including one or more arrays of one or more stimulating/sensing sites (see Fig. 3, different sites with ref nums 120), and a third section configured to be used with a delivery device (Fig. 7, ‘insertion sheath’), the second section being disposed between the first section and the third section (see Figs. 3 and 7, the sensors, ref nums 120, are between the proximal and distal ends of the ‘wire bundles’; also see Fig. 4); and
e. each sensor member including one or more sets of tissue engaging members disposed along a length of the second section (Fig. 4, ‘barbed structure’; Fig. 3, ref num 140; para 0034).
13. Regarding Claim 2, Mackellar teaches a flexible substrate disposed from a first end of the device to a second end of the device; wherein the adapter and sensor body include the flexible substrate (para 0066, “the set of sensors can include a set of traces, each trace having a one-to-one correlation with each sensor, printed onto a flexible substrate of any shape”; para 0102, “the electronics subsystem 160 comprises a printed circuit board (PCB) configured to provide a substrate”).
14. Regarding Claim 3, Mackellar teaches the one or more sets of tissue engaging members includes one or more sets of barbs; and the one or more sets of barbs are disposed on opposite sides of each array (Fig. 4; para 0076, “the set of retention mechanisms 140 includes a set of barbed structures… the barbed protrusions can be radially distributed about a defining longitudinal axis”).
15. Regarding Claim 5, Mackellar teaches the one or more stimulating/sensing sites includes one or more electrodes (para 0037, “the sensors 120 are preferably electrodes”).
16. Regarding Claim 6, Mackellar teaches each electrode is configured to record electrical activity of a muscle in which the device is delivered (para 0023, “embed a long-term multi-lead heart sensing system (e.g., ECG or EKG) within a patient… used to implant sensors close to muscle groups in specific regions… to enable direct sensing of motor activity (e.g., motor neuron activity, muscle activation, etc.)…”; para 0028, “biosignals detected and measured by the system 100 comprise bioelectrical signals”; para 0037, “the sensors 120 are preferably electrodes”).
17. Regarding Claim 9, Mackellar teaches an integrated chip disposed on the sensor body between the one or more arrays and the adapter (para 0096, “the electronics sub system 160 can comprise discrete components, or can alternatively comprise dedicated single-chip modules…custom integrated circuits to perform signal processing”; para 0061, “the coupling system 130 can additionally or alternatively include one or more traces of a printed circuit board (PCB)”).
18. Regarding Claim 10, Mackellar teaches the third section of each sensor member is without electrical components (Fig. 7, ‘insertion sheath’ does not have electrodes disposed thereon, therefore, there would be no electrical components).
19. Regarding Claim 11, Mackellar teaches the delivery device includes a needle (para 0011, “a system insertion element (e.g., surgical tool, needle, sheath, etc.)”).
20. Regarding Claim 12, Mackellar teaches the needle is a hypodermic needle, a suture needle, and/or a Whitacre needle (para 0058).
21. Regarding Claim 13, Mackellar teaches the one or more tissue sets of engaging members includes a tab (para 0072).
22. Regarding Claim 14, Mackellar teaches the tab is disposed distal to the one or more arrays (see Fig. 3, the retention mechanism, ref nums 140, may be distal to ref nums 120).
23. Regarding Claim 16, Mackellar teaches the one or more sensor members includes more than one sensor member (see Fig. 2 and 3, ref nums 120/’wire bundles’ show a plurality of sensor members).
24. Regarding Claim 17, Mackellar teaches the one or more stimulating/sensing sites includes one or more electrodes, one or more pressure sensors, one or more chemical sensors, and/or one or more light-emitting components (para 0037).
25. Regarding Claim 18, Mackellar teaches the one or more stimulating/sensing sites includes one or more light-emitting components (para 0037, “the sensors 120 are… light sensors”).
Claim Rejections - 35 USC § 103
26. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
27. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mackellar and in view of Scheiner U.S. 2021/0228234 (herein referred to as “Scheiner”).
28. Regarding Claim 4, Mackellar teaches each barb extends upwards at an angle (para 0069, “barbs extending at an angle from the coupling subsystem”).
However, Mackellar fails to specifically teach each barb extends upwards towards the adapter.
Scheiner teaches a digital suture device of analogous art (Figs. 1, 2, and 4), wherein the device comprises an adapted (Fig. 1, ref num 17) a sensor body including one or more sensor members (Figs. 1 and 2, ref nums 20, 22, and 30), such that each sensor member includes one or more sets of tissue engaging members (Fig. 2, ref num 32). The tissue engaging members includes one or more sets of barbs (para 0075, “one or more fixation members 32”; para 0078, “fixation member may… include one or more hooks, barbs…”). Each barb is configured to extend upwards towards the adapter (para 0078, “the tines of fixation member 32 may extend radially outward and proximally at an angle relative to the longitudinal axis of lead body 22”; the fixation member extending proximally would be towards ref num 16). This configuration prevents/reduces retraction of the sensor body within the target area (para 0078). Since Mackellar already teaches that the barb extends at an angle relative to the longitudinal axis of the device, then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mackellar to extend the barb upwards towards the adapter in order to reduce retraction of the device when at the target site.
29. Claims 7 and 8 rejected under 35 U.S.C. 103 as being unpatentable over Mackellar and in view of Kinzie U.S. 2022/0183633 (herein referred to as “Kinzie”).
30. Regarding Claim 7, Mackellar fails to teach each electrode has a textured surface.
Kinzie teaches a device of analogous art (Figs. 2A-2G), wherein the device comprises a sensor body with one or more sensor members (Fig. 2A, ref num 201, 213), such that the sensor member includes one or more stimulating/sensing sites (Fig. 2A, ref nums 213A-D). The stimulating/sensing sites include one or more electrodes (Fig. 2A, ref nums 213A-D are electrodes; para 0065, “electrodes 213”). The electrode has a textured surface (para 0069, “the material choice for electrodes can also include materials having a high surface area… and roughness”). This aids with stability of implanting/retaining the sensor body at the target site (para 0069). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mackellar so that the electrode surface has a textured surface in order to aid with the stability of retention at the target site. It has also been held that “the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination” (MPEP 2144.07). In the instant case, one of ordinary skill in the art would recognize the benefits or suitability of the disclosed materials (e.g. cost-effectiveness, manufacturing feasibility, etc.).
31. Regarding Claim 8, Mackellar as modified teaches the textured surface (see Claim 7 above), but fails to specifically teach the textured surface includes one or more 3D cones. However, it has been held that “the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination” (MPEP 2144.07). In the instant case, one of ordinary skill in the art would recognize the benefits or suitability of the disclosed materials (e.g. cost-effectiveness, manufacturing feasibility, etc.). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the textured surface of the electrode to have 3D cones since these materials offer the benefits of cost-effectiveness, manufacturing feasibility, etc., such as the benefit of aiding retention stability.
32. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mackellar and in view of Xiang U.S. 2016/0331326 (herein referred to as “Xiang”).
33. Regarding Claim 15, Mackellar fails to teach the one or more sets of tissue engaging members includes one or more suture holes disposed on the tab and/or along a non-electrical portion of the second section.
Xiang teaches a device of analogous art (Fig. 13), wherein the device comprises one or more tissue sets of engaging members (Fig. 13, ref num 215), such that it includes a tab (ref num 215 is a tab). There is also one or more suture holes disposed on the tab (Fig. 13, ref nums 230). This facilitates the tissue engagement (para 0012, 0046, 0068). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mackellar to have one or more suture holes in order to secure the sensor member to the target site.
Conclusion
34. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794