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.
Response to Arguments
3. Applicant’s arguments with respect to claim(s) 1-13 and 15-18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
4. It is noted that Claims 19 and 20 are newly added.
Drawings
5. The drawings were previously objected to for failing to include all the reference characters not mentioned in the description. However, after reconsideration of the specification, all reference characters are mentioned in the description. Therefore, the objections are withdrawn.
Claim Rejections - 35 USC § 112
6. Claim 15 was rejected to under 35 U.S.C. 112(b) as being definite. The claim has been amended to overcome the rejection. Therefore, the rejection has been withdrawn.
Claim Rejections - 35 USC § 103
7. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
8. Claims 1-3, 5, 6, 9-12, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mackellar U.S. 2018/0317794 (herein referred to as “Mackellar”) and in view of Donoghue U.S. 2021/0267523 (herein referred to as “Donoghue”).
9. 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 more than one 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
f. 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).
Mackellar also teaches conductive traces within the sensors (para 0066, “the set of sensors can include a set of traces”).
Mackellar fails to specifically teach (e) one or more conductive traces that electrically connect each stimulating/sensing site to the adapter; and (g) the third section of each sensor member is without the one or more conductive traces.
Donoghue teaches a device of analogous art (Fig. 2, ref num 100, 150), wherein the device comprises an adapter (Fig. 2, ref num 101), a sensor body comprising one or more sensor members (Fig. 2, ref num 150 has a sensor body including sensor members, ref nums 151), such that each sensor member comprises a third section (see Fig. 3A-3C, the distal end of ref num 151 is the third section, ref num 1513), and one or more conductive traces that electrically connect stimulating/sensing sites of the sensor member to the adapter (Fig. 3A-3B, ref num 160 = sensing sites, ref num 154 = conductive traces; para 0203, “Each lead 151 can be attached to a wire, trace, or other electrical conduit, conductors 154”; para 0204, “ Each sensor 160 can be attached to a different wire or other electrical conduit, conductors 154, four shown. Each conductor 154 can be operably attached to ITX 110”; ref num 110 is part of adapter, ref num 101, see Fig. 2). The third section (ref num 1513) of each sensor member is without the one or more conductive traces (See Fig. 3A-3C, ref num 1513 does not have conductive traces, ref num 154). This section is structured to engage with a delivery tool in order to introduce the sensor body to the target area (para 0222, “tip 1513, which can be configured to be releasably engaged to a tunneling tool, introducer tool 810”). 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 the third section be without one or more conductive traces in order to introduce the sensor body to the target tissue.
10. 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”).
Mackellar fails to teach the third section includes only the flexible substrate.
Donoghue teaches the third section includes the flexible substrate (para 0222, “reinforcing tip 1513 comprise materials (e.g. plastic and/or metal reinforcing materials) and a construction configured to withstand forces (e.g. stretching, compression, twisting, and/or abrasion) incurred during implantation”). This is to allow implantation of the sensor body into the target tissue (para 0222). 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 the third section that only includes the flexible substrate in order to allow the implantation of the sensory body to the target tissue.
11. 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”).
12. Regarding Claim 5, Mackellar teaches the more than one stimulating/sensing site includes more than one electrode (para 0037, “the sensors 120 are preferably electrodes”).
13. 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”).
14. 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)”).
15. 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).
16. Regarding Claim 11, Mackellar teaches the delivery device includes a needle (para 0011, “a system insertion element (e.g., surgical tool, needle, sheath, etc.)”).
17. Regarding Claim 12, Mackellar teaches the needle is a hypodermic needle, a suture needle, and/or a Whitacre needle (para 0058).
18. 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).
19. Regarding Claim 17, Mackellar teaches each stimulating/sensing site 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).
20. Regarding Claim 18, Mackellar teaches the one or more of the more than one stimulating/sensing sites includes one or more light-emitting components (para 0037, “the sensors 120 are… light sensors”).
21. Regarding Claim 19, Mackellar teaches the delivery device is a suture needle (para 0059, 0115).
22. Regarding Claim 20, Mackellar teaches the third section is configured to be attached to the suture needle (para 0118, “each sensor is affixed to a conductive suture-like member, and each conductive suture-like member can be attached to (e.g., configured to conduct signals from) a single sensor or multiple sensors. The sensors are coupled to the user by inserting the conductive suture-like members beneath the skin of the user's scalp, and threaded across the user's head for any suitable distance required to position the sensor(s) at the desired locations relative to the brain of the user. At one or more positions along each conductive suture-like member (e.g., at each sensor position, at one position, at a plurality of positions uncorrelated with the sensor positions, etc.), the member defines a barbed structure configured to lock into soft tissues.”).
23. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mackellar and Donoghue, and further in view of Scheiner U.S. 2021/0228234 (herein referred to as “Scheiner”).
24. 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.
25. Claims 7, 8, and 13 rejected under 35 U.S.C. 103 as being unpatentable over Mackellar and Donoghue, and further in view of Kinzie U.S. 2022/0183633 (herein referred to as “Kinzie”).
26. 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.).
27. 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.
28. Regarding Claim 13, Mackellar teaches each sensor member includes a tab disposed distal to the one or more arrays (para 0072; see Fig. 3, the retention mechanism, ref nums 140, may be distal to ref nums 120).
Mackellar fails to teach the tab includes one or more suture holes.
Kinzie teaches a device of analogous art (Figs. 2A-2G, 3A), wherein the sensor member includes a tab that includes one or more suture holes (Fig. 3A, ref num 336). This provides means to secure the sensor member to the target tissue (para 0084, “includes suture hole 336, which provides another means of securing sensor device 310 to the patient to prevent movement following insert”). 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 include one or more suture holes to secure the device to the target tissue and prevent movement of the insert.
29. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mackellar and Donoghue, and further in view of Xiang U.S. 2016/0331326 (herein referred to as “Xiang”).
30. 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
31. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
32. 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.
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, 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.
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.
/ANNIE L SHOULDERS/Examiner, Art Unit 3794
Prosecution Insights