CTNF 18/606,479 CTNF 82949 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Detailed Action Restriction/Election Applicant's election with traverse of group I, claims 1-19 in the reply filed on 03/02/26 is acknowledged. Applicant’s election of Species 1 - an electrode, Species 2 - heart tissue, Species 3 - one or more hydrophilic polymers, Species 4 - an amine coupling group, and Species 5 - N-hydroxysuccinimide ester is also acknowledged. The traversal is on the ground(s) that searching all the groups would not pose any burden on the office. This is not found persuasive because search of method will not result into the composition and the inventions are distinct with distinct parameters and search of one species would not result in another with distinct structures. The requirement is still deemed proper and is therefore made FINAL. 08-05 AIA Claim s 14, 17-18 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/election , there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/02/26 . Claim Rejections - 35 USC § 112, indefiniteness 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): 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 1-13, 15-16 and 19 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 pre-AIA the applicant regards as the invention. Claim 1 recites the limitation “reduces or minimizes” which makes the claim indefinite because it is a relative term which renders the claim indefinite. The term “reduces or minimizes” 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 § 102 07-07 AIA 07-07-aia 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1, 3 and 7-9 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Rogers et al. (US PG Pub. 2016/0066789 A1) . Rogers teaches provided are implantable or surface mounted biomedical devices and related methods for interfacing with a target tissue, see (Figure 30A; and Figure 30B; and Abstract). The devices have a substrate and device component supported by the substrate; and para [0014]. In an aspect, the device component and substrate form a functional layer comprising a functional electronic device that Interfaces with the target tissue; see para [0039]. To further facilitate tissue transit, and to protect the device components during handling and transit, any of the devices optionally include a delivery substrate that supports the substrate and in an aspect, an adhesive layer is positioned between the delivery substrate and the substrate, such as an adhesive layer that dissolves or is bioresorbed and the delivery substrate removed after implantation and in an aspect, the adhesive layer comprises a silk material; see para [0188]. FIG. 30A focuses on the first end of the device that is in a stacked configuration 165. A plurality of functional layers 160 are stacked on top of each other. For clarity, the device components and functional electronic devices are not shown. The functional layers are stacked on a delivery substrate 200. One example or removing means is provided in FIG. 30B, which illustrates an adhesive layer 210 positioned between delivery substrate 200 and functional layer 160. Upon insertion, 3 stimulus applied to the adhesive layer 210 results in dissolution of the adhesive layer 210; Note that with best reference to Figure 30B, the adhesive composition is defined by the layer 210, and the device is defined by the functional layers 160, 161. After removal of the delivery substrate 200 after implantation, the adhesive 210 contacts a surface of a tissue of the patient); wherein the adhesive composition is configured to form at the surface of the tissue a conformal Interface that reduces or minimizes infiltration of inflammatory cells at the conformal interface (Figure 30B; and Abstract, Provided are implantable or surface mounted biomedical devices and related methods for interfacing with a target tissue; and para [0039], any of the devices include a delivery substrate that supports the substrate, and adhesive layer is positioned between the delivery substrate and the substrate such as an adhesive layer that dissolves or is bioresorbed and the delivery substrate removed after Implantation, the adhesive layer comprises a silk material; and para [0008], surface mounted refers to the functional capability of a device to be provided in conformal contact with a surface of a tissue: para [0071]. Administering devices of the Invention may be carried out in a variety of manners including surgically implanting the device on a surface of, or into, a target biological tissue of a subject and optionally in conformal contact, with a target biological tissue of the subject; and para [0179]. "Conformal contact" refers to contact established between a device and a receiving surface. In one aspect, conformal contact involves 3 macroscopic adaptation of one or more surfaces e.g., contact surfaces of a device to the overall shape of a surface; see para [0166]. The implantation does contemplate some immune response as may occur for any minimally invasive procedures so long as the immune response is locally confined, transient and does not lead to large-scale inflammation and attendant deleterious effects; see Figure 42; see para [0250]. FIG. 42 is a close up view of the implanted device two weeks post implantation. The device appears intact and properly targeted over the sciatic with no observable movement from the Initially implanted position. Scan tissue appears mature and not inflamed; Note that Rogers teaches that the implanted device on tissue does not result in large-scale inflammation. It is reasonably understood that the inflammatory response Involves the movement of inflammatory cells towards B site of tissue injury or an invasive body. Thus, this is interpreted as teaching an adhesive composition that "reduces or minimizes infiltration of inflammatory cells at the conformal interface"). Rogers teaches wherein the device comprises an electrode (see Claim 1. An implantable or surface mounted biomedical device for interfacing with a target tissue; see Claim 4, wherein said device component comprises one or more electrode). Rogers teaches wherein the tissue comprises abdominal wall tissue, colon tissue, stomach tissue, lung tissue, or heart tissue (see Claim 1, wherein it is taught that an implantable or surface mounted biomedical device for interfacing with a target tissue; and Claim 59, wherein said target tissue is selected from the group consisting of brain, heart, kidney, liver, pancreas, bladder, lung, eye, blood vessel, and skin). Rogers teaches an adhesive composition configured to form at a surface of a tissue a conformal interface that reduces or minimizes infiltration of inflammatory cells at the conformal interface (see abstract, wherein it is taught provided are implantable or surface mounted biomedical devices and related methods for interfacing with a target tissue, the devices can be shaped to provide injection in a minimally invasive manner, thereby avoiding unnecessary tissue damage and providing a platform for long-term implantation for interfacing with biological tissue; and it is taught in para [0039], any of the devices include a delivery substrate that supports the substrate, and adhesive layer is positioned between the delivery substrate and the substrate such as an adhesive layer that dissolves or is bio-resorbed and the delivery substrate removed after implantation, the adhesive layer comprises a silk material; in para [0209]. Rogers teaches wherein the arranging of the adhesive composition comprises: providing the adhesive composition, wherein the adhesive composition is affixed to the biomaterial or the device; and contacting the surface of the tissue with the adhesive composition (Figure 30A; and Figure 30B; and Claim 1, An implantable or surface mounted biomedical device for interfacing with a target tissue; and para [0039]. To further facilitate tissue transit, and to protect the device components during handling and transit, any of the devices optionally include a delivery substrate that supports the substrate. In an aspect, an adhesive layer is positioned between the delivery substrate and the substrate, such as an adhesive layer that dissolves or is bio-resorbed and the delivery substrate removed after implantation. In an aspect, the adhesive layer comprises a silk material; and para [0188], FIG. 30A focuses on the first end of the device that is in a stacked configuration 165 . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (US PG Pub. 2016/0066789 A1) in view of Chandorkar et al. ("The Foreign Body Response Demystified" by Chandorkar et al. (hereinafter Chandorkar, presented in IDS) . Rogers as discussed above does not specifically teach wherein the reduction or the minimization of the infiltration of inflammatory cells prevents the formation of a fibrous capsule at the conformal interface for at least 28 days after the implanting of the biomaterial or the device. However, Rogers does teach that inflammation is minimized after two weeks after device implementation (para [0166], The implantation does contemplate some immune response as may occur for any minimally invasive procedures so long as the immune response is locally confined, transient and does not lead to large-scale inflammation and attendant deleterious effects: and Figure 42; and para [0250]. FIG. 42 is a close up view of the implanted device two weeks post implantation. The device appears intact and properly targeted over the sciatic with no observable movement from the initially implanted position. Scar tissue appears mature and not inflamed). Chandorkar teaches a typical inflammation process after the implementation of a foreign implant, where the inflammation response leads to the formation of the fibrous capsule around the implant (Figure 1, Implantation of biomaterials always causes inflammation, leading to the evolution of temporal events collectively termed as foreign body response. Schematic representation of some of the stages involved in acute inflammation and chronic inflammation that ultimately lead to the formation of the fibrous capsule around the implant). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to test for the various parameters associated with the method as taught by Rogers, specifically if the method as taught by Rogers is effective to result in minimal inflammation and avoid the formation of a fibrous capsule as taught by Chandorkar, by routine experimentation, in order to determine the effectiveness and/or potential appropriate applications of the method, and in order to determine if the method provides "wherein the reduction or the minimization of the infiltration of inflammatory cells prevents the formation of a fibrous capsule at the conformal interface for at least 28 days after the implanting of the biomaterial or the device" . 07-21-aia AIA Claim s 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (US PG Pub. 2016/0066789 A1) in view of Sih et al. (US PG Pub. 2006/0134079 A1) . Rogers as discussed above does not specifically teach wherein bi-directional electrical communication between the electrode and the tissue is maintained for at least 28 days after the implanting of the electrode. However, Rogers does teach that the tissue adhered to can be heart tissue (Claim 1, An implantable or surface mounted biomedical device for interfacing with 8 target tissue; and Claim 59, wherein said target tissue is selected from the group consisting of brain, heart, kidney, liver, pancreas, bladder, lung, eye, blood vessel, and skin). Sih teaches a pacemaker device comprising an electrode for interfacing with heart tissue, thus establishing bi-directional electrical communication between the electrode and the heart tissue (Figure 2; and Figure 3; and Abstract, Implantable devices containing extracellular matrix and methods of using the devices are provided: and para [0167], FIG. 2 shows a pacemaker performing the electrical therapy described herein; and para [0169], The pacemaker has atrial sensing/stimulation channels comprising electrode 234, lead 233, sensing amplifier/filter 231, pulse generator 232, and an atrial channel interface 230 which communicates bidirectionally with a port of microprocessor 210; and para [0178], FIG. 3 shows one example of administration of isolated ECM seeded with exogenous cells and electrical therapy to a region of cardiac tissue subject to myocardial infarction. The heart 302 includes a left ventricle 304 which has tissue injured by a myocardial infarction in an affected region 300. Affected region 300 is determined by methods including those described herein. isolated ECM 306 is preferably administered in close proximity to adjacent non-infarcted tissue and/or directly to the affected region 300 and electrical therapy is applied using a programmable pulse generator 308 and lead 310). Therefore, it would have been obvious to one of ordinary skill in the art to use the pacemaker device as taught by Sih in conjunction with the device and adhesive implanted using the method as taught by Rogers, in order to advantageously provide an additional pacemaker application for use with the method, and thus providing "bi-directional electrical communication between the electrode and the tissue". Further, it would have been obvious to one of ordinary skill in the art to test for the various parameters associated with the method as taught by Rogers in view of Sih, specifically if the bi-directional electrical communication is maintained for at least 28 days after the implanting of the electrode, using an appropriate method, by routine experimentation, in order to determine the various parameters associated with the method and the overall efficacy of the method. Regarding claim 5, Rogers in view of Sih teaches the method of claim 4 as described above, Sih further teaches wherein the tissue comprises heart tissue of the patient's heart, and an R-wave of the patient's heart recorded by the electrode (Figure 2: and Figure 3; and para [0169], The pacemaker has atrial sensing/stimulation channels comprising electrode 234, lead 233, sensing amplifier/filter 231, pulse generator 232, and an atrial channel interface 230 which communicates bidirectionally with a port of microprocessor 210. The device also has two ventricular sensing/stimulation channels that include electrodes 224A-B, leads 223A-B, sensing amplifiers 221A-B, pulse generators 222A-B, and ventricular channel interfaces 320A-B where "A" designates one ventricular channel and "B" designates the other. For each channel, the same lead and electrode are used for both sensing i.e., detecting P-waves and R-waves. and stimulation. The channel interfaces 220A-B and 230 include analog-to-digital converters for digitizing sensing signal inputs from the sensing amplifiers and registers which can be written to by the microprocessor in order to output stimulation pulses, change the stimulation pulse amplitude, and adjust the gain and threshold values for the sensing amplifiers), but does not specifically teach an R-wave of the patient's heart recorded by the electrode at least 28 days after the Implanting of the electrode has an amplitude that is 0% to about 5 % less than an Initial amplitude of an initial R-wave of the patient's heart recorded by the electrode within 24 hours after the implanting of the electrode. However, it would have been obvious to one of ordinary skill in the art to test for the various parameters associated with the method as taught by Rogers in view of Sih, specifically to test if the detected R-wave has an amplitude that is to about 5 % less than an initial amplitude of an initial R-wave of the patient's heart recorded by the electrode within 24 hours after the implanting of the electrode, using an appropriate method, by routine experimentation, in order to determine the various parameters associated with the method and the overall efficacy of the method. Regarding claim 6, Rogers in view of Sih teaches the method of claim 4 as described above, Sih further teaches wherein the tissue comprises heart tissue of the patient's heart, and a minimal stimulation current pulse amplitude for pacing emitted by the electrode paces the patient's heart (Figure 2, 232; and Figure 3; and para [0169], The pacemaker has atrial sensing/stimulation channels comprising electrode 234, lead 233, sensing amplifier/filter 231, pulse generator 232, and an atrial channel interface 230 which communicates bidirectionally with a port of microprocessor 210. The device also has two ventricular sensing/stimulation channels that include electrodes 224A-B, leads 223A-B, sensing amplifiers 221A-B, pulse generators 222A-B, and ventricular channel interfaces 320A-B where "A" designates one ventricular channel and "B" designates the other. For each channel, the same lead and electrode are used for both sensing i.e., detecting P-waves and R-waves and stimulation. The ventricular electrodes could be disposed in each of the ventricles for biventricular pacing or in only one ventricle for multi- site pacing of that ventricle the microprocessor. to output stimulation pulses, change the stimulation pulse amplitude; Note that since the device as taught by Sih comprising a pulse generator, electrodes and leads is effective to pace a patient's heart tissue, this is interpreted as teaching where a minimal stimulation current pulse amplitude for pacing emitted by the electrode paces the patient's heart), but does not specifically teach for at least 28 days after the implanting of the electrode. However, it would have been obvious to one of ordinary skill in the art to test for the various parameters associated with the method as taught by Rogers in view of Sih, specifically to test if the method is effective to pulse a patient's heart for at least 28 days after the implanting of the electrode; using an appropriate method, by routine experimentation, in order to determine the various parameters associated with the method and the overall efficacy of the method . 07-21-aia AIA Claim s 10-13, 15-16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (US PG Pub. 2016/0066789 A1) in view of Zhao et al. (US 2021/0380848 A1 to Massachusetts Institute of Technology (MIT848) . Rogers as discussed above does not specifically teach wherein the adhesive composition comprises a crosslinked polymeric composition. Rogers as discussed above does not specifically teach wherein the adhesive composition comprises: (i) one or more hydrophilic polymers, one or more zwitterionic polymers, or a combination thereof; (ii) one or more tissue coupling groups; (iii) one or more crosslinkers; or (iv) a combination thereof. (Rogers does teach that the adhesive composition can be silk, comprising the biopolymer fibroin (para [0039], In an aspect, the adhesive layer comprises a silk material. Useful silk materials for adhesive layers include, for example, silkworm fibroin). Zhao et al. teaches an adhesive material for adhering to tissues, wherein the adhesive composition comprises a crosslinked polymeric composition, where the adhesion is advantageously detachable on-demand (Abstract, An adhesive material that provides fast and robust adhesion on wet surfaces, where the adhesion formed is detachable on-demand. The adhesive material is formed of one or more hydrophilic polymers or copolymers grafted with one or more amine coupling groups via a plurality of cleavable physical bonds and/or cleavable covalent bonds and one or more cross linkers; and para [0012]. According to another aspect, the present invention provides a method of adhering wet tissues using an adhesive material and on-demand removal of the adhesive material comprising: providing the adhesive material). Zhao further teaches wherein the one or more hydrophilic polymers are selected from the group consisting of alginate, cellulose (Claim 1, An adhesive material for adhering one or more wet surfaces and for triggerable detachment from the one or more wet surfaces comprising: (i) one or more hydrophile polymers or copolymers, grafted with (II) one or more amine coupling groups via (iii) a plurality of cleavable physical bonds and/or cleavable covalent bonds, and (iv) one or more cross linkers; and Claim 2, wherein the (i) one or more hydrophilic polymers or copolymers are selected from alginate, oxidized alginate, cellulose, oxidized cellulose). Zhao further teaches wherein the alginate and the cellulose are oxidized alginate and oxidized cellulose, respectively (Claim 2, wherein the (i) one or more hydrophilic polymers or copolymers are selected from alginate, oxidized alginate, cellulose, oxidized cellulose). Zhao further teaches wherein the one or more tissue coupling groups is selected from the group consisting of an amine coupling group (Claim 1. An adhesive material for adhering one or more wet surfaces and for triggerable detachment from the one or more wet surfaces comprising: (i) one or more hydrophilic polymers or copolymers, grafted with (ii) one or more amine coupling groups via (iii) a plurality of cleavable physical bonds and/or cleavable covalent bonds, and (iv) one or more cross linkers). Zhao further teaches wherein the amine coupling group Is selected from the group consisting of an N-hydroxysuccinimide ester (PAAc-co-NHS ester), a PAAm-co-NHS. an N-Hydroxysuccinimide (NHS) PEG, a poly(L-lactide-co-glycolide)-NHS) a poly(D,L-lactide)-polyethylene glycol-CO-NHS, B poly(N- isopropylacrylamide) N-hydroxysuccinimide terminated, an aldehyde, an imidoester, an epoxide, an isocyanate, a catechol, and a combination thereof (Claim 3, wherein the (ii) one or more amine coupling groups are selected from N-hydroxysuccinimide ester, N- hydroxysulfosuccinimide ester, aldehyde, imidoester, epoxide, isocyanate, catechol, and combinations thereof). Zhao further teaches wherein the one or more crosslinkers are selected from the group consisting of gelatin methacrylate, hyaluronic acid methacrylate, oxidized methacrylic alginate, polycaprolactone diacrylate, N,N'-bis(acrvioyl) cystamine, N,N'-methylenebis(acrylamide), polyethylene glycol diacrylate, polyethylene glycol dimethacrylate, and a combination thereof (Claim 6, wherein the (iv) one or more crosslinkers are selected from gelatin methacrylate, hyaluronic acid methacrylate, oxidized methacrylic alginate, polycaprolactone discrylate, N,N-bis(acryloyi) cystamine, N,N- methylenebis(acrylamide), polyethylene giycol diacrylate, polyethylene glycol dimethacrylate, and combinations thereof). Therefore, it would have been obvious to one of ordinary skill in the art to test the effectiveness of substituting the adhesive used in the method as taught by Rogers for various known tissue adhesives in the art, for example to use the adhesive as taught by Zhao, by routine experimentation, thus providing wherein the adhesive composition comprises one or more hydrophilic polymers, one or more tissue coupling groups, and one or more crosslinkers, in order to determine if this provides an improved method and device, for example if improved adhesion and/or improved longevity is achieved, and in order to provide a device where adhesion is advantageously detachable on-demand. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM. 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, Sahana S. Kaup can be reached on 571-272-6897. 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. /SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612 Application/Control Number: 18/606,479 Page 2 Art Unit: 1612 Application/Control Number: 18/606,479 Page 3 Art Unit: 1612 Application/Control Number: 18/606,479 Page 4 Art Unit: 1612 Application/Control Number: 18/606,479 Page 5 Art Unit: 1612 Application/Control Number: 18/606,479 Page 6 Art Unit: 1612 Application/Control Number: 18/606,479 Page 7 Art Unit: 1612 Application/Control Number: 18/606,479 Page 8 Art Unit: 1612 Application/Control Number: 18/606,479 Page 9 Art Unit: 1612 Application/Control Number: 18/606,479 Page 10 Art Unit: 1612 Application/Control Number: 18/606,479 Page 11 Art Unit: 1612 Application/Control Number: 18/606,479 Page 12 Art Unit: 1612 Application/Control Number: 18/606,479 Page 13 Art Unit: 1612 Application/Control Number: 18/606,479 Page 14 Art Unit: 1612 Application/Control Number: 18/606,479 Page 15 Art Unit: 1612
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