DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed 5/5/2026.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/5/2026 has been entered.
Status of the Claims
Claims 8, 9 and 14 have been amended. Claim 11 has been cancelled. No claims are newly added. Accordingly, claims 1-10 and 12-20 remain pending in the application. Claims 1-7 stand withdrawn from further consideration, without traverse. Claims 8-10 and 12-20 are currently under examination.
Information Disclosure Statements
The IDS’s dated 5/5/2026 and 6/23/2026 have been considered. Signed copies are enclosed herewith.
Withdrawn Objections/Rejections
Applicant’s amendment renders the rejection of claim 11 under 35 USC 112(b) moot. Specifically, the claim has been cancelled. Thus, said rejection has been withdrawn.
Applicant’s amendment renders the rejection of claim 14 under 35 USC 112(d) moot. Specifically, the claim has been amended to remedy the further limiting issue. Thus, said rejection has been withdrawn.
Applicant’s amendment renders the rejection of claims 8, 11-17, 19 and 20 under 35 USC 103 over Melvik, Phillips, Fan, Horn and Byrd moot. Specifically, the limitation, “removing the probe from the in situ forming gel after neurostimulation” has been deleted from independent claim 8 and, as such, the Byrd reference that rendered said limitation obvious is no longer needed for independent claim 8 and depending claims 12, 13, 16, 17, 19 and 20. Thus, the rejection has been modified to only include the relevant claims, claims 14 and 15 and a new rejection is made under 35 USC 103 over Melvik, Phillips, Fan and Horn for claims 8, 12, 13, 16, 17, 19 and 20.
Applicant’s amendment renders the rejection of claims 9 and 18 under 35 USC 103 over Melvik, Phillips, Fan, Horn, Byrd and Schulte moot. Specifically, the limitation, “removing the probe from the in situ forming gel after neurostimulation” has been deleted from independent claim 8 and, as such, the Byrd reference that rendered said limitation obvious is no longer needed for claims 9 and 18. Thus, the rejection has been withdrawn and replaced with a new rejection under 35 USC 103 over Melvik, Phillips, Fan, Horn and Schulte.
Applicant’s amendment renders the rejection of claim 10 under 35 USC 103 over Melvik, Phillips, Fan, Horn, Byrd and Stein moot. Specifically, the limitation, “removing the probe from the in situ forming gel after neurostimulation” has been deleted from independent claim 8 and, as such, the Byrd reference that rendered said limitation obvious is no longer needed for claim 10. Thus, the rejection has been withdrawn and replaced with a new rejection under 35 USC 103 over Melvik, Phillips, Fan, Horn and Stein.
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.
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.
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.
Claims 8, 12, 13, 16, 17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Melvik et al. (US 2006/0159823 A1, Jul. 20, 2006, hereafter as “Melvik”) in view of Phillips et al. (“Neural Tissue Engineering: A Self-Organizing Collagen Guidance Conduit”, Tissue Engineering, Vol. 11, No. 9/10, 2005, pp. 1611-1617; hereafter as “Phillips”), Fan et al. (CN105194729 A, Dec. 30, 2015, machine translation, hereafter as “Fan”) and Horn et al. (WO 2020/018120 A1, Jul. 20 2018, hereafter as “Horn”) as evidenced by Layton et al. (“A Mechanical Model for Collagen Fibril Load Sharing in Peripheral Nerve of Diabetic and Nondiabetic Rats”, Journal of Biomechanical Engineering, Dec. 2004, Vol. 126, pages 803-814; hereafter as “Layton”).
The claimed invention is drawn to a method of forming an in situ nerve conduit for nerve regeneration, the method comprising: positioning a nerve in a form; positioning a nerve stimulating device adjacent to the nerve; and delivering an in situ forming gel circumferentially into the form to retain a position of at least one conductive surface of a probe of the nerve stimulating device in electrical communication with the nerve; and covering the nerve circumferentially with a biomaterial thickness around the nerve of 0.5 mm to 10 mm.
Regarding instant claim 8, Melvik teaches methods of dispensing a self-gelling alginate dispersion in solution (in situ) (abstract; [0011] and [0035]). Melvik teaches that the dispersion may be dispensed within an individual as a liquid/slurry to a site where an alginate gel matrix is desirable ([0036]). Melvik also teaches that the dispersion in the form of a slurry can be poured, injected and otherwise self-gel/set within a mold or cavity to form the shape of such mold or cavity ([0053]-[0054] and [0062]). Melvik further teaches filling artificial nerve conduits (i.e., delivering the gel circumferentially into the form) with self-gelling alginate to create constructs with improved guidance and biocompatibility for nerve regrowth ([0095]). Melvik also teaches that the gel can be modified to increase the adhesion between the gel and tissue ([0104]).
Melvik is silent to the explicit teaching of positioning a nerve in a form as well as a biomaterial thickness around the nerve of 0.5 mm to 10 mm.
Phillips teaches that empty nerve conduits/tubes provide limited tissue-level guidance, however seeding the walls or lumen of said conduit/tube with Schwann cells and/or components of the extracellular matrix offers the potential to enhance the outgrowth of regenerating axons (page 1611). Phillips also teaches that entubulation is a technique in which the nerve ends and intervening gap are enclosed within a tube/conduit made of biological or synthetic materials (page 1611). Phillips also teaches an open surgical procedure (paragraph bridging pages 1613-1614). Phillips teaches a nerve conduit/tube having an inner diameter of 1.98 mm (page 1613, left col, 2nd para.). Phillips also teaches utilizing sciatic nerves of rats (paragraph bridging pages 1613-1614). A rat sciatic nerve is known to have a diameter of approximately 1 mm as evidenced by Layton et al. (Fig. 1). Accordingly, a skilled artisan would be able to determine that the space between the nerve and the tube would be approximately 0.5 mm.
[AltContent: connector][AltContent: connector][AltContent: textbox ( dconduit = 1.98 mm)][AltContent: textbox ( dnerve = 1 mm)][AltContent: connector][AltContent: connector][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (Biomaterial thickness = rconduit - rnerve)][AltContent: textbox (d = 2r)]
Both Melvik and Phillips are drawn to methods of regrowth/regeneration of nerves utilizing nerve tubes/conduits, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to include the steps of positioning a nerve into a form cavity into the invention of Melvik, as suggested by Phillips, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Phillips teaches that it is conventional to place a nerve end within a tube/conduit (cavity) in order to provide guidance of regeneration/regrowth of nerves. It would have further been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to include a biomaterial thickness around the nerve of approximately 0.5 mm into the invention of Melvik, as suggested by Phillips, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Melvik generally teaches filling the nerve conduit and Phillips effectively teaches a gap of approximately 0.5 mm between the nerve and inner diameter of the tube yielding a biomaterial thickness of approximately 0.5 mm. It is noted a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (MPEP 2144.05). It would also have been prima facie obvious to optimize the size of the conduit and space between the nerve and conduit by way of routine experimentation with a reasonable expectation of success depending on various design variables, e.g., the type of nerve and diameter thereof, the size of the probe, the conductivity of the gel, etc.
Melvik is also silent to positioning a nerve stimulation device adjacent to the nerve.
Fan teaches a method of regenerating a nerve by using a conductive nerve conduit in combination with an implantable electrode that applies electrical stimulation (page 2, paragraph 14; Fig. 2B).
The references are drawn to methods of regrowth/regeneration of nerves utilizing nerve tubes/conduits, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to include the steps of positioning a nerve stimulation device adjacent to the nerve into the invention of Melvik/Phillips as suggested by Fan with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Fan teaches that utilizing an implantable electrode in combination with a nerve conduit is effective in the regeneration of nerves.
Melvik is silent to the limitation, “to retain a position of at least one conductive surface of a probe of the nerve stimulating device in electrical communication with the nerve”.
Horn teaches bioelectronic neural interface devices with hydrogel adhesion (abstract). Horn teaches that the device comprises an electrode and an adhesive hydrogel that is configured to adhere the electrode to the nerve, ganglion or tissue ([0046]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a gel or hydrogel that is able to retain a position of at least one conductive surface of a probe of the nerve stimulating device in electrical communication with the nerve into the invention of Melvik/Phillips/Fan as suggested by Horn with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Melvik teaches that the gel can fill the nerve conduit and that the gel can be modified to increase the adhesion between the gel and tissue and Horn teaches that an electrode can be adhered to a nerve with an adhesive hydrogel. A skilled artisan would have reasonably expected that filling an adhesive gel/hydrogel in a nerve conduit would effectively retain a position of at least one conductive surface of a probe (electrode) of the nerve stimulating device in electrical communication with the nerve.
Regarding instant claim 13, Phillips, as discussed above, teaches an open surgical procedure (paragraph bridging pages 1613-1614). The references are silent to the order in which positioning a nerve stimulating device and delivering an in situ forming gel occur, however MPEP 2144.04(IV)(C) states, “selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results”.
Regarding instant claim 12, Melvik, as discussed above, teaches alginate hydrogels ([0005]-[0006] and [0058]).
Regarding instant claim 16, Melvik, as discussed above, further teaches embodiments comprising an alginate hydrogel having a conductivity value of 0.4 mS/cm or 0.6 mS/cm (Examples 20 and 22). Melvik additionally teaches starting conductivity levels of, e.g., 78 mS/cm or 40 mS/cm and successively washing in order to lower the conductivity to levels of, e.g., 0.6 mS/cm and 0.0129 mS/cm (Examples). It is further noted that Fan, as discussed above, also teaches utilizing a conductive material (page 2, paragraph 14; Fig. 2B). Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the conductivity to a desired conductively level by way of routine experimentation as suggested by Melvik with a reasonable expectation of success.
Regarding instant claim 17, Melvik, as discussed above, further teaches embodiments comprising an alginate hydrogel having a conductivity value of 0.0159 mS/cm or 0.0129 mS/cm (Examples 21 and 25). Melvik additionally teaches starting conductivity levels of, e.g., 78 mS/cm or 40 mS/cm and successively washing in order to lower the conductivity to levels of, e.g., 0.6 mS/cm and 0.0129 mS/cm (Examples). Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the conductivity to a desired conductively level including a level considered nonconductive by way of routine experimentation as suggested by Melvik with a reasonable expectation of success.
Regarding instant claim 19, Melvik, as discussed above, teaches filling artificial nerve conduits with self-gelling alginate (i.e., provide protection to the nerve) to create constructs with improved guidance and biocompatibility for nerve regrowth ([0095]).
Regarding instant claim 20, Melvik, as discussed above, teaches filling artificial nerve conduits with self-gelling alginate to create constructs with improved guidance and biocompatibility for nerve regrowth (i.e., nerve regeneration) ([0095]).
Thus, the combined teachings of Melvik, Phillips, Fan, Horn and Byrd render the instant claims prima facie obvious.
Claim 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Melvik et al. (US 2006/0159823 A1, Jul. 20, 2006, hereafter as “Melvik”) in view of Phillips et al. (“Neural Tissue Engineering: A self-Organizing Collagen Guidance Conduit”, Tissue Engineering, Vol. 11, No. 9/10, 2005, pp. 1611-1617; hereafter as “Phillips”), Fan et al. (CN105194729 A, Dec. 30, 2015, machine translation, hereafter as “Fan”) and Horn et al. (WO 2020/018120 A1, Jul. 20 2018, hereafter as “Horn”) as evidenced by Layton et al. (“A Mechanical Model for Collagen Fibril Load Sharing in Peripheral Nerve of Diabetic and Nondiabetic Rats”, Journal of Biomechanical Engineering, Dec. 2004, Vol. 126, pages 803-814; hereafter as “Layton”), as applied to claim 8 above, and further in view of Schulte et al. (US 2013/0267837 A1, Oct. 10, 2013, hereafter as “Schulte”).
The claimed invention is described above.
Melvik, Phillips, Fan, Horn and Byrd teach the elements discussed above.
Regarding instant claim 9, Melvik, Phillips, Fan, Horn and Byrd are silent to the form comprising a slit within a wall of the form and inserting the nerve stimulating device into the slit such that the nerve stimulating device is positioned adjacent to the nerve when the nerve is positioned within the cavity and when the nerve stimulating device is inserted into the slit.
Schulte teaches a method for controlling the delivery of electrical energy to a therapy site in the body comprising inserting an electrical lead and insulating device into a patient's body and placing the insulating device between the therapy site and the electrical lead, wherein the method includes aligning the aperture (an elongated slit) of the insulating device with the therapy site and activating the electrical lead to deliver electrical energy to the therapy site through the aperture of the insulating device ([0047]; Fig. 10). Schulte teaches that the insulating device used in conjunction with an electrical lead essentially controls where electrical current can pass into nerve tissue ([0047]; Fig. 10).
The references are all drawn to nerve therapies, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a slit within a wall of the form and inserting the nerve stimulating device into the slit such that the nerve stimulating device is positioned adjacent to the nerve when the nerve is positioned within the cavity and when the nerve stimulating device is inserted into the slit into the invention of Melvik/Phillips/Fan/Horn/Byrd as suggested by Schulte with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Schulte teaches an aperture or slit allows for an electrical lead to be inserted through a device and effectively deliver electrical energy directly to the nerve tissue in need of therapy.
Regarding instant claim 18, Melvik, Phillips, Fan, Horn and Byrd are silent to “positioning the nerve stimulating device at most 2 mm from the nerve”. However, Schulte teaches that the insulating device used in conjunction with an electrical lead essentially controls where electrical current can pass into nerve tissue such as the spinal cord. The references are all drawn to nerve therapies, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the distance between the electric lead and the nerve by way of routine experimentation with a reasonable expectation of success. A skilled artisan would have been motivated to do so because the prior art teaches delivering electrical stimulation in close proximation to the nerve tissue which implicitly encompasses a finite range of distance between the electrical lead and the nerve.
Thus, the combined teachings of Melvik, Phillips, Fan, Horn, Byrd and Schulte render the instant claims prima facie obvious.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Melvik et al. (US 2006/0159823 A1, Jul. 20, 2006, hereafter as “Melvik”) in view of Phillips et al. (“Neural Tissue Engineering: A self-Organizing Collagen Guidance Conduit”, Tissue Engineering, Vol. 11, No. 9/10, 2005, pp. 1611-1617; hereafter as “Phillips”), Fan et al. (CN105194729 A, Dec. 30, 2015, machine translation, hereafter as “Fan”) and Horn et al. (WO 2020/018120 A1, Jul. 20 2018, hereafter as “Horn”) as evidenced by Layton et al. (“A Mechanical Model for Collagen Fibril Load Sharing in Peripheral Nerve of Diabetic and Nondiabetic Rats”, Journal of Biomechanical Engineering, Dec. 2004, Vol. 126, pages 803-814; hereafter as “Layton”), as applied to claim 8 above, and further in view of Stein et al. (USPN 3,955,560, May 11, 1976, hereafter as “Stein”).
The claimed invention is described above.
Melvik, Phillips, Fan, Horn and Byrd teach the elements discussed above.
Regarding instant claim 10, Melvik, Phillips, Fan, Horn and Byrd are silent to securing the nerve stimulating device with a cuff.
Stein teaches an implantable neural electrode wherein the electrode unit is secured with a cuff and either a tie or an adhesive (abstract; col. 2, line 39 – col. 3, line 22; Figs. 3-5).
The references are all drawn to nerve therapies, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a step of securing a nerve stimulating device with a cuff into the invention of Melvik/Phillips/Fan/Horn/Byrd as suggested by Stein with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Stein teaches that a cuff is a suitable fixation device for an implantable electrode (MPEP 2144.07).
Thus, the combined teachings of Melvik, Phillips, Fan, Horn, Byrd and Stein render the instant claim prima facie obvious.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Melvik et al. (US 2006/0159823 A1, Jul. 20, 2006, hereafter as “Melvik”) in view of Phillips et al. (“Neural Tissue Engineering: A Self-Organizing Collagen Guidance Conduit”, Tissue Engineering, Vol. 11, No. 9/10, 2005, pp. 1611-1617; hereafter as “Phillips”), Fan et al. (CN105194729 A, Dec. 30, 2015, machine translation, hereafter as “Fan”), Horn et al. (WO 2020/018120 A1, Jul. 20 2018, hereafter as “Horn”) as evidenced by Layton et al. (“A Mechanical Model for Collagen Fibril Load Sharing in Peripheral Nerve of Diabetic and Nondiabetic Rats”, Journal of Biomechanical Engineering, Dec. 2004, Vol. 126, pages 803-814; hereafter as “Layton”), as applied to claim 8 above, and further in view of Byrd et al. (“Technique for the surgical extraction of permanent pacing leads and electrodes”, The Journal of Thoracic and Cardiovascular Surgery, Volume 89, Issue 1, 1985, pp. 142-144, hereafter as “Byrd”).
The claimed invention is described above.
Melvik, Phillips, Fan and Horn teach the elements discussed above.
Melvik, Phillips, Fan and Horn do not explicitly teach removing the nerve stimulating device after neurostimulation (instant claim 14), wherein removal is during an open surgical procedure (instant claim 15).
However, Byrd, in the analogous art of therapies utilizing electrodes in vivo, teaches techniques for the surgical extraction of pacing leads and electrodes (title). Byrd teaches different techniques of removal including open surgical procedures (page 142).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the step of removing the electrode by way of an open surgery into the invention of Melvik/Phillips/Fan/Horn, as suggested by Byrd, with a reasonable expectation of success. A skilled artisan would have been motivated to remove the lead/electrode because Byrd teaches that if a lead or electrode gets infected, the most expedient and successful therapy is it removal (page 142, 1st paragraph). A skilled artisan would have been motivated to perform the removal during an open surgery because Byrd teaches that a suitable method of removal of a lead or an electrode is an open surgical procedure (MPEP 2144.07).
Thus, the combined teachings of Melvik, Phillips, Fan, Horn and Byrd render the instant claims prima facie obvious.
Response to Arguments
Applicant's arguments, filed 5/5/2026, with respect to the 103 rejections have been fully considered but they are not persuasive.
Applicant argues that the references do not teach the newly added limitation and centers their arguments around Melvik. Remarks, pages 4-6.
In response, it is respectfully submitted that the newly added limitation has been considered and is discussed in the rejection above. It is important to note that the rejection is based on a combination of references and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). With respect to the new limitation, Melvik and Phillips render the limitation obvious.
Thus, for these reasons, Applicant’s arguments are found unpersuasive.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 8-10 and 12-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 and 19 of copending Application No. 17/547,583 in view of Fan et al. (CN105194729 A, Dec. 30, 2015, machine translation, hereafter as “Fan”).
The instant claims are described above.
The copending claims are drawn to a method of facilitating nerve growth, the method comprising: positioning a first nerve end of a first nerve into a form cavity defined by a form; positioning a second nerve end of a second nerve into the form cavity; filling a coaptation site between the first nerve end and the second nerve end with an injected growth permissive hydrogel; introducing an in situ forming media in contact with the first nerve end; introducing the in situ forming media in contact with the second nerve end, the in situ forming media being photoresponsive such that the in situ forming media transitions from a flowable state to a nonflowable state upon photopolymerization of the in situ forming media; and circumferentially delivering light around a portion of the first nerve and a portion of the second nerve for the photopolymerization. Copending claim 8 further recites, “wherein the nonflowable media forms a nerve conduit”. Copending claims 15 and 16 recite, “delivering the in situ forming media circumferentially”.
The copending claims do not recite a biomaterial thickness of 0.5 mm to 10 mm, however the copending specification teaches a gel thickness of 100 microns to 5 mm ([0202]-[0203]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05(I)). Because the claimed range of 0.5 mm to 10 mm overlaps with the copending application’s range of 100 microns to 5 mm, a prima facie case exists. The examiner has relied upon the specification to delineate the scope of the invention embraced by the application, consistent with the decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. U.S. Court of Appeals Federal Circuit, 95 USPQ2d 1797.
The copending claims do not recite positioning a nerve stimulating device adjacent to the nerve.
However, Fan teaches a method of regenerating a nerve by using a conductive nerve conduit in combination with an implantable electrode that applies electrical stimulation (page 2, paragraph 14; Fig. 2B).
Fan and the copending application are drawn to nerve guides/conduits, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to include positioning a nerve stimulation device adjacent to the nerve as suggested by Fan with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Fan teaches that utilizing an implantable electrode in combination with a nerve conduit is effective in the regeneration of nerves.
The copending claims do not recite “delivering an in situ forming gel circumferentially into the form to retain a position of at least one conductive surface of a probe of the nerve stimulating device in electrical communication with the nerve”.
Horn teaches bioelectronic neural interface devices with hydrogel adhesion (abstract). Horn teaches that the device comprises an electrode and an adhesive hydrogel that is configured to adhere the electrode to the nerve, ganglion or tissue ([0046]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a gel or hydrogel that is able to retain a position of at least one conductive surface of a probe of a nerve stimulating device in electrical communication with the nerve into the invention of the copending application/Fan as suggested by Horn with a reasonable expectation of success. A skilled artisan would have been motivated to do so because the copending claims recite delivering the gel circumferentially within a form, Fan teaches the inclusion of an electrode near a nerve within a nerve conduit, and Horn teaches that an electrode can be adhered to a nerve with an adhesive hydrogel. A skilled artisan would have reasonably expected that delivering an adhesive gel/hydrogel to a nerve conduit circumferentially would effectively retain a position of at least one conductive surface of a probe (electrode) of the nerve stimulating device in electrical communication with the nerve.
The copending application/references do not explicitly teach removing the nerve stimulating device after neurostimulation.
However, Byrd, in the analogous art of therapies utilizing electrodes in vivo, teaches techniques for the surgical extraction of pacing leads and electrodes (title). Byrd teaches different techniques of removal including open surgical procedures (page 142).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the step of removing the electrode by way of an open surgery into the invention of the copending application/Fan/Horn as suggested by Byrd with a reasonable expectation of success. A skilled artisan would have been motivated to remove the lead/electrode because Byrd teaches that if a lead or electrode gets infected, the most expedient and successful therapy is it removal (page 142, 1st paragraph). A skilled artisan would have further been motivated to perform the removal during an open surgery because Byrd teaches that a suitable method of removal of a lead or an electrode is an open surgical procedure (MPEP 2144.07).
Thus, the subject matter of the instant claims are unpatentable over the subject matter of the copending claims in view of the teachings of Fan, Horn and Byrd.
This is a provisional nonstatutory double patenting rejection.
Claims 8-10 and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,096,941 B2 in view of Fan et al. (CN105194729 A, Dec. 30, 2015, machine translation, hereafter as “Fan”).
The instant claims are described above.
The patented claims are drawn to a method of forming a protective barrier, the method comprising: identifying a nerve; positioning the nerve at least partially within a form, the form comprising a hydrophobic characteristic; introducing a media into the form to surround the nerve, the media comprising a hydrophilic characteristic; and permitting the media to form a protective barrier at least part way around the nerve, wherein the media is a shorter-term degradable hydrogel, wherein the shorter-term degradable hydrogel is configured to degrade over a term between about 1 hour and about 3 months, and wherein the hydrophilic characteristic of the media and the hydrophobic characteristic of the form are configured to facilitate a rapid of the form and leave the protective barrier from the form.
The patented claims do not recite a biomaterial thickness of 0.5 mm to 10 mm, however the patent’s disclosure teaches the nerve is covered circumferentially with a biomaterial thickness around the nerve of at least 0.1 mm of a protective barrier, preferably 0.5 mm to 10 mm, more preferably 0.5 to 5 mm thickness (col. 15, lines 27-31). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05(I)). Because the claimed range of 0.5 mm to 10 mm overlaps with the patent’s range of 0.1 mm to 10 mm, a prima facie case exists. The examiner has relied upon the specification to delineate the scope of the invention embraced by the patent, consistent with the decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. U.S. Court of Appeals Federal Circuit, 95 USPQ2d 1797.
The patented claims do not recite positioning a nerve stimulating device adjacent to the nerve.
However, Fan teaches a method of regenerating a nerve by using a conductive nerve conduit in combination with an implantable electrode that applies electrical stimulation (page 2, paragraph 14; Fig. 2B).
Fan and the patent are drawn to nerve guides/conduits and methods thereof, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to include positioning a nerve stimulation device adjacent to the nerve as suggested by Fan with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Fan teaches that utilizing an implantable electrode in combination with a nerve conduit is effective in the regeneration of nerves.
The patented claims do not recite “delivering an in situ forming gel circumferentially into the form to retain a position of at least one conductive surface of a probe of the nerve stimulating device in electrical communication with the nerve”.
Horn teaches bioelectronic neural interface devices with hydrogel adhesion (abstract). Horn teaches that the device comprises an electrode and an adhesive hydrogel that is configured to adhere the electrode to the nerve, ganglion or tissue ([0046]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a gel or hydrogel that is able to retain a position of at least one conductive surface of a probe of a nerve stimulating device in electrical communication with the nerve into the invention of the patent/Fan as suggested by Horn with a reasonable expectation of success. A skilled artisan would have been motivated to do so because the patented claims recite delivering the gel by surrounding the nerve within a form (circumferentially), Fan teaches the inclusion of an electrode near a nerve within a nerve conduit, and Horn teaches that an electrode can be adhered to a nerve with an adhesive hydrogel. A skilled artisan would have reasonably expected that delivering an adhesive gel/hydrogel to a nerve conduit circumferentially would effectively retain a position of at least one conductive surface of a probe (electrode) of the nerve stimulating device in electrical communication with the nerve.
The patent/references do not explicitly teach removing the nerve stimulating device after neurostimulation.
However, Byrd, in the analogous art of therapies utilizing electrodes in vivo, teaches techniques for the surgical extraction of pacing leads and electrodes (title). Byrd teaches different techniques of removal including open surgical procedures (page 142).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the step of removing the electrode by way of an open surgery into the invention of the patent/Fan/Horn as suggested by Byrd with a reasonable expectation of success. A skilled artisan would have been motivated to remove the lead/electrode because Byrd teaches that if a lead or electrode gets infected, the most expedient and successful therapy is it removal (page 142, 1st paragraph). A skilled artisan would have further been motivated to perform the removal during an open surgery because Byrd teaches that a suitable method of removal of a lead or an electrode is an open surgical procedure (MPEP 2144.07).
Thus, the subject matter of the instant claims are unpatentable over the subject matter of the patented claims in view of the teachings of Fan, Horn and Byrd.
Response to Arguments
Applicant's arguments, filed 5/5/2026, with respect to the double patenting rejections have been fully considered but they are not persuasive.
Applicant requests that the rejections are held in abeyance until the claims are in condition for allowance. Remarks, pages 6-7.
Applicant’s request is acknowledged. The rejections have been modified to account for the claim amendments. Said rejections are still applicable at this time.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617
