DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on 06/25/2026. As directed by the amendment: claims 1-2, 16, and 19 have been amended. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 8, filed 06/25/2026, with respect to the drawing objections have been fully considered and are persuasive. The applicant’s amendments to the drawings and filed petition under 37 C.F.R. 1.94(a)(2) overcome the drawing objections. The drawing objections have been withdrawn.
Applicant’s arguments, see page 8, filed 06/25/2026, with respect to the USC 112(b) rejections have been fully considered and are persuasive. The applicant’s amendments to the claims overcome the issues of clarity. The USC 112b rejections have been withdrawn.
Applicant’s arguments, see pages 8-10, filed 06/25/2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(2) as being anticipated by Bright et al (US 20220409902 A1), herein referenced to as “Bright” have been fully considered and are persuasive.
The applicant has amended claim 1 to further recite “wherein the one or more channels comprise a central channel and a plurality of peripheral channels positioned around the central channel”. The examiner agrees that Bright does not explicitly disclose a plurality of peripheral channels positioned around the central channel.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Bright in view of Malafosse et al (US 20240188958 A1).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 1-5, 7-12, and 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bright et al (US 20220409902 A1), herein referenced to as “Bright” in view of Malafosse et al (US 20240188958 A1), herein referenced to as “Malafosse”.
Claim 1
Bright discloses: A nerve guidance conduit device 10’ (see Fig. 5N, [0212]), comprising: a tubular outer housing 66’ (see Fig. 5N, [0212]) having an inner lumen 68’ (see Fig. 5N, [0212]); and a plurality of nerve-holding sections 70’ (see Fig. 5N, [0212]) positioned within the inner lumen 68’ of the housing 66’, each nerve-holding section 70’ comprising one or more channels 71’ (see Fig. 5N, [0213]) each configured to receive a nerve (see [0213], receive at least one nerve ends); wherein the inner lumen 68’ of the housing 66’ is divided into an alternating series of nerve-holding sections the sections of 68’ with 70’ (see Fig. 5N) and inner lumen cavities the sections of 68’ without 70’ (see Fig. 5N, [0214], 70’ elevates away from 66’ and separates it from other areas of 68’).
Bright does not explicitly disclose: wherein the one or more channels comprise a central channel and a plurality of peripheral channels positioned around the central channel.
However, Malafosse in a similar field of invention teaches a nerve guidance conduit device 14 (see Figs. 7-8) with a tubular outer housing 14 (see Figs. 7-8) with one or more channels 20 + 41 (see Figs. 7-8). Malafosse further teaches: wherein the one or more channels 20 + 41 comprise a central channel 20 (see Figs. 7-8, [0136]) and a plurality of peripheral channels 41 (see Figs. 7-8, [0136], 41 form smaller separate channels that are fluidically connected to the larger central channel 20) positioned around the central channel 20.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bright to incorporate the teachings of Malafosse and teach a nerve guidance conduit device with the one or more channels comprise a central channel and a plurality of peripheral channels positioned around the central channel. Motivation for such can be found in Malafosse as this shapes the tubular outer housing to facilitate handling during the implantation and surgery while increases the area of contact surface for the efficacy of medical adhesive to secure a respective nerve end (see [0137]).
Claim 2
The combination of Bright and Malafosse teaches: The device of claim 1, see 103 rejection above. Bright does not explicitly disclose: wherein the outer housing and the plurality of nerve-holding sections each comprise a plurality of pores, wherein the plurality of pores of the outer housing align with the plurality of pores of the plurality of nerve-holding sections to form linear fluid paths that extend from the outer housing to the central channel.
However, a variant embodiment of Malafosse teaches a nerve guidance conduit device 10 (see Fig. 9), with an outer housing the tube comprising 10 (see Fig. 9) with an inner cavity the lumen of 10 (see Fig. 9) and a plurality of nerve holding sections 18 + 42 (see Fig. 9) with a central channel the channel of 18 (see Fig. 9). Malafosse (Fig. 9) further teaches: wherein the outer housing the tube comprising 10 and the plurality of nerve-holding sections 18 + 42 each comprise a plurality of pores 44 (see Fig. 9, [0139], 44 is on 18 and 42), wherein the plurality of pores 44 of the outer housing the tube comprising 10 (see Fig. 9) align with the plurality of pores of the plurality 44 of nerve-holding sections 18 + 42 (see Fig. 9, the pores on the outer housing line up with the pores within plurality of nerve-holding sections 18 + 42, which are the lumens within 10, hence forming linear fluid paths through the tube and into the central channel, the channel of 18) to form linear fluid paths that extend from the outer housing the tube comprising 10 to the central channel the channel of 18.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bright to incorporate the teachings of Malafosse and teach a device with the outer housing and the outer housing and the plurality of nerve-holding sections each comprise a plurality of pores, wherein the plurality of pores of the outer housing align with the plurality of pores of the plurality of nerve-holding sections to form linear fluid paths that extend from the outer housing to the central channel. Motivation for such can be found in Malafosse as this this can avoid a pressure build-up or a potential air bubble formation inside the nerve conduit (see [0021]).
Claim 3
The combination of Bright and Malafosse teaches: The device of claim 1, see 103 rejection above. Bright further discloses: further comprising at least one therapeutic-releasing substrate (see [0214], media, see [0193] and [0216], hydrogel) positioned within the inner lumen 68’ (see [0214], between the nerve end slotted into 71’ and the sidewall 66’ is the lumen 68’).
Claim 4
The combination of Bright and Malafosse teaches: The device of claim 3, see 103 rejection above. Bright further discloses: wherein the substrate (see [0214], media, hydrogel) is chosen from a group consisting of: microparticles (see [0460], microspheres), bulk hydrogel (see [0377], hydrogel thickness of 0.05 mm to 10 mm, a bulk hydrogel has a diameter of at least 0.1 mm, hence a hydrogel with a diameter of 0.1 mm to 10 mm is a bulk hydrogel) and hydrogel film (see [0377], hydrogel thickness of 0.05 mm to 10 mm, a hydrogel film has a thickness between 0.1 mm and 0.2 mm, hence a hydrogel with a thickness of 0.1 mm to 0.2 mm as disclosed is a film).
Claim 5
The combination of Bright and Malafosse teaches: The device of claim 3, see 103 rejection above. Bright further discloses: wherein the substrate (see [0214], media or agents, hydrogel) is loaded with a therapeutic selected from the group consisting of: growth factors (see [0466]-[0467], nerve growth factor), neurotrophic factors (see [0466]-[0467], neurotrophic drug), cell adhesion molecules (see [0462], Kindlin-1 and Kindlin-2, bind to the integrin superfamily of cell surface receptors to enhance regeneration), proteins (see [0462], Kindlin-1 is a protein), peptides (see [0065], peptides), small molecules (see [0286], small molecule), nucleic acid molecules (will not be examined here due to being an optional claim limitation), cytokines (see [0416], cytokines), stem cells (see [0064], stems cells), Schwann cells (see [0064], Schwann cells), and upregulators of regeneration-associated genes (will not be examined here due to being an optional claim limitation).
Claim 7
The combination of Bright and Malafosse teaches: The device of claim 3, see 103 rejection above. Bright further discloses: wherein the substrate (see [0214], media, hydrogel) is configured to release the therapeutic over a period of time (see [0033], degrade over time, within 3 months and [0414], trapped in the media and released over time).
Claim 8
The combination of Bright and Malafosse teaches: The device of claim 3, see 103 rejection above. Bright further discloses: wherein the substrate (see [0214], media, hydrogel) is configured to release the therapeutic over a period of at least 50 days (see [0030], about two months or at least about three months, see [0033], degrade over time, within 3 months, which between 2 to 3 months is 50 days, hence at least 50 days and [0414], trapped in the media and released over time).
Claim 9
The combination of Bright and Malafosse teaches: The device of claim 1, see 103 rejection above. Bright further discloses: wherein the one or more channels 71’ have diameters (see [0213], sized and shaped to receive at least a portion of a nerve) ranging from 50 µm to 1000 µm (see [0377], nerve diameter of 1 to 3 mm, which includes values between 0.05 mm to 1 mm, specifically, 1 mm).
Claim 10
The combination of Bright and Malafosse teaches: The device of claim 1, see 103 rejection above. Bright further discloses: wherein the outer housing 66’ (which is a form, see [0212]) has a diameter of at least 0.1 mm (see [0377], forms are sized around 1 to 3mm, which is greater than at least 0.1 mm, hence has a diameter of at least 0.1 mm).
Claim 11
The combination of Bright and Malafosse teaches: The device of claim 1, see 103 rejection above. Bright further discloses: wherein the outer housing 66’ (which is a form, see [0212]) has a length of a least 3 mm (see [0071], between 10 mm and 60 mm, which is greater than 3 mm, hence at least 3 mm).
Claim 12
The combination of Bright and Malafosse teaches: The device of claim 4, see 103 rejection above. Bright further discloses: wherein the hydrogel film (see [0377], hydrogel thickness of 0.05 mm to 10 mm, a hydrogel film has a thickness between 0.1 mm and 0.2 mm, hence a hydrogel with a thickness of 0.1 mm to 0.2 mm as disclosed is a film) has a thickness between 0.1 mm and 0.2 mm (see [0377], thickness of 0.05 mm to 10 mm, a hydrogel film has a thickness between 0.1 mm and 0.2 mm, hence a hydrogel film with a thickness of 0.1 mm to 0.2 mm).
Claim 14
The combination of Bright and Malafosse teaches: The device of claim 4, see 103 rejection above. Bright further discloses: wherein the bulk hydrogel (see [0377], hydrogel thickness of 0.05 mm to 10 mm, a bulk hydrogel has a thickness of at least 0.025 mm, hence a thickness of least 0.025 mm, since 0.05 mm is greater than 0.025 mm) has a thickness of at least 25 µm.
Claim 15
The combination of Bright and Malafosse teaches: The device of claim 4, see 103 rejection above. Bright further discloses: wherein the bulk hydrogel (see [0377], hydrogel thickness of 0.05 mm to 10 mm, a bulk hydrogel has a diameter of at least 0.1 mm, hence a hydrogel with a diameter of 0.1 mm to 10 mm is a bulk hydrogel) has a diameter of at least 100 µm (see [0377], the hydrogel creates a shape similar to the form, which is a tube, hence a thickness is a diameter, at would have a diameter of at least 0.1 mm).
Claim 16
The combination of Bright and Malafosse teaches: The device of claim 3, see 103 rejection above. Bright further discloses: wherein the at least one therapeutic-releasing substrate (see [0214], media, see [0193] and [0216], hydrogel) is positioned in the inner lumen 68’ (see [0214], between the nerve end slotted into 71’ and the sidewall 66’ is the lumen 68’)in a location chosen from at least one of a front location, a middle location and a back location (see Fig. 5N, the locations of 68’, can be in the front, middle, and back in relation to 70’).
Claim 17
The combination of Bright and Malafosse teaches: The device of claim 1, see 103 rejection above. Bright further discloses: wherein the device 10’ (see [0212], 10’ is a form) comprises a material (see [0017], form is a hydrogel) selected from the group consisting of: poly(lactic co-glycolic acid) (PGA) (see [0448], PGA), poly(1-lactic-acid) (PLA) (see [0448], PLA), polycaprolactone (PCL) (see [0448], PCL), poly(ethylene glycol) diacrylate (PEGDA) (the alternatives to the cited materials will not be examined here due to being optional claim limitations), gelatin methacryloyl (GelMA) (see [0431], GelMA), polydimethylsiloxane (PDMS), collagen (see [0052], collagen), chitosan (see [0052], chitosan), decellularized extracellular matrix (dECM) (see [0432], decellularized tissue scaffold), cellulose (see [0331], cellulose), silk (see [0388], silk), and ionic liquids.
Claim 18
The combination of Bright and Malafosse teaches: The device of claim 1, see 103 rejection above. Bright further discloses: further comprising a coating (see [0214], media, which is a hydrogel is put within 68’, which coats at least the inside of 10’) on at least portion of the device 10’ (see Fig. 5N).
Claim 19
The combination of Bright and Malafosse teaches: The device of claim 18, see 103 rejection above. Bright further discloses: wherein the coating (see [0214], media, hydrogel) is a material selected from the group consisting of: conductive materials (see [0436], electrically conductive hydrogel), ferromagnetic materials (see [0250]-[0251], magnetic microstimulator), thermoelectric materials (the alternatives to the cited materials will not be examined here due to being optional claim limitations), nanoparticles, 2D materials, graphene, MXenes, conductive polymers and hydrogels.
Claim 20
The combination of Bright and Malafosse teaches: The device of claim 1, see 103 rejection above. Bright further discloses: A method of treating nerve injury (see Fig. 5N, [0212]-[0214]) comprising: implanting the device of claim 1 at the site of a nerve injury (see [0036] and [0095], nerve injury); thereby treating the injury (see [0031], positioning a form at a treatment site, [0073], treat conditions involving nerves).
Claim(s) 6 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bright in view of Malafosse as applied to claims 5 and 4 respectively above, and further in view of Hadlock et al (US 20010031974 A1), herein referenced to as “Hadlock”.
Claim 6
The combination of Bright and Malafosse teaches: The device of claim 5, see 103 rejection above. The combination of Bright and Malafosse does not explicitly teach: wherein the growth factor is glial cell line-derived neurotrophic factor (GDNF).
However, Hadlock in a similar field of invention teaches a nerve guidance conduit device 10 (see Figs. 1A-1B) with a substrate 22 (see Figs. 1A-1B, hydrogel layer with microspheres) loaded with a therapeutic that are growth factors (see [0008], GDNF ,which is a growth factor). Hadlock further teaches: wherein the growth factor is glial cell line-derived neurotrophic factor (GDNF) (see [0008], GDNF ,which is a growth factor).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bright to incorporate the teachings of Hadlock and teach a device with the growth factor is glial cell line-derived neurotrophic factor (GDNF). Motivation for such can be found in Hadlock as additional growth factor types can contribute to facilitate a neurotrophic agent concentration gradient which can facilitate axon migration (see [0008] and [0029]).
Claim 13
The combination of Bright and Malafosse teaches: The device of claim 4, see 103 rejection above. The combination of Bright and Malafosse does not explicitly teach: wherein the microparticles comprise microspheres with diameters of about 100 µm.
However, Hadlock in a similar field of invention teaches a nerve guidance conduit device 10 (see Figs. 1A-1B) with a substrate 22 + 24 (see Figs. 1A-1B, hydrogel layer with microspheres, microspheres are a form of microparticles). Hadlock further teaches: wherein the microparticles 24 comprise microspheres 24 (see Figs. 1A-1B, [0021]) with diameters of about 100 µm (see [0008], microsphere diameters of 1 micrometer to 150 micrometer, includes 100 micrometer).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bright to incorporate the teachings of Hadlock and teach a device with the microparticles comprise microspheres with diameters of about 100 µm. Motivation for such can be found in Hadlock as the microspheres can be loaded and patterned to facilitate a neurotrophic agent concentration gradient which can facilitate axon migration (see [0008] and [0029]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Romero-Ortega et al (US 20150374887 A1) teaches a nerve guidance conduit device with a plurality of separated channels
Lieberman (US 20100016874 A1) teaches a nerve guidance conduit device with a central channel
Paulos et al (US 20110282448 A1) teaches a nerve guidance conduit device with an inner channel separated from a peripheral channel
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
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