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 .
Election/Restrictions
Applicant’s election of Group I (claims 1-40) in the reply filed on 06/09/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The restriction requirement is made Final.
Claims 1-43 are currently pending.
Claims 41-43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/09/2026.
Claims 1-40 have been examined on their merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation "the biocompatible material of the coating material" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim as there is no prior recitation of a biocompatible material of coating material in claim 8 or the parent claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 9, 17, 19, 21-22, 25-30, 39-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levy et al (Journal of Neuroscience, 1985).
Regarding claim 1, Levy disclose a method for in vitro enzymatic dissociation of nerve roots and peripheral nerves from adult mammals (Title). Nerve tissue comprising one or more fascicles, native extracellular matrix, and an epineurial sheath (epineurium) is treated with an enzyme that degrades the native extracellular matrix and epineurial sheath (epineurium) and washing the treated tissue to substantially remove and/or deactivate the enzyme and to substantially remove the matrix and epineurial sheath (epineurium) degradation products thereby producing one or more nerve fascicles (nerve fibers) substantially free of the native matrix and epineurial sheath and forming a fasciculated nerve graft from at least one nerve fascicle (capable of being used as a nerve graft) (page 285, Results, page 283, Figure 1, page 284-first paragraph).
Regarding claims 2 and 9-10, Levy disclose further comprising separating the one or more nerve fascicles that are substantially free of the matrix material and the epineurial sheath (epineurium) from each other (page 285, results, page 290).
Regarding claim 17, Levy disclose wherein the nerve tissue is from rats (a non-human animal) (page 282 materials and methods).
Regarding claim 19, Levy disclose wherein the fasciculated nerve graft is a peripheral nerve graft (page 282).
Regarding claim 21, Levy disclose wherein the enzyme is one or more of collagenase type I (page 284, first paragraph).
Regarding claims 22 and 26, Levy disclose wherein the treating the nerve tissue with enzyme is performed at 37˚C (page 283) for 2 to 6 hours which can be extended 1-2 hours (page 285, results).
Regarding claim 25, Levy disclose wherein one or both treating and the washing is performed with agitation (abstract, page 284, page 285).
Regarding claims 1 and 27, Levy disclose wherein the fluid level around the treated nerve tissue rises and falls more than once (washes) (pages 284-285).
Regarding claim 28-30, Levy further disclose wherein suspending the washed nerve tissue in a solution and incubating the suspended nerve tissue in the solution with agitation, at 37˚C (page 283) for 2 to 6 hours which can be extended 1-2 hours (pages 284- 285, results).
Regarding claims 39-40, Levy disclose wherein the epineurium and the perineurium are removed/dissolved via the dissociating enzymes (page 285, results) which is interpreted as the entirety of the matrix and epineurial sheath being removed.
Therefore, the teaching of Levy et al anticipates Applicant’s invention as claimed.
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.
Claim(s) 1-2, 9-17, 19-32, 34-40 are rejected under 35 U.S.C. 103 as being unpatentable over Levy et al (Journal of Neuroscience, 1985) in view of Hope at al (Physiological Measurement, 2018).
Regarding claims 1-2, 9, 17, 19, 21-22, 25-30, 39-40, Levy disclose the claimed invention as described above. However, Levy does not explicitly describe wherein the nerve fascicles produced are formulated into a fasciculated nerve graft. Levy teach that the fascicles produced are for research purposes and include nerve fascicles obtained from rat sciatic nerve tissue.
Hope disclose that rat sciatic nerve offers similarities in morphology to the human median nerve which makes it a suitable example in research for peripheral nerve prosthetics (page 2 second paragraph). Hope disclose that a single fascicle model can have a length of 50 mm and a diameter of 680 µm (page 7 first paragraph).
One of ordinary skill in the art would have been motivated to formulate the nerve fascicle of Levy into a nerve graft for research purposes because Hope teach and suggest that the rat sciatic nerve offers similarities in morphology to a human median nerve makes it a suitable example in research for peripheral nerve prosthetics (graft) (page 2 second paragraph). One of ordinary skill in the art would have had a reasonable expectation of success because Levy is also using nerve fascicles from a rat sciatic nerve tissue.
Regarding claim 10, Levy suggest that two or more nerve fascicles can be produced (page 286, Figure 2).
Regarding claims 9-16, Levy is silent with regard to the diameter and length of the nerve fascicles produced.
Hope teach and suggest that a single fascicle model can have a length of 50 mm and a diameter of 680 µm (page 7 first paragraph).
One of ordinary skill in the art would have been motivated to optimize and modify the diameter and lengths of the fascicles used in a graft model such that the fascicles are of substantially similar size in order to better control the consistency of the properties of the nerve graft. One of ordinary skill in the art would have been motivated to select fascicles that have a length of 50 mm and a diameter of 680 µm because Hope teach and suggest that this is a suitable size for research purposes. One of ordinary skill in the art would have had a reasonable expectation of success because Levy and Hope are both directed to the use of nerve fascicles of rat sciatic tissue for research purposes.
Regarding claim 20, Levy would have been motivated with a reasonable expectation of success to use nerve fascicles from two or more nerve tissues because this would have allowed the ability to maximize the final model graft size as well as creating multiple grafts of various sizes as needed for further research.
Regarding claims 23, 32, Levy disclose wherein the treating the nerve tissue with enzyme is performed at 37˚C (page 283) for 2 to 6 hours which can be extended 1-2 hours (page 285, results). The modification of the time in incubation would have been a matter of routine optimization and experimentation as the person of ordinary skill in the art would want to obtain a nerve fascicle with minimal damage from enzyme treatment.
Regarding claims 24, 31, Levy disclose exposing the enzyme treated nerve fascicles to lower temperatures anywhere from 37˚C to below zero (page 284, paragraph 5). The person of ordinary skill in the art would have arrived at the claimed temperatures of 4˚C through routine optimization and experimentation with a reasonable expectation of success because Levy suggest a temperature range that includes 4˚C and thus renders 4˚C obvious. While Levy is silent with regard to the number of hours spent at this lower temperature, a person of ordinary skill in the art would have been able to arrive at the claimed values through routine optimization and experimentation as the person of ordinary skill in the art would want to obtain a nerve fascicle with minimal damage from such treatment.
Regarding claims 34-38, Levy disclose Levy disclose wherein one or both treating and the washing is performed with agitation (abstract, page 284, page 285). Levy disclose wherein the fluid level around the treated nerve tissue rises and falls more than once (washes) (pages 284-285). Levy disclose wherein the solution used in these washes were tested for osmolarity and pH periodically (page 284).
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to perform washes after the enzymatic treatment with a buffered solution in the method of Levy because this is routine and conventional in the art after enzymatic digestion of tissue in order to remove the enzyme and restore the tissue to a neutral pH of about 7.4. Agitation would have been obvious to apply in order to enhance the dissociation of the nerve fascicles. The modification of the time in incubation would have been a matter of routine optimization and experimentation as the person of ordinary skill in the art would want to obtain a nerve fascicle with minimal damage from washing and agitation treatment.
Therefore, the combined teachings of Levy et al and Hope et al render obvious Applicant’s invention as claimed.
Claim(s) 3-8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Levy et al (Journal of Neuroscience, 1985) in view of Hope at al (Physiological Measurement, 2018) as applied to claims 1-2, 9-17, 19-32, 34-40 above, and further in view of Wagner et al (US 2015/0032137).
Regarding claims 3-8 and 18, the combined teaching of Levy and Hope render obvious the claimed invention as described above, but do not specifically describe entubulating one or more nerve fascicles.
Wagner disclose methods, materials and devices for the development of conductive conduits that may be used for the treatment of peripheral nerve injury (abstract). In one aspect a bioabsorbable polymer tube (entubulation material) is used as a support wherein the polymer compound comprises collagen (an extracellular matrix material) (page 1 para 11-12). The method calls for seeding the tube with cells, specifically neural cells (entubulation), which is plural and thus includes at least two never cells (fascicles) (page 2, para 21, para 23, page 16 para 174). Type 1 collagen and combinations thereof, are described as biocompatible material suitable for use with their tubes (page 4 para 65). The conduits provide a protective shell for nerve regrowth (page 5 para 65). In addition, scaffolding materials, including those that are injectable and can be gelled, are suggested as beneficial for providing a supportive matrix for cell infiltration (embedding the cells within a gel in the spaces within the tube) between the ends of a peripheral nerve being repaired (page 7 para 86). Seeding tubular conduits with primary rat neurons is specifically described and can be combined with other cell types such as Schwann cells (page 16, para 174).
One of ordinary skill in the art would have been motivated to isolated nerve fascicles of Levy within biocompatible entubulation (tube) material because Wagner teach and suggest that these tubes provide a protective shell for nerve regrowth. One of ordinary skill in the art would have been motivated to include embedding these nerve fascicles within a gel matrix scaffold within the biocompatible entubulation material because Wagner teach and suggest that this provides a beneficial support for cell infiltration. One of ordinary skill in the art would have been motivated to include various types of cells, such as various types of nerve cells, in the cell seeded entubulation material because Wagner teach and suggest that this is beneficial (page 6 para 82) and that primary rat nerve cells can be seeded with Schwann cells as well (page 16 para 174). Seeding the nerve cells on a coating material on a sheet of the entubulation material would have been an obvious option as Wagner disclose that the tubes are made from sheets of polymer material that is coated (page 10 para 122). One of ordinary skill in the art would have had a reasonable expectation of success because Levy and Wagner are both including isolated primary rat nerve cells and Hope indicate that there is a need for nerve repair using isolated nerve cells.
Therefore, the combined teachings of Levy et al, Hope et al and Wagner et al render obvious Applicant’s invention as claimed.
Claim(s) 33 are rejected under 35 U.S.C. 103 as being unpatentable over Levy et al (Journal of Neuroscience, 1985) in view of Hope at al (Physiological Measurement, 2018) as applied to claims 1-2, 9-17, 19-32, 34-40 above, and further in view of Heggeness (US 2016/0030484) and as evidenced by Paget (US 4,382,028).
Regarding claim 33, the combined teaching of Levy and Hope render obvious the claimed invention as described above, but do not specifically describe wherein the solution that the washed nerve tissue is suspended in comprises alpha-antitrypsin and alpha-2-macroglobulin and the solution is a serum selected from a group.
Heggeness discloses that a nerve tissue treated with collagenase and washed is then suspended in a solution containing fetal bovine serum (FBS) to stop the enzyme digestion (page 7 para 77). It is well known that fetal bovine serum inherently contains alpha-antitrypsin and alpha-2-macroglobulin as evidenced by Paget (column 4 lines 8-21).
One of ordinary skill in the art would have been motivated to further include fetal bovine serum (FBS) in the incubation solution of Levy after the collagenase treatment of the nerve fascicles because Heggeness teach and suggest that this provides the benefit of stopping the enzyme digestion and allowing for the nerve fascicles to be isolated for further use. One of ordinary skill in the art would have had a reasonable expectation of success because both Levy and Heggeness are drawn to the digestion and isolation of rodent sciatic nerves with collagenase.
Therefore, the combined teachings of Levy et al, Hope et al and Heggeness render obvious Applicant’s invention as claimed.
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 1-20 and 39-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11, 998,661.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent are also directed to a fasciculated nerve graft prepared by enzymatically removing the epineurial sheath and the native extracellular matrix material from the nerve and further comprising entubulation material, one or two or more nerve fascicles, similar diameters and lengths, biodegradable material, embedding in gel, coating, further additions such as growth factor and cells, human and non-human sources, peripheral or spinal nerve graft, and the percentage of matrix and sheath removed.
Therefore, the claims of the patent anticipate or at least render obvious the claims of the current application.
Claims 1-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,998,661 in view of Levy et al (Journal of Neuroscience, 1985), and Heggeness (US 2016/0030484) and as evidenced by Paget (US 4,382,028).
While the claims of the patent are also directed to a fasciculated nerve graft prepared by enzymatically removing the epineurial sheath and the native extracellular matrix material from the nerve and further comprising entubulation material, one or two or more nerve fascicles, similar diameters and lengths, biodegradable material, embedding in gel, coating, further additions such as growth factor and cells, human and non-human sources, peripheral or spinal nerve graft, and the percentage of matrix and sheath removed, the claims are silent with regard to the specific enzyme used, timing and temperature of the enzymatic digestion, washing and suspension of the washed nerves.
Levy disclose a method for in vitro enzymatic dissociation of nerve roots and peripheral nerves from adult mammals (Title). Nerve tissue comprising one or more fascicles, native extracellular matrix, and an epineurial sheath (epineurium) is treated with an enzyme that degrades the native extracellular matrix and epineurial sheath (epineurium) and washing the treated tissue to substantially remove and/or deactivate the enzyme and to substantially remove the matrix and epineurial sheath (epineurium) degradation products thereby producing one or more nerve fascicles (nerve fibers) substantially free of the native matrix and epineurial sheath and forming a fasciculated nerve graft from at least one nerve fascicle (capable of being used as a nerve graft) (page 285, Results, page 283, Figure 1, page 284-first paragraph).
Regarding claims 2 and 9-10, Levy disclose further comprising separating the one or more nerve fascicles that are substantially free of the matrix material and the epineurial sheath (epineurium) from each other (page 285, results, page 290).
Regarding claim 17, Levy disclose wherein the nerve tissue is from rats (a non-human animal) (page 282 materials and methods).
Regarding claim 19, Levy disclose wherein the fasciculated nerve graft is a peripheral nerve graft (page 282).
Regarding claim 21, Levy disclose wherein the enzyme is one or more of collagenase type I (page 284, first paragraph).
Regarding claims 22 and 26, Levy disclose wherein the treating the nerve tissue with enzyme is performed at 37˚C (page 283) for 2 to 6 hours which can be extended 1-2 hours (page 285, results).
Regarding claim 25, Levy disclose wherein one or both treating and the washing is performed with agitation (abstract, page 284, page 285).
Regarding claims 1 and 27, Levy disclose wherein the fluid level around the treated nerve tissue rises and falls more than once (washes) (pages 284-285).
Regarding claim 28-30, Levy further disclose wherein suspending the washed nerve tissue in a solution and incubating the suspended nerve tissue in the solution with agitation, at 37˚C (page 283) for 2 to 6 hours which can be extended 1-2 hours (pages 284- 285, results).
Regarding claims 39-40, Levy disclose wherein the epineurium and the perineurium are removed/dissolved via the dissociating enzymes (page 285, results) which is interpreted as the entirety of the matrix and epineurial sheath being removed.
Regarding claims 24, 31, Levy disclose exposing the enzyme treated nerve fascicles to lower temperatures anywhere from 37˚C to below zero (page 284, paragraph 5). The person of ordinary skill in the art would have arrived at the claimed temperatures of 4˚C through routine optimization and experimentation with a reasonable expectation of success because Levy suggest a temperature range that includes 4˚C and thus renders 4˚C obvious. While Levy is silent with regard to the number of hours spent at this lower temperature, a person of ordinary skill in the art would have been able to arrive at the claimed values through routine optimization and experimentation as the person of ordinary skill in the art would want to obtain a nerve fascicle with minimal damage from such treatment.
Regarding claims 34-38, Levy disclose Levy disclose wherein one or both treating and the washing is performed with agitation (abstract, page 284, page 285). Levy disclose wherein the fluid level around the treated nerve tissue rises and falls more than once (washes) (pages 284-285). Levy disclose wherein the solution used in these washes were tested for osmolarity and pH periodically (page 284).
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to perform washes after the enzymatic treatment with a buffered solution in the method of Levy because this is routine and conventional in the art after enzymatic digestion of tissue in order to remove the enzyme and restore the tissue to a neutral pH of about 7.4. Agitation would have been obvious to apply in order to enhance the dissociation of the nerve fascicles. The modification of the time in incubation would have been a matter of routine optimization and experimentation as the person of ordinary skill in the art would want to obtain a nerve fascicle with minimal damage from washing and agitation treatment.
Regarding claim 33, the combined teaching of Levy and the patent claims render obvious the claimed invention as described above, but do not specifically describe wherein the solution that the washed nerve tissue is suspended in comprises alpha-antitrypsin and alpha-2-macroglobulin and the solution is a serum selected from a group.
Heggeness discloses that a nerve tissue treated with collagenase and washed is then suspended in a solution containing fetal bovine serum (FBS) to stop the enzyme digestion (page 7 para 77). It is well known that fetal bovine serum inherently contains alpha-antitrypsin and alpha-2-macroglobulin as evidenced by Paget (column 4 lines 8-21).
One of ordinary skill in the art would have been motivated to further include fetal bovine serum (FBS) in the incubation solution of Levy after the collagenase treatment of the nerve fascicles because Heggeness teach and suggest that this provides the benefit of stopping the enzyme digestion and allowing for the nerve fascicles to be isolated for further use. One of ordinary skill in the art would have had a reasonable expectation of success because both Levy and Heggeness are drawn to the digestion and isolation of rodent sciatic nerves with collagenase.
Therefore, the combined teachings of the patent claims, Levy et al and Heggeness render obvious Applicant’s invention as claimed.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Andersen et al., “A rapid and versatile method for the isolation, purification and cryogenic storage of Schwann cells from adult rodent nerves”, Scientific Reports, 2016, Vol. 6, pp. 1-17.
Anderson discloses enzymatic digestion of rat sciatic nerve tissue and use in grafts.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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