DETAILED ACTION
Status of Claims
The amendments, and arguments filed June 29, 2026, are acknowledged and have been fully considered. Claims 1-3, 5-6, 8, 10, 12-13, 15, 17-18, 20, 22-25, 28, 30, 61 and 65-84 are pending and currently under consideration. Claims 1, 28 and 30 have been amended; new claims 65-84 have been added; and claims 4, 7, 9, 11, 14, 16, 19, 21, 26-27, 29, 31-60 and 62-64 were previously cancelled. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Office Action: Final
Withdrawn Claim Rejections
The rejection of claim 30 under 35 U.S.C. § 102 (a)(1) by KUSHNIR (WO 2022/180627 A1) (at par. 1-4 of the 04/20/2026 Office action), is maintained in modified form, in light of applicant’s 06/29/2026 amendments, which add new claims 75 and 77.
The rejection of claims 1-2, 5-6, 8, 10, 12-13, 15, 17-18, 20 and 22-25 under 35 U.S.C. § 103 over GILBERT (US 2017/0072100 A1) (at par. 5-24 of the 04/20/2026 Office action), is withdrawn in light of applicant’s 06/29/2026 amendments, in particular, the amendment of independent claim 1 reciting “wherein the immunologically anonymized nerve segment contains neither axons nor Schwann cells.”
The rejection of claim 3 under 35 U.S.C. § 103 over GILBERT, in view of BUCKENMEYER (Methods 171 (2020) pp. 41-61) (at par. 25-29 of the 04/20/2026 Office action), is withdrawn in light of applicant’s 06/29/2026 amendments.
The rejection of claims 28 and 61 under 35 U.S.C. § 103 over KUSHNIR, in view of STREHL (WO 2020/026212 A2) (at par. 30-36 of the 04/20/2026 Office action), is maintained in modified form, in light of applicant’s 06/29/2026 amendments, which add new claims 69-71, 74, 76, 78-81 and 84.
New Claim Objections – Necessitated by Amendments
The following claims are objected to because of the following informalities:
A. Claim 70 is objected to because the claim should read:
70. ([…]) The method of claim 28, wherein the contacting is performed for at least 2 days.
B. Claim 71 is objected to because the claim should read:
71. ([…]) The method of claim 30, wherein the contacting is performed for at least 2 days.
C. Claim 72 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all the limitations of the base claim and any intervening claims.
D. Claim 73 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all the limitations of the base claim and any intervening claims.
E. Claim 82 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all the limitations of the base claim and any intervening claims.
F. Claim 83 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all the limitations of the base claim and any intervening claims.
Appropriate correction is required.
Modified Claim Rejections – 35 U.S.C. § 102 – Necessitated by Amendments
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 30, 75 and 77 are rejected under 35 U.S.C. § 102(a)(2) as being anticipated by KUSHNIR (WO 2022/180627 A1, Publ. Sep. 01, 2022; Filed Feb. 23, 2021; on 07/01/2024 IDS; hereinafter, “Kushnir”; of record).
Kushnir is directed to:
Title: KIT FOR TREATING DAMAGED NERVES
Abstract: The present disclosure provides a method and a kit for inducing growth or regeneration of a damaged nerve of a subject, or the treatment thereof by applying a clot of blood that is withdrawn from the subject. The blood that is withdrawn from the subject is introduced to a lumen of a nerve enveloping hollow element that envelopes the damaged portion of the nerve while controllably coagulating within the lumen to form a clot on the damaged portion of the nerve. The clot, while in physical contact with the damaged portion of the nerve, enhances the rehabilitation of the nerve and may partially or fully restore its functionality.
Kushnir, title & abstract. In this regard, Kushnir discloses a claim embodiment drawn to kit for inducing growth or regenerating a damaged nerve portion of a subject, and method of enveloping a damaged nerve portion with a nerve enveloping hollow element having a lumen such that said damaged nerve portion resides in said lumen, and introducing blood of a subjected into said lumen:
1. A kit for inducing growth or regenerating a damaged nerve portion of a subject,
the kit comprising:
a nerve enveloping hollow element having a lumen for enveloping said damaged nerve portion such that said portion resides in at least a portion of said lumen;
one or more blood withdrawal devices for allowing withdrawal of blood from the
subject;
one or more blood collection receptacles for receiving the blood withdrawn from
the subject;
a coagulation assembly configured for permitting mixture of the withdrawn blood with one or more coagulation inducers for initiating coagulation process of the withdrawn blood; and
an applicator for introducing the incomplete coagulated blood into said lumen.
[…]
7. The kit of any one of claims 1-6, for use in a method for treating, inducing growth, or regenerating a damaged nerve portion, the method comprising:
(i) enveloping said damaged nerve portion with a nerve enveloping hollow element having a lumen such that said damaged nerve portion resides in said lumen;
(ii) withdrawing whole blood from the subject;
(iii) mixing the subject’s blood with one or more coagulation inducers;
(iv) prior to complete coagulation of the blood, introducing the blood with the coagulation agent into said lumen; and
(v) permitting the blood to coagulate in said lumen.
Kushnir, claims 1 and 7.
Regarding independent claim 30 and the requirements:
30. ([…]) A method of preparing a personalized nerve graft comprising, contacting a surface of a nerve graft scaffold that contains neither axons nor Schwann cells with an undiluted whole blood sample from a subject in need of the personalized nerve graft, wherein said contacting regenerates axons of the contacted scaffold.
Kushnir clearly teaches enveloping a damaged nerve portion with a nerve enveloping hollow element having a lumen such that said damaged nerve portion resides in said lumen, and introducing blood of a subjected into said lumen (Kushnir, claims 1 and 7), WHEREBY it is noted:
“said damaged nerve portion with a nerve enveloping hollow element having a lumen such that said damaged nerve portion resides in said lumen” (Kushnir, claim 7), which Kushnir teaches as a “film or sheet over the nerve treatment portion and enveloping said portion with said sheet to form the nerve enveloping sleeve” that is “made of a plastic material or any other suitable and biocompatible material” (Kushnir, p. 3, ln. 1-5), thereby reading on a “nerve graft scaffold that contains neither axons nor Schwann cells” of claim 30 (as well as an “artificial nerve graft” at par. [0023] of the instant published application, US 2024/0342342 A1, “[i]n some embodiments, the nerve graft scaffold may be an artificial nerve graft,” e.g., “in some embodiments, the artificial nerve graft may be a 3D-printed nerve graft”); and
“whole blood from the subject” (Kushnir, claim 7) reads on an “undiluted whole blood sample from a subject in need of the personalized nerve graft” of claim 30;
wherein “prior to complete coagulation of the blood, introducing the blood with the coagulation agent into said lumen” (Kushnir, claim 7) reads on the active step requirements of claim 30 for “contacting a surface of a nerve graft scaffold with an undiluted whole blood sample.”
With respect to an an “undiluted whole blood sample” of claim 30, although Kushnir teaches “(iii) mixing the subject’s blood with one or more coagulation inducers” (Kushnir, claim 7), Kushnir also teaches coagulation inducers within the blood collection receptacles of Kushnir’s kit (Kushnir, p. 5, ln. 30-31, “[i]n some embodiments of the kit, the one or more coagulation inducer(s) are comprised within said one or more blood collection receptacle”), in powder form (Kushnir, p. 7, ln. 28-30, “[i]n some embodiments of the nerve graft aspect method, said one or more coagulation inducer(s) are in powder form”), therefore Kushnir’s steps (ii) and (iii) (Kushnir, claim 7) do not require any further liquid dilution, thereby reading on an “undiluted whole blood sample” of claim 30.
With respect to the requirements of claim 30 for “wherein said contacting regenerates axons of the contacted scaffold,” as well as the requirements of claim 75 for:
75. ([…]) The method of claim 30, wherein a population of cells in the whole blood sample populate the nerve graft scaffold.
it is noted that, regarding the use of the “wherein” clauses, MPEP § 2111.04 states that claim scope is not limited by claim language (e.g., “wherein” and “whereby” clauses) that suggests or makes optional, but does not require steps to be performed. A “whereby clause [and by extension, a “wherein” clause] in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” See Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005) quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003). Since Kushnir teaches that “prior to complete coagulation of the blood, introducing the blood with the coagulation agent into said lumen” (Kushnir, claim 7) reading on the active “contacting” step requirements of claim 30, then it reasonably follows that “said contacting regenerates axons of the contacted scaffold” and a “population of cells in the whole blood sample populate the nerve graft scaffold” occur as a result thereof.
Thus, Kushnir anticipates claims 30 and 75.
Regarding claim 77 and the requirements:
77. ([…]) The method of claim 30, wherein the whole blood sample comprises one or more non-cellular factors, wherein the one or more non-cellular factors of the whole blood populate the scaffold, and wherein the non-cellular factors promote cellularization of the nerve graft scaffold and host compatibility of the nerve graft upon grafting.
Kushnir teaches “the coagulation assembly comprises a volume for introducing the withdrawn blood, said volume is contactable with one or more coagulation agents” (Kushnir, claim 7), or an “the anti-anti -coagulant is one or more from a group consisting of: ACD-A (Anticoagulant Citrate Dextrose, Solution A), EDTA (ethylenediaminetetraacetic Acid), EGTA (ethylene glycol tetraacetic acid), a citrate, Heparin and oxalate (“first group”) (Kushnir, p. 4, ln. 25-28), which reads on “one or more non-cellular factors of the whole blood” of claim 77.
Thus, Kushnir anticipates claim 77.
Modified Claim Rejections – 35 U.S.C. § 103 – Necessitated by Amendments
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. § 103(a) 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 C.F.R. § 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 30, 28, 61, 68-71, 74-81 and 84 are rejected under 35 U.S.C. § 103 as being unpatentable over KUSHNIR (WO 2022/180627 A1, Publ. Sep. 01, 2022; Filed Feb. 23, 2021; on 07/01/2024 IDS; hereinafter, “Kushnir”), in view of STREHL (WO 2020/026212 A2, Publ. Feb. 02, 2020; on 07/01/2024 IDS; hereinafter, “Strehl”).
The teachings of Kushnir, as set forth in the above rejection of claim 30, 75 and 77 under 35 U.S.C. § 102 (a)(2) are hereby incorporated. Regarding independent claim 28 and the requirements:
28. ([…]) A method of preparing a personalized nerve graft comprising contacting a nerve graft scaffold that contains neither axons nor Schwann cells with a suspension comprising a whole blood sample from a subject in need of the personalized nerve graft, wherein the whole blood sample is diluted in a physiological solution, and wherein said contacting regenerates axons of the nerve graft scaffold.
Kushnir clearly teaches enveloping a damaged nerve portion with a nerve enveloping hollow element having a lumen such that said damaged nerve portion resides in said lumen, and introducing blood of a subjected into said lumen (Kushnir, claims 1 and 7), WHEREBY it is noted:
“said damaged nerve portion with a nerve enveloping hollow element having a lumen such that said damaged nerve portion resides in said lumen” (Kushnir, claim 7), which Kushnir teaches as a “film or sheet over the nerve treatment portion and enveloping said portion with said sheet to form the nerve enveloping sleeve” that is “made of a plastic material or any other suitable and biocompatible material” (Kushnir, p. 3, ln. 1-5), thereby meeting the requirements for a “nerve graft scaffold that contains neither axons nor Schwann cells” of claim 28 (as well as an “artificial nerve graft” at par. [0023] of the instant published application, US 2024/0342342 A1, “[i]n some embodiments, the nerve graft scaffold may be an artificial nerve graft,” e.g., “in some embodiments, the artificial nerve graft may be a 3D-printed nerve graft”); and
“whole blood from the subject” (Kushnir, claim 7) reads on a “whole blood sample from a subject in need of the personalized nerve graft” of claim 30;
wherein “prior to complete coagulation of the blood, introducing the blood with the coagulation agent into said lumen” (Kushnir, claim 7) reads on the active step requirements of claim 30 for “contacting a nerve graft scaffold.”
However, Kushnir DOES NOT EXPRESSLY TEACH a “suspension comprising a whole blood sample,” wherein “the whole blood sample is diluted in a physiological solution,” as required by claim 28, which is well within the purview of the ordinarily skilled artisan.
Strehl, for instance, is directed to:
Title: METHODS OF PREPARING PERSONALIZED BLOOD VESSELS
Abstract: The present disclosure relates to methods of preparing personalized blood vessels, useful for transplantation with improved host compatibility and reduced susceptibility to thrombosis. Also provided are personalized blood vessels produced by the methods and use thereof in surgery.
Trehl, title & abstract. In this regard, Strehl teaches “contacting a surface of an acellular tubular scaffold with an undiluted whole blood sample” or a “whole blood sample [that] is diluted in a physiological solution”:
SUMMARY OF THE DISCLOSURE
[06] One aspect of the present disclosure relates to a method of preparing a personalized blood vessel comprising, contacting a surface of an acellular tubular scaffold with an undiluted whole blood sample from a subject in need of the personalized blood vessel, wherein the contacting is performed for more than 2 days.
[07] Another aspect of the present disclosure relates to a method of preparing a personalized blood vessel, comprising contacting a surface of an acellular tubular scaffold with a suspension comprising a whole blood sample from a subject in need of the personalize blood vessel, wherein the whole blood sample is diluted in a physiological solution. In some embodiments, the physiological solution maintains colloid oncotic pressure of the extracellular environment, buffers the pH in a CO2 independent mantter, and/or provides a cell protective or antioxidant effect.
(Strehl, par. [0006]-[0007]), wherein a”suspension” of “whole blood sample [that] is diluted in a physiological solution” (Strehl, par. [0007]) is a “suspension” of a “whole blood sample [that] is diluted in a physiological solution” of claim 28.
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to perform Kushnir’s steps (ii) and (iii) (Kushnir, claim 7) with “whole blood” that is “diluted in a physiological solution” per Stehl (Strehl, par. [0006]-[0007]). One would have been motivated to do so with a reasonable expectation of success in order to obtain the advantage of “preparing personalized blood vessels, useful for transplantation with improved host compatibility and reduced susceptibility to thrombosis.” Kushnir, abstract. Further, Kushnir teaches an overlapping set of overlapping blood samples including a “whole blood sample [that] is diluted in a physiological solution” (Strehl, par. [0007]) and “undiluted whole blood sample” (Strehl, par. [0006]), the latter related to Kushnir’s “whole blood from the subject” (Kushnir, claim 7), thereby establishing diluted and undiluted blood samples as functional equivalents for “preparing personalized blood vessels, useful for transplantation” (Stehl, abstract). Regarding equivalents known for the same purpose, MPEP § 2144.06 (II) states: “An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).”
With respect to the requirements of claim 28 for “wherein said contacting regenerates axons of the contacted scaffold,” as well as the requirements of claim 74 for:
74. ([…]) The method of claim 28, wherein a population of cells in the whole blood sample populate the nerve graft scaffold.
it is noted that, regarding the use of the “wherein” clauses, MPEP § 2111.04 states that claim scope is not limited by claim language (e.g., “wherein” and “whereby” clauses) that suggests or makes optional, but does not require steps to be performed. A “whereby clause [and by extension, a “wherein” clause] in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” See Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005) quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003). Since Kushnir teaches that “prior to complete coagulation of the blood, introducing the blood with the coagulation agent into said lumen” (Kushnir, claim 7) meeting the active “contacting” step requirements of claim 28, then it reasonably follows that “said contacting regenerates axons of the contacted scaffold” and a “population of cells in the whole blood sample populate the nerve graft scaffold” occur as a result thereof.
Thus, the prior art renders claims 28 and 74 obvious.
Regarding claims 61 and 68-69 and the requirements:
61. ([…]) A method of regenerating a nerve defect, comprising implanting the personalized nerve graft prepared by claim 28 to the subject, whose blood was used for preparing the personalized nerve graft.
[…]
68. ([…]) The method of claim 61, wherein the nerve defect is a peripheral nerve defect.
69. ([…]) The method of claim 61, wherein the defect is at least 7 cm long.
Kushnir teaches a “method for treating, inducing growth, or regenerating a damaged nerve portion” involving “(i) enveloping said damaged nerve portion with a nerve enveloping hollow element having a lumen such that said damaged nerve portion resides in said lumen,” and “(iv) prior to complete coagulation of the blood, introducing the blood with the coagulation agent into said lumen” (Kushnir, claim 7), which meets the active step requirements of claim 61 for “implanting” a “personalized nerve graft,” as well as encompassing a “peripheral nerve defect” of claim 68, and a 7 cm long defect of claim 69.
Thus, the prior art renders claims 61 and 68-69 obvious.
Regarding claims 70-71 and the requirements:
70. ([…]) The method of claim 28, wherein the contacting is performed for at least 2 days. days.
71. ([…]) The method of claim 30, wherein the contacting is performed for at least 2 days. days.
Strehl teaches “One aspect of the present disclosure relates to a method of preparing a personalized blood vessel comprising, contacting a surface of an acellular tubular scaffold with an undiluted whole blood sample from a subject in need of the personalized blood vessel, wherein the contacting is performed for more than 2 days.” Strehl, par. [0006]. Since it would be obvious to to perform Kushnir’s steps (ii) and (iii) (Kushnir, claim 7) with “whole blood” that is “diluted in a physiological solution” per Stehl (Strehl, par. [0006]-[0007]), one would be further motived to perform contacting “for more than 2 days” (Strehl, par. [0006]). See MPEP § 2144.05 (I) regarding the obviousness of prior art overlapping claimed numerical ranges.
Thus, the prior art renders claims 70-71 obvious.
Regarding claim 76 and the requirements:
76. ([…]) The method of claim 28, wherein the whole blood sample comprises one or more non-cellular factors, wherein the one or more non-cellular factors of the whole blood populate the scaffold, and wherein the non-cellular factors promote cellularization of the nerve graft scaffold and host compatibility of the nerve graft upon grafting.
Kushnir teaches “the coagulation assembly comprises a volume for introducing the withdrawn blood, said volume is contactable with one or more coagulation agents” (Kushnir, claim 7), or an “the anti-anti -coagulant is one or more from a group consisting of: ACD-A (Anticoagulant Citrate Dextrose, Solution A), EDTA (ethylenediaminetetraacetic Acid), EGTA (ethylene glycol tetraacetic acid), a citrate, Heparin and oxalate (“first group”) (Kushnir, p. 4, ln. 25-28), which reads on “one or more non-cellular factors of the whole blood” of claim 76.
Thus, the prior art renders claim 76 obvious.
Regarding claims 78-79 and the requirements:
78. ([…]) The method of claim 28, wherein the suspension comprising the whole blood sample further comprises an anti-thrombotic factor.
79. ([…]) The method of claim 30, wherein the undiluted whole blood sample comprises an anti-thrombotic factor.
Strehl teaches “[i]n some embodiments, the undiluted whole blood sample or the suspension comprising the whole blood sample further comprises an anti-thrombotic factor.” Strehl, par. [0010]. Since it would be obvious to to perform Kushnir’s steps (ii) and (iii) (Kushnir, claim 7) with “whole blood” that is “diluted in a physiological solution” per Stehl (Strehl, par. [0006]-[0007]), one would be further motived to incorporate “an anti-thrombotic factor” (Strehl, par. [0010]) to promote transplantation (Strehl, abstract).
Thus, the prior art renders claims 78-79 obvious.
Regarding claims 80-81 and the requirements:
80. ([…]) The method of claim 28, wherein the suspension further comprises equal to or more than the population average physiological level of one or more growth factors selected from the group consisting of: a granulocyte macrophage-colony stimulating factor (GM-CSF), interleukin (IL)-3, IL-4, neutrophin (NT)-6, pleiotrophin (HB-GAM), midkine (MK), interferon inducible protein-IO (IP-10), platelet factor (PF)-4, monocyte chemotactic protein-I (MCP-1), RANTES (CCL-5, chemokine (C-C motif) ligand 5), IL-8, IGFs, a fibroblast growth factor (FGF)-1, FGF-2, FGF-3, FGF-4, FGF-5, FGF-6, FGF-7, FGF-8, FGF-9, a transforming growth factor (TGF)-β, a vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF)-A, PDGF-B, HB-EGF, hepatocyte growth factor (HGF), tumor necrosis factor (TNF)-α, insulin-like growth factor (IGF)-1, and any combination(s) thereof.
81. ([…]) The method of claim 30, wherein the undiluted whole blood sample further comprises equal to or more than the population average physiological level of one or more growth factors selected from the group consisting of: a granulocyte macrophage-colony stimulating factor (GM-CSF), interleukin (IL)-3, IL-4, neutrophin (NT)-6, pleiotrophin (HB-GAM), midkine (MK), interferon inducible protein-IO (IP-10), platelet factor (PF)-4, monocyte chemotactic protein-I (MCP-1), RANTES (CCL-5, chemokine (C-C motif) ligand 5), IL-8, IGFs, a fibroblast growth factor (FGF)-1, FGF-2, FGF-3, FGF-4, FGF-5, FGF-6, FGF-7, FGF-8, FGF-9, a transforming growth factor (TGF)-β, a vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF)-A, PDGF-B, HB-EGF, hepatocyte growth factor (HGF), tumor necrosis factor (TNF)-α, insulin-like growth factor (IGF)-1, and any combination(s) thereof.
Strehl teaches suitable growth fators:
[023] In some embodiments, the whole blood sample or the suspension comprising the whole blood sample further comprises equal to or more than the population average physiological level of a growth factor selected from the group consisting of: granulocyte macrophage-colony stimulating factor (GM-CSF), interleukin (IL)-3, IL-4, neutrophin (NT)-6, pleiotrophin (HB-GAM), midkine (MK), interferon inducible protein- 10 (IP- 10), platelet factor (PF)-4, monocyte chemotactic protein- 1 (MCP-l), RANTES (CCL-5, chemokine (C-C motif) ligand 5), IL-8, IGFs, fibroblast growth factor (FGF)-l, FGF-2, FGF-3, FGF-4, FGF-5, FGF-6, FGF-7, FGF-8, FGF-9, transforming growth factor (TGFj-b, VEGF, platelet-derived growth factor (PDGF)-A, PDGF-B, HB-EGF, hepatocyte growth factor (HGF), tumor necrosis factor (TNF)-a, insulin-like growth factor (IGF)- 1, and any combination(s) thereof.
Strehl, par. [0023]. Since it would be obvious to to perform Kushnir’s steps (ii) and (iii) (Kushnir, claim 7) with “whole blood” that is “diluted in a physiological solution” per Stehl (Strehl, par. [0006]-[0007]), one would be further motived to incorporate growth factors such as granulocyte macrophage-colony stimulating factor (GM-CSF) (Strehl, par. [0023]) to promote transplantation (Strehl, abstract).
Thus, the prior art renders claims 80-81 obvious.
Regarding claim 84 and the requirements:
84. ([…]) The method of claim 70, wherein the method further comprises measuring a concentration of D-glucose in the suspension every day of contacting and adding D-glucose to the suspension to maintain the concentration of D-glucose in the suspension between 3 mmol/L and 11 mmol/L.
Strehl teaches “In some embodiments, the nutrient is D-glucose, and wherein the D-Glucose concentration is adjusted continuously or regularly to maintain the D-glucose concentration at about 3 to about 11 mmol/L.” Strehl, par. [0050]. Since it would be obvious to perform Kushnir’s steps (ii) and (iii) (Kushnir, claim 7) with “whole blood” that is “diluted in a physiological solution” per Stehl (Strehl, par. [0006]-[0007]), one would be further motived to adjust the D-Glucose concentration continuously or regularly to maintain the D-glucose concentration at about 3 to about 11 mmol/L (Strehl, par. [0050]) to promote transplantation (Strehl, abstract). See MPEP § 2144.05 (I) regarding the obviousness of prior art overlapping claimed numerical ranges.
Thus, the prior art renders claim 84 obvious.
Response to Arguments
Applicants’ arguments filed on June 29, 2026 have been fully considered. With regard to independent claims 28 and 30, it is noted that Kushnir’s “said damaged nerve portion with a nerve enveloping hollow element having a lumen such that said damaged nerve portion resides in said lumen” (Kushnir, claim 7), which Kushnir teaches as a “film or sheet over the nerve treatment portion and enveloping said portion with said sheet to form the nerve enveloping sleeve” that is “made of a plastic material or any other suitable and biocompatible material” (Kushnir, p. 3, ln. 1-5), thereby reading on a “nerve graft scaffold that contains neither axons nor Schwann cells” of claim 28 (as well as an “artificial nerve graft” at par. [0023] of the instant published application, US 2024/0342342 A1, “[i]n some embodiments, the nerve graft scaffold may be an artificial nerve graft,” e.g., “in some embodiments, the artificial nerve graft may be a 3D-printed nerve graft”). Limiting the “nerve graft scaffold” to an “anonymized nerve graft” (per claims 72-73, as objected to above), or limiting the contacting step to being in an anticoagulant coated vessel (per claims 82-83, as objected to above) would overcome the rejections of record based on Kushnir.
Allowable Subject Matter
Claims 1-3, 5-6, 8, 10, 12-13, 15, 17-18, 20, 22-25 and 65-67 are drawn to allowable subject matter. In this regard, GILBERT (US 2017/0072100 A1, Publ. Mar. 16, 2017; on 07/01/2024 IDS; hereinafter, “Gilbert”; of record) is noted as a reference of interest.
Summary/Conclusion
Claims 28, 30, 61, 68-71, 74-81 and 84 are rejected. Claims 72-73 and 82-83 are objected to. Claims 1-3, 5-6, 8, 10, 12-13, 15, 17-18, 20, 22-25 and 65-67 are allowable.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BETHANY BARHAM can be reached on (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOMINIC LAZARO/Primary Examiner, Art Unit 1611
