DETAILED ACTION
Status of Claims
Claims 1-7 and 9-10 are currently pending. Claims 4-7 and 9-10 are currently under consideration and are the subject of this Office Action. This is the first Office Action on the merits of the claims. Non-elected claims 1-3 are withdrawn from consideration. 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: Non-Final.
Election/Restrictions
Applicant’s election of the claims of Group II (claims 4-7 and 9-10 with claim 8 cancelled per the 02/03/2026 amendments) in the response filed on February 03, 2026 (to the December 10, 2025 Requirement for Restriction) is acknowledged. In response to applicant’s election, the claims of Group I (claims 1-3) are withdrawn from further consideration pursuant to 37 C.F.R. § 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant has elected the claims of Group II without traverse.
Accordingly, the December 10, 2025 Requirement for Restriction is made FINAL, and claims 4-7 and 9-10 are examined as follows.
Claim Objections
The following claims are objected to because of the following informalities:
A. Claim 4 is objected to because the claim should read:
4. ([…]) A preparation method of a bionic nerve graft, comprising a helical stent, a nanofiber membrane, guide fibers and hBMSC-ECM (human-derived Bone Mesenchymal Stem Cell-Extracellular Matrix), wherein a surface of the helical stent is coated with the nanofiber membrane; the guide fibers and the hBMSC-ECM are placed in a tube cavity of the helical stent; and formed of; wherein the preparation method comprises[[ing]] the following steps:
providingforming
providingin order to obtain a helical tube with a surface coated with the nanofiber membrane;
providingforming
filling the helical tube with the surface coated with the nanofiber membrane with the guide fibers and the hBMSC-ECM in order ;
wherein the step of forming
providingto[[-]] 7 wt%:
pouring the chitosan solution into a mold with a groove: and
putting the mold with the chitosan solution into a NaOH solution of 5 to [[-]]20% for curing and shaping, and in order to obtain the guide fibers.
B. Claim 5 is objected to because the claim should read:
5. ([…]) The preparation method of the bionic nerve graft according to claim 4, wherein the mold pouring methodforming
providing to [[-]]7 wt %;
pouring the chitosan solution on a threaded inner core mold;
placing the inner core mold with the chitosan solution into a NaOH solution of 5 to [[-]]20% for curing and shaping, and then in order to obtain a helical stent semi-finished product; and
immersing the helical stent semi-finished product into an acetic anhydride solution containing methanol of 5 wt % to perform acetylation for 6 hours, performing fixation for 12 hours by using the NaOH solution of 5 to [[-]]20%, in order to obtain the helical stent.
C. Claim 7 is objected to because the claim should read:
7. ([…]) The preparation method of the bionic nerve graft according to claim 6, wherein setting parameters of the electrostatic spinning comprise: a voltage of[[is]] 5 to [[-]]35 kV, a flow velocity of[[is]] 0.1 to [[-]]2 mL/h, a receiving distance of[[is]] 5 to [[-]]35 cm, and a rotating speed of the receiving apparatus of[[is]] 5 to [[-]]150 rpm.
D. Claim 10 is objected to because the claim should read:
10. ([…]) The preparation method of the bionic nerve graft according to claim 4, wherein the step of preparing the hBMSC-ECM comprises:
coating a culture dish with an MSC adherent reagent diluted 100 times by a DPBS (Dulbecco’s Phosphate-Buffered Saline) solution;
planting resuscitated hBMSC into the coated culture dish, adding a complete culture medium, performing culture in a 5% CO2 incubator at 37° C., and changing the culture medium once every two days; and
when the cell saturation reaches 80%, using a complete culture medium containing ascorbic acid, changing the solution once every two days in a dark place, discarding the culture solution after ten days, performing washing with DPBS for three times, performing hypotonic operation with ultrapure water at 37° C. for 10 min, removing the ultrapure water, adding a cell lysis solution to perform reaction for 5 min, performing washing with DPBS, performing reaction by using DNA enzyme at 37° C. for 2 h after washing, and finally, performing washing with DPBS and performing storage at 4° C.
Appropriate correction is required.
Claim Rejections – 35 U.S.C. § 112 - Indefiniteness
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.
Claims 6-7 and 9-10 are rejected under 35 U.S.C. § 112 (b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or, for pre-AIA , that applicant regards as the invention.
A. Claim 6 is drawn to:
6. ([…]) The preparation method of the bionic nerve graft according to claim 4, wherein the step of preparing the helical tube with the surface coated with the nanofiber membrane comprises:
preparing a blended solution of the chitosan and polyethylene oxide with the total concentration of 3 wt %-5 wt %, the mass ratio of the chitosan to the polyethylene oxide being 100: (5-20);
placing the blended solution of the chitosan and the polyethylene oxide into an electrostatic spinning apparatus, placing the helical stent on a tubular receiving apparatus, performing electrostatic spinning, and coating the surface of the helical stent with one layer of nanofiber membrane; and
placing the helical stent coated with the nanofiber membrane into a NaOH solution of 5-20% for curing and shaping, performing washing with water to remove the polyethylene oxide to obtain the helical tube with the surface coated with the nanofiber membrane.
wherein the recitation, “the mass ratio of the chitosan to the polyethylene oxide being 100: (5-20),” is indefinite because the parenthetical, “(5-20),” renders the metes and bounds of the claim unclear as to whether the intended ratio range is 100:5 to 100:20 or 100 over the difference between “(5-20).” In this regard, it is noted that the Board has held: “if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.” Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008) (expanded panel). Subsequent claim 7 depends on claim 6 and is thus, indefinite as well. To the extent applicant intends the former, examiner suggests amending claim 6 to read:
6. ([…]) The preparation method of the bionic nerve graft according to claim 4, wherein the step of preparing the helical tube with the surface coated with the nanofiber membrane comprises:
preparing a blended solution of the chitosan and polyethylene oxide with the total concentration of 3 wt % to [[-]]5 wt %,wherein the mass ratio of the chitosan to the polyethylene oxide is 100:5 to 100:20
placing the blended solution of the chitosan and the polyethylene oxide into an electrostatic spinning apparatus, placing the helical stent on a tubular receiving apparatus, performing electrostatic spinning, and coating the surface of the helical stent with one layer of nanofiber membrane; and
placing the helical stent coated with the nanofiber membrane into a NaOH solution of 5 to [[-]]20% for curing and shaping, followed byin order to obtain the helical tube with the surface coated with the nanofiber membrane.
B. Claim 9 is drawn to
9. ([…]) The preparation method of the bionic nerve graft according to claim 4, wherein the groove of the mold comprises an inner groove and an outer groove which communicate with each other, the cross-sectional shape of the communicated inner groove and outer groove is shaped like an inverted Chinese character “Pin”, a width of the outer groove is 100-500 μm, a height of the outer groove is 20-50 μm, a width of the inner groove is the same as the height of the outer groove, a height of the inner groove is 25-240 μm, the width of the outer groove is twice the sum of the height of the inner groove and the width of the inner groove, and the inner groove and the outer groove have the same length of 1-3 cm.
wherein the recitation, “the cross-sectional shape of the communicated inner groove and outer groove is shaped like an inverted Chinese character ‘Pin’,” is indefinite because neither the claims nor the instant specification provide a depiction of the particular “Chinese character” in order to ascertain the required structure. Per the discussion in the instant published application, US 2025/0241646 A1, at par. [0052] for Fig. 3, examiner suggests amending claim 9 to read:
9. ([…]) The preparation method of the bionic nerve graft according to claim 4, wherein the groove of the mold comprises an inner groove and an outer groove which communicate with each other, wherein afeatures the inner grove is located in the middle of the outer groove; wherein
a cross-sectional width of the outer groove is 100 to [[-]]500 μm,
a cross-sectional height of the outer groove is 20 to [[-]]50 μm,
a cross-sectional width of the inner groove is the same as the cross-sectional height of the outer groove,
a cross-sectional height of the inner groove is 25 to [[-]]240 μm,
the cross-sectional width of the outer groove is twice the sum of the cross-sectional height of the inner groove and the cross-sectional width of the inner groove, and
the inner groove and the outer groove have the same length of 1 to [[-]]3 cm.
C. Claim 10 is drawn to:
10. ([…]) The preparation method of the bionic nerve graft according to claim 4, wherein the step of preparing the hBMSC-ECM comprises:
coating a culture dish with an MSC adherent reagent diluted 100 times by a DPBS (Dulbecco’s Phosphate-Buffered Saline) solution;
planting resuscitated hBMSC into the coated culture dish, adding a complete culture medium, performing culture in a 5% CO2 incubator at 37° C., and changing the culture medium once every two days; and
when the cell saturation reaches 80%, using a complete culture medium containing ascorbic acid, changing the solution once every two days in a dark place, discarding the culture solution after ten days, performing washing with DPBS for three times, performing hypotonic operation with ultrapure water at 37° C. for 10 min, removing the ultrapure water, adding a cell lysis solution to perform reaction for 5 min, performing washing with DPBS, performing reaction by using DNA enzyme at 37° C. for 2 h after washing, and finally, performing washing with DPBS and performing storage at 4° C.
which is indefinite in the recitation, “the step of preparing the hBMSC-ECM.” There is insufficient antecedent basis for this limitation in the claim as no “step of preparing the hBMSC-ECM” is recited in claim 4 from which claim 10 depends. See MPEP § 2173.05(e). In this regard, examiner suggests amending claim 10 to read:
10. ([…]) The preparation method of the bionic nerve graft according to claim 4, wherein the is obtained by a process comprising[[es]]:
coating a culture dish with an Mesenchymal Stem Cell (MSC) adherent reagent diluted 100 times by (DPBS) solution;
planting resuscitated human-derived Bone Mesenchymal Stem Cell (hBMSC) into the coated culture dish, adding a complete culture medium, performing culture in a 5% CO2 incubator at 37° C[[.]], and changing the culture medium once every two days; and
changing with a complete culture medium containing ascorbic acid when utes, removing the ultrapure water, adding a cell lysis solution to perform reaction for 5 minutes, treating withours after washing, , and storing
Further clarification is required.
Allowable Subject Matter
Claims 4-7 and 9-10 are allowable pending address of the objections and rejection under 35 U.S.C. § 112, discussed above. ZHU (CN 1580255 A, Publ. Feb. 16, 2005; as evidenced by English language translation of CN 1580255 A; of record), YU (US 2014/0379009 A1, Publ. Dec. 25, 2014; of record), and CAI (Cai, S., et al., Directed Differentiation of Human Bone Marrow Stromal Cells to Fate-Committed Schwann Cells, Stem Cell Reports 9 (October, 10, 2017) pp. 1097-1108; of record) are noted as references of interest.
Conclusion
Claims 6-7 and 9-10 are rejected. Claims 4-5 are objected to. No claims are allowed.
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