DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group 2, claims 16-18,20,21,23-27 in the reply filed on 1/9/2026 is acknowledged.
Claims 1,2,4,6-7,9-11,13,14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1/9/2026.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Specification
The abstract of the disclosure is objected to because it contains legal phraseology such as “comprising” in lines 3,11-12,15. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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.
Claim(s) 16-18,20,21,23-24,26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bellamkonda et al U.S 2008/0208358 in view of Khandaker et al WO 2016/210060.
Claim 16: Bellamkonda et al disclose a synthetic nerve graft comprising a multi-layer composite, the multi- layer composite comprising at least a first and second sheets of aligned nanofibers coated with a biodegradable hydrogel, wherein the at least first and second sheets of coated aligned nanofibers are stacked directly on top of each other(see fig. 1, paragraphs 8,13,31), but is silent regarding a portion of the biodegradable hydrogel coating on the first sheet is mixed and crosslinked with a portion of the biodegradable hydrogel coating on the second sheet. Khandaker et al, in the same field of endeavor which teach tissue engineered total disc replacement implants use the principles of cell biology to determine the nature of the NP, AF and cartilage cells at EP, to create composite scaffolds for each of the components of I VD. The ability of AF cells to remodel and grow in fibrous matrices, as well as the abilit of NP cells to assemble hydrogel based extracellular matrix have lead to the fabrication of IVD implants to regenerate AF and NP tissue as a unit. Despite the promise of tissue engineering approaches for design of IVD implants (only one FDA approved implant: Raymedica prosthetic disc nucleus (PDN)), to date no tissue engineered IVD has demonstrated the long term load bearing capability thai is equivalent to a native disc. Currently researched tissue-engineered IVD lacks in withstanding the long-term physiological load (cyclic ad). (see pargarph 5), . Khandaker et al further teach a portion of the biodegradable hydrogel coating on the first sheet is mixed and crosslinked with a portion of the biodegradable hydrogel coating on the second sheet (see pargraph JO 37). It is noted that hydrogel according to the required shape of the composite hydrogel to be produced. PEGDA may be injected in the mold on top of PCI. ENF membrane to build the composite scaffold 75. The same UV light source 501 used to create PEGDA disc (see FIG. 5, 503) when exposed to the sol ution will cure the PEGDA sol ution to solid. The thickness of the PEGDA layer of the scaffold 75 produced may be in the range of 0.3 mm to 0.7 mm with 0.5 nun being preferred. The forgoing ENF membrane and PEGDA curing steps may be repeated three or more times to make L0 mm to 5.0 mm thick cylindrical composite scaffold 76 with 1.5 mm to 3 mm being preferred. The inventor has implemented the preferred methods provided by the process of the present invention to successfully fabricate .10 mm diameter and 3 mm thickness PCLnanofiber and PEGDA composite disc (depicted in FIG. 6, 503). Larger diameter composite discs are also anticipated using the methods disclosed herein, as- well as using the apparatus of U.S. Patent 9,359,694. j038| Referring now to F G. 8, the process 80 is shown for performing (FIG. 3, 321) Step 2; Coating one surface (e.g., top) and the circumferential surface of the NP disc with electrospm random nanofiber. In Step 2 of the process of the present invention, NP disc 503 produced in the plastic syringe 54 may .sup.'be coated with randomly applied PCE nanofiber 88 at a first side (e.g., top) and at circumferential sides by multiple layers of randomly applied nanofiber to produce a coated disc 508 where the thickness of the nanofiber layers comprising the first applied coating is in the range of 1 to 6 microns and preferably at least 2 microns. Figure 8 shows the process for coating of NP disc by randoml deposited PCL nanofibers on a first side ( e.g., top) and on circumferential sides. The embodiment shown in the diagram includes the sealed chamber 81 , a syringe pump 82, a syringe 83 with a tube 84 that is attached with a non-conducting support 89, a syringe needle 85 at the end of the tube 84, a high voltage power supply 86, and a plastic syringe 54 containing the .sup.:NP disc 503. The syringe needle 85 is electrically charged by applying a high- voltage in the range of ( 5 VA to 15 KVA) produced by the power supply 86. .Negative charge is applied to the conductive wire 57 positioned through a hole extending longitudinally through the push rod 56 centered in the syringe 54. j039] Referring now to FIG. 9, the process 90 is shown for performing (FIG. 3, 322} Step 2; Coating on a second uncoated side (e.g., bottom) surface of the N P di sc 508 with eiectrospi randomly applied nanofiber 88. in Step 2 of the process of the present invention (FIG 3, 30), the partially coated NP disc 508 may be inverted and placed in the plastic syringe 54 with the conductive wire 57 inserted through the center. The NP disc 508 is placed again in the plastic chamber 55 with the conductive wire 57 inserted at the center. The bottom side of MP disc 508 that didn't have PCL fiber mesh coating applied is face up so that randomly applied nanofiber 88 can be coated on that side. The uncoated side (e.g., bottom) of the NP disc 508 may be coated with multiple layers of randomly deposited PCL fiber 88 to produce a coated NP disc 509 where the second applied coating is in the range of 5 to 15 microns and preferably at least 10 microns. Figure 9 shows the process by which an NP disc 509 may be coated by randomly deposited fibers on the side where there is no existence of fiber coating. j040] Referring now to FIG. 10, the process 100 is shown for performing (FIG. 3, 33) Step 3: Coating on circumferential surface of the disc by aligned nanofiber structure. The process of the present invention (FIG 3, 30) concludes with the NP disc 509 being completely encased with an eiectrospun nanofiber membrane to support various types of NP disc applications. The NP disc 509 is wrapped with an angle-ply band constructed of aligned eiectrospin. nanofibers in multiple layers where the fibers in one layer are angled at an oblique angl in the range of 40 to 80 degrees and preferably 60 degrees with respect to fibers in adjacent layexs to mimic natural IVD annual fibrous (AF) as shown in FIG. 11. Th AF that comprises discrete fibrous sheets endures the multi-directional loads around the circumference of a natural NP disc, in preferred embodiments, PCL nanofibers can be mixed with collagen solution, to increase the stiffness of the nanofiber mesh. Natural fibers run in a single direction in nati ve AF tissue, ranging from 20° to 60° with respect to the transverse plane .sub.f and adjacent lamellae have opposing fiber orientations, producing a natural angle-ply structure. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Bellamkonda with a portion of the biodegradable hydrogel coating on the first sheet is mixed and crosslinked with a portion of the biodegradable hydrogel coating on the second sheet as taught by Khandaker et al in order to have a great potential in regenerative medicine due to their biocompatibility/biodegradability properties.
Claims 17-18: Bellamkonda et al disclose wherein the synthetic nerve graft
further comprises an outer conduit covering the outside surface of a cylinder-shaped multi-layer composite (see paragraphs 6,8,12)., wherein each of the at least first and second sheets of coated aligned nanofibers independently comprise substantially aligned individual nanofibers having a controlled diameter and spacing (see paragraph 8).
Claims 20, 27: Khandaker et al teach wherein each of the at least first and second sheets of coated aligned nanofibers independently comprise substantially aligned individual nanofibers that are covalently bonded to the biodegradable hydrogel coating; wherein the aligned nanofibers or the coated biodegradable hydrogel has a gradient of a chemical modification in the direction of the nanofibers (see paragraphs 5, JO 37).
Claims 21, 23-24: Bellamkonda et al disclose the invention substantially as claimed but is silent regarding wherein the at least first and second sheets of coated aligned nanofibers comprise substantially aligned individual polycaprolactone, alginate, polyacrylonitrile, or poly(lactic acid) nanofibers., wherein the biodegradable hydrogel coating comprises gelatin, poly(ethylene glycol), hyaluronic acid, collagen, polyacrylamide, alginate, or chemically modified versions thereof., wherein the
biodegradable hydrogel coating comprises gelatin or chemically modified versions thereof. It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the device included at least first and second sheets of coated aligned nanofibers comprise substantially aligned individual polycaprolactone, alginate, polyacrylonitrile, or poly(lactic acid) nanofibers., wherein the biodegradable hydrogel coating comprises gelatin, poly(ethylene glycol), hyaluronic acid, collagen, polyacrylamide, alginate, or chemically modified versions thereof., wherein the
biodegradable hydrogel coating comprises gelatin or chemically modified versions thereof, since it has been held to be within the general skill of a worker in the art to select a known material on the basic of its suitability for the intended use or as a matter of obvious design choice. In re Leshin,125 USPQ 416.
Allowable Subject Matter
Claim 25 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VI X NGUYEN whose telephone number is (571)272-4699. The examiner can normally be reached Monday-Friday (6:30-4:30).
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/VI X NGUYEN/Primary Examiner, Art Unit 3771