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 .
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 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.
Status of Claims
This action is in reply to the communication filed on October 06, 2025.
Claim 1 has been amended and are hereby entered.
Claims 9 – 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected apparatus for making a scaffold construct, a method for making a scaffold construct, and a method of treating volumetric muscle loss, there being no allowable generic or linking claim.
Applicant timely traversed the restriction (election) requirement in the reply filed April 14, 2025.
Claims 1 – 8 are currently pending and have been examined.
This action is made FINAL.
Response to Amendments
Applicant's amendments to the claims, filed October 6, 2025, caused the withdrawal of the rejection of claims 1 – 8 under 35 U.S.C. 103 as being unpatentable over Koob as set forth in the office action filed May 15, 2025.
Response to Arguments
Applicant’s arguments with respect to claims 1 – 8 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Information Disclosure Statement
The references provided in the Information Disclosure Statements filed on May 13, 2025 and October 6, 2025 have been considered. Signed copies of the corresponding 1449 forms have been included with this office action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 – 8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite that the scaffold construct comprises a cross-linked fibrin hydrogen “produced in situ by reacting fibrinogen with thrombin.” Applicant does not point to any place in the specification for support for the claimed limitation. Examiner cannot find any discussion of the production in situ of the fibrin hydrogen. Paragraph [0105] of the specification as filed teaches that a collagen microfiber strand is dispensed with a hydrogel precursor solution and then the fibrinogen solution is dispensed into the thrombin crosslinking solution bath during printing. This teaching appears to be narrower than the claimed “in situ” production as currently claimed. Therefore, the claim amendment does not appear to be supported by the specification as filed and the claim as amended appears to constitute new matter.
Claims 2 – 8 are rejected as being dependent on claim 1.
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.
Claims 1 – 8 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 the applicant regards as the invention.
Claim 1 has been amended to recite that the biomaterial microfiber is “ribbon-shaped.” This renders the claim indefinite because ribbon-shaped is not defined in the specification and it is not clear to what extent the fiber needs to deviate from a circular cross section to be considered “ribbon-shaped.”
Claims 2 – 8 are rejected as being dependent on claim 1.
Claims 7 and 8 refer to “the biocompatible hydrogel.” This phrase lacks antecedent basis as there is no recitation of a biocompatible hydrogel in claim 1.
For examination purposes, the claim is interpreted as reading on the claimed cross-linked fibrin hydrogel.
Examiner recommends amending the claims to recite “a cross-linked fibrin hydrogel.”
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8 recites that the biocompatible hydrogel is crosslinked. As noted above, the phrase is interpreted as reading on the claimed “cross-linked fibrin hydrogel.” As claim 1 already recites that the hydrogel is cross-linked, claim 8 appears to fail to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claims 1 – 8 are rejected under 35 U.S.C. 103 as being unpatentable over Koob (US20190350690A1) in view of Zreiqat (US20190343985A1) and Rocco (US20210161645A1).
As per claims 1, 5, 6, and 8, Koob teaches:
A scaffold construct comprising at least one biomaterial microfiber strand, wherein the biomaterial is collagen, wound to form a plurality of microfiber segments in proximity to one another and arranged in an organized configuration (Abstract: “Implantable medical constructs formed by winding using winding support structures… with biocompatible fibers and/or yarn(s) and at least one continuous length collagen fiber.” Koob teaches that the collagen can be in the form of microfibrils ([0077]). The collagen fiber is interpreted as the claimed biomaterial microfiber strand. The wound fiber is shown in Fig. 3A
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and is interpreted as being in an organized configuration as claimed.)
Koob does not limit the cross-section of the fiber. Koob does not teach:
The biomaterial microfiber strand is a ribbon-shaped biomaterial microfiber strand having a thickness less than 20 micrometers
Zreiqat teaches an implantable scaffold comprising a plurality of polymer fibers (Abstract). This is the same application as the scaffold of Koob. Zreiqat teaches that the diameter of the polymer fibers is between 5 to 30 micrometers and that the fibers can be chosen to be in the form of a ribbon ([0141]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to form the collagen microfibers of Koob in a ribbon shape with a diameter less than 20 micrometers (which is interpreted as the claimed thickness) as claimed, because Zreiqat teaches that the claimed cross-sections and thickness was known as a predictably suitable cross section and thickness for polymer fibers used in implantable scaffold applications. The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960), Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and MPEP § 2144.07.
Koob teaches that the collagen fibers can be coated ([0081]) Koob does not teach:
A cross-linked fibrin hydrogel produced in situ by reacting fibrinogen with thrombin, wherein the cross-linked fibrin hydrogel ensheathes each microfiber segment
Rocco teaches a scaffold for use in tissue engineering applications and surgical repairs ([0006]). Rocco teaches that the scaffold may be a textile formed from fibers ([0123]). This is a similar structure and application as Koob. Rocco teaches that the surface of the fibers may be treated with fibrin to improve cell adhesion ([0135]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to coat the collagen fibers of Koob with fibrin, resulting in the claimed “ensheathed” structure, motivated by the desire to predictably improve cell adhesion as taught by Rocco ([0135]). Regarding the limitation “produced in situ by reacting fibrinogen with thrombin,” Examiner notes that the limitation is a product by process limitation. Absent a showing to the contrary, it is Examiner's position that the article of the applied prior art is identical to or only slightly different than the claimed article. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). The burden has been shifted to Applicant to show unobvious difference between the claimed product and the prior art product. In re Marosi, 218 USPQ 289 (Fed. Cir. 1983). The applied prior art either anticipated or strongly suggested the claimed subject matter. It is noted that if Applicant intends to rely on Examples in the specification or in a submitted declaration to show unobviousness, Applicant should clearly state how the Examples of the present invention are commensurate in scope with the claims and how the Comparative Examples are commensurate in scope with the applied prior art.
As per claim 2, Koob teaches:
Wherein, in the organized configuration, at least some of the plurality of microfiber segments are aligned substantially parallel to one another (In Fig. 3A, shown above, every other fiber appears to be substantially parallel as required by the claim.)
As per claim 3, Koob teaches:
Wherein, in the organized configuration, at least some of the plurality of microfiber segments are arranged obliquely to one another (In Fig. 3A, shown above, several of the fibers intersect in a non-perpendicular fashion, which is interpreted as being arranged obliquely as claimed.)
As per claim 4, Koob teaches:
Wherein the plurality of microfiber segment includes multiple layers of microfibers stacked to form a three-dimensional construct ([00004]: “Repeat winding the at least continuous length collagen fiber a plurality of times such that the at least one continuous length collagen fiber is wound over at least a portion of the length of each support; and forming a medical construct comprising a plurality of overlying layers of the at least one continuous length collagen fiber based at least in part on the winding.”)
As per claim 7, Koob teaches:
Wherein the biocompatible hydrogel further comprises cells distributed therein (In [0081], Koob teaches that the polymeric materials can contain non-collagenous components, such as cells.)
Conclusion
Applicant's amendment necessitated any 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 JENNA N CHANDHOK whose telephone number is (571)272-5780. The examiner can normally be reached on Monday through Friday from 6:30 - 3:30.
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, Marla McConnell can be reached on (571) 270-7692. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNA N CHANDHOK/Primary Examiner, Art Unit 1789
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