DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/22/2025 has been entered.
Claim Objections
Claims 16-19 are objected to because of the following informalities:
Claim 16, line 2, “the” should be inserted before “primary scaffold structure”.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 12-13 and 25 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by US 2006/0286144 (Yang).
12. Yang discloses a method for preparing a double-structured tissue implant (FIG. 1), said method comprising:
adding a basic solution of a secondary scaffold material (“basic collagen solution”) to a primary scaffold structure (“biocompatible reinforcing scaffold”) comprising a substantially homogenous porosity (e.g., “about 100 to about 500 microns” at P0025 of Yang where this application defines “substantially homogenous porosity” at 100-400 at P0044) and a uniformly distributed plurality of pores (e.g., Yang teaches the fibers being formed of non-woven structures at P0024 and shown in FIG. 2a-2b where the current application teaches that “uniformly distributed pores” are “randomly organized” at P0023) such that Yang’s figures meet this required limitation) of substantially the same size (FIG. 2a-2b; P0023-P0025)(“about 100 to about 500 microns” at P0025), wherein the solution of said secondary scaffold material is added to said plurality of pores of said primary scaffold structure (P0029-P0030); and
producing a double-structured tissue implant (FIG. 1; P0032),
wherein said double-structured tissue implant comprises a structurally different secondary scaffold material incorporated into and localized within said plurality of pores of said primary scaffold (e.g., “Once dried, the collagen forms a matrix interspersed within the polymeric fibrous structure, yielding a reinforced basic collagen scaffold” at P0032).
13. The method includes the step of preparing said primary scaffold structure from a material that is biocompatible, biodegradable, or a combination thereof (P0026).
25. The method includes drying and lyophilizing said double-structured tissue implant; and dehydrothermally treating said double-structured tissue implant, thereby solidifying and stabilizing said secondary scaffold material within said plurality of pores of said primary scaffold structure (P0030-P0031).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 14-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2006/0286144 (Yang), as applied above, and further in view of US 2007/0065943 (Smith).
Yang discloses the invention substantially as claimed as discussed above but does not disclose the primary scaffold being from a collagen precursor or Type I collagen. Yang teaches an implant in the same field of endeavor having a primary scaffold from a collagen precursor and Type I collagen (P0066) for the purpose of reconstituting collagen fibrillar structure for matrix protection (P0066). The collagen precursor comprises (i) an alpha 1 (type I) collagen peptide, an alpha 2 (type I) collagen peptide, or a combination thereof; (ii) a precursor of alpha 1 (type I) peptide, a precursor of alpha 2 (type I) peptide, or a combination thereof; or (iii) 2 (alpha 1, type I) peptide, 1 (alpha 2, type I) peptide, or a combination thereof. The primary scaffold comprises a Type I collagen, Type II collagen, Type III collagen, Type IV, Type VI collagen, gelatin, collagen containing agarose, collagen containing hyaluronan, collagen containing proteoglycan, collagen containing glycosaminoglycan, collagen containing glycoprotein, collagen containing glucosamine, collagen containing galactosamine, collagen containing fibronectin, collagen containing laminin, collagen containing a bioactive peptide growth factor, collagen containing cytokine, collagen containing elastin, collagen containing fibrin, collagen containing polylactic, polyglycolic or polyamino acid, collagen containing polycaprolactone, collagen containing polypeptide, or a copolymer thereof (P0066). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the primary scaffold of Yang to be from a collagen precursor as taught by Smith in order to reconstitute collagen fibrillar structure for matrix protection.
Yang discloses the invention substantially as claimed as discussed above but does not disclose the method for preparing the primary scaffold structure. Yang teaches an implant in the same field of endeavor where preparing the primary scaffold structure comprises: producing a solution of said material; and admixing said solution with an ammonia solution to produce an ammonia mixture solution; and precipitating or gelling said ammonia mixture solution under conditions sufficient to produce said primary scaffold structure (P0183 and P0186) for the purpose of forming vertical cone shaped pores (P0186). The method includes washing said primary scaffold structure with water; placing said washed primary scaffold structure in water to produce a solution of primary scaffold structure; and unidirectionally freezing said solution of primary scaffold structure to produce said primary scaffold structure comprising said plurality of pores (P0186). The plurality of pores within said primary scaffold structure are randomly oriented open pores having at least 85% homogeneous pore size (P0038). The plurality of pores have a pore size ranging from about 200 microns to about 300 ± 100 microns (P0038). It would have been obvious to one having ordinary skill in the art at the time the invention was made to method for preparing the primary scaffold structure of Yang to admix the ammonia solution with gelling as taught by Smith in order to form vertical cone shaped pores.
Claim 22-24 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2006/0286144 (Yang), as applied above, and further in view of US 5,830,493 (Yokota).
Yang discloses the invention substantially as claimed as discussed above and further discloses the solution of secondary scaffold material is a basic solution (FIG. 1; P0029-P0030) and comprises a BMP but does not disclose it having a surfactant. Yokota teaches an implant (FIG. 1) in the same field of endeavor where the composition includes a non-ionic surfactant (polysorbate 80 or 20)(col. 6, lns. 17-22 and 36-41) for the purpose of more effectively carrying BMP on the implant (col. 6, lns. 17-22) and improving hydrophilicity and absorption of the implant (col. 6, lns. 42-45). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the secondary scaffold material of Yang to include a non-ionic surfactant as taught by Yokota in order to effectively carry BMP on the implant and improve hydrophilicity and absorption of the implant.
Yang discloses the invention substantially as claimed as discussed above including the surfactant being Pluronic. However, the references do not disclose the surfactant being Triton X100. It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the surfactant to be Triton X100, in place of Pluronic surfactant, in order to stabilize the implant and since it has been held that the selection of a component known in the art to be useful for an intended use is obvious; In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Response to Arguments
Applicant's arguments filed 11/22/2025 have been fully considered but they are not persuasive. Applicant argues that Yang fails to disclose a primary scaffold structure having a substantially homogenous porosity and a uniformly distributed plurality of pores. Examiner respectfully disagrees. Yang teaches a “biocompatible reinforcing scaffold” comprising a substantially homogenous porosity since it teaches the porosity being “about 100 to about 500 microns” at P0025. The current application defines “substantially homogenous porosity” as 100-400 at P0044. Therefore, Yang teaches the relevant range to be a “substantially homogenous porosity” as required by the claims. Yang also teaches uniformly distributed plurality of pores since it teaches fibers being formed of non-woven structures at P0024 and as shown in FIG. 2a-2b. The current application teaches that “uniformly distributed pores” are “randomly organized” at P0023 such that Yang’s figures meet this required limitation. Applicant argues that Yang’s randomly distributed pores in FIG. 2a-2b are not uniformly distributed. However, the current application clearly states that uniformly distributed pores can be either random or non-random. Therefore, Yang’s pore meet the claimed limitation.
Applicant further argues that the fibrous structure of Yang cannot produce a substantially homogenous porosity or uniformly distributed pores. However, as defined by this application, the fibrous structure of Yang meets both of these limitations. Applicant has not provided any further evidence as to why a fibrous structure cannot meet these limitations other than a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant points to Exhibit A with various teachings as to fibrous structures and non-woven fabrics formed from fibrous structures (page 7, filed 11/22/2025). Applicant then alleges that “by virtue of their structural formation, fibrous materials do not have “a substantially homogenous porosity and a uniformly distributed plurality of pores” (page 7, filed 11/22/2025). Examiner respectfully disagrees since applicant has not provided any evidence as to why fibrous structures cannot include these attributes.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 9,149,562 (Shortkroff) appears to be double patenting over the currently recited claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD J SCHERBEL whose telephone number is (571)270-7085. The examiner can normally be reached Mon - Fri 9:00-6:00.
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TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/ Primary Examiner, Art Unit 3771