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 .
Examiner’s Note
The limitation of instant claim 1 “wherein the inner rim has a higher density, a smaller pore size, or a higher tensile strength as compared to the outer rim” is underlined; however, this limitation is consistent with the previously examined claims filed 10/20/2025.
In the interest of compact prosecution, the amended claims have been accepted, but Applicant is reminded that claim amendments should comply with 37 CFR 1.11 (c) (see also MPEP 714 c).
Withdrawn Objections/Rejections
The previous rejections of claims 1-3, 5, 9, 11-12, 16-18, 20, and 22-23 under 35 U.S.C. § 112(a) are withdrawn in view of the claim amendments.
The rejections of claims 1-3, 5, 9, 11-12, 16-18, 20, and 22-23 under 35 U.S.C. § 112(b) are withdrawn in view of the claim amendments.
The previous rejections of claims 1-3, 5, 9, 11-12, 16-18, 20, and 22-23 under 35 U.S.C. § 103 are withdrawn in view of the claim amendments.
Claim Status
Applicants' amendments and arguments filed on 07/01/2026 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 4, 6-8, 10, 13-15, 19, 21, and 27 are cancelled.
Claims 24-26 and 28 are withdrawn.
Claims 1-3, 5, 9, 11-12, 16-18, 20, and 22-23 are under current examination. The claims were read in view of the species election of a glycosaminoglycan of hyaluronic acid and a single bioactive element of cells present in the scaffold in the reply filed 02/10/2025.
New Rejections, Necessitated by Claim Amendments
Claim Rejections - 35 USC § 112(a)-New Matter
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.
Claims 1-3, 5, 9, 11-12, 16-18, 20, and 22-23 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain 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, at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “wherein the scaffold implant has a suture retention strength of at least 5 N”, inclusive of any suture retention strength greater than or equal to 5 N. The specification-as-filed describes that the “suture pull-out strength was 9.4N” (pg. 9, lines 16-17), and in Table 1 (Fig. 6) provides suture retentions of 9.1 ± 1.6 N for random fiber orientation and 9.4 ± 0.8 N for aligned fiber orientation. The specification does not provide support for any suture retention strength of “at least 5 N”. Accordingly, claim 1 introduces new matter.
Dependent claims 2-3, 5, 9, 11-12, 16-18, 20, and 22-23 require the limitations of claim 1 and thus also fail to comply with the written description requirement.
Claim Interpretation
Claim 1 recites the limitation “wherein the glycosaminoglycan is impregnated into the scaffold implant via injection after the scaffold implant has been engineered”. This is interpreted as product-by-process limitation. Per MPEP 2113, “"[E]ven 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, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).”
Here, the structure defined by the process is interpreted as a scaffold implant suitable for repairing injured or diseased human meniscus comprising fibers of a biopolymer impregnated with a glycosaminoglycan of hyaluronic acid, chondroitin sulfate, chitosan, alginic acid, or a combination thereof, with the recited density, pore volume, surface friction coefficient, fiber orientation and inner/outer rim, as previously recited in claim 1.
The limitation of claim 12 that the hyaluronic acid is impregnated into the scaffold via injection after the scaffold has been engineered is similarly interpreted as a product-by-process limitation. The structure defined by the process is interpreted as the scaffold implant of claim 11 wherein hyaluronic acid having a molecular weight ranging from 0. 1x106 Daltons to 3.0x106 Daltons is impregnated into the scaffold.
The instant specification does not provide a definition for the term “impregnated”. The term is therefore being given its ordinary and customary meaning (see MPEP 2111.01). From Merriam-Webster (of record), “impregnate” is defined as “to cause to be filled, imbued, permeated, or saturated” (pg. 6). The limitation of “fibers of a biopolymer impregnated with glycosaminoglycan” is therefore interpreted as glycosaminoglycan filled, imbued, permeated, or saturated in the biopolymer fibers.
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 for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 1-3, 5, 9, 11-12, 16-18, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Smestad et al. (US 2006/0002967 A1, published January 5, 2006; included on IDS submitted 06/06/2023), hereafter “Smestad”, as evidenced by Encyclopaedia Britannica (“newton”, https://www.britannica.com/science/newton-unit-of-measurement), in view of Ghodbane et al. (WO 2018/148722 A1, published August 16, 2018; of record), hereafter “Ghodbane”, Cragg et al. (US 2013/0138209 A1, published May 30, 2013; included on IDS submitted 01/10/2022), and Li et al. (US 2018/0008391 A1, published January 11, 2018), hereafter “Li”.
Regarding instant claim 1, Smestad teaches a biocompatible implant for use in the skeletomuscular system comprising: a polymeric matrix that is at least partially bioresorbable, and a bioresorbable lubricious coating disposed on a surface of the polymeric matrix (claim 1). The implant is taught to be a meniscus implant (claim 2), which acts as a scaffold for regenerating meniscal tissue in human patients (paragraph [0009]); biocompatible and bioresorbable structures for implantation into the knee joint can be used for the treatment of injured or diseased menisci (paragraphs [0006]-[0008]). The polymeric matrix of Smestad is taught to be a biopolymer-based matrix, specifically a collagen-based matrix (claims 4-5), comprising collagen fibers (claim 7). The polymeric matrix further comprises glycosaminoglycans, selected from the group including hyaluronic acid (claims 7-8). Glycosaminoglycan molecules are taught to be interspersed and can be uniformly dispersed throughout the fibers (paragraph [0028]). Smestad further teaches that the coating is selected from the group including hyaluronic acid (claim 13) and that the coating can be partially or wholly integrated (claim 10, paragraphs [0037]-[0038]). It is interpreted that Smestad teaches hyaluronic acid can be permeated (interspersed/uniformly dispersed/wholly integrated) throughout the collagen fibers and thus meets the limitation of being impregnated in the fibers. Smestad teaches that the implant has an outer rim (paragraph [0076]) and a shape consistent with that of the instant invention (compare Smestad Figs. 3, 5a, and 6a with Fig. 2 of the instant specification); it is therefore interpreted that the implant of Smestad has an outer and inner rim.
Smestad further teaches that the fibers can be placed randomly or oriented in specific directions in, for example, mold forms such as a cylindrical form; for example, the fibers can be placed in the mold in a circumferential orientation by rotating the mold as the fibers are placed therein (paragraph [0047]). Smestad teaches that circumferential orientation of the fibers is produced by rotation of the piston about its principal axis as the material is compressed into the mold (paragraph [0057]). This is a substantially identical process described in the instant specification for engineering a circumferentially oriented type I collagen fiber meniscus implant (pg. 9, line 32-pg. 10, line 29), and it is therefore interpreted that the process of Smestad will result in a percentage of fibers in the inner rim oriented along the circumferential direction consistent with the instant claim. See MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).” Smestad further teaches that in menisci, collagen fibers are oriented primarily in the circumferential direction (paragraph [0004]), providing motivation to one of ordinary skill in the art to optimize the amount of fibers oriented along the circumferential direction in a meniscus implant to be consistent with naturally occurring menisci. Per MPEP 2144.05, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
Smestad further teaches that the preferred matrix density is in the range from about 0.15 to about 0.50 g/cm3 (paragraph [0026]), overlapping the range of instant claim 1. Per MPEP 2144.05 I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”. Smestad further teaches that specific densities can be obtained in various regions of the matrix (paragraph [0046]).
Smestad further teaches that a suture pullout test is used to ascertain that the suture pullout strength of the matrix exceeds the strength requirement for surgical implantation, and a suture pullout force greater than 2 lbs. meets this requirement (paragraph [0073]). As evidenced by Encyclopaedia Britannica, a newton is equal to 0.2248 pounds; thus, 2 lbs. is equal to approximately 8.9 N. One of ordinary skill in the art would have been motivated to achieve a suture retention strength of greater than 8.9 N (at least 5 N) in order to meet or exceed known strength requirements for surgical implantation.
Regarding instant claim 2, as noted above, the polymeric matrix of Smestad is taught to be a biopolymer-based matrix, specifically a collagen-based matrix (claims 4-5), comprising collagen fibers (claim 7).
Regarding instant claims 3 and 5, Smestad teaches that in a preferred embodiment, the polymeric matrix is made of collagen-based material, and preferably of Type I collagen fibers (paragraph [0024], claim 6) .
Regarding instant claim 9, Smestad teaches that the polymeric matrix comprises about 1-35 percent by dry weight of glycosaminoglycans (claim 7), overlapping the range of the instant claim. Per MPEP 2144.05 I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding instant claims 11-12, as noted above, Smestad teaches that the coating can be hyaluronic acid, which is a polysaccharide (paragraph [0041]), polysaccharides being hydrophilic polymers (paragraph [0043]). Smestad teaches that hydrophilic polymers preferably have a molecular weight in the range of 50,000 to 5,000,000, and that for an integrated coating, the molecular weight of the hydrophilic polymer has an effect on its adherence to the polymeric matrix, i.e., its degree of immobilization (paragraph [0044]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to optimize the molecular weight of the hyaluronic acid within the range taught by Smestad in order to achieve a desired degree of immobilization within the polymeric matrix. Per MPEP 2144.05 II. A., “"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”. Further, per MPEP 2144.05 I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”. Further, as noted above, the structure defined by the process recited in instant claim 12 is interpreted as the scaffold implant of claim 11 wherein hyaluronic acid having a molecular weight ranging from 0. 1x106 Daltons to 3.0x106 Daltons is impregnated into the scaffold.
Regarding instant claim 16, as noted above, Smestad teaches that the preferred matrix density is in the range from about 0.15 to about 0.50 g/cm3 (paragraph [0026]), overlapping the range of the instant claim. Per MPEP 2144.05 I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding instant claim 18, Smestad teaches that the matrix can be crosslinked using formaldehyde (paragraph [0059]).
Regarding instant claims 20 and 22, Smestad teaches that examples of the polymeric matrix include a collagen-cell composite (paragraph [0023]), cells being a bioactive element.
Smestad does not teach the limitation of instant claim 1 of a pore volume from 60% to 90%.
Ghodbane teaches a resorbable scaffold for partial meniscus regeneration including a polymer filament network and matrix (abstract); the matrix may be fabricated from proteins including collagen (paragraph [0014]). Ghodbane teaches that porosity was found by dividing pore volume by the total volume (paragraph [0116]), which is the same method of determining the percent pore volume described in the instant specification (pg. 8, lines 29-31). Ghodbane teaches that any level of porosity can be used provided that it is sufficient for facilitating adequate cell seeding, fluid flow, and structural integrity, and that a relatively high porosity ensures adequate tissue and cell infiltration (paragraph [0064]). Ghodbane exemplifies a porosity of 69.9 ±8.0% (paragraph [0117]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the pore volume of the implant of Smestad with the porosity of 69.9 ±8.0%, overlapping the range of the instant claims, as suggested by Ghodbane. This could be achieved by routine optimization of the pore volume in order to achieve a pore volume that achieves a desired fluid flow, structural integrity, and that ensures adequate tissue and cell infiltration in a collagen-containing resorbable scaffold for the meniscus, as suggested by Ghodbane. Per MPEP 2144.05 II. A., “"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”. Further, per MPEP 2144.05 I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Smestad does not teach the limitation of a surface friction coefficient from 0.05 to 1.0 (instant claim 1) or a friction coefficient from 0.08 to 0.8 (instant claim 17).
Cragg teaches a medical device and methods to relieve joint pain and adapted for knee joint repair, replacement, and augmentation (abstract), and teaches that hyaluronic acid is used clinically to improve the lubricating ability of synovial fluid (paragraph [0167]). Cragg further teaches that artificial cartilage materials could mimic the properties of natural cartilage and have, for example, a SF lubricated static friction of 0.20-0.40 (paragraph [0176]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the implant of Smestad to have a surface friction of 0.20-0.40, overlapping the range of the instant claims, as taught by Cragg. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in order to achieve a friction that mimics the properties of natural cartilage. There is a reasonable expectation of success as Smestad teaches a lubricious coating, which can be hyaluronic acid, to lower the coefficient of friction for the implant, decrease shear forces exerted on the implant and reduce damage to surfaces in the body which contact the implant (paragraphs [0035], [0041]).
While Smestad suggests that various regions of the implant can have different densities (paragraph [0046]), Smestad does not explicitly teach that the inner rim has a higher density as compared to the outer rim.
Li teaches a density gradient biopolymeric matrix implant with different matrix layers having different densities, one being higher than the other (abstract, claims 1-2); the matrix comprises collagen biopolymeric fibers (claim 4). Li demonstrates an implant in Fig. 3A with an outer rim (30) having a density in the range of 0.02 g/cm3 to 0.3 g/cm3 and an inner portion (31) having a density in the range of 0.3 g/cm3 to 1.0 g/cm3 (paragraph [0047]). The distinct density regions allow the implant to perform multiple roles after implantation and allow for properties such as differential biomechanical and resorption rate properties, a desirable degree of conformability, facilitation of cell ingrowth, and incorporation of bioactive molecules which can be controllably released (paragraph [0003]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the implant of Smestad to have a higher density in the inner rim as compared to the outer rim, as suggested by Li. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to achieve a collagen matrix implant that can perform multiple roles after implantation and has desirable properties such as differential resorption rates and controllable release of incorporated bioactive molecules, as suggested by Li. There is a reasonable expectation of success as Smestad teaches biocompatible collagen matrix implants that are at least partially bioresorbable which can include the bioactive molecules of cells, and Smestad teaches that the implant can have different densities in various regions.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Smestad in view of Ghodbane, Cragg, and Li as applied to claims 1-3, 5, 9, 11-12, 16-18, 20, and 22 above, and further in view of Wadsworth et al. (WO 2017/214736 A1, published December 21, 2017; included on IDS submitted 01/10/2022), hereafter “Wadsworth”.
The teachings of the modified Smestad are described above.
The combination of Smestad, Ghodbane, Cragg, and Li do not teach that the limitation of claim 23 that the bioactive elements are allogenous and include bioactive molecules or stem cells.
Wadsworth teaches meniscus implant compositions that find use in repairing and/or replacing damaged or diseased meniscal tissue in a mammalian subject (abstract); the meniscus implant comprises a solidified biocompatible matrix (claim 13) which comprises one or more of collagen and glycosaminoglycans (GAG) (claim 42), the GAG being hyaluronic acid (claim 44). The biocompatible matrix can comprise cells (paragraph [0011]); mammalian cells such as stem cells can be used, and cells can be allogenic (paragraphs [0085]-[0086]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the implant of Smestad in view of Ghodbane, Cragg, and Li with the allogenic stem cells taught by Wadsworth. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in order to impart a cell type known to be used in artificial meniscus implants capable of repairing and/or replacing damaged or diseased meniscus tissue (Wadsworth, paragraph [0051]) that can be readily differentiated into a desired phenotype (Wadsworth, paragraph [0090]) and used for regenerative medicine purposes (Wadsworth, paragraph [0092]). There is a reasonable expectation of success as Smestad is similarly directed to meniscus implants for the treatment of injured or diseased menisci comprising collagen and hyaluronic acid, and Smestad teaches that examples of the polymeric matrix include a collagen-cell composite (paragraph [0023]).
Rejections Maintained, Slightly Modified to Address Amended Claims
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5, 9, 11-12, 16-18, 20, and 22-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-14, 16-19, 21, and 25 of copending Application No. 18/582,198 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-3, 5, 9, 11-12, 16-18, 20, and 22-23 are directed to an invention not patentably distinct from claims 1-4, 6-14, 16-19, 21, and 25 of commonly assigned Application No. 18/582,198.
Both the instant claims and those of copending Application No. 18/582,198 are directed to a scaffold implant for repairing injured or diseased meniscus comprising fibers of a biopolymer of collagen type I, type II, or type III impregnated with a glycosaminoglycan of hyaluronic acid. Both sets of claims recite overlapping densities, pore volumes, surface friction coefficients, suture retentions, wt.% of hyaluronic acid, and molecular weights of hyaluronic acid. Both sets of claims recite an inner rim and an outer rim with the inner rim having a higher density, higher tensile strength, and a smaller pore size compared to the outer rim. Both sets of claims further recite that the implant is crosslinked by formaldehyde and comprises bioactive elements of cells that are allogenous and comprise stem cells.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned Application No. 18/582,198, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of
one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Arguments
Applicant’s arguments filed 07/01/2026 have been fully considered.
Regarding the claim rejections under 35 U.S.C. § 112(a) and 35 U.S.C. § 112(b), Applicant argues that the claim amendments to remove the phrase “in the inner rim” and to clarify the recited density range have overcome the rejections.
In response, the Examiner notes that, as detailed above, the previous grounds of rejection under 35 U.S.C. § 112(a) and 35 U.S.C. § 112(b) are withdrawn. However, newly applied rejections under 35 U.S.C. § 112(a), necessitated by the claim 1 amendment reciting “the scaffold implant has a suture retention strength of at least 5 N”, are set forth above.
Regarding the claim rejections under 35 U.S.C. § 103, Applicant argues that the non-obviousness of the invention does not relate to any individual aspect of the design, but the simultaneous control of each design parameter in a single implant with proper balance of all variables. The Examiner's rejection relies on combining four separate references, and no single reference, and no combination of the cited references, teaches or suggests the simultaneous achievement and proper balance of all claimed parameters within a single meniscus implant. Applicant argues that the claimed suture retention strength is a direct product of the synergistic interaction between the claimed fiber alignment, density, pore structure, and mechanical properties, and one of ordinary skill in the art, following the teachings of the cited references, would not predictably arrive at an implant that achieves the claimed suture retention strength while also satisfying all other claimed limitations. Applicant further argues that the reliance on the Li reference is misplaced, as Li is directed to density gradient biopolymeric matrix implants for dura mater repair, wound healing, and drug delivery, not meniscus implants, and the density gradients disclosed in the Li reference serve fundamentally different purposes from those in the claimed invention of providing a fluid-tight barrier to prevent cerebral spinal fluid leakage.
These arguments are unpersuasive. The Examiner first notes that, although no single prior art reference teaches all of the claimed parameters within a single implant, the rejection set forth above is an obviousness rejection, not an anticipation rejection. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The Examiner respectfully maintains that, as detailed above, the teachings of the combined references provide motivation to achieve each of the claimed parameters in a collagen-based implant, and a person of ordinary skill in the art who is not an automaton would be motivated to achieve these parameters in a single implant. Per MPEP 2141.03 I., "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397.
In response to applicant's argument that the examiner has combined four separate references, reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991).
The arguments that the reliance on the Li reference is misplaced are unpersuasive. While Li exemplifies a density gradient matrix for dura mater repair, per MPEP 2123 I., “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).” As detailed above, Li teaches a collagen-based implant which can incorporate bioactive molecules, analogous to the claimed invention. Li provides motivation to achieve a density gradient in such implants to control properties such as differential resorption rates and controllable release of incorporated bioactive molecules, particularly as Smestad teaches at least partially bioresorbable collagen matrix implants which include bioactive molecules of cells, and Smestad teaches that such implants can have different densities in various regions. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant further argues that the engineering philosophy of the claimed invention is fundamentally different from that of the prior art of Smestad. The claimed scaffold is not designed to maximize circumferential fiber alignment. Rather, it employs a quantified degree of circumferential alignment while preserving a population of non-aligned fibers within the scaffold architecture. This architecture produces a combination of high circumferential tensile strength and high suture retention strength that would not have been expected from increasing fiber alignment alone. The present invention achieves high suture retention strength (9.4 N) while simultaneously maintaining greater than 70% circumferential fiber alignment, a feat that is counterintuitive because circumferential fiber alignment would be expected to reduce radial suture retention.
These arguments are unpersuasive, as it is not necessary that the prior art teach the same engineering philosophy. Per MPEP 2144 IV., “The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006)”. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Here, as detailed above, Smestad teaches that collagen fibers in meniscus implants may be oriented in specific directions, and teaches a method of production that is substantially identical to the process described in the instant specification for engineering a circumferentially oriented type I collagen fiber meniscus implant. Smestad also teaches that a suture pullout strength greater than 2 lbs (approximately 8.9 N) is required for surgical implantation, motivating the skilled artisan to maintain this strength in an implant for meniscal repair, and suggesting that this strength is achievable in implants with circumferentially oriented fibers.
Applicant further argues that the claimed invention is non-obvious because it produces unexpected results; a person of ordinary skill seeking to maximize circumferential tensile properties would reasonably expect that increasing circumferential alignment would progressively reduce radial reinforcement and suture pull-out strength. Contrary to that expectation, the present invention demonstrates that maintaining greater than 70% circumferential alignment while retaining a remaining population of non-aligned fibers produces unexpectedly high suture retention together with excellent circumferential mechanical properties. Applicant argues that the 70% threshold does not represent an arbitrary design choice; rather, it represents an optimized scaffold architecture that solves competing design constraints. The simultaneous achievement of appropriate fiber alignment, controlled density distribution, adequate pore volume for tissue infiltration, appropriate surface friction, and high suture retention strength, all within a single implant, produces a synergistic effect on the cohesiveness and mechanical integrity of the implant that is far greater than what would be predicted from the individual parameters as described in any of the cited references which address individual parameters in isolation.
The arguments regarding the alleged unexpected results are unpersuasive. The Examiner first notes that the evidence of record does not compare the claimed invention to meniscus implants of the prior art such that any unexpected improvement or synergistic effect can be concluded. Per MPEP 716.02(e), “An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979).”
Further, the Examiner notes that, per MPEP 716.02(d), evidence of unexpected results must be commensurate in scope with the claimed invention. The primary evidence of record is found in Table 1 (Fig. 6), which compares fiber orientations of <50% to those >50%. No evidence of record is found regarding the claimed fiber orientation of greater than 70% of the biopolymer fibers oriented along the circumferential direction, contrary to Applicant’s arguments that this threshold does not represent an arbitrary design choice but rather represents an optimized scaffold architecture.
Regarding the nonstatutory double patenting rejection over Application No. 18/582,198, Applicant argues that the instant application has the earlier patent term filing date, and the rejection should be withdrawn.
In response, the Examiner respectfully maintains that, per MPEP 804 I.B. states, “A provisional double patenting rejection should be made and maintained by the examiner until the rejection has been obviated or is no longer applicable except as noted below”, and, as noted by Applicant MPEP 804 I.B.1 (b)(i) states (emphasis added), “If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.” As detailed above, the provisional nonstatutory double patenting rejection is not the only rejection remaining, and thus the provisional nonstatutory rejection is not withdrawn at this time.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUDITH M KAMM whose telephone number is (703)756-4575. The examiner can normally be reached M-F 8:00 am-4:30 pm EST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611
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