DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Election/Restriction
Applicant’s election without traverse of Group I, claims 1-19 and 35, bovine collagen, poly(L/D)lactide, and chondrocytes in the reply filed on 25 March 2026, is acknowledged.
Status of Claims
Claims 1-35 are pending in the instant Office Action.
Claims 20-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 25 March 2026.
Claims 1-19 and 35 are under consideration in the instant Office Action, to the extent of the following elected species:
the specific animal collagen is bovine collagen;
the specific poly(lactic acid) polymer is poly(L/D)lactide; and
the specific cells are chondrocytes.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of parent Danish Patent Application No. DK PA 2021 70531, filed on 29 October 2021, has been received from the International Bureau.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 26 April 2024, was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
NOTE: The non-patent literature (NPL) titled “Chondrogenic differentiation of human bone marrow-derived mesenchymal stromal cells in a three-dimensional environment” (J. Cell Physiol. 2019, 1, 1.) was submitted at the same time as the other NPL documents but does not appear on the IDS form.
Claim Objections
Claims 4, 7-8, 12, and 35 are objected to because of the following informalities:
Claim 4 recites “fish or jellyfish..” in the final line of the claim. The additional period is extraneous and should be removed.
Claim 7 recites “copolymer (commonly denoted PLA)” in the final line of the claim. The first use of an acronym or initialism should be preceded by the full name and, because the abbreviation “PLA” is used in instant claim 1, this definition of PLA should be in claim 1 rather than claim 7.
Claim 8 recites “the scaffold” in line 2 of the claim. While it is clear that this limitation is referring to the “sterilized scaffold” recited in instant claim 1, clarity and consistency would be improved by amending the claim to recite “the sterilized scaffold” (e.g., as in claims 2 and 3).
Claim 12 and 35 recite a “sterilized PLA-collagen scaffold” in line 2 of claim 12 and line 1 of claim 35. While it is clear that the above recitation is referring to the sterilized scaffold recited in claim 1, clarity would be improved if claims 12 and 35 instead recited “wherein the sterilized scaffold”, consistent with claim 1.
Claim 35 depends from claim 20 which has been withdrawn as being drawn to a nonelected invention (vide supra). Claim 35 should be amended to depend from a claim under consideration and, to avoid issues with antecedent basis, to recite the limitations of the sterilized scaffold or the method steps by which the sterilized scaffold is obtained.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-19 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “PLA” in line 3. The first use of an acronym or initialism should write out the full meaning of the abbreviated words, followed by the abbreviation in parentheses. As currently written, the meaning of “PLA” is unclear, rendering the claim indefinite. Claims 2-19 depend from claim 1, incorporate all of its limitations, and are therefore also indefinite. Applicant may overcome this rejection by amending claim 1 to define the abbreviation “PLA”.
Claims 2-3 and 8 recite “collagen” in line 1 of claim 2, lines 2-3, 5, and 7 of claim 3, and line 2 of claim 8. This limitation lacks antecedent basis because claim 1, from which claims 2-3 and 8 depend, recites “animal collagen” in line 2 of the claim. It is unclear if claims 2-3 and 8 are referring to the animal collagen as recited in claim 1 or if they are further limiting the claims to a different type of collagen, rendering the claims indefinite. Applicant may overcome this rejection by amending the claims to recite “animal collagen”.
Claim 4 recites “such as” in lines 2-4. The phrase “such as” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 7 recites “(commonly denoted PLA)” in line 3. The phrase which is “commonly denoted PLA” is unclear, rendering the claim indefinite. Applicant may overcome this rejection by defining “PLA” the first time it is used and removing the parenthetical statement from claim 7.
Claim 13 recites “(e.g. cells derived…)” in lines 2-3 and “(e.g. bone-marrow derived…)” line lines 3-4. It is unclear if the source of the cells is merely exemplary or intended to be limiting and is therefore indefinite. Applicant may overcome this rejection by removing the parenthetical statements.
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.
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 1-19 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Xiangchen Qiao et al. (J. Funct. Biomater. 2015, 6, 667., provided by Applicant in the IDS filed on 26 April 2024, hereafter referred to as Qiao) in view of Haaparanta et al. (J. Mater. Sci.: Mater. Med. 2014, 25, 1129., hereafter referred to as Haaparanta).
Qiao teaches scaffolds for use in biological environments made from a blend of poly-dl-lactic acid (PDLLA), which is interpreted as equivalent to the elected poly(L/D)lactide, and type I collagen (Abstract). Collagen and PDLLA are taught to be biocompatible materials useful for bone tissue engineering (pg. 668, Introduction, para. 1-3). Qiao investigated the suitability of PDLLA to stabilize collagen in a scaffold for in vitro delivery of human bone marrow stromal cells (HBMSCs) and compared it to scaffolds made from PDLLA and gelatin (pg. 669, para. 4). In one embodiment, the ratio of PDLLA to collagen in the dried scaffold is taught to be 80/20, which is equivalent to 80% w/w PDLLA and 20% w/w collagen and falls within the ranges recited in claims 1-3 (Abstract, Table 1, and pg. 680, 3.2. Preparation of PDLLA/Collagen Scaffolds).
HBMSCs loaded on the PDLLA/Collagen scaffolds were found to be viable 4 weeks after loading, with varying levels of proliferation and differentiation based upon the ratio of PDLLA:Collagen (pg. 673-674, 2.2. Cell Culture on PDLLA/Collagen Scaffolds). Qiao teaches that all scaffolds were sterilized using UV irradiation prior to cell seeding (pg. 681, 3.4. Biological Characterisation of Electrospun PDLLA/Collagen Scaffolds). The method of producing the PDLLA/Collagen scaffolds employed by Qiao inherently possess scaffolds in which “the collagen has been loaded to the scaffold before sterilization” as required by instant claim 8 (pg. 680, 3.2. Preparation of PDLLA/Collagen Scaffolds). Qiao does not teach the form of their fibers, however, figure 1 (pg. 670) shows fibers of PDLLA interwoven and are considered to be equivalent to the fiber mesh as recited in instant claim 7.
Guidelines on the obviousness of similar and overlapping ranges, amounts, and proportions are provided in MPEP § 2144.05. With respect to claimed ranges which “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). These guidelines apply to the quantities of animal collagen and PDLLA – Qiao teaches discrete quantities that fall within the ranges recited in instant claims 1-3, rendering them prima facie obvious.
Qiao does not teach the collagen in their scaffold to be derived from bovines nor the loaded cells to be chondrocytes. These deficiencies are offset by the teachings of Haaparanta.
Haaparanta teaches 3D porous scaffolds comprising collagen and polylactide polymers (PLA) for the purpose of repairing articular cartilage defects (Abstract). Articular cartilage injuries are taught to be difficult to treat “due to the lack of spontaneous tissue regeneration and the nature of the tissue”, including low cell density and low miotic activity of chondrocytes (pg. 1129, Introduction, para. 1). One treatment method is autologous chondrocyte implantation (ACI), which requires a biomaterial scaffold onto which chondrocytes can be loaded with suitable properties (pg. 1129-1130, Introduction, para. 2). Using collagen, chitosan, and PLA, Haaparanta developed 8 new scaffolds to be loaded with chondrocytes for use in cartilage tissue engineering (pg. 1130, right col., para. 2-3 and Table 1). The specific collagen is taught to be type I bovine dermal collagen (pg. 1130, 2.1.1 Fabrication of plain and blend solutions) and the PLA is taught to be medical grade poly(L/D)lactide, which is manufactured in the form of a mesh (pg. 1130, 2.1.2 Fabrication of PLA mesh). Haaparanta found that hybrid scaffolds comprising collagen and PLA possess “desirable properties for articular cartilage tissue engineering applications”, including “high porosity and interconnected pores, improved mechanical strength compared to plain collagen scaffolds, good water uptake, and penetration of chondrocytes” (pg. 1135-1136, 5 Conclusion). The chondrocytes specifically were found to be attached to the scaffolds in vitro and maintain viability, with penetration into tissue being promoted by the presence of PLA (pg. 1135, right col., para. 2).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to use bovine collagen and chondrocytes in the invention of Qiao in view of the teachings of Haaparanta because the combination of prior art elements according to known methods to impart a known benefit yields predictable results. Qiao teaches a sterilized scaffold made from poly-dl-lactic acid and collagen, with quantities that fall within the ranges recited in instant claims 1-3, that may be loaded with cells. In view of the teachings of Haaparanta, a person of ordinary skill in the art would be motivated to use bovine collagen and load the scaffold with chondrocytes because Haaparanta teaches these species to enable treatment of articular cartilage injuries. The ordinary artisan would desire additional applications for their invention and in view of the teachings of Haaparanta, would be motivated to change the source of cartilage and substitute the chondrocyte cells to enable the treatment of articular cartilage injuries.
Qiao and Haaparanta are silent on the improved physical properties of collagen-PLA scaffolds when the collagen is derived from an animal as compared to collagen not derived from an animal. However, the improved physical properties, including the decrease in swelling, are considered properties of the scaffold. 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). See MPEP § 2112.01. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Therefore, because a sterilized scaffold comprising bovine collagen and poly-dl-lactic acid at concentrations that fall within the ranges recited in instant claims 1-3 is prima facie obvious in view of the teachings of Qiao and Haaparanta, the improved physical properties as claimed in instant claims 9-11 would necessarily be present.
Instant claims 15-19 are interpreted as intended use claims. The intended use of an invention is not given patentable weight and the “selection of a known material based on its suitability for its intended use” has previously supported a rejection for being prima facie obvious in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). See MPEP § 2144.07. Because the sterilized scaffold recited in instant claim 1 has been rendered obvious in view of the teachings of Qiao and Haaparanta (vide supra), claims 15-19 are also rejection as being obvious. As a result, there is a reasonable expectation of success in arriving at the invention of claims 1-19 and 35 in view of the teachings of Qiao and Haaparanta.
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 1-19 and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, and 20 of copending Application No. 18/049,464 in view of Qiao (J. Funct. Biomater. 2015, 6, 667., provided by Applicant in the IDS filed on 26 April 2024) and Haaparanta (J. Mater. Sci.: Mater. Med. 2014, 25, 1129.).
This is a provisional nonstatutory double patenting rejection.
Copending Application No. 18/049,464 recites a method for preparing a sterilized scaffold comprising collagen and PLA (claim 1). The scaffold is recited to be recombinant or tissue-derived (claim 16). Application ‘464 additionally recites the PLA is a polylactide (claim 20).
Copending Application No. 18/049,464 does not recite the collagen to be bovine collagen, the PLA to be poly(L/D)lactide, the quantities of collagen or PLA, nor the scaffold to be loaded with chondrocytes. These deficiencies are offset by the teachings of Qiao and Haaparanta.
Qiao and Haaparanta have been described above.
Instant claims 1-19 and 35 are obvious variations of copending Application No. 18/409,464 because it would have been prima facie obvious to a person of ordinary skill in the art at the time of filing to modify the method recited by Application ‘464 to use bovine collagen and poly(L/D)lactide, in the concentrations recited in instant claims 1-3, and to load the scaffold with chondrocytes in view of the teachings of Qiao and Haaparanta.
One of ordinary skill would be motivated to modify the scaffold produced by the method recited by Application ‘494 to use PLA and collagen in a ratio of 80% w/w and 20% w/w, respectively, and the PLA species poly-dl-lactic acid because Application ‘494 does not recite quantities of PLA or collagen, nor specific species, and Qiao teaches the ratio and species to be suitable for in vitro delivery of cells. The ordinary artisan would need information regarding quantities and species, which Qiao teaches, and would recognize an application as beneficial in their invention. One of ordinary skill would further be motivated to use the species bovine collagen in view of the teachings of Haaparanta because copending Application ‘464 does not recite a specific collagen species and Haaparanta teaches missing information the ordinary artisan would need. In addition, Haaparanta teaches that scaffolds comprising bovine collagen and poly(D/L)lactide can be loaded with chondrocytes and used to treat articular cartilage injuries. Application ‘464 does not teach an application of the scaffold produced via their method and a person of ordinary skill would recognize the usefulness of loading their scaffold with chondrocytes for the application of cartilage treatment.
While Application ‘464 is directed to a method, rather than a product, the method recited by ‘464 produces a sterilized PLA-collagen scaffold. "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). Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." (bold added for emphasis) Id. at 418, 82 USPQ2d at 1396. The person of ordinary skill would be capable of taking the creative steps necessary to produce the scaffold recited in the method of Application ‘464 and modify it in view of the teachings of Qiao and Haaparanta.
Application ‘464, Qiao, and Haaparanta are silent on the improved physical properties of collagen-PLA scaffolds when the collagen is derived from an animal as compared to collagen not derived from an animal. However, the improved physical properties, including the decrease in swelling, are considered inherent properties of the scaffold. 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). See MPEP § 2112.01. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Therefore, because a sterilized scaffold comprising bovine collagen and poly-dl-lactic acid at concentrations that fall within the ranges recited in instant claims 1-3 is prima facie obvious in view of the invention recited by Application ‘464 and the teachings of Qiao and Haaparanta, the improved physical properties as claimed in instant claims 9-11 would necessarily be present.
Instant claims 15-19 are interpreted as intended use claims. The intended use of an invention is not given patentable weight and the “selection of a known material based on its suitability for its intended use” has previously supported a rejection for being prima facie obvious in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). See MPEP § 2144.07. Because the sterilized scaffold recited in instant claim 1 has been rendered obvious in view of the invention recited by Application ‘464 and the teachings of Qiao and Haaparanta (vide supra), claims 15-19 are also rejection as being obvious. As a result, there is a reasonable expectation of success in arriving at instant claims 1-19 and 35 in view of the method recited in copending Application No. 18/049,464 and the teachings of Qiao and Haaparanta.
Claims 1-19 and 35 are directed to an invention not patentably distinct from claims 1, 16, and 20 of commonly assigned copending Application No. 18/049,464 in view of the teachings of Qiao and Haaparanta. Specifically, see above.
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 copending Application No. 18/049,464, 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.
Claims 1-19 and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-9, and 20-21 of copending Application No. 18/705,215 in view of Haaparanta (J. Mater. Sci.: Mater. Med. 2014, 25, 1129.).
This is a provisional nonstatutory double patenting rejection.
Copending Application No. 18/705,215 recites a scaffold comprising sterilized PLA and collagen loaded with cells (claim 1). The collagen is recited as being present in an amount from 5-25% w/w and the PLA present in an amount from 75-95% w/w (claims 4-6). The PLA polymer is recited as being a polylactide polymer in the form of a fiber mesh (claims 7-8) and the collagen is recited as being animal collagen (claim 9). Finally, Application ‘215 recites the loaded cells to be tissue-derived cells such as chondrocytes (claims 20-21).
Copending Application No. 18/705,215 does not recite the polylactide polymer to be poly(L/D)lactide nor the animal collagen to be bovine collagen. These deficiencies are offset by the teachings of Haaparanta.
Haaparanta has been described above.
Instant claims 1-19 and 35 are obvious variations of copending Application No. 18/705,215 because it would have been prima facie obvious to a person of ordinary skill in the art at the time of filing to use poly(L/D)lactide in the invention recited by Application ‘215 in view of the teachings of Haaparanta. One of ordinary skill would be motivated to use the PLA polymer poly(L/D)lactide in the scaffold recited by ‘215 because the copending application does not recite a specific species, which would motivate the ordinary artisan to seek a teaching of a suitable species. Haaparanta teaches medical grade poly(L/D)lactide in the form of a mesh to be suitable for forming a scaffold that also comprises collagen and is loaded with chondrocytes, which one of ordinary skill would recognize as suitable to use in the scaffold recited by Application ‘215.
Copending Application ‘215 also does not recite a specific species of animal collagen, which would motivate the ordinary artisan to seek a teaching of a suitable species. Haaparanta teaches bovine collagen to be suitable for forming a scaffold that also comprises collagen, resulting in desirable scaffold properties, and appropriate to load with chondrocytes, which one of ordinary skill would recognize as suitable to use in the scaffold recited by Application ‘215.
Application ‘215 and Haaparanta are silent on the improved physical properties of collagen-PLA scaffolds when the collagen is derived from an animal as compared to collagen not derived from an animal. However, the improved physical properties, including the decrease in swelling, are considered inherent properties of the scaffold. 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). See MPEP § 2112.01. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Therefore, because a sterilized scaffold comprising bovine collagen and poly(L/D)lactide at concentrations that fall within the ranges recited in instant claims 1-3 is prima facie obvious in view of the invention recited by Application ‘215 and the teachings of Haaparanta, the improved physical properties as claimed in instant claims 9-11 would necessarily be present.
Instant claims 15-19 are interpreted as intended use claims. The intended use of an invention is not given patentable weight and the “selection of a known material based on its suitability for its intended use” has previously supported a rejection for being prima facie obvious in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). See MPEP § 2144.07. Because the sterilized scaffold recited in instant claim 1 has been rendered obvious in view of the invention recited by Application ‘215 and the teachings of Haaparanta (vide supra), claims 15-19 are also rejection as being obvious. As a result, there is a reasonable expectation of success in arriving at instant claims 1-19 and 35 in view of the method recited in copending Application No. 18/705,215 and the teachings of Haaparanta.
Claims 1-19 and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-24 and 26 of copending Application No. 18/904,277 in view of Qiao (J. Funct. Biomater. 2015, 6, 667., provided by Applicant in the IDS filed on 26 April 2024) and Haaparanta (J. Mater. Sci.: Mater. Med. 2014, 25, 1129.).
This is a provisional nonstatutory double patenting rejection.
Copending Application No. 18/904,277 recites a sterilized scaffold comprising PLA and collagen, wherein the PLA fibers are in the form of a mesh (claim 23). The scaffold is recited as comprising 5-25% w/w collagen (claim 24) and the PLA polymer is recited as being a polylactide (claim 26).
Copending Application No. 18/904,277 does not recite the collagen to be bovine collagen, the PLA to be poly(L/D)lactide, the quantity of PLA, nor the scaffold to be loaded with chondrocytes. These deficiencies are offset by the teachings of Qiao and Haaparanta.
Qiao and Haaparanta have been described above.
Instant claims 1-19 and 35 are obvious variations of copending Application No. 18/904,277 because it would have been prima facie obvious to a person of ordinary skill in the art at the time of filing to modify the scaffold recited by Application ‘277 to use bovine collagen, poly(L/D)lactide as the PLA polymer in the concentration recited in instant claims 1-3, and to load the scaffold with chondrocytes in view of the teachings of Qiao and Haaparanta.
One of ordinary skill would be motivated to modify the scaffold recited by Application ‘277 to use bovine collagen as the specific collagen species and poly(L/D)lactide as the specific PLA polymer in the PLA-collagen scaffold in view of the teachings of Haaparanta because they teach a specific species of PLA polymer, which Application ‘277 does not recite, and that the combination of bovine collagen and poly(L/D)lactide in a sterilized scaffold enables the treatment of articular cartilage injuries via loaded chondrocytes. A person of ordinary skill would desire an application for the scaffold of ‘277 and would be motivated to make the species selections to enable such an application as autologous chondrocyte implantation.
Copending Application ‘277 does not recite a quantity of PLA polymer to use in its scaffold. In view of the teachings of Qiao, one of ordinary skill would be motivated to use 80% w/w PLA polymer because Qiao teaches the quantity to be appropriate for a scaffold with 20% w/w collagen, a value that falls within the range of 5-25% w/w as recited in claim 24 of Application ‘277.
Application ‘277, Qiao, and Haaparanta are silent on the improved physical properties of collagen-PLA scaffolds when the collagen is derived from an animal as compared to collagen not derived from an animal. However, the improved physical properties, including the decrease in swelling, are considered inherent properties of the scaffold. 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). See MPEP § 2112.01. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Therefore, because a sterilized scaffold comprising bovine collagen and poly(L/D)lactide at concentrations that fall within the ranges recited in instant claims 1-3 is prima facie obvious in view of the invention recited by Application ‘277 and the teachings of Qiao and Haaparanta, the improved physical properties as claimed in instant claims 9-11 would necessarily be present.
Instant claims 15-19 are interpreted as intended use claims. The intended use of an invention is not given patentable weight and the “selection of a known material based on its suitability for its intended use” has previously supported a rejection for being prima facie obvious in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). See MPEP § 2144.07. Because the sterilized scaffold recited in instant claim 1 has been rendered obvious in view of the invention recited by Application ‘277 and the teachings of Qiao and Haaparanta (vide supra), claims 15-19 are also rejection as being obvious. As a result, there is a reasonable expectation of success in arriving at instant claims 1-19 and 35 in view of the method recited in copending Application No. 18/904,277 and the teachings of Qiao and Haaparanta.
Claims 1-19 and 35 are directed to an invention not patentably distinct from claims 23-24 and 26 of commonly assigned copending Application No. 18/904,277 in view of Qiao and Haaparanta. Specifically, see above.
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 copending Application No. 18/904,277, 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.
Conclusion
No claims are allowed.
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/S.J.S./
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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