DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed 2/13/2026.
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/13/2026 has been entered.
Status of the Claims
Claims 1 and 10 have been amended. Claim 3 is cancelled. Claims 15-17 are newly added. Accordingly, claims 1, 2 and 4-17 remain pending in the application. Claims 10-14 stand withdrawn from further consideration, without traverse. Claims 1, 2, 4-9 and 15-17 are currently under examination.
Information Disclosure Statement
Applicant requests previously unconsidered references, Office Action issued in Chinese Application No. 201 880088344.9, mailed on August 3, 2022; Office Action issued in Chilean Application No. 202002004, mailed on September 02, 2022; and Office Action issued in Columbian Application No. NC2020/0009497, mailed on August 9, 2022 to be considered and states that said references are re-filed along with English language counterparts. However, there is no indication that an IDS with the references and translations thereof has been filed. As such, the references have not been considered at this time.
Withdrawn Rejections
Applicant’s amendment renders the double patenting rejection over USPA 17/438,121 (now USPN 12,440,341) moot. Thus, said rejection has been withdrawn. However, after further consideration, a new ground of rejection is made over USPN 12,440,341 in view of Bright.
Response to Declaration under 37 CFR 1.132
The Declaration under 37 CFR 1.132 filed 2/13/2026 is insufficient to overcome the rejection of claims 1, 2 and 4-9 based upon Muller and Detamore under 35 USC 103 as set forth in the last Office action because the evidence presented is not commensurate in scope with the claims. It is respectfully submitted that Examples 1 to 3 include fibrinogen in a concentration of 90 mg/mL and thrombin in a concentration of 500 IU/mL. Comparative Example 3 includes fibrinogen in a concentration of 1000 mg/mL and thrombin in a concentration of 5000 IU/mL. The instant claims recite, “fibrinogen in an amount of 65 mg to 115 mg/mL” and “thrombin in an amount of 400 IU to 600 IU”. Muller teaches fibrinogen in an amount of 75 mg to 115 mg/mL. As discussed in the 112(b) rejection below, the amount of thrombin per amount of liquid is undefined in the claim and, as such, Muller’s teaching of 400-600 IU/l thrombin is being interpreted to read on “thrombin in an amount of 400 IU to 600 IU”. MPEP 716.02(d) states,
“Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range.
The evidence presented is not commensurate in scope with the claims because the thrombin units are undefined in the claim and because the units are different than those presented in the data. Further, a single amount of fibrinogen and thrombin in combination does not provide sufficient data for a claim that includes a range amount for both ingredients. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range (MPEP 716.02(d)(II)). Thus, the evidence provided for ineffective in establishing unexpected results.
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, 2, 4-9 and 15-17 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.
Regarding instant claim 1, said claim recites “thrombin in an amount of 400 IU to 600 IU”. Said claim is indefinite because it is unclear per what amount of liquid the thrombin amount of 400 IU to 600 IU is present. Dependent claims 2, 4-9 and 15-17 do not remedy the indefinite issue and as such said dependent claims suffer from the same deficiency.
Regarding instant claim 15, said claim recites, “wherein, when the first liquid and the second liquid are sequentially applied”. The claim is indefinite because it is unclear to what the first liquid and second liquid are being applied.
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 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 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, 2 and 4-9, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Müller et al. (“Towards an intraoperative engineering of osteogenic and vasculogenic grafts from the stromal vascular fraction of human adipose tissue”, Eur Cell Mater, 2010 Mar 3;19:127-135; hereafter as “Muller”) in view of Detamore et al. (WO 2015/048317 A1, Apr. 2, 2015, hereafter as “Detamore”).
The instant claims are drawn to a bioink composition for cartilage regeneration, the bioink composition comprising: a first liquid comprising an adipose tissue-derived stromal vascular fraction, hyaline cartilage powder, and fibrinogen; and a second liquid comprising thrombin, wherein the first liquid comprises fibrinogen in an amount of 65 mg to 115 mg per mL of the first liquid, wherein the second liquid comprises thrombin in an amount of 400 IU to 600 IU, and wherein a concentration of the hyaline cartilage powder is 5mg to 100mg per mL of the first liquid.
Regarding instant claim 1, Muller teaches osteogenic bone substitute grafts based on scaffolds loaded with osteoprogenitors (page 127, right col, 1st para.). Muller teaches fabrication of grafts comprising a first liquid comprising 75-115 mg/ml fibrinogen and aprotinin and a second liquid comprising 400-600 IU/l thrombin and calcium chloride (page 128, right col., 2nd full para.). Muller further teaches adding adipose tissue derived stromal vascular fraction cells to the first liquid comprising fibrinogen (page 128, left col. 2nd full para. and right col. 2nd full para.). It is noted that due to the 112(b) rejection of claim 1 above, Muller’s teaching of 400-600 IU/l thrombin is being interpreted to read on “thrombin in an amount of 400 IU to 600 IU” because the amount of thrombin per amount of liquid is undefined in the claim.
Muller is silent to hyaline cartilage powder in an amount of 5mg to 100 mg per mL of the first liquid.
Detamore teaches compositions comprising decellularized hyaline cartilage tissue powder in the forms of paste, putty, hydrogel, and scaffolds for the treatment of osteochondral defects as well as full and partial thickness bone and cartilage defects (title; abstract; [0001]). Detamore also teaches that the decellularized hyaline cartilage tissue powder can be included in amounts of between about 10 w/v% and about 90 w/v% ([0012]) and specifically exemplifies 10 mg per 1 mL and 20 mg per 1 mL ([0107] and [0130]).
The references are both drawn to grafts/scaffolds for bone repair, thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include hyaline cartilage powder in amounts of 10 mg per mL or 20 mg per mL into the first liquid and/or the second liquid of Muller as suggested by Detamore with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Detamore teaches that said hyaline cartilage powder is suitable for incorporation into a scaffold for bone and/or cartilage repair. A skilled artisan would have also been motivated to add the hyaline cartilage into the first liquid comprising adipose tissue derived stromal vascular fraction of Muller because both ingredients are taught by the prior art as having bone regenerative properties. MPEP 2144.06(I) states, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." One of ordinary skill would have reasonably expected a bone/cartilage repair construct comprising the claimed elements.
Regarding the limitation, “bioink”, the limitation is not recited in the cited references. However, said limitation is found in the preamble of the claim. MPEP 2111.02(II) states,
The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "'extraneous' limitations from the specification." Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
In this case, “bioink” does not impart any additional structural limitation to the claim and merely implies the purpose or intended use of the invention. Thus, the limitation is not given weight as it does not provide any significance to claim construction.
Regarding instant claim 2, Muller teaches incorporating adipose tissue-derived stromal vascular fraction in amounts of 105 and 106 cells/ml (page 130, left col. 2nd and 3rd para.).
Regarding instant claim 4, Muller teaches that the first liquid comprises aprotinin (page 128, right col., 2nd full para.).
Regarding instant claim 5, Muller teaches that the second liquid comprises thrombin and calcium chloride (page 128, right col., 2nd full para.).
Regarding instant claim 6, it is noted that “extracted from” implies a process step. The claim is drawn to a composition and as such, determination of patentability is based on the product itself, not by the method in which it is made. 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 (MPEP 2113). It is further noted that Muller teaches autologous bone substitute constructs (page 133, left col, last para.). The claim does not further limit the structural components of the composition itself, therefore Muller/Detamore reads on the claim.
Regarding instant claim 7, it is noted that “derived from” implies a process step. The claim is drawn to a composition and as such, determination of patentability is based on the product itself, not by the method in which it is made. 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 (MPEP 2113). It is further noted that Detamore teaches that the cartilage powder can be derived from human or animal cartilage tissue or from synthetic cartilage tissues ([0007]). The claim does not further limit the structural components of the composition itself, therefore Muller/Detamore reads on the claim.
Regarding instant claim 8, Detamore teaches the cartilage powder has a particle diameter of about 1 nm to about 500 microns ([0007]).
Detamore is silent to the particular particle diameter range of 30 to 300 microns.
However, MPEP 2144.05(I) states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Thus, it would have been prima facie obvious to one of ordinary skill in the art to include the claimed particle size range with a reasonable expectation of success because Detamore teaches a range that encompasses the claimed range and is suitable for the intended purpose of a composition for treating osteochondral defects.
Regarding instant claim 9, it is noted that “derived from” implies a process step. The claim is drawn to a composition and as such, determination of patentability is based on the product itself, not by the method in which it is made. 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 (MPEP 2113). It is further noted that Detamore teaches that the cartilage powder can be derived from human or animal cartilage tissue or from synthetic cartilage tissues ([0007]). The claim does not further limit the structural components of the composition itself, therefore Muller/Detamore reads on the claim.
Regarding instant claim 15, said claim recites, “wherein, when the first liquid and the second liquid are sequentially applied, the first liquid and the second liquid are capable of reacting to form a scaffold for cartilage regeneration” (emphasis added). Said limitation is considered a contingent limitation. MPEP 2111.04(II) states, "[i]f the condition for performing a contingent step is not satisfied, the performance recited by the step need not be carried out in order for the claimed method to be performed". In this instance, Muller does not teach the condition of sequential application and, as such, the art need not teach that the first liquid and second liquid are capable of reacting to form a scaffold for cartilage regeneration.
Regarding instant claim 16, said claim recites, “wherein the first liquid and the second liquid capable of reacting within 10 minutes to form a scaffold for cartilage regeneration”. While the references do not explicitly teach that the first liquid and the second liquid can react within 10 minutes, the prior art suggests the claimed composition of claim 1. MPEP 2112.01(I) states,
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). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Since the prior art suggests the same composition, one would reasonably expect the prior art composition to possess the same properties as that of the claimed composition including reaction time.
Thus, the combined teachings of Muller and Detamore render the instant claims prima facie obvious.
Response to Arguments
Applicant's arguments, filed 2/13/2026, regarding the 103 rejection over Muller and Detamore have been fully considered but they are not persuasive.
Applicant argues that Muller fails to teach or suggest a bioink composition that requires a first liquid that includes both the SVF and hyaline cartilage powder in a concentration of 5 mg to 100 mg per mL along with fibrinogen in an amount of 65 mg to 115 mg per mL as required by instant claims. Remarks, pages 6-7.
In response, it is respectfully submitted that the rejection is based on the combination of teaching of Muller and Detamore. As such, 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). Muller teaches fabrication of grafts comprising a first liquid comprising 75-115 mg/ml fibrinogen and aprotinin and a second liquid comprising 400-600 IU/l thrombin and calcium chloride (page 128, right col., 2nd full para.). Muller further teaches adding adipose tissue derived stromal vascular fraction cells to the first liquid comprising fibrinogen (page 128, left col. 2nd full para. and right col. 2nd full para.). Muller is silent to hyaline cartilage powder in an amount of 5mg to 100 mg per mL of the first liquid; however, Detamore cures this deficiency for the reasons of record. Thus, applicant’s argument is unpersuasive.
Applicant also argues there is no teaching or suggestion in either reference to motivate one of ordinary skill to arrive at the instantly claimed bioink composition that includes two separate liquids as required that are capable of forming a scaffold, such as a patient customized scaffold. Remarks, page 7.
In response, it is respectfully submitted that Muller teaches osteogenic bone substitute grafts based on scaffolds loaded with osteoprogenitors (page 127, right col, 1st para.). Muller, as discussed above, explicitly teaches fabrication of said grafts comprising two separate liquids. Muller is silent to hyaline cartilage powder in an amount of 5mg to 100 mg per mL of the first liquid; however, Detamore teaches compositions comprising decellularized hyaline cartilage tissue powder in the forms of paste, putty, hydrogel, and scaffolds for the treatment of osteochondral defects as well as full and partial thickness bone and cartilage defects (title; abstract; [0001]). Detamore also teaches that the decellularized hyaline cartilage tissue powder can be included in amounts of between about 10 w/v% and about 90 w/v% ([0012]) and specifically exemplifies 10 mg per 1 mL and 20 mg per 1 mL ([0107] and [0130]). The references are both drawn to grafts/scaffolds for bone repair and Detamore teaches that said hyaline cartilage powder is suitable for incorporation into a scaffold for bone and/or cartilage repair. A skilled artisan would have also been motivated to add the hyaline cartilage into the first liquid comprising adipose tissue derived stromal vascular fraction of Muller because both ingredients are taught by the prior art as having bone regenerative properties. MPEP 2144.06(I) states, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." One of ordinary skill would have reasonably expected a bone/cartilage repair construct comprising the claimed elements. Accordingly, there is a teaching or suggestion in said references to motivate one of ordinary skill to arrive at the instantly claimed composition that includes two separate liquids as required that are capable of forming a scaffold. Applicant’s argument is unpersuasive.
Applicant argues that the composition of claim 1 is able to stimulate the reaction among an adipose tissue derived from stromal vascular fraction, hyaline cartilage powder, fibrinogen and thrombin by further controlling the concentration of fibrinogen in the first liquid and the concentration of thrombin in the second liquid within a specific range (see [0072], [0073] and [0083]; Examples 1-3 and Comparative Example 3 of the instant specification and Declaration dated 2/13/2026). Remarks, pages 7-8.
In response, it is respectfully submitted that Examples 1 to 3 include fibrinogen in a concentration of 90 mg/mL and thrombin in a concentration of 500 IU/mL. Comparative Example 3 includes fibrinogen in a concentration of 1000 mg/mL and thrombin in a concentration of 5000 IU/mL. The instant claims recite, “fibrinogen in an amount of 65 mg to 115 mg/mL” and “thrombin in an amount of 400 IU to 600 IU”. Muller teaches fibrinogen in an amount of 75 mg to 115 mg/mL. As discussed in the 112(b) rejection above, the amount of thrombin per amount of liquid is undefined in the claim and, as such, Muller’s teaching of 400-600 IU/l thrombin is being interpreted to read on “thrombin in an amount of 400 IU to 600 IU”. MPEP 716.02(d) states,
“Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range.
The evidence presented is not commensurate in scope because the thrombin units are undefined in the claim and are different than those presented in the data. Further, a single amount of fibrinogen and thrombin in combination does not provide sufficient data for a claim that includes a range amount for both ingredients. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range (MPEP 716.02(d)(II)). Thus, the evidence provided for ineffective in establishing unexpected results.
Applicant argues that the combination of SVF and hyaline cartilage in the claimed amount yields the unexpected result of differentiation of chondrocytes and improved capacity for regenerating hyaline cartilage. Remarks, pages 8-9.
In response, it is respectfully submitted that Detamore teaches that said cartilage powder is chondroinductive, that is, induces chondrogenesis ([0006]). More specifically, the cartilage powder stimulates bone marrow stem cell responses including cell attachment, cell differentiation, tissue regeneration and tissue specific marker gene expression such as the expression of chondrogenic marker genes, Sox9 and Col2Al ([0010]). Thus, regarding the allegations of unexpected results, Detamore recognized that hyaline cartilage powder is chondroinductive, that is, induces chondrogenesis and stimulates bone marrow stem cell responses including cell attachment, cell differentiation, tissue regeneration and tissue specific marker gene expression such as the expression of chondrogenic marker genes, Sox9 and Col2Al ([0006] and [0010]). MPEP 716.02 states, “Any differences between the claimed invention and the prior art may be expected to result in some differences in properties… The issue is whether the properties differ to such an extent that the difference is really unexpected”. Given the teachings of Detamore that hyaline cartilage powder induces chondrogenesis, the improved tissue regeneration that applicant’s experimental results demonstrated, does not appear to be unexpected. MPEP 716.02(c)(II) states, "Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof."
Thus, for these reasons, Applicant’s arguments are found unpersuasive. Said rejection is maintained.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 6 and 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 12,440,341 in view of Bright et al. (WO 2014/000031 A1, Jan. 3, 2014, hereafter as “Bright”).
Although the claims at issue are not identical, they are not patentably distinct from each other because they are significantly overlapping.
The instant claims are drawn to a bioink composition for cartilage regeneration, the bioink composition comprising: a first liquid comprising an adipose tissue-derived stromal vascular fraction, hyaline cartilage powder, and fibrinogen; and a second liquid comprising thrombin, wherein the first liquid comprises fibrinogen in an amount of 65 mg to 115 mg per mL of the first liquid, wherein the second liquid comprises thrombin in an amount of 400 IU to 600 IU, and wherein a concentration of the hyaline cartilage powder is 5mg to 100mg per mL of the first liquid.
The patented claim is drawn to a method of producing a patient-customized scaffold for regenerating cartilage, comprising: a) obtaining 3D data of a defective cartilage area using a 3D scanner, and forming a mold for a scaffold using a 3D printer; b) preparing a composition for regenerating cartilage using lyophilization hyaline cartilage powder by the method of claim 1; c) preparing a first liquid by mixing fibrinogen with the composition for regenerating cartilage using the lyophilization hyaline cartilage powder, and forming a first layer by coating the inside of the mold for the scaffold with the first liquid; d) forming a second layer by coating the first layer with a second liquid containing thrombin; and e) forming a scaffold for regenerating cartilage by reacting the first layer and the second layer.
The patented claims are silent to fibrinogen in an amount of 65 mg to 115 mg per mL, thrombin in an amount of 400 IU to 600 IU, and hyaline cartilage powder in an amount of 5 mg to 100 mg per mL. However, the patent teaches the same amount of each ingredient (col. 8, lines 30-32, 37-42 and 46-48). The examiner has relied upon the specification to delineate the scope of the invention embraced by the patent, consistent with the decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. U.S. Court of Appeals Federal Circuit, 95 USPQ2d 1797.
The patented claims are also silent to further include adipose tissue-derived stromal vascular fraction.
Bright teaches adipose tissue-derived stromal vascular fraction containing viable stromal/stem cells for the purpose of treating a cartilage disorder (abstract; page 3, lines 17-20). Bright teaches mesenchymal stem cells make up a subset population derivable from, for example, adipose tissue and bone marrow and defines the term "mesenchymal stem cell" to include within its scope terms such as "stromal stem cell", "marrow stromal cell", "multipotent stromal cell", "mesenchymal precursor cell", "Muse-AT", adipose tissue-derived stromal/stem cells and the like (page 5, lines 18-22). Bright also teaches that the term "mesenchymal stem cell" refers to stromal or mesenchymal cells or early mesenchymal/stromal precursor or adipose tissue-derived stromal/stem cells which are multipotent and can serve as stem cell-like precursors to a variety of different cell types such as but not limited to adipocytes, osteocytes, chondrocytes, muscle and neuronal/glial cell lineages (page 5, lines 13-17).
Both the patent and Bright are drawn to repairing cartilage, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to include adipose tissue-derived stromal vascular fraction in the first liquid with a reasonable expectation of success. A skilled artisan would have been motivated to add the adipose tissue-derived stromal vascular fraction into the first liquid comprising hyaline cartilage because both ingredients are taught by the prior art as having cartilage regenerative properties. MPEP 2144.06(I) states, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." One of ordinary skill would have reasonably expected a cartilage repair construct comprising the claimed elements.
Thus, the instant claims are unpatentable over the patented claim in view of Bright.
Claims 1, 6 and 15-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of copending Application No. 19/299843 in view of Bright et al. (WO 2014/000031 A1, Jan. 3, 2014, hereafter as “Bright”).
The instant claims are described above.
The copending claim is drawn to method of producing a patient-customized scaffold for regenerating cartilage, comprising: a) obtaining 3D data of a defective cartilage area using a 3D scanner, and forming a mold for a scaffold using a 3D printer; b) preparing a composition for regenerating cartilage using lyophilization hyaline cartilage powder by the method of claim 1;c) preparing a first liquid by mixing fibrinogen with the composition for regenerating cartilage using the lyophilization hyaline cartilage powder, and forming a first layer by coating an inside of the mold for the scaffold with the first liquid; d) forming a second layer by coating the first layer with a second liquid containing thrombin; and e) forming a scaffold for regenerating cartilage by reacting the first layer and the second layer.
The copending claims are silent to fibrinogen in an amount of 65 mg to 115 mg per mL, thrombin in an amount of 400 IU to 600 IU, and hyaline cartilage powder in an amount of 5 mg to 100 mg per mL. However, the copending application teaches the same amount of each ingredient (page 16, lines 9-21). The examiner has relied upon the specification to delineate the scope of the invention embraced by the patent, consistent with the decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. U.S. Court of Appeals Federal Circuit, 95 USPQ2d 1797.
The copending claims are also silent to further include adipose tissue-derived stromal vascular fraction.
Bright teaches adipose tissue-derived stromal vascular fraction containing viable stromal/stem cells for the purpose of treating a cartilage disorder (abstract; page 3, lines 17-20). Bright teaches mesenchymal stem cells make up a subset population derivable from, for example, adipose tissue and bone marrow and defines the term "mesenchymal stem cell" to include within its scope terms such as "stromal stem cell", "marrow stromal cell", "multipotent stromal cell", "mesenchymal precursor cell", "Muse-AT", adipose tissue-derived stromal/stem cells and the like (page 5, lines 18-22). Bright also teaches that the term "mesenchymal stem cell" refers to stromal or mesenchymal cells or early mesenchymal/stromal precursor or adipose tissue-derived stromal/stem cells which are multipotent and can serve as stem cell-like precursors to a variety of different cell types such as but not limited to adipocytes, osteocytes, chondrocytes, muscle and neuronal/glial cell lineages (page 5, lines 13-17).
Both the copending application and Bright are drawn to repairing cartilage, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to include adipose tissue-derived stromal vascular fraction in the first liquid with a reasonable expectation of success. A skilled artisan would have been motivated to add the adipose tissue-derived stromal vascular fraction into the first liquid comprising hyaline cartilage because both ingredients are taught by the prior art as having cartilage regenerative properties. MPEP 2144.06(I) states, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." One of ordinary skill would have reasonably expected a cartilage repair construct comprising the claimed elements.
Thus, the instant claims are unpatentable over the copending claim in view of Bright.
This is a provisional nonstatutory double patenting rejection.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached on 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Casey S. Hagopian
Examiner, Art Unit 1617
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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