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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07 July 2026 has been entered.
Status of the Claims
Applicant’s submission filed 07 July 2026 has been entered. Claims 9-12, 15, 20, 23, and 28-30 are pending. Claims 9, 20, and 23 have been amended, while claims 16, 21, and 27 have been cancelled without prejudice or disclaimer and claims 28-30 have been newly added. Therefore, prosecution on the merits continues for claims 9-12, 15, 20, 23, and 28-30. All arguments have been fully considered with the status of each prior ground of rejection set forth below.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claims 9-12, 15-16, 20-21, 23, and 27 under 35 USC 103 over O’Heeron in view of Shi et al
The cancellation of claims 16, 21, and 27 renders the rejection moot for those claims. For the
remaining claims, Applicant has amended independent claims 9, 20, and 23 to require (i) the administration of exogenous TGF-β1 to the mammalian subject, and (ii) the human embryonic kidney cells or epithelial cells to express TGF-β1 in the arthritic joint space of the subject. With that, Applicant’s arguments in the Remarks filed 07 July 2026 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Therefore, the rejection is withdrawn.
New Grounds of Rejection
Claim Objections
Claims 20 and 23 are objected to because of the following informalities:
Regarding claim 20: The instant claim is objected to for reciting “cultured allogeneic mammalian cells” in Line 5, “allogeneic mammalian cells” in Lines 8 and 13, and “cultured mammalian cells” in Line 11. Applicant is required to select one recitation to consistently utilize throughout the claim language.
Appropriate correction is required.
Regarding claim 23: The instant claim is objected to for reciting “protein” in Line 8 instead of “member protein”, which is the term otherwise consistently utilized throughout the claim language.
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 20 and 29 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 claim 20: The instant claim recites the limitation “said transfected allogeneic mammalian cells of b)” in Line 8. There is insufficient antecedent basis for this limitation in the claim, as method step b) of the instant claim broadly requires the population of cultured allogeneic mammalian cells to contain a vector, and does not reference the transfection of the cultured allogeneic mammalian cells. Therefore, the ordinary artisan cannot readily determine the metes and bounds of the claim, thus rendering the scope of the claim indefinite. See MPEP § 2173.05(e).
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 9-12, 15, 20, 23, and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al (US 2003/0175257 A1, of record on IDS filed 27 January 2023) in view of Glorioso et al (US 2002/0098168 A1) and Kolon TissueGene, Inc. (Clinical Trial NCT03203330 Version 1, 2017, hereinafter “Kolon TissueGene, Inc. V1”) as evidenced by Kolon TissueGene, Inc. (Clinical Trial NCT03203330 Version 9, 2020, hereinafter “Kolon TissueGene, Inc. V9”).
Song et al is considered prior art under 35 USC 102(a)(1), with a publication date of 18 September 2003 – which is greater than one year prior to the effective filing date of the instant invention. Glorioso et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2). Kolon TissueGene, Inc. V1 is considered prior art under 35 USC 102(a)(1).
Regarding claims 9, 15, 20, and 23: Song et al disclose methods of regenerating connective tissue or treating osteoarthritis within a mammalian host (Abstract).
As such, Song et al disclose a method of regenerating hyaline cartilage following an injury, comprising: a) generating or obtaining a member of a transforming growth factor superfamily of proteins; b) generating or obtaining a population of cultured connective tissue cells that may contain vector encoding a gene, or a population of cultured connective tissue cells that do not contain any vector encoding a gene; and c) transferring the protein of step a) and the connective tissue cells of step b) by intraarticular injection to an arthritic joint space of a mammalian host, such that the activity of the combination within the joint space results in regenerating hyaline cartilage (Paragraphs [0026]-[0029], [0069]-[0071], [0110]-[0112], [0114]).
Song et al also disclose a method of treating osteoarthritis, comprising: a) generating or obtaining a member of a transforming growth factor superfamily of proteins; b) generating or obtaining a population of cultured connective tissue cells that may contain vector encoding a gene, or a population of cultured connective tissue cells that do not contain any vector encoding a gene; and
c) transferring the protein of step a) and the connective tissue cells of step b) by intraarticular injection to an arthritic joint space of a mammalian host, such that the activity of the combination within the joint space results in regenerating connective tissue (Paragraphs [0017]-[0020].
Song et al further disclose that the member of a transforming growth factor superfamily of proteins is TGF-β1 (Paragraphs [0025], [0074]-[0075]).
Song et al further disclose that the population of cultured connective tissue cells can be irradiated fibroblasts or chondrocytes, which contain a vector encoding a TGF-β1 gene (Paragraphs [0023], [0031]-[0032], [0041], [0057], [0065], [0067], [0108], [0115], [0153]). Song et al further disclose that the cultured mammalian cells are autologous or allogeneic (Paragraphs [0023], [0031], [0067], [0089]).
Song et al do not disclose that human embryonic kidney cells or epithelial cells contain the vector encoding the TGF-β1 gene, as required by instant claims 9, 20, and 23.
Glorioso et al, however, disclose that mammalian non-connective tissue cells comprising recombinantly-introduced TGF-β1 can be intraarticularly administered in the treatment of osteoarthritis (Paragraphs [0007], [0013], [0030]-[0034], [0038]-[0039], [0043], [0049], [0092]-[0095], [0108]-[0111], [0119]).
With that, Kolon TissueGene, Inc. V1 disclose the administration of chondrocytes expressing TGF-β1 in subjects suffering from osteoarthritis (Pages 7, 9). However, it is of note that Kolon TissueGene, Inc. V9 is cited solely to show that the recombinant “chondrocytes” in the Kolon TissueGene, Inc. V1 disclosure are necessarily recombinant GP2-293 cells, which are human embryonic kidney cells. See MPEP § 2112 and Page 2 of Kolon TissueGene, Inc. V9.
Therefore, it would have been prima facie obvious to have modified the methods of Song et al such that human embryonic kidney cells are transfected with a vector encoding a TGF-β1 gene, as suggested in Glorioso et al and Kolon TissueGene, Inc. V1 as evidenced by Kolon TissueGene, Inc. V9. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to combine known osteoarthritic therapeutics, and would have had a reasonable expectation of success given that Glorioso et al teach that non-connective tissue cells can be administered in place of connective tissue cells for the treatment of osteoarthritic conditions, with Kolon TissueGene, Inc. V1 as evidenced by Kolon TissueGene, Inc. V9 showing that human embryonic kidney cells are a viable option since they are capable of successfully expressing TGF proteins in the joint space to regenerate cartilage (Kolon TissueGene, Inc. V1: Page 7). See MPEP § 2143(I)(G).
Consequently, Song et al as modified by Glorioso et al and Kolon TissueGene, Inc. V1 as evidenced by Kolon TissueGene, Inc. V9 render obvious methods of regenerating hyaline cartilage (claim 9) following an injury (claim 23) or treating osteoarthritis (claim 20) in a mammal, comprising a) generating or obtaining a TGF-β1 protein; b) generating or obtaining a population of cultured allogeneic (claim 15) human embryonic kidney cells that contain a vector encoding a TGF-β1 gene; and c) transferring the TGF-β1 protein of step a) and the cultured allogeneic human embryonic kidney cells of step b) by intraarticular injection to an arthritic joint space of a mammalian host, such that the activity of the combination within the joint space results in regenerating hyaline cartilage. This therefore renders obvious the methods of the instant claims.
Regarding claims 10-12: Following the discussion of claim 9, Song et al further disclose that the vector is either a retroviral vector (claims 10-11) or plasmid (claim 12) (Paragraphs [0016], [0021], [0031], [0088], [0091]-[0092], [0095], [0098], [0105], [0136], [0142]). This therefore reads on the method of the instant claims.
Regarding claims 28-30: As aforementioned in the discussion of claims 9, 20, and 23, Song et al disclose that the cultured mammalian cells are irradiated (Paragraphs [0057], [0067], [0153]). This therefore reads on the methods of the instant claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
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/ALYSSA G WESTON/Examiner, Art Unit 1633
