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 .
Amendments
In the reply filed 5/26/2026, Applicant has amended Claims 1, 2, 4 and 14, and cancelled claim 3.
Claims 1-2, 4-14 are under consideration.
Withdrawn Objection to Specification
The prior objection to the disclosure because it contained an embedded hyperlink and/or other form of browser-executable code has been withdrawn in light of Applicant’s amendments.
Withdrawn Claim Objections
The objection to Claims 1 and 4 have been withdrawn due to Applicant’s amendment.
Withdrawn 35 USC § 112(b)
The prior rejection of Claims 2, 4 and 14 under 35 U.S.C. § 112(b), preAIA 2nd paragraph as being indefinite is withdrawn in light of Applicant’s amendments of Claims 2 and 4 to describe the therapeutic peptide, and claim 14 to describe the location.
New Claim Rejections - 35 USC § 112(b)
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.
Claim 4 is 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 pre-AIA the applicant regards as the invention.
Claim 4 recites the limitation "wherein the one or more therapeutic polynucleotides is" in regard to Claim 1. There is insufficient antecedent basis for this limitation in the claim because Claim 1 already recites the identity of the one or more therapeutic polynucleotides, thereby rendering Claim 4 indefinite. The Examiner recommends Applicant amend instant claims to “wherein the one or more therapeutic polynucleotides further comprises…”. Appropriate correction is required.
Maintained Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 14 stands rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Fisher et ,al., (US 7,846,428, patented 12/07/2010, see IDS filed 10/13/2023).
In regard to claim 14, Fisher teaches a method of producing chondrocytes in the joint of an individual in need thereof comprising the step of delivering to the joint an expression vector encoding one or more therapeutic polynucleotides including BMP-7 (Abstract, see Claim 1 of Fisher). Specifically, Fisher teaches the therapeutic polynucleotide that encodes BMP-7 is able to differentiate mesenchymal stem cells in the joint into chondrocytes (col 3, last para.).
Accordingly, Fisher anticipates instant claims.
Claim 14 stands rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Koopman et al., (US Patent 6,737,413, patented 5/18/2004, see IDS filed 10/13/2023).
In regard to claim 14, Koopman teaches and claims a method producing chondrocytes or cartilage-type cells in a joint comprising the step of delivering locally to the joint a therapeutic polynucleotide encoding Sox 9 (see Abstract and claim 1 of Koopman). Specifically, Koopman teaches Sox9 is responsible for mesenchymal stem cell differentiation into cartilage cells and/or chondrocytes (col 12, Experimental., col 21, 3rd para.).
Accordingly, Koopman anticipates instant claims.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 5/26/2026 are acknowledged.
Applicant argues that instant claims now limit the therapeutic polynucleotide to one or more of VEGF, SLC28A3, MMP13, IL-1R1, or IRAK2, which is a limitation neither Fischer nor Koopman anticipate.
Applicant's arguments have been fully considered but they are not persuasive.
In response to Applicant's argument that the references fail to show certain features of applicant’s invention, it is noted that the features upon which applicant relies (i.e., the therapeutic polynucleotide is one or more of VEGF, SLC28A3, MMP13, IL-1R1, or IRAK2) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Withdrawn 35 USC § 102
The prior rejection of Claim 1-2, and 5-13 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Fisher et ,al., (US 7,846,428, patented 12/07/2010, see IDS filed 10/13/2023) is withdrawn in light of Applicant’s amendment of Claim 1 to limit the therapeutic polynucleotide to one or more of VEGF, SLC28A3, MMP13, IL-1R1, or IRAK2, which is a limitation Fischer does not anticipate.
The prior rejection of Claims 1-2, 4-7, 11-12 and 13, under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Koopman et al., (US Patent 6,737,413, patented 5/18/2004, see IDS filed 10/13/2023) is withdrawn in light of Applicant’s amendment of Claim 1 to limit the therapeutic polynucleotide to one or more of VEGF, SLC28A3, MMP13, IL-1R1, or IRAK2, which is a limitation Fischer does not anticipate.
New Claim Rejections - 35 USC § 103
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-2, and 5-14 are rejected under 35 U.S.C. 103 as being unpatentable over Fisher et ,al., (US 7,846,428, patented 12/07/2010, see IDS filed 10/13/2023), in view of Goodrich et al. (US 2009/0104155, filed 4/20/2007, published 4/23/2009) and Zelzer et al., (Development, 2004, 131:2161-2171)
In regard to claims 1 and 14, Fisher teaches a method of producing chondrocytes in the joint of an individual in need thereof comprising the step of delivering to the joint an expression vector encoding one or more therapeutic polynucleotides including BMP-7 (Abstract, see Claim 1 of Fisher). Specifically, Fisher teaches the therapeutic polynucleotide that encodes BMP-7 is able to differentiate mesenchymal stem cells in the joint into chondrocytes (col 3, last para.).
However, Fischer is silent with respect to further administering a therapeutic polynucleotide encoding VEGF.
With respect to claim 1, Goodrich teaches administering to a subject a VEGF polynucleotide for treating connective tissue disorders (e.g., joint disorders) by enhancing cartilage regeneration (Abstract, [0019, 0089, 0104-0106, 0114-0116, 0118-0119, 0141], see Claims 1, 2, 7, and 9 of Goodrich) . Specifically, Goodrich teaches that progenitor cells from the joint are transfected with VEGF and BMP-7, where the modified cell then differentiates into a chondrocyte [0119],
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to practice the method of producing chondrocytes or cartilage-type cells in a joint of an individual as taught by Fischer and combined a therapeutic polynucleotide encoding VEGF as taught by Goodrich with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Zelzer et al. (2014) who teaches VEGF plays a significant role in both early and late states of cartilage vascularization, and is crucial for chondrocyte survival (Abstract, Introduction, last two para.).
In regard to claim 2, as stated supra, Goodrich and Zelzer make obvious the therapeutic polynucleotide encoding VEGF. Furthermore, Zelzer makes obvious using the full-length VEGF-A, which encompasses all three isoforms, because it is the full-length isoform that is required for chondrocyte survival (p. 2170, Discussion, 2nd para.).
In regard to claim 5, the delivering step is intra-articular into the knee (Abstract, see Example 8).
In regard to claim 6, as stated supra, Fisher evidences that the mesenchymal stem cells of knee differentiate into chondrocytes.
In regard to claims 7-8 and 10, Fisher teaches the therapeutic polynucleotides are in viral vectors (col 5, 1st-2nd para., col 28-col 29). In regard to claim 10, the preferred embodiments of Fisher teach the therapeutic polynucleotides are in an adenoviral vector; nevertheless, Fisher teaches that AAV vectors can be used when longer expression is needed.
In regard to claims 8 and 9, alternatively Fisher teaches the therapeutic polynucleotides are in plasmids (col 19, lines 45-55).
In regard to claim 11, Fisher teaches the therapeutic polynucleotides can be combined the same recombinant adenovirus vector (col 29, 2nd para.)
In regard to claim 12, alternatively Fisher teaches the therapeutic polynucleotides are separated into “another viral vectors” (col 28, 2nd para.).
In regard to claim 13, Fisher teaches that the vector comprises a CMV promoter (see Examples 2 and 8), which appeared suitable for the expression in the avascular knee joint.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 5/26/2026 are acknowledged.
Applicant argues that the cited prior art does not teaches a method comprising the therapeutic polynucleotide of VEGF.
Applicant's arguments have been fully considered but they are not persuasive. In response to applicant's argument, a 35 U.S.C. § 103(a) based 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). In instant case, the prior art makes obvious the use of therapeutic polynucleotide to promote differentiation of chondrocyte-like cells, while the secondary references of Goodrich and Zelzer make obvious to include VEGF to promote neovascularization, chondrocyte differentiation, and chondrocyte survival.
Claims 1-2, 4-7, and 14, are rejected under 35 U.S.C. 103 as being unpatentable over Koopman et al., (US Patent 6,737,413, patented 5/18/2004, see IDS filed 10/13/2023), in view of Goodrich et al. (US 2009/0104155, filed 4/20/2007, published 4/23/2009) and Zelzer et al., (Development, 2004, 131:2161-2171)
In regard to claims 1, 4 and 14, Koopman teaches and claims a method producing chondrocytes or cartilage-type cells in a joint comprising the step of delivering locally to the joint a therapeutic polynucleotide encoding Sox 9 (see Abstract and claim 1 of Koopman).
In regard to the administration step of claims 1 and 5, Koopman teaches the local administration encompasses an “injected directly into the joint tissue such as knees, knuckles, elbows or ligaments” (col 6, lines 33-35).
In regard to the mechanism of action of claims 1 and 6, Koopman teaches mesenchymal stem cell differentiation into cartilage cells and/or chondrocytes (col 12, Experimental., col 21, 3rd para.).
However, Koopman is silent with respect to further administering a therapeutic polynucleotide encoding VEGF.
With respect to claim 1, Goodrich teaches administering to a subject a VEGF polynucleotide for treating connective tissue disorders (e.g., joint disorders) by enhancing cartilage regeneration (Abstract, [0019, 0089, 0104-0106, 0114-0116, 0118-0119, 0141], see Claims 1, 2, 7, and 9 of Goodrich) . Specifically, Goodrich teaches that progenitor cells from the joint are transfected with VEGF and Sox9, where the modified cell then differentiates into a chondrocyte [0119],
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to practice the method of producing chondrocytes or cartilage-type cells in a joint of an individual as taught by Koopman and combined a therapeutic polynucleotide encoding VEGF as taught by Goodrich with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Zelzer et al. (2014) who teaches VEGF plays a significant role in both early and late states of cartilage vascularization, and is crucial for chondrocyte survival (Abstract, Introduction, last two para.).
In regard to claim 2, as stated supra, Goodrich and Zelzer make obvious the therapeutic polynucleotide encoding VEGF. Furthermore, Zelzer makes obvious using the full-length VEGF-A, which encompasses all three isoforms, because it is the full-length isoform that is required for chondrocyte survival (p. 2170, Discussion, 2nd para.).
In regard to claim 7, as stated supra, Koopman teaches the polynucleotide (i.e., DNA molecule) is injected locally, and teaches the DNA molecule is an expression vector (col 7, sections ii/iii), which would have been obvious for gene therapy.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 5/26/2026 are acknowledged and have been addressed supra.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-2, 4-14 stand rejected on the grounds of nonstatutory double patenting over claims 1-10 of U.S. Patent No. 11,819,555 (O’Heeron, Patented 11/21/2023).
The subject matter claimed in the instant application is fully disclosed in the referenced patent as follows: the method for producing chondrocytes of cited patent anticipates the methods of instant application. It is clear that all the elements of the cited patent claims are to be found in instant claims. The difference between the cited patent claims and the instant claims lies in the fact that the cited patent claims are more specific with respect to the therapeutic polynucleotides. Thus the invention of said claims of the cited patent are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited patent claims, said claims are not patentably distinct.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 5/26/2026 are acknowledged.
Applicant argues that instant Application and cited patent are no longer co-extensive.
Applicant's arguments have been fully considered but they are not persuasive.
The method of cited patent claims the therapeutic polynucleotides of VEGF (patented claim 10) and Sox 9 (patented claim 1).
Claims 1-2, 4-6 and 14 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-6, 7-12, and 14-34 of copending Application No. 16/068,096. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method for producing chondrocytes of cited of cited application anticipates the methods of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are more specific to the therapeutic gene (e.g., Sox9), additional agents being provided, and the specific location (i.e., a degenerated vertebral disc). Thus the invention of said claims of the cited application are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 5/26/2026 are acknowledged.
Applicant acknowledges the pending provisional rejection but refrains from comment.
Applicant's acknowledgments have been fully considered.
The method of cited application claims the therapeutic polynucleotides of VEGF, SLC28A3, MMP13, IL-1R1, and IRAK2 (copending claim 12).
Claims 7-13 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-6, 7-12, and 14-34 of copending Application No. 16/068,096, in view of Glorioso et al., (US Patent 6,413,511, see IDS filed 10/13/2023). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method for producing chondrocytes of cited of cited application makes obvious the methods of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the instant application claims are more specific with respect to the therapeutic polynucleotides being in one or more vectors, the type of vectors, and the promoter.
Nevertheless, Glorioso teaches a method of producing chondrocytes or cartilage-type cells in a joint of an individual comprising one or more transgenes in one or more expression vectors with promoter suitable for expression of one or more genes in the joint. Specifically, Glorioso teaches either plasmid and retroviral/adenoviral vectors comprising the CMV promoter (col 7, lines 37-43, col 9, lines 22-25, col 24, 2nd para., col 34, 5th, see Examples X, XV, and claims 1-10 of Glorioso).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to practice a method of producing chondrocytes or cartilage type cells comprising delivering a Sox9 gene to the joint as claimed by cited application, and choose the either one or more plasmid and retroviral/adenoviral vectors comprising the CMV promoter for the expression of the gene as taught by Glorioso with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so for several reasons. First, plasmid and retroviral/adenoviral vectors comprising CMV promoter was well known in the art and readily available to the ordinary artisan at the time of filing. Furthermore, Glorioso demonstrates that the CMV promoter produced a high level of expression in vivo after delivery to the joint (col 45, Table II). Finally, the use of the same vector would ensure co-expression of the transgenes in the same cell, while separate vectors allows different promoters to be used (col 38, last para.-39, 1st para.).
Since the instant application claims are obvious over cited application claims in view of Glorioso, said claims are not patentably distinct.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 5/26/2026 are acknowledged and have been addressed supra.
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 extension fee 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 date of this final action.
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631
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