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 .
DETAILED ACTION
Claim status
Claims 1-14 are pending
Claims 1-14 are under examination
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/13/2023, 1/09/2024, 2/07/2024, 1/07/2026 are compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
However, Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase “wherein upon the delivering a cell” is grammatically incorrect as a run-on sentence. Consider using a comma or coordinating conjunction.
Claim 4 is objected to because of the following informalities: The gene MMP13 is repeated, the gene BMP2 is repeated, and the gene Sox9 is repeated.
In addition, Claim 4 is objected to because of the following informalities: instant claim uses unconventional abbreviations for the names of genes, which have not been spelled out upon first use. Although claims are allowed abbreviations, if an abbreviation is not spellout upon first use in a claim, it should be one that is well known and would be clear to someone who had not read the invention description.
Appropriate correction is required.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (p. 34, line 21). Applicant is required to amend or delete the embedded hyperlink and/or other form of browser-executable code. For example, “http” can be replaced with “hypertext transfer protocol” as the domain. See MPEP § 608.01.
The disclosure is objected to because it contains undesignated symbols. It appears that Greek letters were to be used but did not convey (p. 13, 2nd para.)
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.
Claims 2-4 and 14 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 pre-AIA the applicant regards as the invention.
Claims 2-4 recite the limitation "the therapeutic polynucleotide" in regard to Claim 1. There is insufficient antecedent basis for this limitation in the claims because Claim 1 is directed to “one or more” therapeutic polynucleotides, thereby rendering instant claims indefinite as to which therapeutic polynucleotide is encompassed by the scope of the claims.
Claim 4 contains the following trademark/trade names: 244533_at, 222348_at, 236289 at, 22922l_at, 1563414_at, 2256ll_at, 230204_at, 230895_at, cr5q35, 236685_at, 23582l_at, 155584l_at, 229242_at, 228910_at, 1552288_at, 1552289_a_at, RP4-756G23.1, and RP6-213Hl9.1.
Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade names are used to identify/describe gene chip array probes and/or U133 array symbols (see Table 1 of Funari et al. BMC Genomics, 2007, 8:165), and, accordingly, the identification/description of these therapeutic polynucleotides is indefinite.
Because these reagents were developed by the manufacturer Affymetrix at the time of the applicant’s invention under the recited trade names and as a result are proprietary, which means what constitutes as a gene probe/symbol can change, and these changes do not need to be disclosed by these companies to the public. Accordingly, the identification of these trade names are indefinite and the applicant is advised to employ a SEQ ID NO, and/or non-proprietary gene name for these agents.
Claim 14 recites the limitation that the method occurs in a “desired” location. A claim may be rendered indefinite by reference to subjective term (see MPEP 2173.05(b), IV). Specifically, the phrase “desired location” is a subjective term which renders the claim indefinite. The phrase "desired location" is not defined by the claim, the specification does not provide a standard for some standard for measuring the scope of the term, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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 1-3, and 5-14 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 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 encodes BMP-7, which is taught as being able to differentiate mesenchymal stem cells in the joint into chondrocytes (col 3, last para.).
In regard to claims 2 and 3, Fisher teaches the full length BMP-7 and demonstrates its ability to induce cartilage formation (col 38, Example 8, Fig. 3).
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, 10 and 12, Fisher teaches the BMP-7 is combined with a polynucleotide encoding IL10 in different recombinant adenovirus vectors (col 28-col29).
In regard to claims 8 and 9, Fisher teaches the BMP-7 is in a plasmid (col 19, lines 45-55).
In regard to claim 11, Fisher teaches the BMP-7 is combined with a polynucleotide encoding IL10 in the same recombinant adenovirus vector (col 29, 2nd para.)
In regard to claim 13, Fisher teaches that the BMP-7 vector comprises a CMV promoter (see Examples 2 and 8), which appeared suitable for the expression in the avascular knee joint.
Accordingly, Fisher anticipates instant claims.
Claims 1-7, 11-12 and 14, are 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 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 an expression vector comprising the 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 Sox9 is responsible for mesenchymal stem cell differentiation into cartilage cells and/or chondrocytes (col 12, Experimental., col 21, 3rd para.). Furthermore, in regard to claims 1 and 6, it is noted that the "wherein” clauses of instant claims do not recite any additional active method steps, but simply states a characterization or conclusion of the results of process step positively recited (e.g. administering Sox9 gene to a joint). See MPEP 2111.04, which states a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited."
In regard to claim 2, Koopman teaches the full length sequences of Sox 9 (e.g., see SEQ ID NO:20 of Koopman).
In regard to claim 3, Sox9 is a transcription factor.
In regard to claims 7, and 11-12, Koopman teaches a vector that would be necessary for the DNA to be expressed (col 7, sections ii/iii). Note that claims 1, 11 and 12 do not require a second therapeutic polynucleotide. MPEP 2111.04 (II) indicates that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.
Accordingly, Koopman anticipates instant claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory 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 1-14 are 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.
Claims 1-6 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.
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.
Conclusion
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.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631