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 .
Claim Status
Claims 1 – 31 are pending.
Claim Objections
Claims 2, 3, 19 and 20 are objected to because of the following informalities:
In claims 2 and 19, line 2, “Baricinib” should read “Baricitinib”. Appropriate correction is required.
In claims 2 and 19, line 2, “Ocacitinib” should read “Oclacitinib”. Appropriate correction is required.
In claims 3 and 20, line 2, “SB43152” should read “SB431542”. Appropriate correction is required.
Please check the spelling of each in the specification.
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 4, 5, 15, 16 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 claims 4, 5, 15 and 29 the phrases "preferably" and “more preferably” render the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 16 and 29, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 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.
Claims 1 – 2 and 16 – 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dzau et al. (W.O. Patent Application Publication No. 2014/071323; cited on IDS, hereinafter Dzau).
Regarding claims 1 – 2 and 16, Dzau discloses a method for promoting the reprogramming of a non-cardiomyocytic cell (cardiac fibroblast, p. 4, line 13) into a cardiomyocytic cell with a histone methylation modulator (Abstract) and a JAK/Tyk2 inhibitor (p.27, line 1 – 6). Tyrosine kinase 2 (Tyk2) was the first member of the JAK family that was described. Dzau further discloses that the JAK inhibitor can be Ruxolitinib (p. 27, line 12). Regarding claims 17 – 19, Dzau further discloses administering the composition to the heart of a subject with cardiac fibrosis (Abstract) as a result of myocardial infarction (p. 3, line 4 – 15).
Claims 1, 3, 5, 6, 7 – 11, 15 – 18, 20 – 25 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song et al. (U.S. Patent No. 10519423; hereinafter Song).
Regarding claims 1, 3, 5, 6, 16 and 20, Song discloses a method for high efficiency reprogramming of cardiac fibroblasts (Col. 21 line 40 – 45) into cardiomyocytes that includes (Col. 16, Example 5, line 25 – 50) contacting the cell with Y-27632 (30 µM) for up to 4 weeks (Fig. 20). Regarding claims 17, 18, 20 and 30, Song further discloses administering (Col. 3, line 20 – 27) the composition in an expression cassette for treating myocardial infarction in a subject via intracardiac injection.
Regarding claims 7 – 11 and 21 – 25 , Song discloses in certain embodiments that microRNA (miRs) can be combined with MEF2C, TBX5, and GATA4 to be used as reprogramming factors (Col. 2, line 25 – 40).
Regarding claims 15 and 29, Song discloses a lentiviral vector encoding a transcription factor and one or more of an miR (Claims 1 and 3).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4 is rejected under 35 U.S.C. 103 as being unpatentable over Dzau in view of Song et al. (U.S. Patent No. 10519423; hereinafter Song).
Regarding claim 4, Dzau and Song teach all of the elements of the current invention as stated above except a concentration for Ruxolitinib. However, it would have been obvious to utilize Song’s concentration for Y-27632 of 30 µM as a starting concentration for Ruxolitinib in order to optimize the amount used for the protocol. It is a common lab practice to keep reagents at the same concentration to avoid the need for separate optimization steps and to maintain consistency.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the protocol of Dzau with the Song’s concentration (30 µM) for Y-27632 as the potential starting concentration for Ruxolitinib in instant claim 4. Doing so would allow for an optimizable concentration range to be established for administering Ruxolitinib to the cells.
Claims 12 – 14, 26 – 28 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Dzau and Song as applied to claim 4 above, and further in view of Zhou et al (W.O. Patent Application Publication No. 2020/047467; cited on IDS, hereinafter Zhou).
Regarding claims 12 – 14 and 26 – 28, Dzau and Song teach all of the elements of the current invention as stated above except contacting the cells with MYOCD and MESP1. However, Zhou discloses a method for cardiac cell reprogramming that includes contacting the cell with MYOCD and MESP1 (para. [0007]). Zhou further discloses the motivation for adding the two transcription factors was a change in cell morphology from a spindle-like to a rod-like shape (para. [0007]). Also, the cells started to exhibit spontaneous Ca2+ oscillation (hall-mark feature of cardiomyocytes).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reprogramming factor (MEF2C and GATA4) cocktail of Dzau and Song with the MYOCD and MESP1 of Zhou in order to reprogram fibroblasts into cardiomyocytes. Doing so would lead to an increase of cardiomyocyte functionality, according to Zhou.
Regarding claim 31, Zhou discloses (para. [0180]) administering a vector by intracardiac injection or systemic administration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached M-F 7:30A - 5:00P.
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/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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