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 .
Status of the Claims
Claims 1-8 are currently pending.
Claims 1-8 have been considered on the merits.
Claim Objections
Claim 6 and 8 are objected to because of the following informalities: Claim 6 recites “RepSox (E-616452)” and claim 8 limits to “E-616452”. Applicant is kindly requested to employ a standard terminology for the same chemical through the claims. Applicant may choose either term but should remain consistent throughout the claims. Below a 112(b) rejection is provided which addresses the terms in parenthesis, and should claim 6 be amended due to the 112(b) to include only the term “RepSox”, claim 8 should be amended accordingly. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: the phrase “wherein the microRNA is miR-291a; and the…” is grammatically incorrect. The semicolon should be deleted. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 3-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “or a microRNA sequence having at least 90% identity with a sequence of one of the miR-290 family members”. The specification does not describe any sequences at all, further the specification only describes the list of microRNAs provided in claim 2 and [0025]. The concept of any sequence which is 90% identical to any microRNA in the miR-290 family members, as recited in claim 1, lacks written description other than the identified microRNAs provided in claim 2 and at [0025]. The specification does not corelate a microRNA sequence having at least 90% identity with a sequence of any one of the miR-290 family members with a sequence containing the same structural and functional characteristics as the claimed mIR-290 family members.
There is no evidence on the record of a relationship between the structures of microRNA sequences coding for a miR-290 family member and the sequence set forth by claim 1 that would provide any reliable information about the sequence of RNA molecules within the genus of variants. The claimed invention as a whole is not adequately described if the claims require essential or critical elements that are not adequately described in the specification and that is not conventional in the art as of applicants effective filing date.
Possession may be shown by actual reduction to practice, clear depiction of the invention in a detailed drawing, or by describing the invention with sufficient relevant identifying characteristics such that a person skilled in the art would recognize that the inventor had possession of the claimed invention. Pfaff v. Wells Electronics, Inc., 48 USPQ2d 1641,1646 (1998).
With the exception of the exact members of the miR-290 family referred to above, the skilled artisan cannot envision the detailed chemical structure of the encompassed microRNAs, and therefore conception is not achieved until reduction to practice has occurred regardless of the complexity or simplicity of the method of isolation. The skilled artisan cannot envision the detailed chemical structure of the encompassed ribonucleic acid molecules and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The nucleic acid itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF' s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
In view of the above considerations one of skill in the art would not recognize that applicant was in possession of the necessary common features or attributes possessed by any member of the genus of any microRNA which is 90% identical to any member of the miR-290 family encompassed by claim 1.
University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that “to fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude “the inventor invented the claimed invention”.
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 3-7 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.
Claims 3-7 are rejected for being indefinite. Claims 3-7 contain lists of small molecules containing various descriptors and definitions within parenthesis which render the claims unclear. For example, claim 3 contains the phrase “M344 (a HDAC inhibitor)” which renders the claim indefinite due to it being unclear whether the information provided in the parenthesis is claimed material. Parenthesized material should only be present in a claim to describe an acronym. Additionally, there are numerous instances throughout claims 3-7 which provide names of small molecules followed by additional identifying codes which are assumed to be product codes/numbers. The recitation of these product codes renders the claims indefinite because it is not clear if the product codes are intended to limit the claims. For example, claim 4 contains the phrase “binimetinib (MEK162, ARRY-162, ARRY-438162)”, which renders the claim indefinite due to it being unclear whether the product codes provided in parenthesis are claim limitations. In this specific instance, multiple product codes also render the claim further indefinite due to it being unclear if only these forms of the binimetinib are claimed. Applicant is kindly requested to amend claims 3-7 to include only a single name for each claimed chemical and to employ parenthesis only to denote an acronym.
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.
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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Rana et al (US20110189137A1), in view of Shi et al (US20140154805A1).
With regards to claim 1, Rana teaches a composition containing a microRNA ([0138]/[1095]) and a small molecule ([0016]) which is used in a method for generating induced pluripotent stem cells (abstract). Rana teaches that the microRNA is in the mir-290 cluster, including the mmu-mir-290a, and mmu-mir-291a ([0138]/[0195]).
Regarding claim 2, Rana teaches that the microRNA is in the mir-290 cluster, including the mmu-mir-290a ([0138]/[0195]).
Regarding claim 8, Rana teaches that the microRNA is mmu-mir-291a ([0138]).
Rana does not teach the composition specifically includes a combination of small molecules comprising a histone deacetylase inhibitor, a mitogen-activated extracellular signal-regulated kinase inhibitor, a glycogen synthase kinase-3 inhibitor a transforming growth factor beta receptor 1 inhibitor and an inhibitor of histone demethylase as required by claim 1. Rana does not teach that the specific small molecules present in the combination are chosen from the lists provided in claims 3-7. Rana does not teach that the small molecule compounds comprise valproic acid, PD0325901, CHIR-99021, E-616452, and tranylcypromine as required by claim 8.
However, Shi teaches a similar method of reprogramming somatic cells into induced pluripotent stem cells by contacting the cells with a composition containing the listed inhibitors of claim 1.
With regards to claim 3, the histone deacetylase inhibitor can be valproic acid [0151]).
Regarding claim 4, a mitogen-activated extracellular signal-regulated kinase inhibitor is taught to be PD0325901 ([0151]).
Regarding claim 5, Shi teaches that CHIR99021, a glycogen synthase kinase-3 inhibitor, is also included ([0151]).
Regarding claim 6, Shi teaches that RepSox, a transforming growth factor beta receptor 1 inhibitor, is also an inducer ([0119]).
Regarding claim 7, Shi teaches tranylcypromine, a histone demethylase inhibitor, is an inducer ([0150]).
Regarding claim 8, Shi teaches that the small molecule combination can comprise valproic acid ([0151]), PD0325901 ([0151]), CHIR-99021 ([0151]), E-616452 (also known as RepSox) ([0119), and tranylcypromine ([0150]).
Shi further teaches these identified small molecule compounds were characterized for their ability to enhance reprogramming efficiency and accelerate the reprogramming process ([0008]).
One of ordinary skill in the art would find it obvious at the time of the effective filling date to combine the microRNA iPSC inducer taught by Rana with the small molecule iPSC inducers taught by Shi to arrive at a composition containing both the microRNA and small molecule inducers. One of ordinary skill in the art would be motivated to make this combination because Shi teaches these identified small molecule compounds were characterized for their ability to enhance reprogramming efficiency and accelerate the reprogramming process ([0008]). One of ordinary skill in the art would have a reasonable expectation of success when combining Rana with Shi because both are teaching the necessary embodiments to reprogram iPSCs using small molecules and microRNAs.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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, Peter Paras can be reached at 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632
Prosecution Insights