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 .
Election/Restrictions
Applicant’s election of Group I and miR-15a and ROR1 in the reply filed on 12/11/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 109-122 and 129-130 are pending.
Claims 1-108 and 123-128 have been cancelled.
An action on the merits is set forth below.
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 109-122 and 129-130 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.
Claims 109-122 and 129-130 are drawn to methos of treating a subject with cancer comprising administering to the subject an effective amount of one or more agents that increase the expression or activity of miR-15a, and/or reduce the expression of a target gene of the miR gene product (or ROR1).
The claims therefore encompass any agent that increase expression or activity of miR-15a and the reduction of any target gene of the miR gene in any subject. The instant specification does not provide guidance as to the critical structures needed to determine which of these species would functionally provide an association of a or b and an effective amount of any agent in any subject.
The specification asserts that any gene or gene product can be measured in tissue samples (p. 14) however the specification does not provide critical structures for any sample and correlation of agents and expression/activity. Further, the specification does not provide which agents are associated with expression that correlates with treatment selection. Based upon the description in the specification the critical structural elements needed for the recited gene expression to function to identify a subject for treatment of an agent that reduces or increases expression or activity have not been described.
The art does not provide the critical structural elements for the asserted functionality. In particular Enard et al. (Science 2002 Vol 296 p. 340) teaches that even between closely related species gene expression patterns differ (abstract). Enard et al. teaches that mRNA expression levels are different between humans, chimpanzees, orangutans and rhesus marcques (p. 340 1st column last sentence-2nd column 1st paragraph). Enard et al. teaches that there are a large number of quantitative differences in gene expression in closely related mammals (p. 342 2nd column last paragraph). Therefore the art teaches that even between very closely related mammals there is a divergence of gene expression. As such Enard et al. teaches that merely being a biomarker in one species would not be sufficient to provide support for the structure in other species.
The art of Cobb et al (Crit Care Med 2002 Vol. 30 p. 2711) teaches the unpredictability in analysis of gene expression in spleen and liver sample from septic mice. Notably, the reference teaches that, when compared to a non-septic sample, the relevant expression profiles of the septic mouse spleen and the septic mouse liver contain different nucleic acids at different levels (Table 1; p.2714, middle col., lns.2-8). As such the art teaches that expression levels of the same nucleic acids in different tissue samples differ. Therefore the art indicates that an association of expression level to one type of status of treatment one sample would not be functionally correlative to an association to any other sample type.
Accordingly, the specification has not provided the critical elements needed in the structure to predictive functionally. Therefore the specification lacks written description of any subject representative of the broadly claimed genus.
In analysis of the claims for compliance with the written description requirement of 35 U.S.C. 112, first paragraph, the written description guidelines note regarding genus/species situations that “Satisfactory disclosure of a ``representative number'' depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed.” (See: 'Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.)
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 109-122 and 129-130 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 109-122 and 129-130 are indefinite over the phrase “increase the expression or activity” or “reduce the expression or activity”. These phrases are relative terms which renders the claim indefinite. The phrases “increase the expression or activity” or “reduce the expression or activity “are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As there is no comparison step it is not clear which expression or activity would be considered increased or reduced. The same issue occurs with regard to reduced expression and loss in claim 111.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 110, 120-121 recites the broad recitation leukemia, and the claim also recites MDS, AML, CML, BC which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 116 contains the trademark/trade name venetolax. 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 name is used to identify/describe agents and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 109-111, 117-122, 129-130 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ju et al. (US Patent Application Publication 2019/0062754 Feb 28, 2019).
With regard to claim 109, Ju et al. teaches administration of an effective amount of 5-FU-miR-15a that increases expression of miR-15a which is reduced in a subject (para 84 and 251). Ju et al. teaches that this miR-15a expression will reduce the ability of cancer stem cells to induce cancer cell colony formation (para 84). Ju et al. teaches that the patients can include AML and CML (e.g. not CLL)(para 257).
With regard to claim 110, 117, 118, Ju et al teaches that the patients can include AML and CML (para 257).
With regard to claim 111, Ju et al. teaches that the subject has a reduced expression of miR-15a (para 84 and 251).
With regard to claim 119, Ju et al. teaches determining a level of the miR gene product (para 24-27).
With regard to claims 120-121, Ju et al teaches that the patients can include AML and CML (para 257).
With regard to claim 122, Ju et al. teaches blood cells (para 83).
With regard to claims 129-130, Ju et al. teaches that the subject is colorectal, lung, pancreatic or gastric (para 71).
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.
Claim(s) 109-122 and 129-130 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ju et al. (US Patent Application Publication 2019/0062754 Feb 28, 2019) in view of Rassenti et al. (PNAS October 2017 Vol 114 p. 10731-10736 cited on IDS).
Ju et al. teaches administration of an effective amount of 5-FU-miR-15a that increases expression of miR-15a which is reduced in a subject (para 84 and 251). Ju et al. teaches that this miR-15a expression will reduce the ability of cancer stem cells to induce cancer cell colony formation (para 84). Ju et al. teaches that the patients can include AML and CML (e.g. not CLL)(para 257). Ju et al teaches that the patients can include AML and CML (para 257). Ju et al. teaches that the subject has a reduced expression of miR-15a (para 84 and 251).
With regard to claim 110, 117, 118, Ju et al teaches that the patients can include AML and CML (para 257).
With regard to claim 111, Ju et al. teaches that the subject has a reduced expression of miR-15a (para 84 and 251).
With regard to claim 119, Ju et al. teaches determining a level of the miR gene product (para 24-27).
With regard to claims 120-121, Ju et al teaches that the patients can include AML and CML (para 257).
With regard to claim 122, Ju et al. teaches blood cells (para 83).
With regard to claims 129-130, Ju et al. teaches that the subject is colorectal, lung, pancreatic or gastric (para 71).
However, Ju et al. does not teach a target gene of ROR1 or treating with an antibody of RORO1.
With regard to claims 109 and 112, Rassenti et al. teaches methods of administrating antibody of ROR1 in patients with low expression (p. 10731 2nd column).
With regard to claims 113-114, Rassenti et al. teaches methods of administrating antibody of ROR1 in patients with low expression (p. 10731 2nd column).
With regard to claim 115-116, Rassenti teaches a cirmtuzumab (p 10731 send column) which would be considered a monoclonal antibody.
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Ju et al. to use other agents that increase expression levels of genes associated with miR 15 including the ROR-1 antibody of Rassenti et al. The ordinary artisan would be motivated to administer ROR-1 antibody of Rassenti et al. to the samples of Ju et al. as Rassenti et al. taches that this administration will increase expression in patients with low expression.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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/KATHERINE D SALMON/ Primary Examiner, Art Unit 1682