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 without traverse of Group II, claims 70-72 and 117-132, in the reply filed on 05/08/2026 is acknowledged.
Claim 1 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/08/2026.
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 70-72, 117-132 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 are broadly drawn to methods of identifying an epigenetic modulating agent which binds or interacts with one or more SPEARs and formulating such agent for treatment of a cancer associated with epigenetic dysregulation or a genetic disease or disorder associated with epigenetic dysregulation.
Claims encompass a broad genus of SPEARs, a genus of modulating agents binding or interacting with any of the SPEARs further requiring such agents to carry out a variety of functions as recited in dependent claims, a genus of cancers and genetic diseases associated with epigenetic dysregulation.
Instant specification defines SPEARs as specific non-coding S-phase early RNAs (see Abstract). Specification very broadly describes that SPEAR can be a long non-coding RNA of 200 nucleotides or longer, it is encoded in a region adjacent to a promoter of an active gene and is induced in early S phase of the cell cycle, can comprise one or more RM9A motifs and one or more stem-loop-like structures (see paragraph [0041]). Paragraph [0138] of specification teaches that several SPEARs were sequenced. None of those sequences are presented in the disclosure. Further, Examples 1 and 2 define locations of some SPEARs and their interactions with histones. Example 3 evaluates common binding motifs between SPEARs, such as RM9A. Such motif is not known in prior art and its structure is not identified anywhere in the disclosure. Thus, the genus of SPEARs is described in functional terms but there is no structure-function relationship defined for SPEARs, because there is no structure (sequence) disclosed for any of SPEARs.
Further, concerning genus of modulating agents specification teaches that such agents can be small molecules (see paragraph [0031]). No examples of any such small molecules are provided. Further, specification teaches that such agents can be nucleic acids (see paragraph [0120]) and does provide some examples of such siRNAs in Table 1. Thus, genus of modulating agents is extremely wide and varied, which includes a number of undetermined small molecules, nucleic acid based inhibitors and apparently a large number of other compounds capable of interaction with SPEARs. It is noted that what such interaction involves is not defined in specification. Further, there is no agents exemplified in specification that would carry out specific functions such as reduction of epigenetic mark activity or reduction of one of DNA methylation, histone modification or nucleosome remodeling and others as recited in dependent claims. Therefore, structure-function relationship for extremely varied range of compounds of varied chemical structure in relation to their various specific actions is not defined as well.
Concerning genuses of cancers and genetic disorders associated with epigenetic dysregulation specification provides examples of some such cancers in paragraphs [0028-0029], but it is not clear if this is an exhaustive list of all possible cancers associated with epigenetic dysregulation. There are no examples of any genetic diseases associated with epigenetic dysregulation in the disclosure. Further, there is no definition of what such association with epigenetic dysregulation means.
Prior art by Yildirim et al (Cell Reports, May 2020, 31, 107629, cited from IDS) teach a number of non-coding S phase expressed RNAs (see Abstract, whole document).
The genuses of SPEARs and modulating agents encompass a large number of unknown structures and one of skilled in the art cannot reliably predict which member of the genus of modulating agents would successfully interact with target RNA, and which will not, especially if the structure of target RNA is unknown itself. Similarly, the genuses of cancers and genetic diseases associated with epigenetic dysregulation encompass a large number of disorders and one of skilled in the art cannot define if the cancer or genetic disorder is associated with genetic dysregulation, or not.
There is no description of the necessary and sufficient elements of the species encompassed by the breadth of the claims. The only species described in specification are some siRNAs and shRNAs and no species of SPEARs are disclosed. Applicant fails to describe representative members of Applicant's broadly claimed genuses.
One of the skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genuses in view of the disclosed species. Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly variant, siRNAs and shRNAs from Table 1 and some cancers are not sufficient to describe the claimed genuses. Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, it is not clear that Applicant was in possession of the claimed genuses at the time this application was filed.
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 70-72, 117-132 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.
Claim 70 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: actual active steps of determination whether the agent binds or interacts with SPEARs, of classification of the agent and of formulating the agent for therapy. Instant disclosure does not recite any specific steps necessary to be undertaken to determine if the agent binds to SPEAR. Further, meets and bounds of “interaction” of the agent with SPEAR are not defined at all. The terms of classification of the agent are not defined as well. It is also not clear what exactly is involved in formulating the agent for therapy.
Claims 71-72 and 117-132 are rejected based on their dependency on claim 70.
Claims 71-72, 117, 119, 122 recite the word “substantially”. The metes and bounds of what is substantial are not defined in specification or claims, therefore the claims are indefinite. It is suggested to remove the word “substantially” from the claims.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 123-125 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 123 depends on claim 70 and further defines epigenetic dysregulation. Such definition does not affect steps of the method of claim 70, therefore claim 123 does not further limit claim 70.
Claims 124-125 originally depend on claim 70 and add limitations of SPEAR being non-coding and being induced in early S phase of cell cycle. According to paragraph [0003] of instant specification SPEAR stands for non-coding S phase early RNA, so that by definition the RNA is non-coding and expressed in early S phase. Therefore, claims 124-125 do not further limit claim 70.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 70, 117-118, 123-125, 128-132 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yildirim et al (Cell Reports, May 2020, 31, 107629, cited from IDS).
Yildirim teach identifying a number of non-coding RNAs expressed mainly during S phase (see Abstract). Yildirim use antisense oligonucleotides, which are complementary to each RNA sequence, to inhibit expression of three of the RNAs, LINC00704, LUCAT1 and MIAT (see second column on page 7). The type of antisense oligonucleotide used is a gapmer, which is a chemically modified oligonucleotide comprising LNAs (see second column on page 7). Inhibition of LINC00704 leads to some genes downregulation and other genes upregulation (see first column on page 10). Yildirim point out that LINC00704 and LUCAT1 RNAs are overexpressed in cervical and lung cancers, respectively (see first column on page 10). According to paragraph [0029] of instant specification such cancers are associated with epigenetic dysregulation.
Yildirim do not explicitly teach method of making of modulating agent as instantly claimed.
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to make other agents binding to non-coding RNAs described by Yildirim, arriving at instant invention. One of the ordinary skill in the art would be motivated to do so because Yildirim teach identification of modulating agents for some non-coding RNAs taught, such agents are antisense oligonucleotides binding to the RNAs. Further, because such RNAs are overexpressed in cancers it would be reasonable to formulate agents inhibiting such RNAs for cancer treatment. Thus, one of ordinary skill in the art would be motivated to identify other RNAs taught by Yildirim which are overexpressed in cancers and design modulating agents for those RNAs such as antisense oligonucleotides, formulating them for cancer treatment, arriving at instant invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
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