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
2. The amendment filed 02/16/2026 is acknowledged and has been entered.
Claims 72-73, 77, 79, 82 and 85 are amended. Claims 81 and 86-87 have been canceled. Claims 88-89 have been cancelled.
3. Claims 72-80, 82-85 and 88-89 are pending in the application. Claim 74 has been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/25/2025.
4. Claims 72-73, 75-80, 82-85 and 88-89 have been examined.
Grounds of Objection and Rejection Withdrawn
5. Unless specifically reiterated below, Applicant’s amendment and/or arguments have obviated or rendered moot the grounds of objection and rejection set forth in the previous Office action mailed 10/16/2025.
Grounds of Rejection Maintained
Improper Markush Grouping Rejection
6. Claims 79-80 and 82 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 706.03(y).
The Markush grouping of agents recited in claims 79-80 and 82 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: because each agent do not share a “single structural similarity” and a common use that flows from the substantial structural feature. For example, the claimed agents: a small molecule, a ligand, an antibody, antibody fragment or mimetic, a protein, a fusion protein, a peptide, a nucleotide or a small interfering RNA, have different structure and function.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
The Applicant’s arguments:
Claims 79-80, and 82 are directed to: DNMTs or an ortholog, homologue, variant, fragment, subsequence or derivative thereof (all of which are DNMT related proteins), agents that target the activity of the one or more DNMTs or TETs at the heterochromatin in the cell (the elected species in claim 79), wherein the agents have the common activity of promoting the activity of the one or more DNMTs or TETs at the heterochromatin in the cell (the elected species in claim 80), or treating cancer (the elected species in claim 82).
Response to Arguments
Applicant’s arguments have been carefully considered but not found persuasive for the following reasons:
The claimed agents: a small molecule, a ligand, an antibody, antibody fragment or mimetic, a protein, a fusion protein, a peptide, a nucleotide or a small interfering RNA, have different structure.
Claim Rejections - 35 USC § 112
7. 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.
8. 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.
9. Claims 72-73, 75-80, 82-85 and 88-89 remain/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 72-73, 75-80, 82-85 and 88-89 are indefinite because claim 72 recites “an agent that activates, elicits, stimulates, induces, promotes, increases or enhances expression or activity in the cell of one or more DNA methyltransferase (DNMT) or one or more TET methyl-cytosine dioxygenases (TET) proteins, or both to reduce loss of DNA methylation in age-associated genome dysfunction or cancer cells”. It is well known that DNA methyltransferases (DNMTs) catalyze the transfer of a methyl group to DNA to form DNA methylation, TET methyl-cytosine dioxygenases (TETs) are for DNA demethylation.
Thus, the biochemical functions of TETs and DNMTs are opposite. If an agent that activates DNMTs, how it can also activate TETs and reduce loss of DNA methylation? An agent that activates TETs should increase DNA demethylation, not reduce loss of DNA methylation. For these reasons, it is submitted that the claims fail to delineate the metes and bounds of the subject matter that is regarded as the invention with the requisite clarity and particularity to permit the skilled artisan to know or determine infringing subject matter.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
10. The following is a quotation 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.
11. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
12. Claims 72-73, 75-80, 82-85 and 88-89 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a “written description” rejection.
The considerations that are made in determining whether a claimed invention is supported by an adequate written description are outlined by the published Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, para. 1, ``Written Description'' Requirement (Federal Register; Vol. 66, No. 4, January 5, 2001; The 2015 Written Description Workshop materials; hereinafter “Guidelines”).
These guidelines state that rejection of a claim for lack of written description, where the claim recites the language of an original claim should be rare. Nevertheless, these guidelines further state, “the issue of a lack of written description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant has possession of the claimed invention” (Id. at 1105). The “Guidelines” continue:
The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art. This problem may arise where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process.
With further regard to the proposition that, as original claims, the claims themselves provide in haec verba support sufficient to satisfy the written description requirement, the Federal Circuit has explained that in ipsis verbis support for the claims in the specification does not per se establish compliance with the written description requirement:
Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). See also: University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 1892 (CA FC 2004).
Thus, an original claim may provide written description for itself, but it must still be an adequate written description, which establishes that the inventor was in possession of the invention.
The claims are herein drawn to a method comprising an agent that activates, elicits, stimulates, induces, promotes, increases or enhances expression or activity in the cell of one or more DNA methyltransferase (DNMT) or one or more TET methyl-cytosine dioxygenases (TET) proteins, or both to reduce loss of DNA methylation in age-associated genome dysfunction or cancer cells.
In this instance, the claims are directed to a genus of agents that activates DNMTs or TETs to reduce loss of DNA methylation in age-associated genome dysfunction or cancer cells.
A genus of agents may include, for example, a polypeptide, an antibody, a nucleic acid, or small molecule.
Although the specification teaches an activator of TETs, Vitamin C (see Example 9), it is not representative of the claimed a genus of agents; this is because the claimed agent, for example, a polypeptide, an antibody, a nucleic acid, or small molecule have markedly different structures. The artisan would not expect that any given agent would activate DNMTs or TETs to reduce loss of DNA methylation in age-associated genome dysfunction or cancer cells.
There is no correlation between any one particularly identifying structural feature that is shared by at least a substantial number of the members of the claimed a genus of agents; because each agent is structurally and functionally different. Although the artisan could potentially screen agents, it cannot be predicted whether or not one will be successful. The written description provision set forth under 35 USC 112(a) is severable from its enablement provision, so that written description requirement cannot be met by describing how one might make the invention – rather the invention must be described in such clear and particular terms so as to reasonably convey to the skilled artisan that applicant had possession of the claimed invention as of the filing date of the application (i.e., the earlier effective US filing date sought).
The skilled artisan could not immediately envision, recognize or distinguish at least a substantial number of the members of the claimed genus of agents.
The specification therefore would not reasonably convey to the skilled artisan Applicant's possession of the claimed invention as of the filing date of the application.
Notably, the Federal Circuit has decided that a patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated. See Noelle v. Lederman, 69 USPQ2d 1508 1514 (CA FC 2004) (citing Enzo Biochem II, 323 F.3d at 965; Regents, 119 F.3d at 1568).
Furthermore, Applicant is reminded that “generalized language may not suffice if it does not convey the detailed identity of an invention.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1892 (CAFC 2004).
In this instance, there is no language that adequately describes with any of the requisite clarity or particularity the claimed a genus of agents would activate DNMTs or TETs to reduce loss of DNA methylation in age-associated genome dysfunction or cancer cells. A description of what a material does, rather than of what it is, does not suffice to describe the claimed invention.
While the written description requirement can by satisfied without an actual reduction to practice, the disclosure of a catalog of potentially effective substances that might be found to be useful in practicing the claimed invention does not fulfill the written description requirement.
Recognizing that the claims are drawn to a genus of agents would activate DNMTs or TETs to reduce loss of DNA methylation in age-associated genome dysfunction or cancer cells, it is aptly noted that the Federal Circuit has decided that a generic statement that defines a genus of substances by only their functional activity, does not provide an adequate written description of the genus. See The Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The Court indicated that while applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a precise definition of a representative number of members of the genus, such as by reciting the structure, formula, chemical name, or physical properties of those members, rather than by merely reciting a wish for, or even a plan for obtaining a genus of molecules having a particular functional property. The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of genus must be capable of doing, not of the substance and structure of the members.
Finally, Guidelines states, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was ‘ready for patenting’ such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention” (Id. at 1104). “Guidelines” further states, “[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus” (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus. Moreover, because the claims encompass a genus of agents would activate DNMTs or TETs to reduce loss of DNA methylation in age-associated genome dysfunction or cancer cells, but which otherwise vary materially, structurally and/or functionally, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. In this instance, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; Applicant has not shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; and Applicant has not described distinguishing identifying characteristics sufficient to show that Applicant was in possession of the claimed invention at the time the application was filed.
Thus, it is submitted that the instant claims, and the disclosure describing the claimed subject matter, fails to satisfy the written description requirement set forth under 35 U.S.C. § 112, first paragraph.
Conclusion
13. No claim is allowed.
14. Applicant's amendment necessitated the new ground(s) of objection/rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/YAN XIAO/Primary Examiner, Art Unit 1642
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