DETAILED ACTION
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 .
Applicant's election with traverse of group III in the reply filed on 9/9/25 is acknowledged. The traversal is on the ground(s) that the subject matter of all claims is sufficiently related that a search for the subject matter would encompass as subject matter of any of the groups of claims. This is not found persuasive because search burden is not a consideration in 371 applications.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-10 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/11/25.
Sequence Compliance
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 because there are sequences in figure 12, for example, that do not contain a SEQ ID NO.
A complete response to this office action must correct the defects cited above regarding compliance with the sequence rules and a response to the action on the merits which follows.
The aforementioned instance of failure to comply is not intended as an exhaustive list of all such potential failures to comply in the instant application. Applicants are encouraged to thoroughly review the application to ensure that the entire application is in full compliance with all sequence rules. This requirement will not be held in abeyance.
Drawings
The drawings filed on 12/8/22 are objected to because they contain sequences that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2), but each sequence does not contain a SEQ ID NO., as explained in the “Sequence Compliance” section above. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claim(s) recite(s) a product of nature. This judicial exception is not integrated into a practical application because the claims do not recite any markedly different structural requirement than the naturally occurring miRNAs. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the instant composition does not require anything in addition to a naturally occurring miRNA as an active ingredient.
The exception is not integrated into a practical application of the exception.
A patent cannot be granted for a discovery of something that exists in nature, such as a naturally occurring substance. It is noted that incorporation into a pharmaceutical composition comprising a generic carrier, for example, does not result in
"markedly different" characteristics from the nature-based product that exists in nature. There is no evidence that any structural changes occur to the nucleic acid by making a formulation comprising the natural products.
Boon et al. (EP 2446929 A1) teach that miR-143 and miR-145 were isolated from naturally occurring endothelial cells (abstract), evidence that the instant miRNAs are products of nature.
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 11-13 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.
The claims are directed to a drug comprising miR-143 and/or miR-145 or “a compound that acts like miR-143 and/or miR-145 in an individual” as an active ingredient thereof.
The specification does not adequately describe the structure required for the compound to have the required function of acting like miR-143 and/or miR-145 in an individual.
The specification does not disclose even a single species of compounds that act like miR-143 and/or miR-145 in an individual. Without further description of the structure required for the function, one would not be able to readily recognize which compounds necessarily act like miR-143 and/or miR-145 in an individual.
The MPEP states that for a generic claim, the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. See MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad genus. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618. Additionally, in Carnegie Mellon University v. Hoffman-La Roche Inc., Nos. 07-1266, -1267 (Fed. Cir. Sept. 8, 2008), the Federal Circuit affirmed that a claim to a genus described in functional terms was not supported by the specification’s disclosure of species that were not representative of the entire genus. Furthermore, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The claims are rejected under the written description requirement for failing to disclose adequate species to represent the claimed genus, the genus being compounds that act like miR-143 and/or miR-145 in an individual.
The Guidelines for Examination of Patent Applications under the 35 USC § 112, first paragraph, “Written Description” Requirement”, published at Federal Register, Vol. 66, No. 4, pp. 1099-1111 outline the method of analysis of claims to determine whether adequate written description is present. The first step is to determine what the claim as a whole covers, i.e., discussion of the full scope of the claim. Second, the application should be fully reviewed to understand how applicant provides support for the claimed invention including each element and/or step, i.e., compare the scope of the claim with the scope of the description. Third, determine whether the applicant was in possession of the claimed invention as a whole at the time of filing.
For example, Boon et al. (EP 2446929 A1) teach that a vesicle enclosing at least one microRNA selected from the group consisting of miR-150, miR-451, miR-145, miR-143, miR-144, miR-193a-3p, miR-155, miR-181a, miR-214, miR-199b, miR-199a, miR-210, miR-146a, miR-126, miR-378, miR-363 and miR-30b can be used to treat vascular diseases, more specifically acute myocardial infarction (see claims). Therefore, these miRNAs meet the instant limitation of acting like miR-143 and/or miR-145. The specification does not adequately describe the structure required for the function. Without further description of the structure required for the function, one would not be able to readily recognize which compounds are necessarily included or excluded from the recited genus and one would not be able to recognize that applicant was in possession of the entire claimed genus at the time of filing.
Thus, having analyzed the claims with regard to the Written Description guidelines, it is clear that the specification does not disclose a representative number of species for compounds that act like miR-143 and/or miR-145 as claimed. Thus, one skilled in the art would be led to conclude that Applicant was not in possession of the claimed invention at the time the application was filed.
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.
(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.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 102(a)(1) or (a)(2) as being anticipated by Boon et al. (EP 2446929 A1).
Boon et al. teaches: The present invention relates to methods for the production of atheroprotective vesicles. The invention is based on the finding that endothelial cells wherein the activity of the transcription factor KLF2 is induced and/or enhanced surprisingly produce and/or secrete vesicles enclosing various atheroprotective microRNAs, in particular microRNAs of the microRNA-cluster miR-143/145. Thus, the present invention discloses methods for the production of vesicles derived from atheroprotective endothelial cells and the vesicles produced by the disclosed methods. Furthermore artificially produced vesicles enclosing the atheroprotective microRNA composition according to the invention are provided. The vesicles of the present invention are useful in the treatment and prevention of atherosclerotic diseases, such as acute coronary syndromes, plaque rupture, aneurysms, in-stent restenosis, ischemic diseases and heart failure [0001](instant claims 11-13).
The artificially produced vesicles enclosing the atheroprotective microRNA composition according to the invention comprising miR-143/miR-145 of Boon et al. anticipates the instant drug comprising miR-143 and/or miR-145 or compound that acts like miR-143 and/or miR-145 in an individual. Additionally, Boon et al. recites a pharmaceutical composition comprising the vesicles (claim 13 of Boon et al.).
The instantly recited intended use of improving or treating a chronic phase cardiac function after acute myocardial infarction or treating acute myocardial infarction does not introduce a structural limitation into the instant compound claims. The claims are anticipated by Boon et al. because Boon et al. teaches a drug that anticipates the instantly recited structural requirements, which would necessarily result in the instantly recited intended uses, absent evidence to the contrary. As stated in the MPEP (see MPEP 2112), something that is old does not become patentable upon the discovery of a new property.
Additionally, Boon et al. teaches that the composition is for treating acute myocardial infarction [0001] [0036].
Boon et al. recites:
Claim 9: A vesicle enclosing at least one microRNA selected from the group consisting of miR-150, miR-451, miR-145, miR-143, miR-144, miR-193a-3p, miR-155, miR-181a, miR-214, miR-199b, miR-199a, miR-210, miR-146a, miR-126, miR-378, miR-363 and miR-30b.
Claim 10: The vesicle according to claim 9, the vesicle enclosing at least one, preferably all, of the miRNAs miR-145, miR-143, miR-150, miR-144, miR-199a and/or miR-451.
Claim 12: A vesicle according to any one of claims 9 or 10 for use in the treatment or prevention of a vascular disease, wherein the vascular disease is selected from the group consisting of acute coronary syndromes, such as myocardial infarction, unstable angina or sudden cardiac death, plaque rupture, aneurisms, in-stent restenosis and ischemic diseases, such as ischemic stroke, peripheral arterial occlusive disease, acute and chronic ischemic cardiac disease, all types of heart failure, hibernating myocardium and microcirculory dysfunction.
Claim 13: A pharmaceutical composition, comprising a vesicle according to any one of claims 9 to 12 together with a pharmaceutical acceptable carrier and/or excipient.
Regarding instant claim 12, the claim requires for the drug to be administered in an acute phase after an acute myocardial infarction, which is a method step. The instant claims are compound claims, not method claims. The recited step does not introduce a specific structural limitation into the recited compound
Therefore, the instant invention is anticipated by Boon et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amy R Hudson whose telephone number is (571)272-0755. The examiner can normally be reached M-F 8:00am-6:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY ROSE HUDSON/Primary Examiner, Art Unit 1636