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 1 in the reply filed on 12/18/2025 is acknowledged.
The species requirement between miR-200 family members is withdrawn.
Claims 36-38, 42, 43, and 49-62 are pending
Claims 61-62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/18/2025.
Claims 36-38, 42, 43, and 49-59 are examined.
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 36-38 and 49, 52, 55, and 58 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 specification exemplifies an antagomir of miR-141 and gRNA sequences to inhibit miR-141 as potential therapeutics in methods of treating airway disease. The specification also describes an antagomir for each of miR-200a, mir-200b, miR-200c an mir-429. However, the claims encompass a broad scope where the scope lacks adequate written description. The invention, for example is drawn encompass inhibitors of any miR-200 family member to treat a vast scope of airway diseases. The specification as filed does not provide adequate description of mir-200 family member inhibitors such that one could immediately envisage the scope of inhibitors of mir-200 family member to practice the claimed methods. One in the art would not be appraised of the sequence/structure that would provide for the broad scope of miR-200 family member inhibitors where the scope of potential inhibitors is large and includes “The inhibitors of the invention may comprise any composition of matter which inhibits its miRNA target, by any mechanism.” (See for example paragraphs 12 and 36 of the corresponding pregrant publication US20230279393).
One in the art would not know, based on the specification as filed, what the structure/sequences of any other miR-200 family member inhibitors. One in the art would need to make that determination de novo since it is not readily apparent that any of these compounds were described in the instant specification or well known in the prior art, other than those noted above. One in the art would clearly not be capable or able to immediately envisage the sequence/structure of the inhibitors required to practice the claimed invention since they are described by function in the claim, for example.
The specification provides insufficient written description to support the genus encompassed by the claim.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
With the exception of the inhibitors noted above, the skilled artisan cannot envision the detailed chemical structure of the encompassed claimed compounds, 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 for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
Applicant is also directed to AbbVie Deeutchland GmbH v. Janssen BiotechnologyLtd., F.3 1285 (Fed. Cir. 2014)
“[A] sufficient description of a genus . . . requires the disclosure of either a representative number* of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus” (AbbVie, 759 F.3d at 1299, reiterating Eli Lilly, 119 F.3d at 1568-69) (emphasis added).
“The asserted claims attempt to claim every fully human IL-12 antibody that would achieve a desired result, i.e., high binding affinity and neutralizing activity, and cover an antibody as different as Stelara®, whereas the patents do not describe representative examples to support the full scope of the claims.” Jury’s decision of invalidity for lack of adequate written description for the claimed genus affirmed (AbbVie, 759 F.3d at 1301) (emphasis added).
The species specifically disclosed are not representative of the genus because the genus is highly variant. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC 112 is severable from its enablement provision. (See page 1115.)
Claims 36-38 and 49-60 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification exemplifies an antagomir of miR-141 sequence to inhibit mir-141 as potential therapeutic in methods of treating airway disease. However, the claims encompass a broad scope where the scope lacks adequate guidance. The invention, for example is drawn encompass inhibitors of any mir-200 family member to treat a vast scope of airway diseases. The specification as filed does not provide adequate description of mir-200 family member inhibitors such that one could immediately envisage the scope of inhibitors of mir-200 family member to practice the claimed methods without undue trial and error experimentation. At paragraph 12 of the published application it is asserted: “The inhibition of miR-200 miRNAs may be achieved by any number of agents. In a first implementation, the miR-200 miRNA inhibitor is an antagomir or like construct which hybridizes to RISC-associated target miRNAs, blocking their repressive activity. In other implementations, the inhibitor may comprise an agent which reduces the abundance of the targeted miR-200 miRNA by inhibiting the expression of genes thereof, or by disrupting the post-translational processing of the targeted miRNA”, and at paragraph 36 it is asserted: “The inhibitors of the invention may comprise any composition of matter which inhibits its miRNA target, by any mechanism.”. One in the art would be tasked with the de novo trial and error experimentation required to screen and test for a broad scope of potential inhibitors where the inhibitors may comprise any composition of matter which inhibits its miRNA target, by any mechanism.
Further it is noted that the specification provides no working examples that would show by correlation the treatment of the vast range of potential airway diseases encompassed and recited in the claims. The specification also fails to provide guidance or working examples that would show by correlation the targeting of the recited miR-200 family members. Indeed, the specification, at paragraph 88, as filed, asserts the following with emphasis added: “The miR-141/200 family is encoded in two genomic clusters, which give rise to five highly homologous mature miRNAs that are well-conserved across species. A recent study investigating CRISPR/Cas9-based editing of miRNA clusters found that a mutation in one hairpin could affect the expression of a miRNA that resided in the other hairpin of the same cluster. This observation was thought to be due to changes in the tertiary structure of the pri-miRNA leading to a differential expression of the mature miRNA. However, the authors also reported that mutations were well-tolerated, provided they did not disrupt critical elements such as stem length, bulge position and terminal loops (39). These findings are important since they imply that CRISPR/Cas9-editing of miRNAs can affect processing of the hairpin in a dual manner; directly through sequence alteration and disruption of sequence motifs, or structurally through changes to the pri-miRNA, thus highlighting the complexity of CRISPR/Cas9-targeting of miRNAs. Herein, miR-141 significantly downregulated hsa-miR-141-3p expression with relative preservation of the expression of the other miR-141/200 family miRNAs. Importantly, miR-141 has an identical seed sequence to miR-200a such that one could expect miR-141 and miR-200a to play additive or synergistic roles in airway epithelial responses. However, the results clearly show that targeting miR-141 alone is sufficient to repress IL-13-induced mucus production. The remaining miR-141/200 family members are less homologous to miR-141 with additional overlapping effects. Indeed, a recent study of the miR141/200 family found that the two subgroups (distinguished by the seed sequence; 141/200a and 200b/200c/429) bound to largely distinct sites and cross-seed recognition was rare (i.e. 141/200a binding of RNAs with a 200b/200c/429 seedmatch). However, many genes were regulated by multiple family members sharing the same seed sequence suggesting that the miR-141/200 family cooperates in target recognition. Interestingly though, in the study, hsa-miR-200a-3p was the only miR-141/200 family member whose expression did not show any relationship to the frequency of goblet cells in IL-13-stimulated HBEC cultures. This suggests that miR-141 and miR-200a may not share functional overlap in mucus regulation, or that the lower expressed miR-200a alone may not be sufficient to compensate for reduced expression of miR-141.”
The exemplification of miR-141 inhibition can not be accepted as a predictor for the inhibition of the other miR-200 members.
The prior art provides contradictory evidence for the observations of the specification in regard to treating a vast array of diseases via the targeting of any miR-200 family member. Liu et al (Cellular Physiology and Biochemistry Vol.50:2365-2389, 2018) has taught that the administration of miR-200a affects airway remodeling and that miR-200a, not an inhibitor, can potentially be used to treat airway disease.
Qian et al (Cell Death and Disease Vol.10(129):12 pages, 12 February 2019) have asserted that upregulation of miR-141-3p prevented pulmonary fibrogenesis and that inhibition of mir-141-3p reversed that effect.
The lack of guidance and evidence of opposite modulation of mir-200 family members as potential airway treatments for affecting airway disease indicates the unpredictability of the art and leaves one in the art to engage in an undue amount of trial and error experimentation to first, for example, find appropriate miR-200 family member inhibitors and further engage in de novo determination of the relationship of any particular miR-200 family member in any particular airway disease and determine the feasibility of treating such diseases via the inhibition of a miR-200 family member.
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 42 and 43 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 42 and 43 depend from canceled claim 41. The metes and bounds of the claimed invention cannot be determined.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN MCGARRY whose telephone number is (571)272-0761. The examiner can normally be reached M-Th/F 9:00-7:30.
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, Ram Shukla can be reached at 571 272 1600. 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.
/SEAN MCGARRY/Primary Examiner, Art Unit 1635