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
Status of the Application
Claims 1, 2, 7-12 and 17 are pending and are currently under examination.
Claims 1, 2, 7-12 and 17 and SEQ ID No. 4 is free of the prior art searched.
The 102 rejection is withdrawn in response to claim amendments.
The 112(a) written description rejection has been withdrawn in response to claim amendments.
Claim Objections
Claim 7 is objected to because of the following informalities: The claim recites “least one” twice in lines 1-2 . Appropriate correction is required
Maintained Rejections
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970);and, In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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The rejection of claims 1, 2, 7-12 and 17 under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,717,530 is maintained for the reasons of record. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims and the claims of the patent are drawn to patently indistinguishable subject matter
Claims of Patent ‘530 are drawn to methods of treating an IL-17A mediated disease in a subject comprising administering a composition comprising SEQ ID No. 4 wherein the disease is an inflammatory disease such as in claim 3. The instant claims are drawn to the same methods of treatment using SEQ ID No. 4 wherein the oligonucleotide is complementary to SEQ ID Nos. 6 and 7. SEQ ID No. 4 is complementary to SEQ ID Nos. 6 and 7. Furthermore, the claims are drawn to a composition targeted to at least a portion of miR4661-3p of an IL-17A target site. It would have been obvious to use the claimed composition in the methods of Patent ‘530 to treat an IL-17A mediated disease. The Court of Appeals for the Federal Circuit in Pfizer Inc, v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001 at page 1008 (March 2008), indicated that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application. Thus the claims of Patent ‘530 and the instant claims are not patentably distinct.
Acknowledgement is made of Applicant's request that the rejection be held in abeyance until allowable matter is indicted in the instant claims, therefore the rejection is maintained.
Reasons for indicating allowable subject matter
Chen, Kong, and Jay K. Kolls. ("Interluekin-17a (il17a)." Gene 614 (2017): 8-14 of record cited on 892 mailed 03/19/2025) teach IL-17A is involved in human diseases such as psoriasis, rheumatoid arthritis, multiple sclerosis, inflammatory bowel diseases and asthma (see page 9 1.3). Chen et al. does not teach an association between miR4661-3p and IL-17A or methods of blocking the binding of miR4661-3p and IL-17A using the claimed oligonucleotide having SEQ ID No 4.
SEQ ID No. 4 is described in the Specification as targeting a miR4661-3p binding region (TATTTAT) on the gene IL17A. The prior art does not teach a sequence comprising SEQ ID No. 4 and it would not have been obvious to try making this sequence. The prior art of Watts et al. ("Silencing disease genes in the laboratory and the clinic." The Journal of pathology 226.2 (2012): 365-379) teach designing inhibitory oligonucleotides can be challenging using different programs wherein each program results in different oligonucleotides that have to be further tested to determine if they can reduce the target sequence in a cell. Thus nothing in Watts et al. would lead one of skill in the art to a predictable computational tool to design an oligonucleotide that targets a miR4661-3p binding region (TATTTAT) on the gene IL17A .
There is no motivation for one of skill in the art to identify any specific region of the IL17A gene, then choose any of the computational tools to design the claimed sequence and then choose specific modified nucleotides and internucleotide linkages, from the vast amount of known modified nucleotides and linkages, to arrive at the claimed oligonucleotide. Furthermore there is not a design need or market demand to design the claimed antisense because it is not taught in the prior art that using an oligonucleotide to block the interaction between miR4661-3p and IL-17A would be useful in diseases mediated by IL-17A. Lastly there is not a finite number of identified and predictable solutions to make it obvious to try because the prior art does not teach a target region that would predictable yield oligonucleotides comprising SEQ ID No. 4. (MPEP 2143 KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Chong at (571)272-3111. The examiner can normally be reached Monday thru Friday between M-F 8:00am-4:30pm.
If attempts to reach the examiner by telephone are unsuccessful please contact the SPE for 1636 Neil Hammell at 571-272-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY CHONG/
Primary Examiner Art Unit 1636
Prosecution Insights