DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/12/2025 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 7, 10-11, 13-15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ji et al (Circ.Res. 2007, 100: 1579-1588, of record) and in further view of Barst et al (Journal of the American College of Cardiology, 2004, vol.43,12, Supplements: 40S -47S, of recvord) and Mann (US 5406959, April 1995).
Ji et al teach a method of identifying dysregulated miRNAs in injured vascular wall to
clarify the role of such miRNAs in the disease (see Abstract) by taking a sample of affected
artery and of normal one, extracting RNA and comparing levels of miRNAs, identifying
dysregulated, downregulated or upregulated, ones (see second column on page 1580), with
further administration of an agent known to inhibit an upregulated miRNA (see Abstract).
Ji et al do not teach a disease being pulmonary arterial hypertension, or assessing a
stage of the vascular-related disease in the individual based on flow rates and blood pressure
within an artery of the individual or obtaining a biopsy sample from a diseased artery using a pulmonary endoarterial biopsy catheter.
Barst et al teach that such parameters as flow rates and blood pressure within an artery
of individual are routinely used to assess a stage of vascular-related disease, including
pulmonary arterial hypertension (see Abstract, page 41S, last paragraph of first column).
Mann teach pulmonary endoarterial biopsy catheter allowing to obtain a biopsy from the inner surface of artery (see Abstract, lines 35-40 in column 5, lines 30-40 in column 3).
It would have been obvious to one with ordinary skill in the art at the time of the
invention to apply methods of Ji et al to determine dysregulated miRNAs in healthy or diseased
tissues of pulmonary artery of an individual suffering from pulmonary arterial hypertension and
according to stage of the disease as taught by Barst et al by obtaining biopsy using catheter taught by Mann and inhibit or promote respective miRNAs for disease treatment, arriving at instant invention. One of the ordinary skill in the art would be motivated to do so in order to clarify the role of miRNAs in pulmonary arterial hypertension by identifying dysregulated miRNAs according to disease stage as taught by Barst et al and Ji et al and administer the agent known to inhibit upregulated miRNA as taught by Ji et al or an agent to promote miRNA to increase downregulates miRNA. One of the ordinary skill in the art would be motivated to use catheter taught by Mann, because it allows to obtain a biopsy from pulmonary artery.
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. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined 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 § 2146 et seq. 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).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 7, 10-11, 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 9,499,816. Although the claims at issue are not identical, they are not patentably distinct from each other because claims from ‘816 recite methods of treatment of pulmonary arterial hypertension by inhibiting or promoting specific miRNAs based on the stage of the disease. Further, specification of ‘816 teaches obtaining of biopsy from pulmonary artery using endoarterial biopsy catheter (see lines 30-40 in column 3) and comparing level of miRNAs in diseased and healthy artery to identify dysregulated miRNAs (see lines 1-20 in column 5). Therefore claims from ‘816 anticipate instant claims.
Response to Arguments
Applicant's arguments filed 12/12/2025 have been fully considered but they are not persuasive.
Previous 112 rejection is withdrawn in view of new amendments, arguments are moot.
Concerning 103 rejection Applicant argues that the references do not teach newly introduced limitation of obtaining of biopsy from pulmonary artery using endoarterial biopsy catheter. In response, new reference by Mann teaches such catheter. Amended rejection is presented above.
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.
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, Jennifer Dunston can be reached at (571)272-2916. 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.
/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637