DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 are 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 record), Mann (US 5406959, April 1995, of record) and Biedermann (WO 2007/116295, October 2007).
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, or personalization of such treatment.
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 teaches 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).
Biedermann teaches creating personalized treatments for a variety of diseases including pulmonary arterial hypertension (see Abstract, page 2, Table 1, claim 21).
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 designing personalized treatment according to Biedermann, 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. One of the ordinary skill in the art would be motivated to design personalized treatment because Biedermann teaches design of such treatments for a variety of diseases, including pulmonary hypertension.
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). Further, Example IV from ‘816 specification relates to design of personalized treatments. Therefore, claims from '816 anticipate instant claims.
Response to Arguments
Applicant's arguments filed 05/21/2026 have been fully considered but they are not persuasive.
Concerning 103 rejection Applicant argues that none of the reference teach new limitation of personalized treatment. In response, new reference by Biedermann (see amended rejection above) teaches the limitation.
Double patenting rejection is maintained for the reasons of record.
Conclusion
Applicant's amendment necessitated the new ground(s) of 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
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