DETAILED ACTION
Status of Claims
Claims 1-20 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Office Action: Non-Final.
Claim Rejections - Nonstatutory 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 obviousness-type 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); 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 conflicting 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.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-20 are rejected on the ground of nonstatutory double patenting over claims 1-22 of US 10,987,451 B2 to Wang et al., hereinafter, “‘451 Patent”, Issued, Apr. 27, 2021, matured from US Appl. No. 16/986,683.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims recite a balloon catheter with a drug coating comprising a therapeutic agent to one or more additives, whereby claims 1-22 of the ‘451 Patent anticipate claims 1-20.
Claims 1-20 are rejected on the ground of nonstatutory double patenting over claims 1-28 of US 11,648,337 B2 to Wang et al., hereinafter, “‘337 Patent”, Issued, May 16, 2023, matured from US Appl. No. 17/208,518.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims recite a balloon catheter with a drug coating comprising a therapeutic agent to one or more additives, whereby claims 1-28 of the ‘337 Patent anticipate claims 1-20.
Claims 1-20 are rejected on the ground of nonstatutory double patenting over claims 1-27 of US 11,648,338 B2 to Wang et al., hereinafter, “‘338 Patent”, Issued, May 16, 2023, matured from US Appl. No. 17/208,561.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims recite a balloon catheter with a drug coating comprising a therapeutic agent to one or more additives, whereby claims 1-27 of the ‘338 Patent anticipate claims 1-20.
Claims 1-20 are rejected on the ground of nonstatutory double patenting over claims 1-20 of US 12,115,286 B2 to Wang et al., hereinafter, “‘286 Patent”, Issued, Oct. 15, 2025, matured from US Appl. No. 17/843,150.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims recite a balloon catheter with a drug coating comprising a therapeutic agent to one or more additives, whereby claims 1-27 of the ‘150 Patent anticipate claims 1-20.
Claims 1-20 are rejected on the ground of nonstatutory double patenting over claims 1-20 of US 12,168,108 B2 to Wang et al., hereinafter, “‘108 Patent”, Issued, Dec. 17, 2024, matured from US Appl. No. 18/379,505.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims recite a balloon catheter with a drug coating comprising a therapeutic agent to one or more additives, whereby claims 1-20 of the ‘108 Patent anticipate claims 1-20.
Claims 1-20 are rejected on the ground of nonstatutory double patenting over claims 1-21 of US copending Appl. No. 18/379,517 (hereinafter, “‘517 Application”).
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims recite a balloon catheter with a drug coating comprising a therapeutic agent to one or more additives, whereby claims 1-21 of the ‘517 Application anticipate claims 1-20.
Claims 1-6 and 11-20 are rejected on the ground of nonstatutory double patenting over claims 1-20 of US 12,383,710 B2 to Wang et al., hereinafter, “‘710 Patent”, Issued, Aug. 12, 2025, matured from US Appl. No. 18/645,654.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims recite a balloon catheter with a drug coating comprising a therapeutic agent to one or more additives, whereby claims 1-20 of the ‘710 Patent anticipate claims 1-20.
Claims 7-10 are rejected on the ground of nonstatutory double patenting over claims 1-20 of US 12,383,710 B2 to Wang et al., hereinafter, “‘710 Patent”, Issued, Aug. 12, 2025, matured from US Appl. No. 18/645,654, as applied to claims 1-6 and 11-20, above, and further in view of the disclosure of SLAGER (US 2012/0296274 A1, Publ. Nov. 22, 2012; on 08/29/2024 IDS; hereinafter, “Slager”).
The teachings of the ‘383 Patent, as set forth above, are hereby incorporated. However, to the extent that the ‘383 Patent DOES NOT RECITE particular additives, namely pentaerythritol ethoxylate as required by claims 7 and 16, the incorporation thereof would be obvious.
Slager, for instance, is directed to:
DELIVERY OF COATED HYDROPHOBIC ACTIVE AGENT PARTICLES
ABSTRACT
Embodiments of the invention include devices and coatings for devices including coated hydrophobic active agent particles. In an embodiment, the invention includes a drug delivery device including a substrate; and coated therapeutic agent particles disposed on the substrate, the coated therapeutic agent particles comprising a particulate hydrophobic therapeutic agent; and a cationic agent in contact with the particulate hydrophobic therapeutic agent. Other embodiments are also included herein.
(Slager, title & abstract), which are suitable for “urethral balloons and urethral stents for urological treatments.” (Slager, par. [0071]). In this regard, Slager discloses suitable coating materials, inter alia, “Pentaerythritol ethoxylate 15/4 EO/OH” for paclitaxel. Slager, par. [0226]. It is noted that “Pentaerythritol ethoxylate 15/4 EO/OH,” which is disclosed by Slager as a suitable coating material for paclitaxel (Slager, par. [0226]), relates to “pentaerythritol ethoxylate (15/4)” and “pentaerythritol ethoxylate (3/4)” of claims 7-10. In this regard, it is noted that compounds in a homologous series are considered patentably indistinct. MPEP § 2144.09(II) states: “[c]ompounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties, In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious)” (MPEP § 2144.09).
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to take the drug-coated balloon catheter of the ‘710 Patent, and to have incorporated a coating material such as “Pentaerythritol ethoxylate 15/4 EO/OH” per Slager (Slager, par. [0226]). One would have been motivated to do so with a reasonable expectation of success since both the ‘710 Patent and Slager are concerned with similar problems in the art, namely drug release coatings for medical devices (Wang, abstract; Slager, abstract). Further, it is well within the skill of the ordinary artisan to select suitable additives. Doing so amounts to no more than combining prior art elements according to known methods to yield predictable results, namely the manufacture of a coated balloon catheter with “Pentaerythritol ethoxylate 15/4 EO/OH” per Slager (Slager, par. [0226]) in order to obtain the advantage of a suitable coating material for a hydrophobic active agent such as paclitaxel (‘710 Patent, claim 6; Slager, par. [0226]).
Thus, claims 1-20 of the ‘710 Patent per Slager render claims 7-10 obvious.
Conclusion
Claims 1-20 are rejected. No claims are allowed. WO 2009/051614 A1 by Wang, on 08/29/2024 IDS, is noted as a reference of interest.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BETHANY BARHAM can be reached on (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOMINIC LAZARO/Primary Examiner, Art Unit 1611
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