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 I (claims 1-8) in the reply filed on 1/5/26 is acknowledged.
Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 1/5/26.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
MPEP 2111.04 States:
2111.04 "Adapted to," "Adapted for," "Wherein," "Whereby," and Contingent Clauses [R-10.2019]
I. "ADAPTED TO," "ADAPTED FOR," "WHEREIN," and "WHEREBY"
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) "adapted to" or "adapted for" clauses;
(B) "wherein" clauses; and
(C) "whereby" clauses.
Claim(s) 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang et al. 2014/0371837.
Noting for example figure 6(A) below, Huang et al. discloses:
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Regarding claim 1, Huang et al. discloses a delivery device (catheter and sheath combination]) adapted to deliver an implantable medical device to a deployment site, the delivery device comprising: an elongate shaft (see e.g. 6D) extending from a proximal region to a distal region, the elongate shaft defining: a first portion (20) adapted to accommodate the implantable medical device; and a second portion (216) adapted to accommodate a drug eluting component (214) to be delivered along with the implantable medical device; wherein the delivery device is adapted to (see MPEP 2111.04 above) release the implantable medical device at the deployment site.
Regarding claim 2 Huang et al. discloses wherein the second portion comprises a passageway in fluid communication with a source of an elutable drug (This is interpreted because 216 has a porous layer and is in fluid communication with therapeutic agent layer 214).
The current claims are apparatus claims and not method claims. Regarding claims 3-6, the intended use recitation language of:
“adapted to bathe the implantable medical device with the elutable drug prior to releasing the implantable medical device” and “adapted to bathe the deployment site with the elutable drug either before, during or after releasing the implantable medical device”; “wherein the second portion keeps the drug eluting component away from the implantable medical device until deployment”; “wherein a sheath separates the first portion from the second portion until the sheath is retracted.” carries no weight in the absence of any distinguishing structure.
See MPEP 2114 which states”
2114 Apparatus and Article Claims — Functional Language [R-07.2015]
For a discussion of case law which provides guidance in interpreting the functional portion of means-plus-function limitations see MPEP § 2181 - § 2186.
I. INHERENCY AND FUNCTIONAL LIMITATIONS IN APPARATUS CLAIMS
Features of an apparatus may be recited either structurally or functionally. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997). See also MPEP § 2173.05(g). If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. See also Bettcher Industries, Inc. v. Bunzl USA, Inc., 661 F.3d 629, 639-40, 100 USPQ2d 1433, 1440 (Fed. Cir. 2011). The burden then shifts to applicant to establish that the prior art does not possess the characteristic relied on. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432; In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226, 228 (CCPA 1971) ("where the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on")
Huang et al. discloses the structure as claimed and is thus capable of performing the functions.
Regarding claim 7, Huang et al,. discloses that the drug eluting component comprises one or more elongate members carrying an elutable drug. See annotation below.
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Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. 2014/0371837.
Regarding claim 8, Huang et al. has been disclosed supra however does not specifically state that “…the one or more elongate members comprise threads or wires that are impregnated or coated with the elutable drug.” It would have been obvious to one having ordinary skill in the art to modify the invention of Huang et al. and provide elongate members with threads or wires that are impregnated or coated with the elutable drug because Huang et al. envisions nano materials that can have several dimensions and diameters for the therapeutic agent (see [00725]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. 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:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 January 30, 2026