DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election without traverse of Group I in the reply filed on 03/31/2026 is acknowledged.
Claims 10-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/31/2026.
INFORMATION DISCLOSURE STATEMENT
2. No Information Disclosure Statement has been submitted for review.
Claim Rejections- 35 USC § 112
3. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 5 and 7-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 5 recites a period after cm and it is not clear if the rest of the claim are limitations that are part of the claim or not.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation chemotherapeutic agents, and the claim also recites including gemcitabine hydrochloride, paclitaxel or its combinations which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. It is unclear if any chemotherapeutic agent or these specific ones meet this claim. For the purpose of examination, the Examiner interprets the claim to require gemcitabine hydrochloride, paclitaxel or combinations.
Claim 7 recites adapted to provide a time-released drug elution profile of gemcitabine hydrochloride up to 6 months. It is not clear if the recitation of adapted implies additionally altering the structure of the stent or not. For the purpose of examination, this claim is being interpreted such that any stent with the structure of claim 1 that contains gemcitabine hydrochloride meets the claim.
Claims 8-9 recite adapted to be deployed or implanted in a porcine bile duct and it is not clear if the recitation of adapted implies additionally altering the structure of the stent or not. For the purpose of examination these claims are treated as intended use of the composition and the SEMS is deployed endoscopically in porcine bile duct or implanted in a porcine bile duct via an endoscopic procedure and retain stent patency for a duration of 5 months.
Claim Rejections- 35 USC § 102
4. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-2, 6 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Frank et al. (US 2007/0293927).
Frank et al. (US 2007/0293927) (hereinafter Frank et al.) disclose a self-expanding stent with polymeric filaments intertwined with struts at specific locations along the stent (Fig 1-6, paras 0018, 0054-0056 0072, claim 29). Frank et al. disclose functionalization with nanofibers (para 0074 and Figs 6B and 6C, 0092-0093). The stent contains bioactive agents (para 0094). The polymeric filaments include polycaprolactone (para 00085). FIGs 6B and 6C show intertwined and knotted at the ends.
Claim Rejections- 35 USC § 103
5. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 3 rejected under 35 U.S.C. 103 as being unpatentable over Frank et al. (US 2007/0293927).
Frank et al. (US 2007/0293927) (hereinafter Frank et al.) disclose the stent contains bioactive ingredients that include paclitaxel (para 0131). Frank et al. disclose that the polymeric filaments have a diameter from 10 -1000 micron (para 0022).
The specific combination of features claimed is disclosed within the broad generic ranges taught by the reference but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have selected various combinations of the chemotherapeutic agents such as paclitaxel to arrive at compositions yielding no more than one would expect from such an arrangement.
6. Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over in view of Frank et al. (US 2007/0293927) and Koyakutty et al. (US 20140363484).
Frank et al. has been discussed supra and disclose that the polymeric filaments have a diameter from 10 -1000 micron (para 0022). The nanofiber diameter is not disclosed.
Koyakutty et al. (US 20140363484) (hereinafter Koyakutty et al.) disclose polymeric fibers having diameter of about 10 nm-50,000 nm (para 0026). The rate of hydrolysis may be controlled by factors such as diameter for controlled release of the therapeutic (para 0030). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to select the desired nanofiber diameter to control release of therapeutic. One would have been motivated to do so because the rate of hydrolysis is controlled by factors such as diameter and thus tailer the desired release profile.
7. With regards to claim 5, this claim recites a period in the claim therefore is rejected under 112 however, the claim subject matter would be allowable once the 112 is overcome. US 20170231995 disclose gemcitabine for treatment of cancer where gemcitabine is administered at doses of 1000 mg/m2 (para 0647). It does not teach the dosage is between 5 and 10 mg/cm of length of the SEMS.
CORRESPONDENCE
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANAH AL-AWADI/Primary Examiner, Art Unit 1615
Prosecution Insights