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 .
Response to Arguments
Applicant's amendments filed 3/26/2026 have been fully considered.
The Title and Abstract have not been corrected in the specification. Replace the title with what applicant used below as an amendment to the specification.
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The drawings have not been corrected to show the cuff. Applicant states reference numeral 5.3 has been added to new figure 4A. No figure 4A is found.
The rejection under 35 U.S.C. 102(a)(2) as being anticipated by Jackson et al (2020/0229956) has been reapplied due to the extensive amendments.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the cuff on the cuffed distal end as described in the specification. Figure 4 showing a cuff on the cuffed distal part 5.2 with orifices 6 is necessary. The examiner request using shading or a pattern to indicate the cuff.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112, Second Paragraph
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.
Claims 1-4 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 1: What/where is the transitional phrase? The medical device should comprise the structurally continuous stent structure.
Line 4, should “proximal end” be “proximal end region”.
Line 12, “parts” lacks antecedent basis.
Lines 12 and 13, “and” is repeated.
Claim 3: The claim language uses: distal end part region and distal end region; are these supposed to be the same limitation or different? Same for proximal end part region and proximal part.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jackson et al (2020/0229956). Figure 12 is supported as figure 4 in provisional application No. 62/795,836 filed 1/23/2019.
Jackson et al teaches a medical device having a structurally continuous stent structure having a proximal end region (generally 2170 half) dimension to provide adherence to a blood vessel into which it is inserted and a tapered cuffed area at the distal end region (generally 2180 half) which is of smaller diameter than the proximal end (see at least par. 0107-0108 and supported by the drawing) so as to create resistance to blood flow (flow modifying apparatus as described in the abstract) when inserted into a blood vessel.
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Said medical device comprising at least three orifices (depicted) which are situated in a junction level (depicted) between said proximal end region and on the cuffed area at the distal end region.
Claim 2, the device is adjustable in size/area during implantation/expansion and is fully capable of being varied in size/area varying (which includes the orifices if this is being claimed).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bruckheimer et al (10,667,931) – fails to teach a tapered geometry that narrow from the boundary with the proximal region to the exit.
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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 BRUCE EDWARD SNOW whose telephone number is (571)272-4759. The examiner can normally be reached 7:30 am - 5:00 pm Monday through Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached on 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRUCE E SNOW/Primary Examiner, Art Unit 3774