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 II in the reply filed on 9/22/26 is acknowledged.
NOTE: the Examiner thanks the Applicant’s representative for identifying correctly the three groups. The Examiner agrees with the Applicant’s clarification of the three groups.
Claims 1-10 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.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 9/22/26.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “attachment portion protruding” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
For example, the written specification discloses that the “attachment portion” is element (15). Figure 4 shows element (15), however, the Examiner cannot distinguish how element (15) protrudes from the main body. Additionally, the Examiner is not clear what is element (16). Does Figure 4 is the cover in the cylindrical configuration? Does element (15) is the “tab” and element (16) comprise the “slot”? Correction or clarification is required.
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 § 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.
Claims 11 and 14-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Francis et al US Patent Pub. 2002/0123789A1.
Francis et al discloses a biological cover formed of a biological material (paragraphs 13 and 21), comprising a main body of the biological material in a cylindrical configuration having a first cylinder diameter; and at least one fold in the main body, wherein the at least one fold is configured to at least partially unfold upon radial dilation of the biological material to permit enlargement of the cylindrical configuration to a second cylinder diameter. See paragraph 24.
Regarding claims 16 and 17 see paragraph 21 disclosing pericardium tissue, therefore, the pericardium comprises collagen.
Regarding claims 14 and 15, the Examiner interpreted the sutures in paragraph 45 as the protrusions, the sutures are used to attach the cover to the stent.
Claim Rejections - 35 USC § 103
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 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.
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Francis et al US Patent Pub. 2002/0123789A1 in view of Levi et al US Patent Pub. 2014/0249614A1.
Francis et al discloses the invention substantially as claimed. Additionally, Francis in paragraph 24 discloses a cover having overlapping portions or crimped portions. However, Francis is silent regarding having a cover with at least one tab and at least one opening, wherein the at least one tab is arranged through the at least one opening to form a tab-and-slot connection.
Levi et al discloses a stent having a sheath covering the stent. The sheath can have multiple configurations (see Figs. 7A-C), one configuration is a rolled no overlap configuration (Fig. 7A), second an oval-shaped (Fig. 7B) and a third an overlap rolled configuration (Fig. 7C). One of the embodiments of the Levi et al as shown in Figs. 16 and 17 (See paragraphs 175-179) discloses a sheet that includes two tabs and a slot at the other end for the purpose of avoiding the unraveling of the sheet too far to assure proper stent covering and alignment.
It would have been obvious to one ordinary skill in the art to modify the overlapping cover of the Francis et al reference with the overlap cover having the tabs and slot of the Levi et al reference in order to avoid the unraveling of the sheet too far to assure proper stent covering and alignment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Pub. 2010/0122698A1 --- See Figure 2 disclosing attachment portion protruding from body.
US Patent --- See Figs. 1-2B showing tabs extending along a slot creating a connection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 10/14/26
