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
Applicants’ arguments filed 8/12/26 have been fully considered but they are not persuasive. The Applicant’s representative discloses that the Nguyen et al reference does not disclose the claimed subject matter by disclosing that claim 1 shows a single piece integral valve and that the Nguyen et al reference is made of several pieces.
The Examiner wants to point out that the term “integral” is given its broadest reasonable interpretation consistent with the specification. The MPEP discloses that the term “integral” can include structures maintained “in a fixed relationship as a single unit”. The word “integral” can cover multi-piece structures and that nothing inherently limits the term to a monolithic construction. The Examiner is interpreting the claim broad enough that can include components that were initially separate and later joined together to form the complete device. For the reasons above, the Examiner is maintaining the previous rejection.
The term integral was held not to be limited to a fabrication of the parts from a single piece of material, but was inclusive of other means of maintaining the parts fixed together as a single unit. In re Larson et al., 340 F 2d 965, 144 U.S.P.Q. 347 (C.C.P.A. 1965). « integral is sufficiently broad to embrace constructions united by such means as fastening and welding. In re Hotte, 475 F 2d 644, 177 U.S. P.Q. 326 (C.C.P.A. 1973).
NOTE: if the applicant’s representative changes the word “integral” for the word “monolithic” that will overcome the rejection. However, the Examiner believes that by changing the word to monolithic will not place the case in condition for allowance, since, changing the prior-art construction to “monolithic” could be an obvious engineering choice.
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, 20-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen et al US Patent Pub. 2006/0259136 A1.
Nguyen et al discloses valve prosthesis (10) comprising a stent structure (12), a single piece integral (see Fig. 4B) molded valve (see paragraph 23 saying that it can be stitched or molded) coupled to the stent structure, the one-piece integral valve comprising commissures (where elements g, h and I are located, see Fig. 3B), commissure tabs (36, see Fig. 4B) extending from the commissures. Each commissure tab comprising a main body (34 and 35, see Fig. 4A), a first ear (36) attached to the main body; and a second ear (36) attached to the main body. See Figs. 3A-4B.
Regarding claims 20 and 21, see paragraph 23 disclosing pericardiac tissue.
Regarding claim 22, see Figs. 3A and 3B showing multitude of folds, see lines d, e, f, g, h, i.
Claims 11-16 and 20-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biadillah et al US Patent Pub. 2014/0018915A1.
Biadillah et al discloses a valve prosthesis comprising a stent structure, a single piece integral valve coupled to the stent structure, the one-piece integral valve comprising commissures, and the commissure tabs extending from the commissures. Each commissure tab comprising a main body, a first ear attached to the main body and a second ear attached to the main body. The valve is made of stitching the leaflets to the skirt.
Regarding claim 12, see paragraph 111, lines 26-31, the Examiner interpreted that the main body is the section of the tabs (30) passing through the slit (8) of the pericardium tissue (4). See also Fig. 5c.
Regarding claims 13 and 14, see Figs. 5d and 5e, see paragraph 111, lines 35 to the end of the paragraph.
Regarding claim 15, the first and second ears extend perpendicular from the main body when the tabs (30) fold and cover element 22a, see especially the two embodiments in Figs. 4a and 4d.
Regarding claim 16, see Figs. 5d and 5e showing the commissure tab wrapping around and attached to the post.
Regarding claims 20 and 21, see paragraph 11 disclosing pericardium tissue.
Regarding claims 22 and 23, see specifically Figs. 4a and 5c-e. Figure 5c discloses two tabs (g), these two tabs will be folded around structure (22a) in Fig. 4a, as shown in Fig. 5d, therefore, because structure (22a) in Fig. 4a has a rectangular cross-section, it is inherent to the two tabs have four folds in total around element 22a, as shown in Fig. 5c.
Conclusion
THIS ACTION IS MADE FINAL. 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 ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 9/24/26
