/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 .
Detailed Action
This is in response to the amendment filed 10/09/2025
Claim Objections
Claims 5-7 are objected to because of the following informalities: Claims 5-7 refers to the distal buckling member, whereas the previous claims recite one or more distal buckling members. Appropriate correction is required.
Allowable Subject Matter
Claims 10, 12 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 10 recites wherein the distal expansion portion is comprised of a pre-defined sloping geometry on the inner shaft and one or more split distal outer shaft segments on the outer sliding shaft. claim 12 recites indicators along the length of the elongated introducer assembly corresponding to the outer diameter of the distal expansion portion concomitant with the position of the outer sliding shaft relative to the inner shaft.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication Number 2007/0142778 (Elbert et al).
Regarding claim 1, Elbert et al. discloses as shown in Figure 7, an apparatus capable of expanding patient tissue, the apparatus comprising: an elongated introducer assembly configured to be maneuvered toward and positioned proximate to a puncture hole of a tissue wall; the elongated introducer assembly including a distal end (bulbous portion of outer sheath 132 shown in Figure 7), an inner shaft (outer sheath 122, see paragraph [0037]) and an outer sliding shaft (outer sheath 132, see paragraph [0038]); the outer sliding shaft being concentrically situated and longitudinally movable relative to the inner shaft; and a distal expansion portion (wings 136, 137, see paragraph [0036]) contiguous with the outer sliding shaft; wherein selective linear movement of the outer sliding shaft relative to the inner shaft forces the distal expansion portion against the distal end and actuates radial expansion of the distal expansion portion.
Claim(s) 1-5, 9, 11, 13, 14, 16, 19-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Number 5,836,913 (Orth et al).
Regarding claims 1-5, 9, 11, 13, 14, 16, 19-21 Orth et al. discloses as shown in Figures 2A-2C, an apparatus capable of expanding patient tissue and a method for use with a puncture hole in a tissue wall, the apparatus comprising: an elongated introducer assembly configured to be maneuvered toward and positioned proximate to a puncture hole of a tissue wall; the elongated introducer assembly including a distal end (obturator 11, abstract), an inner shaft (tubular member 12, see abstract) and an outer sliding shaft (non-expandable 18, see abstract); the outer sliding shaft being concentrically situated and longitudinally movable relative to the inner shaft; and a distal expansion portion (expandable region 19, see abstract) contiguous with the outer sliding shaft; wherein selective linear movement of the outer sliding shaft relative to the inner shaft forces the distal expansion portion against the distal end and actuates radial expansion of the distal expansion portion, wherein the distal expansion portion is comprised of one or more distal buckling members (strands of braid) that are lower in stiffness than the outer sliding shaft, wherein the distal expansion portion is comprised of an expansion member (one strand of the braid) and one or more distal buckling members (other strands of the braid), wherein the expansion member is a segment of the outer sliding shaft that is adjacent to the one or more distal buckling members, wherein the distal buckling member is lower in stiffness than the outer sliding shaft and the expansion member, wherein the distal buckling member is comprised of a polymer material, wherein the outer sliding shaft is selectively moved relative to the inner shaft via an outer sliding shaft advancer, wherein the inner shaft includes a hollow lumen, wherein the elongated introducer assembly includes a proximal hub.
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.
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.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 5,836,913 (Orth et al) in view of U.S. Patent Publication Number 2003/0023266 (Borillo et al.)
Regarding claims 6, 7 Orth et al. fails to disclose wherein the distal buckling member is comprised of nitinol, wherein the distal buckling member is formed by laser-cutting or any other material-removal process..
Borillo et al. from a related field of endeavor teaches a similar buckling member, where the distal buckling member is comprised of nitinol, wherein the distal buckling member is formed by laser-cutting or any other material-removal process. See paragraph [0041].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the distal buckling member disclosed by Orth by substituting the material of the distal buckling member disclosed by Orth et al. for the material of the distal buckling member because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Regarding claim 8, E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted)
In this case, the product in the product-by-process claim is the same as or obvious from a product of Orth et al. and the Office interprets Orth et al. as disclosing wherein the distal buckling member is formed by laser-cutting or any other material-removal process, wherein the distal buckling member is formed by flattening.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 5,836,913 (Orth et al) in view of U.S. Patent Publication Number 2006/0063973 (Makower et al.)
Regarding claim 15, Orth et al. discloses wherein the proximal hub has a luer connector (28, see paragraph [0025]).
Orth et al. fails to disclose the luer connector is female.
Makower et al., from the same filed of endeavor teaches a similar apparatus as shown in Figure 27A, 27B where the luer connector is female. See paragraph [0222].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the apparatus disclosed by Orth et al. by substituting the luer connector disclosed by Orth et al. for the luer connector taught Makower because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 5,836,913 (Orth et al.) in view of U.S. Patent Publication Number 2011/0152760 (Parker al.)
Regarding claim 17, Orth et al. fails to disclose positioning the distal tip proximate to the puncture hole in the tissue wall further includes forming the puncture wall by advancing a puncture device through a hollow lumen whereby the puncture device exits the elongated introducer assembly via the distal tip of the distal end forms the puncture hole in the wall.
Parker al., from the same field of endeavor teaches a similar method as shown in Figures 6, 7 where the distal tip proximate to the puncture hole in the tissue wall further includes forming the puncture wall by advancing a puncture device (guidewire 80, see paragraph [0026]) through a hollow lumen whereby the puncture device exits the elongated introducer assembly via the distal tip of the distal end forms the puncture hole in the wall, for the purpose of guding the introducer assembly.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method dsicsloed by Orth et al. to include the steps of positioning the distal tip proximate to the puncture hole in the tissue wall further includes forming the puncture wall by advancing a puncture device through a hollow lumen whereby the puncture device exits the elongated introducer assembly via the distal tip of the distal end forms the puncture hole in the wall in order to guide the introducer assembly through the body.
Response to Arguments
Applicant’s arguments, see page 6, filed 10/09/2025, with respect to the rejections of claims 16-20 under 35 USC 112 have been fully considered and are persuasive. The rejections of claims 16-20 under 35 USC 112 have been withdrawn.
The applicant’s remaining remarks have been considered moot in view of the new grounds of rejection.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is (571)270-1965. The examiner can normally be reached on Monday – Friday, 9:30 am – 6 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771