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 of Group I. in the reply filed on 04/06/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Rejections - 35 USC § 112
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 7 and 21 are dependent on canceled claims.. Examiner suggest correcting canceled claim dependency.
Claim 35 recites the limitation " wherein the first sheath is configured to release after the second sheath is released". There is a lack of antecedence for the first sheath and second sheath.
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) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shaw et al. US 20120130475 A1, herein referred to as Shaw.
Regarding claim 1, Shaw discloses an implantable medical device (Fig 1; [0047]) comprising: an expandable device (Fig 1, 102) having a longitudinal length (Fig 1) and operable to be compressed to a first diameter ([0046]) and deployed to a second diameter (feature of expandable element; [0047-0048]), wherein the second diameter is greater than the first diameter ([0048]), and wherein a first portion (Fig 1, 104a) that is less than the longitudinal length of the expandable device (Fig 1, 102) and a second portion (Fig 1, 104b) that is less than the longitudinal length of the expandable device are defined on the expandable device (Fig 1); a first constraining member (Fig 1, 104a) operable to constrain the first portion of the expandable device (102) at the first diameter ([0046-0048]); a second constraining member (Fig 1,104b) operable to constrain the second portion of the expandable device (102) at the first diameter (Fig 1).
Regarding claim 2, Shaw discloses wherein the first constraining member defines a first release zone (Applicant defines release as one or more strands for release the device, see [0075] of the instant application; Fig 2, coupling member 114); the second constraining member defines a second release zone (Fig 3, 314a/b teaches multiple coupling members for releasing device).
Regarding claim 3, Shaw discloses wherein the first deployment line is configured to release the first constraining member along the first release zone by tensioning the first deployment line ([0043-0044]), and wherein the second constraining member further comprises a second deployment line ([0043-0044; Fig 3, 314a/b), wherein the second deployment line is configured to release the second constraining member along the second release zone by tensioning the second deployment line ([0043-0044]; Fig 3, 314a/b; fully capable of corresponding deployment line tension with release zones).
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.
the second constraining member defines a second release zone, as suggest and taught by Shaw in order to allow independent angular manipulation of associated members (Shaw [0050]).
Claim(s) 4, 7, 9-10, 16-18, 21-25, 29-31 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shaw in view of Essinger et al. US 20140200649 A1, herein referred to as Essinger.
Regarding claim 4, Shaw discloses the invention substantially as claimed and as discussed above with respect to claim 3, but fails to disclose wherein the first release zone is configured to release when a first tension force is applied across the first deployment line, wherein the second release zone is configured to release when a second tension force is applied across the second deployment line, and wherein the first tension force is higher than the second tension force.
But Essinger teaches wherein the first release zone is configured to release when a first tension force (Essinger [0023]) is applied across the first deployment line (Essinger [0023]), wherein the second release zone is configured to release when a second tension force is applied across the second deployment line, and wherein the first tension force is higher than the second tension force (Shaw teaches varying angular manipulation yielding unequal forces [0050]; “…wherein the first deployment force is greater than the second deployment force” is a functional recitation that is not given full patentable weight. The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [allow the first deployment force to be greater than a subsequent deployment for] the recited function in order to meet the claim requirements. In this case, the Shaw’s device discloses all the claimed structural features and is considered to be capable of having a greater first deployment force).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Shaw to wherein the first release zone is configured to release when a first tension force is applied across the first deployment line, wherein the second release zone is configured to release when a second tension force is applied across the second deployment line, and wherein the first tension force is higher than the second tension force, as suggest and taught by Essinger in order to allow cover/release of a treatment element (Essinger [0091]).
Regarding claim 7, Shaw/Essinger discloses the invention substantially as claimed and as discussed above with respect to 4 teaches wherein the second constraining member (Shaw Fig 1, 104a) is positioned between the first constraining member (Essinger Fig 7, sheath 706) and the expandable member (Shaw Fig 1, 102) where the second constraining member extends over at least part of the first portion of the expandable member (Shaw Fig 1).
Regarding claim 9, Shaw/Essinger discloses the invention substantially as claimed and as discussed above with respect to 7 teaches wherein the second constraining member includes an everted portion (Essinger Fig 4A-B, 403 or 503; [0087]).
Regarding claim 10, Shaw/Essinger discloses the invention substantially as claimed and as discussed above with respect to 9 teaches wherein the everted portion (Essinger Fig 4A-B, 403 or 503; [0087]) of the second constraining member (Shaw Fig 1, 104a) is disposed about at least part of the first portion expandable member and the first constraining member (Shaw Fig 1).
Regarding claim 16, Shaw/Essinger discloses the invention substantially as claimed and as discussed above with respect to 9 teaches wherein the first constraining member is operable to release after the second constraining member has been released (capable of claimed release operation; Essinger [0023]).
Regarding claim 17, Shaw/Essinger discloses the invention substantially as claimed and as discussed above with respect to 3 teaches wherein the first deployment line (Essinger Fig 8; [0075])) is engaged with the second constraining member such that when the second constraining member is released [0094] teaches unsheathing), the first deployment line is accessible to activate release of the first constraining member (Essinger [0094-0095]).
Regarding claim 18, Shaw/Essinger discloses the invention substantially as claimed and as discussed above with respect to 17 teaches wherein the first deployment line (Essinger Fig 8, pull wire 802 [0095]) is coupled to the second constraining member (Essinger Fig 8, 801) such that when the second constraining member has translated away from the expandable member (Essinger [0024]), the first deployment line is tensioned and activates release of the first constraining member (Essinger [0095]).
Regarding claim 22, Shaw discloses an implantable medical device (Fig 1; [0047]) comprising: an expandable member (Fig 1, 102) having a proximal end and a distal end (Fig 1, [0049]), wherein the expandable member has a longitudinal length defined between the proximal end and the distal end (Fig 1 [0049]; a first constraining member (Fig 1 104a) disposed about the expandable member at a first portion that is less than all of the longitudinal length of the expandable member (Fig 1), wherein the first constraining member maintains the expandable member at the first portion at a constrained diameter ([0046-0049]; and a second constraining member (Fig 1, 104b) including a first segment (Fig 1, [0049] teaches distal, middle and proximal), wherein the first segment of the second constraining member is disposed about the expandable member at a stabilizing portion (Annotated Fig 1 below) that is a remainder of the longitudinal length where the first constraining member is not disposed about the expandable member (Fig 1), wherein the second constraining member maintains the expandable member at the stabilizing portion (Annotated Fig 1) at the constrained diameter ([0048-0049]).
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But does not disclose a second constraining member including an everted segment, wherein the everted segment of the second constraining member is disposed about the first segment of the second constraining member and the stabilizing portion of the expandable member.
But Essinger teaches constraining member (Fig 1, sheath 103; [0008, teaches combing sheath with the rolling membrane shown in Figs A-B]) including an everted segment (Fig 4A-B, 403 or 503; [0087]), wherein the everted segment of the second constraining member is disposed about the first segment of the second constraining member (Annotated Fig 4A below) and the stabilizing portion of the expandable member (Fig 1, shows the claimed configuration with the rolling membrane housed inside the straining member 103).
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Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Shaw to incorporate a second constraining member including an everted segment, wherein the everted segment of the second constraining member is disposed about the first segment of the second constraining member and the stabilizing portion of the expandable member, as taught and suggested by Essinger In order to selectively expose regions of the device (Essinger [0008]).
Regarding claim 23, Shaw/Essinger discloses the invention substantially as claimed and as discussed above with respect to 22 teaches wherein the first constraining member (Shaw Fig 1 104a) further comprises a first release (Applicant defines release as one or more strands for release the device, see [0075] of the instant application; Shaw Fig 2, coupling member 114) and a first deployment line (Essinger Fig 8, pull wire 802 [0095]), and wherein the second constraining member (Shaw Fig 1, 104b) further comprises a second release zone (Fig 3, 314a/b teaches multiple coupling members for releasing device) and a second deployment line (Essinger [0075]).
Regarding claim 24, Shaw/Essinger discloses the invention substantially as claimed and as discussed above with respect to 23 teaches wherein the first deployment line is operable to release the first release zone when at least a first deployment force is applied to the first deployment line (Essinger [0075] teaches intend use limitation), and wherein the second deployment line is operable to release the second release zone when at least a second deployment force is applied to the second deployment line (Essinger [0075] teaches pulling sheaths and required; directed at intended use).
Regarding claim 25, Shaw/Essinger discloses the invention substantially as claimed and as discussed above with respect to 24 teaches wherein the first deployment force is greater than the second deployment force (Shaw teaches varying angular manipulation yielding unequal forces [0050]; “…wherein the first deployment force is greater than the second deployment force” is a functional recitation that is not given full patentable weight. The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [allow the first deployment force to be greater than a subsequent deployment for] the recited function in order to meet the claim requirements. In this case, the Shaw’s device discloses all the claimed structural features and is considered to be capable of having a greater first deployment force).
Regarding claim 29, Shaw/Essinger discloses the invention substantially as claimed and as discussed above with respect to 22 teaches wherein the everted segment (Essinger Fig 4A-B, 403 or 503; [0087]) of the second constraining member is disposed about the first constraining member (Shaw Fig 1).
Regarding claim 30, Shaw/Essinger discloses the invention substantially as claimed and as discussed above with respect to 22 teaches wherein the stabilizing portion (Essinger Annotated Fig 4A above) of the expandable member (Shaw Fig 1, 102) is operable to deploy to a second diameter when the second constraining member is removed from the expandable member (Shaw [0046-0048]).
Regarding claim 31, Shaw/Essinger discloses the invention substantially as claimed and as discussed above with respect to 23 teaches wherein the first deployment line is engaged with the second constraining member such that first constraining member is operable to be released after the second constraining member has been released (capable of claimed deployment order) and the stabilizing portion (Essinger Annotated Fig 4A above) of the expandable member (Shaw Fig 1, 102) has been deployed (capable of claimed deployment order).
Regarding claim 35, Shaw/Essinger discloses the invention substantially as claimed and as discussed above with respect to 22 teaches wherein the first sheath is configured to release after the second sheath is released, such that the proximal end of the expandable member is deployed subsequent to the distal end being deployed (claim is aimed at intended use combination is fully capable of claimed deployment order).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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/A.F./Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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