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
In view of the amendments filed on 11/4/2025, the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejections regarding the two distal tubular implant sections claim language, cited in the office action of 8/4/2025, are moot.
Applicant's arguments filed 11/4/2025, with respect to claim 8 and its dependent claims have been fully considered but they are not persuasive. The Applicant contends that elements 500 and 510 do not constitute a proximal section via which the sleeve can be retracted in the proximal direction so that the opening zone opens and each of the distal tubular implant sections pass through the opening zone and are released in the branching blood vessels. The examiner respectfully disagrees. The proximal section of Eker in reference to claim 8 was interpreted to be elements 102, 112, 500, and 510. Elements 102 and 112 are retracted in the proximal direction in conjunction with the movement of elements 500 and 510 so that the opening zone opens and each of the distal tubular implant sections pass through the opening zone and are released in the branching blood vessels (Figs. 4-10; pgs. 12-13). Since these proximal section elements meet the claim limitations, the rejection has been maintained, as described below.
The Applicant further contends that Eker does not recite the opening zone being designed such that the sleeve opens sequentially from the distal ends of the distal sleeve arms in the proximal direction when the implant is released. The examiner respectfully disagrees. Eker discloses that its opening zones can comprise breakable seals that are broken as the delivery catheter is withdrawn from the bifurcated stent in a proximal direction, thus causing the seals and their associated opening zones to open from a distal to a proximal direction (Figs. 4-10; pgs. 12-13). In addition, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, due to the construction of the opening zones of Eker, they would be fully capable of opening sequentially from the distal ends of the distal sleeve arms in the proximal direction, based on the position of the implant and the delivery catheter.
Applicant’s remaining arguments with respect to claim(s) 1-7 have been considered, but are moot in view of the new grounds of rejection. The Eker reference has been re-interpreted, as described below, to address the claim amendments of 11/4/2025.
Claim Objections
Claims 1 and 8 are objected to because of the following informalities: a grammatical error in claim 1, lines 10-11, which recites “one of the two distal tubular implant section.” This grammatical error is also in claim 8, line 9. Appropriate correction is required.
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 1, 28, and their dependent claims 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. Claim 1 recites the limitation "the proximal sections" in lines 19-20. There is insufficient antecedent basis for this limitation in the claim. The language of “the proximal sections” further renders the claims indefinite as claim 1 previously established only a proximal section in line 15. It is unclear if the claim is intending to recite a single proximal section or multiple proximal sections. Appropriate correction and/or clarification is required.
Claim 28, lines 3-4, recites the implant having two distal tubular implant sections. Claim 28, lines 9-10 also recites a first and a second distal tubular implant section. It is unclear if the first and second distal tubular implant sections are intended to be the same elements as the two distal tubular implant sections. Appropriate correction is required. For the purpose of the present examination, the two distal tubular implant sections and the first and second distal tubular implant sections are being interpreted to be the same elements.
Claim 28 recites the limitation "the first distal sleeve section" and “second distal sleeve section.” There is insufficient antecedent basis for these limitations in the claim. It is further unclear if the first and second distal sleeve sections are intended to be the same elements as the distal sleeve sections previously recited in claim 28. Appropriate correction is required.
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) 1-12 and 28-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eker et al. (WO 2018/134097 A1; hereinafter “Eker”).
As best interpreted, Eker discloses the following regarding claim 1: an insertion system (100) for an implant (200) for influencing the flow of blood in the region of aneurysms located at vessel branches (Figs. 4-10), with the implant having two distal tubular implant sections (220, 222) which are intended to be placed in blood vessels branching off from the parent blood vessel (Figs. 4-10) and which are connected to one another at a branching point (region of element 200 connecting elements 220, 222) (Figs. 4-10), wherein the insertion system is provided with two sleeves (120, 122), each configured to accommodate one of the two distal tubular implant section (Figs. 4, 9, where element 120 accommodates element 220 and element 122 accommodates element 222), wherein the two sleeves each being provided with a distal sleeve section (distal portions of elements 120, 122) and the distal sleeve sections each having a longitudinally extending opening zone (140, 140’, 140”), wherein proximally adjoining each of the distal sleeve sections there is a proximal section (112) via which the sleeves can be withdrawn in the proximal direction (pgs. 5, 12-13) so that the opening zones open and each of the distal tubular implant sections passes through the opening zones and are released in the branching blood vessels (Figs. 4-10; pg. 12) wherein the proximal sections (left and right side sections of element 112 and/or upper and lower sections of element 112) are integral parts of the sleeves (Figs. 1, 4, 9).
Eker discloses the following regarding claim 2: an insertion system according to claim 1, wherein the opening zones are provided in the form of longitudinal slots (Fig. 1).
Eker discloses the following regarding claim 3: an insertion system according to claim 1, wherein the sleeves, at least in the region of the distal sleeve sections, are composed of a flexible tube material (pg. 15).
Eker discloses the following regarding claim 4: an insertion system according to claim 1, wherein the proximal sections (left and right side sections of element 112 and/or upper and lower sections of element 112) are designed to be sleeve-shaped or tubular (Figs. 1, 5-9).
Eker discloses the following regarding claim 5: an insertion system according to claim 1, wherein the proximal sections (left and right side sections of element 112 and/or upper and lower sections of element 112) are designed to be in the form of wires, filaments or strips (Figs. 1, 5-9; pgs. 12-13, 15).
Eker discloses the following regarding claim 6: an insertion system according to claim 1, wherein the insertion system comprises a trunk sleeve (300) provided for accommodating a tubular trunk section (226) of the implant (Fig. 4), the trunk sleeve being withdrawable in proximal direction for releasing the trunk section (pgs. 10, 13-14).
Eker discloses the following regarding claim 7: an insertion system according to claim 6, wherein the trunk sleeve is made of a flexible tube material (pgs. 18-19).
Eker discloses the following regarding claim 8: an insertion system (100) for an implant (200) for influencing the flow of blood in the region of aneurysms located at vessel branches (Figs. 4-10), wherein said implant comprising two distal tubular implant sections (220, 222) which are intended to be placed in blood vessels branching off from the parent blood vessel (Figs. 4-10) and which are connected to each other at a branching point (Figs. 4-10), wherein the insertion system being provided with a sleeve (Fig. 1) having two distal sleeve arms (120, 122) which are each configured to accommodate one of the distal tubular implant section (Figs. 4, 9, where element 120 accommodates element 220 and element 122 accommodates element 222) and which are interconnected, the sleeve having a continuous opening zone (140, 140’, 140”) in the distal direction (Fig. 1) and with the sleeve having a proximal section (102, 112, 500, 510) (Figs. 4-9) via which the sleeve can be retracted in the proximal direction so that the opening zone opens and each of the distal tubular implant sections pass through the opening zone and are released in the branching blood vessels (Figs. 4-10; pg. 12), wherein the opening zone is designed such that the sleeve opens sequentially from the distal ends of the distal sleeve arms in the proximal direction when the implant is released (Figs. 4-10; pg. 12).
Eker discloses the following regarding claim 9: an insertion system according to claim 8, wherein the opening zone comprises a continuous slot pointing in the distal direction (Fig. 1), wherein the edges of the slot at least partially overlap (144’, 144”) in such a way that the overlap increases from distal to proximal (Fig. 1; pgs. 12-13).
Eker discloses the following regarding claim 10: an insertion system according to claim 8, wherein the opening zone comprises a weakening zone (142’, 142”) facing in the distal direction, with said weakening zone being designed such that the force required for opening increases from distal to proximal (Fig. 1; pgs. 12-13).
Eker discloses the following regarding claim 11: an insertion system according to claim 10, wherein the weakening zone is a perforation (Fig. 1; pgs. 12-13).
Eker discloses the following regarding claim 12: an insertion system according to claim 8, wherein the proximal section is a proximal sleeve arm (102, 112) provided for accommodating a tubular trunk section of the implant (Figs. 4-9).
As best interpreted, Eker discloses the following regarding claim 28: an insertion system (100) for an implant (200) for influencing the flow of blood in the region of aneurysms located at vessel branches (Figs. 4-10), with the implant having two distal tubular implant sections (220, 222) which are intended to be placed in blood vessels branching off from the parent blood vessel (Figs. 4-10) and which are connected to one another at a branching point (region of element 200 connecting elements 220, 222) (Figs. 4-10), wherein the insertion system is provided with two sleeves (120, 122), each configured to accommodate a first (220) and a second (222) distal tubular implant section (Figs. 4, 9, where element 120 accommodates element 220 and element 122 accommodates element 222), wherein the two sleeves each being provided with a distal sleeve section (distal portions of elements 120, 122) and the distal sleeve sections each having a longitudinally extending opening zone (140, 140’, 140”), wherein proximally adjoining the first distal sleeve section there is a first proximal section (left side section of element 112) via which the first distal sleeve section (distal portion of element 120) can be withdrawn in the proximal direction (pgs. 5, 12-13) and proximally adjoining the second distal sleeve section (distal portion of element 122) there is a second proximal section (right side section of element 112) via which the second distal sleeve section can be withdrawn in the proximal direction (pgs. 5, 12-13) so that the opening zones open and each of the distal tubular implant sections passes through the opening zones and are released in the branching blood vessels (Figs. 4-10; pg. 12) wherein the proximal sections are integral parts of the sleeves (Figs. 1, 4, 9).
Eker discloses the following regarding claim 29: an insertion system according to claim 28, wherein, the insertion system comprises a trunk sleeve (300) provided for accommodating a tubular trunk section (226) of the implant, the trunk sleeve being withdrawable in proximal direction for releasing the trunk section independently of a withdrawal of the two sleeves (pgs. 10, 13-14).
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 Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774