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
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-17, drawn to a stent for insertion in a vein of a human or animal body.
Group II, claim(s) 18-21, drawn to a catheter stent insertion device.
Group III, claim(s) 22-24, drawn to a method for inserting a stent assembly.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-III lack unity of invention because the inventions of these groups require the technical feature of a stent for insertion in a vein of a human or animal body having a proximal end, a distal end and a longitudinal stent axis, and comprising at least two stent segments, and a means structured in adjusting a distance between two stent segments between a first and second configuration by translating displacement along said longitudinal stent axis of one of said two stent segments relative to the other of the two stent segments. This technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Cocks (US PG Pub No. 2014/0350660). Cocks (US PG Pub No. 2014/0350660) discloses a stent for insertion in a vein of a human or animal body having a proximal end (Fig. 1), a distal end (Fig. 1) and a longitudinal stent axis (Fig. 1, axis 14), and comprising at least two stent segments (Fig. 1, expandable stabilization stent 11, expandable valve stent 12), and a means structured in adjusting a distance (Paragraph [0150]) between two stent segments (Fig. 1, expandable stabilization stent 11, expandable valve stent 12) between a first and second configuration (Paragraph [0148], expanded and compact states) by translating displacement (Paragraph [0148]) along said longitudinal stent axis (Fig. 1, axis 14) of one of said two stent segments (Fig. 1, expandable stabilization stent 11, expandable valve stent 12) relative to the other of the two stent segments (Fig. 1, expandable stabilization stent 11, expandable valve stent 12).
A telephone call was made to Chad Swantz on 02/02/2026 to request an oral election to the above restriction requirement. Mr. Swantz returned the call and left a voicemail on 02/06/2026 electing Group I, Claims 1-17. Traversal was not presented.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 telescopic structure in claim 8 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 Objections
Claim 6 is objected to because of the following informalities: “at least one elongated filament rod is structured to irreversible or reversible extend”. The examiner suggests that this informality is corrected to “at least one elongated filament rod is structured to irreversibly or reversibly extend” for clarity. Appropriate correction is required.
Claim 12 objected to because of the following informalities: “said intermediate stent segments have a third length”. The examiner suggests that this informality is corrected to “said one or more intermediate stent segments have a third length” as seen in Fig. 1A. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: “wherein said maximal distance between said stent segments is between 1 mm”. The examiner suggests that this informality is corrected to “wherein said maximal distance between said stent segments is between 1-20 mm” as seen in specification Paragraph [0022]. 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 3 and 4 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.
Claims 3 and 4 recites the limitations "said first rod end and said second rod end" in line 3. There is insufficient antecedent basis for these limitations in the claim.
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 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cocks et al. (US PG Pub. No. US 2014/0350660).
Regarding claim 1, Cocks discloses a stent for insertion in a vessel of a human or animal body (prosthesis 3), said stent having a proximal end (see annotated Figs. 3a-3b below), a distal end (see annotated Figs. 3a-3b below), and a longitudinal stent axis (Paragraph [0023], Figs. 3a-3b, main axis 34), and comprising at least two stent segments (Figs. 3a-3b, stabilization stent 31, valve stent 32), as well as segment interconnecting means interconnecting two stent segments (Figs. 3a-3b, connectors 331), wherein said segment interconnecting means are structured in adjusting a distance between said two stent segments (31 and 32) when inserted in a vessel between a first configuration, wherein said distance is minimal (Fig. 3a), and a second configuration, wherein said distance is maximal (Fig. 3b), due to a translation displacement (Paragraph [0155], “maintaining concentric alignment”) along said longitudinal stent axis of one of said two stent segments relative to the other of the two stent segments (Paragraph [0155]).
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Regarding claim 3, Cocks discloses wherein in said first configuration (Fig. 3a) and said second configuration (Fig. 3b) said first rod end (first rod end connected to first stent segment (31), see annotated Figs. 3a-3b above) and said second rod end (second rod end connected to second stent segment (32), see annotated Figs. 3a-3b above) are radially offset with respect to each other (Figs. 3a-3b, line L).
Claim(s) 1 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eli et al. (US Patent No. 10,039,656 B2).
Regarding claim 1, Eli discloses a stent for insertion in a vessel of a human or animal body (Fig. 2), said stent having a proximal end (see annotated Fig. 2 below), a distal end (see annotated Fig. 2 below), and a longitudinal stent axis (Fig. 1A-2, Z-axis), and comprising at least two stent segments (Fig. 2, segments A and B), as well as segment interconnecting means interconnecting two stent segments (Fig. 2, coupling 13a), wherein said segment interconnecting means are structured in adjusting a distance between said two stent segments (A and B) when inserted in a vessel between a first configuration (Fig. 1D), wherein said distance is minimal (Fig. 1B, Z2) and a second configuration (Fig. 1C), wherein said distance is maximal (Figs. 1B, Z1), due to a translation displacement along said longitudinal stent axis of one of said two stent segments relative to the other of the two stent segments (Figs. 1B-2, Col. 13, lines 65-67, and Col. 14, lines 1-17).
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Regarding claim 4, Eli further discloses wherein in said first configuration (Fig. 1D) and said second configuration (Fig. 1C) said first rod end (proximal end of 11a) and said second rod end (distal end of 11a) are longitudinally aligned with respect to each other, seen in the direction of said longitudinal stent axis (Fig. 1B-2).
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.
Claim(s) 1, 2, and 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Wittens (US PG Pub. No. US 2019/0328555) in view of Eli et al. (US Patent No. 10,039,656 B2).
Regarding claim 1, Wittens discloses a stent for insertion in a vessel of a human or animal body (Figs. 1-4, Stent assembly 10), said stent having a proximal end (Proximal stent segment 11), a distal end (Distal stent segment 12), and a longitudinal stent axis (Longitudinal axis 10c), and comprising at least two stent segments (13, 13’), as well as segment interconnecting means interconnecting two stent segments (Figs. 1-4, Paragraph [0010], stent interconnecting means 30 interconnecting 13 and 13’), wherein said segment interconnecting means are structured in adjusting a distance between said two stent segments (13 and 13’) when inserted in a vessel between a first configuration, wherein said distance is minimal (Figs. 1, 5A, Distance D1) and a second configuration, wherein said distance is maximal (Figs. 3, 5C, Distance D3), along said longitudinal stent axis of one of said two stent segments (13) relative to the other of the two stent segments (13’, Figs. 3-4, 5B). Wittens fails to disclose the second configuration is due to a translation displacement along said longitudinal stent axis of one of said two stent segments (13) relative to the other of the two stent segments (13’).
Eli also discloses a stent comprising at least two segments (Fig. 2, segments A and B) and a longitudinal axis (Fig. 1A-2, Z-axis). Eli teaches a configuration where a distance is maximal along the longitudinal stent axis of one of said two stent segments (A) relative to the other of the two stent segments (B) due to a translation displacement along said longitudinal stent axis (Figs. 1B-2, Col. 13, lines 65-67, and Col. 14, lines 1-17).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Wittens’ stent such that the second configuration is due to a translation displacement along said longitudinal stent axis of one of said two stent segments relative to the other of the two stent segments, as taught by Eli, in order to reduce the axial load and stress on the segments caused by bending or axial torsion (Col. 4, lines 63-67, Col. 5, lines 1-20).
Regarding claim 2, Wittens in view of Eli further discloses wherein, for interconnecting said at least two stent segments (Proximal stent segment 11, Distal stent segment 12), said segment interconnecting means (Paragraph [0010], stent interconnecting means 30) comprise at least one elongated filament rod (31) having two rod ends (), a first rod end being connected to the first stent segment (13) and the second rod end being connected to the second stent segment (13’, Figs. 1-5C), wherein a distance between both first and second rod ends is smaller in said first configuration (Figs. 1-2, 5A; D1) than in said second configuration (Figs. 3-4, 5B; D2).
Regarding claim 11, Wittens in view of Eli further discloses wherein said stent comprises a proximal stent segment (Proximal stent segment 11), a distal stent segment (Distal stent segment 12) and one or more intermediate stent segments (13”) disposed between the proximal and distal stent segments (Figs. 1-4), and wherein said segment interconnecting means (stent interconnecting means 30) interconnect each of said stent segments (Figs. 1-4).
Regarding claim 12, Wittens in view of Eli further discloses wherein, seen along said longitudinal axis of the stent, said proximal stent segment (11) has a first length (Figs. 1-4, X1), said distal stent segment (12) has a second length (Figs. 1-4, X2), and said one or more intermediate stent segments have a third length (Figs. 1-4, X3), wherein said third length is smaller than said first and second length (Paragraphs [0015 and 0047]).
Regarding claim 13, WIttens in view of Eli further discloses wherein said third length is 5-15 mm (Paragraph [0047], Figs. 1-4, X3).
Regarding claim 14, Wittens in view of Eli further discloses wherein said first length (X1) and said second length (X2) are the same (Paragraph [0047]).
Regarding claim 15, Wittens in view of Eli further discloses wherein said first length (X1) is longer than said second length (X2; Paragraph [0047]), wherein said first length is 30-50 mm (Paragraph [0047], Figs. 1-4, X1) and said second length is 10-30 mm (Paragraph [0047], Figs. 1-4, X2).
Regarding claim 16, Wittens in view of Eli further discloses wherein said maximal distance between said stent segments is between 1-20 mm (Paragraph [0017]).
Regarding claim 17, Wittens in view of Eli further discloses wherein the number of said intermediate stent segments is between 1-30 (Paragraphs [0018 and 0042]).
Claim(s) 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Wittens in view of Eli et al. as applied to claim 1 above, and further in view of Cocks et al. (US PG Pub. No. US 2014/0350660).
Regarding claim 5, Wittens in view of Eli fails to disclose wherein said at least one elongated filament rod is structured to extend in length.
Cocks also discloses a stent (prosthesis 1) comprising at least two segments (11 and 12) at least one elongated filament rod (131). Cocks teaches wherein said at least one elongated filament rod is structured to extend in length (Paragraph [0152]).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Wittens’ in view of Eli wherein said at least one elongated filament rod is structured to extend in length, as taught by Cocks, in order to allow flexible compression and expansion between the at least two segments to aid the surgeon during implantation of the stent to the vessels (Paragraph [0150]).
Regarding claim 6, Wittens in view of Eli and Cocks discloses wherein said at least one elongated filament rod (131) is structured to irreversibly or reversibly extend in length (Cocks Paragraph [0152]).
Regarding claim 7, Wittens in view of Eli and Cocks discloses wherein said at least one elongated filament rod (131) is manufactured from an extendable material, the extendable material including flexible material (Cocks Paragraph [0151-0152]).
Regarding claim 8, Wittens in view of Eli and Cocks fails to disclose wherein said at least one elongated filament rod (131) has a telescopic structure.
Cocks teaches an alternate embodiment of a stent (prosthesis 5) comprising at least two segments (51 and 52) at least one elongated filament rod (531) structured to extend in length (See Figs. 5a-5b). Cocks teaches wherein said at least one elongated filament rod (531) has a telescopic structure (Paragraph [0158], Figs. 5a-5b, slidable portions 5311 and 5312).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Wittens’ in view of Eli and Cocks at least one elongated filament rod to have a telescopic structure, as further taught by Cocks, in order to sufficiently change the distance between stent segments as desired (Paragraph [0158]).
Regarding claim 9, Wittens in view of Eli and Cocks fails to disclose wherein said at least one elongated filament rod (131) has a zigzag structure.
Cocks teaches an alternate embodiment of a stent (prosthesis 4) comprising at least two segments (41 and 42) at least one elongated filament rod (431) structured to extend in length (see Figs. 4a-4b). Cocks teaches wherein said at least one elongated filament rod (431) has a zigzag structure (Paragraph [0157], Figs. 4a-4b, zigzag region 4311).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Wittens’ in view of Eli and Cocks at least one elongated filament rod to have a zigzag structure, as further taught by Cocks in order to sufficiently change the distance between stent segments as desired (Paragraph [0157]).
Regarding claim 10, Wittens in view of Eli and Cocks discloses wherein said at least one elongated filament rod (131) has a coil structure (Paragraph [0151], Fig. 1, connectors 131, curved, S-shape, thereby forming a coil structure).
Conclusion
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to KARI L COCHRAN whose telephone number is (571)272-9637. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARI L COCHRAN/Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774