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
Election/Restriction
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, claims 1-10 and 22, drawn to a fenestration device.
Group II, claims 12-18, drawn to a method for fenestrating an endograft.
Group III, claim 19, drawn to a vessel marker.
Group IV, claims 20 and 21, drawn to a method for marking a blood vessel.
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-IV lack unity of invention because the groups do not share the same or corresponding technical feature.
During a telephone conversation with Joseph Tucker on June 19th 2026 a provisional election was made without traverse to prosecute Invention I, claims 1-10 and 22. Affirmation of this election must be made by applicant in replying to this Office action. Claims 12-21 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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 “control knob on the steerable sheath” (claims 2, 9 and 10); and, the port on the distal end of the cutting member wherein the port is connected to an electrocautery wire that extends through a bore in the cutting member to the blades (claim 8) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the structural details of a control knob on a sheath which can cause rotation of a gear that is within a cutting device, where the cutting device is also retractable relative to the sheath as described in the specification (e.g. claim 10). Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d).
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 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.
Claims 1, 2, 6, 7, 9, 10 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton et al. (US 2012/0024935).
Regarding claim 1, Shelton et al. disclose a fenestration device (1200/900; can create a pleated fenestration as in Figure 52) comprising: a steerable sheath (1200; Figure 56; any sheath is steerable to some degree using at least some means) defining an inner lumen; a cutting member (900; Figures 38-42) disposed in the inner lumen (¶[0142], [0143]), wherein the cutting member has a distal end and a proximal end and is movable between a retracted position and an extended position, the distal end of the cutting member being disposed within the steerable sheath in the retracted position, and the distal end of the cutting member protruding from the steerable sheath in the extended position (the cutting member could be manually retracted and extended within the sheath as claimed); a needle-like tip (470 or a distal region of the cutting member including tip 470; a shaft section having a pointed conical tip can be regarded as a needle-like tip; noting that as claimed, Applicant’s needle-like tip is a distal region of the cutting member; not just the pointed tip - “the blades being disposed within the needle-like tip in the first position”) on the distal end, the needle-like tip having (containing) cutting edges (edges of 1030); and blades (1000) movable between a first position (Figure 41) and a second position (Figure 42), the blades being disposed within the needle-like tip in the first position (Figure 39), and the blades protruding from the needle-like tip in the second position (member 470 could be attached while the blades are extended as in Figure 24).
Regarding claim 2, a control knob (910) on the steerable sheath (a knob disposed adjacent to a sheath as in Applicant’s Figure 5A is considered as --on the sheath-- for the purpose of this examination) is configured to control a height of the blades (¶[0132]).
Regarding claim 6, the blades comprise a thermally conductive material (¶[0133]).
Regarding claim 7, a port (at “930” - Figure 38) is on the distal end of the cutting member configured to connect (capable of connecting) an electrocautery wire within the cutting member to a heat source.
Regarding claim 9, a control knob (910) on the steerable sheath ((a knob disposed adjacent to a sheath as in Applicant’s Figure 5A is considered as --on the sheath-- for the purpose of this examination) is configured to control movement of the blades (¶[0132]).
Regarding claim 10, a central gear (974; Figure 40) and teeth (teeth of gears 1004) are within the needle-like tip; wherein the central gear is connected to the teeth; wherein each of the teeth connects the central gear to one of the blades; wherein rotation of the central gear in a first direction causes extension of the blades outward from a surface of the needle-like tip, and rotation of the central gear in a second direction causes retraction of the blades inward; and wherein rotation of the control knob causes rotation of the central gear (Figures 41 and 42; ¶[0132]-[0133]).
Regarding claim 22, Shelton et al. disclose a fenestration device (900; Figures 38-42) comprising: a needle-like tip (470 or a distal region of the cutting member including tip 470; a shaft section having a pointed conical tip can be regarded as a needle-like tip; noting that as disclosed, Applicant’s needle-like tip is a distal region of the fenestration device; not just the pointed tip) configured to create (capable of creating) a perforation in an endograft material; and blades (1000) extendable from the needle-like tip and configured to be heated by an external heat source to enlarge the perforation in the endograft material (¶[0133] - a metal blade could be heated as claimed)
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 non-obviousness.
Claims 1, 3-8 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Lunsford et al. (US 2010/0268175).
Regarding claim 1, Lunsford et al. disclose a fenestration device (Figures 3-5A; “trocar” - Abstract) comprising: a steerable sheath (70; any sheath is steerable to some degree using at least some means) defining an inner lumen (72); a cutting member (10) disposed in the inner lumen (Figure 4A), wherein the cutting member has a distal end and a proximal end and is movable between a retracted position (Figure 4A) and an extended position (Figure 5A), the distal end of the cutting member being disposed within the steerable sheath in the retracted position (adjacent the proximal end of windows 28), and the distal end of the cutting member protruding from the steerable sheath in the extended position; a needle-like tip (the region from the proximal end of windows 28 to the tip 20; noting that as claimed, Applicant’s needle-like tip is a distal region of the cutting member; not just the pointed tip - “the blades being disposed within the needle-like tip in the first position”) on the distal end; and blades (60/62 or 40/42) movable between a first position (Figure 4A) and a second position (Figure 5A), the blades being disposed within the needle-like tip in the first position (Figure 4A), and the blades protruding from the needle-like tip in the second position (Figure 5A).
Lunsford et al. fail to disclose for the above embodiments that the needle-like tip has cutting edges.
However, Lunsford et al. disclose a needle-like tip (124) having cutting edges in another embodiment (Figure 9A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the cutting member of Figures 3-5A with the needle-like tip of Figure 9A as a simple substitution of one known tip structure for another with a reasonable expectation of success for the intended purpose (puncturing tissue).
Regarding claim 3, the cutting member defines a bore (holding tethers 34) configured to receive a guide wire.
Regarding claim 4, a guide wire (one of tethers 34 can be regarded as a guide wire) is disposed in the bore (the claim does not require the guide wire to pass through an opening in the distal end or the tip).
Regarding claim 5, a proximal opening as claimed would be required for pulling of the tethers.
Regarding claim 6, the blades comprise a thermally conductive material (¶[0011]).
Regarding claim 7, a port (28) on the distal end (see remarks above in regard to claim 1) of the cutting member is configured to connect an electrocautery wire within the cutting member to a heat source (¶[0011]).
Regarding claim 8, the port is connected to an electrocautery wire that extends through a bore in the cutting member to the blades (¶[0011]; as evident from Figure 2, the port would be connected to the electrosurgical wires that are connected to the blades - at least when the blades are in the extended position).
Regarding claim 22, Lunsford et al. disclose a fenestration device (Figures 3-5A; “trocar” - Abstract) comprising: a needle-like tip (from proximal end of windows 28 to tip 20) configured to create (capable of creating) a perforation in an endograft material; and blades (40/42 or 60/62) extendable from the needle-like tip and configured to be heated by an external heat source to enlarge the perforation in the endograft material (¶[0011]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
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