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/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-14, drawn to a sheath, classified in A61M2025/0024.
II. Claims 15-20, drawn to a method of delivering a medical device and expanding an introducer sheath, classified in A61F2/2427.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the product in this case can be practiced with another materially different product, such as one that does not require a medical device within a lumen of the sheath and one that does not require the sheath to expand symmetrically in a radial direction.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions have acquired a separate status in the art in view of their classification;
the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries)..
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Rosie Kim on 07/28/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-14. Affirmation of this election must be made by applicant in replying to this Office action. Claims 15-20 are hereby withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claim 13 is objected to because of the following informalities:
Claim 13: The preamble “The sheath of any of Claim 12,…” is suggested to read “The sheath of Claim 12,…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-7, 9-12, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Avneri (US PGPub 2013/078711).
Regarding Claim 1, Avneri teaches a sheath (300; Figures 7 and Figures 21A-21E; Paragraph 0252) comprising:
a radially expandable cylindrical outer layer (942) having a proximal end and a distal end (Figure 7; Paragraph 0253), and defining a cylindrically shaped lumen extending longitudinally between the proximal end and the distal end, and having an inner surface (see Figures 21A, 21C, and Figure 21D; Paragraph 0253); and
sheath fins (940a; Figure 21A)(940B; Figure 21C)(940C; Figure 21D) distributed circumferentially about the inner surface and coupled thereto Figures 21A-21E; Paragraph 0253), wherein each of the sheath fins (940a,b, or c) extends along a length of the inner surface of the outer layer (942; Figure 21A-21C),
wherein the sheath (300) is movable between an unexpanded state (Figures 21A-21E) and an expanded state (Paragraph 0253), and where in the unexpanded state (Figures 21A-21E) the sheath fins (940a, b, or c) form a continuous surface of the lumen of the outer layer (942) (Paragraph 0257-0258),
wherein each of the sheath fins (940a, b, or c) includes a longitudinally-extending leading edge and a longitudinally-extending trailing edge where the leading edge of each of the sheath fins abuts a trailing edge of an adjacent one of the sheath fins when the sheath is in the unexpanded state (the leading edge and trailing edges are formed by adjacent fins (940a, b, or c) at the separation lines (941a, b, or c) in Figures 21A, 21C and 21D, respectively), and
wherein, in an initial unexpanded state (Figures 21A, 21C, or 21D), adjacent sheath fins (940 a, b, or c) are coupled together along their leading and trailing edges (Paragraphs 0253, 0256 and 258).
Regarding Claim 2, Avneri teaches the sheath of claim 1, wherein in the initial unexpanded state (Figures 21A, 21C, and 21D) the adjacent sheath fins (940a, b, or c) are removably coupled together (Paragraph 0253 and Paragraph 0257).
Regarding Claim 3, Avneri teaches the sheath of claim 1, wherein adjacent sheath fins are uncoupled when the sheath moves from the initial unexpanded state to the expanded state (Paragraph 0253).
Regarding Claim 4, Avneri teaches the sheath of claim 1, wherein, when the sheath expands from the unexpanded to the expanded state, a circumferential spacing between adjacent sheath fins increases to form a gap between each of the sheath fins (Paragraph 0253).
Regarding Claim 5, Avneri teaches the sheath of claim 4, wherein at least one of the leading and the trailing edge of each of the sheath fins includes a surface feature facilitating sliding movement between adjacent sheath fins during expansion and contraction of the sheath (Figures 21C and 21D; Paragraph 0256-0259).
Regarding Claim 6, Avneri teaches the sheath of claim 1, wherein a cross-sectional shape of each of the sheath fins does not change when the sheath moves between the unexpanded and expanded state (Paragraph 0253 states that the fines/beams 940 are rigid).
Regarding Claim 7, Avneri teaches the sheath of claim 1, wherein in the expanded state, a thickness of the outer layer extending between adjacent sheath fins reduces compared to at least one of a thickness of the outer layer in the unexpanded state and a thickness of the outer layer radially outward of each of the sheath fins in both the expanded and unexpanded state (Paragraph 0253 states that the outer layer (942) is elastic or plastic and is expandable and given that the outer layer is expandable, any constant volume material that expands will get thinner as the volume of the material is stretched, which is known as poisson’s ratio).
Regarding Claim 9, Avneri teaches the sheath of claim 1, wherein the sheath fins (941) have a greater stiffness than the outer layer (942; Paragraph 0253).
Regarding Claim 10, Avneri teaches the sheath of claim 1, wherein each of the sheath fins extend along at least a majority of a total length of the inner surface of the outer layer (Paragraph 0253, 0255, 0260; but also see Figure 7 in which 303 (the fins/beams) extend along the total length of the sheath 300).
Regarding Claim 11, Avneri teaches the sheath of claim 1, wherein each of the sheath fins (940;a; Figures 21A) have an arcuate-shaped outer surface and an arcuate-shaped inner surface in cross-section (Paragraph 0253).
Regarding Claim 12, Avneri teaches the sheath of claim 1, wherein the sheath (300) includes a main body portion and a proximal end portion, wherein a thickness of the sheath remains constant along the main body portion and a thickness of the sheath increases along the proximal end portion (see Figure 7 in which the outer diameter thickness increased at the proximal hub 304 but is constant throughout the distal portion).
Regarding Claim 14, Avneri teaches the sheath of claim 1, wherein an inner diameter of the sheath (300) increases along a proximal end portion to correspond to an inner diameter of a hub (304) coupled to the proximal end of the sheath (300; Figure 7).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Avneri (US PGPub 2013/078711) as applied to claim 1 above, and further in view of Nguyen (US PGPub 2012/0083877).
Regarding Claim 8, Avneri teaches the sheath of claim 1, but fails to disclose wherein the outer layer includes a weakened portion extending between adjacent sheath fins such that the outer layer will separate along the weakened portion.
Nguyen teaches an expandable sheath (abstract) (22; Figure 2D) comprising an outer layer (26) disposed over an intermediate (28) and inner (26) tubular layers, wherein the outer layer (26) comprises a weakened portion (36) such that the outer layer (26) will separate along the weakened portion (36; Paragraph 0087 and 0102).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the outer layer of Avneri, to include weakened portions to facilitate separation, as taught by Nguygen, for the advantage of further facilitating the expansion of the sheath only the expansion of the fins without the expansion resistance of the outer layer (Paragraph 0102; Nguygen).
Allowable Subject Matter
Claim 13 is 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.
Regarding Claim 13, Avneri teaches the sheath of any of claim 12, but fails to disclose wherein a thickness of each of the sheath fins and the thickness of the outer layer remains constant along the main body portion, wherein a thickness of each of the sheath fins and the thickness of the outer layer increases along the proximal end portion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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