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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. While the originally filed specification provides support, by virtue of Figure 3B, for an expandable introducer comprising a thin wall region formed of only a liner and a first layer of an outer wall in an expanded, unfolded state, it does not provide support for the broader recitation of an expandable introducer comprising a thin wall region formed of only a liner and a first layer of an outer wall (which would include a thin wall region formed of only a liner and a first layer of an outer wall when the expandable introducer is in an unexpanded, folded state).
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 1, 4-14, 16, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Macaulay et al.’629 (US Pub No. 2014/0121629 – previously cited).
Regarding claim 1, Macaulay et al.’629 discloses an expandable introducer (see ABSTRACT) comprising: a hub (Figure 17, hub 15) having a distal end and a proximal end (section [0030]); and a sheath (Figure 1, sheath 300; section [0030]) defining a central lumen (Figure 1, central lumen 20; section [0032]), the sheath configured to radially expand from a radially unexpanded, folded state having a first diameter (Figure 8; section [0042]) and to a radially expanded, unfolded state having a second diameter (Figure 9; section [0042]) larger than the first diameter in response to a device passing through the central lumen, wherein in cross section, a wall of the sheath includes a thick wall region defining a first portion of a circumference of the sheath (Figure 17, thick wall region 70; section [0030]) having a first wall thickness and a thin wall region defining a second portion of the circumference (Figure 17, thin wall region 90; section [0030]) having a second wall thickness smaller than the first wall thickness, wherein the thick wall region includes a coil embedded within the wall of the sheath (Figure 17, coil 101; section [0030]), wherein the thick wall region includes a liner (Figures 1, 7, 8, and 9, liner 200, section [0032]), an outer wall surrounding the liner (Figures 1, 7, 8, and 9, outer wall 300, section [0032]), and the coil embedded within the outer wall (section [0030]); wherein the thin wall region includes the liner and the outer wall (section [0032]), wherein the outer wall in the thin wall region is thinner than the outer wall in the thick wall region (Figure 11 shows the outer wall in the thin wall region being thinner than the outer wall in the thick wall region).
Regarding claim 4, Figure 7 discloses that the coil is a C-shaped coil including a plurality of circumferential portions coupled by bends (and see sections [0030], [0040]).
Regarding claim 5, adjacent bends of the coil face opposite circumferential directions such that there is a circumferential gap between the bends facing opposite directions in the radially unexpanded, folded state (see Figures 5, 7, 13, and 17).
Regarding claim 6, the coil is a shape memory material (Nitinol) and is shape set to the radially unexpanded, folded state (sections [0008], [0030], [0035]).
Regarding claim 7, Figure 17 discloses that the sheath comprises a proximal portion disposed within a lumen of the hub (seen in Figure 15), an expanded portion 70 distal of the proximal portion, a tapered portion 80 distal of the expanded portion, an expandable coiled portion 90 distal of the tapered portion, and an expandable non-coiled portion (shown in Figure 12) distal of the expandable coiled portion.
Regarding claim 8, the expanded portion 70 is not foldable and is the second diameter (“full diameter” as discussed in section [0030], and section [0048] states that proximal end 12 is non-expandable).
Regarding claim 9, tapered portion 80 tapers in the distal direction such that in the radially unexpanded, folded state of the sheath, a proximal end of the tapered portion has the second diameter and a distal end of the tapered portion has the first diameter (see Figure 17, and section [0030]).
Regarding claim 10, as shown in each of Figures 12-14, when a transcatheter device 400 travels through the expandable introducer, expanding the sheath from a radially unexpanded, folded state (section [0042], collapsed state 40) to radially expanded, unfolded state (section [0042], expanded state 50), both the proximal end and the distal end of the tapered portion have the second diameter (the diameter of expanded state 50).
Regarding claim 11, Figure 17 discloses that the expandable coiled portion 90 has the first diameter in the radially unexpanded, folded state and Figure 14 discloses that the expandable coiled portion has the second diameter in the radially expanded unfolded state.
Regarding claim 12, Figure 12 shows the expandable non-coiled portion having the first diameter in the radially unexpanded, folded state. When transcatheter device 400 travels through the expandable non-coiled portion, the expandable non-coiled portion has the second diameter in the radially expanded, unfolded state.
Regarding claim 13, the coil is embedded in the wall of the sheath along the expanded portion, the tapered portion, and the expandable coiled portion (section [0030]).
Regarding claim 14, the coil is not embedded in the wall of the sheath along the proximal portion and the expandable non-coiled portion (section [0030]).
Regarding claim 16, the coil includes a proximal expanded region embedded in the expanded portion of the sheath, a tapered region embedded in the tapered portion of the sheath, and a distal expandable region embedded in the expandable coiled portion of the sheath (see Figure 16).
Regarding claim 19, the coil comprises a wire, wherein at least one end of the wire is disposed closer to a central longitudinal axis of the sheath than a middle portion of the wire (see Figure 16).
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.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Macaulay et al.’629, as applied to claim 1.
Regarding claim 2, Macaulay et al.’629 discloses all of the elements of the current invention, as discussed in paragraph 5 above, except for the first wall thickness being about 0.4-0.7mm. It is noted that Applicant has failed to provide details of criticality or unexpected results in the specification with regard to the particularly claimed thickness range. Furthermore, sections [0046-0047] of Macaulay et al.’629 disclose that the expandable introducer can be sized depending on particular procedures for which it is to be used. Therefore, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to have determined the optimal first wall thickness of the expandable introducer. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 3, Macaulay et al.’629 discloses all of the elements of the current invention, as discussed in paragraph 5 above, except for the second wall thickness being about 0.05-0.2mm. It is noted that Applicant has failed to provide details of criticality or unexpected results in the specification with regard to the particularly claimed thickness range. Furthermore, sections [0046-0047] of Macaulay et al.’629 disclose that the expandable introducer can be sized depending on particular procedures for which it is to be used. Therefore, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to have determined the optimal second wall thickness of the expandable introducer. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Macaulay et al.’629, as applied to claim 1, in view of Tabor et al.’586 (US Pub No. 2009/0192586 – previously cited).
Regarding claim 18, Macaulay et al.’629 discloses all of the elements of the current invention, as discussed in paragraph 5 above, except for at least one end of the coil/wire being formed into a pigtail. Tabor et al.’586 teaches that the end of a coil can be formed into a pigtail (section [0036]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the coil of Macaulay et al.’629 such that at least one of its ends is formed into a pigtail, as it would merely be combining prior art elements according to known methods to yield predictable results.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Macaulay et al.’629, as applied to claim 1, in view of Toth et al.’929 (US Pub No. 2015/0289929 – previously cited).
Regarding claim 20, Macaulay et al.’629 discloses all of the elements of the current invention, as discussed in paragraph 5 above, except for at least one end of the coil/wire being laser cut such that the at least one end has a smooth profile. Toth et al.’929 teaches that coils with a blunt profile do not puncture lumen walls upon which they are deployed (section [0269]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the coil of Macaulay et al.’629 such that at least one of its ends has a blunt (smooth) profile, as Toth et al.’929 teaches that this would ensure that the coil does not puncture the central lumen wall.
Regarding the requirement that the smooth profile be achieved via laser cutting the coil/wire, it is noted that the determination of patentability is based on the product itself, not on the method of its production (see MPEP 2113 I.).
Examiner’s Note
The following is a statement of reasons for the lack of prior art rejections:
Regarding claim 15, none of the prior art discloses or suggests, either alone or in combination, an expandable introducer comprising a coil made of a shape memory material, wherein an Active A(f) temperature of the coil is higher in a proximal region of the coil than in a distal region of the coil such that the proximal region of the coil expands more easily in the proximal region than in the distal region, in combination with the other claimed elements.
Regarding claim 17, none of the prior art discloses or suggests, either alone or in combination, an expandable introducer comprising a coil including a proximal expanded region embedded in an expanded portion of a sheath of the introducer, a tapered region embedded in a tapered portion of the sheath, and a distal expandable region embedded in an expandable coiled portion of the sheath, wherein the proximal expanded region and the tapered region of the coil have a first Active A(f) temperature and the distal expandable region of the coil has a second Active A(f) temperature lower than the first Active A(f) temperature, in combination with the other claimed elements.
Regarding claim 21, none of the prior art discloses or suggests, either alone or in combination, an expandable introducer comprising a thick wall region that includes a liner and an outer wall surrounding the liner, wherein the outer wall includes a first layer surrounding the liner and a second layer surrounding the first layer, and wherein a thin wall region is formed of only the liner and the first layer of the outer wall, in combination with the other claimed elements.
Claim 15 is allowed.
Claim 17 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.
Response to Arguments
Applicant's arguments filed 06 July 2026 have been fully considered.
Regarding Applicant’s arguments with respect to the rejection of the claims under 35 U.S.C. 102, Applicant’s arguments are not persuasive. Applicant argues that the jacket gap 340 of Macaulay includes only the liner 200 and not the claimed outer wall in the region. Jacket gap 340 is not the “thin wall region”. Region 90 of Figure 17 is the thin wall region. Section [0032] of Macaulay discloses an “outer edge 330 of jacket 300” (jacket 300 being the outer wall). Figure 17 shows outer edge 330 as part of the thin wall region 90. Furthermore, the jacket gap 340 only makes up part of the thin wall region. While section [0030] of Macaulay discloses that the outer wall 300 is “non-continuous” in thin wall region 90, it is present in thin wall region 90.
Regarding the rejections of claims 2 and 3, Applicant’s arguments are not persuasive. Applicant argues against the use of routine optimization to make the rejections of claims 2 and 3 by providing a citation from In re Chu. Applicant’s reliance on In re Chu is not persuasive as Applicant merely provides an excerpt from the decision without any context or explanation as to how it applies to the rejection provided by the Examiner, or how it renders a routine optimization rejection “not the proper standard”. MPEP section 2144.05 II makes clear that rejections based on routine optimization can be made. MPEP section 2144.05 III makes clear how to rebut a prima facie case of obviousness based on routine optimization. Applicant has not provided an argument based on any of the types of rebuttals discussed in the section.
Regarding the rejection of claims 15 and 17, as Applicant has provided details of criticality with respect to the claimed subject matter, the rejections of the claims have been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Turovskiy et al.’718 (US Pub No. 2014/0276718 – previously cited) teaches that shape setting Nitinol is a well-known technique in the art, wherein the Active A(f) temperature of the Nitinol can be adjusted to acquire a desired property (section [0062]). Fitterer et al.’064 (US Pub No. 2018/0161064 – previously cited) and Anderson’998 (US Pub No. 2020/0077998 – previously cited) both disclose an expandable introducer comprising a hub, and a sheath configured to radially expand from a radially unexpanded, folded state having a first diameter to a radially expanded, unfolded state having a second diameter.
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.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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