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 Objections
Claim 11 is objected to because of the following informalities: a comma should be added after the term “expanded” in line 3. 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 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 – cited by Applicant).
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 a wall of the sheath includes a thick wall region (Figure 17, thick wall region 70; section [0030]) having a first wall thickness and a thin wall region (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]).
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 4 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 4 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).
Claims 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Macaulay et al.’629, as applied to claims 7 and 16, in view of Beasley et al.’907 (US Pub No. 2018/0064907).
Regarding claim 15, Macaulay et al.’629 discloses all of the elements of the current invention, as discussed in paragraph 4 above, except for an Active temperature of the coil being higher in a proximal region of the coil than in a distal region of the coil. Beasley et al.’907 teaches that different Active temperatures of Nitinol affect the flexibility and stiffness of Nitinol. Beasley et al.’907 further teaches selecting different Active temperatures along the length of a Nitinol element to acquire a desired flexibility and stiffness of the element along its length (section [0050]). 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 Nitinol coil of Macaulay et al.’629 such that it comprises different Active temperatures along its length, as it would merely be combining prior at elements according to known methods to yield predictable results. The modification to Macaulay et al.’629 would allow for different segments of the coil to have different flexibility and stiffness properties desired for a particular procedure.
It is noted that Applicant has failed to provide details of criticality or unexpected results in the specification with regard to the relative Active temperatures of the segments of the coil. As such, it would have been obvious, through routine experimentation, to have determined an optimal Active temperature for the proximal region of the coil and for the distal region of the coil.
Regarding claim 17, Macaulay et al.’629 discloses all of the elements of the current invention, as discussed in paragraph 4 above, except for the proximal expanded region and the tapered region of the coil having a first Active temperature, and the distal expandable region of the coil having a second Active temperature lower than the first Active temperature. Beasley et al.’907 teaches that different Active temperatures of Nitinol affect the flexibility and stiffness of Nitinol. Beasley et al.’907 further teaches selecting different Active temperatures along the length of a Nitinol element to acquire a desired flexibility and stiffness of the element along its length (section [0050]). 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 Nitinol coil of Macaulay et al.’629 such that it comprises different Active temperatures along its length, as it would merely be combining prior at elements according to known methods to yield predictable results. The modification to Macaulay et al.’629 would allow for different segments of the coil to have different flexibility and stiffness properties desired for a particular procedure.
It is noted that Applicant has failed to provide details of criticality or unexpected results in the specification with regard to the relative Active temperatures of the segments of the coil. As such, it would have been obvious, through routine experimentation, to have determined an optimal Active temperature for the proximal expanded region and the tapered region of the coil and for the distal expandable region of the coil.
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).
Regarding claim 18, Macaulay et al.’629 discloses all of the elements of the current invention, as discussed in paragraph 4 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).
Regarding claim 20, Macaulay et al.’629 discloses all of the elements of the current invention, as discussed in paragraph 4 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.).
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) 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 – cited by Applicant) and Anderson’998 (US Pub No. 2020/0077998 – cited by Applicant) 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.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791