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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6/16/2025 and 8/2/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 “at least one pull ring” recited in claims 1 and 16 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 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) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2022/0387757 A1) in view of Greene (US 6027462 A).
Regarding claim 1, Wang discloses:
A delivery device (bendable sheath device 100, see Fig. 1) comprising:
a handle (handle 1, see Fig. 1) having an immovable portion (housing 11, see Fig. 1);
a sheath (sheath body 2, see Fig. 1) defining a lumen (see Para. [0069] and [0094]; see also Para. [0002] mentioning wherein the purpose of medical sheaths is to transport or withdraw instruments therethrough) and extending distally from the handle (see Fig. 1), the sheath having a deflectable proximal curve (first section 21, see Fig. 1 and Para. [0086]) and a deflectable distal curve (second section 22, see Fig. 1 and Para. [0086]) spaced from the deflectable proximal curve (see Fig. 1);
at least one pull ring formed within the sheath (fixing rings recited in Para. [0094]);
one or more pull wires coupled to the at least one pull ring (traction wires 201/202 recited in Para. [0094]; see also Fig. 17); and
a first deflection knob (first curve adjustment knob 12, see Fig. 1) for actuating the sheath at the deflectable proximal curve (see Para. [0011], [0067], [0069], [0094] and [0103] mentioning wherein rotating first curve adjustment knob 12 causes actuation of a first slider 143 which imparts a force onto first traction wire 201, resulting in a bending of the first section 21), the first deflection knob being disposed adjacent the immovable portion (see Fig. 1; see also Para. [0041] and [0045] mentioning wherein one or both curve adjustment knobs (12/13) may be located in the middle part of the housing as an alternative configuration to the terminal end position locations shown in Fig. 1), and a second deflection knob (second curve adjustment knob 13, see Fig. 1) for actuating the sheath at the deflectable distal curve (see Para. [0011], [0079], [0104] mentioning wherein rotating the second curve adjustment knob 13 causes actuation of a second slider 153 which imparts a force onto second traction wire 202, resulting in a bending of the second section 22), the second deflection knob being disposed adjacent the first deflection knob (see Fig. 1; see also Para. [0045] mentioning wherein one or both adjustment knobs may be positioned at the middle part of the housing; for the purposes of the following rejection, the first curve adjustment knob is understood to reside at a location along the middle part of the housing which would bring the two curve adjustment knobs into closer proximity to one-another such that they are “adjacent”).
However, Wang does not expressly disclose:
wherein the combined length of the immovable portion, the first deflectable knob and the second deflectable knob is less than 7.6 inches.
In the same field of endeavor, namely delivery devices comprising a deflectable elongate shaft, Greene teaches a delivery device (see Fig. 1) comprising a handle (handle portion 12, see Fig. 1) having a deflectable knob portion arranged thereon (knob 14, see Fig. 1); wherein the entirety length of the handle assembly is a little less than 5 inches (see Col. 2, Lines 2-24) so that a user may comfortably grasp the handle with their thumb and forefinger engaging the adjustment knob with their palm and other three fingers are arranged along the handle body (see Col. 4, Lines 2-8).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the size of the handle of Wang to comprise a total length of less than 5 inches as taught and suggested by Greene to, in this case, allow a user to comfortably grasp the handle housing with their thumb and forefinger engaging the adjustment knob(s) with their palm and other three fingers are arranged along the handle body (see Col. 4, Lines 2-8). Put simply, modifying the length of the handle of Wang to be less than 5 inches enables a user to comfortably grasp the handle while allowing easy access to the adjustment knobs without requiring rearrangement of their hand along the length of the device (see Greene Col. 4, Lines 2-24).
Regarding claim 2, the combination of Wang and Greene disclose the invention of claim 1, Wang further discloses wherein the immovable portion is cylindrical (see Fig. 1 showing the housing comprising a cylindrical shape).
Regarding claim 3, the combination of Wang and Greene disclose the invention of claim 1, Wang further discloses wherein the immovable portion increases in diameter from a proximal end to a distal end (see Examiner’s Diagram of Wang Fig. 1 below showing wherein the housing 11 comprises a tapered profile that increases in diameter from a proximal middle portion to the distal end portion; this is also described in Para. [0046]).
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Examiner’s Diagram of Wang Fig. 1
Regarding claim 4, the combination of Wang and Greene disclose the invention of claim 1, Wang further discloses wherein the immovable portion decreases in diameter from a proximal end to a distal end (see Examiner’s Diagram of Wang Fig. 1.2 below showing wherein the housing comprises a tapered profile that tapers radially-inward from a larger diameter distal-end section to a smaller-diameter middle section; this is also described in Para. [0046]).
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Examiner’s Diagram of Wang Fig. 1.2
Regarding claim 5, the combination of Wang and Greene disclose the invention of claim 1, Wang further discloses wherein the first deflection knob and the second deflection knob are both cylindrical (see Fig. 1 showing wherein the curve adjustment knobs 12/13 comprise a cylindrical shape).
Regarding claim 6, the combination of Wang and Greene disclose all of the limitations of the invention of claim 1.
However, while Wang discloses wherein the shape of the handle comprises a tapered shape of varying diameter (see Para. [0046]) and wherein the shape of the adjustment knobs may vary along the length thereof depending on the desired shape of the handle (see Para. [0048]), Wang does not expressly disclose:
wherein the first deflection knob decreases in diameter from a proximal end adjacent the immovable portion to a distal end adjacent the second deflection knob.
However, since Wang discloses wherein one or both curve adjustment knobs (12/13) may be located on the middle portion of the handle (i.e., the tapered middle portion shown in Fig. 1 and described in Para. [0046]) which defines a variable-diameter taper (see Para. [0045]-[0046]) and may be formed in a variety of shapes based on the intended shape of the handle (see Para. [0045]-[0046]), it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the first curve adjustment knob of Wang et al. to be positioned along the middle portion of the handle in which the diameter decreases from the proximal end to a distal end without departing from the scope of the disclosed device since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Wang et al. would not operate differently with the claimed variable diameter of the first curve adjustment knob should a user place the first curve adjustment knob along a middle portion of the housing defining the claimed taper (per Para. [0045]-[0406] of Wang) and since the housing is disclosed to define a taper that decreases in diameter from the terminal ends towards the middle portion of the device, the first curve adjustment knob may reasonably be modified to conform to the disclosed shape of the handle when placed along the middle portion thereof. See Examiner’s Diagram of Wang Fig. 1_Housing below illustrating an exemplary location along the middle portion of the housing along which the first curve adjustment knob may reasonably be placed in the disclosed alternative configuration as a matter of obviousness. Further, Applicant has not placed any criticality on the relative dimensions claimed, reciting only that the diameter of the adjustment knobs vary in diameter (see Spec. Para. [0114]) without disclosing a benefit of the claimed configuration.
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Examiner’s Diagram of Wang Fig. 1_Housing
Regarding claim 7, the combination of Wang and Greene disclose the invention of claim 6, Wang further discloses wherein the second deflection knob decreases in diameter from a proximal end adjacent the first deflection knob to a distal end adjacent the sheath (see Fig. 1 showing wherein second curve adjustment knob 13 decreases in diameter from the proximal end to the distal end thereof).
Regarding claim 8, the combination of Wang and Greene disclose the invention of claim 1, Wang further discloses wherein the first deflection knob increases in diameter from a proximal end adjacent the immovable portion to a distal end adjacent the second deflection knob (see Fig. 1 showing wherein the first curve adjustment knob increases in diameter from the proximal end to the distal end thereof).
However, while Wang discloses wherein the first curve adjustment knob may be located along the middle portion of the housing and may comprise any shape that conforms to the desired shape of the housing (see Para. [0045]-[0046]), Wang does not expressly disclose wherein the first curve deflection knob’s proximal end is adjacent the immovable portion of the handle while having the distal end thereof of adjacent the second curve adjustment knob.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Wang to place the first curve adjustment knob at a location along the middle portion of the variable-diameter handle such that the diameter of the first curve adjustment knob is located along a region of the housing that increases in diameter from a proximal end a distal end without departing from the scope of the disclosed invention. See Examiner’s Diagram of Fig. 1_Adjustment Knob below illustrating an exemplary location along the middle portion of the handle a user may place the first curve adjustment knob to be in-line with the alternative configuration recited in Para. [0045]-[0046] such that the diameter increases from the proximal to the distal end thereof, while having the proximal end be adjacent a portion of the immovable portion while the distal end is adjacent the second curve adjustment knob.
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Examiner’s Diagram of Wang Fig. 1_Adjustment Knob
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2022/0387757 A1) in view of Greene (US 6027462 A), further in view of Cole (US 2017/0368304 A1).
Regarding claim 9, the combination of Wang and Greene disclose all of the limitations of the invention of claim 1.
However, Wang does not expressly disclose one or more markings disposed on the immovable portion to indicate sheath deflection.
In the same field of endeavor, namely delivery devices comprising a deflectable sheath member, Cole teaches a delivery device (see Fig. 1A-4) comprising a deflectable sheath (catheter body 102, see Fig. 3) and a handle (handle 202, see Fig. 4); wherein the handle comprises a deflection knob positioned thereon (rotatable cap 212, see Fig. 4); wherein the handle body comprises markings thereon configured to indicate the amount of sheath deflection imparted to the deflectable sheath by the deflection knob (see Para. [0034] and Fig. 4).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the housing of Wang to comprise indicator markings thereon as taught and suggested by Cole to, in this case, indicate the amount of deflection imparted to the curve sections by the corresponding curve adjustment knob (see Cole Para. [0034]). Examiner notes that while the deflection knob of Cole is not identical to those of Wang, the beneficial concept of providing markings to indicate the amount of deflection an adjustable deflection knob is imparting to the sheath body is understood to be reasonably incorporable into the device of Wang as a matter of being obvious to one of ordinary skill in the art to obtained the disclosed benefit of tracking the amount of deflection in the sheath body.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2022/0387757 A1) in view of Greene (US 6027462 A), further in view of Cole (US 2017/0368304 A1), further in view of Mixter (US 2020/0061340 A1).
Regarding claim 10, the combination of Wang, Cole and Greene disclose all of the limitations of the invention of claim 9.
However, Wang does not expressly disclose a transseptal puncture indicator disposed on a side of the immovable portion and positioned to indicate a knob position that corresponds to a substantially straight proximal sheath curve.
In the same field of endeavor, namely delivery devices comprising a deflectable sheath member, Mixter teaches a delivery device (see Fig. 3) comprising a deflectable sheath (sheath 1208, see Fig. 3) and a handle (handle 1206, see fig. 3); wherein the handle comprises a deflection knob positioned thereon (actuator 1220, see Fig. 3); wherein the deflection knob comprises markings thereon that are configured to align with corresponding markers located on the handle body to provide a visual aid to determine a neutral deflection position of the deflection knob (see Para. [0254]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the curve adjustment knobs and abutting portion of the housing of Wang to include neutral marker elements thereon as taught and suggested by Mixter to, in this case, provide a visual aid to help a user determine the neutral rotational positions of the curve adjustment knobs to allow a user to better track when the sheath body is in the unbent, neutral position (see Mixter Para. [0254]).
Regarding claim 11, the combination of Wang, Cole and Greene disclose all of the limitations of the invention of claim 9.
However, Wang does not expressly disclose a curve indicator disposed on the immovable portion and aligned to a plane of sheath curvature.
In the same field of endeavor, namely delivery devices comprising a deflectable sheath member, Mixter teaches a delivery device (see Fig. 3) comprising a deflectable sheath (sheath 1208, see Fig. 3) and a handle (handle 1206, see fig. 3); wherein the handle comprises a deflection knob positioned thereon (actuator 1220, see Fig. 3); wherein the deflection knob comprises markings thereon that are configured to align with corresponding markers located on the handle body to provide a visual aid to determine a neutral deflection position of the deflection knob (see Para. [0254]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the curve adjustment knobs and abutting portion of the housing of Wang to include neutral marker elements thereon as taught and suggested by Mixter to, in this case, provide a visual aid to help a user determine the neutral rotational positions of the curve adjustment knobs to allow a user to better track when the sheath body is in the unbent, neutral position (see Mixter Para. [0254]). The neutral position indicator markings helps a user determine the amount of deflection imparted to the sheath body based on the degree of offset between the housing neutral marking and the corresponding markings of the curve adjustment knobs.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2022/0387757 A1) in view of Greene (US 6027462 A), further in view of Osypka (US 2021/0386971 A1).
Regarding claim 12, the combination of Wang and Greene disclose the invention of claim 1, Wang further discloses wherein the one or more pull wires are coupled to slidable elements (see Para. [0011], [0067], [0069], [0079] [0094] and [0103]-[0104] mentioning wherein the traction wires 201/202 are connected to sliders 143 and 153 disposed within the handle).
However, Wang does not expressly disclose wherein the slidable elements are visible through the handle.
In the same field of endeavor, namely delivery devices with deflectable sheath bodies, Osypka teaches a delivery device (see Fig. 1) comprising a deflectable sheath (shaft 12, see Figs. 1-2) and a proximal handle (handle 10, see Fig. 1); wherein the proximal handle comprises a transparent viewing window (window 20, see Figs. 1-2) configured to allow a user to visualize axial movement of a slider element configured to drive deflection of the sheath body by axial translation along the length of the handle axis via rotational motion imparted to a rotatable control knob (see Para. [0031]-[0034]), providing a visual element to allow a user to determine the amount of deflection imparted to the sheath body by tracking the location of the slidable element(s) (see Para. [0031]-[0034]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the housing of Wang to include a transparent viewing window therein as taught and suggested by Osypka to, in this case, provide a viewing window to allow a user to view and track the axial location of the slider elements which allows a user to visually track and monitor the amount of deflection imparted to the sheath body via the axial location of the slidable elements (see Osypka Para. [0031]-[0034]).
Regarding claim 13, the combination of Wang, Greene and Osypka disclose the invention of claim 12, Wang, as modified by Osypka, further discloses an indicator disposed on the slideable elements (see Osypka Para. [0011], [0013], [0029] and [0032]-[0034] mentioning wherein the sliding drive screw may either be colored or have a surface feature that allows a user to better visualize and track the screw through the window), and wherein the handle includes a transparent window through which the indicator is visible (see Osypka Para. [0011], [0013], [0029] and [0032]-[0034]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2022/0387757 A1) in view of Greene (US 6027462 A), further in view of Subramaniam (US 2021/0031006 A1).
Regarding claim 14, the combination of Wang and Greene disclose all of the limitations of the invention of claim 1.
However, Wang does not expressly disclose an air bubble window disposed adjacent a proximal end of the immovable portion.
In the same field of endeavor, namely delivery devices comprising a deflectable sheath, Subramaniam teaches wherein the handle of a deflectable delivery device may include a window (window 316, see Fig. 3) to allow an operator to see inside the handle to determine if any air bubbles are present (see Para. [0036]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the housing of Wang to comprise a transparent window therein as taught and suggested by Subramaniam to, in this case, allow an operator to see inside the handle to determine if any air bubbles are present (see Subramaniam Para. [0036]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2022/0387757 A1) in view of Greene (US 6027462 A), further in view of Fujitani (US 2017/0065153 A1).
Regarding claim 15, the combination of Wang and Greene disclose all of the limitations of the invention of claim 1.
However, while Wang further discloses wherein the deflectable proximal curve is capable of deflecting in “three or more bendable positions” (see Para. [0084] and [0098]), Wang does not expressly disclose wherein the deflectable proximal curve is capable of four-way deflection, and wherein the deflectable distal curve is capable of two-way deflection.
In the same field of endeavor, namely deflectable delivery sheath elements, Fujitani teaches a delivery device (see Fig. 1) comprising a deflectable sheath (insertion portion 2, see Fig. 1) controlled by a rotatable member disposed along a handle assembly (bending lever 13, see Fig. 1 and Para. [0027]-[0028]); wherein the bendable sheath may configured to be bent in either two directions (i.e., up and down) or in four directions (up/down and left/right) (see Para. [0027]-[0028]) which allows a user more control over the location and positioning of the distal end of the sheath body.
Since Wang discloses wherein the sheath body may be configured to have “three or more bendable positions” (see Wang Para. [0084] and [0098]), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Wang to have the first curve section and second curve section be configured to bend in four different ways (i.e., up/down and left/right) as taught and suggested by Fujitani to, in this case, allow more degree of freedom for the sheath body which would allow a user greater mobility in navigating the sheath body to an intended target location by providing more flexibility and maneuverability within the sheath body (see Fujitani Para. [0027]-[0028]).
Claim(s) 16 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2022/0387757 A1) in view of Van Ness (US 2022/0338718 A1).
Regarding claim 16, Wang discloses:
A delivery device (bendable sheath device 100, see Fig. 1) comprising:
a handle (handle 1, see Fig. 1);
a sheath (sheath body 2, see Fig. 1) defining a lumen (see Para. [0069] and [0094]; see also Para. [0002] mentioning wherein the purpose of medical sheaths is to transport or withdraw instruments therethrough) and extending distally from the handle (see Fig. 1), the sheath having a deflectable proximal curve (first section 21, see Fig. 1 and Para. [0086]) and a deflectable distal curve (second section 22, see Fig. 1 and Para. [0086]) spaced from the deflectable proximal curve (see Fig. 1);
at least one pull ring formed within the sheath (fixing rings recited in Para. [0094]);
one or more pull wires coupled to the at least one pull ring (traction wires 201/202 recited in Para. [0094]; see also Fig. 17); and
a first deflection knob (first curve adjustment knob 12, see Fig. 1) for actuating the sheath at the deflectable proximal curve (see Para. [0011], [0067], [0069], [0094] and [0103] mentioning wherein rotating first curve adjustment knob 12 causes actuation of a first slider 143 which imparts a force onto first traction wire 201, resulting in a bending of the first section 21), and a second deflection knob (second curve adjustment knob 13, see Fig. 1) for actuating the sheath at the deflectable distal curve (see Para. [0011], [0079], [0104] mentioning wherein rotating the second curve adjustment knob 13 causes actuation of a second slider 153 which imparts a force onto second traction wire 202, resulting in a bending of the second section 22).
However, Wang does not expressly disclose wherein the proximal curve is formed of a first material and the distal curve is formed from a second material different from the first material.
In the same field of endeavor, namely deflectable catheter sheath devices comprising a deflectable sheath body, Van Ness teaches a deflectable catheter device (see Fig. 1) comprising a bendable sheath body having comprising a plurality of deflectable sections (see Fig. 1 identifying different deflectable sections (i.e., 106, 108, 110, etc.)); wherein the different deflectable sections are formed from different materials such that each deflectable section has different flexibility properties (see Para. [0022]-[0023]), allowing for varying amounts of flexibility in different areas of the deflectable sheath (see Para. [0022]-[0203]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the first section and second section of the sheath body of Wang to be formed from different flexible materials as taught and suggested by Van Ness to, in this case, allow for a varied flexibility of the sheath body (i.e., having one portion be stiffer than the other) to obtain a desired level of flexibility along the sheath body (see Van Ness Para. [0022]-[0023]).
Regarding claim 19, the combination of Wang and Van Ness disclose the invention of claim 16, Wang further disclose wherein the deflectable proximal curve is configured to deflect in a single plane (see Para. [0085] and [0089] mentioning wherein the sheath body may be configured to only have one bendable position).
Regarding claim 20, the combination of Wang and Van Ness disclose the invention of claim 16, Wang further discloses wherein the deflectable distal curve is configured to deflect in a single plane (see Para. [0085] and [0089] mentioning wherein the sheath body may be configured to only have one bendable position).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2022/0387757 A1) in view of Van Ness (US 2022/0338718 A1), further in view of Hiorth (US 2022/0288356 A1).
Regarding claim 17, the combination of Wang and Van Ness disclose all of the limitations of the invention of claim 16.
However, none of either Wang or Van Ness expressly disclose wherein the deflectable proximal curve comprises a material with a durometer between 40D and 55D.
In the same field of endeavor, namely deflectable sheath catheter devices, Hiorth teaches a deflectable sheath catheter device (see Figs. 1-4) having a pair of deflectable sections along the length thereof (see Figs. 1-4 and 8); wherein one of the deflectable sections is made from a material having a Shore Hardness of 40D (see Para. [0032]).
Since none of either Wang or Van Ness expressly disclose a material used to form the flexible curve sections, it would have been obvious to one of ordinary skill in the art to have modified the first curve section (21) of Wang to be formed from a material having a Shore Hardness of 40D as disclosed by Hiorth since it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2022/0387757 A1) in view of Van Ness (US 2022/0338718 A1), further in view of Manash (US 2018/0049873 A1).
Regarding claim 18, the combination of Wang and Van Ness disclose all of the limitations of the invention of claim 16.
However, none of either Wang or Van Ness expressly disclose wherein the deflectable distal curve comprises a PEBAX ® blend.
In the same field of endeavor, namely deflectable sheath catheter devices, Manash teaches a deflectable sheath catheter device (see Figs. 1) having a deflectable section along the length thereof (see Figs. 28A-28D); wherein the deflectable section may be made from a PEBAX blend material having a Shore Hardness of either 55D or 35D) (see Para. [0202]).
Since none of either Wang or Van Ness expressly disclose a material used to form the flexible curve sections, it would have been obvious to one of ordinary skill in the art to have modified the second curve section (22) of Wang to be formed from a PEBAX material having a Shore Hardness of either 55D or 35D as disclosed by Manash since it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2021/0001088 A1 to Brannick, US 2014/0107427 A1 to Chow, US 2018/0264230 A1 to Funk and US 2007/0066878 A1 to Worley disclose materials used to form bendable sections of deflection catheter/sheath bodies comprising either PEBA or other similar Shore Hardness materials recited in relevant dependent claims. Additionally, US 2008/0300462 A1 to Intoccia, US 2024/0050702 A1 to Laduca, US 5383852 A to Stevens-Wright and US 2019/0030285 A1 to Prabhu and US 6926669 B1 to Stewart all disclose delivery catheter devices comprising a deflectable shaft capable of deflection in either one or four directions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./ Examiner, Art Unit 3771
/DARWIN P EREZO/ Supervisory Patent Examiner, Art Unit 3771
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