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 .
Priority/Benefit
The application is a National Stage entry under 35 USC 371 of PCT/US2023/017375 (filed 4 April 2023) claiming benefit to US Provisional 63/362,499.
Formal Matters
Claims 10-14 are cancelled. New claims 16-25 are added. Claims 1-9 and 15-25 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9 January 2025 has been considered by the examiner. A signed copy is attached.
Claim Objections
Claim 17 is objected to because of the following informalities: the phrase “a alcohol” in line 2 should be “an alcohol” for grammatical correctness. Appropriate correction is required.
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.
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 nonobviousness.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Gilbert et al., US 20180110966 (26 April 2018) in view of Al-Rashdan et al., US 20140236088 (21 August 2014).
Regarding independent claim 1, Gilbert teaches devices comprising:
a catheter (FIG 6A, 262); and
an insertion tool (250) including an insertion tool housing (254) defining:
an insertion tool lumen (insertion tool lumen is shown accommodating catheter 262 within FIG 6A) configured to receive at least a portion of the catheter (262) (FIG 6A),
a proximal opening (256) to the insertion tool lumen (insertion tool lumen is shown accommodating catheter 262 within FIG 6A), and a distal opening (268) to the insertion tool lumen (insertion tool lumen is shown accommodating catheter 262 within FIG 6A),
the insertion tool housing (254) comprising a sidewall (FIG 6A) extending between the proximal and distal openings (¶58),
wherein the sidewall (260) defines an aperture (252), and when the at least the portion of the catheter (262) is positioned in the insertion tool lumen (insertion tool lumen is shown accommodating catheter 262 within FIG 6A), a distal portion (268) of the catheter is configured to extend out of the insertion tool lumen via the aperture (FIG 6A, catheter 262 is capable of extending out of aperture 252). Gilbert does not teach the components as a kit. Al-Rashdan teaches expandable sheaths and system for intravascular insertion of a medical implement comprising a kit (FIG 8).
Gilbert and Al-Rashdan teach in the same field of endeavor, intraluminal medical devices comprising catheters. Although, Gilbert discloses the claimed base catheter and insertion tool devices together, Gilbert does not disclose them together in a kit. Al-Rashdan specifically addresses providing sheaths and systems for intravascular insertion of medical implants in a kit format (FIG 8). Because Gilbert’s devices are taught together, a person of ordinary skill in the art, seeking to commercialize a catheter and insertion tool, such as the one taught by Gilbert, in joint packaging would reasonably consult Al-Rashdan’s old and well-known kit solution. Al-Rashdan’s kit can incorporated the catheter and insertion tool devices taught together by Gilbert using known assembly methods without redesigning Gilbert’s devices or core features. Because the references address the same engineering problem (medical device catheters/sheaths for luminal insertion) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (packaging the devices as a kit), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 2, Gilbert modified by Al-Rashdan teaches the kit of claim 1, as set forth above. Gilbert also teaches wherein the insertion tool housing (254) further comprises a member (elastic material 280; ¶¶61-62) extending from the insertion tool housing (258) and configured to be gripped by a hand of a user (physician, ¶58) to control a motion of the insertion tool housing (¶61).
Regarding claim 3, Gilbert modified by Al-Rashdan teaches the kit of claim 2, as set forth above.
The embodiment of Gilbert set forth above at FIG 6A (embodiment at ¶¶57-58) does not expressly teach wherein the member is positioned at a proximal end of the insertion tool housing, and wherein the member extends away from a longitudinal axis of the insertion tool housing.
However, Gilbert at FIG 4C (¶48) teaches an embodiment where catheter insertion device 202’’ comprises a member (catheter control handle) located at a proximal end of the insertion tool housing (¶48), and wherein the member extends away from a longitudinal axis of the insertion tool housing (FIG 4C, ¶48).
Gilbert teaches the catheter control handle, located proximally to the catheter insertion device, as an additional embodiment which is useful to control the distal advancement and longitudinal movement of the catheter through the lumens.
Regarding claim 4, Gilbert modified by Al-Rashdan teaches the kit of claim 1, as set forth above. Gilbert also teaches wherein when the at least a portion of the catheter (262) is received in the insertion tool lumen (insertion tool lumen is shown accommodating catheter 262 within FIG 6A), the insertion tool housing (254) is configured to be removed from around the catheter (262) in a direction transverse to a longitudinal axis of the insertion tool housing (FIG 6A, catheter 262 is capable of extending out of aperture 252).
Regarding claim 5, Gilbert modified by Al-Rashdan teaches the kit of claim 4, as set forth above. Gilbert also teaches wherein the insertion tool housing (254) is configured to be opened along its length (FIG 6A) to expose the insertion tool lumen (FIG 6A, catheter 262 is capable of extending out of aperture 252) and enable removal of the catheter (262) in the direction transverse to the longitudinal axis (FIG 6A, ¶¶57-58).
Regarding claim 6, Gilbert modified by Al-Rashdan teaches the kit of claim 1 as set forth above.
In the embodiment of Gilbert of FIG 6A (embodiment at ¶¶57-58), Gilbert does not clearly teach the devices further comprising an introducer defining an introducer lumen (but see ¶58, catheter introducer), wherein at least a distal portion of the insertion tool housing is configured to be received within the introducer lumen, and wherein when the insertion tool housing is fully inserted into the introducer lumen, the aperture is positioned within the introducer lumen.
However, Gilbert at FIG 1 (¶27) teaches an embodiment further comprising an introducer (106) defining an introducer lumen (110), wherein at least a distal portion of the insertion tool housing (108) is configured to be received within the introducer lumen (110), and wherein when the insertion tool housing (108) is fully inserted into the introducer lumen (¶27).
Additionally, the embodiment of Gilbert set forth above at FIG 6A (embodiment at ¶¶57-58) teaches that the catheter insertion device 250 may manually advance the shaft distal end 258 into and/or through a hemostasis valve associated with a catheter introducer (¶58; see also, FIG 1, 112). Gilbert teaches that upon insertion of the catheter insertion device 250 into the catheter introducer (e.g. FIG 1, 106) , catheter 262 can be distally advanced (e.g. protracted) from the catheter insertion device 250 (¶58). The aperture positioned within the introducer lumen (FIG 1, 110) is taught in the embodiment of FIG 6A at ¶58.
Gilbert teaches different embodiments comprising catheters and insertion tools comprising a variety of different features. However, Gilbert does not disclose all of these different features in one singular embodiment. Even so, specifically addresses each feature within the singular reference, providing a basis for one of ordinary skill in the art to select from among several finite features important for use-specific embodiments. Because Gilbert’s devices are taught together in the same reference, even if in different embodiments, a person of ordinary skill in the art, seeking to provide functional features on a catheter and insertion tool, such as the ones taught by Gilbert, would reasonably consult other embodiments taught by Gilbert that would provide relevant variations. Gilberts catheter and insertion tool devices are taught together using known assembly methods and the different features provided in the different embodiments can be accommodated as feature variations without redesigning Gilbert’s devices or core features, as expressly shown by Gilbert. Because the references address the same engineering problem (medical device catheters/sheaths for luminal insertion) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (feature modification of the same base device), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 7, Gilbert modified by Al-Rashdan teaches the kit of claim 1, as set forth above. Gilbert also teaches wherein a length of the aperture (FIG 6A) along a longitudinal axis (FIG 6A) of the insertion tool housing (254) is greater than a width of the aperture (252) in a width direction transverse to a longitudinal axis of the insertion tool housing (FIG 6A; ¶57).
Regarding claim 8, Gilbert modified by Al-Rashdan teaches the kit of claim 1, as set forth above. Gilbert also teaches wherein a stiffness of the insertion tool housing (254) is greater than a stiffness of the catheter (¶58, limiting catheter bend).
Regarding claim 9, Gilbert modified by Al-Rashdan teaches the kit of claim 1, as set forth above.
The embodiment of Gilbert set forth above at FIG 6A (embodiment at ¶¶57-58) does not expressly teach wherein the insertion tool housing (254) is at least partially transparent or translucent.
However, Gilbert at FIG 5A, 5C teaches an embodiment where the insertion tool housing (230) is at least partially transparent and/or translucent (¶¶49, 52).
Gilbert teaches different embodiments comprising catheters and insertion tools comprising a variety of different features. However, Gilbert does not disclose all of these different features in one singular embodiment. Even so, specifically addresses each feature within the singular reference, providing a basis for one of ordinary skill in the art to select from among several finite features important for use-specific embodiments. Because Gilbert’s devices are taught together in the same reference, even if in different embodiments, a person of ordinary skill in the art, seeking to provide functional features on a catheter and insertion tool, such as the ones taught by Gilbert, would reasonably consult other embodiments taught by Gilbert that would provide relevant variations. Gilbert’s catheter and insertion tool devices are taught together using known assembly methods and the different features provided in the different embodiments can be accommodated as feature variations without redesigning Gilbert’s devices or core features, as expressly shown by Gilbert. Because the references address the same engineering problem (medical device catheters/sheaths for luminal insertion) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (feature modification of the same base device), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claims 15, 16, and 18-24 are rejected under 35 U.S.C. 103 as being unpatentable over Gilbert et al., US 20180110966 (26 April 2018).
Regarding independent claim 15, Gilbert teaches a catheter insertion tool (FIG 6A, 250) comprising:
a housing (254) defining a lumen (252),
the housing comprising a sidewall (260) and defining: a proximal opening (FIG 6A) to the lumen (252),
the proximal opening (256) being configured to receive a portion of a catheter (262) into the lumen (252,¶58),
a distal opening to the lumen (268) configured to receive the portion of the catheter (262),an aperture (252) in the sidewall (260) of the lumen (FIG 6A; ¶58),
the aperture (252) being positioned between the proximal (270) and distal (268) openings (FIG 6A; ¶¶57, 58),
wherein when the portion of the catheter is positioned in the insertion tool lumen (FIG 6A), a distal portion of the catheter is configured to extend out of the insertion tool lumen (FIG 6A, catheter 262 is capable of extending out of aperture 252),
wherein the housing (254) is configured to be removed from the catheter (262) received within the insertion tool lumen (FIG 6A, catheter 262 is capable of extending out of aperture 252), in a direction transverse to a longitudinal axis of the catheter (FIG 6A, ¶¶57-58),
wherein a distal portion of the housing (254) including the distal opening (268) is configured to be received within an introducer sheath (¶58, catheter introducer).
In the embodiment of Gilbert of FIG 6A (embodiment at ¶¶57-58), Gilbert does not clearly teach wherein the devices are configured to be received within an introducer lumen (but see ¶58, catheter introducer).
However, Gilbert at FIG 1 (¶27) teaches an embodiment further comprising an introducer (106) defining an introducer lumen (110), wherein at least a distal portion of the insertion tool housing (108) is configured to be received within the introducer lumen (110), and wherein when the insertion tool housing (108) is fully inserted into the introducer lumen (¶27).
Additionally, the embodiment of Gilbert set forth above at FIG 6A (embodiment at ¶¶57-58) teaches that the catheter insertion device 250 may manually advance the shaft distal end 258 into and/or through a hemostasis valve associated with a catheter introducer (¶58; see also FIG 1, 112). Gilbert teaches that upon insertion of the catheter insertion device 250 into the catheter introducer (e.g. FIG 1, 106), catheter 262 can be distally advanced (e.g. protracted) from the catheter insertion device 250 (¶58). The aperture positioned within the introducer lumen (e.g. FIG 1, 110) is taught in the embodiment of FIG 6A at ¶58.
Gilbert teaches different embodiments comprising catheters and insertion tools comprising a variety of different features. However, Gilbert does not disclose all of these different features in one singular embodiment. Even so, specifically addresses each feature within the singular reference, providing a basis for one of ordinary skill in the art to select from among several finite features important for use-specific embodiments. Because Gilbert’s devices are taught together in the same reference, even if in different embodiments, a person of ordinary skill in the art, seeking to provide functional features on a catheter and insertion tool, such as the ones taught by Gilbert, would reasonably consult other embodiments taught by Gilbert that would provide relevant variations. Gilberts catheter and insertion tool devices are taught together using known assembly methods and the different features provided in the different embodiments can be accommodated as feature variations without redesigning Gilbert’s devices or core features, as expressly shown by Gilbert. Because the references address the same engineering problem (medical device catheters/sheaths for luminal insertion) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (feature modification of the same base device), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 16, Gilbert teaches the catheter insertion tool of claim 15, as set forth above, wherein the housing (FIG 1, 118) comprises at least one of a polymer (FIG 1; ¶¶4, 29) or a metal.
Regarding claim 18, Gilbert the catheter insertion tool of claim 15, as set forth above, wherein the housing (254) further comprises a member (elastic material 280; ¶¶61-62) extending from the housing (258) and configured to be gripped by a hand of a user (physician, ¶58) to control a motion of the housing (¶61).
Regarding claim 19, Gilbert the catheter insertion tool of claim 18, as set forth above.
The embodiment of Gilbert set forth above at FIG 6A (embodiment at ¶¶57-58) does not expressly teach wherein the member is positioned at a proximal end of the insertion tool housing.
However, Gilbert at FIG 4C (¶48) teaches an embodiment where catheter insertion device 202’’ comprises a member (catheter control handle) located at a proximal end of the insertion tool housing (¶48).
Gilbert teaches different embodiments comprising catheters and insertion tools comprising a variety of different features. However, Gilbert does not disclose all of these different features in one singular embodiment. Even so, specifically addresses each feature within the singular reference, providing a basis for one of ordinary skill in the art to select from among several finite features important for use-specific embodiments. Because Gilbert’s devices are taught together in the same reference, even if in different embodiments, a person of ordinary skill in the art, seeking to provide functional features on a catheter and insertion tool, such as the ones taught by Gilbert, would reasonably consult other embodiments taught by Gilbert that would provide relevant variations. Gilberts catheter and insertion tool devices are taught together using known assembly methods and the different features provided in the different embodiments can be accommodated as feature variations without redesigning Gilbert’s devices or core features, as expressly shown by Gilbert. Because the references address the same engineering problem (medical device catheters/sheaths for luminal insertion) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (feature modification of the same base device), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 20, Gilbert the catheter insertion tool of claim 19, as set forth above.
The embodiment of Gilbert set forth above at FIG 6A (embodiment at ¶¶57-58) does not expressly teach wherein the member extends away from a longitudinal axis of the insertion tool housing.
However, Gilbert at FIG 4C (¶48) teaches an embodiment where catheter insertion device 202’’ comprises a member (catheter control handle) wherein the member extends away from a longitudinal axis of the insertion tool housing (FIG 4C, ¶48).
Gilbert teaches different embodiments comprising catheters and insertion tools comprising a variety of different features. However, Gilbert does not disclose all of these different features in one singular embodiment. Even so, specifically addresses each feature within the singular reference, providing a basis for one of ordinary skill in the art to select from among several finite features important for use-specific embodiments. Because Gilbert’s devices are taught together in the same reference, even if in different embodiments, a person of ordinary skill in the art, seeking to provide functional features on a catheter and insertion tool, such as the ones taught by Gilbert, would reasonably consult other embodiments taught by Gilbert that would provide relevant variations. Gilberts catheter and insertion tool devices are taught together using known assembly methods and the different features provided in the different embodiments can be accommodated as feature variations without redesigning Gilbert’s devices or core features, as expressly shown by Gilbert. Because the references address the same engineering problem (medical device catheters/sheaths for luminal insertion) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (feature modification of the same base device), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 21, Gilbert teaches the catheter insertion tool of claim 20, as set forth above, wherein the housing (254) is configured to be opened along its length in the longitudinal direction (FIG 6A; ¶¶57-58) to expose the lumen (252) and release the catheter (262).
Regarding claim 22, Gilbert teaches the catheter insertion tool of claim 21, as set forth above, wherein the housing (254) comprises at least one of a groove, a slit, a scoring mark, a seam, or a perforation (¶58, access hole) configured to enable the housing to be opened along its length (¶58).
Regarding claim 23, Gilbert teaches the catheter insertion tool of claim 15, as set forth above, wherein the aperture has an elliptical cross-sectional shape (FIG 6A; oval, ¶57).
Regarding claim 24, Gilbert teaches the catheter insertion tool of claim 15, as set forth above, wherein a length of the aperture (FIG 6A) along a longitudinal axis of the housing is greater than a width of the aperture in a width direction perpendicular to the longitudinal axis (FIG 6A; ¶57).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Gilbert et al., US 20180110966 (26 April 2018) in view of Schon et al., EP 2305338 (6 April 2011).
Regarding claim 17, Gilbert the catheter insertion tool of claim 15, as set forth above.
Gilbert does not teach wherein the housing (254) comprises at least one of nylon, polycarbonate, polyester, polypropylene, a alcohol, a vinyl, or a thermoset plastic.
Schon teaches a multiple catheter assembly where the catheter housing comprises homopolymers and copolymers of vinyl acetate, polycarbonates, and polyesters (¶60).
Gilbert and Schon teach in the same field of endeavor, intraluminal medical devices comprising catheters. Although, Gilbert discloses the claimed base catheter and insertion tool devices together, Gilbert does not disclose wherein the housing comprises at least one of nylon, polycarbonate, polyester, polypropylene, a alcohol, a vinyl, or a thermoset plastic. Schon specifically addresses catheters comprising homopolymers and copolymers of vinyl acetate, polycarbonates, and polyesters (¶60). Because Gilbert teaches wherein the housing (FIG 1, 118) comprises at least one of a polymer (FIG 1; ¶¶4, 29), a person of skill in the art looking for suitable material compositions for catheters would reasonably consult Schon’s solution addressing specific polymer compositions, whereas Gilbert teaches at least one polymer generically. A catheter comprising the specific polymers or copolymers taught by Schon can readily be incorporated into the catheter material taught by Gilbert using known assembly methods without redesigning Gilbert’s devices or core features. Because the references address the same engineering problem (medical device catheters for luminal insertion) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (using manufacturing materials comprising at least one polymer), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Gilbert et al., US 20180110966 (26 April 2018) in view of Imran et al., US 5,607,462 (4 March 1997).
Regarding independent claim 25, Gilbert teaches a method (¶58) comprising:
retracting (¶58) a distal portion (FIG 6A, 268) of a catheter (262) extending through an aperture (252) in a sidewall (260) of an insertion tool housing (254) of an insertion tool (250) into an insertion tool lumen (FIG 6A, catheter 262 is capable of extending out of aperture 252) defined by the insertion tool housing (254),
wherein the distal portion (268) of the catheter comprises a curve (natural bend, ¶58);
inserting a distal portion (268) of the insertion tool housing (254) into an introducer lumen (FIG 1, 110) of an introducer sheath (¶58 catheter introducer); and
advancing the catheter (262) within the insertion tool lumen (FIG 6A, catheter 262 is capable of extending out of aperture 252), distally (268) past the aperture (252), and into the introducer lumen (FIG 1, 110).
Gilbert does not teach rotating the catheter to rotate the distal portion of the catheter within the insertion tool lumen such that the curve is out of alignment with the aperture;
Imran teaches catheter assemblies and multi-catheter introducers comprising torquability characteristics in order to rotate (col 4, lines 49-55). Imran also teaches that preformed bends can be placed in the distal extremity of the flexible elongate member (catheter) and the shape may be assumed as soon as there is space for it to curve (col 4, lines 55-61). Additionally, Imran teaches that a physician can also rotate the catheter (col 5, lines 39-40).
Gilbert and Imran teach in the same field of endeavor, intraluminal medical devices comprising catheters. Although, Gilbert discloses the claimed base catheter and insertion tool devices together, Gilbert does not disclose rotating the catheter. Imran specifically addresses catheters comprising torque transfer capabilities so that the catheter can be rotated as directed by a physician. Because Gilbert teaches that a physician can advance and control the longitudinal movement of the catheters, and because catheters can move longitudinally either proximally or distally with respect to the insertion device, the movement can be controlled via the access lumen (¶58). A person of skill in the art looking to rotate catheters in catheter assemblies or catheter introducers would reasonably consult the Imran’s old and well-known solution addressing torquability characteristics of catheters. Imran’s rotatable catheters with comprising torque transfer capabilities can readily be incorporated into the material forming the catheter using known assembly methods without redesigning Gilbert’s devices or core features. Because the references address the same engineering problem (medical device catheters for luminal insertion) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (using manufacturing materials that permit torque transfer capabilities), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Conclusion
No claim is allowed.
The prior art made of record and not presently relied upon is considered pertinent to applicant's disclosure:
Saurav et al., AU 2006203152 A1 (15 February 2007) teaches catheters comprising metal.
Gately et al., US 2010/0228230 (9 September 2010) teaches shielded tip catheters.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-W (9am-9pm CST) and R-F (9am-3pm CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771