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 .
Formal Matters
Applicant’s Response and Amendments filed 10 April 2026 are acknowledged. Claims 10-14 are cancelled. Claims 1-9 and 15-25 are pending and under examination.
Response to Arguments
Applicant’s argues that the cited prior art references do no teach or suggest the subject matter of the amended claims (Remarks, p. 7). Applicant argues that Al-Rashad does not disclose or suggest a kit including an insertion tool including “a member extending away from an insertion tool housing and configured to be gripped by a hand of a user to control a motion of the insertion tool housing” as recited in amended claim 1 (Remarks, p. 7). Applicant argues that Gilbert’s catheter insertion device 278, the access lumen 279 is covered with an elastic material 280 and, in contrast to FIG 6A, the shaft lumen 290 is not open to an area exterior to the elastic material (Remarks p. 7). Applicant also argues that the catheter control handle of Gilbert FIG 4C is not itself a member of an insertion tool as recited in claim 1 (Remarks, p. 8).
Applicant’s arguments have been fully considered and are persuasive. However, new rejections are provided below in light of Applicant’s amendments.
Objections/Rejections Withdrawn
The objection to claim 17 because the phrase “a alcohol” in line 2 should be “an alcohol” for grammatical correctness, is withdrawn in light of Applicant’s amendments.
The rejection of claims 1-9 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over Gilbert et al., US 20180110966 (26 April 2018) in view of Al-Rashdan et al., US 20140236088 (21 August 2014), is withdrawn in light of Applicant’s arguments and amendments.
The rejection of claims 15, 16, and 18-24 under 35 U.S.C. 103 as being unpatentable over Gilbert et al., US 20180110966 (26 April 2018), is withdrawn in light of Applicant’s arguments and amendments.
The rejection of claim 17 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unpatentable over Gilbert et al., US 20180110966 (26 April 2018) in view of Schon et al., EP 2305338 (6 April 2011), is withdrawn in light of Applicant’s arguments and amendments.
The rejection of claim 25 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over Gilbert et al., US 20180110966 (26 April 2018) in view of Imran et al., US 5,607,462 (4 March 1997), is withdrawn in light of Applicant’s arguments and amendments.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
New Claim Rejections – Necessitated by Amendment
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 15-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schmitt, US 20120210569 (23 August 2012).
Regarding independent claim 15, Schmitt teaches a catheter insertion tool (FIG 1, guidewire funnel tool 100) comprising:
a housing (FIG 1, loading coupler 102, ¶19) defining a lumen (FIGs 2, 2A, continuous lumen 104; ¶20), the housing (102) comprising a sidewall (FIG 1) and defining:
a proximal opening (FIG 1, catheter insertion end/port 106, ¶20) to the lumen (104), the proximal opening (106) being configured to receive a portion of a catheter into the lumen (FIGs 3-5),
a distal opening to the lumen (FIG 1, guidewire insertion end/port 108, ¶20) configured to receive (FIG 5, ¶26) the portion of the catheter (322), and
an aperture (FIG 1, area of weakness/slit/slot 120; ¶29) in the sidewall (FIG 1) of the lumen (102), the aperture (120) being positioned between the proximal and distal openings (FIG 1),
a member extending away from the insertion tool housing and configured to be gripped by a hand of a user to control a motion of the insertion tool housing (FIG 1, grip tab 116; ¶19),
wherein when the portion of the catheter (322) is positioned in the insertion tool lumen (104) a distal portion of the catheter is configured to extend out of the insertion tool lumen (FIG 5),
wherein the housing is configured to be removed from the catheter received within the insertion tool lumen, in a direction transverse to a longitudinal axis of the catheter (FIG 1, area of weakness/slit/slot 120; “[d]ue to the pliable and flexible material of loading coupler 102, guidewire funnel tool 100 transversely pulls or peels off the catheter and guidewire combination when grip tab 116 is pulled away from the catheter” ¶29), wherein a distal portion (FIGs 4, 5) of the housing (102) including the distal opening (108) is configured to be received within an introducer sheath (FIGs 4, 5; ¶26).
Regarding claim 16, Schmitt teaches the catheter insertion tool of claim 15, as set forth above, wherein the housing (102) comprises at least one of a polymer (polyurethane; ¶19) or a metal.
Regarding claim 17, Schmitt teaches the catheter insertion tool of claim 15, as set forth above, wherein the housing (102) comprises at least one of nylon, polycarbonate, polyester, polypropylene, an alcohol, a vinyl, or a thermoset plastic (¶19).
Regarding claim 18, Schmitt teaches the catheter insertion tool of claim 15, as set forth above, wherein the housing comprises a tab (FIG 1, grip tab 116; ¶19).
Regarding claim 19, Schmitt teaches the catheter insertion tool of claim 17, as set forth above, wherein the member is positioned at a proximal end of the housing (FIGs 3-5).
Regarding claim 20, Schmitt teaches catheter insertion tool of claim 19, as set forth above, wherein the member (116, ¶29) extends away from a longitudinal axis of the insertion tool housing (102) (FIG 2; ¶29).
Regarding claim 21, Schmitt teaches the catheter insertion tool of claim 20, as set forth above, wherein the housing (102) is configured to be opened along its length (FIG 6) in the longitudinal direction to expose the lumen and release the catheter (¶29).
Regarding claim 22, Schmitt teaches the catheter insertion tool of claim 21, as set forth above, wherein the housing (102) comprises at least one of a groove, a slit, a scoring mark, a seam, or a perforation (FIG 6, flared of V-shaped end 123; ¶29 ) configured to enable the housing to be opened along its length (¶29).
Regarding claim 23, Schmitt teaches the catheter insertion tool of claim 15, as set forth above, wherein the aperture has an elliptical cross-sectional shape (slot/aperture 120 extends the length of loading coupler 102 with a width W.sub.S approximately 0.005 inches; ¶29).
Regarding claim 24, Schmitt teaches the catheter insertion tool of claim 15, as set forth above, wherein a length of the aperture (120) along a longitudinal axis of the housing (102) is greater than a width of the aperture in a width direction perpendicular to the longitudinal axis (slot/aperture 120 extends the length of loading coupler 102 with a width W.sub.S approximately 0.005 inches; ¶29).
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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Schmitt, US 20120210569 (23 August 2012) in view of Al-Rashdan et al., US 20140236088 (21 August 2014) (previously cited of record).
Regarding independent claim 1, Schmitt teaches devices comprising:
a catheter (FIGs 3-5, catheter 322, ¶25); and
an insertion tool (FIG 1, guidewire insertion tool 100; ¶19) including an insertion tool housing (FIG 1, loading coupler 102, ¶19) defining:
an insertion tool lumen (FIGs 2, 2A, continuous lumen 104; ¶20) configured to receive at least a portion of the catheter (FIGs 3-5; catheter 322 ¶25),
a proximal opening to the insertion tool lumen (FIG 1, catheter insertion end/port 106, ¶20), and a distal opening (FIG 1, guidewire insertion end/port 108, ¶20) to the insertion tool lumen (104; ¶20), and
a member extending away from the insertion tool housing and configured to be gripped by a hand of a user to control a motion of the insertion tool housing (FIG 1, grip tab 116; ¶19),
the insertion tool housing (102) comprising a sidewall (FIG 1) extending between the proximal and distal openings (FIG 1),
wherein the sidewall (FIG 1) defines an aperture (FIG 1, area of weakness/slot/aperture 120; ¶29), and when the at least the portion of the catheter (¶29) is positioned in the insertion tool lumen (104), a distal portion of the catheter (FIG 5) is configured to extend out of the insertion tool lumen via the aperture (¶29).
Schmitt 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).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Schmitt and Al-Rashdan, given that the prior art included each element claimed, although not necessarily in a single reference. Schmitt and Al-Rashdan teach in the same field of endeavor, intraluminal medical devices comprising catheters.
Although, Schmitt discloses the claimed base catheter and insertion tool devices together, Schmitt 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 Schmitt’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 Schmitt, 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 Schmitt using known assembly methods without redesigning Schmitt’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.
Claim 1, line 9, adds an amendment drawn to “a member”. The Specification discloses that “the insertion tool housing further comprises a member extending from the insertion tool housing and configured to be gripped by a hand of a user to control a motion of the insertion tool housing” (¶¶79, 105, 151). The “member” is also disclosed as “being positioned at the proximal end of the housing” (¶¶80, 161) and “extending away from a longitudinal axis of the housing (¶¶81, 105, 117). Accordingly, the member is broadly interpreted in view of the disclosure that the member is positioned at the proximal end of the housing, extending away from a longitudinal axis of the housing, and is configured to be gripped by a hand of a user to control a motion of the insertion housing tool. Grip tab 116 (FIG 1; ¶19) of Schmitt meets these requirements.
Regarding claim 2, Schmitt modified by Al-Rashdan teaches the kit of claim 1, as set forth above, for the reasons set forth above.
Schmitt also teaches wherein the member comprises a tab (FIG 1, grip tab 116; ¶19).
Regarding claim 3, Schmitt modified by Al-Rashdan teaches the kit of claim 1, as set forth above, for the reasons set forth above.
Schmitt teaches wherein the member (116; ¶29) is positioned at a proximal end of the insertion tool housing (102) (FIGs 3-5; ¶29), and wherein the member extends away from a longitudinal axis of the insertion tool housing (FIG 2).
Regarding claim 4, Schmitt modified by Al-Rashdan teaches the kit of claim 1, as set forth above, for the reasons set forth above.
Schmitt teaches wherein when the at least a portion of the catheter (322) is received in the insertion tool lumen (FIG 3), the insertion tool housing (102) is configured to be removed from around the catheter (322) in a direction transverse to a longitudinal axis of the insertion tool housing (FIG 1, area of weakness/slot/aperture 120; “[d]ue to the pliable and flexible material of loading coupler 102, guidewire funnel tool 100 transversely pulls or peels off the catheter and guidewire combination when grip tab 116 is pulled away from the catheter” ¶29).
Regarding claim 5, Schmitt modified by Al-Rashdan teaches the kit of claim 4, as set forth above, for the reasons set forth above.
Schmitt teaches wherein the insertion tool housing (102) is configured to be opened along its length (FIG 6; ¶29) to expose the insertion tool lumen (FIG 6; ¶29) and enable removal of the catheter (322) in the direction transverse to the longitudinal axis (¶29).
Regarding claim 6, Schmitt modified by Al-Rashdan teaches the kit of claim 1, as set forth above, for the reasons set forth above.
Schmitt teaches further comprising an introducer defining an introducer lumen (guidewire lumen of a catheter, ¶25), wherein at least a distal portion of the insertion tool housing (102) is configured to be received within the introducer lumen (FIGs 4, 5), and wherein when the insertion tool housing is fully inserted into the introducer lumen, the aperture (120; ¶29) is positioned within the introducer lumen (FIGs 3-5).
Regarding claim 7, Schmitt modified by Al-Rashdan teaches the kit of claim 1, as set forth above, for the reasons set forth above.
Schmitt teaches wherein a length of the aperture (120; ¶29) along a longitudinal axis (FIGs, 6) of the insertion tool housing (102) is greater than a width of the aperture (120) in a width direction transverse to a longitudinal axis of the insertion tool housing (¶29).
Regarding claim 8, Schmitt modified by Al-Rashdan teaches the kit of claim 1, as set forth above, for the reasons set forth above.
Schmitt teaches wherein a stiffness of the insertion tool housing (102) is greater than a stiffness of the catheter (¶¶3, 4).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Schmitt, US 20120210569 (23 August 2012) in view of Al-Rashdan et al., US 20140236088 (21 August 2014) (previously cited of record) in further view of (PEBAX® Clear 400, Safety Data Sheet of 11 April 2015, last accessed 7/2/2026).
Regarding claim 9, Schmitt modified by Al-Rashdan teaches the kit of claim 1, as set forth above, for the reasons set forth above.
Schmitt teaches wherein the insertion tool housing (102) is formed from PEBAX (¶19).
Schmitt does not expressly teach that the PEBAX is at least partially transparent or translucent.
PEBAX® is a commercially available brand of thermoplastic with known physical material properties. PEBAX® Clear 400, is a known commercially available PEBAX product, which is considered transparent (PEBAX® Clear 400, Safety Data Sheet of 11 April 2015, last accessed 7/2/2026).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Schmitt and Al-Rashdan, given that the prior art included each element claimed, although not necessarily in a single reference. Schmitt and Al-Rashdan teach in the same field of endeavor, intraluminal medical devices comprising catheters.
Although, Schmitt discloses the claimed base catheter and insertion tool devices together, Schmitt 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 Schmitt’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 Schmitt, 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 Schmitt using known assembly methods without redesigning Schmitt’s devices or core features.
Schmitt expressly teaches that the loading coupler 102 (insertion tool housing), grip tab 116 may be formed from the commercially available pliable material PEBAX. Although Schmitt does not specify which species of PEBAX is useful, the finite number of types of PEBAX makes it an obvious selection among a finite group of commercially available products from which one of ordinary skill in the art could select as a results-effective variable, depending on the material properties desired.
The property of being “at least partially transparent or translucent” is a physical property of the material used and is a results-effective variable that can be optimized based on the specific use-case or desired features. One of skill in the art would clearly recognize that the light transmissivity of materials can be optimized depending on the end effect desired for the use case, such as being able to see the catheter inside of the insertion tool housing or otherwise be able to visually check for insertion compliance. One of ordinary skill in the art would have had a reasonable expectation of success based on the known material properties of commercially available products, which can be optimized by a person of ordinary skill in the art without undue experimentation based on design choice, intended use case, and any anatomical structures that the device is designed to service. As such, the selection of a finite species of PEBAX expressly taught by Schmitt would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Because the references address the same engineering problem (using commercially available materials to form the insertion tool housing) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (using a commercially available product with known material properties), 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 Schmitt, US 20120210569 (23 August 2012).
Regarding independent claim 25, Schmitt teaches a method comprising:
Retracting (backloading, ¶27) a distal portion (FIGS 3-5, distal tip 324; ¶25) of a catheter (FIGs 3-5, catheter 322, ¶25) extending through an aperture (FIG 6, slot/aperture 120; ¶29) in a sidewall (FIG 1) of an insertion tool housing (102) of an insertion tool (100) into an insertion tool lumen (104) defined by the insertion tool housing (102),
inserting a distal portion (FIG 5, distal section 114) of the insertion tool housing (102) into an introducer lumen (FIG 1, 110) of an introducer sheath (FIGs 4, 5; ¶26); and
¶29), wherein a distal portion (FIGs 4, 5) of the housing (102) including the distal opening (108) is configured to be received within an introducer sheath (FIGs 4, 5; ¶26).
advancing the catheter (322) within the insertion tool lumen (104), distally past the aperture (120), and into the introducer lumen (FIGs 4-5),
wherein the insertion tool (100) comprises a member extending away from the insertion tool housing and configured to be gripped by a hand of a user to control a motion of the insertion tool housing (FIG 1, grip tab 116; ¶19).
The embodiment of Schmitt related to FIGs 1-6 and insertion tool 100 does not teach wherein the distal portion of the catheter comprises a curve.
However, the embodiment of Schmitt drawn to FIGs 9 and 10 teach wherein the distal portion (conical distal tip 1024; ¶31) of the catheter (FIG 10, 1022; ¶31) comprises a curve (circumferential groove or channel 1042; ¶31).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of the multiple embodiments of Schmitt given that the prior art reference as a whole included each element claimed, although not necessarily in a single embodiment. The multiple embodiments in Schmitt provide a teaching, suggestion, or motivation in the reference itself, as a whole, and in the knowledge generally available to one of ordinary skill in the art, to combine reference teachings with a reasonable expectation of success.
A person of ordinary skill in the art would have been motivated to combine teachings within the four corners of a reference to achieve the claimed invention with a reasonable expectation of success. Schmitt expressly states that the different embodiments of catheters include different features that one might encounter in using a guidewire funnel tool in place over the distal top of the catheter during use (¶31), each solving known problems in the art. One of ordinary skill in the art would be motivated to select among the various embodiments of Schmitt depending on the particular catheter used in a particular surgical procedure. One would have a reasonable expectation of success in selecting from the finite embodiments taught by Schmitt that are best suited for the particular end-use case.
Claim Objections
Claim 1 is objected to because of the following informalities: line 12 recites the awkward phrase “and when the at least the portion of”. Appropriate correction is recommended.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Wood, US 20160243355 (25 August 2016) teaches catheters for deploying implantable medical devices and associated tethering assemblies and methods.
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.
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-F 9am-6pm (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
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