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 .
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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120, as follows.
This application claims the benefit of prior-filed application No. 16/894,966 (“ ‘966 application”) under 35 U.S.C. 120, 121, 365(c), or 386(c). Copendency between the current application and the prior application is required. Since the applications are not copending, the benefit claim to the prior-filed application is improper. Applicant is required to delete the claim to the benefit of the prior-filed application, unless applicant can establish copendency between the applications.
A final rejection was mailed in the ‘966 application on 17 August 2022 (“Final Action”), setting a three (3) month shortened statutory period for response. Applicant filed no paper in response to the Final Action, resulting in the abandonment of that application; notably, Applicant did not file a Petition for Extension of Time under 37 C.F.R. § 1.136(a) in the ‘966 application at that time. Accordingly, the ‘966 application went abandoned after expiry of the shortened statutory period for response, on 18 November 2022. 37 C.F.R. § 1.135; M.P.E.P. §§ 211, 711, 711.04(a).
The instant application was filed on 17 February 2023, nearly three months after the ‘966 application went abandoned. Accordingly, at no time were the ‘966 application and the instant application copending, and thus Applicant’s claim for priority is improper.
Specification
The disclosure is objected to because of the following informalities: [0001] must be updated to remove the claims for priority to the prior applications (see explanation above).
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.
Claims 1-7, 17, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent App. Pub. No. 2009/0024084, by Khosla et al. (“Khosla”).
Khosla describes a device as claimed by Applicant, as follows.
Claim 1: A catheter device (100, Figs. 2-4) comprising:
a housing (134) extending from a proximal end (left end in Fig. 3) to a distal end (left end in Fig. 3);
a fixed tubular segment (220) extending from a proximal end to a distal end (see Fig. 4), the proximal end of the fixed tubular segment immovably coupled to the housing adjacent the proximal end of the housing ([0023]);
an outer tubular member extending (102) from a proximal end (within end 140 in Fig. 5) to a distal end (Fig. 3), the proximal end of the outer tubular member immovably coupled to the housing adjacent the distal end of the housing ([0023]);
an inner tubular member (112) extending from a proximal end (114 in 144) to a distal end (116), the inner tubular member slidably received within an interior of the outer tubular member and slidably received over an exterior of the fixed tubular segment ([0023]), the inner tubular member configured to slide relative to each of the fixed tubular segment and the outer tubular member to selectively extend the distal end of the inner tubular member in a distal direction away from the distal end of the outer tubular member and/or to retract the distal end of the inner tubular member in a proximal direction towards the distal end of the outer tubular member ([0023], [0038], and Figs. 6A-6C).
Claim 2: (The catheter device of Claim 1,) further comprising a slider (144) immovably coupled to the inner tubular member ([0025]), wherein the slider is configured to slide relative to the housing to cause the inner tubular member to slide relative to the fixed tubular segment and the outer tubular member (id.).
Claim 3: (The catheter device of Claim 2,) wherein the housing defines a proximal stop (448 in Fig. 4) and a distal stop (Fig. 5, unlabeled annular element against which the slider 144 abuts), wherein the slider is configured to slide between a retracted position wherein the slider abuts the proximal stop and an extended position wherein the slider abuts the distal stop ([0025]).
Claim 4: (The catheter device of Claim 1,) wherein a length of a portion of the inner tubular member extending beyond the distal end of the outer tubular member increases when the inner tubular member is slid in the distal direction ([0023], [0038], and Figs. 6A-6C).
Claim 5: (The catheter device of Claim 4,) wherein a length of a portion of the inner tubular member received around the fixed tubular segment decreases when the inner tubular member is slid in the distal direction ([0023], [0038], and Figs. 6A-6C).
Claim 6: (The catheter device of Claim 1,) wherein a length of an inner luminal space formed by cooperation of an interior of the fixed tubular segment and an interior of the inner tubular member is increased when the inner tubular member is slid in the distal direction (id.).
Claim 7: (The catheter device of Claim 1,) wherein the inner tubular member is disposed directly radially outwardly of the fixed tubular segment where the inner tubular member is received over the fixed tubular segment, and wherein the outer tubular member is disposed directly radially outwardly of the inner tubular member where the inner tubular member is received within the outer tubular member (Fig. 2).
Claim 17: (The catheter device of Claim 1,) wherein the proximal end of the housing includes an integrated fitting or hub (450 in Fig. 4) configured as an interface to attach an accessory to the catheter device (450 is a fluid fitting), wherein the proximal end of the fixed tubular segment is coupled to the integrated fitting or hub (coupled via 448 and the intervening hub).
Claim 19: (The catheter device of Claim 1,) wherein the distal end of the inner tubular member is formed at the end of a radially inwardly tapered segment of the inner tubular member ([0021] states that any or all of the three tube can have the taper 232 in Fig. 2).
Claim 20: (The catheter device of Claim 1,) wherein the distal end of the outer tubular member is formed at the end of a radially inwardly tapered segment of the outer tubular member (id.).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 8, 9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Khosla as applied to Claims 1-7 above, and further in view of U.S. Patent App. Pub. No. 2010/0217234, by Grovender et al. (“Grovender”).
Khosla describes a device substantially as claimed by Applicant; see above. While it states that its catheter can be formed of any material ([0046]), it does not describe that:
the fixed tubular segment is formed from a metallic material, and a first segment of the inner tubular member configured to slide over the fixed tubular segment is formed from a thermoset polymer (Claim 8);
the first segment of the inner tubular member formed from the thermoset polymer is coupled to a second segment of the inner tubular member formed from a thermoplastic polymer (Claim 9); or
the first segment of the inner tubular member formed from the thermoset polymer is configured to slide within a first segment of the outer tubular member formed from a thermoset polymer (Claim 12).
Grovender relates to catheter construction and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Grovender is representative of a large number of disclosures in the catheter arts concerning the selection of materials used to construct catheters and their handles, and teaches a person of ordinary skill in the art a number of points, including that:
metals and polymers are interchangeable (see [0079], [0080]) for portions of a medical device requiring rigidity (such as Khosla’s support tube 220);
the use of thermoset materials as a segment of a catheter (see [0006], [0007]), “in order to enhance the pushability” of the device ([0054]); and
the use of thermoplastic materials as other segments of a catheter (passim; see, e.g., Abstract, [0063], [0077]), in order to increase the flexibility of the shaft relative to portions formed of a thermoset material, and that these two segments overlap where joined to form a continuous shaft (id.).
It 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, to construct Khosla’s device with the foregoing features of Claims 8, 9, and 12, because Grovender teaches that metals are useful in the construction of portions of medical devices in need of rigidity, such as Khosla’s tube 220, and are interchangeable with polymers for this purpose; thermoset materials are useful in the construction of portions of medical devices in need of rigidity, such as Khosla’s tube 102; thermoplastics are useful in the construction of portions of medical devices in need of increased flexibility, such as distal segments of Khosla’s tube 102. The result of incorporating these teachings from Grovender into Khosla’s device is read on by Claims 8, 9, and 12.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Khosla and Grovender as applied to Claim 9 above, and further in view of U.S. Patent No. 5,545,138, granted to Fugoso et al. (“Fugoso”).
Khosla and Grovender together describe a device substantially as claimed by Applicant; see above. They do not, however, describe a lap joint is formed where the first segment of the inner tubular member is coupled to the second segment of the inner tubular member.
Fugoso relates to the construction of catheters and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Fugoso teaches (col. 4, lines 34-43, and Fig. 6) that lap joints can be used in the construction of catheter segments formed of different materials, in order to use the well-understood method of heat shrinking to join together the segments.
It 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, to construct a Khosla-Grovender catheter with a lap joint where the first segment of the inner tubular member is coupled to the second segment of the inner tubular member, because Fugoso teaches doing so in a closely related catheter, in order to be able to use the well-understood method of heat shrinking to form the catheter.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Khosla and Grovender as applied to Claim 9 above, and further in view of U.S. Patent App. Pub. No. 2022/0008692, by Pulugurtha et al. (“Pulugurtha”).
Khosla and Grovender together describe a device substantially as claimed by Applicant; see above. They do not, however, describe a third segment of the inner tubular member coupled to the second segment thereof, wherein the third segment of the inner tubular member includes a reinforcing braid disposed within an overcoat formed from a thermoplastic polymer.
Pulugurtha relates to the construction of catheters with multiple segments, having different flexibilities, and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Pulugurtha teaches that such catheters can be formed of multiple segments 17A, 17b, 17C, 46A, 46B, 46C, with different flexibilities ([0067]), to balance pushability and torque transmission with flexibility of distal portions of the catheter; and, can include a third segment (17C, 46C) of coupled to a second segment thereof (17B, 46B), wherein the third segment includes a reinforcing braid (20 and [0069]) disposed within an overcoat (44c) formed from a thermoplastic polymer ([0071], the support layer containing the braid can be a thermoset or a thermoplastic), in order to increase the flexibility of the catheter distally, and to better bond the catheter’s elements together ([0135]-[0136]).
It 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, to construct a Khosla-Grovender catheter with a third segment of the inner tubular member coupled to the second segment thereof, wherein the third segment of the inner tubular member includes a reinforcing braid disposed within an overcoat formed from a thermoplastic polymer, because Pulugurtha teaches doing so in a closely related catheter, in order to increase the flexibility of the catheter distally, and to better bond together the catheter elements.
Claims 13-15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Khosla as applied to Claim 1 above, and further in view of Pulugurtha.
Khosla describes a device substantially as claimed by Applicant; see above. It does not, however, describe that:
the inner tubular member is formed from a plurality of segments, wherein the plurality of segments includes a first segment of the inner tubular member and a second segment of the inner tubular member, wherein the second segment of the inner tubular member is disposed towards the distal end of the inner tubular member relative to the first segment of the inner tubular member and wherein the second segment of the inner tubular member includes a lower bending stiffness than the first segment of the inner tubular member (Claim 13);
the plurality of segments further includes a third segment of the inner tubular member, wherein the third segment of the inner tubular member is disposed towards the distal end of the inner tubular member relative to the second segment of the inner tubular member and the third segment of the inner tubular member includes a lower bending stiffness than the second segment of the inner tubular member (Claim 14);
the outer tubular member is formed from a plurality of segments, wherein the plurality of segments includes a first segment of the outer tubular member and a second segment of the outer tubular member, wherein the second segment of the outer tubular member is disposed towards the distal end of the outer tubular member relative to the first segment of the outer tubular member and wherein the second segment of the outer tubular member includes a lower bending stiffness than the first segment of the outer tubular member (Claim 15); or
the outer tubular member changes in flexibility between the proximal end and the distal end thereof and wherein the inner tubular member changes in flexibility between the proximal end and the distal end thereof (Claim 18).
See above concerning Pulugurtha’s disclosure.
It 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, to construct a Khosla-Grovender catheter with three segments, each segment with a higher flexibility that the segment proximal to it (this is a shorthand summary of the subject matter of Claims 13-15 and 18), because Pulugurtha teaches doing so in a closely-related catheter, in order for the catheter to better navigate a patient’s vasculature ([0048]-[0049]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Khosla as applied to Claims 1-7 above, and further in view of U.S. Patent No. 3,503,385, by Stevens (“Stevens”).
Khosla describes a device substantially as claimed by Applicant; see above. It does not, however, describe that the outer tubular member is shaped adjacent the distal end thereof and includes at least one curved segment.
Stevens relates to catheters with slide control handles and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Stevens teaches that the outer tubular member (18) can be shaped adjacent the distal end thereof (curve A in Fig. 1) and includes at least one curved segment (same), in order to assist the practitioner in guiding the catheter into branch vessels when in use (col. 2, lines 58-66).
It 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, to construct Khosla’s device such that the outer tubular member is shaped adjacent the distal end thereof and includes at least one curved segment, because Stevens teaches doing so in a closely-related catheter, in order to assist the practitioner in guiding the catheter into branch vessels when in use.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent App. Pub. Nos. 2021/0298730 and 2019/0366036 are exemplary of many disclosures (see Search Results, L41) of catheters with varying flexibility formed, at least in part, of thermoset materials.
The balance of the documents cited with this Office Action relate generally to catheter handles with several coaxial members.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866.217.9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800.786.9199 (IN USA OR CANADA) or 571.272.1000.
/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 01/08/2026