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 .
Election/Restrictions
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 14 November 2025.
The traversal is on the ground(s) that there would not be a substantial burden to examine the remaining claims. This is not found persuasive because there are numerous limitations in the method claims which are not required to render obvious the claimed catheter structure. This, in combination with the previously noted distinctions in classification, would impose a significant burden on the examiner.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claim(s) 1-4, 10-13 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 5,322,509 to Rickerd (Rickerd hereinafter) in view of U.S. Patent 5,445,625 to Voda (Voda).
Regarding claim 1, Rickerd teaches a catheter comprising: a tubular body (12) extending from a proximal end (lower end in Fig. 1) to a distal end (upper end in Fig. 1), the tubular body including a substantially linear main body portion (A) and a shaped portion that is bent so that the shaped portion lies in substantially a common plane (see Fig. 2), the shaped portion including: a first bent portion (between A and B) defining a first angle (135 degrees) distal of the main body portion, the first bent portion being bent to the left side; a second bent portion (CO) defining a second angle distal of the first bent portion, the second bent portion being bent to the left side; a third bent portion (D) defining a third angle distal of the second bent portion and bent to a side opposite to the one side; and a most distal portion (i.e. the tip of D) disposed distal of the third bent portion. Rickerd does not teach that the tubular body includes an inner layer, an outer layer, and a reinforcement body embedded in the tubular body or that a physical property changing point is provided between a proximal portion of the first bent portion and a distal portion of the second bent portion. Voda teaches another catheter generally, and particularly teaches an inner layer (Teflon, see col. 18, ln. 50-64), an outer layer (e.g. polyether block amide material) with a reinforcing section (wire braiding) therebetween. Voda further teaches that a catheter may advantageously possess a physical property changing point (e.g. bond ring 278) which may be provided between a proximal portion and a distal portion analogous to the claimed portions of the catheter of Rickerd. Voda teaches that this allows for increased flexibility at the distal end (e.g. inverse of hardness (col. 28, ln. 26-43). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a multilayer catheter with a reinforcement body and a property changing point in order to increase flexibility and adaptability of the catheter to different environments.
Regarding claims 2-4, Rickerd is silent to the positioning of a property changing point. Voda teaches that the property changing point (e.g. 278) is between two curves (e.g. 260 and 269 in Fig. 11). Since there are only three bent portions in Rickerd, one of skill in the art would face a finite set of possible locations for the physical property changing point (i.e. within each curve or between any pair thereof). Voda indicates that methods of construction and use of such catheters were well known at the time of filing. Therefore, the examiner concludes that it would have been obvious at the time of the effective filing date to try the various possible locations to select a location for the property changing point when applying the teachings of Voda to the catheter of Rickerd.
Regarding claim 10, Rickerd teaches a catheter comprising: a longitudinally extending tubular (12) body having a longitudinal extent that extends from a proximal end of the tubular body to a distal end of the tubular body, the tubular body including a lumen (col. 3, ln. 54) that extends throughout the longitudinal extent of the tubular body from the proximal end of the tubular body to the distal end of the tubular body; the tubular body including, as seen in a longitudinal cross-section through a central axis of the tubular body, a longitudinally extending inner layer (PTFE, per Voda) that extends along at least a part of the longitudinal extent of the tubular body, a longitudinally extending outer layer (vascularly compatible polymer plastic, Rickerd col. 3 ln. 51-57) that extends along at least a part of the longitudinal extent of the tubular body, and a longitudinally extending reinforcement body (metallic or Kevlar braid, same citation) embedded in the tubular body and extending along at least a part of the longitudinal extent of the tubular body, the longitudinally extending reinforcement body extending from a distal end (not illustrated) of the longitudinally extending reinforcement body to a proximal end of the longitudinally extending reinforcement body; the tubular body including a substantially linear main body portion (A) and a shaped portion (distal of A), the shaped portion extending distally away from a distal end of the linear main body portion; the shaped portion of the tubular body including: a first bent portion (between A and B) distal of the main body portion, the first bent portion being bent a left side of the tubular body and defining a first angle, the first bent portion including a proximal end and a distal end; a second bent portion (between B and C) that is located distal of the first bent portion, the second bent portion bent to the one side of the tubular body to define a second angle and so that the first and second bent portions are bent to the left side of the tubular body; a third bent portion (D) that is located distal of the second bent portion, the third bent portion being bent to a right side of the tubular body opposite the one side of the tubular body and defining a third angle; and a most distal portion disposed distal of the third bent portion, the most distal portion including a proximal end (arbitrarily chosen between D and the tip thereof); and the distal end of the longitudinally extending reinforcement body being located distal of the proximal end of the first bent portion and proximal of the most distal portion of the shaped portion.
Regarding claims 11-13 and 17, Rickerd and Voda teach that the reinforcement portion extends through essentially the whole of the catheter, and therefore one of ordinary skill in the art would expect that it would be present in each of the claimed locations along the length of the catheter.
Claim(s) 5-9 and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rickerd in view of Voda as applied to claims 1 and 10 above, and further in view of US Pre-Grant Publication 2014/0025041 to Fukuoka et al. (Fukuoka).
Regarding claim 5, the previously applied references teach the limitations of claim 1 from which claim 5 depends, but do not teach that the physical property changing point is an end portion of the reinforcement body. Fukuoka teaches another coronary catheter generally, and teaches that a distal portion (22) of a catheter (20) may be formed without a reinforcement portion (paragraphs 46-48) so as to avoid damage to the heart. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to end the reinforcement body before the distal portion of the catheter of Rickerd in order to avoid damage to the patient during use as taught by Fukuoka.
Regarding claim 6, RIckerd is silent to a hepatic artery and the other claimed contact locations present when used in trans-radial intervention. Fukouka is directed to a catheter for use in such trans-radial interventions (see paragraph 65), which is a technique known in the art to provide coronary and arterial access with lessened detrimental effects on the patient. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to configure and locate the catheter of Rickerd as taught by Fukuoka in order to operate on a patient with minimal detrimental effect.
Regarding claims 7-9 and 14-16, Fukuoka teaches that the reinforcement body has a proximal end commensurate with the proximal end of the catheter, and a distal end beyond which the shaped portion is defined. Fukuoka teaches that the catheter may have a length of from 400-1200 mm (paragraph 33), and that the distal portion may be 0.5-150 mm (paragraph 46). Fukuoka teaches that this provides torque transmission while preventing damage (paragraphs 46-48). Since the range of lengths taught by Fukuoka overlaps the claimed length ratio ranges of claim 6, the claimed ranges are rendered obvious by the teachings of Fukuoka as one of ordinary skill in the art would have been motivated at the time of the effective filing date of the application to arrive at the claimed ranges in order to provide torque transmission and prevent damage when using the catheter of Rickerd.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Pre-Grant Publication 2016/0317788 to Merkel teaches catheters at the hepatic arteries (paragraph 45).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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, Chelsea Stinson can be reached at 571-270-1744. 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.
/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 29 November 2025