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
Applicant’s election with traverse of Group I, Species B and Subspecies 2 in the reply filed on 6/10/2026 is acknowledged. The traversal is on the ground that Group I and Group II should not be restricted from each other because (a) Group I is a product and Group II is a process of manufacture and (b) 37 CFR 1.475(b) states that groupings of claims will be considered to have unity of invention if the claims are drawn only to one of five categories of invention, one of which is “a product and a process specifically adapted for the manufacture of said product”. This is not found persuasive because the process of Group II is not “specifically adapted” for the manufacture of the product of Group I because the process of Group II can be used to make a product different than that of Group I – for example, the process of Group II can be used to make a catheter assembly in which the reinforcement sleeve does not overlap with the catheter tube at a distal end of the catheter hub and in which the needle shaft does not project through the reinforcement sleeve as required by Group I.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 34-44 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements filed 7/16/2025, 5/4/2026 and 6/11/2026 fail to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Although an English translation of DE 29712676 (Foreign Patent Document Cite No. 2, 5/4/2026 IDS) has been provided, a copy of the actual foreign patent document has not been provided. A copy of EP 3500329 (Foreign Patent Document Cite No. 1, 6/11/2026 IDS) has not been provided. A copy of the First Office Action for JP Patent Application No. 2023-521189 (Non-Patent Literature Document Cite No. 1, 7/16/2025 IDS) has not been provided. The IDSes have been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Claim 23 is objected to because of the following informalities: The term “and” should be inserted after the semi-colon on line 8 in order to be grammatically correct. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 23-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 23 recites “a catheter tube having a first length, a lumen, and a distal opening sleeved over the bushing”. As written, it is unclear whether the “sleeved over the bushing” limitation applies to the “catheter tube” or the “distal opening [of the catheter tube”. Since the term “distal” is used in the specification to indicate the direction closest to the point of insertion of the device, this limitation is interpreted as requiring the catheter tube to be “sleeved over the bushing”. Accordingly, claim 23 is interpreted as reciting “a catheter tube having a first length, a lumen and a distal opening, the catheter tube sleeved over the bushing”. In order to overcome this rejection, it is suggested to amend the claim in this manner. Claims 24-33 are rejected due to their dependence on claim 23.
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.
Claims 23-27, 29, 30 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Neoh (PG PUB 2019/0192825) in view of Kinoshita (JP 2002-301161)1.
Re claim 23, Neoh discloses a catheter assembly 100 (Fig 1,1A; it is noted that all reference characters cited below refer to Fig 1,1A unless otherwise noted) comprising: a catheter hub 102 having a hub body (the structure forming the hub 102 itself) with an exterior surface (seen in Fig 1,1A) and an interior surface (“interior wall surfaces”, Para 211) defining an interior cavity (as seen in Fig 2,3); a bushing 138 having a distal section (to the left in Fig 1) and a proximal section (to the right in Fig 1) disposed in the interior cavity (as seen in Fig 2,3); a catheter tube 104 having a first length (as seen in Fig 1), a lumen (within which needle 108 resides in Fig 1A), and a distal opening 112 sleeved over the bushing (Para 211); and a needle hub 106 with a needle 108 extending out a distal end of the needle hub (as seen in Fig 2,3), the needle comprising a needle shaft (forming the needle 108 itself) having a needle lumen (through which flashback blood can flow, Para 214) and a needle tip 110, the needle shaft projecting through the bushing and the catheter tube in a ready to use position (as seen in Fig 1A,2,3). Neoh does not disclose a reinforcement sleeve (a) made from a non-metallic material, (b) having a second length sleeved over the bushing, and (c) overlapping with at least a section of the catheter tube at a distal end of the catheter hub to resist or prevent kinking of the catheter tube, wherein the needle shaft also projects through the reinforcement sleeve in the ready to use position. Kinoshita, however, teaches a catheter assembly 7 (Fig 6) comprising a catheter hub 73 (Fig 6), a bushing 63 (Fig 6) disposed in an interior cavity of the catheter hub (as seen in Fig 6), a catheter tube 4 (Fig 6) having a first length and being sleeved over the bushing (as seen in Fig 6), and a reinforcement sleeve 61 (Fig 6) made from a non-metallic material (Para 47), having a second length sleeved over the bushing (as seen in Fig 6), and overlapping with at least a section of the catheter tube at a distal end of the catheter hub (as seen in Fig 6) to resist or prevent kinking of the catheter tube (Para 47) for the purpose of ensuring that pushability and torque can be reliably transmitted to the distal end of the catheter tube from the catheter hub (Para 5). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Neoh to include a reinforcement sleeve, as taught by Kinoshita, for the purpose of ensuring that pushability and torque can be reliably transmitted to the distal end of the catheter tube from the catheter hub (Para 5).
Re claims 24-27 and 29, Neoh as modified by Kinoshita in the rejection of claim 23 above discloses all the claimed features with Kinoshita teaching that the first length [of the catheter tube] is greater than the second length [of the reinforcement sleeve] (as seen in Fig 6), that the catheter tube or the reinforcement sleeve is in direct contact with the bushing (as seen in Fig 6, the catheter tube 4 is in direct contact with the bushing 63), that the reinforcement sleeve is disposed over the catheter tube or within the catheter tube (as seen in Fig 6, the reinforcement sleeve 61 is disposed over the catheter tube 4), that the reinforcement sleeve is a heat shrink tube (Para 47), and that 20% to 70% of the second length extends distally of catheter hub (as seen in Fig 6, about 50% of the second length of the reinforcement sleeve extends distally of the catheter hub 73). The motivation cited in the rejection of claim 23 also applies to this claim.
Re claim 30, Neoh discloses a needle guard 132 (Fig 1,22A) having a proximal wall (seen in Fig 1,22A and labeled in Fig A below) with a proximal opening (through which 108 extends in Fig 22A, labeled in Fig A below) and two resilient arms (seen in Fig 1,22A and labeled in Fig A below) slidably mounted on the needle shaft (Para 213).
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Re claim 33, Neoh discloses a side fluid port 50 (Fig 1A) extending radially of the hub body 102 (as seen in Fig 1A), the side fluid port having a tubing 54 (Fig 1A) secured to a lumen of the side fluid port (Para 217). Neoh does not explicitly disclose that the tubing is secured to the side port by a bushing. Kinoshita, however, teaches using bushings 63,64 (Fig 6) to secure all tubing 4,2 (Fig 6) in their respective ports 73,72 (Fig 6) (Para 47,48) wherein the use of a bushing aids in the assembling of the catheter assembly (Para 47,48). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Neoh to include a bushing securing the tubing the side fluid port, as taught by Kinoshita, for the purpose not only securing the tubing but also aid in assembling the tubing into the side port (Para 47,48).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Neoh (PG PUB 2019/0192825)/Kinoshita (JP 2002-301161) in view of Haslam et al. (PG PUB 2021/0283377).
Re claim 28, Neoh/Kinoshita discloses all the claimed features except that the heat shrink tube [of the reinforcement sleeve] covers at least part of an exterior of the catheter hub. Haslam, however, teaches a catheter assembly 120 (Fig 2B) comprising a catheter hub 130 (Fig 2B), a bushing 134 (Fig 2B), a catheter tube 121 (Fig 2B) and a reinforcement sleeve 125 (Fig 2B) overlapping with at least a section of the catheter tube at a distal end of the catheter hub (as seen in Fig 2B) and covering at least part of an exterior of the catheter hub (as seen in Fig 2B, the reinforcement sleeve 125 covers a distal part of the exterior of the catheter hub 130) to resist or prevent kinking of the catheter tube (Para 41). Haslam teaches that providing the reinforcement sleeve over at least part of the exterior of the catheter hub also allows the reinforcement sleeve to provide stabilization to the catheter assembly (Para 42). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Neoh/Kinoshita to include the reinforcement sleeve such that it is located over the catheter hub as opposed to within the catheter hub, as taught by Haslam, for the purpose of providing stabilization to the catheter assembly (Para 42).
Claims 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Neoh (PG PUB 2019/0192825)/Kinoshita (JP 2002-301161) in view of Woehr et al. (PG PUB 2010/0249707).
Re claim 31, Neoh discloses a valve 136 for limiting fluid flow through the catheter hub (Para 136), but does not explicitly disclose that the valve comprises at least one slit defining at least two flaps. Woehr, however, teaches a catheter assembly (Fig 1) comprising a catheter hub 3+5 (Fig 1), a valve 7 (Fig 1) and a valve actuator 10 (Fig 1) (like catheter hub 102, valve 136, and valve actuator 134 of Neoh) wherein the valve comprises at least one slit 7a (Fig 6) defining at least two flaps (Fig 6) for the purpose of ensuring that the valve will close when not activated to inhibit the flow of fluid therethrough (Para 19). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Neoh to include the valve as one with at least one slit defining at least two flaps, as taught by Woehr, for the purpose of ensuring that the valve will close when not activated to inhibit the flow of fluid therethrough (Para 19).
Re claim 32, Neoh discloses a valve actuator 134 located within the catheter hub and proximally of the valve (as seen in Fig 2,3), said valve actuator comprising a nose section (to the left in Fig 1) having a fluid passage (Para and at least one plunger element (to the right in Fig 1) for pushing by a male Luer tip (Para 213).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. PG PUB 2004/0162522 and PG PUB 2012/0172806 to Woehr, PG PUB 2007/0005001 to Rowe et al., PG PUB 2017/0119997 to Burkholz et al., and PG PUB 2020/0121896 to Baid each disclose a catheter assembly comprising a number of the claimed features.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 An English translation of this reference was provided by the Applicant with the 7/16/2026 IDS. This is the translation that will be referred to in the rejections.
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