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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on November 3, 2025. As directed by the amendment: claims 1 and 8 have been amended and claims 23-25 have been added. Thus, claims 1, 8, and 19-25 are presently pending in this application with claims 19-22 presently withdrawn.
Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every 112(a) rejections previously set forth in the Non-Final Office Action mailed August 12, 2025; however, the examiner notes that the amendments appear to raise new 112(a) issues, discussed in further detail below.
Response to Arguments
Applicant's arguments filed November 3, 2025 have been fully considered but they are not persuasive. Applicant argues on pg. 6 of the Remarks that support for the amendment can be found in paragraphs 44 and 45 of the Specification and in Fig. 1 and 2. The examiner notes that paragraphs 44 and 45 are silent in regards to the diameter of the lumen being constant along a length between the proximal end and distal tip. Paragraph 45 discloses that the outer diameter is configured to form an interference fit with the inner diameter of the -distal tip. As such, there is support for the outer diameter of the obturator to form an interference fit with the inner diameter of the lumen of the catheter at the distal tip; however, there is not explicit support for the interference fit to exist between an entirety of movement between the first and second positions. The examiner notes that while Figs. 1 and 2 of the Drawings appear to show a constant inner diameter, the specification is devoid of such language and it is the examiner’s opinion that the figures are not sufficient to provide such support.
Additionally, Applicant argues on pg. 6 that Besser does not teach or disclose the inner diameter of the lumen being constant along a length of the catheter. The examiner notes that the catheter of Besser is depicted in the figures as seemingly having a constant inner diameter (inner diameter of elongate body 402 in fig. 4A) similar to Applicant’s figures; however, Besser does not explicitly disclose that the inner diameter is constant, as noted by Applicant. The examiner notes that similar logic would be applied to Applicant’s disclosure in that the figures do not provide support for the claimed limitation.
The examiner notes that newly found reference Lui discloses a catheter having an inner diameter which is constant along a length of the catheter between the proximal end and distal tip (paragraph 20). While Applicant notes that Burkholz only teaches providing an interference at the distal tip (pg. 7 of Remarks), Burkholz was solely relied upon for the teaching of an interference fit between the obturator and the catheter. Since Besser modified with Lui teaches a catheter with a constant inner lumen diameter between the proximal end and the distal tip, the examiner maintains that modifying the device of modified Besser with the teachings of Burkholz would involve providing the interference fit from the proximal end to the distal tip.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 8, and 23-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the claim has been amended to recite “the inner diameter of the lumen is constant along a length of the catheter between the proximal end and the distal tip, such that the interference fit is provided between the outer diameter of the distal end of the obturator and the inner diameter during an entirety of movement between the first position and the second position”. The disclosure as originally filed fails to provide support for such amendment. The examiner notes that there is no indication in the specification that the inner diameter is constant along the length of the catheter between the proximal end and the distal tip. While the drawings appear to show such a configuration, it is the examiner’s opinion that the drawings are insufficient to provide support for such amendment, as discussed above. Additionally, in every recitation of the interference fit provided in the specification, the interference fit is only described as existing between the outer diameter of the obturator and the inner diameter of the distal tip of the catheter (paragraph 45). For these reasons, the amendment is considered to be drawn to new matter. See response to arguments above.
Claims 8 and 23-25 are also rejected by virtue of being dependent on claim 1.
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 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.
Regarding claim 23, there is a lack of antecedent basis in the term “the inner diameter of the catheter” in line 1. It is unclear if this limitation should be interpreted to mean “the inner diameter of the lumen” or if the claim should be amended to recite “an inner diameter of the catheter”. The examiner notes that the second interpretation would appear to raise further ambiguity over how the inner diameter of the catheter is distinguished over the inner diameter of the lumen. For examination purposes, the limitation is interpreted to mean “the inner diameter of the lumen”. However, under this interpretation, the claim appears to fail to further limit claim 1. As such, a 112(d) rejection is made below.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 23 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 23, as discussed above, the limitation “the inner diameter of the catheter” is interpreted to mean “the inner diameter of the lumen”. As such, using this interpretation, the claim fails to further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1, 8, and 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Besser (WO 2019067391) in view of Fortson (US 20140081134) in view of Heck (US 20120078095) in view of Lui (US 20120277576) and in view of Burkholz (US 20180093074).
Regarding claims 1 and 23, Besser discloses a vascular access device for performing a blood draw from the vasculature of a patient, comprising:
a catheter (elongate body 402 in fig. 4A) comprising a proximal end (see below), a distal tip (see below) comprising an opening (fig. 4A), a sidewall (see below) defining a lumen between the proximal end and distal tip (central lumen 404 in fig. 4A; paragraph 33), the lumen having an inner diameter (see below), and a first fluid pathway through the opening (fluid can flow out of opening below), the sidewall comprising a plurality of fenestrations forming a second fluid pathway through the plurality of fenestrations (side ports 406 in fig. 4A), the plurality of fenestrations positioned adjacent the distal tip to decrease fluid velocity at the distal tip (see below, the bottommost side port 406 below, equated to port 106C in fig. 2A, is shown to be positioned adjacent to the distal tip and would be configured to decrease fluid velocity at the distal tip, see response to arguments in Non-Final Rejection mailed on 9/25/2024), and thereby facilitate the blood draw (the side port is shown to be positioned adjacent the distal tip and would facilitate blood draw, see response to arguments in Non-Final Rejection mailed on 9/25/2024); and
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an obturator slidably positioned within the lumen of the catheter (inner sheath 420’ in fig. 4B; paragraph 34) and comprising a distal end with an outer diameter configured to form a close fit with the inner diameter of the lumen (fig. 4A shows the outer diameter of the sheath abutting the inner diameter of the elongate body 420), the obturator further comprising a tubular shaft (fig. 4B) and a third fluid pathway extending through a length of the tubular shaft (fig. 4A shows the sheath as having a lumen extending therethrough; claim 8 discloses a lumen extending therethrough);
wherein the tubular shaft is movable between a first position within the lumen of the catheter and a second position within the lumen of the catheter (paragraph 34 discloses translating the sheath to cover and uncover the side ports), and wherein:
with the tubular shaft at the first position, the second fluid pathway is open, so as to enable blood flow through the second fluid pathway and into and through the third fluid pathway (paragraph 34 and fig. 4A shows that moving the sheath 420 proximally relative to the ports 406 would allow blood to flow through the ports and into the lumen of the sheath); and
with the tubular shaft at the second position, the second fluid pathway is closed, so as to enable blood flow through the first fluid pathway and into and through the third fluid pathway (fig. 4A and paragraph 34 shows that moving the sheath distally relative to the ports would block the ports but allow blood to flow through the opening at the distal tip and into the lumen of the sheath); and
wherein the close fit is provided between the outer diameter of the obturator and the inner diameter of the lumen during an entirety of movement between the first position and the second position (fig. 4A shows that the outer diameter of the obturator 420 closely matches the inner diameter of the lumen of the catheter 420 along the length shown in fig. 4A so that the “close fit” would be provided between movement between the first and second positions).
While Besser teaches that the positioning/location of the plurality of fenestrations is exemplary and that the device “may comprise any pattern” including portions which are circumferentially arranged (paragraph 28), Besser does not explicitly teach or disclose the distal tip comprises a tapered distal tip, where the sidewall tapers radially inward at the distal tip to define the opening, with the plurality of fenestrations aligned longitudinally on the sidewall and arranged about the sidewall at a location proximal to where the sidewall tapers radially inward. Additionally, Besser does not explicitly teach or disclose the close fit between the outer diameter of the obturator and the inner diameter of the lumen to be an interference fit and where the inner diameter of the lumen is constant along a length of the catheter between the proximal end and the distal tip.
Fortson teaches a catheter (flexible element 12 in fig. 2A) comprising a tapered distal tip (fig. 2A shows the sidewall of distal tip 28 tapering in thickness), where the sidewall tapers radially inward at the distal tip to define the opening (fig. 2A). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the distal tip of Besser to be a tapered distal tip with the sidewall tapering radially inward to define the opening, as taught by Fortson, for the purpose of easing insertion into the body.
Heck teaches a vascular access device (fig. 8b) comprising a catheter (catheter 14 in fig. 8b) having a tapered distal end (conical shape 66 in fig. 8B) and a plurality of fenestrations (outlet ports 78 in fig. 8B) which are aligned longitudinally on the sidewall (fig. 8B and paragraph 46 discloses “at least one circumferential row of side ports”) and arranged about the sidewall at a location proximal to where the sidewall tapers radially inward (fig. 8B, paragraph 46). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the plurality of fenestrations of modified Besser to be aligned longitudinally on the sidewall and arranged about the sidewall at a location proximal to where the sidewall tapers radially inward, as taught by Heck. Besser discloses that the plurality of fenestrations can be arranged in any pattern (paragraph 28) so that aligning the fenestrations longitudinally appears within the scope of Besser and allows for a greater distribution of therapeutic fluid (paragraph 21 of Besser discloses administering therapeutic fluid). Since Besser teaches that the plurality of fenestrations are positioned at a distance from the distal tip (fig. 4A), PHOSITA would understand that the plurality of fenestrations would be positioned proximal to the tapered distal tip. Additionally, placing the fenestrations at a location where the wall thickness of the sidewall is the thickest would ensure the integrity of the sidewall is not unduly compromised.
Lui teaches a catheter (catheter 222 in fig. 3) and an obturator configured to be received within the catheter (obturator 224 in fig. 3). Lui further teaches that a lumen of the catheter (lumen 239 in fig. 3) comprises an inner diameter which is constant along a length of the catheter between a proximal end and a distal tip (paragraph 48). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the inner diameter of the lumen of the catheter of modified Besser to be constant along a length of the catheter between a proximal end and a distal tip, as taught by Lui, as this modification appears to be already disclosed by Besser (fig. 4A appears to show the lumen having a constant diameter along its length) and doing so would not modify operation of the device of modified Besser.
Burkholz teaches a similar device (fig. 1) comprising a catheter (catheter 12 in fig. 1) having a tip with an inner diameter (inner diameter of land portion 64 in fig. 3A) and an obturator (introducer needle 16 in fig. 1). Burkholz teaches that the obturator is positionable within the catheter to block a fenestration of the catheter positioned adjacent to the distal tip (side hole 62 in fig. 3A) and that the outer diameter of the obturator and the inner diameter of the lumen form an interference fit (paragraph 65).
Since Besser discloses that the “close fit” between the inner diameter of the lumen and the outer diameter of the obturator is provided during an entirety of movement between the first and second position (fig. 4A shows that the close fit between the catheter 402 and obturator 420 extends along the length shown in the fig), it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the outer diameter of the obturator and the inner diameter of the lumen of the catheter of modified Besser to form an interference fit so that the interference fit is provided during an entirety of movement between the first and second positions, as taught by Burkholz. This modification would ensure the port is sealed to prevent any fluid inadvertently exiting or entering the fenestration of Besser and would decrease the likelihood the obturator of Besser is accidentally translated.
Regarding claim 8, in the modified device of Besser, Besser discloses the obturator is slid distally and proximally within the lumen to move the obturator between the first position and the second position (paragraph 34 discloses translating the sheath 420’ to move between covering and uncovering positions).
Regarding claim 24, in the modified device of Besser, Besser modified with Burkholz teaches with the tubular shaft at the first position, the distal end of the obturator is flush with the distal tip of the catheter (in the first position, the outer surface of the distal end of the obturator is flush with the inner surface of the distal tip of the catheter due to the interference fit; see fig. 4A of Besser).
Regarding claim 25, in the modified device of Besser, the tubular shaft comprises a continuous cylindrical sidewall with no holes or openings formed therein (fig. 4B shows an embodiment where the inner sheath 420’ does not comprise any holes or openings; paragraph 34).
Conclusion
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 COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783