DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Invention I: Claims 1-8 in the reply filed on 4/20/2026 is acknowledged.
Applicant's election with traverse of Species 1A, Species 2A, and Species 3B in the reply filed on 4/20/2026 is acknowledged. The traversal is on the ground(s) that no claim limitations are addressed in the discussion for the elected species..However, the examiner notes that claims are not species. Rather, the species are are drawn to the distinct embodiments of the system disclosed in the specification.
Applicant also argues that no showing of serious search and/or examination burden has been established. This argument has not been found persuasive. As noted in the Restriction requirement, the species listed are drawn to a number of distinct structures. If all of these distinct species were examined, the examiner would need to search for and examine a wide variety of non-overlapping structures for a dual-lumen cannula system.
However, upon further consideration of Species 2B (Figure 4), the examiner has determined that this species is not sufficiently distinct from Species 2A (Figure 1D) to warrant an election of species. Therefore, Species 2B has been examined along with Species 2A.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-8 have been examined on the merits.
Claims 9-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/20/2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following elements of the claims must be shown or the feature(s) canceled from the claims:
A crossbar opposite the inner and outer cannulas (Claims 6 and 7)
A stem of the hub (Claims 4, 6, and 7).
No new matter should be entered.
The examiner notes that it appears that these elements are shown in the embodiment of Figure 1D, but they should be clearly labeled in the figure.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 4, 6, and 7 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.
Claims 4, 6, and 7 recite wherein the hub has a T shape with one of the first and second ports on a crossbar opposite the inner and outer cannulas and the other of the first and second ports on a stem of the crossbar. It is not immediately clear what configuration is required by this limitation, as the crossbar and stem are not clearly shown in the figures.
For examination purposes, the examiner has interpreted the crossbar and stem to comprise the following elements in Figure 1D:
The perpendicular element (adjacent numeral 136) that projects outwardly at 90 degrees, and
the proximal section (adjacent numerals 122 and 134) that is parallel with the cannulas).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 4, and 6-8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Burbank et al. (US 2004/0186415) in view of Phillips et al. (US 2010/0191166).
With respect to Claim 1, Burbank teaches a dual-lumen needle (Figures 2-5), comprising:
an inner cannula 221 in the embodiment of Figures 2-3; 430 in the embodiment of Figures 4-5) having an inner lumen;
an outer cannula (220 in Figures 2-3; 425 in Figures 4-5) having an inner lumen;
a hub (205/215 in Figures 2-3; 400 in Figures 4-5) having a first port (connected to venous line 206/445 in the embodiments of Figures 2-3 and 4-5) and a second port ( connected to arterial line 207/415 in the embodiments of Figures 2-3 and 4-5), the hub being configured to support the inner and outer cannulas with the outer cannula in coaxial relation to the inner cannula thereby defining an annular channel between the inner and outer cannulas (Figures 2-5; paragraphs [0023-0028]: );
the hub being further configured to define a first fluid channel connecting the first port with the inner cannula inner lumen and second fluid channel connecting the annular channel to the second port (Figures 2-5; paragraphs [0023-0028]);
wherein the inner cannula (221/430) extends through and beyond the outer cannula (220/425) at a distal end thereof extending away from the hub (note that Figure 5 shows a detailed view of the distal ends of the inner and outer cannulas. See Figures 2-5 and paragraphs [0023-0028].
Burbank suggests that dual-lumen extracorporeal cannulas of this type may be used with subcutaneous ports (paragraph [0003]), but does not specifically teach that the inner and outer cannulas are blunt tip needles adapted for use with buttonhole-type vascular accesses.
Phillips teaches a subcutaneous vascular access port , wherein the port is a buttonhole access site that is configured for use with a blunt-tip needle (paragraphs [0025-0031], [0053], [0111-0112], [0119] and [0123-0127]). This configuration allows for easy, repeated access of the same vascular site and is extraordinarily well known in the art, (see at least paragraphs [0053] and [0119]). It would have been obvious to one of ordinary skill in the art at the time of invention to modify Burbank’s dual-lumen needle assembly to provide the inner and outer cannulas with blunt tip needles adapted for use with buttonhole-type vascular accesses, as suggested by Phillips, in order to allow the dual-lumen needle assembly to be used with an art-established buttonhole-type vascular access port, thereby enabling repeated access of the vessel.
With respect to Claim 2, Burbank’s hub is a substantially rigid structure that holds the inner and outer cannulas in a fixed relation to each other. Specifically, in the embodiment of Figures 2- 3, the hub 205/215 holds inner and outer catheters (220, 221) in a fixed concentric relation, such that removal of one cannula causes the removal of both cannulas (paragraphs [0023-0027]. In the embodiment of Figures 4-5, the functionality is the same as in that of Figures 2-3, and the hub 400 is further disclosed as being sufficiently rigid to allow helical attachment of element 460 and compression of o-ring 440 (paragraph [0028]).
With respect to Claims 4, 6, and 7, Burbank teaches that the hub has a T shape (Figures 2 and 3) with one of the first and second ports on a crossbar opposite the inner and outer cannulas (220, 221) and the other of the first and second ports on a stem of the hub. As noted above with respect to Claim 1, the first and second ports are the ports at which the venous line 206 and arterial line 207 connect to the hub 205/215; Figures 2-3).
With respect to Claim 8, Burbank teaches that the hub 400 is substantially Y-shaped, such that the atrial line 415 extends from the hub at an angle between 0-90 degrees.
In the alternative, it has been held that mere changes in shape do not constitute patentable improvements in the art when said changes do not result in a non-obvious change in functionality ()MPEP 2144.04.IV.B). In this case, it is unclear why changing Burbank’s dual-lumen needle devices of Figures 2-3 or Figures 4-5 to be generally Y-shaped would substantially change the functionality of the device in an unexpected way. It would have been an obvious matter of design choice to one having ordinary skill in the art at the time of invention to provide the lumens and cannulas of the hub in a Y shape, of whatever form or shape was desired or expedient, because a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results.
Claims 3 and 5 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Burbank and Phillips as applied to claim 1 above, and further in view of Hiejima et al. (US 2010/0234804).
With respect to Claims 3 and 5, Burbank is silent as to the exact materials of the hub and cannulas, and therefore does not explicitly teach that the inner and outer cannulas are metal and the hub is a rigid material such as resin.
However, these materials are commonplace in the art of access needles. For example, Hiejima teaches a vascular access cannula system comprising a resin hub and a steel cannula, thereby proofing a hard, resilient materials for providing the vascular access (paragraphs [0063-0064]). It would have been obvious to one of ordinary skill in the art at the time of invention to further modify Burbank’s vascular access system to have a resin hub and a inner and outer cannulas made of metal such as stainless steel, as suggested by Hiejima, in order to provide art-established materials that make the hub and cannulas sufficiently rigid and resilient for use as a vascular access device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wariar (US 2002/0198483) teaches a system for detecting needle dislodgement during extracorporeal treatment
Waulerson (US 2010/0076406) teaches a dual-lumen cannula with a Y-shaped hub. Kleinekofort (US 2009/0198171) teaches a dual lumen system for detecting an access disconnection and removing both needles simultaneously.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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