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 Species A in the reply filed on 1/15/2026 is acknowledged. The traversal is on the ground(s) that Species A-C are so related that results from a search of any species will necessarily produce results applicable for examination of the other species. This is not found persuasive because the species include distinct features that will require different fields of search. For example, a search for the seal body having a magnet will require distinct search queries from the seal body having a wedge shape, as would a search for the species having a rack and pinion.
The requirement is still deemed proper and is therefore made FINAL.
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) 1-6, 15, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cole et al (US 10,265,466) in view of Vaillancourt (US 6,699,221).
Regarding claim 1, Cole discloses a vascular access device comprising an adapter body 200 having a first end (fig. 2, skin contacting surface) and a second end opposite the first end, the adapter body defining a passageway (fig. 2: passageway through portions 202), a catheter 228 received by the adapter body (fig. 3), a needle 302 received by the adapter body, a portion of the needle positioned within the catheter 202 (fig. 3), and a seal assembly comprising a seal body 227 positioned within the passageway of the adapter body (fig. 5; col. 6, lines 57-61), and an actuator 100 (fig. 3), the catheter connected to the seal body (col. 6, lines 57-61), where the actuator is configured to move the seal body from a first position within the adapter body (fig. 2) to a second position within the adapter body that is spaced from the first position (fig. 4).
Claim 1 further calls for the seal body forming a seal with the adapter body. It is not clear from the disclosure of Cole whether or not the seal body is sealingly engaged with the adapter body. Vaillancourt teaches an adapter body 11 and a catheter 15 carried by a seal 16 (fig. 3), the seal forming a seal with the adaptor body thereby allowing the catheter to remain in position in an interference fit until it is actuated to the second position (figs. 5, 6; col. 3, lines 32-34; col. 4, lines 15-21). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the seal of Cole to form a seal with the adapter body as taught by Vaillancourt to ensure that the catheter remains in the desired position prior to and after being actuated by the actuator.
Regarding claim 2, Cole discloses an end cap position at the first end of the adapter body, the end cap configured to engage the seal body to limit movement of the seal body (fig. 5: end cap formed by bottom horizontal surface of body, contacting seal body 227).
Regarding claim 3, Cole discloses that the catheter 228 is connected to the seal body 226 via a wedge 230 (fig. 5; col. 6, lines 57-61).
Regarding claim 4, Cole discloses that a portion of the catheter 228 is positioned over the wedge 230, the wedge connected to the seal body via an interference fit (fig. 5; definition of wedge implies an interference fit).
Regarding claim 5, Cole discloses that the actuator 100 comprises an extension member connected to the seal body 226 and extending outside of the passageway of the adapter body (fig. 3).
Regarding claim 6, Cole discloses an actuator seal 226 positioning within the passageway of the adapter body, the extension member and the needle received by the actuator seal (fig. 3).
Regarding claim 15, Cole discloses that the adapter body comprises a side port 212 extending between the first and second ends of the adapter body (fig. 3), the side port defining a side passageway in fluid communication with the passageway of the adapter body (fig. 3: opening 212 necessarily provides a fluid pathway into the adapter body).
Claim 16 calls for the side port to extend from the adaptor body at an angle of 25-75 degrees. Applicant has not provided any criticality to this angle by describing any particular purpose or benefit to the recited angle. Additionally, the disclosure recites that “other suitable angles may be utilized” (specification page 6, para. 0038). Therefore, there is no criticality to the claimed angle. Therefore, it would have been a matter of obvious design choice to modify the angle of the port of Cole to have an angle within the claimed range because doing so would not affect the operation of the device nor provide any benefit or particular purpose.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cole in view of Vaillancourt as applied to claim 1 above, and further in view of Schertiger et al (US 8,491,568).
Claim 14 differs from Cole in view of Vaillancourt in calling for the seal body to comprise a plurality of seal rings. Schertiger teaches a seal body comprising a plurality of rings 19a, 19b, 19c that provide small contact areas which results in a concentration of the pressure that holds the catheter in the extended or retracted position within the hub thereby preventing unintended movement of the catheter (col. 6, lines 5-24; fig. 3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the seal body of Cole in view of Vaillancourt to include a plurality of seal rings as taught by Schertiger to provide a secure holding force between the catheter and the hub to prevent unintentional movement of the catheter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783