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 .
Acknowledgments
This office action is in response to the reply filed on 7/6/26. In the reply,
the applicant amended claim 15; added new claim 20. Claims 1-20 are pending.
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claim 12 is further objected to based on dependency.
Claim 20 is allowed.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 5-8, 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kujawa et al. (US 2021/0244920) (“Kujawa”). Kujawa discloses:
(claim 1) A vascular access device (Fig. 7), comprising: a catheter insertion apparatus including: a housing 102 having a distal housing end and a proximal housing end and defining a longitudinal passage therein; a needle 104 slideably mounted within the longitudinal passage and defining a needle lumen; and a catheter assembly comprising a frame 110 (210) and a catheter 106 retained by the frame, the frame being slideably mounted within the housing to advance the catheter within the needle lumen; wherein the catheter insertion apparatus is operable in an initial configuration where the needle extends distally from the distal housing end and the catheter is proximally retracted within the needle lumen (Fig. 7, 8a, 19a, 20a [0083]), and is operable in an actuated configuration where the needle is retracted back into the longitudinal passage of the housing and the catheter extends through the needle lumen and distally from the distal housing end (Fig. 19c, 20c [0102-0103]); and a needleless access connector (NAC) unit 108 (218, 318) positioned at a proximal end of the frame of the catheter assembly, the NAC unit providing an access port (luer) 116 [0082] to the catheter.
Claim 2: the NAC unit comprises a connector portion 116 including a proximal coupler, the proximal coupler comprising a split-septum 334 NAC. (Fig. 22a)
Claim 5: the NAC unit further comprises a stabilization portion 216 coupled to the connector portion, the stabilization portion configured to be placed in contact with a skin surface of a patient. (Fig. 21b)
Claim 6: positioning of the NAC unit at the proximal end of the frame of the catheter assembly provides a closed-system VAD. (Fig. 7)
Claim 7: the frame has a distal frame end and a proximal frame end, the frame comprising: a push member 118a (208a) positioned at the proximal frame end; and a plurality of arms 110 extending distally from the push member to the distal frame end, the plurality of arms engaging with the housing to form a sliding engagement between the frame and the housing; wherein the push member is configured to be pushed distally to slide the plurality of arms into the housing and thereby advance the catheter within the needle lumen. (Figs. 8a-c, 19a-c, 20a-c)
Claim 8: the NAC unit is integrated with the push member of the frame. Figs. 8a
Claim 14: the access port and the catheter form an instrument compatible fluid path. (See abstract, last sentence)
Claim 15: in transitioning from the initial configuration to the actuated configuration, the push member is pushed distally and into contact with the housing, with the plurality of arms sliding into the housing as the push member is pushed distally. (Figs. 19a-c, 20a-c)
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.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Kujawa in view of Burkholz et al. (US 2019/0021640) (“Burkholz”).
Kujawa discloses the invention as substantially claimed but does not directly disclose a side port provided on the connector portion, the side port in fluid communication with the proximal coupler via a lumen defined in the connector portion; and an extension tube coupled to the side port to provide a fluid path into the connector portion; wherein the connector portion of the NAC unit comprises a flush enhancing feature. Burkholz, in the analogous art, teaches these features (integrated extension tube 22) Fig. 1A-c. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to have modified the device of Kujawa with the side port and extension tube to provide an additional fluid path and flush to the system as is well known in the art.
Claims 9, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kujawa in view of Huang et al. (US 2022/0362523) (“Huang”).
Kujawa discloses the invention as substantially claimed but does not directly disclose the NAC unit is separate from the catheter insertion apparatus and coupleable to the push member. Huang, in the analogous art, teaches the first and second portion engaged via a separable configuration [0053] Fig. 4A. The NAC unit is coupled to the push member 49 with the catheter insertion apparatus in the initial configuration or in the actuated configuration, Fig. 4A. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to have modified the device of Kujawa with the separable configuration as taught by Huang to optimize use and reuse of the device at a cost savings or to fit specific design need.
Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kujawa in view of Burkholz.
(claim 16) As above with claim 1, Kujawa discloses the invention as substantially claimed: (Fig. 7) a catheter insertion apparatus including: a housing 102 having a distal housing end and a proximal housing end and defining a longitudinal passage therein; a needle 104 slideably mounted within the longitudinal passage and defining a needle lumen; and a catheter assembly comprising a frame 110 (210) and a catheter 106 retained by the frame, the frame being slideably mounted within the housing to advance the catheter within the needle lumen; wherein the catheter insertion apparatus is operable in an initial configuration where the needle extends distally from the distal housing end and the catheter is proximally retracted within the needle lumen (Fig. 7, 8a, 19a, 20a [0083]), and is operable in an actuated configuration where the needle is retracted back into the longitudinal passage of the housing and the catheter extends through the needle lumen and distally from the distal housing end (Fig. 19c, 20c [0102-0103]); and a needleless access connector (NAC) unit 108 (218, 318) positioned at a proximal end of the frame of the catheter assembly, the NAC unit providing an access port (luer) 116 [0082] to the catheter.
Kujawa does not directly disclose an instrument delivery device or blood draw device coupled to the access port of the NAC unit. Burkholz, in the analogous art, teaches this feature ([0063] Fig. 1C, instrument 12 being inserted via extension 10 to the NAC unit 14. Also (claim 18), the instrument in Burkholz is a catheter or other probe instrument [0005]. (claim 17) The instrument is advanced out distally 42 past the catheter [0055]. (claim 19) The instrument comprises a lock to secure the instrument to the NAC unit [0063]. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to have modified the device of Kujawa with the instrument delivery as taught by Burkholz such that blood samples can be taken without additional needle sticks (Burkholz [0005]).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Applicant appears to disagree with the proximal connector 108 of Kujawa being characterized as the NAC connector unit in independent claim 1 and 16. In Kujawa [0082], as applicant highlights on page 7 of remarks, the proximal connector 108 “may be a conventional luer-type fitting having proximal threads 116 of the type which mate with conventional medical fluid delivery systems.” Examiner agrees and this is why that element was used for the NAC unit. The NAC unit 14a, from applicant’s specification [0047], for example, proximal end 78 connector portion 72 has a coupler 80 that provides a proximal port on the NAC unit 14a (Fig.1). This connector and coupler is also a luer connector, as is Kujawa, 108,116. Examiner disagrees with applicant’s distinction and maintains rejection.
Conclusion
THIS ACTION IS MADE FINAL. 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 DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783
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