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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks filed on 05/12/2026. Claims 1, 5-8, 15, 16, 21, 23, 24, 26-29, 39 and 40 are pending. Claims 17, 20, 22, 25 and 35 are canceled.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/12/2026 has been entered.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
1. Claims 1, 5-8, 15, 16 and 21, 23, 24, 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2018/0369069 to Whelan in view of U.S. Patent No. 6,656,433 to Sasso and U.S. Patent Application Publication No. 2012/0078214 to Finke et al.
Whelan teaching a sampling port that includes a spike portion (cannula 24 of needle assembly 22).
As shown in Fig. 6 the cannula in aligned with a tubular part of a male Luer connector. [0079]
In Whelan the guide member 66 includes a first portion 36 (Fig. 6) that functions as a cap in Fig. 12, with the spike portion (cannula 24 of the needle assembly 22) being located in the interior to the cap portion and adapted to be passed through a pierceable closure (septum 152) as shown in Fig. 12.
Whelan teaches a male Luer lock connector 30, which as shown in Fig. 12 would extend away from the exterior of the cap portion and located outside of the interior of the cap portion and having a female sealing surface adapted to sealing engage with a complementary male sealing fitting. [0079]
Whelan teaches that a male or female Luer connector can be used, rendering the use of a female sealing fitting obvious. [0079]
Whelan does not teach a passageway that extends from the free end of the spike portion (cannula 24) to the end of the tubular part of the Luer connector.
Sasso teaches a vial access device that includes a tubular cannula 28 that projects downward and terminates at a sharpened or pointed, e.g., conical, free end 30 that forms a piercing tip. (column 3, line 65 – column 4, line 2). The cannula form a central passageway through the adaptor 20. (column 4, lines 12-16)
It would have been obvious to one of ordinary skill in the art to modify Whelan so that the cannula includes a passageway that extends from the free end of the cannula to the tubular part of the male Luer connector as taught by Sasso for purposes of providing an adapter for mounting on drug vial of various sizes to provide needleless access to the interior of the vials as taught by Sasso.
The device of Whelan as modified by Sasso would resemble the following:
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The female sealing fitting would extend along side and around the tubular outlet portion.
Whelan in view of Sasso does not teach a female sealing fitting in which the tubular outlet portion extends pas a free end of the female dealing fitting.
Finke et al. teaches a female Luer connector structure shown in Fig. 2 in which a lumen 20a extends past the free end of the female Luer connector.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Whelan in view of Sasso to include a female Luer connector that extends alongside and around the tubular outlet portion for part of the length of the tubular outlet portion, with the female sealing surface of the first female fitting spaced from and opposing an outer surface of the tubular outlet portion, and the tubular outlet portion extending past a free end of the first female sealing fitting, as taught by Finke et al. as a simple substitution of one known female Luer connector element for another to obtain predictable results.
I.) Regarding applicant’s claim 1, as noted above Whelan in view of Sasso teaches or renders all the limitations of claim 1 obvious.
Therefore, Whelan in view of Sasso and Finke et al. renders claim 1 obvious.
II.) Regarding applicant’s claim 5, as noted above Whelan in view of Sasso renders claim 1 obvious from which claim 5 depends.
Claim 5 recites that the first passageway has a length L and a cross sectional area equivalent to a circle of diameter D, wherein L divided by D is more than about 19.
Whelan in view of Sasso does not teach that the passageway has a length L and a cross sectional area equivalent to a circle of diameter D, wherein L divided by D is more than about 19.
It would have been obvious to one of ordinary skill in the art to configure the length and cross sectional area of the passageway of Whelan in view of Sasso and Finke et al. for use with vessels of different sizes and different septums, including a passageway having a length and cross sectional area having a ratio of more than 19. Differences in size and proportions are obvious unless a difference in performance is established. (MPEP2144.04(IV)A)).
Therefore, Whelan in view of Sasso and Finke et al. renders claim 5 obvious.
III.) Regarding applicant’s claim 6, as noted above Whelan in view of Sasso and Finke et al. renders claim 5 obvious from which claim 6 depends.
Claim 6 recites that the diameter of the passageway is less than about 0.6 mm
Whelan in view of Sasso and Finke et al. does not teach that the passageway has a diameter that is less than about 0.6 mm.
It would have been obvious to one of ordinary skill in the art to configure the diameter of the passageway of Whelan in view of Sasso and Finke et al. for use with vessels of different sizes and different septums, including a passageway having a diameter of less than 0.6 mm. Differences in size and proportions are obvious unless a difference in performance is established. (MPEP2144.04(IV)A)).
Therefore, Whelan in view of Sasso and Finke et al. renders claim 6 obvious.
IV.) Regarding applicant’s claim 7, as noted above Whelan in view of Sasso and Finke et al. renders claim 6 obvious from which claim 7 depends.
Claim 7 recites that the first passageway is more that about 20 mm long.
Whelan does not teach that the first passageway is more that about 20 mm long.
It would have been obvious to one of ordinary skill in the art to configure the length of the passageway of Whelan in view of Sasso and Finke et al. for use with vessels of different sizes and different septums, including a passageway having a length of more than 20 mm. Differences in size and proportions are obvious unless a difference in performance is established. (MPEP2144.04(IV)A)).
Therefore, Whelan in view of Sasso and Finke et al. renders claim 7 obvious.
V.) Regarding applicant’s claim 8, as noted above Whelan in view of Sasso and Finke et al. renders claim 7 obvious from which claim 8 depends.
Claim 8 recites that the tubular outlet portion is sized to fit within an internal passageway of a medical male Luer fitting.
Whelan in view of Sasso and Finke et al. does not teach that the tubular outlet portion is sized to fit within an internal passageway of a medical male Luer fitting.
Whelan teaches that either a male or female Luer connector can be used [0079], which renders obvious an outlet portion is sized to fit within an internal passageway of a medical male Luer fitting.
Therefore Whelan in view of Sasso and Finke et al. renders claim 8 obvious.
VI.) Regarding applicant’s claim 15, as noted above Whelan in view of Sasso and Finke et al. renders claim 8 obvious from which claim 15 depends.
Claim 15 recites that the tubular outlet portion fits within a circle with a diameter of about 1.6 mm.
Whelan in view of Sasso and Finke et al. does not teach that the tubular outlet portion fits within a circle with a diameter of about 1.6 mm.
Whelan in view of Sasso and Finke et al. includes a tubular portion that is within a Luer lock connection similar to applicant’s and is therefore of a size that would fit into a circle with a diameter of about 1.6 mm.
Therefore, Whelan in view of Sasso and Finke et al. renders claim 15 obvious.
VII.) Regarding applicant’s claim 16, as noted above Whelan in view of Sasso and Finke et al. renders claim 15 obvious from which claim 16 depends.
Claim 16 recites that the outlet portion fits within a circle with a diameter of about 1.6 mm.
Whelan in view of Sasso and Finke et al. does not teach that the outlet portion fits within a circle with a diameter of about 1.6 mm.
As noted above, Whelan in view of Sasso and Finke et al. includes a tubular portion that is within a Luer lock connection similar to applicant’s and is therefore of a size that would fit into a circle with a diameter of about 1.6 mm.
Therefore, Whelan in view of Sasso and Finke et al. renders claim 16 obvious.
VIII.) Regarding applicant’s claim 21, as noted above Whelan in view of Sasso and Finke et al. renders claim 1 obvious from which claim 21 depends.
Claim 21 recites that the first female sealing fitting comprises a female Luer fitting.
As noted above, Whelan teaches that either a male or female Luer connector can be used. [0079]
Therefore, Whelan in view of Sasso and Finke et al. renders claim 21 obvious.
IX.) Regarding applicant’s claim 23, as noted above Whelan in view of Sasso and Finke et al. renders claim 8 obvious from which claim 23 depends.
Claim 23 recites that the cap portion is integrally formed with the hollow plastics spike.
Whelan in view of Sasso and Finke et al. does not teach that the cap portion is integrally formed with the hollow plastics spike.
It would have been obvious to modify Whelan in view of Sasso and Finke et al. to have the cap portion and the spike portion and the tubular outlet portion integrally formed. Note the use of a one piece construction would be merely a matter of obvious engineering choice. (MPEP 2144.04 (C)(B)).
Sasso teaches this use of a plastic construction material. The use of a plastic material would have been obvious for purposes of being able to mold the device of Whelan in view of Sasso and Finke et al.
Therefore, Whelan in view of Sasso and Finke et al. renders claim 23 obvious.
X.) Regarding applicant’s claim 24, as noted above Whelan in view of Sasso and Finke et al. renders claim 8 obvious from which claim 24 depends.
Claim 24 recites that cap portion is formed separately from the hollow plastics spike.
In Whelan the cap portion and hollow spike are shown as being formed separately in Fig. 4
Therefore, Whelan in view of Sasso and Finke et al. renders claim 24 obvious.
XI.) Regarding applicant’s claim 26, as noted above Whelan in view of Sasso and Finke et al. renders claim 24 obvious from which claim 26 depends.
Claim 26 recites that the first female sealing fitting is located on the cap portion.
In Whelan the Luer connection is provided on the cap portion as shown in Fig. 12.
Therefore, Whelan in view of Sasso and Finke et al. renders claim 26 obvious.
XII.) Regarding applicant’s claim 27, as noted above Whelan in view of Sasso and Finke et al. renders claim 24 obvious from which claim 27 depends.
Claim 27 recites that the first female sealing fitting is integrally formed on the hollow plastics spike.
Whelan in view of Sasso and Finke et al. does not teach that the first female sealing fitting is integrally formed on the hollow plastics spike.
It would have been obvious to modify Whelan in view of Sasso and Finke et al. to have the first female sealing fitting and the spike portion and the tubular outlet portion integrally formed. Note the use of a one piece construction would be merely a matter of obvious engineering choice. (MPEP 2144.04 (C)(B)).
Sasso teaches this use of a plastic construction material. The use of a plastic material would have been obvious for purposes of being able to mold the device of Whelan in view of Sasso and Finke et al.
Therefore, Whelan in view of Sasso and Finke et al. renders claim 27 obvious.
2. Claims 28, 29, 39 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Whelan in view of Sasso and Finke et al. as applied to claim 1 above and further in view of U.S. Patent Application Publication No. 2019/0201888 to McIntyre et al.
I.) Regarding applicant’s claim 28, recites the combination of a vent cap and the medical device of claim 1, the vent cap having a main body with a second passageway extending through the main body, the second passageway having first and second ends and at least one internal surface; the first end adapted to receive the tubular outlet and sized so that the tubular outlet is clear of the at least one internal surface; the second end open to the environment; a biological filter located in the passageway; the main body including a second male sealing fitting
As noted above, Whelan in view of Sasso and Finke et al. renders the device of claim 1 obvious.
Whelan in view of Sasso and Finke et al. does not teach a vent cap having a main body with a second passageway extending through the main body, the second passageway having first and second ends and at least one internal surface; the first end adapted to receive the tubular outlet and sized so that the tubular outlet is clear of the at least one internal surface; the second end open to the environment; a biological filter located in the passageway; the main body including a second male sealing fitting complementary to and engaging the first female sealing fitting on the medical device, with the tubular outlet extending into the first end the second passageway and being clear of the at least one internal surface, whereby, the first end of the passageway is blocked from communication with the environment except via the filter or the tubular outlet.
McIntyre et al. teaches a vented cap 104 that includes a passageway (cannula) that can extend into a biological-fluid container. The vented caps 110 and 112 include filters on ports 106 and 108.
It would have been obvious to modify Whelan in view of Sasso and Finke et al. to include a vented cap attach to the Luer fitting on the outlet in order to provide for venting as taught by McIntyre et al.
Therefore, Whelan in view of Sasso, Finke et al. and McIntyre et al. renders claim 28 obvious.
II.) Regarding applicant’s claim 29, as noted above Whelan in view of Sasso, Finke et al. and McIntyre et al. renders claim 28 obvious from which claim 29 depends.
Claim 29 recites a retaining portion adapted to engage the medical device to retain the vent cap to the medical device.
As shown in Fig. 13 of Whelan, the shoulders of the device are adapted to engage a medical device (sample bottle 110).
Therefore, Whelan in view of Sasso, Finke et al. and McIntyre et al. renders claim 29 obvious.
III.) Regarding applicant’s claim 39, as noted above Whelan in view of Sasso and Finke et al. renders claim 29 obvious from which claim 39 depends.
Claim 39 recites that the cap portion and hollow plastics spike are integrally formed.
Whelan in view of Sasso, Finke et al. and McIntyre et al. does not teach that the cap portion and hollow plastics spike are integrally formed.
It would have been obvious to modify Whelan in view of Sasso, Finke et al. and McIntyre et al. to have the spike portion and the tubular outlet portion integrally formed. Note the use of a one piece construction would be merely a matter of obvious engineering choice. (MPEP 2144.04 (C)(B)).
Therefore, Whelan in view of Sasso, Finke et al. and McIntyre et al. renders claim 39 obvious.
IV.) Regarding applicant’s claim 40, as noted above Whelan in view of Sasso and Finke et al. renders claim 39 obvious from which claim 40 depends.
Claim 40 recites that the first sealing fitting comprises a female Luer fitting and the second male sealing fitting comprises a male luer fitting..
As noted above, Whelan teaches that either a male or female Luer connector can be used. [0079]
Therefore, Whelan in view of Sasso, Finke et al. and McIntyre et al. renders claim 40 obvious.
Response to Arguments
Applicant’s arguments with respect to claims 1, 5-8, 15, 16, 21, 23, 24, 26-29, 39 and 40 have been considered but are moot because the new ground of rejection that relies upon the new prior art reference to Finke et al. that teaches a female Luer connector that extends alongside and around the tubular outlet portion for part of the length of the tubular outlet portion, with the female sealing surface of the first female fitting spaced from and opposing an outer surface of the tubular outlet portion, and the tubular outlet portion extending past a free end of the first female sealing fitting, as necessitated by applicant’s amendments to the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL S. GZYBOWSKI whose telephone number is (571)270-3487. The examiner can normally be reached M-F 8:30-5:00.
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/MICHAEL STANLEY GZYBOWSKI/ Examiner, Art Unit 1798
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