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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
1. Claims 1, 5-8, 15-17 and 20-27 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.
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]
Also in paragraph [0079] Whelan refers to the piercing device of the needle assembly.
Whelan does not teach a passageway that extend from the free end of the spike portion (cannula 24) to the end of the tubular part of the male 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:
[AltContent: arrow][AltContent: arrow][AltContent: textbox (From Sasso)][AltContent: textbox (From Whelan)]
PNG
media_image1.png
342
288
media_image1.png
Greyscale
As shown in Fig. 25 of Whelan the cylindrical wall having shoulder 48 in Fig. 4 provides a seal with respect to a sampling bottle 320 and reads on a first sealing fitting.
Therefore, Whelan in view of Sasso teaches a spike portion adapted to pass through
a pierceable closure of a container, and a tubular outlet portion, with the hollow spike having a first passageway extending from at or near a free end of the spike portion to a free end of the tubular outlet portion, and a first sealing fitting, wherein the free end of the tubular outlet portion extends longitudinally out of the first sealing fitting, and an outer surface of the tubular outlet portion is spaced from an inner surface of the first sealing fitting that extends around at least part of the tubular outlet portion.
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 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 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 renders claim 5 obvious.
III.) Regarding applicant’s claim 6, as noted above Whelan in view of Sasso 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 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 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 renders claim 6 obvious.
IV.) Regarding applicant’s claim 7, as noted above Whelan in view of Sasso 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 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 renders claim 7 obvious.
V.) Regarding applicant’s claim 8, as noted above Whelan in view of Sasso 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 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 renders claim 8 obvious.
VI.) Regarding applicant’s claim 15, as noted above Whelan in view of Sasso 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 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 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 renders claim 15 obvious.
VII.) Regarding applicant’s claim 16, as noted above Whelan in view of Sasso 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 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 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 renders claim 16 obvious.
VIII.) Regarding applicant’s claim 17, as noted above Whelan in view of Sasso renders claim 16 obvious from which claim 17 depends.
Claim 17 recites that the spike portion and the tubular outlet portion are integrally formed.
Whelan in view of Sasso does not specially teach that the spike portion and the tubular outlet portion are integrally formed.
It would have been obvious to modify Whelan in view of Sasso 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 renders claim 17 obvious.
IX.) Regarding applicant’s claim 20, as noted above Whelan in view of Sasso renders claim 17 obvious from which claim 20 depends.
Claim 20 recites that the first sealing fitting comprises a female or male fitting.
As noted above, Whelan teaches that either a male or female Luer connector can be used. [0079]
Therefore, Whelan in view of Sasso renders claim 20 obvious.
X.) Regarding applicant’s claim 21, as noted above Whelan in view of Sasso renders claim 20 obvious from which claim 21 depends.
Claim 21 recites that the first sealing fitting comprises a female or 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 renders claim 21 obvious.
XI.) Regarding applicant’s claim 22, as noted above Whelan in view of Sasso renders claim 21 obvious from which claim 22 depends.
Claim 22 recites that the device comprises the hollow plastics spike and a secondary component.
Whelan teaches a guide member 66 having a first portion 36 (Fig. 6) that is interpreted as being a secondary component.
Therefore, Whelan in view of Sasso renders claim 22 obvious.
XII.) Regarding applicant’s claim 23, as noted above Whelan in view of Sasso renders claim 22 obvious from which claim 23 depends.
Claim 23 recites that the secondary component medical device is integrally formed with the hollow plastics spike.
Whelan in view of Sasso does not teach that the secondary component medical device is integrally formed with the hollow plastics spike.
Whelan in view of Sasso does not teach that the secondary component medical device is integrally formed with the hollow plastics spike.
It would have been obvious to modify Whelan in view of Sasso to have the secondary component 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.
Therefore, Whelan in view of Sasso renders claim 23 obvious.
XIII.) Regarding applicant’s claim 24, as noted above Whelan in view of Sasso renders claim 23 obvious from which claim 24 depends.
Claim 24 recites that secondary component is formed separately from the hollow plastics spike.
In Whelan the secondary component and hollow spike are shown as being formed separately in Fig. 4
Therefore, Whelan in view of Sasso renders claim 24 obvious.
XIV.) Regarding applicant’s claim 25, as noted above Whelan in view of Sasso renders claim 23 obvious from which claim 25 depends.
Claim 25 recites that the secondary component comprises at least the cap portion of a sampling cap or port.
In Whelan the guide member 66 includes a first portion 36 (Fig. 6) that functions as a cap in Fig. 12.
Therefore, Whelan in view of Sasso renders claim 25 obvious.
XV.) Regarding applicant’s claim 26, as noted above Whelan in view of Sasso renders claim 22 obvious from which claim 26 depends.
Claim 26 recites that the first sealing fitting is located on the secondary component.
In Whelan the Luer connection is provided on the first portion 36 (at wall portion 32) of the secondary component.
Therefore, Whelan in view of Sasso renders claim 26 obvious.
XVI.) Regarding applicant’s claim 27, as noted above Whelan in view of Sasso renders claim 5 obvious from which claim 27 depends.
Claim 27 recites that the device consists of the hollow plastics spike with the first sealing fitting integrally formed on the hollow plastics spike.
Whelan in view of Sasso does not teach that the device consists of the hollow plastics spike with the first sealing fitting integrally formed on the hollow plastics spike.
It would have been obvious to modify Whelan in view of Sasso to have the secondary component 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.
Therefore, Whelan in view of Sasso renders claim 27 obvious.
2. Claims 28, 29, 35, 39 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Whelan in view of Sasso 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 sealing fitting
As noted above, Whelan in view of Sasso renders the device of claim 1 obvious.
Whelan in view of Sasso 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 sealing fitting complementary to and engaging the first 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 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 and McIntyre et al. renders claim 28 obvious.
II.) Regarding applicant’s claim 29, as noted above Whelan in view of Sasso 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 and McIntyre et al. renders claim 29 obvious.
III.) Regarding applicant’s claim 35, as noted above Whelan in view of Sasso and McIntyre et al. renders claim 29 obvious from which claim 35 depends.
Claim 35 recites that the medical device comprises a sampling cap assembly comprising: a cap portion and the hollow plastics spike
As noted above, Whelan in view of Sasso and McIntyre et al. provides a cap assembly having a cap portion and a hollow spike.
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 McIntyre et al.
Therefore, Whelan in view of Sasso and McIntyre et al. renders claim 27 obvious.
IV.) Regarding applicant’s claim 39, as noted above Whelan in view of Sasso renders claim 35 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 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 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 and McIntyre et al. renders claim 39 obvious.
V) Regarding applicant’s claim 40, as noted above Whelan in view of Sasso renders claim 39 obvious from which claim 40 depends.
Claim 40 recites that the first 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 McIntyre et al. renders claim 40 obvious.
Response to Arguments
Applicant's arguments filed 10/21/2025 have been fully considered but they are not persuasive.
Applicant argues that Whelan in view of Sasso does not teach a sealing fitting.
As noted above, in Fig. 25 of Whelan shows that the cylindrical wall having shoulder 48 in Fig. 4 provides a seal with respect to a sampling bottle 320 and therefore reads on applicant’s sealing fitting.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 MICHAEL S. GZYBOWSKI whose telephone number is (571)270-3487. The examiner can normally be reached M-F 8:30-5:00.
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, Jill Warden can be reached at 571-272-1267. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.S.G./Examiner, Art Unit 1798
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798