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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on April 1, 2026. As directed by the amendment: claim 1 has been amended, claims 1-11 and 20 has been cancelled, and claims 21-31 have been added. Thus, claims 12-19 and 21-31 are presently pending in this application.
Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every 112(b) rejections previously set forth in the Non-Final Office Action mailed January 21, 2026.
Response to Arguments
Applicant’s arguments with respect to claim 21 have been considered but are moot because the arguments do not apply to the current grounds of rejection as necessitated by applicant’s amendments.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12-19 and 21-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 12, the claim has been amended to recite that the breakaway connector includes a breakaway force associated with detaching the breakaway component from the housing. There is insufficient support in the originally filed disclosure for the breakaway component to detach from the housing. As seen in fig. 3, the breakaway component 50 is engaged to the shell 40 which is connected to housing 30 so that the breakaway component is not attached to the housing. Thus, there is support for the breakaway component 50 to detach from the shell 40 but not from the housing 30.
Claims 13-19 and 21-31 are also rejected by virtue of being dependent on claim 12.
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) 12, 17, 21, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones (US 20210236794) in view of Burkholz (US 20200222681).
Regarding claim 12, Jones discloses a breakaway connector apparatus for attachment to a needle-free connector (fig. 17a), comprising:
a breakaway connector (device 120 in fig. 17a) including a housing (see below) having a fixed cannula (see below), and a breakaway component detachably secured to the housing (snap fit connector 140 in fig. 17a); and
wherein the breakaway component includes a socket configured for engagement with the needle-free connector (see below; a needle-free connector is functionally capable of being inserted into the socket below), such that the needle-free connector imparts a push-out force on the housing (the device is capable of receiving a needle-free connector which can impart a push-out force on the bottom of cannula below),
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wherein the breakaway connector includes a breakaway force associated with detaching the breakaway component from the housing (paragraph 59 discloses an axial force).
The examiner notes that the claim has been amended to recite “ a push-out force is imparted on the housing by the needle-free connector when the breakaway connector is detachably secured to the needle-free connector” indicating that the breakaway connector merely needs to be capable of receiving a needle-free connector capable of exerting a push-out force on the housing when the needle-free connector is attached to the housing. The breakaway connector of Jones is functionally capable of receiving such a connector – the needle-free connector could be inserted into the socketed denoted above and exert a push-out force on the bottom of the cannula, which is a part of the housing. The examiner further notes that since the needle-free connector is a functional aspect of the breakaway connector and the breakaway component inherently provides a breakaway force, the breakaway connector is capable of being used with a needle-free connector which provides a push-out force which, when summed with the breakaway force, provides a force within a selected range of separation force (i.e. a user is capable of selecting a needle-free connector which has a push-out force which would yield the claimed separation force range).
The examiner notes that an amendment which amends the claim to be drawn to a system comprising the claimed breakaway connector apparatus and the needle-free connector would overcome the current rejection and would place the application in condition for allowance (excepting the 112a rejection above).
However, Jones does not teach or disclose only one valve disposed within the fixed cannula.
Burkholz teaches a connector (fig. 2a) comprising a fixed cannula (see below) comprising only one valve within the fixed cannula (see below; anti-reflux valve 42 in fig. 6). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the fixed cannula of Jones to include the one valve, as taught by Burkholz, for the purpose of protecting against microbial ingress (paragraph 54).
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Regarding claim 17, in the modified apparatus of Jones, Jones discloses the breakaway connector further includes a shell disposed on the housing (shield 127 in fig. 17a), and wherein the shell includes a securing arm (arm guards 136 in fig. 13).
Regarding claim 21, in the modified apparatus of Jones, Jones discloses the selected range of separation force is between one pound and six pounds (the socket denoted above is capable of being engaged to a needle-free connector which would provide the claimed separation force in conjunction with the breakaway force of Jones).
Regarding claim 22, in the modified apparatus of Jones, Jones discloses the breakaway force associated with detaching the breakaway connector from the housing is higher than the push-out force imparted on the housing by the needle-free connector (the socket denoted above is capable of engaging a needle-free connector which provides a push-out force lower than the breakaway force).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones in view of Burkholz, as applied to claim 12 above, and further in view of Hiejima (US 20010021829).
Regarding claim 14, modified Jones teaches all of the claimed limitations set forth in claim 12, as discussed above. Burkholz further discloses that the valve can be a tapered valve with a slit (paragraph 54), suggesting a duckbill valve; however, modified Jones does not explicitly teach or disclose this limitation.
Hiejima teaches an example of an anti-reflux valve is a duckbill valve (check valves 14 in fig. 1). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the valve of modified Jones to be a duckbill valve, as taught by Hiejima, since Hiejima appears to already teach this limitation and Hiejima teaches that this valve is an example anti-reflux valve.
Claim(s) 23-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones in view of Burkholz, as applied to claim 12 above, and further in view of Hallisey (US 20170036007).
Regarding claim 23, modified Jones teaches all of the claimed limitations set forth in claim 12, as discussed above. Jones further discloses that the push-out force is between 2.3-3.4 pounds (the socket denoted above is functionally capable of engaging to a needle-free connector providing the claimed push-out force). However, modified Jones does not teach or disclose the breakaway force is higher than the push-out force, and the selected range of separation force is between 2.9 pounds and four pounds.
Hallisey teaches a breakaway connector (fig. 1A) which can comprise a breakaway force of 7 pounds (paragraph 44). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the breakaway connector of modified Jones to have selected the breakaway force to be 7 pounds as taught by Hallisey since Hallisey teaches this is within a range of art recognized breakaway forces for medical connectors.
Once modified with the teachings of Hallisey, modified Jones teaches that the breakaway force is greater than the push-out force and provides a separation force of 4 pounds when the push-out force is 3 pounds.
Regarding claim 24, modified Jones teaches all of the claimed limitations set forth in claim 12, as discussed above. Jones further discloses that the push-out force is between 2.7-3.6 pounds (the socket denoted above is functionally capable of engaging to a needle-free connector providing the claimed push-out force). However, modified Jones does not teach or disclose the breakaway force is higher than the push-out force, and the selected range of separation force is between 2.9 pounds and 3.8 pounds.
Hallisey teaches a breakaway connector (fig. 1A) which can comprise a breakaway force of 6 pounds (paragraph 44). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the breakaway connector of modified Jones to have selected the breakaway force to be 6 pounds as taught by Hallisey since Hallisey teaches this is within a range of art recognized breakaway forces for medical connectors.
Once modified with the teachings of Hallisey, modified Jones teaches that the breakaway force is greater than the push-out force and provides a separation force of 3 pounds when the push-out force is 3 pounds.
Regarding claim 25, modified Jones teaches all of the claimed limitations set forth in claim 12, as discussed above. Jones further discloses that the push-out force is between 3.4-6.7 pounds (the socket denoted above is functionally capable of engaging to a needle-free connector providing the claimed push-out force). However, modified Jones does not teach or disclose the breakaway force is higher than the push-out force, and the selected range of separation force is between 1.9 pounds and 2.5 pounds.
Hallisey teaches a breakaway connector (fig. 1A) which can comprise a breakaway force of 8 pounds (paragraph 44). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the breakaway connector of modified Jones to have selected the breakaway force to be 8 pounds as taught by Hallisey since Hallisey teaches this is within a range of art recognized breakaway forces for medical connectors.
Once modified with the teachings of Hallisey, modified Jones teaches that the breakaway force is greater than the push-out force and provides a separation force of 2 pounds when the push-out force is 6 pounds.
Regarding claim 23, modified Jones teaches all of the claimed limitations set forth in claim 12, as discussed above. Jones further discloses that the push-out force is between 1-2 pounds (the socket denoted above is functionally capable of engaging to a needle-free connector providing the claimed push-out force). However, modified Jones does not teach or disclose the breakaway force is higher than the push-out force, and the selected range of separation force is between three pounds and four pounds.
Hallisey teaches a breakaway connector (fig. 1A) which can comprise a breakaway force of 6 pounds (paragraph 44). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the breakaway connector of modified Jones to have selected the breakaway force to be 6 pounds as taught by Hallisey since Hallisey teaches this is within a range of art recognized breakaway forces for medical connectors.
Once modified with the teachings of Hallisey, modified Jones teaches that the breakaway force is greater than the push-out force and provides a separation force of 4 pounds when the push-out force is 2 pounds.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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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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/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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