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 .
Response to Amendment
This office action is responsive to the amendment filed on January 27, 2026. As directed by the amendment: claims 1 and 8 have been amended, claims 9-20 have been cancelled, and claims 21 and 22 been added. Thus, claims 1-8, 21, and 22 are presently pending in this application.
Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed October 27, 2025.
Response to Arguments
Applicant’s arguments, filed January 27, 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive, specifically in regards to Fangrow modified with Ryan not teaching or disclosing the new limitations. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments.
With regards to new claims 21 and 22, although no specific arguments are presented, it is the examiner’s opinion that Fangrow modified with Ryan discloses the limitations set forth in claim 21. The examiner notes that it appears that claim 22 raises new matter issues, discussed in further detail below.
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.
Claim 22 is 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 22, the claim is drawn to a concentric port comprising an outer surface having a circular opening and a bellow disposed within or extending through the circular opening. The application as originally filed does not provide support for such amendment. The concentric port is designated as element 210 and the bellow is element 220. As seen in the drawings, the concentric port is received within the bellow. Fig. 6 shows the concentric port 210 having an outer surface with circular openings 240. However, there is no support for the bellow 220 to be disposed within or extending through one of these circular openings. As such, the claim is drawn to new matter.
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 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) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fangrow (US 20130226099) in view of Ryan (US 20160129235) in view of Hayes-Pankhurst (GB 2459015).
Regarding claim 1, Fangrow discloses a peripheral intravenous catheter assembly, comprising:
a catheter (conduit 132 in fig. 15);
an injection port configured to be attached to a catheter hub (body member 1422 and base member 1424 in fig. 61 form the “injection port”) comprising a top (see below); and
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an injection port backflow control device (seal member 1426, support member 1428, and duckbill check valve 1405 in fig. 61 form the “backflow control device), comprising:
a concentric port (support member 1428 in fig. 61 is shown to be concentric to both the seal member 1426 and body member 1422 in that all three elements share a common longitudinal axis);
a bellow (seal member 1426 in fig. 61); and
a duckbill valve (duckbill check valve 1405 in fig. 61).
Fangrow further teaches that the injection port comprises threads and a male tip on the distal end (threads 150 in fig. 13 and male tip protrusion 1441 in fig. 61). However, Fangrow does not explicitly teach or disclose a catheter hub coupled to the catheter. Additionally, while Fangrow discloses that the top of the bellow is even with the top of the injection port (fig. 61), Fangrow does not explicitly teach or disclose a top of the concentric port is even with or above the top of the injection port
Ryan is directed towards a substantially similar injection port comprising threads and male tip (injection port assembly 10 in fig. 6 has threads 22 and male tip 23) and a catheter (catheter 62 in fig. 8). Ryan further teaches a catheter hub coupled to the catheter (female luer lumen 61 in fig. 8). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the catheter of Fangrow to comprise the catheter hub of Ryan so that the hub can fluidically connect the injection port to the catheter in a leak-free manner as known in the art (paragraph 61).
Hayes-Pankhurst teaches a substantially similar assembly (fig. 1) comprising an injection port (housing 5 in fig. 1), a concentric port (pin 9 in fig. 1) and a bellow surrounding the concentric port (resilient member 7 in fig. 1). Hayes-Pankhurst further teaches that the top of the concentric port (tip portion 9b in fig. 1) is even with the top of the bellow and the injection port (fig. 1; pg. 28, lines 17-18). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the top of the concentric port of modified Fangrow to be even with the top of the bellow and the injection port, as taught by Hayes-Pankhurst, in order to provide a flat, unbroken receiving surface (pg. 28, lines 17-18) which would enable the top of the concentric port to be swabbed with an aseptic wiping to improve sterility and since Hayes-Pankhurst teaches that the assembly would operate in an identical manner.
Regarding claim 2, in the modified assembly of Fangrow, Fangrow discloses the injection port is configured to receive a needleless syringe (fig. 62).
Regarding claim 3, in the modified assembly of Fangrow, Fangrow discloses the injection port backflow control device is configured to permit fluids to flow into the catheter hub (fig. 62 shows fluid flowing from the syringe and through male tip protrusion 441 so that fluid would enter the attached hub) and prevent fluids from flowing out of the catheter hub through the injection port (paragraph 319 discloses backflow is prevented).
Regarding claim 4, in the modified assembly of Fangrow, Fangrow discloses the bellow is vertically compressible (fig. 62).
Regarding claim 5, in the modified assembly of Fangrow, Fangrow discloses the bellow blocks a sidewall opening of the concentric port when the bellow is in an expanded state (fig. 61 shows that when the seal member 1426 is in a closed state, a radial opening of support member 1428 is blocked; the examiner notes that the radial opening is shown more explicitly in the embodiment 3 which shows an equivalent support member 28 with a lateral opening 68).
Regarding claim 6, in the modified assembly of Fangrow, Fangrow discloses the bellow is compressible to permit fluid to flow into a sidewall opening of the concentric port (fig. 62).
Regarding claim 7, in the modified assembly of Fangrow, Fangrow discloses the bellow surrounds the concentric port and covers a sidewall opening in the concentric port when the bellow is not compressed (fig. 61 shows the seal member 1426 surrounding and covering a lateral opening 68 of support member 1428), the concentric port comprising a vertical opening connecting the sidewall opening with an opening in the base of the concentric port (see below), the opening in the base of the concentric port connecting with an opening in the duckbill valve (elongate slit 1410 in fig. 62), the duckbill valve opening to permit a fluid to flow into the catheter hub (fig. 62).
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Regarding claim 8, Fangrow discloses a fluid pathway within the injection port backflow control device is defined by a sidewall opening in the concentric port (lateral opening 68 in fig. 3; the examiner notes that support member 1428 has an equivalent opening in fig. 62), a vertical opening in the center of the concentric port connecting the sidewall opening to the top of the duckbill valve (fluid passageway 1469 in fig. 62), the duckbill valve expanding to permit passage of a fluid into the catheter hub (fig. 62; paragraph 318).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fangrow in view of Ryan.
Regarding claim 21, Fangrow discloses a peripheral intravenous catheter assembly, comprising:
a catheter (conduit 132 in fig. 15);
an injection port configured to attach to a catheter hub (body member 1422 and base member 1424 in fig. 61 form the "injection port"); and
an injection port backflow control device (seal member 1426, support member 1428, and duckbill check valve 1405 in fig. 61 form the "backflow control device), comprising:
a concentric port (support member 1428 in fig. 61 is shown to be concentric to both the seal member 1426 and body member 1422 in that all three elements share a common longitudinal axis);
a bellow (seal member 1426 in fig. 61), wherein the bellow contacts the concentric port to form a seal such that the bellow and the concentric port seal off the injection port (fig. 61 shows the seal member 1426 contacting support member 1428 and sealing lateral opening 68 which would seal off the injection port); and
a duckbill valve (duckbill check valve 1405 in fig. 61).
Fangrow further teaches that the injection port comprises threads and a male tip on the distal end (threads 150 in fig. 13 and male tip protrusion 1441 in fig. 61). However, Fangrow does not explicitly teach or disclose a catheter hub coupled to the catheter.
Ryan is directed towards a substantially similar injection port comprising threads and male tip (injection port assembly 10 in fig. 6 has threads 22 and male tip 23) and a catheter (catheter 62 in fig. 8). Ryan further teaches a catheter hub coupled to the catheter (female luer lumen 61 in fig. 8). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the catheter of Fangrow to comprise the catheter hub of Ryan so that the hub can fluidically connect the injection port to the catheter in a leak-free manner as known in the art (paragraph 61).
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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/COURTNEY B FREDRICKSON/ Primary Examiner, Art Unit 3783