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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 26, 2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on May 11, 2026. As directed by the amendment: claims 1, 5, 7, and 8 have been amended and claims 21 and 22 have been cancelled. Thus, claims 1-8 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pg. 1, filed May 11, 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 the prior art not teaching or disclosing the fluid being contained within the lumen of the concentric port until the fluid exits an opening at the base. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments.
Claim Objections
Claims 6-8 are objected to because of the following informalities:
Regarding claim 6, the claim should be amended to recite “…into [[a]] the sidewall openings” to align claim language.
Regarding claim 7, the claim should be amended to recite “…connecting the sidewall openings” in line 4 to align claim language.
Regarding claim 8, the claim should be amended to recite “defined by [[a]] the sidewall openings” in lines 2-3, “opening in [[the]] a center” in line 3, and “opening to [[the]] a top” in line 4 to align claim terminology and to provide antecedent basis for the claim terminology.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 7, the claim recites “the concentric port comprising the opening connecting the sidewall opening with an opening in the base of the concentric port”. The “opening” recited first in this limitation is defined in claim 1 as being an opening in a base of the concentric port. Therefore, it is unclear if the other “opening” is the same opening or if it is another opening in the base of the concentric port. As the originally filed disclosure does not appear to support the latter interpretation, the second opening is considered to be the same as the first opening. As such, it seems that the claim is reciting that the opening connects the sidewall opening[s] to itself. For examination purposes, the claim is interpreted to mean that the opening connects the sidewall opening[s] with an opening in the duckbill valve.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 6 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 2, the claim recites that the injection port is configured to receive a needleless syringe. Claim 1, from which claim 2 depends, recites that a needleless syringe is inserted into the injection port so that claim 2 fails to further limit claim 1.
Regarding claim 6, the claim recites that the bellow is compressible to permit fluid to flow into a sidewall opening. Claim 1, from which claim 6 depends, recites that the bellow is configured to compress and fluid from the needleless syringe flows through the sidewall openings so that claim 6 fails to further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 Hayes-Pankhurst (GB 2459015) and in further view of Ryan (US 20160129235).
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 722 and base member 724 in fig. 48 form the “injection port”); and
an injection port backflow control device, comprising:
a concentric port (support member 728 in fig. 48) comprising a plurality of sidewall openings (openings 68 in fig. 3; paragraph 144 discloses the opening can be a plurality of openings) and in fluid communication with a lumen of the concentric port (fig. 48),
a bellow (seal member 726 in fig. 48), wherein in response insertion of a needleless syringe into the injection port, the bellow is configured to compress (see fig. 14 as an example), and fluid from the needleless syringe is configured to flow through the sidewall openings into the lumen of the concentric port (fig. 14), wherein the fluid flowing through the sidewall openings is contained within the lumen of the concentric port until the fluid exits the concentric port at an opening in a base of the concentric port (see below; the embodiment shown in fig. 48 comprises no further openings between openings 68 and the opening below); and
a valve (valve member 730 in fig. 48), wherein the opening in the base of the concentric port is proximate the valve (see annotated figure below).
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In this embodiment, Fangrow does not explicitly teach or disclose the valve is a duckbill valve and the plurality of sidewall openings are spaced apart around a circumference of the concentric port. Additionally, while Fangrow further teaches that the injection port comprises threads and a male tip on the distal end (see below), Fangrow does not explicitly teach or disclose a catheter hub coupled to the catheter.
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In a different embodiment, Fangrow teaches that the valve can be a duckbill valve (duckbill check valve 1405 in fig. 61). Additionally, Fangrow teaches “various other types of valves can be used to prevent backflow” (paragraph 316). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the dome-shaped valve of the first embodiment (valve member 730 in fig. 48) to be a duckbill valve as taught in the second embodiment since Fangrow teaches that various valves can be used to prevent backflow (paragraph 316) so that it appears device would work equally well with a duckbill valve.
Hayes-Pankhurst is directed towards a substantially similar device (fig. 1) comprising a concentric port (pin 9 in fig. 1) having a plurality of sidewall openings spaced apart around a circumference of the concentric port (apertures 11a-c in fig. 5a). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the plurality of sidewall openings of modified Fangrow to be spaced apart around a circumference of the concentric port, as taught by Hayes-Pankhurst, in order to balance flow rate of the infused fluid (pg. 19, lines 6-9).
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).
Regarding claim 2, in the modified assembly of Fangrow, Fangrow discloses the injection port is configured to receive a needleless syringe (the injection port in fig. 48 is configured to receive a needleless syringe; see fig. 13 as an example).
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 and prevent fluids from flowing out of the catheter hub through the injection port (paragraph 297 discloses resisting backflow).
Regarding claim 4, in the modified assembly of Fangrow, Fangrow discloses the bellow is vertically compressible (seal member 726 in fig. 48 is vertically compressible; see fig. 14 as an example).
Regarding claim 5, in the modified assembly of Fangrow, Fangrow discloses the bellow blocks the plurality of sidewall openings of the concentric port when the bellow is in an expanded state (fig. 48 shows the seal member 726 engaging the surface of support member 728 so that the openings would be blocked).
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 (seal member 726 in fig. 48 is compressible to allow fluid to flow into the opening shown in fig. 48; see fig. 14 as an example).
Regarding claim 7, in the modified assembly of Fangrow, Fangrow discloses the bellow surrounds the concentric port and covers the plurality of sidewall openings in the concentric port when the bellow is not compressed (fig. 48), the concentric port comprising the opening connecting the sidewall opening with an opening in the base of the concentric port (see below; see 112(b) rejection/interpretation above), the opening in the base of the concentric port connecting with an opening in the duckbill valve (see below), the duckbill valve opening to permit a fluid to flow into the catheter hub (paragraph 318 discloses the duckbill 1405 opening).
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Regarding claim 8, in the modified assembly of Fangrow, Fangrow discloses a fluid pathway within the injection port backflow control device is defined by a sidewall opening in the concentric port, the opening in the center of the concentric port connecting the sidewall opening to the top of the duckbill valve (fig. 48), the duckbill valve expanding to permit passage of a fluid into the catheter hub (paragraph 318).
Conclusion
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 FREDRICKSON/Primary Examiner, Art Unit 3783
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