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
The Amendment filed 4/15/2026 has been entered. Claims 1-10, 12-15, 17-21 and 23 remain pending in the application. Applicant’s amendments to the Specification and Claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 1/27/2026.
The specification was received on 4/15/2026. This specification is acceptable.
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12 recites the limitation “the second connector side” in line 18. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “the distal end” in line 21. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 17-21 are 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.
Claims 17-21 are directly or indirectly depending on claim 16 which is cancelled thereby making the scope of the claimed invention indefinite because claim 16 does not define any claimed invention. Therefore, claims 17-21 fails to define the metes and bounds of the claims. For examination purposes, examiner construes claims 17-21 being dependent on claim 12.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-9 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by White et al. (US 2011/0040281 A1).
Regarding claim 1, White teaches an apparatus (figures 1, 4A-4D) comprising:
a connector (see “C” in figure 4A below) having:
a distal port (see “D” in figure 4A below) comprising a distal coupler (coupler at element “D” in figure 4A below that enables connection to element 170) and configured to be coupled to a hub (portion of element “170” that enables or connects to “D” in figure 4A below) of a catheter 170;
a proximal port (see “P” in figure 4A below) comprising a proximal coupler (coupler at element “P” in figure 4A below that enables connection to the needle, paragraph 0026, lines 12-27);
a first lumen (hollow portion inside element “C” in figure 4A below, paragraph 0026, lines 12-27) extending between the distal port (see “D” in figure 4A below) and the proximal port (see “P” in figure 4A below), the lumen (hollow portion inside element “C” in figure 4A below) being in fluid communication with a second lumen (hollow portion inside element 170) defined by the catheter 170 when the distal port is coupled to the hub;
a side port (port in element “C” in figure 4A below that connects to one of two elements 140’) arranged in the connector (see “C” in figure 4A below) between the proximal coupler (coupler at element “P” in figure 4A below that enables connection to the needle, paragraph 0026, lines 12-27) and the distal coupler (coupler at element “D” in figure 4A below that enables connection to element 170), the side port configured to be in fluid communication with the first lumen (paragraph 0034, lines 1-3, in order to deliver the fluid to the element 170, port in element “C” in figure 4A below that connects to one of two elements 140’ has to be in fluid communication with hollow portion inside element “C” in figure 4A below); and
a fluid conduit (one of two elements 140’) having a proximal end (end of one of two elements 140’ in contact with element “C” in figure 4A below) coupled to the side port and a distal end (end of one of two elements 140’ in contact with element 120), the fluid conduit in fluid communication with the side port and configured to extend distally from the connector (see “C” in figure 4A below);
a stabilization platform 130 integrally formed with at least a part of the connector (see “C” in figure 4A below), the stabilization platform configured to be in contact with a patient when the distal coupler is coupled to the hub of the catheter to stabilize the connector and the catheter (paragraph 0017, lines 12-17); and
an elongated arm (other of two elements 140’) configured to extend distally from the connector (see “C” in figure 4A below) or the stabilization platform 130;
wherein the fluid conduit (one of two elements 140’) is coupled, at the distal end thereof, to a needless access connector 120.
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Regarding claim 2, White teaches wherein the elongated arm (other of two elements 140’) and the fluid conduit (one of two elements 140’) are configured to intersect one another at a location (location where element 120 is present i.e. where both elements 140’ comes in contact with element 180) distal to the distal port (see “D” in figure 4A above) of the connector (see “C” in figure 4A above).
Regarding claim 3, White teaches further comprising an anchor 120 configured to reversibly couple to the patient (paragraph 0021, lines 12-18).
Regarding claim 4, White teaches wherein the anchor 120 is coupled to the fluid conduit (one of two elements 140’).
Regarding claim 5, White teaches wherein the anchor 120 is arranged at an intersection of the elongated arm (other of two elements 140’) and the fluid conduit (one of two elements 140’).
Regarding claim 6, White teaches wherein the connector (see “C” in figure 4A above) comprises a second side port (port that allows communication with other of two elements 140’).
Regarding claim 7, White teaches further comprising a second fluid conduit 150 (associated with other of two elements 140’) coupled to the second side port (port that allows communication with other of two elements 140’).
Regarding claim 8, White teaches wherein the second fluid conduit 150 is configured to extend proximally from the second side port (see figure 5B where element 150 could be made to extend proximally from the second side port).
Regarding claim 9, White teaches wherein the elongated arm (other of two elements 140’) is a second fluid conduit (element 150 is located inside element 140’ and therefore element 140’ could be construed as a second fluid conduit) and is in fluid communication with the second side port.
Regarding claim 23, White teaches a system (figures 1, 4A-4D) comprising:
a catheter 170; and
an adapter (entire structure shown in figures 1, 4A-4D except for element 170), the adapter comprising;
a connector (see “C” in figure 4A above) having:
a distal port (see “D” in figure 4A above) comprising a distal coupler (coupler at element “D” in figure 4A above that enables connection to element 170) and configured to be coupled to a hub (portion of element “170” that enables or connects to “D” in figure 4A above) of a catheter 170;
a proximal port (see “P” in figure 4A above) comprising a proximal coupler (coupler at element “P” in figure 4A above that enables connection to the needle, paragraph 0026, lines 12-27);
a first lumen (hollow portion inside element “C” in figure 4A above, paragraph 0026, lines 12-27) extending between the distal port (see “D” in figure 4A above) and the proximal port (see “P” in figure 4A above), the lumen (hollow portion inside element “C” in figure 4A above) being in fluid communication with a second lumen (hollow portion inside element 170) defined by the catheter 170 when the distal port is coupled to the hub;
a side port (port in element “C” in figure 4A above that connects to one of two elements 140’) arranged in the connector (see “C” in figure 4A above) between the proximal coupler (coupler at element “P” in figure 4A above that enables connection to the needle, paragraph 0026, lines 12-27) and the distal coupler (coupler at element “D” in figure 4A above that enables connection to element 170), the side port configured to be in fluid communication with the first lumen (paragraph 0034, lines 1-3, in order to deliver the fluid to the element 170, port in element “C” in figure 4A below that connects to one of two elements 140’ has to be in fluid communication with hollow portion inside element “C” in figure 4A above); and
a fluid conduit (one of two elements 140’) having a proximal end (end of one of two elements 140’ in contact with element “C” in figure 4A below) coupled to the side port and a distal end (end of one of two elements 140’ in contact with element 120), the fluid conduit in fluid communication with the side port and configured to extend distally from the connector (see “C” in figure 4A above);
a stabilization platform 130 integrally formed with at least a part of the connector (see “C” in figure 4A above), the stabilization platform configured to be in contact with a patient when the distal coupler is coupled to the hub of the catheter to stabilize the connector and the catheter (paragraph 0017, lines 12-17); and
an elongated arm (other of two elements 140’) configured to extend distally from the connector (see “C” in figure 4A above) or the stabilization platform 130
wherein the fluid conduit (one of two elements 140’) is coupled, at the distal end thereof, to a needless access connector 120.
Claim Rejections - 35 USC § 103
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over White et al. (US 2011/0040281 A1) in view of Roy (US 2016/0230914 A1).
Regarding claim 10, White discloses the claimed invention substantially as claimed, as set forth above in claim 1. White further discloses the connection of the fluid conduit with the element 120 but fails to disclose the type of connection and therefore, White is silent regarding wherein the fluid conduit comprises a luer adapter at the distal end thereof.
However, Roy teaches a design of a connector assembly comprising a luer adapter 100 or 200 (figure 1) for the purpose of enabling the connection to the other component using a well-known connection approach (paragraph 0019).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the distal end of the fluid conduit of White to incorporate a luer adapter as taught by Roy for the purpose of enabling the connection to the other component using a well-known connection approach (paragraph 0019).
Allowable Subject Matter
Claims 12-15 would be allowable if rewritten to overcome the objections set forth in this office action.
Claims 17-21 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The closest prior art of record, Burkholz (US 2019/0366052 A1) discloses each and every limitations of amended claim 12 as previously explained in the rejection of claims 12, 16 (previously presented now canceled) and 22 (previously presented now cancelled) however, examiner construed an elongated arm configured to extend distally from the connector or stabilization platform and the second fluid conduit configured to extend distally from the second connector as being able to bend the flexible tube to make the elongated arm or the second fluid conduit to extend distally. Based on applicant’s arguments and the disclosure, claims need to be construed to have the fluid conduit and elongated arm to extend distally as being a fixed structure or being directly extending distally instead of being able to manipulate other structures to make the elongated arm or second fluid conduit extend distally. Accordingly, claim 12 is indicated allowable.
Claims 13-15 being dependent on claim 12 are also indicated allowable.
Response to Arguments
Applicant's arguments filed 4/15/2026 have been fully considered but they are not persuasive.
Applicant argues on page 11, line 1-last line that White fails to disclose a fluid conduit that is coupled at a distal end thereof to a needless access connector because element 120 appears to simply house a portion of the fluidic channel therein. Examiner respectfully disagrees. White discloses in paragraph 0024, lines 1-4 that element 150 is fixed to element 120 which maybe coupled to an extension tube and/or fluid supply conduit. Furthermore, figure 4A shows that elements 180 and 150 are connected somewhere in element 120 thereby construing that element 120 enables connecting two tubes together. Thus, even though element 120 appears as an element that houses a portion of the fluid channel, element 120 based on the figures and specification of White, appears to be a needless access connector. Therefore, rejection of claims 1 and 23 under White is proper.
Applicant argues on page 12, line 6-last line that Burkholz fails to disclose the claimed invention as claimed in the amended claim 12 because side port of y-adapter 109 does not extend distally from the catheter adapter 101 or wings 106. Additionally, applicant argues that the side port (Element A in the Office Action) extends from the body of the y-adapter to extension tubing 102 wherein y-adapter 109 also does not extend “distally” from a connector or a stabilization platform. It appears that in order to construe the side port as being extending distally, the side port has to fixedly extend in distal direction instead of being flexible enough that the portion could be bent to have the side port extend distally. Under such interpretation, examiner finds applicant’s arguments persuasive and agrees to withdraw the rejection of claim 12.
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 NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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