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 .
Election/Restrictions
Applicant’s election without traverse of group I, species B, species C, species F, and species G in the reply filed on 2/27/2026 is acknowledged.
Claims 7 and 10-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie or invention there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/27/2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 5/5/2023, 5/23/2024, 8/30/2024, and 3/28/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: item 322A
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because:
Line 2 recites “a catheter”. As a catheter is already introduced in line 1 of the abstract, Examiner suggests replacing “a catheter” in line 2 with “the catheter” to put the abstract in clearer form.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 1 objected to because of the following informalities:
Line 1-2 recites “A coupling system configured to couple a catheter to an access port, comprising:”. Examiner suggests replacing “A coupling system configured to couple a catheter to an access port, comprising:” in line 1-2 of claim 1 with “A coupling system configured to couple a catheter to an access port, the coupling system comprising:” to put the claim in clearer form and make clear that the coupling system comprises the listed components.
Claim 2 objected to because of the following informalities:
Line 2 recites “and configured to engage”. Examiner suggests removing the term “and” to put the claim in clearer form as the male-end quick connector is configured to engage a female-end quick connector.
Claim 6 objected to because of the following informalities:
Line 1-3 recites “wherein the sealing member includes one of a silicone, polymer, elastomer, or rubber materials that exhibit fluid tight properties”. Examiner suggests replacing “wherein the sealing member includes one of a silicone, polymer, elastomer, or rubber materials that exhibit fluid tight properties” in line 1-3 of claim 6 with “wherein the sealing member includes a material selected from a silicone, a polymer, an elastomer, or a rubber material that exhibits fluid tight properties” to put the claim in clearer form as one of the listed materials is claimed as being included, not multiple materials.
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 1-6 and 8-9 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.
In regard to claim 1,
Line 3 recites “a catheter”. Line 1 also recites “a catheter”. It is unclear if the catheter of line 3 is intended to be the catheter of line 1 or if the catheter of line 3 is intended to be a second catheter. For examination purposes Examiner construes “a catheter” in line 3 to be “the catheter”. Examiner suggests replacing “a catheter” in line 3 of claim 1 with “the catheter”.
Line 5-6 recites “the fluid coupling device”. There is insufficient antecedent basis for the limitation in this claim. It is unclear if “the fluid coupling device” refers to a fluid coupling device or to the coupling system. For examination purposes Examiner construes “the fluid coupling device” to be “the coupling system”. Examiner suggests replacing “the fluid coupling device” in line 5-6 of claim 1 with “the coupling system”.
Line 5-6 recites “a recess extending longitudinally from a first end of the fluid coupling device and including an internal stem”. It is unclear what structure includes an internal stem as the internal stem would not be a component of the recess. For examination purposes Examiner construes the toothed grip connector system to include an internal stem positioned within the recess. Examiner suggests replacing “and including an internal stem” in line 6 of claim 1 with “, the toothed grip connector system including an internal stem within the recess”.
Line 7-8 recites “a gripping member extending radially about the internal stem and including a plurality of teeth”. It is unclear if the gripping member includes/is the plurality of teeth or if the plurality of teeth is an additional structure of the toothed grip connector system i.e. a gripping member and a plurality of teeth are present. For examination purposes Examiner construes the gripping member to include a plurality of teeth. Examiner suggests replacing “a gripping member extending radially about the internal stem and including a plurality of teeth” in line 7-8 of claim 1 with “a gripping member extending radially about the internal stem, the gripping member including a plurality of teeth”.
Line 9-10 recites “the catheter”. Line 1 and line 3 both recite “a catheter”. It is unclear which catheter “the catheter” of line 9-10 refers to. For examination purposes Examiner construes the catheter of line 1 and 3 to be the same. Examiner suggests replacing “a catheter” in line 3 of claim 1 with “the catheter”.
Line 13 recites “an outer surface of the catheter”. Line 9-10 recites “an outer surface of the end portion of the catheter”. It is unclear if the outer surface of line 13 is the same or different than the outer surface of line 9-10. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “an outer surface of the catheter” in line 13 of claim 1 with “the outer surface of the end portion of the catheter”.
Examiner notes claims 2-6 and 8-9 are similarly rejected by virtue of their dependency on claim 1.
In regard to claim 2,
Line 1-2 recites “a second end thereof”. It is unclear what structure “thereof” refers to. It is unclear if thereof refers to the coupling system, the toothed grip connector system, or to a different structure. For examination purposes Examiner construes “thereof” to be “of the coupling system”. Examiner suggests replacing “a second end thereof” in line 2 of claim 2 with “a second end of the coupling system”.
Line 3 recites “an access port”. Claim 2 depends on claim 1. Claim 1 requires an access port. It is unclear if the access port of claim 2 is the same as the access port of claim 1 or if the access port of claim 2 is a second access port. For examination purposes Examiner construes them to be same. Examiner suggests replacing “an access port” in line 3 of claim 2 with “the access port”.
In regard to claim 3,
Line 2 recites “the first end”. Claim 3 is dependent on claim 1. Claim 1 introduces a first end of the fluid coupling device, not a first end of the coupling system. For examination purposes Examiner construes the first end of line 2 of claim 3 to be the first end of the coupling system. Examiner suggests amending line 5-6 of claim 1 as suggested above AND replacing “the first end” of line 2 of claim 3 with “the first end of the coupling system”.
In regard to claim 4,
Line 2 recites “a wall of the recess”. Based on the figures, it appears a wall would define the recess and the recess itself would be the hollow space and not include a wall. For examination purposes Examiner construes the wall to define the recess. Examiner suggests replacing “a wall of the recess” in line 2 of claim 4 with “a wall defining the recess”.
In regard to claim 5,
Line 2 recites “a wall of the recess”. Based on the figures, it appears a wall would define the recess and the recess itself would be the hollow space and not include a wall. For examination purposes Examiner construes the wall to define the recess. Examiner suggests replacing “a wall of the recess” in line 2 of claim 5 with “a wall defining the recess”.
Line 3 recites “thereof”. It is unclear what structure “thereof” refers to. For examination purposes Examiner construes “thereof” to be “of the gripping member or the sealing member”. Examiner suggests replacing “thereof” in line 3 with “of the gripping member or the sealing member”.
In regard to claim 8,
Line 2 recites “the second end”. There is insufficient antecedent basis for the limitation in this claim. It is unclear what structure the second end is of. For examination purposes Examiner construes “the second end” to be “a second end of the coupling system”. Examiner suggests replacing “the second end” in line 2 of claim 8 with “a second end of the coupling system”.
Line 3 recites “the first end”. Claim 8 is dependent on claim 1. Claim 1 introduces a first end of the fluid coupling device, not a first end of the coupling system. For examination purposes Examiner construes the first end of line 3 of claim 8 to be the first end of the coupling system. Examiner suggests amending line 5-6 of claim 1 as suggested above AND replacing “the first end” of line 3 of claim 8 with “the first end of the coupling system”.
In regard to claim 9,
Line 2 recites “a portion thereof”. It is unclear what structure thereof refers to. For examination purposes Examiner construes thereof to be of the disengagement tool. Examiner suggests replacing “a portion thereof” in line 2 of claim 9 with “a portion of the disengagement tool”.
Line 2-3 recites “an outer surface of the catheter”. Claim 9 depends on claim 1. Claim 1 introduces “an outer surface of the end portion of the catheter” and “an outer surface of the catheter”. It is unclear if the outer surface of the catheter of claim 9 is an additional outer surface or the same outer surface of claim 1. For examination purposes Examiner construes “an outer surface of the catheter” to be “the outer surface of the end portion of the catheter”. Examiner suggests replacing “an outer surface of the catheter” in line 2-3 of claim 9 “the outer surface of the end portion of the catheter”.
Line 4-5 recites “the first longitudinal direction”. There is insufficient antecedent basis for the limitation in this claim. Claim 9 depends on claim 1. Claim 1 introduces a first direction. It is unclear if the first longitudinal direction is the same as the first direction of claim 1 or is a different direction. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the first longitudinal direction” with “the first direction”.
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 1-6 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blake (U.S. PG publication 20160178101).
In regard to claim 1,
Blake discloses a coupling system (figure 2, item 1 and 2) configured to couple a catheter (figure 2, item 11) to an access port (Examiner notes “configured to couple a catheter to an access port” is a functional limitation. The coupling system is fully capable of coupling a catheter to an appropriately sized access port due to its structure. Item 6 of the coupling system could be received within an appropriately sized connector of an access port to couple the coupling system to an access port and therefore couple a catheter to an access port via the coupling system. The catheter and access port are not positively required by the claim; paragraph [0002]) comprising:
a toothed grip connector system (figure 2, item 3, 9, and 2; see figure 2 wherein the system has multiple teeth, each tab has at least one tooth as disclosed in paragraph [0064]) configured to retain an end portion of a catheter (figure 2, item 11; paragraph [0064]; Examiner notes “configured to retain an end portion of a catheter” is a functional limitation. The toothed grip connector system is fully capable of the recited function due to its structure as supported by paragraph [0064]),
the toothed grip connector system comprising:
[AltContent: arrow][AltContent: arrow][AltContent: connector][AltContent: connector][AltContent: textbox (First end or second end)][AltContent: textbox (First end or second end)]
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a recess (see recess formed by item 2; Examiner notes the recess is construed as the hollow space of item 2) extending longitudinally from a first end (see 112 rejection above for claim interpretation; Examiner notes the first end can be construed as either of the ends located above. It is noted when one end is construed as the first end, the opposite end is construed as the second end) of the fluid coupling device (see figure 2 and 3) and including an internal stem (figure 2 and 3, item 9); and
a gripping member (tabs 3 which include teeth 31; paragraph [0064]; Examiner notes another tooth can also be located near item 32 as disclosed in paragraph [0064]) extending radially about the internal stem (see figure 3) and including a plurality of teeth (teeth 31 on each tab 3; paragraph [0064]; Examiner notes another tooth can also be located near item 32 as disclosed in paragraph [0064]) extending radially inward (see figure 2 and 3), the plurality of teeth configured to engage an outer surface of the end portion of the catheter to prevent longitudinal movement in at least a first direction following insertion of the end portion of the catheter into the recess (paragraph [0064] and [0028]); and
a sealing member (figure 2, item 23) configured to impinge an outer surface of the catheter to provide a seal between the end portion of the catheter and the internal stem (paragraph [0072]-[0074]).
In regard to claim 2,
[AltContent: arrow][AltContent: arrow][AltContent: connector][AltContent: connector][AltContent: textbox (First end)][AltContent: textbox (Second end)]
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Blake discloses the coupling system according to claim 1, further including a male-end quick connector (figure 2, item 6) disposed at a second end thereof (see figure 3 above), and configured to engage a female-end quick connector (figure 1, item 20; paragraph [0060]) coupled to an access port (Examiner notes “configured to engage a female-end quick connector coupled to an access port” is a functional limitation. A female-end quick connector coupled to an access port is not positively required by the claim. The male-end quick connector is fully capable of the recited function as supported by paragraph [0060]).
In regard to claim 3,
[AltContent: arrow][AltContent: arrow][AltContent: connector][AltContent: connector][AltContent: textbox (Second end)][AltContent: textbox (First end)]
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Blake discloses the coupling system according to claim 1, wherein the plurality of teeth is angled toward a second end of the coupling system, opposite the first end (see figure 3 above).
In regard to claim 4,
[AltContent: textbox (Groove )][AltContent: arrow]
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Blake discloses the coupling system according to claim 1, wherein one of the gripping member or the sealing member is retained within a groove in a wall of the recess (see 112 rejection above for claim interpretation; see figure 3 above; Examiner notes a groove is formed on either side of item 28 which the gripping member is retained within), the groove extending annularly about the internal stem (see figure 3 above).
In regard to claim 5,
Blake discloses the coupling system according to claim 1, wherein a protrusion (figure 3, item 28) extends radially inward from a wall of the recess (see 112 rejection above for claim interpretation; see figure 3) and is configured to abut against one of the gripping member or the sealing member to inhibit longitudinal movement thereof in at least the first direction (see figure 3 wherein item 28 abuts against the gripping member to inhibit longitudinal movement thereof in at least the first direction; paragraph [0035]).
In regard to claim 6,
Blake discloses the coupling system according to claim 1, wherein the sealing member (figure 2, item 23) includes one of a silicone, polymer, elastomer, or rubber materials that exhibit fluid tight properties (paragraph [0066] and [0053]).
In regard to claim 8,
[AltContent: arrow][AltContent: arrow][AltContent: connector][AltContent: connector][AltContent: textbox (Second end)][AltContent: textbox (First end)]
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Blake discloses the coupling system according to claim 1, wherein the sealing member is located proximate the second end (see figure 3 above; Examiner notes the term “proximate” means close as defined by Merriam-Webster Dictionary) and the gripping member is located proximate the first end (see figure 3 above).
Allowable Subject Matter
Claim 9 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 following is a statement of reasons for the indication of allowable subject matter:
In regard to claim 9,
The prior art of record does not teach or otherwise render obvious before the effective filing date of the claimed invention in combination with all claim limitations the coupling system according to claim 1, further including a disengagement tool, a portion thereof configured to extend into the recess between an outer surface of the catheter and a tooth of the plurality of teeth, to disengage the plurality of teeth from the catheter and allow the catheter to be withdrawn along the first longitudinal direction.
Blake (U.S. PG publication 20160178101) discloses the coupling system (figure 2, item 2 and 1) according to claim 1. Blake fails to disclose a disengagement tool, a portion thereof configured to extend into the recess between an outer surface of the catheter and a tooth of the plurality of teeth, to disengage the plurality of teeth from the catheter and allow the catheter to be withdrawn along the first longitudinal direction. Item 2 is removed from item 1 in Blake in order to disengage the plurality of teeth from the catheter. Item 2 does not include a portion thereof configured to extend into the recess between an outer surface of the catheter and a tooth of the plurality of teeth, to disengage the plurality of teeth from the catheter and allow the catheter to be withdrawn along the first longitudinal direction. The subject matter of a disengagement tool, a portion thereof configured to extend into the recess between an outer surface of the catheter and a tooth of the plurality of teeth, to disengage the plurality of teeth from the catheter and allow the catheter to be withdrawn along the first longitudinal direction in combination with all other limitations of claim 1 could not be found nor was suggested elsewhere in the prior art of record. Accordingly, claim 9 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/BRANDY S LEE/ Supervisory Patent Examiner, Art Unit 3785