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 .
Acknowledgments
In the reply, filed on January 29, 2026, Applicant amended claims 1-4, 6-9, 13-15, and 17-18.
Applicant cancelled claims 11-12.
Applicant added new claim 22.
In the non-final rejection of October 29, 2025, Examiner objected to the Abstract. Applicant amended the Abstract. Objection is withdrawn.
Examiner objected to claims 1-4, 6-9, 11-12, 14-15, and 17-18. Applicant amended claims 1-4, 6-9, 14-15, and 17-18, and cancelled claims 11-12; however, Applicant did not address all of the objections. Objection is maintained.
Examiner rejected claims 1-4, 6-9, and 11-18 under 35 U.S.C. 112(b). Applicant amended claims 1, 3, 6, 8, 15, 17-18; however, Applicant did not address all of the rejections. Rejection is maintained.
Currently, claims 1-4, 6-9, 13-18, and 22 are under examination.
Claim Objections
Claims 7-8, 14, and 17 are objected to because of the following informalities:
In regards to claim 7, line 2, “second detent” should be changed to “the second detent”.
In regards to claim 8, line 1, “second detent” should be changed to “the second detent”.
In regards to claim 14, lines 2-3, “nested orientation” should be changed to “the nested orientation”.
In regards to claim 14, line 4, “the inner one” should be changed to “an inner one”.
In regards to claim 17, line 2, “the first detent and second detent” should be changed to “the first detent or the second detent”.
Appropriate correction is required.
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 1-4, 6-9, 13-18, and 22 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.
In regards to claim 1, lines 15-18 recite: so that relative rotation of “the Luer connector coupling and the port coupling” causes the mating first detent and the second detent to generate audible and/or tactile vibrations as the mating first detent and the second detent slide relative to each other; however, such is new matter not described in the Specification. Claims 2-4 and 22 are rejected by virtue of being dependent upon claim 1.
In regards to claim 6, lines 9-12 recite: so that relative rotation of “the connector that is rotatively coupled to the first portion” causes the mating first detent and the second detent to generate audible and/or tactile vibrations as the mating first detent and the second detent slide relative to each other; however, such is new matter not described in the Specification. Claims 7-9 and 13-18 are rejected by virtue of being dependent upon claim 6.
In regards to claim 22, lines 1-2 recite: “the port connector comprising threads that are construed to facilitate coupling to a catheter”; however, such is new matter not described in the Specification.
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 1-4, 6-9, 13-18, and 22 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 regards to claim 1, lines 1-7 recite: A coupling for a Luer connector, the coupling comprising:… the Luer connector. It is unclear how the Luer connector can be both separate from the coupling (A coupling for a Luer connector) and part of the coupling (the coupling comprising:… the Luer connector). Claims 2-4 and 22 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, line 11 recites “a first plug-in connector”. Claim 1, line 2 previously recites “a first fitting”. It is unclear whether the two recitations are the same component or different components. Claims 2-4 and 22 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, line 11 recites “a second plug-in connector”. Claim 1, line 3 previously recites “a second fitting”. It is unclear whether the two recitations are the same component or different components. Claims 2-4 and 22 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, line 15 recites “the Luer connector coupling”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 1, line 1 previously recites “a Luer connector”. It is unclear whether the two recitations are the same component or different components. Claims 2-4 and 22 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, line 15 recites “the port coupling”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 1, line 12 previously recites “a port connector”. It is unclear whether the two recitations are the same component or different components. Claims 2-4 and 22 are rejected by virtue of being dependent upon claim 1.
In regards to claim 6, lines 1-2 recite: A coupling for a Luer connector, the coupling comprising: a first fitting having the Luer connector. It is unclear how the Luer connector can be both separate from the coupling (A coupling for a Luer connector) and part of the coupling (the coupling comprising: a first fitting having the Luer connector). Claims 7-9 and 13-18 are rejected by virtue of being dependent upon claim 6.
In regards to claim 6, line 9 recites “the connector”. There is insufficient antecedent basis for this limitation in the claim. Claims 7-9 and 13-18 are rejected by virtue of being dependent upon claim 6.
In regards to claim 14, line 1 recites: The coupling “of claim 11”. However, claim 11 is a cancelled claim. Thus, the dependency of claim 14 is unclear. For the purposes of examination, claim 14 is being examined as if dependent upon claim 6. Claims 15-18 are rejected by virtue of being dependent upon claim 14.
In regards to claim 15, line 7 recites “the at least one first detent”. There is insufficient antecedent basis for this limitation in the claim. Claims 16-18 are rejected by virtue of being dependent upon claim 15.
In regards to claim 15, line 7 recites “the at least one second detent”. There is insufficient antecedent basis for this limitation in the claim. Claims 16-18 are rejected by virtue of being dependent upon claim 15.
Claim Rejections - 35 USC § 102
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 1-4, 6-9, and 13-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Iwakata et al (US 2018/0369559).
In regards to claim 1, Iwakata et al teaches a coupling (Figures 1-6B) for a Luer connector, the coupling comprising:
a first fitting (20/2), having a first fluid passage (of 2) and a first detent (31)
a second fitting (10), rotatively coupled to the first fitting about a rotational axis, the second fitting having a second fluid passage (of 10) in fluid communication with the first fluid passage (Figure 5), and a second detent (33) oriented in slidable, mating, abutting engagement with the first detent (Figure 5)
the Luer connector (21/2a/2b) coupled to the first fitting or the second fitting, in fluid communication with the first fluid passage or the second fluid passage, respectively (Figure 5)
an O-ring seat (labeled in Figure 4 below) for receipt of an O-ring that is interposed between and fluidly seals, a first plug-in connector and a second plug-in connector
a port connector (12) coupled to the other of the first fitting or the second fitting, in fluid communication with the first fluid passage or the second fluid passage, respectively (Figure 5)
so that relative rotation of the Luer connector coupling and the port coupling causes the mating first detent and the second detent to generate audible and/or tactile vibrations as the mating first detent and the second detent slide relative to each other (Figure 6B)(paragraph [0067]: the threadedly engageable cylinder 20 is turned in a tightening direction indicated by letter T. Since inclined surfaces 33a of the engageable claws 33 slide on inclined surfaces 31a of tooth portions of the ratchet teeth 31 at this time, the engageable claws 33 are moved over the ratchet teeth 31 of the threadedly engageable cylinder 20)(it is known in the art that a ratchet creates audible and tactile feedback upon rotation)
PNG
media_image1.png
412
411
media_image1.png
Greyscale
In regards to claim 2, Iwakata et al teaches one of the first detent or the second detent comprising a ratchet (31) and the other of the first detent or the second detent comprising a biased pawl (33) in slidable, mating, abutting engagement with the ratchet, the pawl defining a pawl translation axis (Figure 5).
In regards to claim 3, Iwakata et al teaches the first detent and the second detent of the mating ratchet and the pawl allowing rotation of the first fitting or the second fitting coupled to the Luer connector relative to the first fitting or the second fitting coupled to the port connector upon application of a first rotational torque force threshold in a first rotational direction (Figure 6B) but preventing corresponding relative counter rotation between said first fitting and said second fitting in an opposite rotational direction (Abstract: a loosening prevention mechanism (30) that prohibits rotation of the threadedly engageable cylinder (20) in a loosening direction with respect to the male connector (10) when the male luer portion (11) and the female luer portion (2a) are joined. The loosening prevention mechanism (30) includes ratchet teeth (31) formed in an inner periphery of the threadedly engageable cylinder (20), an elastic projection (32) formed in the male connector (10) and an engageable claw (33) protruded from a free end of the elastic projection (32) and engageable with the ratchet teeth).
In regards to claim 4, Iwakata et al teaches the mating ratchet and the pawl circumferentially oriented about the rotational axis of the first fitting and the second fitting (Figures 6A-6B), with the pawl translation axis parallel to said rotational axis (Figure 5).
In regards to claim 6, Iwakata et al teaches a coupling (Figures 1-6B) for a Luer connector, the coupling comprising:
a first fitting (20/2) having the Luer connector (21/2b) in fluid communication with a first portion (2a) of a mating, plug-in connector (2a/11), and a first detent (31)
a second fitting (10), having a second portion (11) of the mating, plug-in connector that is rotatively coupled to the first portion thereof about a rotational axis (Figure 5), a port (12) in fluid communication with the first portion and the second portion of the plug-in connector, and a second detent (33) oriented in slidable, mating, abutting engagement with the first detent (Figure 5)
so that relative rotation of the connector that is rotatively coupled to the first portion causes the mating first detent and the second detent to generate audible and/or tactile vibrations as the mating first detent and the second detent slide relative to each other (Figure 6B)(paragraph [0067]: the threadedly engageable cylinder 20 is turned in a tightening direction indicated by letter T. Since inclined surfaces 33a of the engageable claws 33 slide on inclined surfaces 31a of tooth portions of the ratchet teeth 31 at this time, the engageable claws 33 are moved over the ratchet teeth 31 of the threadedly engageable cylinder 20)(it is known in the art that a ratchet creates audible and tactile feedback upon rotation)
a necked bushing (22), defining an engagement surface (31), formed on the first fitting or the second fitting
a biased, mating cantilever finger (32) projecting from the other of the first fitting or the second fitting, the finger defining a ledge (33) that projects tangentially relative to a cantilever translation axis, the ledge in biased engagement with the engagement surface of the necked bushing, preventing relative axial separation of the first fitting and the second fitting (Figure 5), while allowing relative rotation therebetween about the rotational axis (Figure 6B)
the first portion and the second portion of the plug-in connector in nested orientation, and a circumferential fluid seal (13b) interposed there between, for preventing fluid communication outside of the coupling (Figure 5)
In regards to claim 7, Iwakata et al teaches one of the first detent or the second detent comprising a ratchet (31) and the other of the first detent or second detent comprising a biased pawl (33) in slidable, mating, abutting engagement with the ratchet, the pawl defining a pawl translation axis (Figure 5).
In regards to claim 8, Iwakata et al teaches the first detent and second detent of the mating ratchet and the pawl allowing rotation of the first fitting having the Luer connector relative to the second fitting having the port upon application of a first rotational torque force threshold in a first rotational direction (Figure 6B) but preventing corresponding relative counter rotation between said first fitting and said second fitting in an opposite rotational direction (Abstract: a loosening prevention mechanism (30) that prohibits rotation of the threadedly engageable cylinder (20) in a loosening direction with respect to the male connector (10) when the male luer portion (11) and the female luer portion (2a) are joined. The loosening prevention mechanism (30) includes ratchet teeth (31) formed in an inner periphery of the threadedly engageable cylinder (20), an elastic projection (32) formed in the male connector (10) and an engageable claw (33) protruded from a free end of the elastic projection (32) and engageable with the ratchet teeth).
In regards to claim 9, Iwakata et al teaches the ratchet and the pawl circumferentially oriented about the rotational axis of the first fitting and the second fitting (Figures 6A-6B), with the pawl translation axis parallel to said rotational axis (Figure 5).
In regards to claim 13, Iwakata et al teaches the fluid seal comprising an O-ring (13b) (Figures 2, 4).
In regards to claim 14, Iwakata et al teaches:
the first portion and the second portion of the plug-in connector in nested orientation, coaxial with the rotational axis (Figure 5)
the first detent or the second detent, respectively, of the inner one of the nested connector first portion or the second portion projecting radially outwardly from an outer circumferential wall thereof (Figure 5)
the first detent or the second detent, respectively, of an outer one of the nested connector first portion or the second portion projecting radially inwardly from an inner circumferential wall thereof, in abutting, opposed, slidable engagement with the first detent or the second detent, respectively, of the inner one of the first portion and the second portion (Figure 5)
In regards to claim 15, Iwakata et al teaches:
the outer one of the nested connector first portion or the second portion defining a plurality of the first detent or the second detent (31) that are symmetric and circumferentially spaced, which respectively define outer tips (31a) axially aligned with the rotational axis
the inner one of the nested connector first portion or the second portion defining the at least one first detent or the at least one second detent (33), which respectively defines an inner tip (33a) axially aligned with the rotational axis
In regards to claim 16, Iwakata et al teaches the outer tips comprising a ratchet (31) and the inner tip comprising a biased pawl (33) in slidable, mating, abutting engagement with the ratchet, the pawl defining a pawl translation axis (Figure 5).
In regards to claim 17, Iwakata et al teaches one of the first detent or the second detent comprising the ratchet and the other of the first detent and second detent comprising the biased pawl in slidable, mating, abutting engagement with the ratchet, the pawl defining the pawl translation axis that is parallel to the rotational axis of the first fitting and the second fitting (Figure 5).
In regards to claim 18, Iwakata et al teaches the first detent and the second detent of the ratchet and the pawl that are mating, allowing rotation of the first fitting having the Luer connector relative to the second fitting having the port upon application of a first rotational torque force threshold in a first rotational direction (Figure 6B) but preventing corresponding relative counter rotation between said first fitting and said second fitting in an opposite rotational direction (Abstract: a loosening prevention mechanism (30) that prohibits rotation of the threadedly engageable cylinder (20) in a loosening direction with respect to the male connector (10) when the male luer portion (11) and the female luer portion (2a) are joined. The loosening prevention mechanism (30) includes ratchet teeth (31) formed in an inner periphery of the threadedly engageable cylinder (20), an elastic projection (32) formed in the male connector (10) and an engageable claw (33) protruded from a free end of the elastic projection (32) and engageable with the ratchet teeth).
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 22 is rejected under 35 U.S.C. 103 as being unpatentable over Iwakata et al, as applied to claim 1 above, and further in view of TW I686220.
In regards to claim 22, Iwakata et al does not teach the port connector comprising threads that are construed to facilitate coupling to a catheter, as Iwakata et al instead teaches the port connector comprising an inner surface (of 12) that is construed to facilitate coupling to a catheter (5) (Figures 4-5). TW I686220 teaches a coupling (Figures 1-5) comprising a port connector (11) comprising threads (111) that are construed to facilitate coupling to a catheter (70) (Figure 3). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the port connector, of the coupling of Iwakata et al, to comprise threads, as taught by TW I686220, as either the inner surface of the port connector, as taught by Iwakata et al, or the threads of the port connector, as taught by TW I686220, will provide for the same end result of allowing for connection of the coupling to a catheter.
Response to Arguments
Applicant's arguments filed January 29, 2026, have been fully considered but they are not persuasive:
In regards to claim 1, Applicant argued: The Office Action states that Iwakata discloses a fluid seal comprising an O-ring as described in Applicant's disclosure, claim 13. (See Office Action at p. 16). The Office Action refers to reference numeral 13b of Iwakata as being the structure that allegedly equates to Applicant's O-ring. (See Id.). In Iwakata, reference numeral 13b refers to an annular protrusion. Iwakata states that the annular protrusion 13b is "formed in an outer periphery of a boundary portion between the small-diameter cylindrical portion" and that "the threadedly engageable cylinder 20 is abutted against an outer periphery of the annular protrusion 13b of the male connector 10". (See Iwakata at paras. [0058] and [0061]). The Applicant's disclosure states "[t]he Luer coupling 10 incorporates a first plug-in connector 26 in its first fitting 14, which includes an O-ring seat 28 for receipt of O-ring 30" and "[t]he O-ring 30 is a circumferential fluid seal interposed between the first 26 and second 32 plug-in connectors". (See Applicant at para. [0031]). Iwakata makes no explicit or implicit mention of an O-ring or an O-ring seat, and neither Iwakata FIGS. 2 or 4 illustrate an O-ring or an O-ring seat. Annotated Iwakata FIG. 2 and annotated Applicant FIG. 3 have been reproduced below to showcase the O-ring differences between the inventions. Claim 1 has been amended to further enumerate the difference of Applicant's O-ring over the prior art, reciting "an O-ring seat for receipt of an O-ring that is interposed between, and fluidly seals, a first plug-in connector and a second plug-in connector; and" (Remarks, page 14). Examiner disagrees. First, in regards to claim 1, the coupling of claim 1 does not positively require an O-ring. The coupling of claim 1 instead positively requires an O-ring seat that is structurally capable of receiving an O-ring. Iwakata et al teaches an O-ring seat (labeled in Figure 4 above) that is structurally capable of receiving an O-ring. Second, in regards to claim 13, reference numeral 13b of Iwakata et al meets the claim structure for an O-ring.
In regards to claim 6, Applicant argued: The Office Action states that Iwakata discloses a biased, mating cantilever finger projecting from the other of the first fitting or the second fitting, as described in Applicant's disclosure claim 11. (See Office Action at p. 1 5). In Iwakata, an engageable claw is formed in an outer surface of a distal end portion of the elastic projection, such that the engageable claw is engaged with ratchet teeth. (See Iwakata at [0064]-[0065]). The engageable claw is connected to the elastic projection in Iwakata. The elastic projection deforms inward, allowing the connected engageable claw to engage with the ratchet teeth of the threadedly engageable cylinder, creating a loosening prevention mechanism. (See /d.). This differs from Applicant, where the first detent (i.e., engageable claw in Iwakata) and the second detent (i.e., ratchet teeth in Iwakata) are separate from the mating cantilever fingers (i.e., elastic projection in Iwakata). (See Applicant at FIG. 5). Applicant states "[e]ach of the cantilever fingers 38 defines a ledge 40 that projects tangentially relative to its cantilever translation axis" and "[e]ach ledge 40 is in biased engagement with the engagement surface 36 of the necked bushing 34, thereby preventing relative axial separation of the first 12 and second 16 fittings, while allowing relative rotation therebetween about their common rotational axis." (See Id. at [0032]). Thus, the mating cantilever fingers are positioned so that the ledges on the fingers have biased engagement with the engagement surface of the necked brushing, which is in a location of the device entirely separate from the first detent and second detent. Iwakata's FIG. 4 and Applicant FIG. 5 have been reproduced below for comparison. Thus, Iwakata does not disclose the mating cantilever fingers as described in Applicant's disclosure. Therefore, the entirety of claim 11 and claim 12 are integrated into independent claim 6. Accordingly, claims 11 and 12 are canceled (Remarks, pages 16-17). Examiner disagrees. First, the claim does not require the first detent and the second detent to be separate from the biased, mating cantilever finger, as argued by Applicant. Second, the claim does not require the biased, mating cantilever finger to be in a separate location from the first detent and the second detent, as argued by Applicant. Thus, Examiner maintains that Iwakata et al teaches a first detent (31), a second detent (33), and a biased, mating cantilever finger (32).
In regards to claim 6, Applicant argued: Iwakata does not disclose an O-ring seat for receipt of an O-ring that is interposed between, and fluidly seals, a first and a second plug-in connector, does Iwakata disclose a threaded port connector, and does not disclose mating cantilever fingers that are positioned so that the ledges on the fingers have biased engagement with an engagement surface of a necked brushing. Accordingly, the claimed invention is not anticipated by Iwakata. Withdrawal of this basis of rejection is respectfully requested (Remarks, page 17). Examiner disagrees. First, in regards to claim 1, Iwakata et al teaches an O-ring seat (labeled in Figure 4 above) that is structurally capable of receiving an O-ring. Second, in the new grounds of rejection under Iwakata et al and TW I686220 for new claim 22, TW I686220 renders obvious a port connector (11) comprising threads (111). Third, in regards to claim 6, Iwakata et al teaches a biased, mating cantilever finger (32) defining a ledge (33) in biased engagement with the engagement surface (31) of the necked bushing (22).
Conclusion
THIS ACTION IS MADE FINAL. 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 SHEFALI D PATEL whose telephone number is (571)270-3645. The examiner can normally be reached Monday-Friday 8:30am-4:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin C Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
Prosecution Insights