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 .
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 22 December 2025.
Claims 1-7 and 9-20 are pending.
Claim 8 is cancelled.
Claims 14-20 are withdrawn.
No claims are newly added.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Dalton (US PAT 5,312,377 A), hereinafter “Dalton”, in view of Butler et al. (US 2014/0228710 A1), hereinafter “Butler”, and Feith et al. (US 2020/0316358 A1), hereinafter “Feith”.
Regarding Claim 1, Dalton teaches a Luer lock 80 (Fig. 10 and Abstract: “An improvement in the luer taper connectors used to join two fluid conduits, especially in medical applications.”), comprising:
a tapered male member 30/70 defining a passage 36/74 having an inner surface ([col. 6, line 18]: “Set 80 includes male luer member 30 coupled with female luer member 40.” and [col. 6, line 24]: “The luer taper 41 is deformed by the male luer taper 31 to provide a substantially smooth transition from one member to the other.” – Further, Figs. 9 and 12 show the internal passages 36 and 74 of the male members.);
a tubing disposed through the passage, ([col. 3, line 6]: “According to the prior art, the first fluid conduit terminates in a rigid or semi-rigid, axially-hollowed, conical male luer nozzle member equipped with one part of a two-part mating thread means.” – see also Figs. 6, 8, and 9 showing the lead 46 through which a tubing is inserted.); and
a tapered female member 40 (Fig. 8 and [col. 5, line 36]: “FIGS. 5, 6 and 8 together illustrate a female luer member of this invention having several optional, but preferred, features. Soft, resilient, elastomeric female luer socket member 40 is axially and conically hollowed to provide female luer taper 41 and a lead 46 to a fluid conduit.”) configured to be coupled to the tapered male member 30/70 with the tubing disposed therein such that the tubing is in fluid communication with the tapered female member (See Fig. 10 showing the male luer member 30 inserted into the female luer member 40. – See also [col 2, line 58]: “Furthermore, use of the new, soft, resilient, elastomeric luer member can create a secondary seal against fluid leakage, while retaining the axial compression needed to maintain a tight luer slip fit between the male and female luer members.” – Therein, such mating provides for fluid communication between the tubing and the female member.), as in Claim 1.
Further regarding Claim 1, Dalton does not specifically teach the Luer fittings discussed above wherein the tapered male member with the tubing disposed therethrough exerts a compressive force at a mating surface between the tapered male member and the tapered female member to increase friction therebetween and inhibit leakage, as in Claim 1. – (Herein, this claim recitation is interpreted as the male member and tubing together providing a compressive force, as the male member providing a compressive force against the female member is accounted for by Dalton (col 2, line 58).
However, Butler teaches a respective set of male and female luer fittings for medical use ([0012]) comprising a male luer element having an inner passage with and a length of medical tubing inserted therethrough (Fig. 30A), wherein said tubing exerts a compressive force at the opening surface of a female member so as to improve a fluid-tight seal ([0011]: “The connector can further include a force-exerting structure that uses a resilient property to improve a seal where the extender tube abuts the opening of the other connecting device.”) -- see Fig. 37H.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the Luer fittings of Dalton wherein the tubing exerts a compressive force at a mating surface between the tapered male member and the tapered female member, such as suggested by Butler, so as to improve the fluid tight seal between Luer elements and reduce errors due to leakage; and would have a reasonable expectation of success therein given that Dalton similarly discusses insertion of tubing into a luer fitting (col. 5, line 38).
Further regarding Claim 1, Dalton does not specifically teach the Luer fittings discussed above wherein the tubing defines an outer cross-section greater than an inner cross-section of the passage such that the tubing is in contact with and compresses against the inner surface along a length of the passage, as in Claim 1.
However, Feith teaches respective luer fittings wherein a tubing 170 is inserted into a luer fitting 105, the tubing having a greater cross section than the tubing port 120 of the luer fitting 105 such that the outer area of the tubing 170 compresses against the inner surface of the tubbing port 120 of the luer connector 105 so as to provide a fluid-tight seal and reduce leaks (See Fig. 5 and para. [0030].).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Dalton wherein the tubing defines an outer cross-section greater than an inner cross-section of the passage such that the tubing is in contact with and compresses against the inner surface along a length of the passage, such as suggested by Feith, so as to provide a fluid-tight seal and reduce leaks.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, given that Dalton specifically teaches the male and female elements as Luer fittings (Abstract), Dalton teaches the Luer fittings discussed above wherein the male member and the female member have an equal taper angle in the range of 1 to 100 (Luer fitting angles are standardized at 6% taper (or 3.44 degrees from centerline); Dalton teaches Luer fittings in a medical context, which would thereby be subject to ISO 594 standards for lock fittings passed in 1991, motivating Dalton to follow the 6% taper angle requirement. – See Dalton [col. 1, line 45]: “The American National Standard Institute (ANSI) first proposed an American National Standard in 1955 to make luer slip fittings and luer-lock fittings uniform from manufacturer to manufacturer. ANSI MD70.1-1955 was subsequently adopted by the industry. Thus, individual luer fittings for use in medical device applications can make leakproof and mechanically secure connection with any other available individual mating luer fitting. At the time the standard was written the luer taper dimensions required a cone 4.318 mm in diameter at the large end, 3.937 mm in diameter at the small end and 6.350 mm in length, i.e., a 6% taper. In 1955, luer taper fittings were generally made of rigid glass or metal, but semi-rigid thermoplastic fittings of polycarbonate, polypropylene, etc. now predominate.”), as in Claim 3.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, Dalton teaches the Luer fittings discussed above wherein at least one of the female member or the male member includes threads for coupling the female member to the male member (Figs 9 and 11, and [col. 3, line 25]: “According to a second aspect of the invention, an improved female luer member is provided by substituting for a rigid or semi-rigid, axially and conically-hollowed female luer socket member of the prior art, which carries one part of a two-part thread means externally on the socket wall, a soft, resilient, elastomeric female luer member which carries neither part of the thread means, but n which the socket wall is sized externally to interfere with and conform itself to that part of the thread means carried by the male luer member when the members are joined.”), as in Claim 4.
Regarding Claim 5, the prior art meets the limitations of Claim 1 as discussed above. Further, Dalton teaches the Luer fittings discussed above wherein neither the male member nor the female member includes threads to couple the female member to the male member (Figs. 10 and 12, and [col. 3, line 13]: “The improvement comprises substituting at least one soft, resilient, elastomeric luer member carrying neither part of the thread means for either the male or the female luer member of the prior art, or for both members of the prior art.”), as in Claim 5.
Regarding Claim 6, the prior art meets the limitations of Claim 1 as discussed above. Further, Dalton does not specifically teach the Luer fittings discussed above wherein the tubing extends beyond the passage of the tapered male member into a cavity of the female member, as in Claim 6.
However, Butler teaches a respective set of male and female luer fittings for medical use ([0012]) comprising a male luer element having an inner passage with and a length of medical tubing inserted therethrough (Fig. 30A), wherein said tubing extends beyond the passage of the tapered male member into a cavity of the female member to exert a compressive force at the opening surface of a female member so as to improve a fluid-tight seal ([0011]: “The connector can further include a force-exerting structure that uses a resilient property to improve a seal where the extender tube abuts the opening of the other connecting device.”) -- see Fig. 37H.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the Luer fittings of Dalton wherein the tubing extends beyond the passage of the tapered male member into a cavity of the female member, such as suggested by Butler, so as to improve the fluid tight seal between Luer elements and reduce errors due to leakage; and would have a reasonable expectation of success therein.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Dalton in view of Butler and Feith, as applied to Claims 1 and 3-6 above, and in further view of Peterson et al. (US PAT 5,098,405 A), hereinafter “Peterson”.
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, combined Dalton/Butler does not specifically teach the Luer fittings discussed above wherein the male member defines a side port defined on a side wall thereof, the side port providing an additional fluid pathway for application of vacuum or external pressure, as in Claim 2.
However, Peterson teaches a respective set of male and female luer fittings for medical use ([col. 1, line 15]), wherein the male member comprises a side port 12 (Figs. 1 and 2). Therein, said side port offers the advantage of an additional site for an additional fluid pathway ([col. 1, line 12]: “Side port adapters may be added to an inserted catheter to provide an additional site for infusion...”).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the luer fittings of combined Dalton/Butler wherein the male member defines a side port defined on a side wall thereof, such as suggested by Peterson, so as to provide an additional site for IV infusion such as necessitated in critical/intensive care situations requiring numerous medications administered simultaneously; and would have a reasonable expectation of success therein.
Claims 7 and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Dalton in view of Butler, Feith, and Peterson. Dalton, Butler, Feith, and Peterson have been discussed above.
Regarding Claim 7, Dalton teaches a Luer lock 80 (Fig. 10 and Abstract: “An improvement in the luer taper connectors used to join two fluid conduits, especially in medical applications.”), comprising:
a tapered male member 30/70 defining a central axis and a passage 36/74 having an inner surface along the central axis ([col. 6, line 18]: “Set 80 includes male luer member 30 coupled with female luer member 40.” and [col. 6, line 24]: “The luer taper 41 is deformed by the male luer taper 31 to provide a substantially smooth transition from one member to the other.” – Further, Figs. 9 and 12 show the internal passages 36 and 74 of the male members. – Note that as seen through Figs. 9 and 12, the central passage lies along the central axis of the male Luer elements. – Note that Applicant has not specifically defined the orientation of “a central axis”. Applicant may wish to describe the axis as the cylindrical longitudinal axis and describe a cylindrical shape pf the male member, if in accordance with the instant disclosure.); and
a tubing disposed through the passage along the central axis, the tubing defining an outer cross-section ([col. 3, line 6]: “According to the prior art, the first fluid conduit terminates in a rigid or semi-rigid, axially-hollowed, conical male luer nozzle member equipped with one part of a two-part mating thread means.” – see also Figs. 6, 8, and 9 showing the lead 46 through which a tubing is inserted.),
a tapered female member 40 (Fig. 8 and [col. 5, line 36]: “FIGS. 5, 6 and 8 together illustrate a female luer member of this invention having several optional, but preferred, features. Soft, resilient, elastomeric female luer socket member 40 is axially and conically hollowed to provide female luer taper 41 and a lead 46 to a fluid conduit.”) configured to be coupled to the tapered male member 30/70 with the tubing disposed therein such that the tubing is in fluid communication with the tapered female member (See Fig. 10 showing the male luer member 30 inserted into the female luer member 40. – See also [col 2, line 58]: “Furthermore, use of the new, soft, resilient, elastomeric luer member can create a secondary seal against fluid leakage, while retaining the axial compression needed to maintain a tight luer slip fit between the male and female luer members.” – Therein, such mating provides for fluid communication between the tubing and the female member.), as in Claim 7.
Further regarding Claim 7, Dalton does not specifically teach the Luer fittings discussed above wherein the tubing defines an outer cross-section greater than an inner cross-section of the passage such that the tubing is in contact with and compresses against the inner surface along a length of the passage, as in Claim 7.
However, Feith teaches respective luer fittings wherein a tubing 170 is inserted into a luer fitting 105, the tubing having a greater cross section than the tubing port 120 of the luer fitting 105 such that the outer area of the tubing 170 compresses against the inner surface of the tubbing port 120 of the luer connector 105 so as to provide a fluid-tight seal and reduce leaks (See Fig. 5 and para. [0030].).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Dalton wherein the tubing defines an outer cross-section greater than an inner cross-section of the passage such that the tubing is in contact with and compresses against the inner surface along a length of the passage, such as suggested by Feith, so as to provide a fluid-tight seal and reduce leaks.
Further regarding Claim 7, Dalton does not specifically teach the Luer fittings discussed above comprising a side port defined through a sidewall of the tapered male member, the side port defining a lateral passage, as in Claim 7.
However, Peterson teaches a respective set of male and female luer fittings for medical use ([col. 1, line 15]), wherein the male member comprises a side port 12 (Figs. 1 and 2). Therein, said side port offers the advantage of an additional site for an additional fluid pathway ([col. 1, line 12]: “Side port adapters may be added to an inserted catheter to provide an additional site for infusion...”). – Further note that Figs. 1 and 2 show the side port as defining a passage lateral to a main flow passage parallel with the flow path through the fittings.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the luer fittings of combined Dalton/Butler wherein the male member defines a side port defined on a side wall thereof, such as suggested by Peterson, so as to provide an additional site for IV infusion such as necessitated in critical/intensive care situations requiring numerous medications administered simultaneously; and would have a reasonable expectation of success therein.
Further regarding Claim 7, Dalton does not specifically teach the Luer fittings discussed above wherein the tapered male member with the tubing disposed therethrough exerts a compressive force at a mating surface between the tapered male member and the tapered female member to increase friction therebetween and inhibit leakage, as in Claim 7. – (Herein, this claim recitation is interpreted as the male member and tubing together providing such a compressive force, as the male member providing a compressive force against the female member is accounted for by Dalton (col 2, line 58).
However, Butler teaches a respective set of male and female luer fittings for medical use ([0012]) comprising a male luer element having an inner passage with and a length of medical tubing inserted therethrough (Fig. 30A), wherein said tubing exerts a compressive force at the opening surface of a female member so as to improve a fluid-tight seal ([0011]: “The connector can further include a force-exerting structure that uses a resilient property to improve a seal where the extender tube abuts the opening of the other connecting device.”) -- see Fig. 37H.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the Luer fittings of Dalton wherein the tubing exerts a compressive force at a mating surface between the tapered male member and the tapered female member, such as suggested by Butler, so as to improve the fluid tight seal between Luer elements and reduce errors due to leakage; and would have a reasonable expectation of success therein given that Dalton similarly discusses insertion of tubing into a luer fitting (col. 5, line 38).
Regarding Claim 9, the prior art meets the limitations of Claim 7 as discussed above. Further, combined Dalton/Peterson teaches the Luer fittings wherein the side port provides an additional fluid pathway for application of vacuum or external pressure (As discussed by Peterson [col. 1, line 12]: “Side port adapters may be added to an inserted catheter to provide an additional site for infusion...”), as in Claim 9.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that when modifying the male Luer connector of Dalton with a side port suggested by Peterson, that the side port provide an additional fluid pathway for application of vacuum or external pressure, as suggested by Peterson so as to achieve the primary goal of the side port for providing an additional fluidic pathway as in Peterson; and would have a reasonable expectation of success therein.
Regarding Claim 10, the prior art meets the limitations of Claim 7 as discussed above. Further, given that Dalton specifically teaches the male and female elements as Luer fittings (Abstract), Dalton inherently teaches the Luer fittings discussed above wherein the male member and the female member have an equal taper angle in the range of 1 to 100 (Luer fitting angles are standardized at 6% taper (or 3.44 degrees from centerline); Dalton teaches Luer fittings in a medical context, which would thereby be subject to ISO 594 standards for lock fittings passed in 1991, motivating Dalton to follow the 6% taper angle requirement. – See Dalton [col., line]: “The American National Standard Institute (ANSI) first proposed an American National Standard in 1955 to make luer slip fittings and luer-lock fittings uniform from manufacturer to manufacturer. ANSI MD70.1-1955 was subsequently adopted by the industry. Thus, individual luer fittings for use in medical device applications can make leakproof and mechanically secure connection with any other available individual mating luer fitting. At the time the standard was written the luer taper dimensions required a cone 4.318 mm in diameter at the large end, 3.937 mm in diameter at the small end and 6.350 mm in length, i.e., a 6% taper. In 1955, luer taper fittings were generally made of rigid glass or metal, but semi-rigid thermoplastic fittings of polycarbonate, polypropylene, etc. now predominate.”), as in Claim 10.
Regarding Claim 11, the prior art meets the limitations of Claim 7 as discussed above. Further, Dalton teaches the Luer fittings discussed above wherein at least one of the female member or the male member includes threads for coupling the female member to the male member (Figs 9 and 11, and [col. 3, line 25]: “According to a second aspect of the invention, an improved female luer member is provided by substituting for a rigid or semi-rigid, axially and conically-hollowed female luer socket member of the prior art, which carries one part of a two-part thread means externally on the socket wall, a soft, resilient, elastomeric female luer member which carries neither part of the thread means, but n which the socket wall is sized externally to interfere with and conform itself to that part of the thread means carried by the male luer member when the members are joined.”), as in Claim 11.
Regarding Claim 12, the prior art meets the limitations of Claim 7 as discussed above. Further, Dalton teaches the Luer fittings discussed above wherein neither the male member nor the female member includes threads to couple the female member to the male member (Figs. 10 and 12, and [col. 3, line 13]: “The improvement comprises substituting at least one soft, resilient, elastomeric luer member carrying neither part of the thread means for either the male or the female luer member of the prior art, or for both members of the prior art.”), as in Claim 12.
Regarding Claim 13, the prior art meets the limitations of Claim 7 as discussed above. Further, combined Dalton/Peterson does not specifically teach the Luer fittings discussed above wherein the tubing extends beyond the passage of the tapered male member into a cavity of the female member, as in Claim 13.
However, Butler teaches a respective set of male and female luer fittings for medical use ([0012]) comprising a male luer element having an inner passage with and a length of medical tubing inserted therethrough (Fig. 30A), wherein said tubing extends beyond the passage of the tapered male member into a cavity of the female member to exert a compressive force at the opening surface of a female member so as to improve a fluid-tight seal ([0011]: “The connector can further include a force-exerting structure that uses a resilient property to improve a seal where the extender tube abuts the opening of the other connecting device.”) -- see Fig. 37H.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the Luer fittings of combined Dalton/Peterson wherein the tubing extends beyond the passage of the tapered male member into a cavity of the female member, such as suggested by Butler, so as to improve the fluid tight seal between Luer elements and reduce errors due to leakage; and would have a reasonable expectation of success therein.
Response to Arguments
35 USC 112
Applicant’s amendments sufficiently overcome those rejections of Claims 4 and 7 rejected as indefinite under 35 USC 112(b) by the previous office action. As such, those rejections of Claims 4 and 7 under 35 USC 112(b) are withdrawn.
35 USC 103
Applicant’s arguments are on the grounds that none of the applied references account for the amended Claims 1 and 7 recitations requiring the outer cross sectional area of the tubing being greater than that of the inner cross sectional area of the inner surface the luer fitting such that the tubing compresses against said inner surface of the luer fitting, as discussed in the interview on Dec. 2 2025.
Applicant’s arguments are not persuasive because this deficiency in the previously applied references of Dalton/Butler/Peterson is made up for by obvious combination with Feith as discussed above in the body of the action, wherein such new grounds are necessitated concordant with the amendments made herein. Therein, Feith specifically teaches respective luer fittings wherein a tubing 170 is inserted into a luer fitting 105, the tubing having a greater cross section than the tubing port 120 of the luer fitting 105 such that the outer area of the tubing 170 compresses against the inner surface of the tubbing port 120 of the luer connector 105 so as to provide a fluid-tight seal and reduce leaks (See Fig. 5 and para. [0030].), wherein one skilled in the art would thereby find it obvious to provide this arrangement to the device of Dalton so as to reduce/prevent leaks.
Thus, Examiner respectfully sets forth the rejection of Claims 1 and 3-6 as unpatentable under 35 U.S.C. 103 over Dalton in view of Butler and Feith; and the rejection of Claims 7 and 9-13 as unpatentable under 35 U.S.C. 103 over Dalton in view of Butler, Feith, and Peterson, as necessitated by Applicant’s amendments specifying the cross-section/diameter of the tube and luer component fittings.
Regarding the additional recitations cited by Applicant, the “a tapered male member defining a central axis a passage having an inner surface, a tubing disposed through the passage, the tubing defining an outer cross-section and a tapered female member configured to be coupled to the tapered male member with the tubing disposed therein such that the tubing is in fluid communication with the tapered female member, wherein the tapered male member with the tubing disposed therethrough exerts a compressive force at a mating surface between the tapered male member and the tapered female member to increase friction therebetween and inhibit leakage” are accounted for by the references of Dalton (teaching the tapered male member defining a central axis a passage having an inner surface, a tubing disposed through the passage, the tubing defining an outer cross-section) and Butler (teaching the tapered male member with the tubing disposed therethrough exerting a compressive force at a mating surface between the tapered male member and the tapered female member to increase friction therebetween and inhibit leakage) as discussed above in the body of the action.
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.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798