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 .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1, and any claim depending therefrom, is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the term "the cap" lacks antecedent basis.
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 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fehr et al. (U.S. Pat. 7,322,956 B2, hereinafter "Fehr").
Regarding claim 18, Fehr discloses a method for producing a mixture with a mixing system to deliver to a treatment site, the method comprising:
coupling a distal end of a syringe 21 or 22 (see Fig. 1) with a first port 16 or 16b (see Fig. 1) of the multi-reservoir system;
injecting a first constituent (one of K3 or K4) into a first reservoir of the multi-reservoir system to mix the first constituent with a second constituent (one of K1 or K2) contained in the first reservoir of the multi-reservoir system and form a precursor (one of M1 [K1+K3] or M2 [K2+K4]; see Figs. 3a and 3b),
coupling a needle hub 30 having a mixing region to a distal end of the multi-reservoir system (see Fig. 9d; see col. 10, lines 59-61, describing the needle hub 30 as a "mixer");
and actuating a plunger assembly (two plunger rods 14) to distally advance the precursor (one of M1 or M2) and a third constituent (the other of M1 or M2) disposed within a second reservoir of the multi-reservoir system into the mixing region of the needle hub to form an injectable mixture (see col. 13, lines 34-36).
Regarding claim 19, Fehr discloses removing a retainer (such as part 60, which retains the syringe arrangements 10 and 20 together; see Fig. 6a) from the plunger assembly prior to actuating the plunger assembly (i.e., the retainer, along with the syringe arrangement 20, is removed prior to actuating the plunger assembly to deliver M1 and M2 into the mixing region of the needle hub; see Fig. 6d).
Regarding claim 20, Fehr discloses actuating the plunger assembly after removing a plug 60' (see Fig. 7) from a port 75 (see Fig. 7) of a cap 72 (see Fig. 7) of the multi-reservoir system (i.e., the plug is removed prior to attaching the needle hub and delivering the material M1 or M2) and prior to removing the cap to purge air from the multi-reservoir system (the step of purging air from the system does not appear to be positively recited; Fehr makes no mention of purging air from the system, thus, the actuating step is understood to occur before any air purging would be carried out).
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.
Claims 1 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Fehr in view of Bryant et al. (U.S. Pub. 2015/0105734 A1, hereinafter "Bryant").
Regarding claim 1, Fehr discloses a system for producing a mixture to deliver to a treatment site, comprising:
a needle hub 30 (see Fig. 2);
a multi-reservoir system, the multi-reservoir system comprising:
a plunger assembly (two plunger rods 14; see Fig. 2) including a first tubular plunger and a second tubular plunger (plunger rods 14 in Fig. 2);
a barrel portion including a housing 17 (see Fig. 2) defining a first reservoir 12 (see Fig. 2) in fluid communication with a first port 16b (see Fig. 2) and configured to contain a first constituent and a second reservoir 12 (see Fig. 2) in fluid communication with a second port 16a (see Fig. 12) and configured to contain a second constituent (first reservoir 12 contains constituent K2 and second reservoir 11 contains constituent K1; see Fig. 3a) ;
a first plunger (the stopper at the distal end of one of the plunger rods 14) disposed relative to the plunger assembly and at least partially within the reservoir;
and a syringe 22 (see Fig. 3a) defining a lumen configured to contain a third constituent K4 (see Fig. 3a);
wherein a distal end of the syringe is configured to be releasably coupled to the barrel portion (housing 17 and syringe 22 are releasably couplable to one another; see col. 5, lines 48-50 and col. 6, lines 10-12; and see Figs. 3a-3c) such that actuation of the syringe 22 causes the third constituent K4 to be injected into the first reservoir 12 via a lumen to mix with the first constituent and form a precursor M2 (see Fig. 3b);
and wherein actuating the plunger assembly 10 relative to the barrel portion causes the precursor M2 and the second constituent K1 to be delivered into the needle hub (i.e., K1 is delivered as part of mixture M1 [M1=K1+K3]).
It is noted that Fehr does not appear to disclose that the first plunger, i.e., a stopper, is a floating piston—Fehr appears to show that its sealing piston is secured to the first tubular plunger 14 of the plunger assembly1.
Bryant discloses a syringe 1 (see Fig. 2) for use in a medical injection, comprising a tubular plunger 26 (see Fig. 2), a barrel portion 2 (see Fig. 2) defining a reservoir 36 (see Fig. 2), and a first floating plunger, i.e., stopper, 10 (see Fig. 2 and para [0005], disclosing "a plunger which does not couple to the stopper"). Bryant teaches numerous advantages to a floating stopper (see para [0005]).
A skilled artisan would have found it obvious, at the time the invention was filed, to modify the plunger assembly of Fehr so that the plunger, i.e., stopper, is not coupled to the tubular plunger—and is, therefore, a floating plunger—in order to achieve numerous art-recognized advantages taught in Bryant (see para [0005]) including reducing incorrect handling of the syringe (e.g., by preventing a user from withdrawing the plunger along with the secured stopper and causing undesirable air or other fluid to be drawn into the syringe), as well as reducing the possibility of stopper distortion that would compromise sealing and/or sterility of the final product (known to occur during the securement of the tubular plunger to the stopper). A skilled artisan would have had a likelihood of success from making this modification, since it would still have enabled the syringe assembly of Fehr to be filled and for the mixture to be expelled through the needle after filling.
Regarding claim 10, Fehr discloses that the needle hub comprises a first lumen in fluid communication with the first reservoir of the barrel portion via the first port, a second lumen in fluid communication with the second reservoir of the barrel portion via the second port, a central lumen configured to be in fluid communication with a needle, and a mixing region connecting the first and second lumens with the central lumen.
Regarding claim 11, Fehr discloses that the needle hub is removably coupled to a distal end region of the barrel portion of the multi-reservoir system (see Fig. 3c).
Regarding claim 12, Fehr discloses that the plunger assembly and the barrel portion are assembled in a telescoping arrangement (plunger rods 14 are telescoped within the barrel portion).
Claims 1, 2, 4, 5, 7-9, 13, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Mathys et al (U.S. Pat. 9,155,680 B2, hereinafter "Mathys") in view of Fehr, further in view of Bryant.
Regarding claims 1 and 2, Mathys discloses a kit for producing a mixture for delivery to a treatment site, the kit comprising:
a multi-reservoir system, the multi-reservoir system comprising:
a plunger assembly 100 (see Fig. 2) including a first tubular plunger 121 (see Fig. 1) and a second tubular plunger 122 (see Fig. 1);
a barrel portion including a housing defining a first reservoir 111 (see Fig. 1) in fluid communication with a first port (outlet of the first reservoir leading to one of the inlet connection pieces 211; see Fig. 2) and configured to contain a first constituent (although a first constituent is not shown, the reservoir is designed to hold constituents) and a second reservoir 112 (see Fig. 1) in fluid communication with a second port (outlet of the second reservoir leading to the other of the inlet connection pieces 211; see Fig. 2) and configured to contain a second constituent (although a second constituent is not shown, the reservoir is designed to hold constituents);
a first plunger (gasket-shaped stopper at the head of the plunger 121, shown unlabeled in Fig. 2) movably disposed relative to the plunger assembly and at least partially within the first reservoir;
and (as per claim 2) a cap 200 (see Fig. 1) removably coupled to a distal portion of the barrel portion (see col. 7, lines 24-28, disclosing that the cap 200 has a snap-type connection to the barrel portion and can be released by compressing wings located on the cap), the cap including a port 216 (see Fig. 5) and a lumen 214 (see Fig. 5) extending from the port to a proximal end of the cap; and
a syringe 300 (see Fig. 1) defining a lumen configured to contain a third constituent such that actuation of the syringe causes the third constituent to be injected into the first reservoir via the lumen of the cap to mix with the first constituent and form a precursor (although a first constituent is not shown, the reservoir is designed to hold constituents such that when the syringe 300 is actuated into the first reservoir via the lumen of the cap, the constituents mix).
It is noted that Mathys does not appear to disclose that the kit comprises:
a needle hub; and
a needle coupled to the needle hub.
Fehr discloses a system for producing a mixture to deliver to a treatment site, comprising:
a needle hub 30 (see Fig. 2);
and a needle 31 coupled to the needle hub (see Fig. 2).
A skilled artisan would have found it obvious at the time of the invention to modify the kit of Mathys to include a needle hub and a needle coupled thereto, as taught in Fehr, with a reasonable expectation of success in carrying out the intended function of the kit of Mathys, namely, to deliver fluid from Mathys' "applicator" 100 in areas requiring precise local administration.
It is further noted that Mathys, in view of Fehr, does not disclose that the first plunger, i.e., the gasket at the head of one of the tubular plungers, a floating piston—Mathys appears to show that its stopper is secured to the first tubular plunger 121 of the plunger assembly2.
Bryant discloses a syringe 1 (see Fig. 2) for use in a medical injection, comprising a tubular plunger 26 (see Fig. 2), a barrel portion 2 (see Fig. 2) defining a reservoir 36 (see Fig. 2), and a first floating plunger, i.e., stopper, 10 (see Fig. 2 and para [0005], disclosing "a plunger which does not couple to the stopper"). Bryant teaches numerous advantages to a floating stopper (see para [0005]).
A skilled artisan would have found it obvious, at the time the invention was filed, to modify the plunger assembly of Mathys so that the plunger, i.e., stopper, is not coupled to the tubular plunger—and is, therefore, a floating plunger—in order to achieve numerous art-recognized advantages taught in Bryant (see para [0005]) including reducing incorrect handling of the syringe (e.g., by preventing a user from withdrawing the plunger along with the secured stopper and causing undesirable air or other fluid to be drawn into the syringe), as well as reducing the possibility of stopper distortion that would compromise sealing and/or sterility of the final product (known to occur during the securement of the tubular plunger to the stopper). A skilled artisan would have had a likelihood of success from making this modification, since it would have still enabled the syringe assembly of Mathys, in view of Fehr, to be filled and for the mixture to be expelled through the needle after filling.
Regarding claim 4, Mathys discloses a plug (container holder 310; see Fig. 1) removably coupled with the port of the cap.
Regarding claim 5, Mathys discloses that the cap further comprises a cavity, e.g., 213 (see Fig. 1) in selective fluid communication with the second reservoir.
Regarding claim 7, Bryant discloses the first floating plunger, as described above, being unsecured to the plunger assembly or the barrel portion (see para [0005], disclosing "a plunger which does not couple to the stopper"; and the plunger is free to move within the barrel as well).
Regarding claims 8 and 9, Mathys, in view of Fehr, does not appear to disclose a second floating plunger movably disposed relative to the plunger assembly and at least partially within the second reservoir— Mathys appears to show that its stopper is secured to the second tubular plunger 122 of the plunger assembly 3.
A skilled artisan would have found it obvious at the time of the invention to modify the second plunger, i.e., the second stopper, so that it is not coupled to the tubular plunger—and is, therefore, a floating plunger—in order to achieve numerous art-recognized advantages taught in Bryant (see para [0005]) including reducing incorrect handling of the syringe (e.g., by preventing a user from withdrawing the plunger along with the secured stopper and causing undesirable air or other fluid to be drawn into the syringe), as well as reducing the possibility of stopper distortion that would compromise sealing and/or sterility of the final product (known to occur during the securement of the tubular plunger to the stopper). A skilled artisan would have had a likelihood of success from making this modification, since it would have still enabled the syringe assembly of Mathys, in view of Fehr, to be filled and for the mixture to be expelled through the needle after filling.
Regarding claim 13, Mathys discloses a kit for producing a mixture for delivery to a treatment site, the kit comprising:
a multi-reservoir system, the multi-reservoir system comprising:
a plunger assembly 100 (see Fig. 2) including a first tubular plunger 121 (see Fig. 1) and a second tubular plunger 122 (see Fig. 1);
a barrel portion including a housing defining a first reservoir 111 (see Fig. 1) in fluid communication with a first port (outlet of the first reservoir leading to one of the inlet connection pieces 211; see Fig. 2) and configured to contain a first constituent (although a first constituent is not shown, the reservoir is designed to hold constituents) and a second reservoir 112 (see Fig. 1) in fluid communication with a second port (outlet of the second reservoir leading to the other of the inlet connection pieces 211; see Fig. 2) and configured to contain a second constituent (although a second constituent is not shown, the reservoir is designed to hold constituents);
a first plunger (gasket-shaped stopper at the head of the plunger 121, shown unlabeled in Fig. 2) movably disposed relative to the plunger assembly and at least partially within the first reservoir;
and a cap 200 (see Fig. 1) removably coupled to a distal portion of the barrel portion (see col. 7, lines 24-28, disclosing that the cap 200 has a snap-type connection to the barrel portion and can be released by compressing wings located on the cap), the cap including a port 216 (see Fig. 5) and a lumen 214 (see Fig. 5) extending from the port to a proximal end of the cap; and
a syringe 300 (see Fig. 1) defining a lumen configured to contain a third constituent (although a third constituent is not shown, the reservoir is designed to hold constituents).
It is noted that Mathys does not appear to disclose that the kit comprises:
and an injection system, the injection system comprising:
a needle hub; and
a needle coupled to the needle hub.
Fehr discloses a system for producing a mixture to deliver to a treatment site, comprising:
a needle hub 30 (see Fig. 2);
and a needle 31 coupled to the needle hub (see Fig. 2).
A skilled artisan would have found it obvious at the time of the invention to modify the kit of Mathys to include a needle hub and a needle coupled thereto, as taught in Fehr, with a reasonable expectation of success in carrying out the intended function of the kit of Mathys, namely, to deliver fluid from Mathys' "applicator" 100 in areas requiring precise local administration.
It is further noted that Mathys, in view of Fehr, does not disclose that the first plunger, i.e., the gasket at the head of one of the tubular plungers, a floating piston—Mathys appears to show that its stopper is secured to the first tubular plunger 121 of the plunger assembly4.
Bryant discloses a syringe 1 (see Fig. 2) for use in a medical injection, comprising a tubular plunger 26 (see Fig. 2), a barrel portion 2 (see Fig. 2) defining a reservoir 36 (see Fig. 2), and a first floating plunger, i.e., stopper, 10 (see Fig. 2 and para [0005], disclosing "a plunger which does not couple to the stopper"). Bryant teaches numerous advantages to a floating stopper (see para [0005]).
A skilled artisan would have found it obvious, at the time the invention was filed, to modify the plunger assembly of Mathys so that the plunger, i.e., stopper, is not coupled to the tubular plunger—and is, therefore, a floating plunger—in order to achieve numerous art-recognized advantages taught in Bryant (see para [0005]) including reducing incorrect handling of the syringe (e.g., by preventing a user from withdrawing the plunger along with the secured stopper and causing undesirable air or other fluid to be drawn into the syringe), as well as reducing the possibility of stopper distortion that would compromise sealing and/or sterility of the final product (known to occur during the securement of the tubular plunger to the stopper). A skilled artisan would have had a likelihood of success from making this modification, since it would have still enabled the syringe assembly of Mathys, in view of Fehr, to be filled and for the mixture to be expelled through the needle after filling.
Regarding claim 15, Mathys discloses a plug (container holder 310; see Fig. 1) removably coupled with the port of the cap.
Regarding claim 16, Mathys, in view of Fehr, does not appear to disclose a second floating plunger movably disposed relative to the plunger assembly and at least partially within the second reservoir— Mathys appears to show that its stopper is secured to the second tubular plunger 122 of the plunger assembly 5.
A skilled artisan would have found it obvious at the time of the invention to modify the second plunger, i.e., the second stopper, so that it is not coupled to the tubular plunger—and is, therefore, a floating plunger—in order to achieve numerous art-recognized advantages taught in Bryant (see para [0005]) including reducing incorrect handling of the syringe (e.g., by preventing a user from withdrawing the plunger along with the secured stopper and causing undesirable air or other fluid to be drawn into the syringe), as well as reducing the possibility of stopper distortion that would compromise sealing and/or sterility of the final product (known to occur during the securement of the tubular plunger to the stopper). A skilled artisan would have had a likelihood of success from making this modification, since it would have still enabled the syringe assembly of Mathys, in view of Fehr, to be filled and for the mixture to be expelled through the needle after filling.
Claims 3 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Mathys, in view of Fehr, further in view of Bryant, further in view of Glass (U.S. Pat. 4,434,820, hereinafter "Glass").
Regarding claims 3 and 14, it is noted that Mathys, in view of Fehr, does not appear to disclose a removable retainer positioned between a proximal end of the barrel portion and a proximal end of the plunger assembly, the removable retainer configured to limit movement of the plunger assembly relative to the barrel portion.
Glass discloses a removable retainer, in the form of a dosage gauge 73 and/or a dosage stop 61 (see Fig. 1) that limits movement of the plunger assembly relative to the barrel portion (see col. 4, lines 34-48).
A skilled artisan would have found it obvious at the time of the invention to modify the kit of Mathys, in view of Fehr, further in view of Bryant, by providing a removable retainer positioned between a proximal end of the barrel portion and a proximal end of the plunger assembly, the removable retainer configured to limit movement of the plunger assembly relative to the barrel portion, as taught in Glass, if one wished to modify the specific dosage of material to be drawn into and/or administered from the multi-reservoir system, with a reasonable expectation of success.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mathys, in view of Fehr, further in view of Bryant, further in view of Guo et al (U.S. Pub. 2019/0321554 A1, hereinafter "Guo").
Regarding claim 6, it is noted that Mathys, in view of Fehr, further in view of Bryant, does not appear to disclose a floating seal disposed within the cavity of the cap, the floating seal configured to selectively seal the second port6.
Guo discloses a kit comprising a cap 110 (see Fig. 7) for a multi-reservoir assembly 210 (see Fig. 6) used to deliver fluid through the cap, and the cap comprises a cavity 112 (see Fig. 3) provided with a floating seal 138 (see Fig. 2, and see paras [0062] and [0063] disclosing that the floating seal 138 is a gasket that seals syringe connectors 130 within the cavity 112, and moves under pressure against the bias force of a spring 134).
A skilled artisan would have found it obvious at the time of the invention to modify the kit of Mathys, in view of Fehr, further in view of Bryant, by providing a floating seal disposed within the cavity of the cap, the floating seal configured to selectively seal the second port, as taught in Guo, in order to seal the cavity of the cap, thereby preventing or reducing undesirable contamination and/or ingress and/or leakage of material, with a reasonable expectation of success.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Mathys, in view of Fehr, further in view of Bryant, further in view of Kirk (U.S. Pub. 2014/0121647 A1, hereinafter "Kirk").
Regarding claim 17, it is noted that Mathys, in view of Fehr, does not appear to disclose a connector, the connector configured to couple the needle hub to an additional syringe.
Kirk discloses a kit having a reservoir assembly 10 (see Fig. 1), and a needle hub 26 (see Fig. 1) connected to the multi-reservoir assembly, along with a connector 44 (see Fig. 1) configured to couple the hub to an additional syringe (although the additional syringe is not shown, Kirk discloses that the connector is adapted to communicate with a gas source, which may be a syringe).
A skilled artisan would have found it obvious at the time of the invention to modify the kit of Mathys, in view of Fehr, further in view of Bryant, by providing a connector configured to couple the needle hub to an additional syringe, as taught in Kirk, in order to deliver the contents from the multi-reservoir assembly and the additional syringe either simultaneously or sequentially without requiring removal of the needle hub that may otherwise cause undesirable contamination.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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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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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 07/02/2026
1 The phrase "floating piston" was given its broadest reasonable interpretation consistent with the specification. See specification at para [0083], disclosing a floating plunger 148a that "may not be secured to either the plunger assembly 124 or the barrel portion 126."
2 The phrase "floating piston" was given its broadest reasonable interpretation consistent with the specification. See specification at para [0083], disclosing a floating plunger 148a that "may not be secured to either the plunger assembly 124 or the barrel portion 126."
3 The phrase "floating piston" was given its broadest reasonable interpretation consistent with the specification. See specification at para [0083], disclosing a floating plunger 148a that "may not be secured to either the plunger assembly 124 or the barrel portion 126."
4 The phrase "floating piston" was given its broadest reasonable interpretation consistent with the specification. See specification at para [0083], disclosing a floating plunger 148a that "may not be secured to either the plunger assembly 124 or the barrel portion 126."
5 The phrase "floating piston" was given its broadest reasonable interpretation consistent with the specification. See specification at para [0083], disclosing a floating plunger 148a that "may not be secured to either the plunger assembly 124 or the barrel portion 126."
6 The phrase "floating seal" was given its broadest reasonable interpretation consistent with the specification. See specification at para [0095], disclosing a floating seal 196 that "may be configured to move away from the distal opening 162b in response to pressure generated through actuation of the plunger assembly 124."
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