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 .
Status of Claims
This office action is responsive to the amendment filed 18 December 2025.
Claims 1 and 12 are amended.
Claims 21 and 22 are added.
Claims 6 and 13 are canceled.
Claims 1-5, 7-12, and 14-22 are presently pending in this application.
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, 7, 11, 19, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Imbert (US Patent No. 5624402 A), in view of Pedrussio et al. (US Patent Application No. 20180264111 A1), hereinafter Pedrussio, in further view of Yanai et al. (US Patent No. 5782815 A), hereinafter Yanai, and Gallotto et al. (US Patent Publication No. 20170105903 A1), hereinafter Gallotto.
Regarding claim 1, Imbert discloses an applicator syringe (Imbert: Fig. 1, hypodermic syringe 10) containing a sterile solution (solution is kept sterile; col 4, ln 12-18) having a medical active substance (syringe is pre-filled with medication; col 4, ln 12-18) for introducing the sterile solution (solution is kept sterile; col 4, ln 12-18) containing the medical active substance (syringe is pre-filled with medication; col 4, ln 12-18), wherein the applicator syringe (Fig. 1, hypodermic syringe 10) comprises: a cylindrical jacket (Fig. 1, cylindrical wall 18); a cavity defined by the cylindrical jacket (Fig. 1, fluid-receiving chamber 20); a syringe cover (Fig. 1 and 10, distal end 22 and 316) integrally formed with the jacket (Fig. 1 and 10, distal end 316 is integral with cylindrical wall 18), wherein one side of the cylindrical jacket (Fig. 1, cylindrical wall 18) is closed by the syringe cover (Fig. 1 and 10, distal end 316 closes off wall 18 distally); an outlet opening (Fig. 1, passageway 24) defined by the syringe cover (Fig. 1 and 10, passageway 24 is defined by the distal end 316 proximally), the outlet opening (Fig. 1, passageway 24) being in fluid communication with the cavity (Fig. 1, chamber 20 is in fluid communication with passageway 24; col 3, ln 36-49); wherein the outlet opening (Fig. 1, passageway 24) is formed in a stepped cone (Fig. 10, comprised of tip 322 and rib 323, which are stepped with one another), which is integrally formed with the jacket (Fig. 1 and 10, tip 323 is integral with distal end 316, which is integral with the wall 18) and the syringe cover (Fig. 1 and 10, distal end 22 and 316) and the stepped cone (Fig. 10, comprised of tip 322 and rib 323, which are stepped with one another) has at least two sections (Fig. 10, tip 322 and rib 323) integrally engaged with one another (Fig. 10, tip 322 and rib 323 are integral with each other) and each having different diameters (Fig. 10, rib 323 has a larger diameter than tip 322) which become smaller toward a tip of the stepped cone (Fig. 10, tip 322 is distal of rib 323 and is smaller than rib 323): and a plunger (Fig. 1, comprising plunger 26 and stopper 28), the plunger (Fig. 1, comprising plunger 26 and stopper 28) being movably received within the cavity (Fig. 1, comprising plunger 26 and stopper 28 is slidably engaged within chamber 20; col 3, ln 36-49); wherein the sterile solution (solution is kept sterile; col 4, ln 12-18) containing the medical active substance (syringe is pre-filled with medication; col 4, ln 12-18) is received in the cavity (syringe is pre-filled with medication within chamber 20; col 4, ln 12-18) delimited by the cylindrical jacket (Fig. 1, cylindrical wall 18) having syringe cover (Fig. 1 and 10, distal end 22 and 316) and the plunger (Fig. 1, comprising plunger 26 and stopper 28).
Imbert does not expressly disclose that the two sections are cylindrical and that the stepped cone enables the applicator syringe to be coupled to at least two catheters with differently configured connection cones.
Gallotto teaches a stepped cone (Gallotto: Fig. 2, second connector 270) comprising two cylindrical sections (Fig. 2, second connector 270 comprises tubular sections; para. 0112); the cylindrical sections enables a device (Fig. 2, device 200) to be coupled to at least two catheters with differently configured connection cones (connector 270 is configured to connect to any standardized connector of a tube; para. 0112).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the stepped cone of Imbert such that the two sections are cylindrical; the stepped cone enables the applicator syringe to be coupled to at least two catheters with differently configured connection cones as taught by Gallotto in order to facilitate connection to any connector of a tube (Gallotto: para. 0112).
Imbert does not expressly disclose the cylindrical jacket is formed from a cycloolefin copolymer.
Pedrussio teaches an applicator syringe (Pedrussio: para. 0008), wherein a cylindrical jacket (syringe comprises a barrel; para. 0078) is formed from a cycloolefin copolymer (para. 0016).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the cylindrical jacket and plunger of Imbert such that the cylindrical jacket is formed from a cycloolefin copolymer as taught by Pedrussio in order to allow for storage of solutions within the syringe and to allow the syringe to be resistant to mechanical damage (Pedrussio: para. 0008).
Imbert does not expressly disclose the plunger is formed from an isobutene-isoprene rubber.
Yanai teaches an applicator syringe (Yanai: Fig. 1, glass cartridge 1), wherein the plunger (Fig. 1, comprising plunger 7 and stopper 2) is formed from an isobutene-isoprene rubber (col 8, ln 37-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plunger of Imbert such that the plunger is formed from an isobutene-isoprene rubber as taught by Yanai in order to prevent deformation by heat during steam sterilization (col 8, ln 37-45).
Regarding claim 7, Imbert in view of Pedrussio, Yanai, and Gallotto discloses the applicator syringe above.
Imbert in view of Pedrussio and Yanai does not expressly disclose that the stepped cone includes ten to fifteen cylindrical sections having different diameters which become smaller toward a tip of the stepped cone
Gallotto teaches a stepped cone (Gallotto: Fig. 2, second connector 270 consists of stepped, hallow truncated cones; para. 0112) that includes ten to fifteen cylindrical sections (Gallotto: one or more stepped tubular portions; para. 0112) having different diameters which become smaller toward a tip of the stepped cone (Gallotto: Fig. 2, second connector 270 consists of hallow cylinders whose perimeters decrease with each additional step; para. 0112).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the stepped cone of Imbert in view of Pedrussio and Yanai such that the stepped cone has ten to fifteen cylindrical sections having different diameters which become smaller toward the tip of the stepped cone as taught by Gallotto in order to match any suitable standardized connector or facilitate connection to a tube (Gallotto: para. 0112).
Regarding claim 11, Imbert in view of Pedrussio, Yanai, and Gallotto discloses the applicator syringe above.
Imbert does not expressly disclose the applicator syringe is packaged in a sterilized manner.
Pedrussio teaches an applicator syringe (Pedrussio: pre-filled polymer syringe; para. 0008) packaged in a sterilized manner (the syringe is supplied in a blister pack that is sterile; para. 0009 and 0032).
It would have been obvious to one of ordinary skill in the art before the effective filing date to package the applicator syringe of Imbert in a sterilized manner as taught by Pedrussio in order to allow for storage of the syringe for at least 18 months with no adverse effect on product quality (Pedrussio: para. 0008).
Regarding claim 19, Imbert in view of Pedrussio, Yanai, and Gallotto discloses the applicator syringe above.
Imbert in view of Pedrussio and Yanai does not expressly disclose that the stepped cone that has at least three cylindrical sections having different diameters which become smaller toward a tip of the stepped cone.
Gallotto teaches a stepped cone (Gallotto: Fig. 2, second connector 270 consists of stepped, hallow truncated cones; para. 0112) that has at least three cylindrical sections (Gallotto: one or more stepped tubular portions; para. 0112) having different diameters which become smaller toward the tip of the stepped cone (Gallotto: Fig. 2, second connector 270 consists of hallow cylinders whose perimeters decrease with each additional step; para. 0112).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the stepped cone of Imbert in view of Pedrussio and Yanai such that the stepped cone has at least three cylindrical sections having different diameters which become smaller toward the tip of the stepped cone as taught by Gallotto in order to match any suitable standardized connector or facilitate connection to a tube (Gallotto: para. 0112).
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Regarding claim 21, Imbert in view of Pedrussio, Yanai, and Gallotto discloses the applicator syringe above, wherein each section (Fig. 10, tip 322 and rib 323) includes an outer peripheral edge (Fig. 10 above, tip outer peripheral edge C and rib outer peripheral edge A) and an upper peripheral edge (Fig. 10 above, tip upper peripheral edge D and rib upper peripheral edge B).
Regarding claim 22, Imbert in view of Pedrussio, Yanai, and Gallotto discloses the applicator syringe above, wherein the upper peripheral edge (Fig. 10 above, rib upper peripheral edge B) of a first cylindrical section (Fig. 10, rib 323) of the at least two cylindrical sections (Fig. 10, tip 322 and rib 323) is integrally engaged with the outer peripheral edge (Fig. 10 above, edge B is shown to be integral with tip outer peripheral edge C) of a second cylindrical section (Fig. 10, tip 322) of the at least two cylindrical sections (Fig. 10, tip 322 and rib 323).
Claims 2, 3, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Imbert in view of Pedrussio, Yanai, and Gallotto, in further view of Campbell et al. (US Patent Application No. 20070088414 A1), hereinafter Campbell.
Regarding claim 2, Imbert in view of Pedrussio, Yanai, and Gallotto discloses the applicator syringe above.
Imbert in view of Pedrussio, Yanai, and Gallotto does not expressly disclose a parasympatholytic agent contained in the sterile solution as the medical active substance.
Campbell teaches an applicator syringe (Campbell: pre-filled syringe, para. 0174), wherein a parasympatholytic agent (therapeutic agent may include parasympatholytics; para. 0132) contained in a sterile solution (therapeutic agent may contain a sterile diluent; para. 0151) as a medical active substance (therapeutic agent is medically active, intended to treat accumulation of toxic substances in critical organs; para. 0002).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the medical active substance of Imbert in view of Pedrussio, Yanai, and Gallotto to be the parasympatholytic agent as taught by Campbell for therapy of a specific disease or disorder (Campbell: para. 0050).
Regarding claim 3, Imbert in view of Pedrussio, Yanai, and Campbell discloses the applicator syringe above.
Imbert in view of Pedrussio, Yanai, and Gallotto does not expressly disclose the parasympatholytic agent is contained in the sterile solution at a proportion of 0.01 to 1.0 wt. %.
Campbell teaches a parasympatholytic agent (Campbell: therapeutic agent may include parasympatholytics; para. 0132) that is contained in a sterile solution (therapeutic agent may contain a sterile diluent; para. 0151) at a proportion of 0.01 to 1.0 wt. % (0.07 to 7.0 wt. %; para. 0022).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have the parasympatholytic agent of Fiedler in view of Campbell to be at a proportion of 0.01 to 1.0 wt. % as taught by Campbell in order to achieve a specific treatment threshold (Campbell: para. 0022). Furthermore, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 18, Imbert in view of Pedrussio, Yanai, and Campbell discloses the applicator syringe above.
Imbert in view of Pedrussio, Yanai, and Gallotto does not expressly disclose a parasympatholytic agent is contained in the sterile solution at a proportion of 0.05 to 0.5 wt. %.
Campbell teaches a parasympatholytic agent is contained in the sterile solution at a proportion of 0.05 to 0.5 wt. % (Campbell: 0.07 to 7.0 wt. %; para. 0022).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have the parasympatholytic agent of Imbert in view of Pedrussio, Yanai, and Gallotto to be at a proportion of 0.05 to 0.5 wt. % as taught by Campbell in order to achieve a specific treatment threshold (Campbell: para. 0022), and, furthermore, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Imbert in view of Pedrussio, Yanai, and Gallotto, in further view of Prestrelski et al. (US Patent Application No. 20060211982 A1), hereinafter Prestrelski.
Regarding claim 4, Imbert in view of Pedrussio, Yanai, and Gallotto discloses the applicator syringe and sterile solution above.
Imbert in view of Pedrussio, Yanai, and Gallotto does not expressly disclose that the sterile solution containing the medical active substance is an NaCl solution containing oxybutynin hydrochloride.
Prestrelski teaches an applicator syringe (Prestrelski: pre-filled syringe; para. 0108-0109) containing a sterile solution (solution is sterile; para. 0005 and 0063) containing a medical active substance (therapeutic agent; para. 0061-0065) that is an NaCl solution (isotonic saline which is a NaCl solution; para. 0063) containing oxybutynin hydrochloride (can contain oxybutynin hydrochloride, examiner interprets solution containing oxybutynin hydrochloride para. 0086).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sterile solution of Fiedler to be a NaCl solution containing oxybutynin hydrochloride as taught by Prestrelski in order to dilute the formulation prior to injection and deliver a therapeutic agent (Prestrelski: para. 0063 and 0087).
Regarding claim 5, Imbert in view of Pedrussio, Yanai, and Gallotto and Prestrelski discloses the applicator syringe above.
Imbert in view of Pedrussio, Yanai, and Gallotto does not expressly disclose the sterile solution containing the medical active substance is an isotonic NaCI solution containing oxybutynin hydrochloride.
Prestrelski teaches a sterile solution (Prestrelski: solution is sterile; para. 0005 and 0063) containing a medical active substance (therapeutic agent; para. 0061-0065) is an isotonic NaCl solution (isotonic saline which is a NaCl solution; para. 0063) containing oxybutynin hydrochloride (can contain oxybutynin hydrochloride, examiner interprets solution containing oxybutynin hydrochloride; para. 0086).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sterile solution of Imbert in view of Pedrussio, Yanai, and Gallotto to be an isotonic NaCl solution containing oxybutynin hydrochloride as taught by Prestrelski in order to dilute the formulation prior to injection and deliver a therapeutic agent (Prestrelski: para. 0063 and 0087).
Claims 8, 10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Imbert in view of Pedrussio, Yanai, and Gallotto, in further view of Maeda et al. (US Patent Publication No. 20170296757 A1), hereinafter Maeda.
Regarding claim 8, Imbert in view of Pedrussio, Yanai, and Gallotto discloses the applicatory syringe above, comprising a plunger tip (Imbert: Fig. 1, tip of stopper 28).
Imbert in view of Pedrussio does not expressly disclose a plunger tip is made of a rubber that is able to be autoclaved.
Yanai teaches an applicator syringe (Yanai: Fig. 1, glass cartridge 1), wherein a plunger tip (Fig. 1, tip of stopper 2) is made of a rubber (stopper is made from butyl rubber; col 8, ln 37-45) that is able to be autoclaved (sterilization is performed in an autoclave; col 2, ln 9-23 and col 8, ln 37-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plunger tip of Imbert in view of Pedrussio and Gallotto such that it was made of a rubber that is able to be autoclaved as taught by Yanai in order to prevent allow for heat resistance and prevent deformation during sterilization (Yanai: col 8, ln 37-45).
Imbert in view of Pedrussio, Yanai, and Gallotto does not expressly disclose that the plunger tip is made of a bromobutyl rubber.
Maeda teaches a plunger tip that is made of bromobutyl rubber (Maeda: the nozzle cap can be referred to as a plunger tip, comprised of brominated isobutylene-isoprene rubber BIIR, para. 0005 and 0042).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plunger tip of Imbert in view of Pedrussio, Yanai, and Gallotto such that it was made of a bromobutyl rubber in order to allow the plunger tip to have chemical and heat resistance (Maeda: para. 0041).
Regarding claim 10, Imbert in view of Pedrussio, Yanai, and Gallotto discloses the applicator syringe above, wherein the outlet opening (Imbert: Fig. 1, passageway 24) is closed using a closure element (Fig. 1, tip cap assembly 54).
Imbert in view of Pedrussio, Yanai, and Gallotto do not expressly disclose the closure element is made of isobutene-isoprene rubber.
Maeda teaches an applicator syringe (Fig. 1a-1b, syringe 5), wherein a closure element (Fig. 1a-1b, nozzle cap 1 can be referred to as a syringe seal plug; para. 0005) is made of isobutene-isoprene rubber (nozzle cap 1 is made from isobutene-isoprene rubber; para. 0011 and 0042).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the closure element of Imbert in view of Pedrussio, Yanai, and Gallotto such that the closure element is made of isobutene-isoprene rubber as taught by Maeda in order to allow the closure element to have chemical and heat resistance (Maeda: para. 0041).
Regarding claim 16, Imbert in view of Pedrussio, Yanai, and Gallotto discloses the applicator syringe above.
Imbert does not expressly disclose the plunger is made of an isobutene-isoprene rubber.
Yanai teaches an applicator syringe (Yanai: Fig. 1, glass cartridge 1), wherein the plunger (Fig. 1, comprising plunger 7 and stopper 2) is formed from an isobutene-isoprene rubber (col 8, ln 37-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plunger of Imbert in view of Pedrussio such that it is made of isobutene-isoprene rubber in order to prevent deformation by heat during steam sterilization (Yanai: col 8, ln 37-45).
Examiner interprets the plunger (Yanai: Fig. 1, comprising plunger 7 and stopper 2) to be equivalent to the claimed plunger since it performs the same function of the plunger of Imbert as cited above. However, Yanai fails to teach that the plunger is made of halogenated isobutene-isoprene rubber.
Maeda teaches an applicator syringe (Fig. 1a-1b, syringe 5), wherein a closure element (Fig. 1a-1b, nozzle cap 1 can be referred to as a syringe seal plug; para. 0005) is made of a halogenated isobutene-isoprene rubber (nozzle cap 1 is made from chlorinated isobutene-isoprene rubber; para. 0011 and 0042).
It would have been obvious modify the plunger so that it is halogenated isobutene-isoprene rubber since one of ordinary skill in the art before the effective filing date would modify various parts of the syringe with halogenated rubber in order to allow for the parts to have chemical and heat resistance (Maeda: para. 0041).
Claims 9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Imbert in view of Pedrussio, Yanai, and Campbell, in further view of Prestrelski.
Regarding claim 9, Imbert in view of Pedrussio, Yanai, and Campbell discloses the applicator syringe above.
Imbert in view of Pedrussio, Yanai, and Campbell does not expressly disclose that the sterile solution contains oxybutynin hydrochloride as the parasympatholytic agent, and the sterile solution is of a volume of 1 to 50 mL in the cavity.
Prestrelski teaches a sterile solution (Prestrelski: solution is sterile; para. 0005 and 0063) contains oxybutynin hydrochloride (can contain oxybutynin hydrochloride, examiner interprets solution containing oxybutynin hydrochloride; para. 0086) as a parasympatholytic agent (para. 0086), and the sterile solution (solution is sterile; para. 0005 and 0063) is of a volume of 1-50 mL (0.1-1.0 mL injection volume; para. 0060).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sterile solution contained within the cavity of Imbert in view of Pedrussio, Yanai, and Campbell to contain oxybutynin hydrochloride as a parasympatholytic agent at a volume of 1-50 mL in the cavity as taught by Prestrelski in order to access and inject into subcutaneous or intramuscular regions. Furthermore, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 17, Imbert in view of Pedrussio, Yanai, and Campbell discloses the applicator syringe and parasympatholytic agent above.
Imbert in view of Pedrussio, Yanai, and Campbell does not expressly disclose that the parasympatholytic agent is oxybutynin hydrochloride.
Prestrelski teaches an applicator syringe (Prestrelski: pre-filled syringe; para. 0108-0109), wherein a parasympatholytic agent (para. 0086) is oxybutynin hydrochloride (Prestrelski: para. 0086).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the parasympatholytic agent of Imbert in view of Pedrussio, Yanai, and Campbell to be oxybutynin hydrochloride as taught by Prestrelski in order to deliver a therapeutic agent (Prestrelski: para. 0063 and 0087).
Claims 12, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Imbert in view of Pedrussio, Yanai, Gallotto, and Maeda, in further view of Prestrelski et al. (US Patent Application No. 20060211982 A1), hereinafter Prestrelski.
Regarding claim 12, Imbert teaches a method of providing the applicator syringe (Imbert: Fig. 1, hypodermic syringe 10) above, wherein the method has the following steps: providing the sterile applicator syringe (Fig. 1, hypodermic syringe 10 is kept sterile; col 4, ln 12-18) which includes the cylindrical jacket (Fig. 1, cylindrical wall 18) that is closed on the one side by the syringe cover (Fig. 1 and 10, distal end 316 closes off wall 18 distally), which is integrally formed with the jacket (Fig. 1 and 10, distal end 316 is integral with cylindrical wall 18) and includes the outlet opening (Fig. 1, passageway 24), wherein the outlet opening (Fig. 1, passageway 24) is formed in a stepped cone (Fig. 10, comprised of tip 322 and rib 323, which are stepped with one another), which is integrally formed with the jacket (Fig. 1 and 10, tip 323 is integral with distal end 316, which is integral with the wall 18) and the syringe cover (Fig. 1 and 10, distal end 22 and 316) and the stepped cone (Fig. 10, comprised of tip 322 and rib 323, which are stepped with one another) has at least two sections (Fig. 10, tip 322 and rib 323) integrally engaged with one another (Fig. 10, tip 322 and rib 323 are integral with each other) and each having different diameters (Fig. 10, rib 323 has a larger diameter than tip 322) which become smaller toward a tip of the stepped cone (Fig. 10, tip 322 is distal of rib 323 and is smaller than rib 323); filling the cavity (Fig. 1, fluid-receiving chamber 20) of the applicator syringe (Fig. 1, hypodermic syringe 10) delimited by the cylindrical jacket (Fig. 1, cylindrical wall 18) having the syringe cover (Fig. 1 and 10, distal end 22 and 316) and the plunger (Fig. 1, comprising plunger 26 and stopper 28) using the solution (syringe is pre-filled with medication within chamber 20; col 4, ln 12-18); closing the outlet opening (Fig. 1, passageway 24) of the applicator syringe (Fig. 1, hypodermic syringe 10) using a closure element (Fig. 1, tip cap assembly 54).
It would have been an obvious matter of design choice to make the sections of the stepped cone of whatever form or shape was desired or expedient, including a cylindrical shape. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Imbert does not expressly disclose that the applicator syringe is formed from the cycloolefin copolymer (COC).
Pedrussio teaches an applicator syringe (Pedrussio: para. 0008) that is formed from a cycloolefin copolymer (Pedrussio: para. 0008).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Imbert such that it comprised the cycloolefin polymer as taught by Pedrussio in order to allow for storage of solutions within the syringe and to allow the syringe to be resistant to mechanical damage (Pedrussio: para. 0008).
Imbert in view of Pedrussio does not expressly disclose that the plunger is made of isobutene-isoprene rubber.
Yanai teaches an applicator syringe (Yanai: Fig. 1, glass cartridge 1), wherein the plunger (Fig. 1, comprising plunger 7 and stopper 2) is made of isobutene-isoprene rubber (col 8, ln 37-45); steam pressure sterilizing (sterilization is performed in an autoclave; col 2, ln 9-23 and col 8, ln 37-45) the applicator syringe (Fig. 1, glass cartridge 1) filled with the solution (pharmaceutical liquid is prefilled into the glass cartridge before sterilization; col 2, ln 59 – col 3, ln 7) and closed using the closure element (Fig. 1, flanged cap 6) in an autoclave (sterilization is performed in an autoclave; col 2, ln 9-23 and col 8, ln 37-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the invention of Imbert in view of Pedrussio such that the plunger is made of isobutene-isoprene rubber; steam pressure sterilizing the applicator syringe filled with a solution and closed using a closure element in an autoclave as taught by Yanai in order to prevent deformation by heat during steam sterilization (col 8, ln 37-45) and to sterilize the entire invention (col 8, ln 37-45).
Imbert in view of Yanai and Pedrussio does not expressly disclose the closure element made of isobutene-isoprene rubber.
Maeda teaches an applicator syringe (Fig. 1a-1b, syringe 5), wherein a closure element (Fig. 1a-1b, nozzle cap 1) is made of isobutene-isoprene rubber (nozzle cap 1 is made from isobutene-isoprene rubber; para. 0011 and 0042).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the closure element of Imbert in view of Pedrussio, Yanai, and Gallotto such that the closure element is made of isobutene-isoprene rubber as taught by Maeda in order to allow the closure element to have chemical and heat resistance (Maeda: para. 0041).
Imbert in view of Yanai, Pedrussio, and Maeda does not expressly disclose the stepped cone enables the applicator syringe to be coupled to at least two catheters with differently configured connection cones.
Gallotto teaches a stepped cone (Gallotto: Fig. 2, second connector 270) that enables the device (Fig. 2, device 200) to be coupled to at least two catheters with differently configured connection cones (connector 270 is configured to connect to any standardized connector of a tube; para. 0112).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the stepped cone of Imbert in view of Pedrussio, Yanai, and Maeda such that the stepped cone enables the applicator syringe to be coupled to at least two catheters with differently configured connection cones as taught by Gallotto in order to facilitate connection to any connector of a tube (Gallotto: para. 0112).
Imbert in view of Pedrussio, Yanai, Gallotto, and Maeda does not expressly disclose providing a solution containing oxybutynin hydrochloride as a medication to form the sterile solution containing the medical active substance.
Prestrelski teaches providing a solution (Prestrelski: para. 0063) containing oxybutynin hydrochloride (can contain oxybutynin hydrochloride, examiner interprets solution containing oxybutynin hydrochloride; para. 0086) as a medication (therapeutic agent; para. 0061-0065) to form the sterile solution (solution is sterile; para. 0063) containing the medical active substance (therapeutic agent; para. 0061-0065).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Imbert in view of Pedrussio, Yanai, Gallotto, and Maeda to include providing a solution containing oxybutynin hydrochloride as a medication to form the sterile solution containing the medical active substance as taught by Prestrelski in order to provide a desired therapeutic agent (Prestrelski: para. 0038).
Regarding claim 14, Imbert in view of Pedrussio, Yanai, Gallotto, Maeda, and Prestrelski discloses the method above.
Imbert in view of Pedrussio, Gallotto, Maeda, and Prestrelski does not expressly disclose the steam pressure sterilizing is carried out in the autoclave for at least 10 minutes.
Yanai teaches an applicator syringe, wherein steam pressure sterilizing is carried out in the autoclave for at least 10 minutes (steam sterilization at 121 degrees Celsius for 20 minutes; col 8, ln 37-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Imbert in view of Pedrussio, Gallotto, Maeda, and Prestrelski such that the steam pressure sterilizing is carried out in the autoclave for at least 10 minutes as taught by Yanai in order to sterilize the invention.
Regarding claim 15, Imbert in view of Pedrussio, Yanai, Gallotto, Maeda, and Prestrelski discloses the method above, wherein the applicator syringe is closed using a closure element (Imbert: Fig. 1, tip cap assembly 54).
Imbert in view of Yanai, Gallotto, Maeda, and Prestrelski does not expressly disclose a step of packaging the applicator syringe.
Pedrussio teaches a step of packaging the applicator syringe (Pedrussio: polymer syringe is packaged; para. 0009).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Imbert in view of Yanai, Gallotto, Maeda, and Prestrelski to include a step of packaging the applicator syringe as taught by Pedrussio in order to allow for storage of the syringe for at least 18 months with no adverse effect on product quality (Pedrussio: para. 0008).
Imbert in view of Pedrussio, Yanai, Gallotto, and Maeda does not expressly disclose the applicator syringe is filled with the solution containing oxybutynin hydrochloride.
Prestrelski teaches an applicator syringe (Prestrelski: pre-filled syringe; para. 0108-0109) that is filled with the solution containing oxybutynin hydrochloride (Prestrelski: para. 0086).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the solution of Imbert in view of Pedrussio, Yanai, Gallotto, and Maeda such that it contains oxybutynin hydrochloride as taught by Prestrelski in order to deliver a therapeutic agent (Prestrelski: para. 0063 and 0087).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Imbert in view of Pedrussio, Yanai, Gallotto, Campbell, and Prestrelski, in further view of Goyani et al. (US Patent No. 10,532,049 B1), hereinafter Goyani.
Regarding claim 20, Imbert in view of Pedrussio, Yanai, Gallotto, and Prestrelski discloses the applicator syringe and sterile solution above.
Imbert in view of Pedrussio, Yanai, Gallotto, and Prestrelski does not expressly disclose that the sterile solution is of a volume of 5-25 mL in the cavity.
Goyani teaches an applicator syringe (Goyani: col 7, ln 11-45), wherein a solution (aqueous solution; col 7, ln 5-10) is of a volume of 5-25 mL (dose ranges from 0.5-10mL; col 7, ln 5-10) in a cavity (reservoir; col 7, ln 11-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sterile solution contained within the cavity of Imbert in view of Pedrussio, Yanai, Gallotto, and Prestrelski to be at a volume of 5-25 mL in the cavity as taught by Goyani in order to treat a desired illness (Goyani: col 7, ln 1-10). Furthermore, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Response to Arguments
Applicant’s arguments, see page 13, filed 18 December 2025, with respect to the rejection of claim 19 under 35 USC 112(b) have been fully considered and are persuasive. The rejection of claim 19 has been withdrawn.
Applicant’s arguments, see page 13-23, filed 18 December 2025, with respect to the rejections of claims 1-5, 7-12, and 14-20 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Imbert in view of Pedrussio, Yanai, and Gallotto cited above.
Applicant also argues that Imbert explicitly teaches the use of glass barrels instead of plastic barrels, and, therefore, there would be no motivation to modify Imbert in view of Pedrussio.
Imbert explicitly describes that the syringe barrel can be made of plastic or glass (Imbert: col 2, ln 55-64 and col 3, ln 36-49). Therefore, there would be motivation to modify Imbert in view of Pedrussio in order to allow for storage of solutions within the syringe and to allow the syringe to be resistant to mechanical damage (Pedrussio: para. 0008).
Applicant also argues that modifying Imbert in view of Gallotto’s stepped cone would render the device of Imbert inoperable, as the stepped cone of Gallotto is be able to fit onto a luer-lock and, therefore, there is no motivation to combine.
Applicant fails to provide any reason that the stepped cone of Gallotto would not be capable of fitting into a luer connector. It is explicitly stated in Gallotto that the stepped cone may fit into the female fitting of an enteral tube via friction fit, twist fit, snap fit, clasp, and/or press fit (para. 0112), which would allow for a variety of different connectors, including a luer connector, to be connected. There is no explicit statement that a luer connector would not be able to fit onto the stepped cone of Gallotto and, therefore, modification of Imbert in view of Gallotto would not render Imbert inoperable.
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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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783