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 .
Reissue Applications
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 10,806,628 (hereinafter the ‘628 patent) is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 25, 2025, has been entered.
Claim Rejections – 35 USC § 103
Claims 1-3, 5-6, 9-10, 12-16, and 18-28 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nardi (US Patent Pub. 2010/0147899, hereinafter Nardi) in view of Buxmann (US Patent No. 7,249,693, hereinafter Buxmann).
Regarding claim 1, Nardi discloses an apparatus for dispensing a sterile, non-preserved therapeutic liquid (Fig. 1; see ¶¶ 1 and 34) comprising:
a container (1) configured to hold the sterile, non-preserved therapeutic liquid and having
a dispensing tip (dropper nozzle 5 with sleeve 9; ¶¶ 28, 49-50) configured to dispense a dose of the therapeutic liquid (¶ 28);
a first cap (screw cap 17, Figs. 1 and 3; ¶ 56) configured to fit over at least a portion of the container (1) including the dispensing tip (5, 9);
a second cap (external overcap 20, Figs. 1, 3, and 9A-C) configured to fit over at least a portion of the first cap (17, Figs. 1 and 3); and
a tamper-evident seal (tear-off removable collar 22, Figs. 1 and 3, “having function of guarantee seal (tamper-evident),” ¶ 58) coupled to the second cap (20) and the container (see Fig. 1). As shown in Fig. 1, a cavity is defined between the first cap (17) and the dispensing tip (adjacent to terminal portion 6 of dropper nozzle 5).
Nardi does not teach one or more vents in the first cap that allow air to pass into and out of the cavity between the first cap and the dispensing tip. However, Buxmann teaches a container (9, Fig. 1) configured to hold and dispense a sterile, non-preserved therapeutic liquid (col. 3:5-10) with a vented cap (cap 3) configured to fit over at least a portion of the container including a dispensing tip (tip 16; col. 7:49-56) and having one or more vents (hole 3b) that allow air to pass into and out of a cavity defined between the vented cap (3) and the dispensing tip (16). See col. 7:53-56: “The hole 3b functions as an aeration means. By passing air through this hole 3b, the excess fluid remaining after use is allowed to evaporate, thus giving still more protection against contamination.” Therefore, it would have been obvious to one of ordinary skill in the art before the invention was made to modify the invention of Nardi by adding a vent as taught by Buxmann in the first cap (such that the first cap is a vented cap) to allow air to pass into and out of the cavity defined between the vented cap and the dispensing tip, in order to increase protection against contamination by allowing evaporation of excess fluid that remains after use.
Regarding claim 2, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 1. Nardi further teaches the container is configured to dispense a plurality of single doses of the therapeutic liquid (“multidose dispenser … for dispensing pharmaceutical products drop by drop,” ¶ 34) in the form of an ophthalmic solution (“solutions or mixtures of one or more liquid components with one or more dissolved solids,” including “ophthalmic products, such as eye-drops and artificial tears,” ¶ 2).
Regarding claim 3, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 1. Buxmann further teaches that the vent (3b) is configured to allow passage of air into and out of the cavity sufficient to accelerate drying of residual therapeutic liquid at the dispensing tip (16) of the container after dispensing the therapeutic liquid dose (“By passing air through this hole 3b, the excess fluid remaining after use is allowed to evaporate,” col. 5:54-55).
Regarding claim 5, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 1. Nardi further teaches that the second cap (20) and the vented cap (cap 17 of Nardi with vent 3b of Buxmann, as discussed above) are an integral structure1 (¶ 58:1-3; see Fig. 3 showing the two caps 17, 20 united to form closure capsule 3), and the tamper evident seal (22, Figs. 1-3) is configured to break away from the second cap (20, ¶ 58).
Regarding claim 6, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 1. Nardi further teaches that the second cap (20), the vented cap (cap 17 of Nardi with vent 3b of Buxmann, as discussed above), and the tamper evident seal (22) are an integral structure2 (¶ 58:1-3; see Fig. 3 showing the two caps 17, 20 and seal 22 united to form closure capsule 3), and the tamper evident seal (22, Figs. 1-3) is configured to break away from the second cap (20, ¶ 58).
Regarding claim 9, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 1. Nardi further teaches the vented cap (cap 17 of Nardi with vent 3b of Buxmann, as discussed above) comprises a protrusion (cylindrical projection 21, Figs. 1 and 3; ¶¶ 56-57) arranged on the vented cap to establish contact with the dispensing tip of the container (i.e., with the sleeve 9 at intermediate portion 7 of dropper nozzle 5; see Fig. 1 and ¶ 56) when the vented cap is fitted on the container (Fig. 1).
Regarding claim 10, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 9. Nardi further teaches the protrusion (21) is configured to seal the dispensing tip (5, 9) of the container when the vented cap is fitted on the container (“the cooperation between the dropper nozzle (5) and the cylindrical projection (21) of the cap (17), right in the portion where the ports (8) for the passage of the product are present, guarantees against accidental leakage of the product,” ¶ 57).
Regarding claim 12, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 1. Nardi does not explicitly teach that one or both of the dispensing tip and the vented cap comprise an antimicrobial. However, Nardi teaches that the use of an antimicrobial at a dispensing tip was already known in the art, in the form of an antimicrobial or antibacterial filter (¶¶ 8, 12) or a solid silver-based substance with germicide action (¶ 9). Moreover, Buxmann further teaches at least the dispensing tip (16) comprises an antimicrobial (decontamination means 33 comprising “a material capable of interacting via an … oligodynamically active substance,” col. 4:51-60). Buxmann discloses that the oligodynamically active substance functions “to prevent microbiological contamination by reducing count of potential arising germs from the environment,” col. 3:10-13, which is understood to be antimicrobial as claimed. (See also col. 2:28-49, describing the “antimicrobial effect” of interaction between the decontamination means and contaminated liquid.) Therefore, it would have been obvious to one of ordinary skill in the art before the invention was made to further modify the apparatus of Nardi to include an antimicrobial as taught by Buxmann and generally known in the art as part of at least the dispensing tip, in order to improve sterility of the therapeutic liquid.
Regarding claim 13, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 1. Nardi further teaches that the vented cap (cap 17 of Nardi with vent 3b of Buxmann, as discussed above) and the dispensing tip (5, 9) are connected (when the container is closed, as shown in Fig. 1).
Regarding claim 14, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 1. The examiner notes that the claims are directed to “[a]n apparatus for dispensing a … therapeutic liquid” (claim 1 preamble). The recitation “for dispensing a … therapeutic liquid” in the preamble of claim 1 describes an intended use of the apparatus. Because the therapeutic liquid is not positively claimed as part of the apparatus, the composition of the therapeutic liquid recited in claim 14 does not further limit the claimed apparatus. The apparatus of Nardi is expressly capable of dispensing a therapeutic liquid in solution and would be inherently capable of dispensing a therapeutic liquid in solution that has bimatoprost as a therapeutic agent.
Regarding claims 15-16, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 14. Nardi further teaches a unidirectional flow valve (“unidirectional flow sleeve valve,” ¶ 20; sleeve 9, Fig. 1, ¶ 50) situated at the dispensing tip (5, 9) and configured to prevent fluid return to the container (“unidirectional flow,” ¶ 20; see also ¶ 17) (claim 15); wherein the unidirectional valve (9) is configured to prevent contamination of the therapeutic liquid from a source external to the container (the purpose of the sleeve valve being to prevent “zones where potentially polluted air may return or stay, after the supply,” ¶ 17) (claim 16).
Regarding claim 18, Nardi discloses a method comprising:
storing a sterile, non-preserved therapeutic liquid (¶¶ 1, 34) in a reservoir (1, Fig. 1) of a container configured to hold the sterile, non-preserved therapeutic liquid (¶ 49), the container comprising:
a dispensing tip (dropper nozzle 5 with sleeve 9; ¶¶ 28, 49-50) configured to dispense a dose of the therapeutic liquid (¶ 28);
a first cap (screw cap 17, Figs. 1 and 3; ¶ 56) configured to fit over at least a portion of the container (1) including the dispensing tip (5, 9);
a second cap (external overcap 20, Figs. 1, 3, and 9A-C) configured to fit over at least a portion of the first cap (17, Figs. 1 and 3); and
a tamper-evident seal (tear-off removable collar 22, Figs. 1 and 3, “having function of guarantee seal (tamper-evident),” ¶ 58) coupled to the second cap (20) and the container (see Fig. 1). As shown in Fig. 1, a cavity is defined between the first cap (17) and the dispensing tip (adjacent to terminal portion 6 of dropper nozzle 5).
Nardi does not teach one or more vents in the first cap that allow air to pass into and out of the cavity between the first cap and the dispensing tip. However, Buxmann teaches a container (9, Fig. 1) configured to hold and dispense a sterile, non-preserved therapeutic liquid (col. 3:5-10) with a vented cap (cap 3) configured to fit over at least a portion of the container including a dispensing tip (tip 16; col. 7:49-56) and having one or more vents (hole 3b) that allow air to pass into and out of a cavity defined between the vented cap (3) and the dispensing tip (16). See col. 7:53-56, cited above. Therefore, it would have been obvious to one of ordinary skill in the art before the invention was made to modify the invention of Nardi by adding a vent as taught by Buxmann in the first cap (such that the first cap is a vented cap) to allow air to pass into and out of the cavity defined between the vented cap and the dispensing tip, in order to increase protection against contamination by allowing evaporation of excess fluid that remains after use.
Regarding claim 19, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 18. Nardi further teaches the container is configured to dispense a plurality of single doses of the therapeutic liquid (“multidose dispenser … for dispensing pharmaceutical products drop by drop,” ¶ 34) in the form of an ophthalmic solution (“solutions or mixtures of one or more liquid components with one or more dissolved solids,” including “ophthalmic products, such as eye-drops and artificial tears,” ¶ 2).
Regarding claim 20, Nardi discloses a method comprising:
removing a cap (closing capsule 3, Fig. 1; ¶ 58) from a container configured to hold a sterile, non-preserved therapeutic liquid (¶ 49), the container comprising a dispensing tip (dropper nozzle 5 with sleeve 9; ¶¶ 28, 49-50) configured to dispense a dose of the non-preserved, sterile therapeutic liquid (¶ 28), the cap comprising:
a first cap (screw cap 17, Figs. 1 and 3; ¶ 56) configured to fit over at least a portion of the container (1) including the dispensing tip (5, 9); and
a second cap (external overcap 20, Figs. 1, 3, and 9A-C) configured to fit over at least a portion of the first cap (17, Figs. 1 and 3); and
dispensing the therapeutic liquid from the container (¶ 59).
Nardi does not teach one or more vents in the first cap that allow air to pass into and out of the cavity between the first cap and the dispensing tip. However, Buxmann teaches a container (9, Fig. 1) configured to hold and dispense a sterile, non-preserved therapeutic liquid (col. 3:5-10) with a vented cap (cap 3) configured to fit over at least a portion of the container including a dispensing tip (tip 16; col. 7:49-56) and having one or more vents (hole 3b) that allow air to pass into and out of a cavity defined between the vented cap (3) and the dispensing tip (16). See col. 7:53-56, cited above. Therefore, it would have been obvious to one of ordinary skill in the art before the invention was made to modify the invention of Nardi by adding a vent as taught by Buxmann in the first cap (such that the first cap is a vented cap) to allow air to pass into and out of the cavity defined between the vented cap and the dispensing tip, in order to increase protection against contamination by allowing evaporation of excess fluid that remains after use.
Regarding claims 21-27, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 1. The examiner notes that the claims are directed to “[a]n apparatus for dispensing a … therapeutic liquid” (claim 1 preamble). The recitation “for dispensing a … therapeutic liquid” in the preamble of claim 1 describes an intended use of the apparatus. Because the therapeutic liquid is not positively claimed as part of the apparatus, the form and therapeutic agent of the therapeutic liquid recited in claims 21-27 does not further limit the claimed apparatus. The apparatus of Nardi is expressly capable of dispensing a therapeutic liquid in solution and would be inherently capable of dispensing a therapeutic liquid in solution with a therapeutic agent which is brimonidine (claim 21), timolol (claim 22), gatifloxacin (claim 23), ocufloxacin (claim 24), prednisolone (claim 25), carnitine (claim 26), or ketorolac (claim 27). Therefore, the apparatus covered by claims 21-27 is not patentably distinct from the apparatus of Nardi as modified in view of Buxmann as discussed above.
Regarding claim 28, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 1. Buxmann further teaches that the vent (3b) is configured to allow passage of air into and out of the cavity sufficient to accelerate drying of residual therapeutic liquid at the dispensing tip (16) of the container after dispensing the therapeutic liquid dose (“By passing air through this hole 3b, the excess fluid remaining after use is allowed to evaporate,” col. 5:54-55). Nardi further teaches a unidirectional flow valve (“unidirectional flow sleeve valve,” ¶ 20; sleeve 9, Fig. 1, ¶ 50) situated at the dispensing tip (5, 9) and configured to prevent fluid return to the container (“unidirectional flow,” ¶ 20; see also ¶ 17).
Claim 4 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nardi in view of Buxmann, in further view of Davis et al. (US Patent No. 4,541,536, hereinafter Davis).
Regarding claim 4, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 1. Nardi further teaches that the second cap (20, Fig. 1) is configured to be removed from the apparatus and the tamper-evident seal (22) is configured to break in response to the removal of the second cap (¶ 58). Nardi is silent with respect to the manual operation by which the second cap is removed and does not explicitly disclose that the removal of the second cap and breaking of the tamper-evident seal is configured to be accomplished by twisting. However, Davis teaches a similar cap (closure 1, Fig. 1) with a tamper-evident seal (safety band 5 with frangible tongues 6; col. 1:66-2:1), wherein the cap (1) is configured to be twisted and removed from the container, and the tamper-evident seal (5) is configured to break in response to the twisting of the cap (“When the closure is turned to unscr[e]w it … the upper part of the closure rises and the tongues 6 break giving evidence that the container has been opened,” col. 2:46-50). Therefore, it would have been obvious to one of ordinary skill in the art before the invention was made to further modify the invention of Nardi by configuring the second cap to be removed by twisting and the seal to be broken in response to the twisting of the second cap, as taught by Davis, in order to facilitate the removal of the second cap and breaking of the tamper-evident seal.
Claims 7-8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nardi in view of Buxmann, in further view of Sams (EP 0239358 B1, hereinafter Sams).
Regarding claim 7, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 6. Nardi and Buxmann do not teach that the second cap defines a vented cap such that twisting the second vented cap relative to the container causes vents of the vented cap and the second vented cap to overlap. However, in the art of fluid dispensing containers, Sams teaches a second vented cap (closure cap 164, Figs. 13-16; col. 11:58-12:5) configured such that twisting the second vented cap (164) relative to the container causes vents of a first vented cap (sleeve spout 174 with vent hole 178; col. 12:17-19) and the second vented cap (164) to overlap (see Fig. 16; “In use, the openings are brought into and out of register by rotating the cap [164],” col. 12:29-31). It would have been obvious to one of ordinary skill in the art before the invention was made to further modify the invention of Nardi by configuring the second cap as a second vented cap such that twisting the second vented cap relative to the container causes vents of the vented cap and the second vented cap to overlap, as taught by Sams, in order to facilitate venting when the container is closed by the vented cap and the second cap.
Regarding claim 8, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 7. Nardi further teaches the container contains more than one dose of the therapeutic liquid (“multidose,” ¶ 1).
Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nardi in view of Buxmann, in further view of Nilson (US Patent No. 6,000,580, hereinafter Nilson).
Regarding claim 11, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 1. Nardi and Buxmann do not teach a desiccant system. However, Nilson teaches a cap (4, Fig. 2) for a container of sterile, preservative-free eye drops (col. 1:50-54, 4:20-26) comprising a desiccant system (col. 4:15-20). Nilson teaches that the desiccant system aids in preventing bacterial growth by keeping the dispensing area of the container dry (col. 1:58-67). Therefore, it would have been obvious to one of ordinary skill in the art before the invention was made to further modify the invention of Nardi by including a desiccant system as taught by Nilson in the second cap, in order to prevent bacterial growth.
Claim 17 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nardi in view of Buxmann, in further view of Khopade et al. (US Patent Pub. 2010/0137432, hereinafter Khopade).
Regarding claim 17, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 1. Nardi further teaches that the dispensing tip is formed of one or more polymers (“plastic,” ¶ 49) but is otherwise silent with respect to the material of the container and tip. However, Khopade teaches that low-density polyethylene was known prior to Applicant’s invention to be a suitable polymer for forming a container and dispensing tip for ophthalmic solutions (“clear low density polyethylene bottle with a clear low-density polyethylene dropper tip,” ¶ 2; see also ¶ 73). Therefore, it would have been obvious to one of ordinary skill in the art before the invention was made to further modify the invention of Nardi by selecting low-density polyethylene as taught by Khopade for the container and dispensing tip, since this involves nothing more than the selection of a plastic material known to be suitable for the same purpose.
Claims 14-16, 21-22, 25, and 27 are rejected, in the alternative, under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nardi in view of Buxmann, in further view of Pardes et al. (US Patent Pub. 2009/0218373, hereinafter Pardes).
Regarding claims 14, 21-22, 25, and 27, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 1. As discussed above, it is the examiner’s position that the claimed apparatus is not limited by the composition of the therapeutic liquid because the therapeutic liquid is not positively claimed as part of the apparatus. If there is any doubt regarding the examiner’s interpretation of these claims, Nardi further teaches that the apparatus is preferably used for dispensing liquid ophthalmic solutions (¶¶ 2, 5-7). Although Nardi is silent with respect to the therapeutic agent, Pardes teaches that it was known prior to Applicant’s invention to use such an apparatus for dispensing liquid ophthalmic compositions in a solution having a therapeutic agent which is bimatoprost (“glaucoma products comprising … bimatoprost,” ¶ 65) (claim 14), brimonidine (“brimonidine tartrate,” ¶ 65) (claim 21), timolol (“timolol,” ¶ 65) (claim 22), prednisolone (see Pardes claim 24, “prednisolone acetate”) (claim 25), or ketorolac (“NSAID products comprising ketorolac,” ¶ 65) (claim 27). Therefore, it would have been obvious to one of ordinary skill in the art before the invention was made to further modify the invention of Nardi by selecting, as the therapeutic liquid to be dispensed, a solution having a therapeutic agent which is bimatoprost (claim 14), brimonidine (claim 21), timolol (claim 22), prednisolone (claim 25), or ketorolac (claim 27), as taught by Pardes, in order to treat eye problems such as glaucoma, allergies, or inflammation.
Regarding claims 15-16, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 14. Nardi further teaches a unidirectional flow valve (“unidirectional flow sleeve valve,” ¶ 20; sleeve 9, Fig. 1, ¶ 50) situated at the dispensing tip (5, 9) and configured to prevent fluid return to the container (“unidirectional flow,” ¶ 20; see also ¶ 17) (claim 15); wherein the unidirectional valve (9) is configured to prevent contamination of the therapeutic liquid from a source external to the container (the purpose of the sleeve valve being to prevent “zones where potentially polluted air may return or stay, after the supply,” ¶ 17) (claim 16).
Claims 14-16, 21, and 23 are rejected, in the alternative, under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nardi in view of Buxmann, in further view of Wochele (US Patent No. 9,833,356, hereinafter Wochele).
Regarding claims 14, 21, and 23, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 1. As discussed above, it is the examiner’s position that the claimed apparatus is not limited by the composition of the therapeutic liquid because the therapeutic liquid is not positively claimed as part of the apparatus. If there is any doubt regarding the examiner’s interpretation of these claims, Nardi further teaches that the apparatus is preferably used for dispensing liquid ophthalmic solutions (¶¶ 2, 5-7). Although Nardi is silent with respect to the therapeutic agent, Wochele teaches that it was known prior to Applicant’s invention to use such an apparatus for dispensing liquid ophthalmic compositions in a solution having a therapeutic agent which is bimatoprost (see col. 3:8-17) (claim 14), brimonidine (col. 3:15-16) (claim 21), or gatifloxacin (col. 3:17) (claim 23), for treatment of eye diseases. Therefore, it would have been obvious to one of ordinary skill in the art before the invention was made to further modify the invention of Nardi by selecting as the therapeutic liquid to be dispensed a solution having a therapeutic agent which is bimatoprost (claim 14), brimonidine (claim 21), or gatifloxacin (claim 23), as taught by Wochele, in order to treat eye diseases.
Regarding claims 15-16, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 14. Nardi further teaches a unidirectional flow valve (“unidirectional flow sleeve valve,” ¶ 20; sleeve 9, Fig. 1, ¶ 50) situated at the dispensing tip (5, 9) and configured to prevent fluid return to the container (“unidirectional flow,” ¶ 20; see also ¶ 17) (claim 15); wherein the unidirectional valve (9) is configured to prevent contamination of the therapeutic liquid from a source external to the container (the purpose of the sleeve valve being to prevent “zones where potentially polluted air may return or stay, after the supply,” ¶ 17) (claim 16).
Claim 24 is rejected, in the alternative, under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nardi in view of Buxmann, in further view of Hill et al, “Bacterial Susceptibility Profiles in Endophthalmitis after Intravitreal Injection” (hereinafter Hill).
Regarding claim 24, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 1. As discussed above, it is the examiner’s position that the claimed apparatus is not limited by the composition of the therapeutic liquid because the therapeutic liquid is not positively claimed as part of the apparatus. If there is any doubt regarding the examiner’s interpretation of these claims, Nardi further teaches that the apparatus is preferably used for dispensing liquid ophthalmic solutions (¶¶ 2, 5-7). Although Nardi is silent with respect to the therapeutic agent, Hill teaches that ocufloxacin was known prior to Applicant’s invention to be a suitable therapeutic agent for use in ophthalmic solutions (see Hill, pg. 2, Results), for example, as a prophylactic antibiotic, with the advantage of being less expensive than newer generation antibiotics (Hill, pg. 2, Conclusions). Therefore, it would have been obvious to one of ordinary skill in the art before the invention was made to modify the invention of Nardi by selecting as the therapeutic liquid to be dispensed a solution having a therapeutic agent which is ocufloxacin, in order to prevent or treat eye infections.
Claim 26 is rejected, in the alternative, under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nardi in view of Buxmann, in further view of Vehige et al. (US Patent Pub. 2006/0106104, hereinafter Vehige).
Regarding claim 26, the modified Nardi teaches the claimed invention substantially as claimed, as set forth above for claim 1. As discussed above, it is the examiner’s position that the claimed apparatus is not limited by the composition of the therapeutic liquid because the therapeutic liquid is not positively claimed as part of the apparatus. If there is any doubt regarding the examiner’s interpretation of these claims, Nardi further teaches that the apparatus is preferably used for dispensing liquid ophthalmic compositions (¶¶ 2, 5-7). Although Nardi is silent with respect to the therapeutic agent, Vehige teaches that carnitine was known prior to Applicant’s invention to be a beneficial therapeutic agent for use in ophthalmic solutions (“of the agents tested, carnitine produced the most benefit,” ¶ 138; “preferably, carnitine … may be useful in ophthalmic compositions, for example, to mitigate against hypertonic conditions on ocular surfaces of human or animal eyes,” ¶ 140). Therefore, it would have been obvious to one of ordinary skill in the art before the invention was made to modify the invention of Nardi by selecting as the therapeutic liquid to be dispensed a solution having a therapeutic agent which is carnitine, in order to mitigate against hypertonic conditions on ocular surfaces.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-17 and 21-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 19/530,053 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 1-17 describe substantially the same invention as instant claims 1-17, with the Markush group of reference claim 14 listing the therapeutic agents recited in instant claims 21-27. The reference claims differ from the instant claims only in omitting the recitation of the therapeutic liquid being “sterile, non-preserved,” as recited in the preamble of instant claim 1. Because these claims are directed to an apparatus “for dispensing” such liquid and do not positively recite the liquid as part of the apparatus, features of the liquid do not patentably distinguish the claimed apparatus from that of the reference claims. Additionally, the reference claims do not include a claim directly corresponding to instant claim 13 (“the vented cap and the dispensing tip are connected”); however, reference claims 9 and 10 describes a protrusion of the vented cap establishing contact with and sealing the dispensing tip, which is understood to describe a connection of the vented cap and the dispensing tip as broadly described in instant claim 13.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-20 of copending Application No. 18/345,638 (reference application) in view of Nardi. Reference claims 18-20 differ from instant claims 18-20 only in omitting the recitation of the therapeutic liquid being “sterile, non-preserved,” as recited in instant method claims 18 and 20. However, it was known prior to Applicant’s invention to store and dispense a sterile, non-preserved therapeutic liquid from a container designed to keep the liquid germ-free without added preservatives, as evidenced by Nardi, cited above in the rejection of claims 18-20 under 35 U.S.C. 103. Therefore, it would have been obvious to one of ordinary skill in the art before the invention was made to practice the method of reference claims 18-20 using a sterile, non-preserved therapeutic liquid as taught by Nardi, in order to maintain microbiological safety of the system without the need for added preservatives.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed September 25, 2025, have been fully considered and are addressed below.
35 U.S.C. 103
Applicant argues that it would not have been obvious to one of ordinary skill in the art to add an overcap (i.e., a second cap) as taught by Nardi to the double-walled container of Buxmann because Nardi teaches away from double-walled containers, citing Nardi’s discussion of a preferred single-walled embodiment (¶ 30) which avoids the manufacturing complexity of a double-walled container (¶ 15). This argument is not persuasive because Nardi explicitly teaches that the container may either have “a single-walled container body” or “it may be of the double-walled type.” ¶ 29. Preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. See MPEP § 2123, subsection II, citing In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971); In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994); and In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Applicant additionally argues that the combination of Buxmann and Nardi proposed by the examiner would not have been obvious to one of ordinary skill in the art because the second cap and tamper-evident seal of Nardi are not physically compatible with the apparatus of Buxmann, given the position of Buxmann’s vented cap (3, Fig. 1) on the operating part (5) of the plunger (2), and in view of Nardi’s teaching regarding the relationship of the second cap (overcap 20, Fig. 1) to the underlying screw cap (17). See Remarks, pg. 10-13. The examiner does not find these arguments entirely persuasive because the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, the examiner finds that the claimed invention would have been obvious in view of the combined teachings of the two cited references, with Buxmann teaching the advantages of a vented cap and Nardi teaching advantages of an additional overcap with a tamper-evident seal, both for the purpose of ensuring sterility of non-preserved therapeutic liquids in a dispensing container. One of ordinary skill in the art would have been motivated to combine these features in a single dispensing container in order to improve sterile storage of the non-preserved liquid. That said, in the interest of advancing prosecution, the examiner has set forth new grounds of rejection above, based on the same references but using Nardi as the base reference and Buxmann as the teaching reference. The combination of Nardi and Buxmann discussed above would not require modification of the container body, only the addition of a vent hole as taught by Buxmann in the first cap of Nardi.
Double Patenting
In response to Applicant’s request to hold the provisional double patenting rejections in abeyance, the examiner notes that double patenting rejections are not held in abeyance because filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims. See MPEP § 804, subsection I.B.1. The examiner notes that the provisional double patenting rejection with respect to U.S. Application No. 18/345,638 (hereinafter the ‘638 application), set forth in the prior Office action, has been obviated by the abandonment of the ‘638 application. See Notice of Abandonment mailed March 6, 2026, in the ‘638 application. New provisional double patenting rejections are set forth above with respect to newly-filed U.S. Application No. 19/530,053.
Conclusion
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/Laura Davison/Reexamination Specialist, Art Unit 3993
Conferees:
/JOSHUA KADING/Reexamination Specialist, Art Unit 3993
/EILEEN D LILLIS/SPRS, Art Unit 3993
1 The term “integral structure” is broadly interpreted to encompass “a united structure, e.g., one formed either by uniting parts together or by one-piece formation.” Non-final 5; see Remarks filed May 5,2025, pg. 9.
2 See fn. 1 above.