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 .
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 2, 4-6 and 8-14 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3, 5-6, 9-12 and 15-17 of DeWoolfson ‘092; Bruce H. et al. (US 11938092 B1).
Regarding pending claim 1, DeWoolfson ‘092 claims all limitations in patented claims 1, 7, 10 and 11, namely a method of treating a subject using a medical device (claim 1. A medical device; claim 10. A method of treating a subject using the device of claim 9);
comprising a housing and a flexible fitting (claim 1, a body including a housing that defines a lumen … and a flexible fitting configured for direct application to an eye of a subject);
wherein the housing defines a lumen that contains a cartridge and a piston operably coupled to an actuator (claim 1, a piston within the housing, and an actuator operably coupled to the piston… a cartridge insertable into the lumen);
the method comprising: pressing the actuator of the device to move the piston distally to establish fluid communication between a first subcartridge and a second subcartridge of the cartridge (claim 7, wherein the cartridge includes a first subcartridge proximal to a second subcartridge; claim 10, pressing the actuator to move the piston distally to establish fluid communication between the first subcartridge and the second subcartridge, wherein moving the piston distally breaks a pierceable material between the first and second subcartridges);
wherein the first subcartridge contains a buffer solution and an active agent (claim 10, wherein the liquid comprises a buffer solution; claim 11 wherein the first subcartridge further comprises an active agent mixed with the buffer solution);
wherein the second subcartridge contains an acylating agent (claim 10, wherein … the powder comprises an acylating agent); and
wherein the buffer solution, the active agent, and the acylating agent combine to form a therapeutic composition (claim 10, mixing the composition);
placing the fitting against an eye of the subject; and administering the therapeutic composition to the eye by expelling the therapeutic composition into an enclosed space between the fitting and the eye (claim 10, placing the fitting against an eye of the subject; and administering the composition to the eye by expelling the composition into an enclosed space between the fitting and the eye);
wherein the active agent comprises a steroid, an anti-inflammatory agent, an antihistamine, a prostaglandin, an anesthetic agent, an antifungal agent, an antibiotic, an antibacterial agent, an antiviral agent, timolol, latanoprost, epinephrine, neosynephrine, phenylephrine, hydroxyamphetamine, tropicamide, cyclopentolate, atropine, homatropine, scopolamine, deflazacort, or prednisone (claim 11, wherein the active agent comprises a steroid, an anti-inflammatory agent, an antihistamine, a prostaglandin, an anesthetic agent, or an antimicrobial agent).
Regarding pending claim 12, DeWoolfson ‘092 claims all limitations in patented claims 1, 5, 6, 10 and 11, namely a cartridge for administering a therapeutic composition to an eye of a subject (claim 1, A medical device; claim 10, preparing a composition … administering the composition to the eye);
the cartridge comprising: a first subcartridge comprising a buffer solution and an active agent (claim 10, wherein the liquid comprises a buffer solution; claim 11 wherein the first subcartridge further comprises an active agent mixed with the buffer solution);
wherein the active agent comprises a steroid, an anti-inflammatory agent, an antihistamine, a prostaglandin, an anesthetic agent, an antifungal agent, an antibiotic, an antibacterial agent, an antiviral agent, timolol, latanoprost, epinephrine, neosynephrine, phenylephrine, hydroxyamphetamine, tropicamide, cyclopentolate, atropine, homatropine, scopolamine, deflazacort, or prednisone (claim 11, wherein the active agent comprises a steroid, an anti-inflammatory agent, an antihistamine, a prostaglandin, an anesthetic agent, or an antimicrobial agent);
a second subcartridge comprising an acylating agent (claim 10, wherein … the powder comprises an acylating agent);
a piercing element within the first subcartridge (claim 6, wherein a proximal end of the cartridge is sealed with an element that includes a piercing tip extending toward the distal end of the cartridge); and
wherein the first subcartridge is separated from the second subcartridge by a thin foil or polymeric film (claim 1, wherein a distal end of the cartridge is sealed with a pierceable material; claim 5, wherein the pierceable material comprises metallic foil or polymeric film).
DeWoolfson ‘092 does not explicitly claim an outer container around the first subcartridge and the second subcartridge. However, DeWoolfson ‘092 claims that the two subcartridges are arranged next to each other (claim 7, wherein the cartridge includes a first subcartridge proximal to a second subcartridge). This implies that the two subcartridges are connected, joined or united by an additional element. Conversely, without a connecting element, the two subcartridges will dissociate and the user will need to handle them individually instead of as a single cartridge. Enclosing the two subcartridges with an external wrapper or outer container would have been an obvious way to assemble the two subcartridges and hold them together.
Regarding claim 8, DeWoolfson ‘092 does not explicitly claim a cylindrical outer container around the first and second subcartridges. However, DeWoolfson ‘092 claims that the two subcartridges are arranged next to each other, which implies that the two subcartridges are connected, joined or united by an additional element (claim 7). Regarding the rationale and motivation to add an outer container around DeWoolfson ‘092’s two subcartridges, see the discussion of claim 12 above.
Regarding pending claim 9, DeWoolfson ‘092 does not explicitly claim steps of inserting the cartridge into the lumen before pressing the actuator, and removing the cartridge from the lumen after administering the therapeutic composition to the eye. However, DeWoolfson ‘092 claims that the cartridge is insertable into the lumen (claim 1, a cartridge insertable into the lumen); and that the cartridge is removable from the lumen (claim 3, the cartridge being removable from the lumen through the slot).
Inserting the cartridge into the lumen before pressing the actuator, and removing the cartridge from the lumen after administering the therapeutic composition to the eye both appear to be necessary steps for practicing DeWoolfson ‘092’s method.
Regarding pending claims 2, 4-6, 10-11 and 13-14, DeWoolfson ‘092 claims all limitations in patented claims 5-6, 9, 12 and 15-17 as shown in table 1.
Table 1: DeWoolfson ‘092 double patenting
Pending claim
DeWoolfson ‘092
Pending claim
DeWoolfson ‘092
Pending claim
DeWoolfson ‘092
2
12
6
15, 16, 17
13
9
4
5
10
12
14
15, 16, 17
5
6
11
12
Claims 3 and 17 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of DeWoolfson ‘092; Bruce H. et al. (US 11938092 B1) in view of Von Bünau; Rudolf Murai et al. (US 20210145278 A1).
Regarding pending claims 3 and 17, DeWoolfson ‘092 does not explicitly claim that the therapeutic composition does not comprise a preservative. Von Bünau discloses a tonometer that incorporates a medication dispensing unit (¶ [0001], [0013], [0015], [0035], FIG. 1A … exemplary rebound tonometer 100; ¶ [0040], FIG. 2 illustrates a rebound tonometer 200);
including a cartridge filled with a therapeutic composition that does not comprise a preservative (¶ [0035], a single dose fluid cartridge 105 with medication inside (such as glaucoma medication) housed within the tonometer's rod 103; ¶ [0036], Use of a single or unit dose medication cartridge has the advantage of allowing preservative free drugs; ¶ [0040], the rebound tonometer 200 of FIG. 2 shows a multi-dose (fluid) cartridge as the drug reservoir 205; ¶ [0059], FIG. 7, the drug reservoir is a unit-dose smart cartridge 705, so that a dosing unit is not required. Unit dose medication has the advantage of allowing preservative free drugs).
Von Bünau demonstrates that single-dose or unit-dose medication can be packaged without preservatives (¶ [0036], [0059]). Omitting preservatives from a medication cartridge avoids exposing the patient to unnecessary risks and also simplifies the formula for the therapeutic composition. One would be motivated to modify DeWoolfson ‘092’s claims with Von Bünau’s preservative-free formulation to avoid side effects from preservatives. Therefore, it would have been obvious to modify DeWoolfson ‘092’s claims with Von Bünau’s preservative-free formulation in order to avoid side effects and to simplify the composition’s formula.
Claims 7, 16, 19 and 20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of DeWoolfson ‘092; Bruce H. et al. (US 11938092 B1) in view of Cane'; Claudio et al. (US 20210268177 A1).
Regarding pending claims 7, 16, 19 and 20, DeWoolfson ‘092 does not explicitly claim that the piercing element includes one or more apertures, and is silent whether the piercing element comprises a polymer or metal. Cane' discloses a compact drug infusion pump (¶ [0001], [0002], [0017], [0058], [0059] According to the invention, the pump 11);
comprising a piercing element that includes one or more apertures (¶ [0065] The pump 11 according to the invention further comprises the hollow piercing element or “spike” 19 … said piercing element 19 is in fluid communication with the inside of the reservoir by means of said duct 21; ¶ [0083], The reservoir 101 is communicatable with the outside by means of the piercing element or “spike” 19 having a through channel or duct 21 provided at the front end of the container 15);
wherein the piercing element comprises a polymer (¶ [0086], the container 15 and the piercing element 19 are preferably made of different plastic materials … and the piercing element 19 will be made of polycarbonate or acrylonitrile-butadiene-styrene (ABS), which are more resistant); or
wherein the piercing element comprises a metal (¶ [0088] In other embodiments it is possible to provide, instead of the described piercing element, a metal needle, possibly surrounded by a plastic sleeve, co-molded with the container of the pump).
Cane' describes how to establish fluid communication between a pair of chambers with a piercing element, and also how to construct the piercing element from easily obtained materials. One would be motivated to modify DeWoolfson ‘092’s claims with Cane'’s apertures and polymer or metal materials to construct DeWoolfson ‘092’s piercing element since DeWoolfson ‘092 requires the piercing element to establish communication between the two subcartridges (claim 10, to establish fluid communication between the first subcartridge and the second subcartridge, wherein moving the piston distally breaks a pierceable material between the first and second subcartridges). Therefore, it would have been obvious to modify DeWoolfson ‘092’s claims with Cane'’s apertures and polymer or metal materials in order to construct a workable piercing element for DeWoolfson ‘092’s claims.
Claim 18 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of DeWoolfson ‘092; Bruce H. et al. (US 11938092 B1) in view of DeWoolfson ‘121; Bruce H. et al. (US 20120057121 A1).
Regarding pending claim 18, DeWoolfson ‘092 does not explicitly claim that the second subcartridge comprises from about 3 mg to about 10 mg of glutaric anhydride. DeWoolfson ‘121 discloses methods of correcting or treating myopia, hyperopia, and astigmatism (¶ [0002], [0010], [0011], [0044]),
comprising: administering a composition to the eye, including a buffer solution and an acylating agent (¶ [0050], The solution may be composed of a single component, such as disodium phosphate or sodium pyrophosphate or sodium borate, or may be a buffer composition providing a pH ranging from 7.5-9.5; ¶ [0074], Acylation solution is injected into the open ring through this delivery port to treat the exposed tissue surface; ¶ [0079], adding drops of buffer containing the active agent, a 20 mg/ml solution of glutaric anhydride; ¶ [0087], Buffer solution (0.02M disodium phosphate solution at pH 9.0) was first applied to the corneal surface. This was immediately followed by application of a solution of glutaric anhydride in disodium phosphate).
DeWoolfson ‘121 selects a specific acylating agent. A skilled artisan would have been motivated to modify DeWoolfson ‘092’s claims with DeWoolfson ‘121’s glutaric anhydride since DeWoolfson ‘092 requires an acylating agent (claim 10).
DeWoolfson ‘092 and DeWoolfson ‘121 are silent whether the total amount of acylating agent in the second subcartridge comprises from about 3 mg to about 10 mg of glutaric anhydride.
The glutaric anhydride dosage is interpreted as a result-effective variable, subject to experimentation and testing. A result-effective variable is a parameter which achieves a recognized result. These results are obtained by the determination of optimum or workable ranges of said variable through routine experimentation. The glutaric anhydride dosage depends on the amounts of other agents in the composition and the patient’s eye size, and can be optimized through routine experimentation. For example, the glutaric anhydride dosage must be adjusted to avoid under- or over-dosing the patient.
Too low
Glutaric anhydride will fail to exert its intended effect
Optimized range
Glutaric anhydride will modify the cornea according to an intended treatment
Too high
Excess glutaric anhydride will cause uncontrolled swelling of the cornea or become toxic
Therefore, it would have been obvious to adjust the glutaric anhydride dosage in order to modify the patient’s cornea according to a treatment plan and to avoid damaging the patient’s cornea. See MPEP 2144.05(II)(A,B). Also see in re Boesch and Slaney, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claims 1-5, 8-13 and 17 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8 and 12-13 of DeWoolfson ‘598; Bruce H. et al. (US 12102598 B2).
Regarding pending claim 1, DeWoolfson ‘598 claims all limitations in patented claims 1-3, namely a method of treating a subject using a medical device (claim 1. A method of treating a subject using a medical device);
comprising a housing and a flexible fitting, wherein the housing defines a lumen that contains a cartridge and a piston operably coupled to an actuator (claim 1, a housing and a flexible fitting, wherein the housing defines a lumen that contains a cartridge and a piston operably coupled to an actuator);
the method comprising: pressing the actuator of the device to move the piston distally to establish fluid communication between a first subcartridge and a second subcartridge of the cartridge (claim 1, pressing the actuator of the device to move the piston distally to establish fluid communication between the first subcartridge and the second subcartridge);
wherein the first subcartridge contains a buffer solution and an active agent (claim 1, wherein the cartridge includes a first subcartridge that contains a buffer solution; claim 3, wherein the active agent is a first active agent and the first subcartridge further comprises a second active agent mixed with the buffer solution);
wherein the second subcartridge contains an acylating agent (claim 1, a second subcartridge that contains an active agent; claim 2, wherein the active agent is an acylating agent); and
wherein the buffer solution, the active agent, and the acylating agent combine to form a therapeutic composition (claim 1, preparing a composition by combining the buffer solution with the active agent … mixing the composition);
placing the fitting against an eye of the subject; and administering the therapeutic composition to the eye by expelling the therapeutic composition into an enclosed space between the fitting and the eye (claim 1, placing the fitting against an eye of the subject … and administering the composition to the eye by expelling the composition into an enclosed space between the fitting and the eye);
wherein the active agent comprises a steroid, an anti-inflammatory agent, an antihistamine, a prostaglandin, an anesthetic agent, an antifungal agent, an antibiotic, an antibacterial agent, an antiviral agent, timolol, latanoprost, epinephrine, neosynephrine, phenylephrine, hydroxyamphetamine, tropicamide, cyclopentolate, atropine, homatropine, scopolamine, deflazacort, or prednisone (claim 3, wherein the second active agent comprises a steroid, an anti-inflammatory agent, an antihistamine, a prostaglandin, an anesthetic agent, or an antimicrobial agent).
Regarding pending claim 12, DeWoolfson ‘598 claims all limitations in patented claims 1-3 and 5, namely a cartridge for administering a therapeutic composition to an eye of a subject (claim 1, A method of treating a subject using a medical device comprising … a cartridge);
the cartridge comprising: a first subcartridge comprising a buffer solution and an active agent (claim 1, wherein the cartridge includes a first subcartridge that contains a buffer solution; claim 3, wherein the active agent is a first active agent and the first subcartridge further comprises a second active agent mixed with the buffer solution);
wherein the active agent comprises a steroid, an anti-inflammatory agent, an antihistamine, a prostaglandin, an anesthetic agent, an antifungal agent, an antibiotic, an antibacterial agent, an antiviral agent, timolol, latanoprost, epinephrine, neosynephrine, phenylephrine, hydroxyamphetamine, tropicamide, cyclopentolate, atropine, homatropine, scopolamine, deflazacort, or prednisone (claim 3, wherein the second active agent comprises a steroid, an anti-inflammatory agent, an antihistamine, a prostaglandin, an anesthetic agent, or an antimicrobial agent);
a second subcartridge comprising an acylating agent (claim 1, a second subcartridge that contains an active agent; claim 2, wherein the active agent is an acylating agent);
wherein the first subcartridge is separated from the second subcartridge by a thin foil or polymeric film (claim 5, wherein establishing fluid communication between the first subcartridge and the second subcartridge includes piercing a thin foil or polymeric film between the first subcartridge and the second subcartridge).
DeWoolfson ‘598 does not explicitly construct the claim as a cartridge and instead claims a method (claim 1). However, DeWoolfson ‘598’s claims describe substantially all physical elements and functions of the claimed cartridge.
DeWoolfson ‘598 does not explicitly claim a piercing element within the first subcartridge. However, DeWoolfson ‘598 claims a method that pierces a foil or film between the two subcartridges (claim 5. The method of claim 1, wherein establishing fluid communication between the first subcartridge and the second subcartridge includes piercing a thin foil or polymeric film between the first subcartridge and the second subcartridge).
DeWoolfson ‘598 also claims that moving a piston opens communication between the two subcartridges (claim 1, pressing the actuator of the device to move the piston distally to establish fluid communication between the first subcartridge and the second subcartridge). This suggests that a further element, distinct from the piston, pierces the foil or film.
DeWoolfson ‘598 does not explicitly claim an outer container around the first subcartridge and the second subcartridge. However, DeWoolfson ‘598 claims that the two subcartridges are arranged next to each other and separated by a foil or film (claim 5, piercing a thin foil or polymeric film between the first subcartridge and the second subcartridge). This implies that the two subcartridges are connected, joined or united by an additional element. Conversely, without a connecting element, the two subcartridges will dissociate and the user will need to handle them individually instead of as a single cartridge. Enclosing the two subcartridges with an external wrapper or outer container would have been an obvious way to assemble the two subcartridges and hold them together.
Regarding pending claim 5, DeWoolfson ‘598 does not explicitly claim a piercing element within the first subcartridge. However, DeWoolfson ‘598 claims a method that pierces a foil or film between the two subcartridges (claim 5. The method of claim 1, wherein establishing fluid communication between the first subcartridge and the second subcartridge includes piercing a thin foil or polymeric film between the first subcartridge and the second subcartridge).
Regarding pending claim 8, DeWoolfson ‘598 does not explicitly claim an outer container around the first subcartridge and the second subcartridge. However, DeWoolfson ‘598 claims that the two subcartridges are arranged next to each other and separated by a foil or film (claim 5, piercing a thin foil or polymeric film between the first subcartridge and the second subcartridge). This implies that the two subcartridges are connected, joined or united by an additional element.
Regarding pending claims 2-4, 9-11, 13 and 17, DeWoolfson ‘598 claims all limitations in patented claims 1-8 and 12-13 as shown in table 2.
Table 2: DeWoolfson ‘598 double patenting
Pending claim
DeWoolfson ‘598
Pending claim
DeWoolfson ‘598
Pending claim
DeWoolfson ‘598
2
2
9
6
13
1, 12, 13
3
4
10
7
17
3
4
5
11
8
Claims 16, 19 and 20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of DeWoolfson ‘598; Bruce H. et al. (US 12102598 B2) in view of Cane'; Claudio et al. (US 20210268177 A1).
Regarding pending claims 16, 19 and 20, DeWoolfson ‘598 does not explicitly claim that the piercing element includes one or more apertures, and is silent whether the piercing element comprises a polymer or metal. Cane' discloses a compact drug infusion pump (¶ [0001], [0002], [0017], [0058], [0059] According to the invention, the pump 11);
comprising a piercing element that includes one or more apertures (¶ [0065] The pump 11 according to the invention further comprises the hollow piercing element or “spike” 19 … said piercing element 19 is in fluid communication with the inside of the reservoir by means of said duct 21; ¶ [0083], The reservoir 101 is communicatable with the outside by means of the piercing element or “spike” 19 having a through channel or duct 21 provided at the front end of the container 15);
wherein the piercing element comprises a polymer (¶ [0086], the container 15 and the piercing element 19 are preferably made of different plastic materials … and the piercing element 19 will be made of polycarbonate or acrylonitrile-butadiene-styrene (ABS), which are more resistant); or
wherein the piercing element comprises a metal (¶ [0088] In other embodiments it is possible to provide, instead of the described piercing element, a metal needle, possibly surrounded by a plastic sleeve, co-molded with the container of the pump).
Cane' describes how to establish fluid communication between a pair of chambers with a piercing element, and also how to construct the piercing element from easily obtained materials. Regarding the rationale and motivation to modify DeWoolfson ‘598’s claims with Cane'’s apertures and polymer or metal materials, see the discussion of claims 16, 19 and 20 above.
Claim 18 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of DeWoolfson ‘598; Bruce H. et al. (US 12102598 B2) in view of DeWoolfson ‘121; Bruce H. et al. (US 20120057121 A1).
Regarding pending claim 18, DeWoolfson ‘598 does not explicitly claim that the second subcartridge comprises from about 3 mg to about 10 mg of glutaric anhydride. DeWoolfson ‘121 discloses methods of correcting or treating myopia, hyperopia, and astigmatism (¶ [0002], [0010], [0011], [0044]),
comprising: administering a composition to the eye, including a buffer solution and an acylating agent (¶ [0050], [0074], [0079], [0087]).
DeWoolfson ‘121 selects a specific acylating agent. A skilled artisan would have been motivated to modify DeWoolfson ‘598’s claims with DeWoolfson ‘121’s glutaric anhydride since DeWoolfson ‘598 requires an acylating agent (claim 1).
DeWoolfson ‘598 and DeWoolfson ‘121 are silent whether the total amount of acylating agent in the second subcartridge comprises from about 3 mg to about 10 mg of glutaric anhydride.
The glutaric anhydride dosage is interpreted as a result-effective variable, subject to experimentation and testing. The glutaric anhydride dosage depends on the amounts of other agents in the composition and the patient’s eye size, and can be optimized through routine experimentation.
Regarding the rationale and motivation to optimize the amount of glutaric anhydride, see the discussion of claim 18 above.
Allowable Subject Matter
Claim 15 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Alternatively, the double patenting rejections may be overcome by a timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shahaf; Daniel et al. US 20210316088 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
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