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 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 11, 12, 14, 29-33 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12,023,276. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the elements of the application claims can be found in the patent claims.
Regarding claim 11 of the application, claim 1 of the patent recites a tip structure of an intracanalicular injectable applicator device (claim 1, lines 12, 20), wherein the tip structure comprises: a first distal end configured to attach to a body of the intracanalicular injectable applicator device (claim 1, line 20); an inner surface forming a recess configured to receive a first cannula distal end of a cannula of the intracanalicular injectable applicator device (claim 1, lines 20-22), wherein a second cannula distal end of the cannula is coupled to the body (claim 1, line 15); and a second distal end comprising a beveled tip configured to be inserted in a lacrimal punctum to dilate the lacrimal punctum and to inject an intracanalicular injectable from the cannula into a canaliculus via the lacrimal punctum (claim 1, lines 22-25). The difference between the application claim and the patent claim lies in the fact that the patent claim includes more features and is therefore more specific. It has been held that the generic claim is anticipated by the specific claim. See In re Goodman, USPQ2d 2010 (Fed. Cir. 1993). Since the application claim is anticipated by the patent claim, it is not patentably distinct therefrom.
Regarding claim 12 of the application, claim 1 of the patent recites wherein the tip structure has a Shore A durometer of about 50 to about 120 (claim 1, lines 25-26), and wherein an opening of the second distal end of the tip structure has a diameter that is smaller than an outer diameter of the intracanalicular injectable (claim 1, lines 27-28).
Regarding claim 14 of the application, claim 1 of the patent recites a system comprising: a intracanalicular injectable applicator device (claim 1, line 13) comprising: a body forming a cavity (claim 1, line 14); a cannula coupled to a first distal end of the body (claim 1, line 15), wherein the cannula forms a channel that is aligned with the cavity of the body (claim 1, lines 15-17); a tip structure coupled to the body (claim 1, line 20), wherein the tip structure is disposed around at least a portion of the cannula (claim 1, lines 20-21), wherein a distal end of the tip
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structure is configured to dilate a lacrimal punctum by inserting the distal end of the tip structure into a canaliculus via the lacrimal punctum (claim 1, lines 22-25); and an actuating structure (claim 1, line 30); and an intracanalicular injectable loaded in the channel of the cannula of the intracanalicular injectable applicator device (claim 1, lines 17-19), wherein the actuating structure is configured to push the intracanalicular injectable through the channel and the distal end of the tip structure into the canaliculus via the lacrimal punctum while the distal end of the tip structure is inserted into the canaliculus via the lacrimal punctum (claim 1, lines 30-34). The difference between the application claim and the patent claim lies in the fact that the patent claim includes more features and is therefore more specific. It has been held that the generic claim is anticipated by the specific claim. See In re Goodman, USPQ2d 2010 (Fed. Cir. 1993). Since the application claim is anticipated by the patent claim, it is not patentably distinct therefrom.
Regarding claim 29 of the application, claim 1 of the patent recites that the distal end of the tip structure has a Shore A durometer of about 50 to about 120, and wherein an opening of the distal end of the tip structure has a diameter that is smaller than an outer diameter of the intracanalicular injectable (claim 1, lines 25-29).
Regarding claim 30 of the application, claim 2 of the patent recites the actuating structure comprises: a plunger structure configured to be disposed at least partially in the cavity of the body, wherein a first distal end of the plunger structure is configured to receive a force to cause actuation of the actuating structure (claim 2, lines 36-40); and a push-wire, wherein a first distal end of the push-wire is attached to a second distal end of the plunger structure, wherein a second distal end of the push-wire is disposed in the channel of the cannula prior to the actuation of the actuating structure, wherein the push-wire is configured to push the intracanalicular injectable through the channel responsive to the actuation of the actuating structure (claim 2, lines 41-48).
Regarding claim 31 of the application, claim 3 of the patent recites the plunger structure comprises hooked clips configured to insert into corresponding recesses formed by an outer surface of the body to prevent the plunger structure and the body from separating and to constrain movement of the intracanalicular injectable in the cannula (claim 3, lines 49-54).
Regarding claim 32 of the application, claim 4 of the patent recites a portion of the plunger structure disposed in the cavity of the body has a non-circular perimeter (claim 4, lines 57-58); a portion of the cavity of the body has a non-circular profile that corresponds to the non- circular perimeter (claim 4, lines 59-60); and the actuating structure is to be rotated to align the non-circular perimeter of the portion of the plunger structure with the non-circular profile of the portion of the cavity of the body to actuate the actuating structure (claim 4, lines 62-65)
Regarding claim 33 of the application, claim 5 of the patent recites at least one of: the cannula is affixed to the body via adhesion or insert molding, wherein the second distal end of the plunger structure forms a slot, wherein the push-wire is adhered or insert molded into the slot; or the cavity of the body and an outer profile of the plunger structure are tapered to direct the push-wire into the cannula (claim 5, line 66-3).
Claims 24, 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,023,276 in view of Chang (US 8,668,676).
Claim 24 differs from claim 1 of the patent in calling for the intracanalicular injectable comprises travoprost, cyclosporine or dexamethasone. Chang teaches a therapeutic agent for treatment of the eye wherein the agent is dexamethasone (col. 9, line 19). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 1 to include the intracanalicular injectable to include dexamethasone as taught by Chang because dexamethasone is helpful in treating the eye.
Claim 28 differs from claim 1 of the patent in calling for the intracanalicular injectable comprises travoprost, cyclosporine or dexamethasone. Chang teaches a therapeutic agent for treatment of the eye wherein the agent is dexamethasone (col. 9, line 19). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 1 to include the intracanalicular injectable to include dexamethasone as taught by Chang because dexamethasone is helpful in treating the eye.
Claims 15, 17, 34-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12,023,276 in view of Wallace et al (US 6,527,780).
Regarding claim 15 of the application, claim 1 of the patent recites a plurality of components comprising: a intracanalicular injectable applicator device (claim 1, line 12) comprising: a body forming a cavity (claim 1, line 14); a cannula coupled to a first distal end of the body (claim 1, line 15), wherein the cannula forms a channel that is aligned with the cavity of the body (claim 1, lines 15-16), and wherein the cannula is configured to store an intracanalicular injectable in the channel (claim 1, lines 18-19); a tip structure coupled to the body (claim 1, line 20), wherein the tip structure is disposed around at least a portion of the cannula (claim 1, lines 20-22), wherein a distal end of the tip structure is configured to dilate a lacrimal punctum by inserting the distal end of the tip structure into a canaliculus via the lacrimal punctum (claim 20, lines 22-25); and an actuating structure configured to push the intracanalicular injectable through the channel and the distal end of the tip structure into the canaliculus via the lacrimal punctum while the distal end of the tip structure is inserted into the canaliculus via the lacrimal punctum; and the intracanalicular injectable (claim 1, lines 30-34).
Claim 15 differs from claim 1 in calling for a kit comprising an enclosure to house a plurality of components. Wallace teaches a medical device for treating the eye wherein the device includes a kit comprising an enclosure surrounding the plurality of components to allow the device to be sterilized and remain sterile prior to use and be used with a standard “peel and drop” technique (col. 4, lines 56-62). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 1 of the application to be included in a kit comprising an enclosure as taught by Wallace to provide a sterilized package that can be opened in a sterile field. Further the difference between the application claim and the patent claim lies in the fact that the patent claim includes more features and is therefore more specific. It has been held that the generic claim is anticipated by the specific claim. See In re Goodman, USPQ2d 2010 (Fed. Cir. 1993). Since the application claim is anticipated by the patent claim, it is not patentably distinct therefrom.
Regarding claim 17 of the application, claim 1 of the intracanalicular injectable is loaded into the intracanalicular injectable applicator device in the kit (claim 1, lines 17-19).
Regarding claim 34 of the application, claim 1 of the patent recites the distal end of the tip structure has a Shore A durometer of about 50 to about 120, and wherein an opening of the distal end of the tip structure has a diameter that is smaller than an outer diameter of the intracanalicular injectable (claim 1, lines 25-29).
Regarding claim 35 of the application, claim 2 of the patent recites the actuating structure comprises: a plunger structure configured to be disposed at least partially in the cavity of the body, wherein a first distal end of the plunger structure is configured to receive a force to cause actuation of the actuating structure; and a push-wire, wherein a first distal end of the push-wire is attached to a second distal end of the plunger structure, wherein a second distal end of the push-wire is disposed in the channel of the cannula prior to the actuation of the actuating structure, wherein the push-wire is configured to push the intracanalicular injectable through the channel responsive to the actuation of the actuating structure (claim 2, lines 35-48).
Regarding claim 36 of the application, claim 3 of the patent recites the plunger structure comprises hooked clips configured to insert into corresponding recesses formed by an outer surface of the body to prevent the plunger structure and the body from separating and to constrain movement of the intracanalicular injectable in the cannula (claim 3, lines 50-54).
Regarding claim 37 of the application, claim 4 of the patent recites a portion of the plunger structure disposed in the cavity of the body has a non-circular perimeter; a portion of the cavity of the body has a non-circular profile that corresponds to the non- circular perimeter; and the actuating structure is to be rotated to align the non-circular perimeter of the portion of the plunger structure with the non-circular profile of the portion of the cavity of the body to actuate the actuating structure (claim 4, lines 56-65).
Regarding claim 38 of the application, claim 5 of the patent recites at least one of: the cannula is affixed to the body via adhesion or insert molding, wherein the second distal end of the plunger structure forms a slot, wherein the push-wire is adhered or insert molded into the slot; or the cavity of the body and an outer profile of the plunger structure are tapered to direct the push-wire into the cannula (claim 5, line 66-3).
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,023,276 in view of Wallace as discussed with regard to claim 15 above and further in view of Shiah et al (US 8,034,370).
Claim 16 differs from the teachings above in calling for the enclosure is a foil pouch, and wherein the plurality of components further comprises a desiccant. Shiah teaches a kit for an ocular treatment device wherein the system is placed in a foil pouch containing a desiccant (col. 32, lines 30-33) to preserve the system prior to use. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the kit discussed above with regard to claim 15 to include a foil pouch and a desiccant as taught by Shiah to preserve the device prior to use.
Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,023,276 in view of Wallace as applied to claim 15 above and further in view of Chang (US 8,668,676).
Claim 25 differs from claim 1 of the patent in calling for the intracanalicular injectable comprises travoprost, cyclosporine or dexamethasone. Chang teaches a therapeutic agent for treatment of the eye wherein the agent is dexamethasone (col. 9, line 19). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 1 to include the intracanalicular injectable to include dexamethasone as taught by Chang because dexamethasone is helpful in treating the eye.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 11, 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weber et al (US 7,468,065).
Regarding claim 11, Weber discloses a tip structure 30 comprising a first distal end configured to attach to a body 24 of an applicator (fig. 4), an inner surface forming a recess configured to receive an injectable 1 (fig. 5), and a second distal end comprising a beveled tip 41 (fig. 5). The limitation “of an intracanalicular injectable application device” is interpreted to be an intended use limitation. Further, the limitations “configured to attach to a body of the intracanalicular injectable applicator device”, “configured to receive a first cannula distal end of a cannula of the intracanalicular injectable applicator device”, configured to be inserted in a lacrimal punctum to dilate the lacrimal punctum and to inject an intracanalicular injectable from the cannula into a canaliculus via the lacrimal punctum” are interpreted to be functional limitations. The tip of Weber is capable of performing these functions.
Regarding claim 28, the intracanalicular injectable is not positively recited as discussed above with regard to claim 11. Since the inner surface of the tip structure of Weber is capable of injecting the intracanalicular injectable, it is further capable of injecting the injectable comprising travoprost, cyclosporine or dexamethasone.
Allowable Subject Matter
Claims 14, 21, 29-33, and 15-17, 25, 34-38 are allowable over the prior art of record but for the double patenting rejections above.
Claims 12, 13 are 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.
The following is a statement of reasons for the indication of allowable subject matter: see prosecution history for parent application 18/278,538.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783