DETAILED ACTION
Status of Claims
Claims 55-66 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims. The present application is being examined under the pre-AIA first to invent provisions.
Status of Office Action: Non-Final
Claim Rejections – pre-AIA 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim 66 is rejected under pre-AIA 35 U.S.C. § 102(b) as being anticipated by POLER (US 4,540,417, Issued Sep. 10, 1985; on 02/06/2025 IDS).
Poler is directed to an eye-medicating haptic. Poler, title & abstract. In this regard, Poler teaches an eye-medicating device (Poler, col. 1, ln. 41-43, e.g., col. 4, ln. 1-11, Fig. 10) comprising annular haptics (Poler, col. 2, ln. 11-16) with a central opening (Poler, col. 1, ln. 51-60) formed by the product of bonding three very thin plies (Poler, col. 4, ln. 1-11, Fig. 10, referring to Fig. 10, Items 60, 61, 62 and 75), wherein the three plies contain receptors for the storage and slow releasability of medication (Poler, Fig. 10, Item 62).
Regarding independent claim 66 and the requirements:
66. (New) A method of treating an eye, the method comprising: placing a first skeletal structure on an anterior portion of the eye outside of an optical zone of the eye, wherein a second structure is at least partially disposed along a length of the first structure so as to provide cushioning to and to deliver at least one drug to the eye on at least one of the two structures.
Poler clearly teaches an eye-medicating device (Poler, col. 1, ln. 41-43, e.g., col. 4, ln. 1-11, Fig. 10), WHEREBY it is noted:
Poler’s Item 60 of Fig. 10 (Poler, col. 4, ln. 1-11) reads on a “first skeletal structure on an anterior portion of the eye outside of an optical zone of the eye” of claim 66; and
Poler’s Items 61, 62 and 75 of Fig. 10 (Poler, col. 4, ln. 1-11) reads on a “second structure is at least partially disposed along a length of the first structure so as to provide cushioning to and to deliver at least one drug to the eye on at least one of the two structures” of claim 66;
thereby reading of the active “providing” step of claim 66.
Thus, Poler anticipates claim 66.
The instant claims, namely independent claim 24, are drawn to an ocular insert formed of an inner structure and a drug-containing outer structure supported by the inner structure; wherein “[the] outer structure [is] supported by the inner structure, the outer structure comprising one or more tubular segments of a drug delivery matrix surrounding the circumferential length of the suture, the outer structure forming an anterior surface, a posterior surface, an inner edge, and an outer edge of the ocular insert along the circumferential length.” In comparison to Poler, the instant claims recite an “outer structure” which “surround[s] the circumferential length of the suture” forming “an anterior surface, a posterior surface, an inner edge, and an outer edge of the ocular insert along the circumferential length” of the insert (see Fig.’s 7-2, 7-3 & 9-1 of applicant’s specification), WHEREAS the device of Poler features multiple plies or structures configured as a stack (Poler, Fig.'s 6-10) with no ply structure completely surrounding another ply structure. Thus, the instant claims are distinguishable from the closest prior art.
Claim Rejections – pre-AIA 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. § 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. § 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. § 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR § 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. § 103(c) and potential pre-AIA 35 U.S.C. § 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. § 103(a).
Claim 65 is rejected under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over POLER (US 4,540,417, Issued Sep. 10, 1985; on 02/06/2025 IDS), in view of PRICE (US 4,037,866, Issued July 26, 1977; hereinafter, “Price”).
The teachings of Poler, as set forth in the above rejection under 35 U.S.C. § 102 (a)(1) are hereby incorporated.
Regarding independent claim 65 and the requirements:
65. (New) An ocular insert system for treating an eye, the eye having upper and lower lids extendable along an anterior eye surface with an optical zone therebetween, the system comprising: an insert engageable against the anterior surface of the eye under at least one of the lids; a re-configuration material or tool coupled to the insert so as to configure the insert in an insertion configuration, wherein activation of the material or tool reconfigures the insert to deployed configuration comprising an annulus disposable outside the optical zone between the anterior surface of the eye and the lids; and at least one drug supported by the annulus so as release a safe and therapeutically effective quantity of the drug to the eye for each of the plurality of days when deployed therein.
Poler clearly teaches an eye-medicating device (Poler, col. 1, ln. 41-43, e.g., col. 4, ln. 1-11, Fig. 10), which is an “insert engageable against the anterior surface of the eye under at least one of the lids” of claim 65. However, Poler DOES NOT TEACH a “re-configuration material or tool coupled to the insert so as to configure the insert in an insertion configuration” as required by claim 65, which is well within the purview of the ordinarily skilled artisan.
Price, for instance is directed to:
CONTACT LENS APPLICATOR
ABSTRACT
An applicator for contact lenses. A stem having a bore is provided with a flexible neoprene cap or sleeve on the end of the stem, the cap having an end wall forming a diaphragm which is configurated to have the convex side of a wet contact lens placed against it to be held by surface tension. Within the bore of the stem is a manually actuatable plunger. An opening is provided in the side wall of the stem. The lens carried at the end of the applicator can be placed adjacent the eyeball. By manually pushing in the stem, pressure is developed behind the diaphragm holding the lens to deform it and release the contact lens against the eyeball.
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(Price, title & abstract), which relates to an “insert engageable against the anterior surface of the eye under at least one of the lids” of claim 65.
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to place Poler’s eye-medicating device (Poler, col. 1, ln. 41-43, e.g., col. 4, ln. 1-11, Fig. 10) into the eye with Price’s contact lens applicator (Price, abstract). One would have been motivated to do so with a reasonable expectation of success in order to obtain the advantage of a suitable tool for placing an medical device for the eye. See MPEP § 2144.07 stating that the selection of a known material based on its suitability for its intended use is prima facie obvious, which cites Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), wherein “Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” It is further noted that the requirements of claim 65 for “wherein activation of the material or tool reconfigures the insert to deployed configuration comprising an annulus disposable outside the optical zone between the anterior surface of the eye and the lids; and at least one drug supported by the annulus so as release a safe and therapeutically effective quantity of the drug to the eye for each of the plurality of days when deployed therein” are functional limitations. In this regard, it is noted that the structure, material or act in the claim that is connected to (i.e., performs) the recited function is the combination of recited elements of claim 65, which achieve the resulting deployment and release effects. Therefore, the broadest reasonable interpretation (see MPEP § 2111 with respect to broadest reasonable interpretation) of the functional language is: intended deployment and release effects of a device and tool that meets the structural requirements of claim 65. Because this functional language merely recites the intended result of the recited structural limitations, it imposes no patentable distinction on the claim (i.e., the functional language is not further limiting beyond the noted structural limitations). Therefore, one of ordinary skill in the art would understand that a composition meeting the structural requirements of claim 65 will achieve the intended result of the functional limitations and fall within the boundaries of the claims.
Thus, the prior art renders claim 65 obvious.
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 55-64 and 66 are rejected on the ground of nonstatutory double patenting over claims 1-30 of U.S. Patent 9,421,126 to Alster et al., hereinafter “‘126 Patent,” matured from copending Application No. 13/151,001.
Although the conflicting claims are not identical, they are not patentably distinct because:
Claim 1 of the ‘126 Patent recites the “first structure” as “an annulus formed of a configuration-altering material,” corresponds to claim 55 in reciting “a first structure comprising an annulus formed of a non-biodegradable suture having a length disposable along the anterior surface of the eye of a patient sized to fit outside the optical zone of the cornea”; and
Claim 1 of the ‘126 Patent recites a “second structure [...], wherein the second structure completely surrounds the portion of the first structure in a cross-section taken from the anterior surface to the posterior surface of the second structure” and “at least one drug disposed on or embedded into the second structure so as to release a safe and therapeutically effective quantity of the drug from the second structure to the eye for each of the plurality of days” corresponding to instant claim 55 in reciting the “a second structure completely surrounding the suture such that at least a portion of the length of the suture threads through an interior of the second structure, the second structure cushioning engagement between the insert and the eye so as to inhibit irritation of the eye when the first structure helps maintain the insert in contact with the eye for a plurality of days; and at least one drug disposed on or embedded into the second structure so as release a safe and therapeutically effective quantity of the drug to the eye for each of the plurality of days.”
Therefore, claim 1 of the ‘126 Patent anticipates instant claim 55. Claims 1-30 of the ‘126 Patent correspond to instant claims 56-64 and 66, whereby the ‘126 Patent anticipates the instant claims.
Claims 55-64 and 66 are rejected on the ground of nonstatutory double patenting over claims 1-20 of U.S. Patent 8,939,948 B2 to de Juan, Jr., et al., hereinafter “‘948 Patent,” matured from copending Application No. 13/618,052.
Although the conflicting claims are not identical, they are not patentably distinct because the ‘948 Patent is of overlapping scope because independent claims 1 and 16 of the ‘948 Patent recite first and second structure forming an annular ring structure corresponding to the device of claim 55, while claim 16 of the ‘948 Patent further recites that the support material corresponding to the second structure of the instant claims contains a therapeutic agent, thereby anticipating claim 55. Claims 1-20 of the ‘126 Patent further anticipate claims 56-64 and 66.
Claims 55-64 and 66 are rejected on the ground of nonstatutory double patenting over claims 1-25 of U.S. Patent 8,715,712 B2 to de Juan, Jr, et al., hereinafter “‘712 Patent,” matured from copending Application No. 13/688,019.
Although the conflicting claims are not identical, they are not patentably distinct because independent claim 1 of the ‘712 Patent is drawn to an ocular insert for the anterior segment of the eye (outside the cornea) with a first structure, second structure and therapeutic agent, wherein the second structure is supported by the first structure (which reasonably encompasses a second structure completely surrounding the first structure), thereby anticipating claim 55. Claims 1-25 of the ‘712 patent correspond to instant claims 56-64 and 66, whereby the ‘712 Patent anticipates the instant claims.
Claims 55-64 and 66 are rejected on the ground of nonstatutory double patenting over claims 1-30 of U.S. Patent 9,750,636 B2 to Rubin et al., herein after “‘636 Patent,” matured from co-pending Application No. 14/063,571.
Although the conflicting claims are not identical, they are not patentably distinct because independent claim 1 of the ‘636 Patent is drawn to a tubular ocular device for the anterior segment of the eye (outside the cornea) with a first structure completely surrounding a second structure, but differs in scope from the instant claims by:
reciting a therapeutic agent dispersed in at least one of the first and second structure,
requiring that the second structure has grooves on the outer surface to contain at least two grooves that affect release of the therapeutic agent, and
dependent claim 63 is drawn to a first shape that is annular.
Therefore, the ‘636 Patent is non-statutory double patenting, not statutory double patenting, and anticipates independent claim 55. Claims 1-30 correspond to instant claims 56-64 and 66, whereby the ‘636 Patent anticipates the instant claims.
Claims 55-64 and 66 are rejected on the ground of nonstatutory double patenting over claims 1-29 of U.S. Patent 9,937,073 B2 to de Juan, Jr. et al., herein after “‘073 Patent,” matured from co-pending Application No. 14/600,505.
Although the conflicting claims are not identical, they are not patentably distinct because independent claim 1 of the ‘073 Patent is drawn to an ocular insert (configured for positioning on the eye, outside the cornea) that is an annular first inner structure encapsulated by a second outer structure with at least one therapeutic agent that differs in scope from the instant claims because the ‘073 Patent does not requires the therapeutic agent associated with the first or second structure, while independent claim 55 requires the drug disposed on or embedded in the second structure. Claim 1 of the 073 Patent also differs in scope from the instant claims by requiring that the outer structure is of a lower durometer that the inner structure. Therefore, claim 1 of the 073 Patent anticipates independent claim 55 for nonstatutory double patenting. Claims 1-29 of the ‘073 Patent correspond to instant claims 56-64 and 66, whereby the ‘073 Patent anticipates the instant claims.
Claims 55-64 and 66 are rejected on the ground of nonstatutory double patenting over claims 1-19 of U.S. Patent 10,004,636 B2 to Alster et al., hereinafter “‘636 Patent,” matured from co-pending Application No. 15/230,275.
Although the conflicting claims are not identical, they are not patentably distinct because independent claim 1 of the ‘636 Patent is drawn to a similar ocular insert of claim 55. Therefore, claim 1 of Alster anticipates independent claim 55 for nonstatutory double patenting. Claims 1-19 of the ‘636 Patent correspond to instant claims 56-64 and 66, whereby the ‘636 Patent anticipates the instant claims.
Claims 55-64 and 66 are rejected on the ground of nonstatutory double patenting over claims 1-22 of U.S. Patent 10,736,774 B2 to Alster et al., hereinafter “‘774 Patent,” matured from co-pending Application No. 16/003,857.
Although the conflicting claims are not identical, they are not patentably distinct because independent claim 1 of the ‘774 Patent is drawn to a similar ocular insert of claim 55. Therefore, claim 1 of the ‘774 Patent anticipates independent claim 55 for nonstatutory double patenting. Claims 1-22 of the ‘774 Patent correspond to instant claims 56-64 and 66, whereby Alster anticipates the instant claims.
Conclusion
Claims 55-66 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BETHANY BARHAM can be reached on (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOMINIC LAZARO/Primary Examiner, Art Unit 1611
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