-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 .
Applicant’s response dated December 29, 2025, is acknowledged.
Priority
This application is a CON of 16/107,059 filed on 08/21/2018, which is a DIV of
14/888,387 filed on 10/30/2015, which is a 371 of PCT/US2014/036370 filed on 05/01/2014,
which claims benefit in provisional application 61/818,568 filed on 05/02/2013.
Claim Status
Claims 17-31 and 33-37 are pending. Claims 1-16 and 32 were canceled. Claims 24, 25, 27, and 28 remain withdrawn. Claims 17, 26, and 36 were amended. Claims 17-23, 26, 29-31, and 33-37 are examined.
Withdrawn Claim Objections
Objections to claims 17, 32, and 36 are withdrawn because objections were overcome with claim amendments.
Withdrawn Claim Rejections -35 USC§ 103
Rejection of claim 32 is withdrawn because the claim was canceled.
Rejections of claims 17-23, 26, 29-31, and 34-37 over Yaacobi (US Patent 6,416,777 Date of Patent July 9, 2002 - of record in IDS dated 25 May 2021) and Arnold (Patent 4,014,335 Date of Patent March 29, 1977) are withdrawn because claims 17 and 36 were amended to require performing step b) with an applicator device, which is not obvious over the cited references. Arguments directed to these rejections are moot because rejections are withdrawn.
Withdrawn Double Patenting Rejections
Rejection of claim 32 is withdrawn because claim 32 was canceled. Rejections of claims 17-23, 26, and 34-37 over claims 1-19 of U.S. Patent No. 10,449,145 (of record in IDS dated 05/25/2021) are withdrawn because claims 17 and 36 were amended to require using an applicator device in step b.
Maintained Claim Objections
Claim 33 is objected to because the phrase "sub-Tenon's space the eye" appear to have
typographical error where the phrase is missing "of' between the space and the eye.
Appropriate correction is required.
New Claim Rejections -35 USC§ 112
Necessitated by Amendment
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 33 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 33 does not further limit claim 17 because claim 17 already requires using an applicator device to place the ocular implant into the sub-Tenon’s space of the eye.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
New Claim Rejections -35 USC§ 103
Necessitated by Amendment
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness
rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.
Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35
U.S.C. 103 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.
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.
Claims 17-23, 26, 29-31, and 33-37 are rejected under 35 U.S.C. 103 as being
unpatentable over Yaacobi (US Patent 6,416,777 Date of Patent July 9, 2002 - of record in IDS
dated 25 May 2021), Arnold (Patent 4,014,335 Date of Patent March 29, 1977), and Robinson et al. (US 2010/0098772 Published April 22, 2010 - of record in IDS dated
05/25/2021).
The claims are drawn to a method of treating an eye disorder in the eye of a subject
suffering from an eye disorder comprising steps a) and b). The disease is limited to macular
degeneration, the polymer of the outer layer is limited to ethylene vinyl acetate copolymer, and
the polymer of the inner layer is limited to a silicone material.
The teachings of Yaacobi are related to a drug delivery device for a human eye. The
device includes a pharmaceutically active agent, and a geometry that facilitates the implantation
of the device on an outer surface of the sclera, beneath the inferior oblique muscle, and with the
pharmaceutically active agent disposed above the macula. Methods of delivery a pharmaceutically active agent to the posterior segment of the human eye are also disclosed
(Abstract). Figures 7 and 9 schematically illustrate an ophthalmic drug delivery device 50, which
may be used for localized delivery of the active agent to the posterior segment of the eye. A
preferred use of the device is for delivery of active agents to the retina proximate the macula for
treating ARMD. The device generally includes a body 21 having a convex dome-shaped orbital
surface 12 and a concave, come-shaped, scleral surface 14. Scleral surface 14 is designed with a
radius of curvature that facilitates direct contract with sclera 100. Orbital surface 12 is preferably
designed with a radius of curvature that facilitates implantation under Tenon's capsule 101
(column 5, lines 22-30). In one embodiment, device 50 may be formed without well 20 or inner
core 81, and the pharmaceutically active agent(s) in the form of a suspension, solution, powder,
or combination thereof may be dispersed throughout body 21 of device 50. In this embodiment,
the pharmaceutically active agent diffuses through body 21 into the target tissue (column 6 lines
17-23). Body 21 is formed from a material comprising a biocompatible, non-bioerodable
polymer compositions comprising silicone and ethylene vinyl acetate (column 6 lines 33-40).
Device 50 is preferably surgically placed directly on the outer surface of sclera 100 below
Tenon's capsule 101 with well 20 and inner core 81 directly over the area of sclera 100 above
macula 98 (column 7 lines 61-64). It is believed that device 50 can be used to deliver a
pharmaceutically effective amount of a pharmaceutically active agent to retina 97 for many
years, depending on the particular physicochemical properties of the pharmaceutically active
agent employed (column 8 lines 52-56). The device provides for safe, effective, rate-controlled,
localized delivery of active agents to the posterior segment of the eye to combat ARMD (column
11 lines 60-64). Although, the device is described as having F-shaped, C-shaped, and L-shaped
geometries when viewed from the top, other geometries may be used especially if they facilitate
the placement of the device under the inferior oblique muscle and the location of the
pharmaceutically active agent over the macula when the device is implanted on the outer surface
of the sclera and below the Tenon's capsule of the human eye (column 12 lines 9-18).
Yaacobi does not teach the claimed configuration of an implant where the inner layer
underlies the outer layer as required by the claims.
The teachings of Arnold are related to ocular drug dispensing device for administering a
drug at a controlled and continuous dosage unit rate to the eye to produce a local or systemic
physiological or pharmacological effect is comprised of a shaped body insoluble in tear fluid and
comprised of a first wall, a third wall distant from the first wall, a second wall interposed
between the first and third wall and extending around their peripheries for sealingly engaging the
first and third wall, a reservoir defined by the inner surfaces of the walls and containing the drug
or a mixture of the drug in a carrier and wherein at least one of the first and third walls is formed
of an imperforate drug release rate controlling material permeable to the passage of drug or a
microporous material containing in the micropores a drug release rate controlling medium
permeable to the passage of drug for administering a therapeutically effective amount of drug
over a prolonged period of time (Abstract). Figures 1-3 show an illustration of the device from
various views. When one of walls 11 and 14 is permeable to the passage of drug 13, the distant
wall can optionally be formed of a material essentially impermeable to the passage of drug or of
a material permeable to drug of either the homogenous or microporous types described above.
Wall 12 of device 10 is formed of a flexible, non-allergenic, biologically inert, material insoluble
in tear fluid which is suitable for joining wall 11 and wall 14 together to form an essentially
closed reservoir 15 as defined by the inner surfaces of the walls 11, 12 and 14. Drug 13 is in a
solid form, either alone or mixed with a carrier (column 4 lines 1-11). One advantage of the
device is the ease of construction by standard manufacturing techniques into devices of various
sizes, shapes, and forms. Typical shapes include circular and ellipsoid. In cross section, it can be
doubly convex, concavo-convex, and rectangular as the device during use, will tend to conform
to the configuration of the eye. The dimensions of the device can vary with the size of the device,
the amount of drug in the reservoir, the membrane which governs the rate drug is to be
administered, and by the size of the eye. Satisfactory devices generally have a length of 4-20
mm, a width of 1-15 mm, and thickness of 0.1-4 mm, a reservoir with a diameter of 1.2-14.8
mm, and contain from 1 microgram to 100 mg of drug (column 5 lines 23-44). The walls are
formed from polymers biocompatible with bodily fluids and eye tissues, and essentially insoluble
in body fluids, where the polymers include ethylene vinylacetate copolymer, silicone rubbers,
medical grade poly(dimethylsiloxane), and silicone-carbonate copolymers (from column 5 line
45 to column 6 lines 1-6). The drug is present in the reservoir defined by the walls in a manner,
mode and quantity in which it will be in intimate contact, at a constant thermodynamic activity,
with the drug permeable wall of the device throughout the administration period. For this
purpose, it will be present together with a drug-permeable solid or semi-solid carrier which
provides a formulation which may be cast or otherwise formed into a body which may be readily
handled and assembled in combination with the walls. Examples of solid carriers include silicone
carbonate copolymers and surface treated silicone rubber (from column 9 lines 26 to column 10
line 31). The material forming the drug-permeable wall and the carrier are preferably chemically
and structurally different within a single device. The permeability of the wall to drug should be
lower than is the permeability of the carrier to drug to ensure that release kinetics of the device
are controlled by the wall (column 10 lines 32-37).
Yaacobi and Arnold do not teach using an applicator device.
The teachings of Robinson are related to a drug delivery system that can be implanted or
injected into an intraocular location (such as an anterior sub-Tenon, subconjunctival or
suprachoroidal location) to provide sustained release of a therapeutic agent without the
occurrence of or the persistence of significant immunogenicity at and adjacent to the site of the
intraocular implantation or injection (paragraph 0073). The drug delivery systems can be injected
to an intraocular location by syringe or can be inserted (implanted) into the eye by a variety of
methods, including placement by forceps, by trocar, or by other types of applicators, after
making an incision in the sclera. In some instances, a trocar or applicator may be used without
creating an incision. In a preferred variation, a hand held applicator is used to insert one or more
biodegradable implants into the eye (paragraph 0081). Ocular conditions to be treated include
age related macular degeneration (paragraphs 0125-0126).
The teachings of Yaacobi and Arnold are related to ophthalmic implants intended for
local, prolonged, and controlled delivery of a drug to the eye, wherein the ophthalmic implants
are made from biocompatible and non-bioerodible polymers comprising ethylene vinylacetate
and silicone, and it would have been obvious to have combined them because they are in the
same field of endeavor.
Regarding claims 17, 33, and 36, it would have been prima facie obvious to a person of
ordinary skill in the art before the effective filing date of the claimed invention to have practiced
a method of treating macular degeneration in the eye of a subject suffering from macular
degeneration comprising the steps of providing an ocular implant comprising a therapeutically
active agent, and placing the ocular implant into the sub-tenon's space and in contact with the
sclera of the eye, with a reasonable expectation of success because Yaacobi teaches a method of
treating an eye disease including macular degeneration by placing an ocular implant comprising
a therapeutically active agent into the sub-tenon's space an in contact with the sclera of the eye.
It would have been obvious to have replaced Yaacobi's ocular implant with Arnold's ocular implant, with a reasonable expectation of success because Arnold teaches an ocular implant formed from biocompatible and non-biodegradable polymers where the implant is intended for prolonged and controlled release of a therapeutically active agent to the eye, and replacing one implant with another to obtain predictable results supports obviousness.
It would have been obvious to have formed Arnold's implant comprising a layer
impermeable to drug, a ring around the first layer forming a reservoir, a combination of drug and
carrier in the form of a solid placed in the reservoir, and a second layer permeable to the drug
placed over the ring, with a reasonable expectation of success because Arnold teaches an ocular
implant having a first wall, a second wall in the shape of a ring placed around the first wall
forming a reservoir, a drug and a carrier in the form of solid placed in the reservoir, and a third
wall placed on top of the second wall enclosing the reservoir, where at least one of the first wall
or the third wall is permeable to drug. It would have been obvious to have formed the implant
having circular or oval shape because Arnold teaches circular and oval as suitable implant
shapes. It would have been obvious to have formed the implant to have a concavo convex cross
section because Arnold teaches that the cross section of the implant may be concavo convex. An
implant having a cross section that is concavo convex comprises an outer layer and an inner layer
underlying the outer layer where both layers have a curvature at both surfaces. It would have
been obvious to have formed the first layer and the ring from ethylene vinyl acetate copolymer
because Arnold teaches ethylene vinyl acetate as a suitable polymer for making the ring and the
layers. It would have been obvious to have selected silicon rubber as the carrier to form a solid
drug/carrier layer in the reservoir because Arnold teaches silicon rubber is suitable as the carrier,
where the carrier is a drug-permeable solid which provides a formulation that may be cast and
assembled in combination with the walls. It would have been obvious to have formed the second
layer as a drug permeable layer comprising silicon carbonate copolymer because Arnold teaches
forming the layers from silicon carbonate copolymers and further teaches silicone carbonate
copolymers as suitable for forming drug permeable solid.
Yaacobi does not limit the size or the shape of the implant, and it would have been
obvious to have formed the implant having dimensions that depend on the amount of drug in the
reservoir, the membrane which governs the rate drug is to be administered, and by the size of the
eye. Arnold teaches that the implant generally has a length of 4-20 mm, a width of 1-15 mm, and
thickness of 0.1-4 mm. The claimed cross sectional dimension or diameter range 1-8 mm is
obvious because it overlaps with the dimensions of the prior art implant. The skilled artisan
would have been capable of varying the dimensions in order to form an implant suitable for
treating macular degeneration by placing into the sub-tenon's space and in contact with the sclera
of the eye.
Arnold's implant meets the limitations of the claimed multilayer implant because it has a
concavo convex cross section and comprises three layers: a drug impermeable layer comprising
ethylene vinyl acetate, a solid layer in the reservoir comprising the drug and silicone rubber, and
the drug permeable layer comprising a silicone carbonate copolymer; the implant is oval or circular shaped, having a length of 4-20 mm, a width of 1-15 mm, and thickness of 0.1-4 mm and comprises a therapeutic agent, an outer layer impermeable to drug comprising ethylene vinyl acetate copolymer and having a curvature at both surfaces, and an inner layer that underlies the outer layer and comprises silicone rubber and the therapeutic agent and comprises a curvature at both surfaces.
The teachings of Robinson, and Yaacobi modified with Arnold are related to methods of
treating disorder of the eye including age related macular degeneration by administering a
sustained release drug composition, and it would have been obvious to have combined them
because they are in the same field of endeavor.
It would have been prima facie obvious to a person skilled in the art before the effective filing date of the claimed invention to have practiced the method of Yaacobi modified by Arnold by placing the implant into the sub-tenon's space and in the contact with the sclera of the eye using an applicator, with a reasonable expectation of success because it was known from Robinson that a sustained release drug composition may be administered into the eye using an applicator in a method of treating an ocular disease such as age-related macular degeneration. The selection of a known material suitable for its intended purpose supports obviousness.
Regarding claim 18, Arnold teaches circular shaped implant.
Regarding claim 19, Arnold teaches oval shaped implant (Figure 1).
Regarding claim 20, the claimed diameter or cross sectional dimension is obvious
because it is encompassed by prior art width of 1-15 mm, and thickness of 0.1-4 mm.
Regarding claims 21 and 22, Yaacobi teaches a drug impermeable body of an implant
formed from a polymer such as ethylene vinyl acetate and Arnold teaches that the implant
comprises at least one of the two walls as impermeable to drug. The skilled artisan would have
been capable of determining which layer, outer layer or inner layer, to make impermeable to
drug and the outer layer will be either impermeable or permeable and both options would have
been equally obvious.
Regarding claim 23, Arnold teaches ethylene vinyl acetate copolymer as suitable for
making the two walls enclosing the reservoir.
Regarding claim 26, Arnold teaches a combination of drug and silicone rubber cast into
the reservoir, which reads on the inner layer comprising silicone rubber and the therapeutic
agent.
Regarding claim 29, Yaacobi teaches treating macular degeneration.
Regarding claim 30, it would have been obvious to have treated age-related macular
degeneration because Yaacobi teaches treating age-related macular degeneration.
Regarding claim 31, it would have been obvious to have placed the implant in the
posterior of the eye near the macula of the eye because Y aacobi teaches placing the implant in
the posterior of the eye near the macula of the eye.
Regarding claims 34, 35, and 37, the inner layer comprises silicone rubber which is a
polymer and a silicone material.
Maintained Claim Rejections - 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 1.32l(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 1.32l(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 1.11 l(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 autoprocessed
and approved immediately upon submission. For more information about eTerminal
Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 17-23, 26, 29-31, and 33-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,449,145 in view of Robinson et al. ("Robinson", US 2010/0098772).
Patented claim 1 is drawn to an ocular implant comprising a therapeutic agent for treatment or prevention of a disorder of the eye, the implant comprising: a first hardened layer comprising a polymer, the first hardened layer comprising curvature at both surfaces; and a second hardened layer comprising a silicone adhesive and the therapeutic agent, the second hardened layer comprising curvature at both surfaces; wherein the first hardened layer extends circumferentially beyond the second hardened layer such that the surface of the circumferential extension of the first hardened layer is capable of making contact with the sclera of the eye; and wherein at least one surface of the second hardened layer is capable of making contact with the sclera of the eye.
Claim 1 recites an ocular implant comprising a therapeutic agent "for treating prevention of a disorder of the eye', and thus the skilled artisan would readily envisage treatment
of an eye disorder by providing the ocular implant as recited in claim 1 above. Additionally, US
'145 teaches the implant is "for placement in the sub-Tenon's space of the eye" (e.g., abstract),
and that the implant makes contact with the sclera when in use (e.g., col. 14, lines 36-37), and
thus the skilled artisan would recognize the definition of "treatment", when read in light of the
specification, would include placing the ocular implant into the sub-Tenon's space and in contact
with the sclera of the eye. The implant is circular or oval shaped (claim 2) with a diameter
ranging between about 1 mm and 8 mm (claim 10).
The limitations of instant dependent claims 18-23, 26, and 34, 35, and 37 are recited in
claims 1-5 and 10 of US '145. Further regarding claim 26, it is noted that US '145 teaches its
silicone adhesive is generally a medical-grade polydimethylsiloxane (e.g., col. 16, lines 40-42),
and thus the skilled artisan would recognize the definition of "silicone adhesive', when read in
light of the specification, would include a medical- grade polydimethylsiloxane as recited in
instant claim 26.
Regarding claims 29 and 30 (and more generally regarding the remaining
claims), US '145 does not specifically claim its ocular implant is for treatment of macular
degeneration, such as age-related macular degeneration (AMD). However, Robinson is in the
field of ocular implants, and teaches a posterior ocular condition can include a disease, ailment,
or condition such as macular degeneration and age-related macular degeneration (e.g., see
paragraphs [0033] and [0126]). Therefore, it would be within the purview of the skilled artisan to
select (age-related) macular degeneration as the eye disorder to be treated with the implant of US
'145, with a reasonable expectation of success.
Regarding claim 31 (and more generally regarding the remaining claims), US
'145 does not specifically claim the ocular implant is placed in the posterior of the eye near the
macula of the eye. However, Robinson is in the field of ocular implants, and teaches it is known
to administer a drug depot to the posterior (i.e. near the macula) sub-Tenon space ( e.g., see
paragraph [0011]). Therefore, the ordinarily skilled artisan, when placing an ocular implant in
the sub-Tenon space as in the treatment of US' 145, would find it obvious to place the ocular
implant in the posterior of the eye near the macula, with a reasonable expectation of success.
US '145 does not specifically claim an applicator device is used to place the ocular
implant into the sub-Tenon's space of the eye. However, Robinson is in the field of ocular
implants, and teaches the implants can be inserted into the eye by a variety of methods, including
placement by forceps, by trocar, or by other types of applicators, or a hand held applicator is
used to insert one or more biodegradable implants into the eye (e.g., see paragraph [0081]).
Therefore, it would be within the purview of the skilled artisan to use an applicator device to
place the ocular implant into the sub-Tenon's space of the eye, with a reasonable expectation of
success.
Response to Arguments
Applicant’s arguments submitted in the remarks dated December 29, 2025, were fully considered but are not persuasive for the following reasons.
Argument that a skilled worker would not have had any incentive or direction to combine features of the devices of Yaacobi and Arnold as proposed in the Office Action is not persuasive because the rejection is not based on combining features of the devices. The rejection is based on replacing Yaacobi’s device with Arnold’s device in Yaacobi’s treatment method.
Arguments against Robinson are not persuasive because it is irrelevant that Robinson’s formulation provides extended release, and that Robinson does not teach the claimed implant. The skilled artisan would have been motivated to use the teachings of Robinson because Robinson teaches a method of implanting a drug delivery system to an intraocular location such as an anterior sub-Tenon. Using an applicator device to implant a drug delivery device into sub-Tenon’s space of the eye was known from Robinson and would have been obvious to use in Yaacobi’s method modified by Arnold.
The instant rejection does not suggest modifying Yaacobi’s and Arnold’s devices in view of Robinson’s device. Robinson is only relied upon for use of an applicator in the method of implanting the device, which would have been obvious.
Arguments against double patenting rejections are not persuasive because claim 32 (currently canceled) was rejected over the patented claims in view of Robinson, and it is irrelevant that Robinson does not teach the claimed device.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617