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 .
Claim Objections
Claim 6 is objected to because of the following informalities: LCST should be defined “lowest critical solution temperature” in the first instance it is used in the claims.
Claim 19 is objected to because of the following informalities: the claim has been amended but the amendments make the claim grammatically incorrect and/or the claim does not read properly. The examiner suggests rewriting the claim to read as follows: The method of claim 1, further comprising maintaining said stimuli-responsive polymer at a temperature below the lower critical solution temperature of said stimuli-responsive polymer prior to injecting the stimuli-responsive polymer into the tear duct.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-7, 10-11, 13-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Whalen et al. (US20160220725, with priority to 02/02/2015, from IDS), and further in view of Zhou et al. (US6234175, from IDS) and Fedorchak et al. (WO2017165449, with priority to 03/22/2016).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1, 14, 31, Whalen teaches administering (including by the claimed route of injection/injecting) a hydrogel comprising a stimuli-responsive polymer to a subject, specifically wherein the stimuli-responsive polymer is activated by a trigger/stimuli for a phase transition which forms a solid or semi-solid from the administered liquid or semi-liquid, wherein the trigger is a change in temperature, specifically heating the stimuli-responsive polymer, and the stimuli-responsive polymer is a thermoresponsive polymer so that the polymer is in liquid form prior to administering and becomes solid after administering with body heat/body temperature and wherein the hydrogel can form a solid/solid like plug when administered to the body and being exposed to the temperature increase of the body’s temperature and wherein the formulations are/can be administered/injected into various parts of the eye (which reads on the area surrounding the tear duct because the eye is in the area surrounding the tear duct), and as such the formulations are appropriate for treating or using in ocular/ophthalmic diseases/conditions (See entire document; [0009-0012]; [0055-0058]; [0035]; [0060-0069]; [0030]; [0078]; [0126, injection/injecting]; [0139, injected into chamber of eye]; [0122, injecting eye wall]; examples; claims; abstract).
Regarding claims 1, 24-26, Whalen teaches wherein the thermoresponsive polymer is copolymer, and wherein the copolymer comprises at least one first monomer and at least one second monomer wherein the first monomer and the second monomer are not the same, specifically wherein the first monomer is N-isopropylacrylamide and the second monomer is butylacrylate ([0055-0058]; [0035]; [0060-0069]; [0030]; [0078]; examples; claims). Whalen also teaches wherein the first monomer and second monomer have a weight percentage of about 99:1 to about 50:50, more specifically 99:1 to about 80:20 which overlap the claimed ranges of at least 98 wt% N-isopropylacrylamide (first monomer) and at most 2 wt% of butylacrylate (second monomer), and the amounts of monomer claimed in claims 24-26 (See entire document; see claims 1-5; [0009-0012]; [0055-0057]; [0060-0061, including table 1]).
Regarding claims 15-16, Whalen teaches wherein the thermoresponsive polymer is administered as an aqueous solution, and wherein the polymer further comprises at least one excipient/additive ([0063-0066]; examples/claim 11, claim 14). Whalen teaches wherein the thermoresponsive polymer is copolymer, and wherein the copolymer comprises at least one first monomer and at least one second monomer wherein the first monomer and the second monomer are not the same, specifically wherein the first monomer is N-isopropylacrylamide and the second monomer is butylacrylate ([0055-0058]; [0035]; [0060-0069]; [0030]; [0078]; examples; claims).
Regarding claim 17, Whalen teaches wherein the thermoresponsive polymer has a concentration of about 10 wt% to about 60 wt% in said aqueous solution, preferably about 20 wt% to about 50 wt%, more preferably about 30 wt% to about 40 wt% and most preferably about 30 wt% which read on the claimed range (See entire document; [0064]; claim 8).
Regarding claims 1, 18-19 and 27, Whalen teaches maintaining the thermoresponsive polymer at a temperature at least approximately below the lower critical solution temperature (LCST) prior to injecting the polymer, and wherein the LCST is from about 10 °C to about 35 °C which reads on the ranges claimed in claims 18 and 27, and wherein the heating of the polymer, e.g. the temperature trigger for phase change is a subject’s body temperature (See entire document; examples; [0062]; [0068]; claim 9, claims 18-20; [0126, injection/injecting]; [0139, injected into chamber of eye]; [0122, injecting eye wall]).
Regarding claim 21, Whalen teaches wherein the subject can be a human (See [0006-0007]).
Regarding claims 1, 13, Whalen teaches a method of occluding an orifice in a subject the method comprising administering/injecting a hydrogel comprising thermoresponsive polymer to said orifice in said subject and permitting the hydrogel to conform to the shape of the orifice/at least partially fill said orifice, activating the thermoresponsive hydrogel with the body temperature wherein the temperature change initiates a phase transition of the thermoresponsive polymer from a liquid or semi-liquid state to a solid or semi-solid thereby forming a plug in said orifice (See [0039]; [0054]; [0115]; [0116]; [0121-0122]; [0125]; [0126]; [0128-0129]).
Whalen teaches an injecting device and a hydrogel comprising a thermoresponsive polymer, wherein the thermoresponsive polymer is in aqueous solution, and wherein the first monomer is N-isopropylacrylamide and the second monomer is butyl acrylate and wherein the weight ratio of the first monomer to the second monomer is 95:5 and even up to 99:1 of isoproylacrylamide to a second monomer, and further wherein second monomer is butyl acrylate and the thermoresponsive polymer has a concentration of about 30 weight percent in said aqueous solution (See entire document; figures; [0009-0012 isopropyacrylamide: butyl acrylate 99:1]; [0064]; claim 8; [0055-0058]; [0035]; [0060-0069]; [0030]; [0078]; examples; claims; claims 1-5; [0009-0012]; [0055-0057]; [0060-0061, including table 1]; [0094]; [0122]; [0126]).
Regarding claims 28-30, Whalen teaches wherein their thermoresponsive polymer is cross-linked and can be crosslinked via irradiation and/or can be sterilized ([0072-0073]; [0099]; [0109]; [0121]; [0148]).
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)
Regarding claims 1, 3-7, 10-11, 13-31, Whalen does not teach wherein the method is for treating dry eye, specifically wherein the hydrogel is administered to a tear duct via injection and is allowed to at least partially fill the channel and adapt to the shape of the channel/conform to the shape of the channel or using a dilator or increases tear volume, etc., as claimed in claims 1, 3-7, 10-11, 13, 20, 22-23. However, Whalen does teach that administering/injecting aqueous solutions of the same concentrations of the same hydrogel polymers at temperatures lower than body temperatures allows the solution to fill the voids in the area it was applied/used e.g. orifices, and upon administration it warms to the body temperature and hardens forming a plug (See the discussion above). Thus, it would have been obvious that the solution will form a plug if injected/applied into tear ducts, to treat ocular discomfort, etc. especially since it was known to be useful for application into and on and around the eye. However, these deficiencies in Whalen are addressed by Zhou and Fedorchak.
Zhou teaches that it was known to use thermoresponsive polymers to treat dry eye, which is caused by insufficient tear production which causes inflammation and discomfort of the eye as claimed, specifically wherein the thermoresponsive polymers form an ocular plug that is used to plug the ocular channel to block tear drainage (e.g. block a tear duct, specifically the punctal or canalicular opening which are parts of the tear duct claimed in claim 20) whereby it blocks the tear drainage through the punctum or canalicum (Abstract; see entire document; Col. 1, ln. 11-20; Col. 2, ln. 66-Col. 4, ln. 3; claims; examples; Col. 4, ln. 33-Col. 5, ln. 6, etc.).
Regarding claim 22, Zhou further teaches that it was known in the art to use a dilator before inserting a plug/substance which forms a plug (See Col. 2, ln. 7-22; figure 2; Col. 2, ln. 37-55; Figure 4; Col. 2, ln. 56-63). Regarding claims 11 and 23, because Zhou forms a plug which blocks the channel(s) for the tear duct to drain it obviously also accomplishes the claimed method of being effective to increase tear moisture/volume in the eye which would obviously help to treat the now claimed ocular symptoms of discomfort and inflammation, (See entire document; abstract; claims; examples; Col. 2, ln. 66-Col. 4, ln. 3; claims; examples; Col. 4, ln. 33-Col. 5, ln. 6, etc.).
Regarding claims 1, 3-7, 10-11, 13-31, Fedorchak teaches that it was known in the art to administer microparticle hydrogel systems to the eyes that conform/adapt in shape to the area treated, e.g. fornix, and which harden with the increase in temperature to body/physiological temperature (e.g. they are maintained below the LCST prior to administering) and wherein hydrogel systems comprise poly-n-isopropylacrylamide and mixtures thereof with butyl methacrylate, polyisobutylacrylate, PEG, etc., wherein they prefer temperature triggered polymers and wherein these formulations can be used to treat dry eye, which is caused by insufficient tear production, which leads to/causes the claimed ocular symptoms of inflammation and discomfort, etc. as claimed (See pg. 11, ln. 1-pg. 13, ln. 10; pg. 9, ln. 35-pg. 10, ln. 10; pg. 17, ln. 11-12;). Fedorchak teaches wherein upon administration of the hydrogel liquid suspension the formulation releases water and can become an opaque solid gel member which conforms to the shape of where it was administered/applied (e.g. fornix) which promotes retention of the formulation and wherein removal is as easy as flushing the eye with cold saline which would liquefy/dissolve the thermoresponsive polymer that hardens at physiological temperature because the cold saline/water would be below the LCST of the isopropylacrylamide polymer (see pg. 13, ln. 9-2; pg. 15, ln. 17-31; pg. 11, ln. 10-33), and Fedorchak teaches wherein the formulation can comprise excipients/additives (See pg. 15, ln. 32-pg. 16, ln. 6), and wherein the water content of the swollen hydrogel is from 50-80% which means that the polymer can comprise up to 50% of the hydrogel, which reads on the claimed concentrations and wherein the polymer which forms the hydrogel can be up to 100% polyisopropylacrylamide (See entire document; claims; pg.11, ln. 1-pg. 13, ln. 9).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art at the time of the instant filing to use the composition of Whalen to perform the claimed methods because Whalen specifically teaches that orifices can be filled/partially filled via injections of the claimed aqueous solutions of the exact same polymer blends as are instantly claimed and wherein these injections can be used in/on/around the eye and as such is safe for treating ophthalmic/ocular conditions/diseases and it would have been obvious to use them to treat dry eye and therefore treat ocular symptoms of dry eye such as eye discomfort and inflammation, etc. by forming a punctal plug because as is taught by the combination of Zhou and Fedorchak it was known in the art to use thermoresponsive polymers in the tear ducts of humans, specifically in the puncta or canaliculi to treat dry eye wherein the conform/adapt to the shape of the orifice and/or channel as it was known to use plugs to treat dry eye because they keep the tears from draining from the ducts as is discussed above. One of ordinary skill in the art would want to inject the thermoresponsive polymer compositions of Whalen in the combined method of Zhou and Fedorchak because these polymers are easily removed by rinsing/flushing/irrigating the tear duct/eye with cold saline which exposes the hydrogel polymers to the cool fluid for removal which cools the polymer to lower than the LCST of the polymer so that it dissolves/the viscosity of the polymer is reduced as per (d) in amended claim 1, thereby allowing the patient to be able to safely remove the plug if necessary without treatment by a doctor. In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
Regarding the newly added steps b) and c) in claim 1, the permitting and activating steps are result effective of injecting the claimed hydrogel into a tear duct of the subject which is taught/rendered obvious by the combined references as discussed above, because the trigger which activates said stimuli responsive polymer to initiate the phase change is temperature, e.g. body temperature, which prompts the phase transition of the polymer, the step of injecting the hydrogel into the tear duct is what leads to the hydrogel conforming to the shape of the tear duct and then warming with the body temperature prompts the phase change which forms the plug in the tear duct.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Whalen et al. (US20160220725, with priority to 02/02/2015, from IDS), and further in view of Zhou et al. (US6234175, from IDS) and Fedorchak et al. (WO2017165449, with priority to 03/22/2016) as applied to claims 1, 3-7, 10-11, 13-31 above and further in view of Shenon (https://clspectrum.com/issues/1996/april/punctal-occlusion/, 1997).
Determination of the scope and content of the prior art
(MPEP 2141.01)
The combined references together teach the method of claims 1, 3-7, 10-11, 13-31 above and incorporated herein.
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)
The combined references do not teach wherein the claimed method further comprises administering a topical pharmaceutical prior to or after occluding the tear duct as now claimed in claim 12.
However, this deficiency in the combined references is addressed by Shenon.
Shenon teaches that punctal plugs such as those taught by combined references allow for artificial tears which read on the claimed topical pharmaceutical to be retained longer after the plug is placed because the topical pharmaceutical/topical artificial tears do not drain from the blocked/occluded tear duct and read on administration of the topical pharmaceutical after occluding the tear duct since the artificial tears are retained in/on the eye longer because the duct is blocked with the plug (see who will benefit from punctal occlusion? Section; educating patients section).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art that occlusion of the tear duct by a punctal plug which is taught by the combined references increases retention of a topical pharmaceutical because this is already a known function of punctal plugs as taught by Shenon which is what applicant’s invention which is taught and/or rendered obvious by the combined prior art is also accomplishing. Thus, it would be obvious to use the occluding plugs taught by the combined references to develop the claimed method and to increase retention of topical pharmaceuticals such as artificial tears in order to provide adequate lubrication to a user’s/subject’s eyes.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1, 3-7, 10-11, 13-28, 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fedorchak (WO2017165449, with priority to 03/22/2016), Zhou et al. (US6234175, from IDS), and Stayton et al. (US20070224241).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1, 3-7, 10-11, 13-28, 30-31, Fedorchak teaches that it was known in the art to administer/inject aqueous microparticle containing hydrogel systems to the eyes of humans or animals (which reads on initially applying to the area surrounding the tear duct) that conform/adapt in shape to the area treated, and which harden/gel to a solid/semi-solid state via a phase transition upon the increase in temperature to body/physiological temperature (e.g. they are maintained below the LCST prior to administering, wherein the LCST is from around 25 to about 37 C which reads on the claimed ranges and wherein hydrogel systems comprise/can comprise poly-n-isopropylacrylamide and mixtures thereof with butyl methacrylate, poly isobutylacrylate, which read on the claimed butylacrylate second monomers, and Fedorchak teaches wherein they prefer temperature triggered polymers and wherein these formulations can be used to treat dry eye, which is caused by insufficient tear production and is known to cause discomfort, inflammation, etc. (See entire document; e.g. pg. 4, ln. 13-17; pg. 11, ln. 1-pg. 13, ln. 10; pg. 9, ln. 35-pg. 10, ln. 10; pg. 17, ln. 11-12; pg. 11, ln. 10-15). Fedorchak teaches wherein upon administration of the hydrogel liquid suspension the formulation releases water and can become an opaque solid gel member which conforms to/adapts to the shape of where it was administered/applied which promotes retention of the formulation and continuous drug delivery and wherein removal is as easy as flushing the eye (irrigating the hydrogel through the tear duct) with cold saline which would liquefy/partially dissolve/reduces the viscosity of the thermoresponsive polymer that hardens at physiological temperature because the cold saline would be below the LCST of the isopropylacrylamide polymer (see pg. 13, ln. 9-30; pg. 15, ln. 17-31; pg. 11, ln. 10-33), and regarding claims 15-16, Fedorchak teaches wherein the formulation can comprise excipients/additives (See pg. 15, ln. 32-pg. 16, ln. 6), and wherein the water content of the swollen hydrogel is from 50-80% which means that the polymer can comprise up to 50% of the hydrogel, which reads on the claimed concentration of 10 to about 60wt% claimed in claim 17 and wherein the polymer which forms the hydrogel can be up to 100% polyisopropylacrylamide or blends thereof which reads on the claimed at least 98 wt% polyisopropylacrylamide and at most 2 wt% of butylacrylate (See entire document; claims; pg.11, ln. 1-pg. 13, ln. 9; e.g. pg. 11, ln. 1-pg. 13, ln. 10; pg. 9, ln. 35-pg. 10, ln. 10; pg. 17, ln. 11-12).
Regarding claim 8, Fedorchak teaches wherein the plug can be removed with tweezers which reads on mechanical probing/application of pressure (pg. 8, ln. 1-3).
Regarding claim 28 and 30, Fedorchak teaches wherein their compositions/gels can be sterilized and/or crosslinked (pg. 15, ln. 32-34; pg. 22, ln. 13-15).
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)
Fedorchak does not teach wherein the hydrogel fills/occludes a tear duct, and is specifically for occluding a tear duct as is claimed in claims 1-8, 10-11, and 13-28, 30-31. However, this deficiency in Fedorchak is addressed by Zhou.
Regarding claims 1, 3-7, 10-11, 13, 20, Zhou teaches methods of treating dry eye, which is caused by insufficient tear product, in a human wherein a solid thermoresponsive polymer is administered into the duct that is used to plug/occlude the ocular channel/tear ducts and at least partially fills the channel by forming hydrogel plug which blocks the tear drainage through the punctum or canalicum/tear duct which reads on administering a hydrogel composition comprising thermoresponsive polymers (Abstract; see entire document; Col. 1, ln. 11-20; Col. 2, ln. 66-Col. 4, ln. 3; claims; examples; Col. 4, ln. 33-Col. 5, ln. 6, etc.).
Fedorchak also does not specifically teach that it was known to use a dilator before inserting the plug into the tear duct or the properties of claims 22-23. However, these deficiencies are also addressed by Zhou.
Regarding claim 22, Zhou further teaches that it was known in the art to use a dilator before inserting a plug/substance which forms the plug (See Col. 2, ln. 7-22; figure 2; Col. 2, ln. 37-55; Figure 4; Col. 2, ln. 56-63). Regarding claim 23, because the method of Zhou also forms a plug which blocks the channel(s) for the tear duct to drain it obviously also accomplishes the claimed method of being effective to increase tear moisture/volume in the eye (See entire document; abstract; claims; examples; Col. 2, ln. 66-Col. 4, ln. 3; claims; examples; Col. 4, ln. 33-Col. 5, ln. 6, etc.).
Fedorchak also does not teach wherein their hydrogel is a aqueous solution because theirs has microparticles or wherein the thermoresponsive polymer comprises the claimed polymer blends or used as an aqueous solution in the claimed concentrations. However, these deficiencies in in Fedorchak are further addressed by Stayton.
Regarding claims 1, 3-7, 10-11, 13-28, 30-31, Stayton teaches that it was known in the art to administer hydrogels comprising thermopolymer and thermosreversible solutions of n-isopropylacrylamide copolymer blends comprising butylacrylate as drug delivery devices which are temperature sensitive to triggers at for instance body temperature and exhibit a phase change, e.g. from liquid to solid when triggered by administration to the body and warming to physiological temperature, which means for administration the solution should be kept below the LCST so that it does not gel/solidify before it is administered which reads on claims 1, 19, ([0010-0014]; [0004]; [0006, phase transition at heating above 32 C]; [0007]; [0029]; examples; figure 10; [0079]; [0086]), and regarding claims 1, 3-7, 10-11, 17, 24-26, Stayton teaches wherein the aqueous solutions comprise 10-20 wt% of the hydrogel polymers regarding the instantly claimed concentrations of isopropylacrylamide to butylacrylate instantly claimed, Stayton teaches examples using up to about 50 wt% of isopropylacrylamide monomers in the polymer (See entire document; [0017]). Regarding claims 18 and 27, Stayton further teaches wherein the LCST is preferably below body temperature/physiological temperature of 37 C, and wherein phase transition occurs with heating above 32 C which reads on the claimed LCSTs (see [0086]; [0006, phase transition at heating above 32 C];). Regarding claims 15-16, Stayton further teaches wherein the hydrogels can comprise additives/excipients, e.g. therapeutic drugs and PEG as a pore forming agents (See [0027]; [0116]).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art to use the liquid/semi-liquid solution hydrogel formulations of Stayton to treat dry eye/occlude a tear duct in the method of Fedorchak and Zhou because Fedorchak teaches hydrogel polymer blends which also comprise thermoresponsive polymers specifically in concentrations of up to 50% of the liquid hydrogel formulation, specifically wherein the polymers include the same polyisopropylacrylamide as Stayton in amounts of up to 100% of the hydrogel polymer or blends thereof with other acrylate polymers, including the claimed butyl acrylates which are also taught by Stayton, and wherein these blends can be used to form the claimed hydrogel solution having a concentration of about 30 wt% as is instantly claimed because Stayton and Fedorchak teach that it was known to administer hydrogel blends of the thermopolymer polyisopropylacrylamide into/around the eye to treat dry eye, wherein the isopropylacrylamide can be the sole/100% of the hydrogel or it can comprise blends of isopropylacrylamide with other acrylate polymers, e.g. butyl acrylate and wherein when added to the body the hydrogel polymers lose water and solidify at physiological temperature thereby conforming to the shape of area of the body/orifice to which they were administered. Further, it would have been obvious to optimize the concentration to the claimed about 30 wt% of the aqueous solution because the prior art teaches 10-20 wt% as per Stayton and up to 50 wt% as per Fedorchak. Thus, it would have been obvious to one of ordinary skill in the art use these hydrogel solutions to form plugs for tear ducts/ocular channels by injecting the formulation into a tear duct in order to develop the instantly claimed method because isopropylacrylamide blends of polymer with the claimed butylacrylate were known to be administered to the eye and it was known to use thermoresponsive polymers to form plugs in the tear ducts to treat dry eye and/or form an occlusion in the channel/duct as is taught by Zhou, and the formulation of Stayton and Fedorchak would solidify after application when warming to physiological temperature which would allow the plug to conform to a patients channel and thereby give a better fit similar to the fit of Zhou which also conforms to the shape of the channel/duct. Further, it would be obvious to optimize the concentration of the polymer in the aqueous solution to afford a solution that can be administered effectively, e.g. by injection and affords a plug having the desired consistency. Additionally, one of ordinary skill in the art would be motivated to use the claimed polymer blends as taught by Stayton and Fedorchak because they were known to be safe for administration to the eye and are easily removable by flushing with cold saline and as such would not require a doctor to remove these plugs if necessary.
Regarding the claimed ratios of the first monomer to the second monomer of the thermoresponsive polymer that is instantly claimed and concentrations of the polymer in the hydrogel solutions it would have been obvious to one of ordinary skill in the art to optimize these ratios and concentrations to yield a polymer having a desired LCST of around body temperature as is instantly claimed because Stayton teaches using up to 50% by weight of the thermoresponsive monomer in their hydrogel solution and Fedorchak teaches using up to 100% of the thermoresponsive monomers, e.g. isopropylacrylamide in their aqueous hydrogels formulation and also teaches wherein their thermoresponsive hydrogels can comprise the same blends of polymers instantly claimed, including butylmethacrylate or isobutylacrylate which are types of butylacrylate as monomers in their polymer. Thus, it would have been routine optimization for one of ordinary skill in the art to determine the ratios of first monomer and second monomer, specifically isopropylacrylamide and butylacrylate to the claimed ratios of about 95:5 and 99:1 to 80:20 instantly claimed. One of ordinary skill in the art would be motivated to determine these ratios in order to afford a thermoresponsive polymer that has the desired LCST when administered to the eye/tear duct as is instantly claimed. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
It also would have been obvious to optimize the concentration of the hydrogel polymers in the aqueous solution to be the instantly claimed about 30 wt% because Stayton teaches the concentrations can be up to about 20 wt% and Fedorchak teaches that the concentrations can be up to about 50 wt% of the hydrogel solution/suspension because isopropylacrylamide blends of polymer with the claimed butylacrylate were known to be administered to the eye to treat dry eye. Further, it would be obvious to optimize the concentration of the polymer in the aqueous solution to afford a solution that can be administered effectively, e.g. by injection and affords a plug having the desired consistency. Additionally, one of ordinary skill in the art would be motivated to use the claimed polymer blends as taught by Stayton and Fedorchak because they were known to be safe for administration to the eye and are easily removable by flushing with cold saline and as such would not require a doctor to remove these plugs if necessary. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding the newly added steps b) and c) in claim 1, the permitting and activating steps are result effective of injecting the claimed hydrogel into a tear duct of the subject which is taught/rendered obvious by the combined references as discussed above, because the trigger which activates said stimuli responsive polymer to initiate the phase change is temperature, e.g. body temperature, which prompts the phase transition of the polymer, the step of injecting the hydrogel into the tear duct is what leads to the hydrogel conforming to the shape of the tear duct and then warming with the body temperature prompts the phase change which forms the plug in the tear duct.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fedorchak (WO2017165449, with priority to 03/22/2016), Zhou et al. (US6234175, from IDS), and Stayton et al. (US20070224241) as applied to claims 1, 3-7, 10-11, 13-28, 30-31 above and further in view of Shenon (https://clspectrum.com/issues/1996/april/punctal-occlusion/, 1997).
Determination of the scope and content of the prior art
(MPEP 2141.01)
The combined references together teach the method of claims 1, 3-7, 10-11, 13-28, 30-31 above and incorporated herein.
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)
The combined references do not teach wherein the occlusion of the tear duct increases retention of a topical pharmaceutical, etc. as claimed in claim 12.
However, this deficiency in the combined references is addressed by Shenon.
Shenon teaches that punctal plugs such as those taught by combined references allow for artificial tears which read on the claimed topical pharmaceutical to be retained longer after the plug is placed because the topical pharmaceutical/topical artificial tears do not drain from the blocked/occluded tear duct (see who will benefit from punctal occlusion? Section; educating patients section)
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art that occlusion of the tear duct by a punctal plug which is taught by the combined references increases retention of a topical pharmaceutical because this is already a known function of punctal plugs as taught by Shenon which is what applicant’s invention which is taught and/or rendered obvious by the combined prior art is also accomplishing. Thus, it would be obvious to use the occluding plugs taught by the combined references to develop the claimed method and to increase retention of topical pharmaceuticals such as artificial tears in order to provide adequate lubrication to a user’s/subject’s eyes.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fedorchak (WO2017165449, with priority to 03/22/2016), Zhou et al. (US6234175, from IDS), and Stayton et al. (US20070224241) as applied to claims 1, 3-7, 10-11, 13-28, 30-31 above and further in view of Nagaoka et al. (Macromolecules, 1993, 26, 7386-7388).
Determination of the scope and content of the prior art
(MPEP 2141.01)
The combined references together teach the method of claims 1, 3-7, 10-11, 13-28, 30-31 above and incorporated herein.
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)
The combined references do not teach wherein the polymer/copolymer is crosslinked via irradiation. However, this deficiency in the combined references is addressed by Nagaoka.
Nagaoka teaches that crosslinking of isopropylacryamide based hydrogels can be readily crosslinked with irradiation (See pg. 7386, left col., 1st paragraph, 3rd paragraph; see entire document).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art that the crosslinking of polymers/copolymer hydrogels of the combined references can be crosslinked using irradiation because Nagaoka teaches that crosslinking of isopropylacryamide based hydrogels can be readily crosslinked with irradiation, and because this is a known method of crosslinking the claimed types of polymers it would be obvious to use irradiation to crosslink the polymers of Fedorchak and the combined references since it provides easy methods to crosslink isopropylacryamide based hydrogels.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-7, 10-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11400044 in view of Shenon (https://clspectrum.com/issues/1996/april/punctal-occlusion/, 1997).
‘044 claims methods of treating dry eye (which is caused by insufficient tear production) comprising the claimed step of injecting the same hydrogel comprising the same stimuli responsive polymers, specifically the same copolymer as instantly claimed to the same tear duct of a subject and wherein the copolymer of N-isopropylacrylamide and butylacrylate, wherein the N-isopropylacrylamide is at least 98 wt % of the copolymer and the butylacrylate is at most 2 wt % of the copolymer, the copolymer has the same LCST as instantly claimed and is present in an aqueous solution in the same/overlapping concentrations that are instantly claimed, and wherein the polymer further comprises at least excipient and/or at least one additive, and also wherein said stimuli-responsive polymer is a liquid or semi-liquid prior to injecting, and wherein said stimuli-responsive polymer at least partially fills said tear duct, and wherein said trigger is a change in temperature. ‘044 also teaches removing the plug after treatment of said dry eye by applying a stimulus to the plug so that the viscosity of the stimuli-responsive polymer in the plug decreases. ‘044 further teaches/claims the same subjects as instantly claimed, and increasing the tear volume/moisture in the eye, and wherein the stimuli responsive polymer is crosslinked and sterilized and wherein the polymer has the same properties instantly claimed and wherein a dilator is inserted into the tear duct for dilation prior to said injection. f
‘044 does not teach that the occlusion of the tear duct increases the retention of a topical pharmaceutical and specifically limits their method to treating dry eye while the instant method is to occluding a tear duct. Shenon teaches that punctal plugs such as those taught by combined references allow for artificial tears which read on the claimed topical pharmaceutical to be retained longer after the plug is placed because the topical pharmaceutical/topical artificial tears do not drain from the blocked/occluded tear duct (see who will benefit from punctal occlusion? Section; educating patients section)
However, as all of the active steps of the claimed method are the same as those taught by ‘044 and or rendered obvious by the combination of ‘044 and Shenon. It is clear the instant application is a variant of the invention taught by ‘044 in view of Shenon.
Response to Arguments/Remarks
Applicant’s amendments to the claims have overcome/rendered moot the previous 112 rejections and claim objections which are hereby withdrawn.
Regarding applicants arguments with respect to the 103 rejection, these arguments have been fully considered at length but in light of this further consideration and discussion with another examiner, these arguments are not persuasive at this time.
Firstly, applicants argue that the only reference that there is no motivation to combine the references of the prior art. Applicants argue that the only prior art which mentions tear duct is Zhou, and that because of this the prior art is not combinable. Applicants further argue that the selection of the stimuli-response polymer is important with respect to the overall performance of the claimed methods. The examiner respectfully disagrees because applicants have not demonstrated any criticality with respect to the claimed tear duct administration, e.g. they have not demonstrated that other ranges of polymers do not work and that administration to the tear duct leads to different results/effects that administration of the polymers to other parts of the eye to plug injuries, etc. as discussed above.
Applicants then argue the references separately. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicants then further argue that Whalen and Fedorchak are both silent to injection of the hydrogel into channels such as a tear duct, and that Zhou teaches mechanical removal of the punctal plug to ensure the plug is hard because they say this removes any risks of removing a soft plug that may break into small pieces when pulled out with forceps and that Zhou requires cooling to harden the plug, whereas the instant invention plug is removed by applying a stimulus so that the plug dissolves for removal and that this feature is contrary/counter-intuitive to the teachings of Zhou because Zhou wants to harden the material prior to removal because they say there is a risk of breakage into small pieces and as such applicant’s argue that it is their Declarant’s opinion (the declaration filed by applicant’s Declarant will be addressed fully below in a separate section) that a skilled artisan would not incorporate or use the stimuli-responsive polymers of Whalen and Fedorchak in tear ducts to plug the duct as is taught by Zhou because Zhou wants the polymers to harden. The examiner respectfully disagrees because the instantly claimed polymers are solubilized and do not break up into small pieces and as such the removal of the stimuli-responsive polymers of Whalen and Fedorchak would be less invasive than the manual removal of Zhou and these types of polymers were already known for use in the eye to plug wounds, etc. and to be removed via irrigation which solubilizes/dissolves the polymer and decreases the viscosity and allows for removal from the eye as is taught by Whalen and/or Fedorchak above and thereby these polymers can be removed without the risk of breaking into small pieces contrary to applicants assertion and contrary to the risks discussed in Zhou.
Applicants then argue that Zhou clearly teaches away from the claimed method of step of irrigating with fluid to remove the plug as Zhou teaches the punctal plug should be cooled to harden it further for removal. The examiner respectfully points out that Zhou was not being used to teach the removal step, only that it was known to use thermoresponsive polymers in tear ducts to block/plug the tear duct and to remove these plugs from the duct, and that it was known to use a dilator prior to injecting the polymer into the tear duct, and respectfully it is the combination of the prior art references together which still renders obvious the instantly claimed method for the reasons discussed above which are incorporated herein. Further, Zhou is not the primary reference contrary to applicants arguments that appear to be treating Zhou as the primary reference and contrary to these arguments the rejection above does not make Zhou unsatisfactory for its intended purpose, which is treating dry eye and plugging a tear duct with a polymer plug which is injected into the duct.
Applicants then argue that they have evidence of unexpected results which are presented in the declaration. They argue that one of the key features of the present invention is the easy removal of the plug from the tear duct with their claimed polymer blend. They argue that in the declaration their irrigation study shows that their specifically claimed blend e.g. at least 98% N-isopropylacrylamide and at most 2% of butyl acrylate is easier to remove than other blends of the same polymers, e.g. 5% butylacrylate and 95% N-isopropylacrylamide. They argue that a significant difference was observed with the blends that specifically their claimed blends do not require as high of irrigation pressure to remove the plug as blends outside the scope of their claims, e.g. 5% butylacrylate and 95% N-isopropylacrylamide. The examiner respectfully points out that this result does not actually appear to be unexpected. Because 5% of butylacrylate is more than double the amount of butyl acrylate claimed so it is not unexpected that the irrigation pressure is different from the claimed polymer blends, e.g. more than double the amount of pressure required to remove the plug. Thus, contrary to applicants arguments their results are not in fact unexpected and are merely the optimization of the prior art ranges discussed by Whalen in order to form the most effective and easily removed polymer plugs for filling ducts/openings, e.g. tear ducts as taught by Zhou, in patients in need thereof especially since Whalen already teaches using cold fluids to remove their plugs/thermoresponsive polymers from where they are used in the body. Thus, again it is the combination of the references together which renders obvious applicant’s claimed method(s).
Declaration under 1.132
Roby Menefee provided a declaration under 1.132, filed 08/29/25. The Declaration meets the formal requirements. In the most relevant part, the Declaration presents the Declarant’s opinion that the present invention is directed to treating dry eye in a subject, that the method involves injection of a hydrogel comprising stimuli-response polymers into a tear duct of a subject, and that the declarant has concerns that all of the prior art documents do not discuss placing/injecting/administering polymers to tear ducts. The declarant argues that the closest prior art is Zhou. The examiner respectfully disagrees. Zhou is merely being used to teach that it was known to place thermoresponsive polymer into the tear duct to plug/occlude the ocular channel/tear ducts and at least partially fills the channel by forming hydrogel plug, and that it was known to use a dilator before inserting a plug/substance which forms a plug, etc. wherein the teachings of Zhou used are clearly addressed above and Zhou is not the primary reference used. Declarant then further argues that their approach to removal of the plug is different from that of Zhou. Again the examiner does not agree that Zhou is the closest prior art merely because Zhou is directed to tear ducts. Further, applicant’s removal method of irrigating with a cold fluid to reduce the viscosity of the polymer plug/solubilize the polymer plug was already known in the art as is taught by Whalen with the same/overlapping polymer blends of the same polymers which are instantly claimed. The Declarant further discusses the results from their irrigation experiment which were also discussed above with respect to applicants remarks.
A Declaration is due full consideration and weight for all that it discloses. Declarations are reviewed for the following considerations: 1) whether the Declaration presents a nexus such as a side-by-side or single-variable comparison (In re Huang, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996)), 2) whether the Declaration presents a comparison to the closest art, 3) whether the Declaration is commensurate in scope with the scope of the claims (In re Kulling, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)), 4) whether the Declaration shows a difference in kind rather than merely a difference in degree (In re Waymouth, 182 USPQ 290, 293 (C.C.P.A. 1974)), and 5) whether the prima facie case is sufficiently strong that allegedly superior results are insufficient to overcome the case for obviousness (Pfizer Inc. v. Apotex, Inc., 82 USPQ2d 1321, 1339 (Fed. Cir. 2007)).
The relevant criterion here is No. 4, whether the Declaration shows a difference in kind rather than merely a difference in degree (In re Waymouth, 182 USPQ 290, 293 (C.C.P.A. 1974)). The examiner has carefully reviewed the Declaration, including the data presented in the Declaration. The data shows that the claimed polymer blends use lower irrigation pressure to remove than blends with increased amounts of butylacrylate. However, the claimed N-isopropyl acrylamide and butyl acrylate polymer blends were already known in the art to be used in the body as Whalen teaches administering (including by the claimed route of injection/injecting) a hydrogel comprising the same/overlapping blends of the same stimuli-responsive polymer to a subject, specifically wherein the stimuli-responsive polymer are activated by a trigger/stimuli for a phase transition which forms a solid or semi-solid from the administered liquid or semi-liquid, wherein the trigger is a change in temperature, specifically heating the stimuli-responsive polymer, and the stimuli-responsive polymer is a thermoresponsive polymer so that the polymer is in liquid form prior to administering and becomes solid after administering with body heat/body temperature and wherein the hydrogel can form a solid/solid like plug when administered to the body and being exposed to the temperature increase of the body’s temperature and wherein the formulations are/can be administered/injected into various parts of the eye which would broadly include the claimed tear duct and because Whalen already teaches forming hydrogel plugs/implants for use in the eye and which are removed by irrigation with cold fluids it would be obvious to optimize the blends of the polymers being used in the eye/parts of the eye which would include the tear ducts to provide the most effective plugs/implants which can be easily removed with as low of irrigation pressures as are acceptable for complete removal of the plugs/implants in order to provide the safest and easiest removal for patients using these plugs/implants in their eyes. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, because the ranges/ratios of the N-isopropylacrylamide and butylacrylate in Whalen overlap with those instantly claimed the courts have previously determined, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.” In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). That is the results merely show that the lower amounts of butylacrylate require less irrigation pressure, but do not demonstrate that these effects are actually unexpected and/or a difference in kind from the comparative results which contain more than double the amount of butylacrylate, e.g. 5% butylacrylate and 95% N-isopropylacrylamide which the examiner would expect would require a different irrigation pressure to remove and as discussed above Whalen clearly teaches blend of polymers which encompass the claimed N-isopropylacrylamide and butylacrylate of 98:2-99:1, etc.
Declarant then argues their opinion that Whalen does not appreciate that the butyl acrylate content is critical with respect to removing the hydrogel. The examiner respectfully disagrees as Whalen teaches that any blend of N-isopropylacrylamide and butyl acrylate in ratios of 50:50 to 99:1 can be used in their inventions to fill/plug tears and perforations, etc. and eye damage but they clearly teach that these ratios of N-isopropylacrylamide and butyl acrylate can be optimized to provide the most effective plugging and removal by irrigation with cold fluid as is discussed above and in the cited portions of the Whalen reference. The courts have previously determined, “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, the examiner disagrees with declarant’s opinion because it would be obvious to optimize the ratios of N-isopropylacrylamide and butyl acrylate to have the butyl acrylate be no more than 2% as claimed in order to provide the most effective N-isopropylacrylamide and butyl acrylate plug which can be easily removed with irrigation with cold fluid which is already taught by Whalen, especially since Whalen already teaches using the claimed N-isopropylacrylamide and butyl acrylate in and around the eye. Thus, it would be obvious to use these polymers to treat dry eye and/or administer to the tear ducts as necessary to patients in need thereof (the examiner notes that applicants subjects do not even have to be in need of said treatment as the claim currently reads) because it was known to use polymer plugs in tear ducts to treat dry eye, etc. and other plugs which are more easily and safely removed and are known to be safe to the eye would be obvious when taken in view of the teachings of Whalen and/or Fedorchak for the reasons discussed above.
In assessing the probative value of an expert opinion, the examiner must consider the nature of the matter sought to be established, the strength of any opposing evidence, the interest of the expert in the outcome of the case, and the presence or absence of factual support for the expert’s opinion. Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 227 USPQ 657 (Fed. Cir. 1985), cert. denied, 475 U.S. 1017 (1986). See also In re Oelrich, 579 F.2d 86, 198 USPQ 210 (CCPA 1978). In the instant case, declarant’s opinion has some weight but the examiner notes that the expert/declarant has a very high level of interest in the outcome of the case as the declarant works for the assignee/applicant, and the evidence/factual support of the argued unexpected results does not appear to be very strong as the prior art Whalen clearly teaches using the claimed polymer blends in the eye as plugs/implants/inserts to plug/close tears/deformations/wounds, etc. in the eye in ratios which encompass those instantly claimed and to remove these plugs/implants via the same cold fluid irrigation instantly claimed and it was known to use thermoresponsive polymers to plug tear ducts. Thus, it would be obvious to use the polymer blends of Whalen in tear ducts to provide the same plugging action taught by Zhou and to remove using the cold irrigation with fluid taught by Whalen because these polymers were known to be safe for use in the eye in the claimed ratios. Determining which ratios of the known polymer blends of Whalen which are/would be easiest to remove with cold fluid irrigation is optimizable and something one of ordinary skill in the art would routinely do in order to make the plugs easy to use and safely remove for users.
Finally, Declarant argues/opines that the polymers of Whalen which teaches the same polymers instantly claimed in ratios which overlap those instantly claimed, are directed for sealing an ocular perforation which is different than treating a tear duct. The examiner respectfully points out that it was known to use the claimed polymer blends to plug openings (e.g. tears, perforations, etc.) in the eye and to remove them by the same cold fluid irrigation that is instantly claimed. One of ordinary skill in the art who knows that ocular plugs are routinely used to plug tear ducts and which can be difficult/painful to remove as is taught by Zhou, would be motivated to try the polymer plugs of Whalen to plug the tear duct because these polymer plugs are readily solubilized by the cold irrigation fluid for removal and are safe for the eye as is taught by Whalen in order to provide plugs which are less painful and easier to remove for the patient. Thus, the examiner respectfully disagrees with the Declarant that the instantly claimed method is not obvious when taken in view of the prior art at this time upon further consideration of teachings of the prior art and updated searching. Thus, this declaration does not overcome the rejections of record at this time.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Applicant's amendments necessitated the revised/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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin E Hirt whose telephone number is (571)270-1077. The examiner can normally be reached 10:30-7:30 ET M-F.
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/ERIN E HIRT/Primary Examiner, Art Unit 1616