DETAILED ACTION
The receipt is acknowledged of applicant’s amendment filed 02/05/2026.
Claims 1-4, 7-8, 10-20 previously presented. Claims 13-20 have been canceled. Claims 1-4, 7-8 and 10-12 are currently pending.
Claims 3 and 7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions and species. Election was made without traverse in the reply filed on 11/19/2024.
Claims 1-2, 4, 8, 10-12 are subject of this office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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, 2, 4, 8, 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Qiu et al (US 6,896,926, previously cited on PTO 892), and Brown et al. (2017/0266352, IDS filed 09/20/2021).
Applicant Claims
Claim 1 is directed to a contact lens for treating an ocular disorder comprising: (a) a lens body; and
(b) a uniform coating thereon,
wherein the uniform coating comprises a plurality of polycation layers and a plurality of polyanion layers forming plurality of bilayers;
wherein each bilayer comprises a polycation layer and a polyanion layer;
wherein the polycation layer is selected from the group consisting of chitosan, a glycol-chitosan, an amine-grafted chitosan, a fluorescent-tagged chitosan, collagen, and combinations thereof;
wherein the polyanion layer is selected from the group consisting of dermatan, dermatan sulfate, hyaluronate, an alginate, chondroitin sulfate, heparan sulfate, and combinations thereof,
wherein at least one layer of the plurality of bilayers comprises a combination of dermatan sulfate and an M2 polarizing active agent;
wherein the M2 polarizing active agent and the dermatan sulfate are present within the at least one layer at a ratio between about 1:10 to about 1:2000;
wherein the total number of bilayers comprising the dermatan sulfate and the M2 polarizing agent ranges from about 20 to about 90; and
wherein the uniform coating releases the M2 polarizing active agent in an amount from about 100 pg to about 450 pg over a period of 30 days.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Qiu teaches contact lens to enhance wear’s health and ocular comfort. The lens is coated with multiple layers of polyanionic materials comprising first and second polymer (abstract; col.2, lines 56-67). The coating layers comprise alternative layers of two oppositely charges polymeric materials deposited onto the surface of contact lens (col.3, lines 15-20; col.10, lines 17-26). The alternative layers are polyanionic polymers and polycationic polymers forming a coating comprising 20-40 layers. Each layer is bilayers comprising polycationic and polyanionic polymer. Polyanionic polymers include polysaccharides, e.g. chondroitin sulfate (dermatan sulfate), hyaluronate and alginate (col.7, lines 10-60; col.10, lines 17-43). Polycationic polymers include chitosan (col.8, lines 52-54; col.11, lines45-50; claim 13). The contact lens is silicone hydrogel (col.7, lines 10-60; col.9, lines 11-46). The coating materials further comprises active agent and cell growth inducing materials (col.12, lines 53-56; col.13, lines 1-9).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Qiu teaches Polyanionic polymers include chondroitin sulfate (dermatan sulfate), and Polycationic polymers include chitosan, however the reference does not teaches the species of chitosan as claimed by claim 1. The reference does not exemplify dermatan sulfate and chitosan.
While Qiu teaches coating layers comprising active agent and cell growth inducing materials, the reference does not explicitly teach M2 polarizing active agent, its amount and its period of release as claimed by claim 1.
Brown teaches biomaterials, e.g. lens, coated with alternating layers of polycation and polyanion, and comprises active agent. Polycations can be chitosan, e.g. glycol chitosan, amine-grafted chitosan and fluorescent-tagged chitosan. Polyanions can be dermatan sulfate. Active agent comprises M2 polarizing agent., e.g. HGF, IL-4. The coating can have thickness of 0.5 nm to 500 µm. The coated lens releases the active agent when degrades by chitosan degrading enzymes. The coated lens results in improved integration of the biomaterials to the host tissues compared to none coated biomaterials resulting into faster tissue regeneration and reduced morbidities. The number and sequence of layers can be easily modified in order to provide the desired amount and release time of the active agent. Brown teaches, in preparing the drug eluting coating, 1.5 µg/ml of IL4 (M2 polarizing agent) mixed with 2 mg/ml dermatan sulphate. This constitute the ratio on 1.5 µg: 2000 µg of M2 polarizing agent to dermatan sulfate, i.e. ratio of 1.5:2000 that falls within the claimed ratio. The active agent is released for 30 days. The multiple polycationic and polyanionic coating provides the advantage of significant effect on macrophages polarization at lower controllable and safer doses of only picograms to nanograms. The coating comprises 30-70 layers, each is a bilayer of polycation and polyanion (¶¶ 0006-0010, 0036, 0038-0043, 0051, 0092-0093, 0102, 0126-129, 0142).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide contact lens coated with alternating layers of polycations and polyanion wherein the coating layers comprises active agent and cell growth inducing materials as taught by Qiu, and use chitosan selected from glycol chitosan, amine-grafted chitosan and fluorescent-tagged chitosan as polycation and dermatan sulfate as polyanion and use M2 polarizing agent including HGF and IL-4 as taught by Brown. One would have been motivated to do so because Brown teaches device, e.g. contact lens, coated with alternating layers of chitosan, e.g. glycol chitosan, amine-grafted chitosan and fluorescent-tagged chitosan, and dermatan sulfate and comprises HGF and IL-4 results in improved integration of biomaterials to the host tissues compared to none coated biomaterials resulting into faster tissue regeneration and reduced morbidities. One would reasonably expect formulating contact lens coated with alternating layers of polycations and polyanion comprising M2 wherein the polycations layer comprises chitosan and polyanion layers comprises dermatan sulfate wherein the lens has improved integration of biomaterials to the host tissues compared to none coated biomaterials resulting into faster tissue regeneration and reduced morbidities.
Further, it would have been obvious to one having ordinary skill in the art to use the active agent in picograms amounts as taught by Brown because Brown teaches multiple polycationic and polyanionic coating provides the advantage of significant effect on macrophages polarization at lower controllable and safer doses of only picograms.
Regarding the claimed polycations claimed by claim 1, Qui teaches chitosan and Brown teaches the claimed species of chitosan.
Regarding the claimed polyanions claimed by claim 1, Qui and Brown both teach dermatan sulfate, hyaluronate and alginate.
Regarding claim 1 that the coating comprises dermatan sulfate and M2, combination of the cited references teaches polyanion layer comprises active agent and teaches polyanion layer can be dermatan sulfate and active agent can be M2. Therefore, combination of the both elements is suggested by combination of cited references.
Regarding the ratio of M2 polarizing agent to the dermatan sulfate as claimed by claim 1, Brown teaches 1.5 µg/ml of IL4 (M2 polarizing agent) mixed with 2 mg/ml dermatan sulphate. This constitute the ratio on 1.5 µg: 2000 µg of M2 polarizing agent to dermatan sulfate, i.e. ratio of 1.5:2000 that falls within the claimed ratio. It has been held that where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In any event, one having ordinary skill in the art would have determined the ratio within the claimed broad ratio according to specific condition to be treated and its severity. Applicants failed to show unexpected results obtained from any specific ratio.
Regarding the number of bilayers ranging from about 20 to about 90 bilayers as claimed by claim 1, Qiu teaches 20-40 bilayers that overlaps with the claimed number of bilayers, and Brown teaches 30-70 bilayers that falls within the claimed number of bilayers. 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 re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ 2d 1934 (Fed. Cir.1990). Determining the optimal concentration of plasticizer and water-soluble flavoring is deemed to be routine and well within the skill of the artisan.
Regarding the amount of the active agent released from the coating, and its period of release as claimed by claim 1, Brown teaches release of safer controllable amount in picograms and teaches period up to 30 days of release. One having ordinary skill in the art would have determined the amount of the drug needed based on the required period of using the drug because the reference teaches the number and sequence of layers can be easily modified in order to provide the desired amount and release time of the active agent.
Regarding silicone hydrogel claimed by claim 2, it is taught by Qiu.
Regarding the intended use of the contact lens to treat the disorders claimed by claim 4, the cited references teach treating ocular disorders, e.g. discomfort, corneal haze and scar. In any event the intended use of the claimed lens does not impart patentability to the claims.
Regarding the thickness of the coating as claimed by claim 8 of 0.5 nm to 500 µm, Brown teaches the same claimed coating thickness.
Regarding coating comprises protein as claimed by claim 10, one having ordinary skill in the art would have added microphage enzymes in the coating to help degrading and release of the active agents including enzymes from the multilayered coating because Brown teaches release of active agent upon degradation of the multiple layers. Applicants failed to show unexpected results obtained from the claimed enzymes in particular.
Regarding claim 11 that coating is placed on the lens body without altering an optical property of the contact lens, wherein the optical property includes vision correction, this is an expected function from the contact lens obtained from combination of the prior art that comprises the claimed material and the claimed coating.
Regarding claim 12 that the coating is uniformly coated on a surface of the lens body without being exposed to plasma gas, Qui teaches method of coating the lens without using plasma gas. The process of coating the lens is directed to process of making the lens that impart no patentability to product claims.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 02/05/2027 have been fully considered but they are not persuasive.
Rejections Under 35 U.S.C. § 103
Claims 1, 2, 4, 8 and 10-12 over Qiu and Brown
Applicants argue that Brown does not suggest any means of optimizing a coating for a lens with the claimed total number of bilayers capable delivering 100 pg to 450 pg of an M2 polarizing agent over a period of 30 days as claimed by amended claim 1 because Brown fails to consider how the physical properties of the device to which the coating is applied (e.g., a contact lens or a mesh) impacts the amount of the coating, and therefore the amount of the M2 polarizing agent that is incorporated into the device. Brown teaches a bilayer coating comprising an M2 polarizing agent is coated on a mesh of intertwined fibers, and the release of specific amounts of the M2 polarizing agent can be tuned by the controlling the number of bilayers containing the agent (see Brown [0129]). For example, Brown demonstrates applying 20-60 layers containing the M2 polarizing active agent to a mesh results in delivering 0.5 ng/cm² (for 20 bilayers) to 3.5 ng/cm² (for 60 bilayers) of IL- 4 over 30 days (see Brown, Figure 5B).
In response to this argument, applicant’s attention is directed to the scope of the present claims that are directed to a product, and all the elements of the claimed product are taught by combination of Qiu and Brown. Both references suggest the claimed number of bilayers on lens. Qiu teaches 20-40 bilayers that overlaps with the claimed number of bilayers, and Brown teaches 30-70 bilayers that falls within the claimed number of bilayers. The ingredients and materials of each layer of the bilayer are taught by combination of the prior art. The ratio of M2 polarizing agent to the dermatan sulfate as claimed by claim 1 is taught by Brown that teaches 1.5 µg/ml of IL4 (M2 polarizing agent) mixed with 2 mg/ml dermatan sulphate. This constitute the ratio on 1.5 µg: 2000 µg of M2 polarizing agent to dermatan sulfate, i.e. ratio of 1.5:2000 that falls within the claimed ratio. Therefore, capability of the bilayer coating of the claimed device to deliver is specific amount of M2 for specific time is expected from combination of the cited references, absence evidence to the contrary. Further, the physical properties of the device and coating taught by combination of the cited references that have the same material of coating the same number of bilayers and same amount of active agent are expected to have the same claimed delivery rate of active agent for the same period.
Applicants argue that Brown fails to suggest how the properties of the device, such as the geometry mesh, impacts the amount of the coating that adheres to the device and does not provide any guidance regarding how to differentially tune the bilayer to control the release of an M2 polarizing agent when the coating is applied to a geometrically different device (e.g., the hemisphere of a lens).
In response to this argument, it is argued that the combination of Qiu with Brown suggests the claimed device that is an intraocular lens made from the same materials and having the same coating, as set forth in this office action, and any properties applicants achieves would have been expected from the prior art. The discovery of a new action underlying a known process does not make it patentable. MEHL/Biophile, 192 F.3d at 1365, 52 U.S.P.Q.2d at 1303. Also, it is irrelevant that the prior art observers did not recognize the property or function of the disputed claim; if the prior art inherently possessed that characteristic, it anticipates. See Verdeegal Brothers, lnc. v. Union Oil Co. of Cal., 814 F.2d 628, 633, 2 U.S.P.Q.2d 1051, 1054 (Fed. Cir. 1987). This is believed to be applicable here because anticipation is the epitome of obviousness.
It is further noted that applicants argue against Brown reference individually, and one cannot show non-obviousness by attacking the references individually wherein obviousness is based on combination of the cited references.
Applicants argue that the geometry of the fibrous mesh of Brown is distinct from the claimed lens, thereby differentially impacting how an M2 polarizing agent (e.g., IL-4) is absorbed by and released from the device. For instance, Brown teaches a mesh coated with 40 bilayers containing IL-4 at a ratio of 1.5:2000 of IL-4 to dermatan sulfate, which releases 2000 pg of IL-4 per cm² of mesh over a period of 30 days. In contrast, the present application shows that a coated lens comprising 40 bilayers containing IL-4 at the same ratio as Brown releases significantly less IL-4 over the same 30-day period. Figure 5 of the application demonstrates that the coated lens, treated with the same enzyme concentration used by Brown, releases a total of 450 pg of IL-4 from the coating. Changing the underlying device to which the bilayer coating is applied (e.g., from a mesh to a lens) significantly impacts the amount of the active agent released. The coating cannot be readily modified to tune the desired release amount and duration, as it behaves differently depending on the substrate to which it is applied.
In response to this argument, applicant’s attention is directed to the teachings of Brown in paragraphs [0006]-[0007] wherein the reference clearly teaches the drug released in mainly dependent on the coating material and not on the device. The reference teaches: “….wherein implantation of the coated biomaterial results in modulation of the local immune reaction and reduced implant-related complications and/or improved integration of the biomaterial into the host tissue.….”, ….“It is based, at least in part, on the discovery that biomaterial coated with a cytokine eluting coating resulted in the shift of early stage macrophage polarization that was associated with positive long-term effects such as minimized capsule formation and improved tissue quality and composition as compared to uncoated biomaterials….” “….the biomaterials are coated with at least one polycation layer, at least one polyanion layer, and at least one active agent containing layer. In certain embodiments, the active agent is released from the coating and polarizes macrophages to an M2 phenotype. In certain embodiments, the biomaterial can be, but is not limited to, …. intraocular lenses”.
The reference compare the coated and uncoated biomaterials, and discovered that the coated biomaterials, including intraocular lenses, shows release of included bioactive agents. The reference does not differentiate between the material of the active agent in terms of drug release, rather the coating material because the drug release is based on the coating itself and not on the coated material or device. Therefore, changing the underlying device to which the bilayer coating is applied (e.g., from a mesh to a lens), does not significantly impacts the amount of the active agent released. The coating can be modified to tune the desired release amount and duration regardless of the and independent on the underlying device and material on which the coating is applied, as drawn from the teachings of Brown.
It is noted that, again, applicants argue against Brown reference individually, and one cannot show non-obviousness by attacking the references individually wherein obviousness is based on combination of the cited references: Qiu and Brown. Combination of the cited references will results on intraocular lens made of the material taught by Qiu and coated with the bilayer coating as claimed.
In making the rejection, the examiner did not replace the intraocular lens of Qiu with the mesh of Brown, rather, one having ordinary skill in the art would have provided contact lens coated with alternating bilayer comprising layers of polycations and polyanion as taught by Qiu wherein the coating layers comprises active agent and cell growth inducing materials. One having ordinary skill in the art would have modified the coating of Qiu to use chitosan taught by Brown selected from glycol chitosan, amine-grafted chitosan and fluorescent-tagged chitosan as polycation and dermatan sulfate as polyanion and use M2 polarizing agent including HGF and IL-4. Motivation to do so are discussed above in the rejection, and reasonable expectation to achieve the present invention has been presented above.
Applicants argue that amended claim 1 requires the coating comprises between 20 and 90 bilayers that releases up to about 450 pg of IL-4 over 30 days. Nothing in Brown indicates that its bilayer coating is capable of possessing the claimed number of bilayers (from 20 to 90) while delivering a maximum amount of 450 pg of IL-4. Rather, Brown demonstrates a bilayer coating comprising 20-bilayers containing an M2 polarizing agent delivers more than 500 pg of IL-4 per cm² of the device, which exceeds the release profile required by amended claim 1. Applicant submits that neither Qui nor Brown provides guidance to a skilled artisan to modify the coating or the concentration of the M2 polarizing active agent in a manner that accounts for the markedly different release properties observed when the coating is applied to a lens. Accordingly, a skilled artisan would not be motivated to combine Qui and Brown to arrive at the claimed invention with any expectation of success.
In response to this argument, it is argued that cited references in combination teaches controlled release of active agents M2 from multilayered polyelectrolyte film used on contact lenses comprising the number of the claimed bilayers. In particular, Brown clearly teaches safe controllable delivery of M2 in picogram amount. Regarding the amount of the active agent, and time of its release, Brown teaches release of safer controllable amount in picograms and teaches period up to 30 days of release. One having ordinary skill in the art would have determined the amount of the drug needed based on the required period of using the drug because Brown teaches the number and sequence of layers can be easily modified in order to provide the desired amount and release time of the active agent. Applicants attention is directed to the scope of the present claims that are directed to a product, and all the elements of the claimed product are taught by the combination of the cited references. Further, it is argued that the claimed number of layers are suggested by both reference as set up in this office action. Furthermore, the thickness of the coating as instantly claimed is taught by Brown. Brown recognized the advantage of using small doses in picogram for safety and controllability of the M2 release for prolonged period of 30 days. Brown further teaches that the number and sequence of layers can be easily modified in order to provide the desired amount and release time of the active agent.
Note that Brown teaches composition comprising dermatan sulfate and M2 provides controlled delivery of M2 polarizing agents in pg doses that are therapeutically effective amounts to induce an anti-inflammatory M2 phenotype in macrophages, which can target macrophage-centric pathways associated with inflammatory diseases, as applicants had done. Any property applicants achieved is expected from the combination of the cited references especially the combination teaches the same claimed cationic and anionic polymers to provide controlled release of active agents and enzymes, and the ratio of the polymers to the M2 polarizing agent which is IL-4 is taught by Brown, as discussed above.
The combination of the cited references teaches the instantly claimed composition as claimed by claim 1. These references show that it was well known in the art at before the effective filing date of the present invention to use the claimed ingredients in coating composition for biomedical use. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art. ln re Pinten, 459 F.2d 1053, 173 USPQ 801 (CCPA
1972); ln re Susi, 58 CCPA 1074, 1079-80) 440 F.2d 442, 445; 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21; 279 F.2d 274, 276-277; 126 USPQ 186, 188 (1960). Based on the disclosure by the cited references that the claimed substances are used in compositions for coating biomedical surface, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions to the same purpose. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See ln re Sussman, 1943 C.D. 518; In re Huellmantel 139 USPQ 496; ln re Crockett 126 USPQ 186.
Finally, obviousness does not require absolute predictability, only reasonable expectation of success. Brown suggests coating contact lens with multiple layers comprising dermatan sulfate and M2 as applicants, and applicants did not compare the prior art coating on the lens with the instant composition in order to establish superiority of the present invention. The obviousness does not require absolute predictability of success all that is required is a reasonable expectation of success. See In re Kubin, 561 F.3d at 1360. The Court has held that "the test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them." See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965). "There is no requirement (under 35 USC 103(a)) that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art." Motorola, Inc. v. Interdigital Tech. Corp., 43 USPQ2d 1481, 1489 (Fed. Cir.1997). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR Int'l Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.").
Conclusion
THIS ACTION IS MADE FINAL. 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 Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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/Isis A Ghali/Primary Examiner, Art Unit 1611 /I.G./
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