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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/11/2025 has been entered.
Status of the Claims
Claims 1-5, 8-11, and 15-20 were cancelled in a previous communication.
Claims 6-7 and 12-14 are pending and currently under examination.
All rejections not reiterated have been withdrawn.
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 6 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18268614 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘614 application claims render obvious the instant claims.
Inter alia the claims of the ‘614 application embrace a contact lens for drug delivery, comprising: a lens main unit; a chamber unit for storing a drug (i.e., drug storage structure), spaced apart from the center of the lens main unit; and a blocking unit (i.e., cover member) for controlling drug release, bonded to a portion of the chamber unit, wherein the chamber unit comprises a channel unit (i.e., discharge structure) through which a drug moves from the chamber unit and is released to an eye (i.e., rear surface). The ‘614 application also embraces wherein the channel unit comprises an outlet through which the drug is released; and a discharge passage through which a drug moves in order to be released (i.e., discharge path), wherein the blocking unit (i.e., cover member) is formed in a size that is able to cover 50 area% to 95 area% of the chamber unit. The ‘614 application further embraces wherein the drug comprises at least one selected from hyaluronic acid, sodium chloride, glucose, trehalose, taurine, propylene glycol, cetrimide, asparagine, retinol palmitate (i.e., dry eye syndrome treatment drug), timolol, dorzolamide, latanoprost, brimonidine, tafluprost, brinzolamide, travoprost, bimatoprost, betaxolol, carteolol, nipradilol, apraclonidine, pilocarpine, levobunolol, isopropyl unoprostone, befunolol, acetazolamide, methazolamide, diclofenamide, unoprostone (i.e., glaucoma treatment drug), levofloxacin, ofloxacin, tobramycin, moxifloxacin, gatifloxacin, oxytetracycline, sulfamethoxazole, glycyrrhizic acid, tosufloxacin, lomefloxacin, chloramphenicol, dexanethasone, tetrahydrozoline, chlorpheniranine, natamycin, ciprofloxacin, enoxolone, fusidic acid, guaiazulene, azulene, erythromycin, gentamicin, sulfanethizole, cefmuenoxime, norfloxacin, micronomycin, tetracycline (i.e., antibacterial agent) etc. The ‘614 application also embraces a vision correcting lens part. With regards to the limitation of “having a depth”, the examiner interprets the limitation to mean that the drug chamber and the drug discharge path both have a dimensions as the contact lens is a 3 dimensional structure which has at least a depth portion to it, therefore, the drug chamber and the drug discharge path of the ‘614 application has a depth.
The ‘614 independent claim does not require the instantly claimed vision correcting lens portion positioned in a center portion of the contact lens to refract light; however, a ‘614 dependent claim recites further comprising a vision correcting lens part. And one of ordinary skill in the art would have found it obvious to place to vision correcting lens part in the center portion of the contact lens to refract light as such would align with, for example, the cornea which is the part of the eye that refracts most of the light.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 7 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18268614 in view of Harris et al. (EP0608341B1, Published 03/27/2002; cited in the IDS filed 09/26/23).
The relevant limitations of the ‘614 application are set forth.
The ‘614 application does not embrace wherein the cover member comprises a microporous polymer in which micropores are formed. The ‘614 application also does not embrace a plurality of discharge paths connected to the single drug chamber.
However Harris et al. teaches in the analogous art of contact lens with enzyme/drug delivery, the rigid contact lenses designed for enzyme-orthokeratology comprises a lens made of a fluoro-silicone-acrylate material (methylmethacrylate difluoroitaconate siloxanyl copolymer) (page 14, paragraph [0105]). Harris further discloses one or more holes 116 (fig. 12) are made in the central portion 128 of the posterior portion 113 of the contact lens of this design. Preferably, the holes 116 are produced by mechanical drilling with a microcarbon bit or by means of a laser such as an argon laser, and will have a diameter of from about 0.002 mm to about 0.010 mm, which is equal to 2 micrometers to 10 micrometers, making micropores in the polymer (page 11, paragraph [0076]). Harris also teaches wherein the plurality of holes 116 (i.e., discharge paths) are connected to the single drug chamber 130, wherein the holes 116 (i.e., discharge paths) discharge the drug to the posterior portion 113 (i.e., end portion of the contact lens) (page 11, paragraph [0076]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have a the cover member comprise a microporous polymer having micropores in the ‘614 contact lens because Harris teaches a plurality of microscopic holes 16 are provided in the posterior portion of the lens 10 to allow fluid communication between the chamber 11 and the eye, thereby facilitating the timed release of the enzyme/agents into the cornea (page 10, paragraph [0068]), and that the lens is made of a polymer, therefore the microporous polymer will help in controlling the drug release to the eye. With regards to the plurality of discharge paths connected to the single drug chamber, it would have been obvious to one of ordinary skill to have this in the ‘614 contact lens because Harris teaches that the discharge paths facilitate the release of the drugs into the cornea (page 10, paragraph [0068]).
This is a provisional nonstatutory double patenting rejection.
Claim 12 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18268614 in view of Kim et al. (US20180143453A1, Published 05/24/2018; cited in the IDS filed 09/26/2023).
The relevant limitations of the ‘614 application are set forth.
The ‘614 does not teach a plurality of drug chambers which are apart from each other and not connected to each other; and a plurality of drug discharge paths respectively connected to the plurality of drug chambers, wherein the plurality of drug chambers store identical or different drugs.
However, in the analogous art of contact lens with drug delivery, Kim teaches in Fig. 8, a contact lens intended to deliver a drug to the eyeball, wherein the drug (i.e., identical) is filled in the chambers 50 (i.e. plurality of chambers) and the drug chambers are apart and not connected to each other as depicted in Fig. 8 (page 3, paragraph [0079]). Kim continues to teach a plurality of drug outlets 43 (i.e., drug discharge paths) wherein, the drug outlets 43 are connected to the plurality of drug chambers 50 as depicted in Fig. 8 (page 3, paragraph [0079]).
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the contact lens of ‘614 application with a plurality of drug chambers which are not connected to each other to store drugs, wherein the plurality of drug chambers have drug discharge paths connected to the drug chambers, to achieve the predictable result of obtaining a composition suitable for drug delivery to the eye. One of ordinary skill in the art would have been motivated to do so because Kim et al. teaches that this contact lens is advantageous for the drug being delivered to the eyeball wherein the drug would be evenly spread over the entire eyeball (page 4, paragraph [0084]), as well as ensuring high productivity and excellent efficiency (page 4, paragraph [0097]). Therefore, given the state of the art as evidenced by the teachings of Kim, and absent to any evidence of the contrary, there would have been a reasonable expectation of success in combining the teachings of the ‘614 application and Kim to form a contact lens with a plurality of drug chambers.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 06/11/2025 with respect to the nonstatutory double patenting have been fully considered but they are not persuasive.
On page 11 of Applicants remarks, Applicant comment that since there are other rejections raised against the instant application, an appropriate reply will be submitted to the office at the conclusion of the prosecution of the instant application if the nonstatutory double patenting rejection is properly based. Applicants further argue that the instant application has an effective filing date 01/24/2022 earlier than the effective filing date 06/21/2023 of the co-pending U.S. patent application 18/268,614.
Regarding Applicant's argument that an appropriate reply will be submitted at the conclusion of the prosecution with regards to the double patenting rejections means that the double patenting rejections should be held in abeyance, the double patenting rejections apply to the claims as they are currently written, therefore these double patenting rejections are maintained. Further, Applicants' request to hold the rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an objection or requirements as to form (see MPEP 37 CFR 1.111(b) and 714.02). Thus, the rejection is maintained in the absence of a terminal disclaimer.
With regards to the argument that the instant application has an effective filing date 01/24/2022 earlier than the effective filing date 06/21/2023 of the co-pending U.S. patent application 18/268,614, the Examiner points out that the rejection is maintained because it is not yet clear which application of these two applications will issue first.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 6-7 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harris et al. (EP0608341B1, Published 03/27/2002; cited in the IDS filed 09/26/23) as evidenced by Harooni et al. (Arch Ophthalmol, Published 1998;116(9):1218-1221).
The claims are drawn to a contact lens comprising: a vision correction lens portion positioned in a center portion of the contact lens to refract light; and a drug storage structure arranged apart from the center portion and configured to store a drug, wherein the drug is provided to an eye of a user wearing the contact lens, wherein the drug storage structure comprises: a drug chamber having a concave structure and formed in the contact lens to store the drug in the concave structure; a drug discharge path having a concave structure and formed in the contact lens, the drug discharge path being connected to the drug chamber to release the drug; and a cover member wherein the concave structure of the drug chamber and the concave structure of the drug discharge path are both formed in a rear surface of the contact lens and have a depth, the cover member covers the rear surface of the contact lens and covers the drug discharge path and the drug chamber, and the cover member does not cover an end portion of the drug discharge path, thereby forming a drug outlet.
Regarding claim 6, Harris discloses a method and apparatus for correcting refractive errors of the eye wherein the cornea is fitted with a rigid contact lens (Abstract). Harris also discloses the central (i.e., center portion) optic zone 18 (Fig. 2) is transparent and corrects the refractive error of the eye to produce excellent visual acuity (page 14, paragraph [0106]). Harris further discloses the lens is provided with an internal chamber 11 (Fig. 2) for storing the cornea softening agent (page 10, paragraph [0066]). Fig. 2 shows that chamber 11 is not overlapping with the central optic zone 18, therefore the drug storage structure is arranged apart from the center portion. Harris continues to disclose a number of enzymes and other agents, including drugs can be administered to soften a cornea in addition to or instead of administering enzymes (page 6, paragraph [0031]). Harris further discloses a plurality of microscopic holes provided to allow fluid communication between chamber 11 and the eye, thereby facilitating the timed release of the enzyme/agents into the cornea (page 10, paragraph [0068]).
PNG
media_image1.png
407
530
media_image1.png
Greyscale
PNG
media_image2.png
302
630
media_image2.png
Greyscale
Harris discloses in Fig. 12 a drug chamber 130 having a concave structure and formed in the contact lens to store the drug in the concave structure, an outer perimeters 124, 128, and 113 which covers at least the drug chamber (i.e., cover member) (page 11, paragraph [0074]). Harris continues to disclose in Fig. 12, a hole 116 (i.e., drug discharge path, see Fig. 12 for depiction of concave form) wherein the hole 116 provides communication between the chamber 130 and the surface of the eye of a subject (page 11, paragraph [0076]). Harris further discloses an outer perimeters 124, 128, and 113 (i.e., cover member) (i.e., rear surface) which covers the sides of the hole 116 (i.e., discharge path) and the drug chamber 130, but does not cover the end portion of the hole 116, thereby allowing the drug to be released (i.e., drug outlet) (page 11, paragraph [0074]).
Regarding claim 7, Harris discloses the rigid contact lenses designed for enzyme-orthokeratology comprises a lens made of a fluoro-silicone-acrylate material (methylmethacrylate difluoroitaconate siloxanyl copolymer) (page 14, paragraph [0105]). Harris further discloses one or more holes 116 (fig. 12) wherein the holes have a diameter of from about 0.002-0.010 mm (i.e., 2-10 micrometers) (page 11, paragraph [0076]).
Regarding claim 13, Harris discloses in Fig. 12, a single drug chamber 130 having a circular shape, wherein the plurality of holes 116 (i.e., discharge paths) are connected to the single drug chamber 130, wherein the holes 116 (i.e., discharge paths) discharge the drug to the posterior portion 113 (i.e., end portion of the contact lens) (page 11, paragraph [0076]).
Regarding claim 14, Harris discloses the primary enzyme used to soften a cornea is hyaluronidase (page 6, paragraph [0034]). As evidenced by Harooni et al., hyaluronidase effectively prevents increases in intraocular pressure (abstract, first conclusions paragraph). Therefore, Harris discloses hyaluronidase as the primary enzyme which is a species of an intraocular pressure lowering agent of instant claim 14.
Accordingly, Harris anticipated the claimed invention.
Response to Arguments
Applicants arguments filed 06/11/2025 have been fully considered but they are not persuasive.
On pages 13-14 of Applicants remarks, Applicant argues that Harris does not disclose “the drug chamber and the discharge path each having the concave structure formed in the contact lens and having a depth”.
These arguments are not persuasive. The Examiner points out that the contact lens taught by Harris is concave in structure. The contact as a whole is concave in structure as can be seen in fig. 12.
PNG
media_image3.png
308
215
media_image3.png
Greyscale
It is clear that the drug chamber 130 is concave in fig. 12, and the hole 116 (i.e., drug discharge path) is also within the concave structure in the contact lens, therefore meeting the limitations wherein the drug chamber and drug discharge path each having concave structures formed in the contact lens. The examiner also points out that at the very top of the hole 116 (i.e., drug discharge path) that meets the drug chamber 130 wherein the drug flows to the hole 116, is also in a concave structure, which is part of the hole 116 (i.e., drug discharge path). With regards to the limitation of “having a depth”, the examiner interprets the limitation to mean that the drug chamber and the drug discharge path both have a dimensions as the contact lens is a 3 dimensional structure which has at least a depth portion to it. With regards to the limitation wherein the cover member covers the rear surface of the contact lens and covers the drug discharge path and the drug chamber the examiner point out that Harris further teaches an outer perimeter 124, 128, and 113 (i.e., cover member) (i.e., rear surface) which covers the sides of the hole 116 (i.e., discharge path, see Fig. 12 for depiction of concave form) and the drug chamber 130, but does not cover the end portion of the hole 116, thereby allowing the drug to be released (i.e., drug outlet) (page 11, paragraph [0074]), therefore, the drug discharge path is not fully covered by the cover member allowing for the release of the drug.
On pages 16-17 of Applicants remarks, Applicants argue that the amended claim 6 does not require a separate machining process (e.g., a drilling process) for forming a drug outlet, and that Harris has a part of the contact lens has to be perforated to form a hole.
This argument is not persuasive. The examiner points that the instant claims are directed to a product, therefore, Applicants arguments that claim 6 does not require a separate machining process is not a distinguishing feature because the claims are directed to a product claim and not a process of making. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I). Also, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the contact lens does not require a separate machining process) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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 6-7 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (EP0608341B1, Published 03/27/2002; cited in the IDS filed 09/26/23) in view of Kim et al. (US20180143453A1, Published 05/24/2018; cited in the IDS filed 09/26/2023) as evidenced by Harooni et al. (Arch Ophthalmol, Published 1998;116(9):1218-1221).
Applicant’s invention
The applicants claims are drawn to a contact lens comprising: a vision correction lens portion positioned in a center portion of the contact lens to refract light; and a drug storage structure arranged apart from the center portion and configured to store a drug, wherein the drug is provided to an eye of a user wearing the contact lens, wherein the drug storage structure comprises: a drug chamber having a concave structure and formed in the contact lens to store the drug in the concave structure; a drug discharge path having a concave structure and formed in the contact lens, the drug discharge path being connected to the drug chamber to release the drug; and a cover member wherein the concave structure of the drug chamber and the concave structure of the drug discharge path are both formed in a rear surface of the contact lens and have a depth, the cover member covers the rear surface of the contact lens and covers the drug discharge path and the drug chamber, and the cover member does not cover an end portion of the drug discharge path, thereby forming a drug outlet.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
PNG
media_image4.png
407
530
media_image4.png
Greyscale
PNG
media_image2.png
302
630
media_image2.png
Greyscale
Regarding claim 6, Harris teaches a method and apparatus for correcting refractive errors of the eye wherein the cornea is fitted with a rigid contact lens (Abstract). Harris also teaches the central (i.e., center portion) optic zone 18 (Fig. 2) is transparent and corrects the refractive error of the eye to produce excellent visual acuity (page 14, paragraph [0106]). Harris further teaches the lens is provided with an internal chamber 11 (Fig. 2) for storing the cornea softening agent (page 10, paragraph [0066]). Fig. 2 shows that chamber 11 is not overlapping with the central optic zone 18, therefore the drug storage structure is arranged apart from the center portion. Harris continues to teaches a number of enzymes and other agents, including drugs can be administered to soften a cornea in addition to or instead of administering enzymes (page 6, paragraph [0031]). Harris further teaches a plurality of microscopic holes provided to allow fluid communication between chamber 11 and the eye, thereby facilitating the timed release of the enzyme/agents into the cornea (page 10, paragraph [0068]). Harris teaches in Fig. 12 a drug chamber 130 having a concave structure and formed in the contact lens to store the drug in the concave structure, an outer perimeter 124, 128, and 113 which covers at least the drug chamber (i.e., cover member) (page 11, paragraph [0074]). Harris continues to teach in Fig. 12, a hole 116 (i.e., drug discharge path, see Fig. 12 for depiction of concave form) wherein the hole 116 provides communication between the chamber 130 and the surface of the eye of a subject (page 11, paragraph [0076]). Harris further teaches an outer perimeter 124, 128, and 113 (i.e., cover member) (i.e., rear surface) which covers the sides of the hole 116 (i.e., discharge path, see Fig. 12 for depiction of concave form) and the drug chamber 130, but does not cover the end portion of the hole 116, thereby allowing the drug to be released (i.e., drug outlet) (page 11, paragraph [0074]).
Regarding claim 7, Harris teaches the rigid contact lenses designed for enzyme-orthokeratology comprises a lens made of a fluoro-silicone-acrylate material (methylmethacrylate difluoroitaconate siloxanyl copolymer) (page 14, paragraph [0105]). Harris further discloses one or more holes 116 (fig. 12) wherein the holes have a diameter of from about 0.002-0.010 mm (i.e., 2-10 micrometers) (page 11, paragraph [0076]).
Regarding claim 13, Harris teaches in Fig. 12, a single drug chamber 130 having a circular shape, wherein the plurality of holes 116 (i.e., discharge paths) are connected to the single drug chamber 130, wherein the holes 116 (i.e., discharge paths) discharge the drug to the posterior portion 113 (i.e., end portion of the contact lens) (page 11, paragraph [0076]).
Regarding claim 14, Harris teaches the primary enzyme used to soften a cornea is hyaluronidase (page 6, paragraph [0034]). As evidenced by Harooni et al., hyaluronidase effectively prevents increases in intraocular pressure (abstract, first conclusions paragraph). Therefore, Harris teaches hyaluronidase as the primary enzyme which is a species of an intraocular pressure lowering agent of instant claim 14.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Harris does not teach, the contact lens, wherein the drug storage structure comprises: a plurality of drug chambers which are apart from each other and not connected to each other; and a plurality of drug discharge paths respectively connected to the plurality of drug chambers, wherein the plurality of drug chambers store identical or different drugs, as required by instant claim 12. However, these deficiencies are cured by Kim et al.
PNG
media_image5.png
698
729
media_image5.png
Greyscale
In the analogous art of contact lens for delivering drug, Kim teaches in Fig. 8, a contact lens intended to deliver a drug to the eyeball, wherein the drug (i.e., identical) is filled in the chambers 50 (i.e. plurality of chambers) and the drug chambers are apart and not connected to each other as depicted in Fig. 8 (page 3, paragraph [0079]). Kim continues to teach a plurality of drug outlets 43 (i.e., drug discharge paths) wherein, the drug outlets 43 are connected to the plurality of drug chambers 50 as depicted in Fig. 8 (page 3, paragraph [0079]).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It is well settled that lack of novelty is the epitome of obviousness. In re May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974)). Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the contact lens of Harris with a plurality of drug chambers which are not connected to each other to store drugs, wherein the plurality of drug chambers have drug discharge paths connected to the drug chambers, to achieve the predictable result of obtaining a composition suitable for drug delivery to the eye. One of ordinary skill in the art would have been motivated to do so because Kim et al. teaches that this contact lens is advantageous for the drug being delivered to the eyeball wherein the drug would be evenly spread over the entire eyeball (page 4, paragraph [0084]), as well as ensuring high productivity and excellent efficiency (page 4, paragraph [0097]). Therefore, given the state of the art as evidenced by the teachings of Kim, and absent to any evidence of the contrary, there would have been a reasonable expectation of success in combining the teachings of Harris and Kim to form a contact lens with a plurality of drug chambers.
Response to Arguments
Applicants arguments filed 06/11/2025 have been fully considered but they are not persuasive.
Applicant’s remarks on page 13-17 corresponds to both the 102 and 103 rejections and arguments are the same. On pages 13-14 of Applicants remarks, Applicant argues that Harris does not disclose “the drug chamber and the discharge path each having the concave structure formed in the contact lens and having a depth”.
These arguments are not persuasive for the same reasons explained above following the 35 USC §102 anticipation rejection.
These arguments are not persuasive. The Examiner points out that the contact lens taught by Harris is concave in structure. The contact as a whole is concave in structure as can be seen in fig. 12.
PNG
media_image3.png
308
215
media_image3.png
Greyscale
It is clear that the drug chamber 130 is concave in fig. 12, and the hole 116 (i.e., drug discharge path) is also within the concave structure in the contact lens, therefore meeting the limitations wherein the drug chamber and drug discharge path each having concave structures formed in the contact lens. The examiner also points out that at the very top of the hole 116 (i.e., drug discharge path) that meets the drug chamber 130 wherein the drug flows to the hole 116, is also in a concave structure, which is part of the hole 116 (i.e., drug discharge path). With regards to the limitation of “having a depth”, the examiner interprets the limitation to mean that the drug chamber and the drug discharge path both have a dimensions as the contact lens is a 3 dimensional structure which has at least a depth portion to it. With regards to the limitation wherein the cover member covers the rear surface of the contact lens and covers the drug discharge path and the drug chamber the examiner point out that Harris further teaches an outer perimeter 124, 128, and 113 (i.e., cover member) (i.e., rear surface) which covers the sides of the hole 116 (i.e., discharge path, see Fig. 12 for depiction of concave form) and the drug chamber 130, but does not cover the end portion of the hole 116, thereby allowing the drug to be released (i.e., drug outlet) (page 11, paragraph [0074]), therefore, the drug discharge path is not fully covered by the cover member allowing for the release of the drug.
On pages 14-15 of Applicants remarks, Applicants further argue that Kim and Harooni also do not disclose all the features corresponding to the concave structures formed in the rear surface of the contact lens and having a depth.
These arguments are not persuasive. In response to applicant's argument that Kim and Harooni also do not disclose all the features corresponding to the concave structures formed in the rear surface of the contact lens and having a depth, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The Examiner reiterates that Harris teaches all the features corresponding to the concave structures formed in the rear surface of the contact lens and having a depth. The Examiner further points out that Kim was cited for teaching the limitation of a plurality of drug chambers which are not connected to each other to store drugs, wherein the plurality of drug chambers have drug discharge paths connected to the drug chambers. Harooni was cited as evidence that hyaluronidase effectively prevents increases in intraocular pressure (abstract, first conclusions paragraph). Therefore, Harris taught hyaluronidase as the primary enzyme which is a species of an intraocular pressure lowering agent of instant claim 14.
On pages 16-17 of Applicants remarks, Applicants argue that the amended claim 6 does not require a separate machining process (e.g., a drilling process) for forming a drug outlet, and that Harris has a part of the contact lens has to be perforated to form a hole.
This argument is not persuasive. The examiner points that the instant claims are directed to a product, therefore, Applicants arguments that claim 6 does not require a separate machining process is not a distinguishing feature because the claims are directed to a product claim and not a process of making. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I). Also, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the contact lens does not require a separate machining process) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AFUA BAMFOAA BOATENG whose telephone number is (703)756-1358. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
AFUA BAMFOAA BOATENGExaminer, Art Unit 1617 /ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614