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 .
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 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.
Restriction Requirement
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-12, drawn to an ocular drug delivery device comprising: a contact lens having a curvature configured to fit a cornea of an eye; an array of nanoneedles attached to and protruding from a surface of the contact lens; and a therapeutic drug cargo loaded onto individual nanoneedles of the array of nanoneedles.
Group II, claims 13-16, drawn to a method of fabricating the ocular drug delivery device of claim 1.
Group III, claims 17-20, drawn to method of releasing a therapeutic drug cargo to an eye.
As set for the in Rule 13.1 of the Patent Cooperation Treaty (PCT), “the international application shall relate to one invention only or to a group of inventions so linked as to from a single general inventive concept.” Moreover, as stated in PCT Rule 13.2, “where a group of inventions is claimed in one and the same international application, the requirement of unity of invention referred to in Rule 13.1 shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features." Furthermore, Rule 13.2 defines “special technical features” as “those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.”
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
The special technical feature of Group I is an ocular drug delivery device comprising: a contact lens having a curvature configured to fit a cornea of an eye; an array of nanoneedles attached to and protruding from a surface of the contact lens; and a therapeutic drug cargo loaded onto individual nanoneedles of the array of nanoneedles. This composition is not novel in view of Prausnitz (US 7,918,814; cited herein as “Prausnitz ‘814”). Prausnitz ‘814 teaches a drug delivery device comprising microneedles that conforms to the shape of the ocular surface (col 11: 5-12), reading on the claim 1 limitation of “a contact lens having a curvature configured to fit a cornea of an eye” and “an array to nanoneedles attached to and protruding from a surface of the contact lens”. Prausnitz ‘814 also teaches a “wide range of drugs may be formulated for delivery to ocular tissues with the present microneedle devices and methods.
As such, Group I does not share a special technical feature with the instant claims of Groups II and III. Therefore, the claims are not so linked within the meaning of PCT Rule 13.2 so as to form a single inventive concept, and unity between Groups I-III is broken.
Inventorship
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Rejoinder
The examiner has required restriction between product and process claims. Where applicant elects claims directed to the product, and the product claims are subsequently found allowable, withdrawn process claims that depend from or otherwise require all the limitations of the allowable product claim will be considered for rejoinder. All claims directed to a nonelected process invention must require all the limitations of an allowable product claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product are found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product claim will not be rejoined. See MPEP § 821.04(b). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product claims. Failure to do so may result in a loss of the right to rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Telephonic Election
In view of the telephonic message from attorney Gary Hartman on February 10, 2026, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-12. The phone message was in response to a telephone call between the Examiner and attorney on February 9, 2026. Affirmation of this election must be made by applicant in replying to this Office action.
Claims 13-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Status
Claims 1-20 are pending.
Claims 13-20 are withdrawn.
Claims 1-12 are examined on the merits in this prosecution.
CLAIM REJECTIONS
Obviousness Rejection
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 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.
1) Claims 1-3, 5, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz (US 7,918,814; cited herein as “Prausnitz ‘814”).
It is initially noted that the claim term “nanoneedle” is defined by the applicant in the Specification (¶ [0036]) as follows:
the term "nanoneedle" refers to a nanoscale or nanoscopic needle that is generally conical or tubular in shape and has geometric features that include minimum tip diameters of less than 1 µm, base diameters of less than 10 µm, and lengths of at least 1 µm. silicon nanoneedles disclosed herein preferably have minimum tip diameters of about 50 to 900 nm, base diameters of about 0.9 to 5 µm, and lengths of about 1 to 100 µm, and more preferably minimum tip diameters of about 150 nm, base diameters of about 2 to 4 µm, and lengths of about 10 to 70 µm.
Prausnitz ‘814 teaches a drug delivery device comprising microneedles that conforms to the shape of the ocular surface (col 11: 5-12), reading on the claim 1 limitation of “a contact lens having a curvature configured to fit a cornea of an eye” and “an array to nanoneedles attached to and protruding from a surface of the contact lens”. Prausnitz ‘814 also teaches a “wide range of drugs may be formulated for delivery to ocular tissues with the present microneedle devices and methods (col 11: 35-38). Prausnitz ‘814 teaches the pinpoint delivery of a drug to the scleral or corneal tissues (col 1: 53-61).
For claims 2 and 3, Prausnitz ‘814 teaches the microneedles are fabricated to dissolve after insertion into the ocular tissue (col 11: 20-35).
For claim 5, Prausnitz ‘814 teaches (col 1, Summary of the invention):
Methods are provided for administering a drug to an eye of
a patient. The methods may be used, for example, in the
treatment of uveitis, glaucoma, diabetic macular edema, age
related macular degeneration, corneal infection, or cytomegalovirus retinitis.
For claim 8, Prausnitz ‘814 teaches the device may be used to deliver multiple drug formulations to the eye (col 5, 34-36).
For claim 10, Prausnitz ‘814 teaches the microneedle may have a length of about 50 mm to about 2000 mm, within the claimed range, and a base diameter of 20 mm to about 500 mm (col 10; 8-29), also within the claimed range. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
The examiner acknowledges that some picking and choosing was used to arrive at the instantly claimed methods in view of Prausnitz ‘814. However, the claimed combination of components, including the therapeutic drug cargo, is taught as known and used for administration by a nanoneedle/microneedle drug delivery device in the shape of a contact lens. It would have therefore been prima facie obvious to a person having ordinary skill in the art to administer the therapeutic drug to a subject by application with a nanoneedle array through the cornea with a reasonable expectation of success that the treatment would be efficacious, as taught by Prausnitz ‘814.
2) Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz ‘814 (cited above), in view of Taylor (WO 2020/252077 A1).
The teachings of Prausnitz ‘814 are discussed above.
Prausnitz ‘814 does not teach the therapeutic drug as covalently bound to the individual nanoneedles.
Taylor teaches the missing element of Prausnitz ‘814.
Taylor teaches active agent-delivering degradable medical devices such as microneedle arrays which may comprise degradable compositions for controlled delivery of pharmaceutical agents locally to a body (pg 2, [0010]; pg 20, [0064]). Taylor teaches the active agent is bound to the surface of the medical drug delivering devices by covalent interactions (pg 48, [0161]).
The skilled artisan would have expected success in substituting Taylor's active agent is bound to the surface of the medical drug delivering devices by covalent interactions instead of the coating method of Prausnitz ‘814 since Taylor teaches the covalent interactions or bonding allow for controlled delivery of pharmaceutical agents.
3) Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz ‘814 (cited above), in view of Thakur (“Rapidly dissolving polymeric microneedles for minimally invasive intraocular drug delivery,” Drug Deliv. and Transl. Res. (2016) 6:800–815).
The teachings of Prausnitz ‘814 are discussed above.
Prausnitz ‘814 does not teach a dissolvable drug delivery device comprising nanoneedles.
Thakur teaches the missing element of Prausnitz ‘814.
Thakur teaches an ocular drug delivery device comprising dissolving microneedles comprising polyvinylpyrrolidone (PVP) (Abstract). For claim 9, PVP microneedles showed rapid dissolution that ranged from 10 to 180 seconds, wherein the rate is dependent upon the molecular weight of the polyvinylpyrrolidone (Abstract). Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
The skilled artisan would have expected success in utilizing polyvinylpyrrolidone, as taught by Thakur, as the substrate for the device taught by Prausnitz ‘814 because Thakur teaches an ocular drug delivery device comprising nanoneedles or microneedles are effective in delivering a drug and that the device containing the drug dissolves within the claimed range, and the range can be manipulated by optimizing the molecular weight of the polyvinylpyrrolidone.
4) Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz ‘814 (cited above), in view of Shikamura (US 9,486,362).
The teachings of Prausnitz ‘814 are discussed above.
Prausnitz ‘814 does not teach the ocular drug delivery device comprising a hole as covalently bound to the individual nanoneedles.
Shikamura teaches the missing element of Prausnitz ‘814.
Shikamura teaches a ring-shaped device superior in the wearing comfort and intraocular stability while being worn on the eye, which has an opening to expose the cornea (Abstract). Shikamura teaches “a ring-shaped device containing a drug is applied on the scleral surface, the drug can be efficiently delivered to posterior ocular tissues. Since long-term wearing is possible, a sufficient amount of a drug can be delivered to posterior ocular tissues (col 2: 48-55).
The skilled artisan would have expected success in substituting the ring-shaped device taught by Shikamura for the device not having the hole in the pupal area as taught by Prausnitz ‘814 because Shikamura teaches the ring-shaped device containing a drug allows the drug to be efficiently delivered to posterior ocular tissues, and since the ring-shaped device allows possible, a larger amount of a drug can be delivered to ocular tissues.
5) Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz ‘814 (cited above), in view of Prausnitz (WO 2015/095772 A1; referred to herein as “Prausnitz ‘772”)
The teachings of Prausnitz ‘814 are discussed above.
Prausnitz ‘814 does not teach nanoneedles having a minimum tip diameter of 50-900 nm, a base diameter of 0.9 to 5 mm, or a length of 1-100 mm.
Prausnitz ‘772 teaches the missing element of Prausnitz ‘814.
Prausnitz ‘772 teaches an ocular drug delivery device comprising an array of microneedles formed from biocompatible polymers (Abstract; pg 48: 33 to pg 49: 11). Prausnitz ‘772 teaches the microneedles may have a length from about 75 mm to about 1500 mm (pg 47: 14-18), and a tip radius of curvature from about 200 nm or about 500 nm (pg 47: 26-30), in each case overlapping the claimed range.
Of note is that Prausnitz ‘772 teaches the microneedles may have a base from about 100 mm (pg 47: 20-21), greater than the claimed range. However, “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980); In re Aller, 220 F.2d 454, 456 (CCPA 1955) (“[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.”). One of ordinary skill would seek to minimize the diameter of the base since a smaller base would be expected to be less irritating to the subject and easier to insert onto the surface of the cornea.
The skilled artisan would have expected success in substituting the micro- or nano-needles comprising the length and tip diameter taught by Prausnitz ‘772 since both Prausnitz ‘814 and Prausnitz ‘772 teach a device for the same purpose and the skilled artisan could have substituted a nanoneedle taught by Prausnitz ‘772 for those having the dimensions taught by Prausnitz ‘814 since both are suitable and effective for delivery of a drug to the ocular surface.
5) Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz ‘814 (cited above), in view of Prausnitz (US 6,743,211; referred to herein as “Prausnitz ‘211”).
The teachings of Prausnitz ‘814 are discussed above.
Prausnitz ‘814 does not teach nanoneedles having nanoneedles with an average porosity of about 0-80 percent.
Prausnitz ‘211 teaches the missing element of Prausnitz ‘814.
Prausnitz ‘211 teaches an ocular drug delivery device comprising porous microneedles that provide for the enhanced transport of molecules, including drugs and biological molecules, across tissue by improving the interaction of microneedles and a deformable, elastic biological barrier (Abstract). Prausnitz ‘211 teaches one of skill in the art can select the appropriate porosity required for specific applications. For example, one can adjust the pore size to permit passage of a particular material to be transported through the microneedle device (col 6: 11-15).
Routine optimization of the porosity of the ocular drug delivery device of Prausnitz ‘814 would have led to the claimed porosity of the needle substrate since Prausnitz ‘211 teaches that optimizing the porosity of the substrate allows for passage of particular materials or drugs to be transported through the device. It is further noted that one of ordinary skill would expect higher porosity to increase the rate of dissolution since the surface area of the device would increase allowing the natural fluids in the eye to have greater penetration into the porous microneedle.
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612