DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed 12/23/2025.
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 .
Status of the Claims
Claim 20 has been amended. No claims were cancelled or newly added. Accordingly, claims 1-20 remain pending in the application and are currently under examination.
Information Disclosure Statement
The IDS filed 12/23/2025 has been considered. A signed copy is enclosed herewith.
Withdrawn Rejections
Applicant’s amendment renders the rejection of claim 20 under 35 USC 112(b) moot. Specifically, “including power supply and regulator” has been deleted from the claim. Thus, said rejection has been withdrawn.
Applicant’s arguments regarding the rejection of claims 1-20 under 35 USC 103 over Hoerr in view of Mehta is persuasive. Thus, said rejection has been withdrawn. However, after further consideration, a new grounds of rejection under 35 USC 103 over Hoerr in view of Mehta and Smith is presented below.
New Rejections
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hoerr er al. (EP 2529761 A1, Dec. 5, 2012, hereafter as “Hoerr”) in view of Mehta (“Advanced Engineering of Contact Lens Coatings using Electrohydrodynamic Atomization”, De Montfort University, 2018, available at https://dora.dmu.ac.uk/handle/2086/17476, cited on ISR for PCT/GB2021/051334 as published on January 23, 2019; hereafter as “Mehta) and Smith et al. (“The sensitivity of volumetric flow rate to applied voltage in cone-jet mode electrospray and the influence of solution properties and emitter geometry”, Physics of Fluid, 18, 092104, September 2006, pp. 1-7; hereafter as “Smith”).
The claims are drawn to a method of coating a surface of a prosthetic device, the method comprising nanoelectrospraying droplets comprising an active ingredient and/or a carrier species onto the surface in a predetermined pattern, the nanoelectrospraying involving controlling the flow rate of the droplets from a nozzle of the nanoelectrospraying equipment by controlling the voltage between the nozzle and the prosthetic device.
Regarding instant claims 1, 4, 13 and 16-18 and 20, Hoerr teaches a process for coating a medical device such as stents and hydrogel polymer surfaces including contact lenses, the process comprising electrospraying a surface with a nanoparticle composition comprising an active agent and a polymer (abstract; [0004], [0006], [0067] and [0283]-[0287]). Hoerr also teaches that a relatively high voltage (about 2000-6000 V) may be applied between the object being coated and the capillary tube (i.e., nozzle) to establish the potential difference between the first and second electrode of the spraying apparatus and cause operation in cone-jet mode ([0156]; Fig. 2D). Said teaching speaks to directly to claimed limitation “controlling the voltage between the nozzle and the ocular prosthetic device”.
It is noted claims 16 and 17 are deemed product-by-process claims due to the limitation, “formable according to the method of claim 1” and as such, determination of patentability is based on the product itself, not by the method in which it is made. 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 (MPEP 2113).
Hoerr is silent to the coating is in a predetermined pattern (instant claim 1), wherein the pattern covers only a portion of the surface of the ocular prosthetic device, and wherein a further portion of the ocular prosthetic device that, in use, would cover at least some of a pupil of an eye of a wearer of the ocular prosthetic device, is free of the predetermined pattern of droplets, and optionally the pattern comprises one or more features selected from dots, lines and regular shapes (instant claim 2), and wherein the droplets, and the active ingredient and/or carrier species, are coated on the ocular prosthetic device so that they form a ring, which may be continuous or discontinuous, around the periphery of the ocular prosthetic device, when viewed from above the ocular prosthetic device (instant claim 3).
Mehta teaches drug eluting contact lenses provides controlled and sustained release of drugs for the treatment of various ocular disease such as glaucoma (pages 113-114). Mehta teaches controlled deposition of a coating comprising a polymer and a drug onto a contact lens using a mask to allow for deposition of the coating onto the peripheral region of the contact lens and keeping the central region of the contact lens clear for vision (pages 115-116; page 118, section 4.3.2.6).
Hoerr and Mehta are both drawn to coating medical devices including contact lenses with a drug/polymer coating, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include coating a medical device in a predetermined pattern, wherein the predetermined pattern forms a ring around the periphery of the ocular prosthetic device and the central portion of the device is free of the coating with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Mehta teaches drug eluting contact lenses having said patterned coating allows for controlled and sustained release of drugs while keeping the central region of the contact lens clear for vision.
While Hoerr teaches controlling the voltage between the nozzle and the object being coated; Hoerr is silent to the flow rate of the droplets being controlled via the voltage between the nozzle and the object being coated.
Smith teaches the effect of applied voltage on the volumetric flow rate through an electrospray system (abstract). Smith demonstrates the direct relationship between voltage and flow rate in cone-jet mode (as the applied voltage is incrementally increased, the flow rate is also found to increase; see page 3, right col. – page 4, left col.; Fig. 2 and 3).
Hoerr and Smith are both drawn to electrospraying in cone-jet mode, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to control the flow rate by controlling the voltage with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Smith teaches that controlling the voltage necessarily controls the flow rate in cone-jet mode and Hoerr reaches controlling the voltage in cone-jet mode. Accordingly, a skilled artisan would have reasonably expected that controlling the voltage in Hoerr would necessarily control the flow rate.
Regarding instant claims 5 and 7, Hoerr and Mehta teach the elements discussed above and Hoerr further teaches a mixture of poly(DL-lactide-co-ɛ-caprolactone) and dexamethasone ([0287]).
Regarding instant claim 6, Hoerr and Mehta teach the elements discussed above.
Hoerr is silent to the particular active agents recited (e.g., timolol).
Mehta additionally teaches the particular active agent, timolol, is effective in the treatment of glaucoma (pages 113-115).
The Hoerr and Mehta are both drawn to coating medical devices including contact lenses with a drug/polymer coating, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the particular drug, timolol, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Mehta teaches that the particular drug, timolol, formulated in a composition comprising a polymer is effective as a coating on a contact lens in the treatment of glaucoma.
Regarding instant claim 8, Hoerr and Mehta teach the elements discussed above.
Hoerr and Mehta are silent to the polymer concentration of 5 mg/ml to 75 mg/ml.
However, Hoerr teaches that the liquid spray composition comprises an active agent and a polymer and that the weight ratio of polymer to active agent is generally between 5:1 to 10:1 ([0170]). Hoerr additionally teaches that the weight concentration of the active ingredient (e.g., the polymer or the polymer and biologically active ingredient) may be less than 5 percent of the total weight of the liquid spray composition, and may be less than 1 percent of the total weight concentration of the liquid spray concentration ([0170]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount polymer in liquid spray concentration and thereby the droplets by way of routine experimentation. A skilled artisan would have been motivated to do so because Hoerr teaches the general conditions and it is the normal desire of scientists or artisans to improve upon what is already generally known to determine in a disclosed range the optimum values. Additionally, it is understood in the art that varying the amount of active agent and polymer in a composition alters the drug release profile and, as such, adjusting said amounts is routine in determining the optimal release profile.
Regarding instant claims 9 and 10, Hoerr and Mehta teach the elements discussed above and Hoerr further teaches that the nozzle has an inner opening having a diameter of about 6 microns to about 2 millimeters ([0100]). MPEP 2144.05(I) states, “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 this case, the claimed ranges of 250 microns or less and 150 microns or less overlap with the range of about 6 microns to about 2 mm disclosed in the prior art. Accordingly, a prima facie case exists. Further, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the diameter of inner opening of the nozzle by way of routine experimentation with a reasonable expectation of success. MPEP 2144.05(II)(A) states, “[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”. A skilled artisan would have been motivated to do so because Hoerr teaches the general conditions of the claims and it is the normal desire of scientists or artisans to improve upon what is already generally known to determine where in a disclosed range is the optimum values.
Regarding instant claim 11, Hoerr and Mehta teach the elements discussed above and Hoerr further teaches that the nozzle is about 2-5 mm away from the surface of the device ([0153). ]). MPEP 2144.05(I) states, “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 this case, the claimed range of 0.5-3 mm overlaps with the range of about 2-5 mm disclosed in the prior art. Accordingly, a prima facie case exists. Further, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the distance between the nozzle and the surface of the device by way of routine experimentation with a reasonable expectation of success. MPEP 2144.05(II)(A) states, “[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”. A skilled artisan would have been motivated to do so because Hoerr teaches the general conditions of the claims and it is the normal desire of scientists or artisans to improve upon what is already generally known to determine where in a disclosed range is the optimum values. A skilled artisan would have also been motivated to adjust said distance because Hoerr teaches that increasing said distance allows more time of flight for evaporation of the microdroplets resulting in an open matrix coating and decreasing the distance allows less time for evaporation resulting in a closed film coating ([0172]).
Regarding instant claim 12, Hoerr and Mehta teach the elements discussed above and Hoerr further exemplifies voltages within the claimed voltage range of 1.5-3.0 kV (Fig. 2D) as well as teaches a voltage range of about 2000-6000 volts (2-6 kV) ([0156]). It is noted “where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists” (MPEP 2144.05(I)).
Regarding instant claim 14, Hoerr and Mehta teach the elements discussed above including hydrogel contact lenses as a coated substrate. Mehta further exemplifies pHEMA contact lenses that are able to retain up to 38% water (page 17, 2nd paragraph).
Regarding instant claim 15, Hoerr and Mehta teach the elements discussed above and Hoerr further teaches a conductivity range of 0.3-1.0 µS/cm (equivalent to 30-100 µS/m) as well as a particular embodiment having a conductivity of 0.4 µS/cm (equivalent to 40 µS/m) ([0332]).
Regarding instant claim 19, Hoerr and Mehta teach the elements discussed above and Hoerr further teaches that the surface of the device may be conductive and/or curved ([0076] and [0121]).
Thus, the combined teachings of Hoerr, Mehta and Smith render the instant claims prima facie obvious.
Response to Arguments
The arguments filed 12/23/2025 regarding the 103 rejection over Hoerr and Mehta are moot in view of the withdrawn rejection discussed above.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 5:00 pm.
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617
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