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 .
Summary
Claims 1-6, 8-10, 12-15, 17-22 are pending in this office action. Claims 7, 11 and 16 are cancelled. All pending claims are under examination in this application.
Priority
The current application was filed on January 4, 2024. The current application claims domestic priority to provisional patent application 63/436,932 filed January 4, 2023.
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 non-obviousness.
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 1-6, 8-10, 12-15, and 17-22 are rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez (WO2020/146362A1) in view of Miller et al. (WO99/20265A1).
[The Examiner is going to introduce each reference and then combine them where appropriate to reject the instant claims.]
1. Gutierrez
Gutierrez is considered the closest prior art as it teaches an eye mounted device for therapeutic agent release (see title). Furthermore, Gutierrez discloses that the present disclosure relates to devices and systems for targeted and controlled delivery of a therapeutic agent to a treatment site of an eye. Particularly, aspects are directed to
a therapeutic agent delivery device that includes a polymeric substrate having a release region, a delivery region, and a receiving region; one or more reservoirs formed within the release region; a therapeutic agent disposed within the one or more reservoirs; an active, passive, or combination thereof controlled release mechanism for release of the
therapeutic agent from the one or more reservoirs into the delivery region; and a circuit formed on the polymeric substrate, the circuit having a current source, a first iontophoresis electrode located within the delivery region for transport of the therapeutic agent from the delivery region into a target tissue via electromigration, and a second
iontophoresis electrode located within the receiving region for maintaining electroneutrality within the tissue (see abstract).
2. Miller et al.
Miller et al. teach compositions containing histamine H2 agonists and methods of use in treating dry eye (see title). In addition, Miller et al. disclose compositions containing histamine H2 agonists and methods of use for treating dry eye (see abstract).
Combination of Gutierrez and Miller et al.
Regarding instant claims 1, 21, and 22, Gutierrez and Miller et al. teach a dry eye treatment device. The necessary citations of Gutierrez and Miller et al. that pertain to instant claims 1, 21, and 22 are presented in Table I. Instant claims 21 and 22 overlap with claim 1 and are therefore included herein.
Table I
Instant Claims 1, 21, and 22
Gutierrez and Miller et al. Citations
A dry eye treatment device, comprising: a substrate; at least one reservoir formed in the substrate; and a histamine agonist disposed within the at least one reservoir, the histamine agonist being configured to be delivered to at least one histamine receptor on or adjacent to an eye;
Gutierrez discloses a device for eye treatment (see title and abstract within Gutierrez). Figure 7A within Gutierrez summarizes the device (700):
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Substrate (705)
At least one reservoir formed in the substrate (725)
(see Figure 7A and paragraphs [0094] and [0099]; all within Gutierrez).
Gutierrez does not specifically disclose the use delivery of a histamine agonist to a histamine receptor (only general therapeutic agents). However, Miller et al. disclose the use of both elements.
Miller et al. disclose ophthalmic compositions
containing histamine H2 agonists and methods for treating dry eye. The H2 agonists work by increasing mucin production and secretion from ocular surface epithelial cells of the cornea and conjunctiva. The increased mucin provides the
base level of lubricant and aqueous attractant to provide the necessary layer of tear fluid.
The increased production of tear fluid lubricates the surface of the eye and prevents the symptoms associated with dry eye (see page 5, lines 4-10 within Miller et al.). A skilled artisan would use the H2 agonists of Miller et al. as the therapeutic agent within the eye mounted device for therapeutic agent release disclosed by Gutierrez.
and an electrode disposed on the substrate for electrically stimulating a target tissue in the eye or adjacent to the eye, wherein the electrode is adjacent the at least one reservoir such that the electrical stimulation is configured to urge the histamine agonist into the at least one histamine receptor via iontophoresis;
Gutierrez discloses wherein the at least one electrode is adjacent to the at least one reservoir such that the selective electrical stimulation at least partially urges the released therapeutic agent via iontophoresis (see paragraphs [0070-0071] and [0094]; also see abstract; all within Gutierrez).
a sensor configured to generate a signal indicative of the eye being dry or drying; and
an electronics control unit ("ECU") electrically connected to the electrode, the ECU comprising logic that, when executed, causes the dry eye device to perform operations comprising:
applying a voltage to the electrode to electrically to urge the histamine agonist into the at least one histamine receptor via iontophoresis in response to the signal indicative of the eye being dry or drying.
Gutierrez disclose a system supportive of the instant claim limitations (therapeutic agent delivery device, see paragraphs [0052-0098]; systems for therapeutic agent release and delivery, [0099-0108]; also see Figures 1A-9 all within Gutierrez). Furthermore, the additional claim limitations disclosed within claims 21-22 are taught by Gutierrez in the above citations.
Gutierrez disclose the general delivery of a therapeutic agent and its administration to the eye (see title, abstract, and claims within Gutierrez). However, a skilled artisan (POSITA; person of ordinary skill in the art) would configure the device disclosed by Gutierrez to detect parameters of dry eye and administer the H2 agonist disclosed by Miller et al. for the treatment of dry eye, within the patient under routine conditions.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Gutierrez with the teachings of Miller et al. The motivation to combine the two references would be to create a device specifically to address patients experiencing dry eye, using the H2 agonists of Miller et al. Hj
The remaining instant claims within this 35 U.S.C. § 103 section are directly or indirectly dependent on instant claim 1 and are taught in full by the combination of Gutierrez and Miller et al.
The Examiner has made the simple substitution with the H2 agonists of Miller et al. for the treatment of dry eye instead of Gutierrez’s general therapeutic.
Regarding instant claims 2 and 3, Gutierrez and Miller et al. teach the device of instant claim 1, further comprising at least one controlled release mechanism adjacent the at least one reservoir, the at least one controlled release mechanism being configured to release the histamine agonist from the at least one reservoir to the at least one histamine receptor.
Gutierrez discloses the use of a polymeric layer or a valve as a controlled release mechanism from the at least one reservoir for a therapeutic agent (see claims 12, 13, and 34 within Gutierrez).
Regarding instant claim 4, Gutierrez and Miller et al. teach the device of instant claim 3, wherein the valve is a metallic film electrically connected to a power source that selectively stimulates the metallic film to release the histamine agonist.
Gutierrez discloses wherein the valve is a metallic film electrically connected to a power source that selectively stimulates the metallic film to release the therapeutic agent (see paragraph [0066] within Gutierrez).
Regarding instant claim 5, Gutierrez and Miller et al. teach the device of instant claim 4, wherein the at least one controlled release mechanism further comprises a polymeric layer overlying the metallic film, the metallic film being between the at least one reservoir and the polymeric layer such that histamine agonist released from the at least one reservoir via the metallic film egresses into the polymeric layer.
Gutierrez discloses wherein the at least one controlled release mechanism further comprises a polymeric layer overlying the metallic film, the metallic film being between the at least one reservoir and the polymeric layer such that histamine agonist released from the at least one reservoir via the metallic film egresses into the polymeric layer (see paragraph [0068] within Gutierrez; one or more active and one or more passive devices).
Regarding instant claim 6, Gutierrez and Miller et al. teach the device of instant claim 5, wherein the polymeric layer is formed of at least one of polymethylmethacrylate, polyhydroxyethylmethacrylate, a hydrogel, a silicon-based polymer, a silicone elastomer, and a rigid gas permeable polymer.
Gutierrez discloses wherein the polymeric layer is formed of at least one of polymethylmethacrylate, polyhydroxyethylmethacrylate, a hydrogel, a silicon-based polymer, a silicone elastomer, or a combination thereof (see paragraph [0025] within Gutierrez).
Regarding instant claim 13, Gutierrez and Miller et al. teach the device of instant claim 2, further comprising at least one sensor for monitoring at least one eye condition, the histamine agonist being released in response to the at least one monitored eye condition.
Gutierrez discloses at least one sensor for monitoring at least one eye condition, the histamine agonist being released in response to the at least one monitored eye condition (see paragraph [0058] within Gutierrez).
Regarding instant claim 8, Gutierrez and Miller et al. teach the device of instant claim 2, wherein the at least one controlled release mechanism is a polymeric layer that facilitates a passive delivery of the histamine agonist to the at least one histamine receptor.
Gutierrez discloses wherein the at least one controlled release mechanism is a polymeric layer that facilitates a passive delivery of the therapeutic agent (see abstract within Gutierrez).
Regarding instant claim 9, Gutierrez and Miller et al. teach the device of instant claim 2, further comprising an ECU electrically connected to the at least one controlled release mechanism and configured to selectively cause the at least one controlled release mechanism to release the histamine agonist from the at least one reservoir.
Gutierrez discloses an ECU (electronic control unit) electrically connected to the at least one controlled release mechanism and configured to selectively cause the at least one controlled release mechanism to release the histamine agonist from the at least one reservoir (see paragraph [0063]; also see abstract; all within Gutierrez).
Regarding instant claim 10, Gutierrez and Miller et al. teach the device of instant claim 1, further comprising at least one electrode disposed on the substrate for selectively electrically stimulating a target tissue in or adjacent to the eye.
Gutierrez discloses at least one electrode disposed on the substrate for selectively electrically stimulating a target tissue in or adjacent to the eye (see paragraph [0094] within Gutierrez).
Regarding instant claim 12, Gutierrez and Miller et al. teach the device of instant claim 10, further comprising an ECU configured to selectively cause the at least one electrode to electrically stimulate a target tissue in or adjacent to the eye.
Gutierrez discloses wherein the at least one electrode is adjacent the at least one reservoir such that the selective electrical stimulation at least partially urges the released histamine agonist into the at least one histamine receptor via iontophoresis (see paragraph [0094]; and abstract; both within Gutierrez). Furthermore, Gutierrez discloses using an ECU configured to selectively cause the at least one electrode to electrically stimulate a target tissue in or adjacent to the eye (see paragraph [0094] within Gutierrez).
Regarding instant claim 14, Gutierrez and Miller et al. teach a dry eye treatment system, comprising: the device of claim 1, the device comprising an ECU and at least one electrode disposed on the substrate, the ECU being electrically connected to the at least one electrode, the ECU being configured to selectively cause the at least one electrode to electrically stimulate a target tissue in or adjacent to the eye; and an external controller in electronic communication with the ECU for selectively controlling the ECU.
Please see the discussion and citations within instant claim 12 regarding at least one electrode disposed on the substrate, the ECU being electrically connected to the at least one electrode, the ECU being configured to selectively cause the at least one electrode to electrically stimulate a target tissue in or adjacent to the eye; and an external controller in electronic communication with the ECU for selectively controlling the ECU (see abstract and claims within Gutierrez).
Regarding instant claim 15, Gutierrez and Miller et al. teach the system of instant claim 12, wherein the external controller includes a trigger via which the ECU is commanded to cause the at least one electrode to electrically stimulate a target tissue in or adjacent to the eye.
A skilled artisan (POSITA) would be able to program the electronic control unit to issue a command to cause the at least one electrode to electrically stimulate a target tissue in or adjacent to the eye when the subject reached a certain biological threshold (further see abstract within Gutierrez).
Regarding instant claim 17, Gutierrez and Miller et al. teach the system of instant claim 12, further comprising an external device electrically connected to at least one of the external controller and the ECU, the external device being configured for: adjusting operating characteristics of at least one of the external controller and the ECU; monitoring at least one eye condition; monitoring histamine agonist dosage; and/or monitoring histamine agonist delivery.
Please see the discussion and citations for the relevant rejection text within instant claims 1, 9, and 12 (additionally see abstract and claims within Gutierrez).
Regarding instant claim 18, Gutierrez and Miller et al. teach the device of instant claim 1, wherein the device is configured to be inserted into the inferior fornix of a patient.
A skilled artisan (POSITA) would be able to position this device into the inferior fornix of a patient.
Regarding instant claim 19, Gutierrez and Miller et al. teach the device of instant claim 1, wherein the substrate is ring-shaped and configured to be positioned in or adjacent to the ocular fornix to at least partially encircle a portion of the eye.
Gutierrez discloses the polymeric substrate has a donut or ring shape (see claim 16 within Gutierrez). A skilled artisan (POSITA) would be able to position this device in or adjacent to the ocular fornix to at least partially encircle a portion of the eye under routine conditions.
Regarding instant claim 20, Gutierrez and Miller et al. teach the device of instant claim 1, wherein the device is configured to be worn on the eye.
Gutierrez discloses eye mounted device for therapeutic agent release (see title and abstract within Gutierrez).
Analogous Art
The Gutierrez and Miller et al. references are directed to the same field of endeavor as the instant claims, that is, a dry eye treatment device, comprising: a substrate; at least one reservoir formed in the substrate; and a histamine agonist disposed within the at least one reservoir, the histamine agonist being configured to be delivered to at least one histamine receptor on or adjacent to an eye.
Obviousness Analysis
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the eye mounted device for therapeutic agent release as disclosed by Gutierrez, using the teachings of Miller et al. in order to arrive at the subject matter of the instant claims.
The Gutierrez and Miller et al. references both have considerable overlap in the eye therapy arts. In this instance, Gutierrez supplies the template for the eye mounted device for therapeutic agent release, while Miller et al. supplies the H2 agonists for the treatment of dry eye. Both references are directed to the application of therapy to the eye and therefore constitute analogous art under MPEP §2141.01(a). A POSITA would have reasonably consulted the two references when seeking to develop an eye mounted device for therapeutic agent release of a H2 agonist treating dry eye.
Given these teachings, a POSITA would have been motivated to combine the template for the eye mounted device for therapeutic agent release disclosed by Gutierrez into the H2 agonists for the treatment of dry eye.
The modification constitutes a simple substitution of one known element for another to obtain a predictable results [MPEP §2143(I)(B)].
The combination represents the use of a known technique to improve a similar device/composition in the same way [MPEP §2143(I)(C)].
The art provides a finite number of identified, predictable solutions, and the POSITA would have pursued the claimed configuration with a reasonable expectation of success [MPEP §2143(I)(E); KSR].
The combination of the eye mounted device for therapeutic agent release taught by Gutierrez along with the use of the necessary claim limitations taught by Miller et al. would allow a research and development scientist (POSITA) to create the invention taught in the instant application.
Furthermore, the additional claim limitations taught by Miller et al. would have been viewed by a POSITA as routine design optimizations or known modifications for the therapeutic delivery of an agent to the eye. The motivation to combine the two references would be to create a device specifically to address patients experiencing dry eye, using the H2 agonists of Miller et al. Hj
Implementing these features in Gutierrez’s eye mounted device for therapeutic agent release would not require more than ordinary skill or routine experimentation.
Accordingly, the combination of Gutierrez, supplemented by Miller et al. provides all the elements of the claimed invention. The resulting eye mounted device for therapeutic agent release of a H2 agonist treating dry eye constitutes no more than the predictable outcome of combining familiar prior art components, and therefore the claimed subject matter would have been obvious to a POSITA prior to the effective filing date of the invention.
Response to Arguments
Applicant's arguments filed August 13, 2026 have been fully considered but they are not persuasive.
Applicant Argument: The Applicant argues that the use of a histamine receptor agonist is impractical and that the Nakano et al. reference teaches away from using the agonist to treat allergic conjunctivitis.
Examiner’s Rebuttal: The argument is now moot. The Nakano et al. reference has been withdrawn from the record and the Miller et al. reference has been added. The Miller et al. reference is applicable to the instant application and teaches compositions containing histamine H2 agonists and methods of use in treating dry eye (see title, abstract, and claims within Miller et al.).
Thus, the 35 U.S.C. §103 rejection for instant claims 1-6, 8-10, 12-15, and 17-22 is maintained.
Conclusion
No claims are allowed.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615
