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 1-10, 12-15, 17-22 are pending in this office action. Claims 21-22 are new. Claims 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. [The Examiner has updated the continuity map within the Office to reflect the priority defined on the ADS.]
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 1-10, 12-15, and 17-22 are rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez (WO2020/146362A1) in view of Nakano et al. (European Journal of Pharmacology, 2009).
[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. Nakano et al.
Nakano et al. teach role of histamine H4 receptor in allergic conjunctivitis in mice (see title). In addition, Nakano et al. disclose that we investigated the character of histamine H1 receptor and H4 receptor in allergic conjunctivitis. Histamine is the most important mediator in allergic conjunctivitis. We measured eye scratching behavior and allergic-like symptoms score, that is, hyperemia and edema in ICR mice, and examined which receptors are intimately involved in allergic conjunctivitis. Histamine caused a dose-dependent eye scratching behavior and allergic-like symptoms. Histamine H1 receptor antagonist (levocabastine) and H4 receptor antagonist (JNJ7777120) inhibited eye scratching behavior and histamine H1 receptor antagonist inhibited allergic-like symptoms induced by histamine. Additionally, combination of levocabastine and JNJ7777120 caused more potent inhibition in allergic conjunctivitis. On the other hand, both selective histamine H1 receptor agonist (HTMT) and selective H4 receptor agonist (4-methylhistamine) induced a dose-dependent eye scratching behavior and allergic-like symptoms. JNJ7777120 inhibited the effect of HTMT. However, levocabastine caused no inhibition on the response of 4-methylhistamine. H4 receptor was closely related with allergic conjunctivitis. H4 receptor antagonists may be effective in allergic conjunctivitis which showed no inhibition by histamine H1 receptor antagonists (see abstract).
Combination of Gutierrez and Nakano et al.
Regarding instant claims 1, 21, and 22, Gutierrez and Nakano et al. teach a dry eye treatment device. The necessary citations of Gutierrez and Nakano 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 Nakano 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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200
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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, Nakano et al. disclose the use of both elements.
Nakano et al. disclose that identified selective histamine H1 receptor agonist (HTMT) and selective H4 receptor agonist (4-methylhistamine) induced a dose-dependent eye scratching behavior and allergic-like symptoms (see abstract). The histamine agonist surrounding conjunctivitis supplies the specific therapeutic agent.
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).
Therefore, a skilled artisan (POSITA; person of ordinary skill in the art) would combine the disclosures of Gutierrez and Nakano et al. and substitute in the histamine agonist within Nakano et al. for the therapeutic agent of Gutierrez in order to teach every element of instant claim 1.
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 Nakano et al.
Regarding instant claims 2 and 3, Gutierrez and Nakano 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 Nakano 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 Nakano 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 Nakano 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 claims 7 and 13, Gutierrez and Nakano 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 Nakano 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 Nakano 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 Nakano 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 Nakano 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 Nakano 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 (further see abstract within Gutierrez).
Regarding instant claim 15, Gutierrez and Nakano 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 Nakano 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 within Gutierrez).
Regarding instant claim 18, Gutierrez and Nakano 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 Nakano 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 Nakano 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 Nakano 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
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 modify the eye device for therapeutic agent release disclosed by Gutierrez, using the teachings of Nakano et al. to incorporate the necessary claim limitations.
The Gutierrez and Nakano et al. references both have considerable overlap with the treatment of ocular symptoms. In this instance, Gutierrez supplies the eye device for controlled release of a therapeutic agent, while Nakano et al. supplies the histamine agonist surrounding conjunctivitis (dry irritated eye; see PTO-892 NPL X). Both references are analogous art.
Starting with Gutierrez, the skilled person only had to try the necessary claim limitations disclosed by Nakano et al. The combination of Gutierrez and Nakano et al. would allow one to arrive at the present application without employing inventive skill. This combination of the eye device for therapeutic agent release taught by Gutierrez along with the use of the necessary claim limitations taught by Nakano et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application.
It would have only required routine experimentation to modify the eye device for therapeutic agent release disclosed by Gutierrez with the use of the necessary claim limitations taught by Nakano et al. This combined modification would have led to an enhanced eye device employing a histamine agonist that would be beneficial for patients.
Response to Arguments
Applicant's arguments filed March 17, 2026 have been fully considered but they are not persuasive.
The instant claim amendments were sufficient to address the claim objections. Therefore, the claim objections are withdrawn from the Non-Final office action dated December 17, 2025.
The amendments did necessitate a new ground of rejection.
The domestic priority to the present application has been applied and corrected.
Applicant Argument: The Applicant argues that impermissible hindsight was used by the Examiner in constructing a 35 U.S.C. §103 rejection.
Examiner’s Rebuttal: The Examiner respectfully disagrees. It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
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 Examiner respectfully disagrees.
First, allergic conjunctivitis and dry eye are not the same, and are distinct conditions (see PTO-892 NPL V). Also, there is evidence that a histamine agonist can treat dry eye (see PTO-892 NPL U; also see US6,274,160B1). Therefore, Nakano et al. does not teach away from the application but gives an example of a histamine H1 receptor agonist.
Second, Gutierrez discloses that as used herein, the term "therapeutic agent" or "agent" comprises any desired pharmaceutical agent or mixture of individual pharmaceutical agents or the like, for the administration of one or more active agents to a region of a patient (see paragraph [0048] within Gutierrez). This statement from Gutierrez would encompass all histamine receptor agonists. The specific use of a histamine agonist is not required based on the above broad generalization.
In summary, there is evidence for the use of a histamine receptor agonist to treat a dry eye and that the Nakano et al. reference presents an example of such an agonist.
Thus, the 35 U.S.C. §103 rejection for instant claims 1-10, 12-15, and 17-22 is maintained.
Conclusion
No claims are allowed.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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