DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after October 11, 2023, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt is acknowledged of Applicants’ claimed invention filed on 10/11/2023 in the matter of Application N° 18/554,928. Said documents are entered on the record. The Examiner further acknowledges the following:
Thus, claims 1-12 and 22-23, represent all claims currently under consideration.
Applicant’s response to the Restriction Requirement has been considered. Applicant elected Group 1, encompassing claims 1-12 and 22-23, without traverse. Accordingly, the election has been accepted, and the instant action is directed to the elected invention. Claims directed to the nonelected invention have been withdrawn from further consideration pursuant to the restriction requirement.
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.
Claims 1-12 and 22-23, are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (US20170135960A1), and Astafieva et al. (US20140276482A1).
Yu et al. discloses injectable formulations comprising surface-treated microparticles. In certain embodiments, the microparticles are intended for ocular therapy, and Yu et al. further describes methods for preparing the surface treated microparticles and injectable formulations containing them. The reference also teaches formulations suitable for ocular administration, indicating that long-term, sustained intraocular drug delivery may be achieved while minimizing disruption to vision (See paragraph 0002). Yu et al. teaches that the solid aggregating microparticles may be used in injectable formulations for intermittent administration and can include one or more therapeutic, prophylactic, or diagnostic agents (See paragraph 0096). Yu et al. describes controlled delivery of therapeutic agents through the use of microparticle formulations. The reference further teaches, in one embodiment, that the pharmaceutical agent is a tyrosine kinase inhibitor, such as sunitinib, provided in the form of microparticles (See paragraph 0040). Yu et al. describes mildly surface-treated biodegradable microparticles that are capable of aggregating into larger particles after being injected in vivo. The reference also discloses the inclusion of one or more pharmaceutically acceptable excipients suitable for administration to the eye (See paragraph 0023). Yu et al. discloses an injectable composition comprising the disclosed microparticles suspended in a pharmaceutically acceptable carrier for in vivo administration. However, Yu et al. does not teach or suggest that the therapeutic agent is provided in the form of a microcrystal. In contrast, Astafieva et al., discloses a formulation in which the therapeutic agent is present as a microcrystal (See paragraph 0110). Yu et al. teach a formulation of a therapeutic agent comprising one or more therapeutics and systems comprising a therapeutic device (See paragraph 0002). Yu et al. disclose wherein tyrosine kinase inhibitor is a low water-soluble compound, for example, the tyrosine kinase inhibitor is, without being a limiting example, sunitinib, in crystalline form (See paragraph 0016). Yu et al. teaches that the therapeutic agent delivered to the vitreous may be replenished over time by a crystalline therapeutic agent (See paragraph 0281). Accordingly, one of ordinary skill in the art would have been motivated to combine the teachings of Yu et al. with Astafieva et al, disclosure of therapeutic microcrystals in order to provide the therapeutic agent in microcrystalline form, with a reasonable expectation of achieving sustained intraocular drug replenishment. Yu et al. disclose wherein a formulation comprising the therapeutic agent in a salt form may provide buffering capacity as additional therapeutic agent dissolves to replenish the therapeutic agent delivered over time (See paragraph 0281).
Regarding claim 2, Yu et al., in view of Astafieva et al., teaches an injectable formulation as recited in claim 1. Yu et al., further teaches that the formulation may comprise one or more therapeutic, prophylactic, or diagnostic agents capable of binding to a ligand or receptor in or on the eye. The reference also describes, in one embodiment, surface-treated microparticles comprising a therapeutic agent for the treatment of glaucoma, including a dual leucine zipper kinase (DLK) inhibitor (See paragraph 0201).
Regarding claim 3, Yu et al., in view of Astafieva et al., teaches the injectable formulation of claim 2. Yu et al. further discloses that the therapeutic agent may comprise a dual leucine zipper kinase (DLK) inhibitor (See paragraph 0201). In one embodiment, the surface-treated microparticles include a compound for treating glaucoma, such as the disclosed DLK inhibitor.
Regarding claim 4, Astafieva et al. teaches that one or more therapeutic, prophylactic, and/or diagnostic agents may bind to melanin. The reference further discloses that target specificity is initially evaluated using biochemical kinase inhibition assays and that melanin binding is assessed to estimate biological barriers (See paragraph 0128). However, Astafieva et al. does not expressly disclose a dissociation constant of less than 1x10- 3 M, 1x10-4 M, 1x10-5M, or 1x10-6M. Nevertheless, it would have been obvious to one of ordinary skill in the art to optimize the dissociation constant through routine experimentation to achieve the desired binding characteristics, as such optimization would have involved only routine adjustments of a result-effective variable.
Regarding claim 5, Yu et al., teach the injectable formulation of claim 5. Yu et al. further discloses that the therapeutic agent may comprise a tyrosine kinase inhibitor, such as sunitinib, incorporated into the disclosed microparticles. Accordingly, the combined teachings of the references suggest an injectable formulation in which the therapeutic or prophylactic agent comprises sunitinib, as recited in claim 5.
Regarding claim 6, Yu et al., teach the injectable formulation of claim 6. Yu et al., further discloses microcrystals formed from sunitinib and pamoic acid for use in the injectable formulation. Accordingly, Yu et al. teaches the limitation wherein the microcrystals are formed of sunitinib and pamoic acid, as recited in claim 6 (See paragraph 0020 and 0120).
Regarding claims 7, and 22, Yu et al. discloses wherein the size of the microcrystals is between about 0.1 microns and about 500 microns. The particles having an average particle size of between 1 micron and 100 microns (See paragraph 0269).
Regarding claim 8, Yu et al. teaches the injectable formulation of claim 1. Yu et al. further discloses, in claims 79 and 116, a process for preparing surface modified solid aggregating microparticles, wherein the process is carried out at a pH below about 8 and above about 6.
It would have been obvious to one of ordinary skill in the art to prepare the injectable formulation using the disclosed pH conditions, thereby obtaining a formulation having a pH between 6 and 8, as recited in claim 8, with a reasonable expectation of success.
Regarding claim 9, Yu et al. teaches the injectable formulation of claim 1. Yu et al., further discloses that typical routes of ocular administration include intravitreal and subconjunctival injection (See paragraph 0005). Additionally, Yu et al. teaches therapeutic particles dispersed in a non-Newtonian fluid that facilitates migration of the particles from the injection site within the suprachoroidal space to the intended treatment site (See paragraph 0020).
Regarding claim 10, Yu et al. teaches the injectable formulation of claim 1. Yu et al. further discloses that pharmaceutically acceptable excipients, including preservatives, may optionally be incorporated into the particles during particle formation (See paragraph 0271). Yu et al. also teaches that the therapeutic agent and polymer may optionally be mixed with a surfactant (See paragraph 0273). Because the inclusion of preservatives and surfactants is expressly described as optional, Yu et al., teaches formulations that do not contain a preservative or a surfactant, as recited in claim 10.
Regarding claims 11, and 23, Yu et al. teaches the injectable formulation of claim 1. Yu et al. further discloses that the STMP suspension in diluted ProVisc® remained stable at room temperature for a sufficient period to permit consistent administration of a relatively small injection volume, for example, about 10 microliters (See paragraph 0351). Because the disclosed injection volume of about 10 microliters falls within the claimed range of about 0.1 microliters to about 100 microliters, Yu et al. teaches the limitation of claim 11.
Regarding claim 12, Yu et al. teaches an injectable ocular formulation comprising microparticles that provide controlled, sustained intraocular delivery of a therapeutic agent. Yu et al. further discloses that the therapeutic agent may be replenished over time by dissolution of a crystalline therapeutic agent, thereby maintaining therapeutic levels at the site of administration. Yu et al. further discloses surface-modified solid-aggregating microparticles comprising at least one pellet that is capable of sustained drug delivery for at least six months (See claim 9). Accordingly, Yu et al. teaches that one or more active agents are present in an amount effective to provide therapeutic or prophylactic efficacy for at least six months at or around the site of application in the eye, as recited in claim 12.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Barber whose telephone number is (703) 756-5302. The examiner can normally be reached on Monday through Friday from 6:30 AM to 3:30 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax, can be reached at telephone number (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY BARBER/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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