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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of group II, claims 38-40, Figs. 3A-3D in the reply filed on 04/28/2026 is acknowledged. Newly added claim 50 is directed to a non-elected embodiment since elected Figs. 3A-3D disclose a lens 24. Thus, claims 38-40 and newly added claims 41-49 and 51-56 are presently pending in this application.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 38-39, 42, 45-49, 51 and 54 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Venkatraman (2015/0209274).
Regarding claims 38, 45-46 and 49, Venkatraman discloses an ophthalmic implant 500 (Fig. 1) comprising: a primary device comprising an intraocular structure 510 comprising an anterior side, a posterior side opposite the anterior side, a circumferential edge having an anterior rim (the intraocular lens has a top and bottom side with a circular edge having an outer edge/rim; Figs 1 and 7a), a first haptic extending outwardly from the circumferential edge at a first edge-haptic junction, and a second haptic extending outwardly from the circumferential edge at a second edge-haptic junction (haptics 520 extending outwardly from outer edge of lens portion 510);
and a secondary device comprising a first drug delivery device 100 comprising a first pad 102 and a first fixation portion 152 attached to the first pad, the first pad comprising at least one therapeutic agent embedded in a first drug eluting matrix (par. 0065 discloses the drug eluting member is biodegradable and par. 0101 discloses the drugs are dissolved throughout the polymer matrix), the first drug delivery device 100 configured to releasably attach to a periphery 512 of the intraocular structure 510 via the first fixation portion 152 such that the first pad lies anteriorly to a plane defined by the anterior rim of the circumferential edge of the intraocular structure (the anterior surface 104 has an anterior rim 106 that attaches removably to the anterior/top side of lens 510 via channel 152; pars. 0059-0062 and Fig. 2).
Regarding claims 39 and 51, Venkatraman discloses wherein the first drug delivery device 100 is configured to releasably attach to a portion of the intraocular structure 510 that is between the first and second edge-haptic junctions 52 (as shown in Fig. 1).
Regarding claims 42 and 54, Venkatraman discloses wherein the at least one therapeutic agent comprises an aptamer, an antibody, an anti-oxidant, an anti-inflammatory agent, an anti- proliferative agent, an anti-mitotic agent, an antibiotic, or a combination thereof (par. 0102 discloses an antibiotic).
Regarding claims 47-48, Venkatraman discloses wherein the secondary device further comprises a second device, the second device comprising a second pad and a second fixation portion attached to the second pad, the second device configured to releasably attach to the periphery of the intraocular structure via the second fixation portion such that the second pad lies anteriorly to a plane defined by the anterior rim of the circumferential edge of the intraocular structure (Fig. 5 discloses a second drug eluting device 220 and Fig. 2 discloses the anterior surface 104 has an anterior rim 106 that attaches removably to the anterior/top side of lens 510 via channel 152; pars. 0059-0062) and wherein the second device comprises a second drug delivery device, the second pad comprising the at least one therapeutic agent embedded in a second drug eluting matrix (par. 0065 discloses the drug eluting member which includes second device 220 is biodegradable and par. 0101 discloses the drugs are dissolved throughout the polymer matrix).
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.
Claims 43, 44 and 55-56 are rejected under 35 U.S.C. 103 as being unpatentable over Venkatraman (2015/0209274) in view of Kahook et al. (2018/0368974) “Kahook”.
Venkatraman discloses the claimed invention of claims 38 and 45; except for wherein at least one therapeutic agent comprises a beta blocker, an alpha agonist, a ROCK inhibitor, an adenosine receptor agonist, a carbonic anhydrase inhibitor, an adrenergic receptor activating agent, a cholinergic receptor activating agent, a prostaglandin analogue, a steroid, a complement factor, or any combination thereof and wherein the at least one therapeutic agent comprises a prostaglandin analogue. However, Kahook teaches a similar ophthalmic implant comprising at least one therapeutic agent comprises a beta blocker, an alpha agonist, a ROCK inhibitor, an adenosine receptor agonist, a carbonic anhydrase inhibitor, an adrenergic receptor activating agent, a cholinergic receptor activating agent, a prostaglandin analogue, a steroid, a complement factor, or any combination thereof and wherein the at least one therapeutic agent comprises a prostaglandin analogue (par. 0061). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ophthalmic device in Venkatraman to include at least one therapeutic agent comprises a beta blocker, an alpha agonist, a ROCK inhibitor, an adenosine receptor agonist, a carbonic anhydrase inhibitor, an adrenergic receptor activating agent, a cholinergic receptor activating agent, a prostaglandin analogue, a steroid, a complement factor, or any combination thereof and wherein the at least one therapeutic agent comprises a prostaglandin analogue, as taught and suggested by Kahook, for treatment of clinical indications such as macular degeneration or glaucoma (par. 0061).
Allowable Subject Matter
Claims 40-41 and 52-53 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the subject matter is allowable due to the limitations of “wherein the portion is a first tab extending outwardly from the circumferential edge of the intraocular structure”, as set forth in claims 40 and 52 and “wherein the fixation portion is devoid of the therapeutic agent”, as set forth in claims 41 and 53, which has not been found anticipated by or obvious over prior art. The closest prior art of record of Venkatraman and Kahook fail to disclose a first tab on the circumferential edge of the intraocular structure extending outwardly and where the fixation portion of the drug delivery device is devoid of the therapeutic agent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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