DETAILED ACTION
Receipt is acknowledged of applicant’s Preliminary Amendment filed 5/5/2025.
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
Claims 1-160 are cancelled. Claims 161-186 are newly added. Accordingly, claims 161-186 are pending in the application.
Information Disclosure Statements
The IDS’s dated 6/3/2025 and 6/2/2026 have been considered. Signed copies are enclosed herewith.
Claim Objections
Claim 164 is objected to because of the following informalities: the claim recites the acronym PVA for polyvinyl alcohol. The acronym is defined in the specification, however, when an acronym appears in the claims, it is appropriate to recite the full name, followed by the acronym in parenthesis, such as “polyvinyl alcohol (PVA)” and then recite only the acronym in subsequent reiterations.
Claim 171 is objected to because of the following informalities: the claim recites the acronym AMD for age-related macular degeneration. The acronym is defined in the specification, however, when an acronym appears in the claims, it is appropriate to recite the full name, followed by the acronym in parenthesis, such as “age-related macular degeneration (AMD)” and then recite only the acronym in subsequent reiterations.
Claim 177 is objected to because of the following informalities: the claim recites the acronym VEGF for vascular endothelial growth factor. The acronym is defined in the specification, however, when an acronym appears in the claims, it is appropriate to recite the full name, followed by the acronym in parenthesis, such as “vascular endothelial growth factor (VEGF)” and then recite only the acronym in subsequent reiterations.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 167 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 167 does not end with a period and as such the claim is not definitively limited only to the limitations expressly recited in the claim. See MPEP 608.01(m).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 174 and 175 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 174 recites, “wherein each initial ocular drug delivery insert has an average drug release rate over a 30 day period of amount 0.1 µg/day to about 150 µg/day”, Claim 174 depends from claim 161. Claim 61 recites, “wherein the release rate for each initial ocular drug delivery insert is about 0.1 µg/day to about 150 µg/day of vorolanib for at least 30 days”. The limitations are essentially identical. Thus, the subject matter of claim 174 does not properly further limit the subject matter of claim 161.
Claim 175 recites, “wherein each additional ocular drug delivery insert has an average drug release rate over a 30 day period of amount 0.1 µg/day to about 100 µg/day”, Claim 175 depends from claim 161. Claim 61 recites, “wherein the release rate of each additional ocular drug delivery insert is about 0.1 µg/day to about 100 µg/day of vorolanib for at least 90 days”. Thirty days is less than the required “at least 90 days”. Thus, the subject matter of claim 175 does not properly further limit the subject matter of claim 161.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 161-176 are rejected under 35 U.S.C. 103 as being unpatentable over Saim et al. (WO 2022/056392 A1, pub. Mar. 17, 2022, eff. filing date Sep. 14, 2020; hereafter as “Saim”) in view of Caldwell (US 2021/0340516 A1, Nov. 4, 2021, hereafter as “Caldwell”).
The instant claims are drawn to various methods of treating a posterior ocular condition, comprising:(a) injecting into an eye of a human subject, wherein the eye has the posterior ocular condition, one or more loading doses of one or more initial ocular drug delivery inserts, each insert comprising a solid matrix core comprising a matrix polymer and vorolanib or a pharmaceutically acceptable salt thereof and/or one or more maintenance doses.
Regarding instant claims 161, 174, 175 and 178-186, Saim teaches implantable bioerodible inserts for delivering an active pharmaceutical ingredient to the eye and methods of treating thereof (abstract). Said inserts are injected ([0014]). Saim teaches that the inserts may be administered to teat a posterior ocular condition including ([00213]). Saim teaches that the ocular drug delivery insert comprising a solid matrix core comprising a matrix polymer and vorolanib or a pharmaceutically acceptable salt thereof ([0016]). Saim teaches, in one embodiment, the drug release rate for the insert is about 0.01 µg/day to about 100 µg/day for at least 14 days and wherein the insert is capable of at least 20% erosion within 95 days ([0016]). Saim also teaches the duration of release of vorolanib can be for at least 30 days, for at least 60 days, for at least 90 days, or between about 60 days to about 270 days ([0024] and [0042]-[0044]). Saim further teaches multiple inserts can be injected ([0039]). Saim teaches devices having different drug delivery periods/durations and rates of delivery ([00201]). Saim also teaches that curing temperature, curing duration and insert surface area all impact release rate and an increase in diameter with length kept constant, increased release rate while when the diameter was kept constant, increasing the length of the insert, increased the release rate ([00204]).
Saim does not teach repeat dosing such as a second loading dose or maintenance doses (instant claims 161 and 178-186). It is noted that the claims recite that the repeat dose(s) occur at various time ranges or various percentage ranges of release. It is also noted that said percentage ranges of release are directly related to an amount of time.
Caldwell teaches a method of treating retinal diseases including retinopathy of prematurity (ROP), diabetic retinopathy, age-related macular degeneration and central vein occlusion, the method comprising administering a composition comprising PEGylated arginase 1 to a subject, wherein the composition can be in the form of a bioerodible insert or ocular insert (abstract; [0092]). Caldwell teaches that the composition can be administered by intravitreal injection and can be administered once a week, once every other week, once a month, once every two months, once every three months, once every four months, once every five months, or once every six months ([0111]). Caldwell further teaches, in some embodiments, the subject receives injections once a month for the first five injections, and then once every two months for the remainder of the treatment; in other embodiments, the subject receives the injections until the symptoms of their disease are reduced and then receive less frequent maintenance doses as needed; and in other embodiments, the subject receives the injections on an as needed basis, for example as symptoms begin to reappear ([0111]).
Saim and Caldwell are both drawn to methods of treating the eye by administering an erodible drug delivery insert via intravitreal injection, 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 repeat doses such as a second loading dose or maintenance doses into Saim, as suggested by Caldwell, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Caldwell teaches various dosing frequencies and regimens depending on whether the patient’s symptoms improve or reappear. One of ordinary skill would have reasonably expected tailoring the dosing frequency/regimen depending on whether the patient’s symptoms improve, reappear, etc.
Regarding instant claim 162, Saim and Caldwell teach the elements discussed above. Saim further teaches the amount of the vorolanib or pharmaceutically acceptable salt thereof in the insert is about 60% w/w to about 98% w/w ([0016]).
Regarding instant claim 163, Saim and Caldwell teach the elements discussed above. Saim further teaches that the core comprises about 200 µg to about 2000 µg of vorolanib or a pharmaceutically acceptable salt thereof ([0023]).
Regarding instant claim 164, Saim and Caldwell teach the elements discussed above. Saim further teaches that the core comprises about 1% w/w to about 15% w/w PVA ([0024]).
Regarding instant claim 165, Saim and Caldwell teach the elements discussed above. Saim further teaches that a coating substantially surrounding the core ([0017]).
Regarding instant claim 166, Saim and Caldwell teach the elements discussed above. Caldwell teaches administering maintenance doses every four months, every five months, every six month, or as needed ([0111]). Saim and Caldwell are both drawn to methods of treating the eye by administering an erodible drug delivery insert via intravitreal injection, 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 optimize the frequency of the maintenance doses by way of routine experimentation, as suggested by Caldwell, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Caldwell teaches administering maintenance doses every four months, every five months, every six month, or as needed depending on whether the patient’s symptoms improve or reappear. One of ordinary skill would have reasonably expected tailoring the dosing frequency/regimen depending on whether the patient’s symptoms improve, reappear, etc.
Regarding instant claim 167, Saim and Caldwell teach the elements discussed above. Saim further teaches an embodiment wherein the drug release rate is about 0.1 µg/day to about 20 µg/day ([0022]).
Regarding instant claim 168, Saim and Caldwell teach the elements discussed above. Saim further teaches that the insert is cured for about 30 minutes to about 4 hours (720 minutes) at about 130 °C to about 150 °C ([0024]. It is noted that said claim is deemed a product-by-process claim due to the limitation, “...was cured for...” 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).
Regarding instant claim 169, Saim and Caldwell teach the elements discussed above. Saim further teaches that the insert is sized and shaped to fit through a 20 to 27 gauge needle or cannula and the insert has a length of about 1 mm to about 10 mm ([0018]).
Regarding instant claim 170, Saim and Caldwell teach the elements discussed above. Saim further teaches intravitreal injection ([0014]).
Regarding instant claim 171, Saim and Caldwell teach the elements discussed above. Saim further teaches treating the particular conditions, macular edema, wet age-related macular degeneration (AMD), diabetic macular edema, retinal vein occlusion, and diabetic retinopathy ([0217] and [0220]).
Regarding instant claim 172, Saim and Caldwell teach the elements discussed above. Saim further teaches that the insert comprises about 200 µg to about 2000 µg ([0040]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). Because the claimed range of 1000 µg to about 4000 µg overlaps with the range of about 200 µg to about 2000 µg disclosed by the prior art, a prima facie case of obviousness exists.
Regarding instant claim 173, Saim and Caldwell teach the elements discussed above. Saim further teaches multiple inserts can be injected and each insert comprises about 200 µg to about 2000 µg ([0039]-[0040]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). Because the claimed range of 500 µg to about 3800 µg overlaps with the range of about 200 µg to about 2000 µg disclosed by the prior art, a prima facie case of obviousness exists.
Regarding instant claim 176, Saim and Caldwell teach the elements discussed above. Saim further teaches that the eye previously received laser choroidal neovascularization (CNV) induction ([0313]).
Regarding instant claim 177, Saim and Caldwell teach the elements discussed above. Saim further teaches multiple inserts can be injected at once (supplemental; [0019] and [0239]). As discussed above, the inserts comprising vorolanib which is a known VEGF and PDGFR inhibitor ([00221]).
Thus, the combined teachings of Saim and Caldwell render the instant claims prima facie obvious.
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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