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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/16/2025 has been entered.
Response to Arguments
All of Applicant’s arguments filed 9/19/2025 have been fully considered.
In view of the amendments filed, the rejection over Bafna is withdrawn.
In summary Applicant argues that Jarrett and Ness are not combinable as Jarrett is directed to degradable inserts for the canaliculus while Ness is directed to insoluble inserts for use in the cul-de-sac of the conjunctiva.
Applicant arguments are not persuasive. It appears applicants are arguing that the references are non-analogous, however, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the references are in the same field of endeavors (i.e. ocular inserts comprising dexamethasone).
Applicant argues that combining Ness and Jarrett would result in an ocular formulation adapted for the cul-de-sac of the conjunctive and not the canaliculus as claimed.
This is not persuasive as the rejection is not based on attempting to incorporate the composition of Ness into the composition of Jarrett, Ness is only cited for the proposition that the amounts of dexamethosone used in the insert of Jarrett could be optimized depending on the therapeutic effect desired and the time span of the insert.
Claim Objections
Claim 17 is objected to because of the following informalities: Claim 17 recites “wherein the insert upon hydration…the diameter of the insert” instead of “wherein upon hydration…”. Appropriate correction is required.
New Claim Rejections - 35 USC § 112(b)
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 8 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 8 depends from canceled claim 7 this rending the metes and bounds of the claim unclear. For purposes of examination, claim 8 will be examined as depending from claim 1.
Maintained/Modified 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.
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.
Claim(s) 1, 3, 8, 10-11 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jarrett (US 8,563,027) and Ness (US 3,618,604).
Jarrett discloses a medical prosthesis for blocking or reducing tear flow through a punctum or canaliculus of a human eye and delivering a drug to the eye that comprises a dehydrated covalently crosslinked synthetic hydrophilic polymer hydrogel with dimensions to pass through a puncta lacrimali, with the dehydrated hydrogel absorbing physiological water to swell to at least 1 mm in cross-sectional width and conformably fit a canaliculus, with the hydrogel comprising a therapeutic agent dispersed through the hydrogel for release to an eye (Abs).
Regarding claim 1: Jarrett teaches a suitable embodiment to be one wherein a drug is entrapped within microspheres dispersed within a hydrogel is a drug dispersed within the hydrogel (col. 6, lines 50-60). Jarrett teaches that suitable therapeutic agents for use in the hydrogel include dexamethasone, selected from a finite number of options (table 2), this reads on an ocular insert comprising dexamethasone particles dispersed within the hydrogel as required by instant claim 1 and glucocorticoids of instant claim 4. Jarrett teaches that both biodegradable or non-biodegradable hydrogels maybe formulated (col. 6, lines 48-50) and teaches the plugs maybe hydrolytically biodegradable (col. 24, line 18), thus the selection of either type of hydrogel is prima facie obvious and simply a matter of design choice.
Jarrett teaches that the insert to be a plug, such as a punctal plug which includes intracanalicular plugs which are inserted into the canalicula (title and col. 4, lines 64-67).
Jarrett teaches the hydrogels maybe used as punctal plugs having a substantially cylindrical shape (reading on essentially cylindrical) and the length of the desiccated or dehydrated hydrogel ranges from 0.5 to about 15mm (col. 23, lines 50-53) and a suitable dried diameter sizes ranging from .39-.64mm, which overlaps with the claimed length of “about 2.14 to about 2.36mm” and diameter of “about 0.14 to 0.55mm” (tables 4 and 5 and fig. 21A).
Jarrett teaches that swelling of the diameter of about 2x after placement will provide a snug fit for most patients (col. 23, lines 55-60) which reads on insert closely fitting within the individual size of the canaliculus of the patient, upon hydration.
Figures 18 and 19 of Jarrett show sustained release of the drug in the hydrogel.
Regarding claim 3: Fig 20 shows release of drug of about 22 days. Jarrett teaches that the hydrogel can be selected to be absorbable over days, weeks or months, depending on the drug selected and the duration for release that is needed (col. 22, lines 50-55). Jarret teaches that the therapeutic can be entrapped in particles or capsules that degrade at a different rate than the hydrogel in the plug, a faster rate accelerated drug delivery while a slower rate delays it. A combination of rates can be used to deliver a desired dosage regimen over time. It would have been prima facie obvious to a skilled artisan to optimize the degradation rate of the hydrogel and active agent in order to obtain a desired release rate.
Regarding claim 17: Figures 2E and 2F show that when the dry insert is hydrated, the diameter increases and the length decreases. While the prior art fails to teach “upon hydration after 24hrs…” the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Regarding claims 18-19: Jarrett teaches that swelling of the diameter of about 2x after placement will provide a snug fit for most patients, this provides a ratio of hydrated diameter to dry diameter of 2, which overlaps with the claimed ranges.
Regarding claim 20: Figures 2C and 2D show that when the dry insert is hydrated, the length remains substantially the same with a slight decrease in size, which reads on the claimed ratio 0.9 or less. Fig 2E and 2F shows a hydrated plug with a significant size decrease that reads on the claimed ratio. In the instance that the amounts do not overlap, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close, as such the claimed length is obvious absent unexpected results or criticality.
Jarrett teaches that upon hydration the hydrogel, the hydrogel has internal covalent crosslinks between its polymeric members so that even when it swells in all directions, constraints on the hydrogel volume caused by the lumen of the canal prevent it from unduly lengthening (col. 5, lines 40-50).
However, Jarrett does not teach the amounts in which dexamethasone is present in the insert as recited by instant claims 8 and 10-11.
Ness teaches drug dispensing ocular inserts comprising a polymeric material, such as a hydrogel (col. 2 and Ness – claim 2). The insert can comprise dexamethasone in therapeutically effective amounts which depends on the on the particular drug, the desired therapeutic effect, and the time span for which the ocular insert will be used. Typically amounts from 1 microgram to 1mg of drug are incorporated (col. 3, lines 40-55).
It would have been prima facie obvious for a skilled artisan to optimize the amount of dexamethasone used in the formulation of Jarrett with a reasonable expectation of success as the prior art is clear that the amounts of active agent (1 microgram to 1mg) can be optimized depending on the desired therapeutic effect (reading on instant claims 8 and 10-11), and the time span for which the ocular insert will be used. One of skill in the art would have a reasonable expectation of success as both Jarrett and Ness teaches ocular inserts comprising dexamethasone.
Conclusion
No claims are allowable.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613