DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Status of the Claims
The response and amendment filed 12/16/2025 is acknowledged.
Claims 1-9, 11-13, and 15-16 are pending.
Claims 15-16 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/19/2025.
Claims 1-9 and 11-13 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Terminal Disclaimer
The terminal disclaimer filed on 12/16/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Pat. No. 12102559, 1177937, 11395797 and US App. No. 18145180, 18145256, and 18978032 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn
The rejection of claim 9 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subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention has been withdrawn because of Applicant’s amendment.
The rejection of claim(s) 1-14 on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-12 of US 12102559 in view of Ketelson, US 20200345544 has been withdrawn because of Applicant’s amendment and the terminal disclaimer.
The rejection of claim(s) 1-14 on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-19 of US 11779537 in view of Ketelson, US 20200345544 has been withdrawn because of Applicant’s amendment and the terminal disclaimer.
The rejection of claim(s) 1-14 on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-19 of US 11395797 has been withdrawn because of Applicant’s amendment and the terminal disclaimer.
The rejection of claim(s) 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-2, 4-9, 11-13 of US 18145180 has been withdrawn because of Applicant’s amendment and the terminal disclaimer.
The rejection of claim(s) 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 4-12, and 14-18 of US 18145256 has been withdrawn because of Applicant’s amendment and the terminal disclaimer.
The rejection of claim(s) 1-8 and 10-14 on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-14 of US 18978032 has been withdrawn because of Applicant’s amendment and the terminal disclaimer.
Response to Arguments
Applicant's arguments filed 12/16/2025 have been fully considered but they are not persuasive.
Applicant has argued the amended claims are novel and non-obvious over Ketelson, US 202000345544 because Ketelson does not teaches a polymeric film having sufficient dimensions to cover a cornea when applied to an eye, wherein the polymeric film is circular and has a diameter ranging from 11 mm to 13 mm as recited in the amended claims.
This argument is unpersuasive in light of the rejections below addressing the claim amendment.
The claimed invention recites about 11 mm to 13 mm, and therefore encompasses values less than 11 mm. Ketelson teaches a broader range for diameter of approximately 0.5 to 10 mm (Ketelson, e.g., 0109). There appears to be overlap in these ranges since they are each modified by about or approximately. Even if the ranges were not approximate, the ranges are close and there does not appear to be any evidence the difference in size is critical or offers unexpected properties. Further still, the range is within the range suggested by Wirostko as effective for mucoadhesive film diameters useful for topical mucoadhesive films as explained below.
With respect to the double patenting rejection, Applicant has argued 18248000 is assigned to Novartis, not Alcon.
This argument is unpersuasive. The reference application has a common joint inventor, i.e., Howard Allen Ketelson. This is sufficient to raise the issue of non-statutory double patenting. See MPEP 804, e.g., Chart I-B AIA and Section I, B: An examiner may become aware of two or more copending applications which share the same inventive entity, at least one common (joint) inventor, a common applicant, and/or a common owner/assignee, or that claim an invention resulting from activities undertaken within the scope of a joint research agreement as defined in 35 U.S.C. 102(c) or pre-AIA 35 U.S.C. 103(c)(2) and (3), that would raise an issue of double patenting if one of the applications became a patent.
Since the copending application has a common joint inventor, the rejection is maintained at this time.
Rejections Addressing Applicant’s Amendment
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.
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.
Claim 2 is 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 2 does not include all of the limitations required by claim 1 since claim 1 limits the one or more mucoadhesive polymers to a closed group consisting of HP guar, hyaluronic acid, polyvinyl pyrrolidone and combinations thereof.
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.
Claims 1-9 and 11-13 are 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 1 includes the limitation of “within first 24 hours wound.” It is not clear what this was intended to mean since the phrase does not appear to be complete.
Claim 1 includes the limitation of “compared to a topical steroid treatment.” The specification does not define a topical steroid treatment and the claims do not specify a topical steroid treatment. Thus, the skilled artisan is unable to determine which topical steroid treatment is required for comparison to determine faster healing within the first 24 hours.
Dependent claims do not clarify these issues.
Clarification is required.
Claim Rejections - 35 USC § 102/103
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.
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 1-9 and 11-13 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by, or in the alternative, under 35 U.S.C. 103 as obvious over Ketelson, US 20200345544.
Ketelson teaches devices for placing on the outer exposed surface of the eye (Ketelson, entire document, e.g., Abstract, Figs., and claims). The disks are polymeric films (Ketelson, e.g., 0062-0067). Ketelson, e.g., claim 9 and 0112 and Table 3, teaches films having a composition of 40% HPGuar/40% HA/10% PVP/10% PEG which meets the composition limitations of claims 1-9. Polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP) are named plasticizers, i.e., softeners (Ketelson, entire document, e.g., 0047). The claimed mucoadhesive polymers read on Ketelson, e.g., claims 1-3 and 0037-0038. Ketelson’s films contain a total amount of mucoadhesive polymers equal to or less than 100% w/w on by dry weight of the film because the films include mucoadhesive polymers and plasticizing polymers, e.g., PVP and PEG. Films are dissolvable and clear and maintain a film on the cornea (Ketelson, e.g., 0060, and 0064, and 0047 clear polymer solution, and 0056, residue was visible on the corneal surface after 1 hour). Film dimensions are found in Ketelson, e.g., 0109, e.g., film of approximately 0.5 to 10 mm. Film thickness range of 150-250 microns is entirely within the claimed range (Ketelson, e.g., 0043-0044)). Film thickness is related to time to dissolve (Ketelson, e.g., 0110). Films dissolve at times within the claimed range (Ketelson, e.g., Tables 2-5). Applicable to claims 10-14: The films are expressly disclosed as compatible with the ocular surface (Ketelson, entire document, e.g., Abstract and claims) and is expressly intended to be applied to the surface of the eye (Ketelson, e.g., 0048-0049). Thus, the films of Ketelson additionally meet the intended use limitations of claims 1 and 11-13.
Regarding the limitations of the dissolvable medical device provides faster healing of the corneal within first 24 hours wound compared to a topical steroid treatment according to a Fluorescein Index Change test (demonstrates corneal damage), wherein the corneal wound is selected from a group consisting of glaucoma surgery wound, vision correction laser surgery wound for treating refraction defects, cataract surgery wound and GVHD induced ocular damage in transplant patients: These are properties of the composition of the insert according to an intended use. Since the prior art teaches the same composition, the claimed properties are presumed to be inherent to the prior art composition if used in the same way. See MPEP 2112.01.
Ketelson does not expressly teach the range of about 11 mm to about 13 mm. However, the claimed range encompasses values within the range of approximately 0.5 to 10 mm taught by Ketelson. This is because the term about means the claimed range is inclusive to sizes somewhat less than 11 mm, and because Ketelson’s use of the modifier approximately implies values somewhat larger than 10 mm. The claimed range reads on the general range suggested by Ketelson. Moreover, the treatable surface area of the eye clearly limits the possible diameters of a topical ocular insert to a small and finite range of values. Thus, Ketelson is found to teach the claimed range with sufficient specificity to anticipate the claimed range. See MPEP 2131.03, II.
Alternatively, in the event it is found that Ketelson does not teach the claimed range with sufficient specificity to anticipate the claimed range, the claimed range would have been obvious. The skilled artisan would have found the claimed range obvious since the prior art range and the claimed range overlap because of the approximate nature of the ranges. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
Even if the ranges did not overlap, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). MPEP 2144.05. Here, the prior art ranges even absent the approximation modifiers are close because the numbers are consecutive. An additional factor includes the fact that there is limited and finite range of possible dimensions a topical ocular insert can take to fit in the eye. An additional factor includes the fact that there is no evidence of criticality which is commensurate in scope with the claimed range. The skilled artisan would have expected that similarly sized inserts would have similar properties. Since the claimed range does not offer any unexpected results commensurate in scope with the claimed range, there is no evidence the values of the claimed range have different properties.
See also MPEP 2144.04, IV, A where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Here, there is no evidence the claimed device would perform differently than the prior art device to deliver lubricant to the eye.
Ketelson’s preference for a particular size does not teach away from Ketelson’s broader teachings. See MPEP 2123, II.
Ketelson anticipates the subject matter of instant claims 1-9 and 11-13.
Alternatively, the subject matter of claims 1-9 and 11-13 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim(s) 1-9 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ketelson, US 20200345544.
This rejection is made under a different interpretation of Ketelson. Therefore, this rejection is made separately.
The teachings of Ketelson enumerated above apply here.
Ketelson does not expressly teach the range of about 11 mm to about 13 mm.
However, Ketelson teaches films may range in size from 0.5 to 10 mm (Ketelson, e.g., 0109). Additionally, Ketelson teaches films which have a diameter of 150 mm and 20 mm (Ketelson, e.g., 0064). Ketelson teaches the film may be cut of any desired size (Ketelson, e.g., 0042 and 0046).
Ketelson’s teachings considered as a whole teach a diameter ranging from 0.5 mm to 150 mm, such as 20 mm, such as 0.5-10 mm. The claimed range is within the broader range suggested by Ketelson and close to the 20 mm size, 6-7 mm size and 10 mm size suggested within the reference. Each of these sizes in Ketelson are prepared with a goal to provide a dissolvable medical device for placing on the eye. The skilled artisan clearly understood that 150 mm is too large to be placed directly in the eye. But Ketelson teaches this size is useful to cut the size desired to be placed in the eye. Moreover, smaller sizes within the larger range disclosed in Ketelson have various utility, e.g., testing film uniformity, moisture absorption, folding endurance, dissolution time and pH modification, physical properties, e.g., tensile strength, modulus (Ketelson, e.g., example 2, 0060-0070). Ketelson teaches optimizing the film for various testing procedures, ease of insertion, comfort upon placement, irritation, foreign body sensation, ocular tolerability (Ketelson, e.g., 0106-0110) and desired clinical endpoints (Ketelson, e.g., example 7, 0115-0162).
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
It would have been obvious before the effective filing date of the presently claimed invention to optimize the diameter of a film known from Ketelson within the range of from 0.5 to 150 mm with a reasonable expectation of success. The skilled artisan would have optimized the size within the broader range disclosed in Ketelson for various testing procedures, ease of insertion, comfort upon placement, irritation, foreign body sensation, ocular tolerability and desired clinical endpoints related to tolerability, vision blur, comfort, etc. The skilled artisan would have had a reasonable expectation of success since Ketelson exemplifies films having a diameter of 150 mm, 20 mm, and 6-7 mm.
Accordingly, the subject matter of claims 1-9 and 11-13 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim(s) 1-9 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ketelson, US 20200345544 and Wirostko, US 20150157563.
The teachings of Ketelson enumerated above are reiterated here.
Ketelson teaches the film may be used for delivery of pharmaceutically active agents (Ketelson, e.g., 0045 and 0049).
Ketelson does not expressly teach the range of about 11 mm to about 13 mm.
However, Ketelson teaches films may range in size from 0.5 to 10 mm (Ketelson, e.g., 0109). Additionally, Ketelson teaches films which have a diameter of 150 mm and 20 mm (Ketelson, e.g., 0064). Ketelson teaches the film may be cut of any desired size (Ketelson, e.g., 0042 and 0046).
Further, the skilled artisan understood the claimed dimensions are within the effective ranges for mucoadhesive films for drug delivery to the eye.
For example, Wirostko teaches a film for placement on the surface of the eye, wherein the film has a circular shape with a diameter from about 2 mm to about 20mm, e.g., from about 2 mm to about 16 mm, wherein the film has a thickness ranging from about 0.05 mm to about 3 mm (Wirostko, e.g., 0048). For drug delivery, Wirostko teaches inserts may be placed in the cul-de-sac of the eye or on the surface of the cornea (Wirostko, e.g., 0076).
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
The claimed ranges for diameter are similar to those of Ketelson and within the range suggested by Wirostko as effective for placement of topical mucoadhesive films on the surface of the eye.
It would have been obvious before the effective filing date of the presently claimed invention to optimize the dimensions of films understood from Ketelson using dimensions known from the prior art as effective for placing on the surface of the eye such as a diameter from about 2 mm to about 20 mm, e.g., from about 2 mm to about 16 mm taught by Wirostko with a reasonable expectation of success. The skilled artisan would have been motivated to optimize the film dimensions within the range suggested by Wirostko to achieve predictable results depending on the size of the eye being treated, and desired film placement and/or need for specific drug delivery location, e.g., cul-de-sac or cornea as taught in Wirostko. The skilled artisan would have had a reasonable expectation of success because both references teach mucoadhesive films for placing on the surface of the eye. The skilled artisan would have had a reasonable expectation of success because both references teach mucoadhesive films for placing on the surface of the eye.
Accordingly, the subject matter of claims 1-9 and 11-13 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 1-9 and 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-2, 4, 6, 8, 11-12, 15-17, 20-21, 24, 28, 31, 34, 36, 39, 41-42, 44-45, 52 of US 18248000 in view of in view of Wirostko, US 20150157563.
The reference claims are directed to a polymeric eye insert, the insert comprising: one or more mucoadhesive polymers that are biocompatible with the ocular surface and tear film of the eye; and one or more pharmaceutically active agent (claim 1). 2. The polymeric eye insert of claim 1, wherein the one or more mucoadhesive polymers are selected from the group consisting of: hyaluronic acid or salts thereof, hydroxypropyl methylcellulose (HPMC), methylcellulose, tamarind seed polysaccharide (TSP), guar, hydroxypropyl guar (HP guar), scleroglucan poloxamer, poly(galacturonic) acid, sodium alginate, pectin, xanthan gum, xyloglucan gum, chitosan, sodium carboxymethylcellulose, polyvinyl alcohol, polyvinyl pyrrolidine, carbomer, polyacrylic acid and combinations thereof. 4. The polymeric eye insert of any of the preceding claims, wherein the one or more mucoadhesive polymers are present in an amount of from about 50% to about 99% w/w, about 60% to about 95% w/w, about 70% to about 90% w/w, or about 80% to about 90% w/w of the polymeric eye insert. 6. The polymeric eye insert of claim 2, further comprising a plasticizer or softener, wherein the plasticizer or softener is selected from the group consisting of: polyethylene glycol (PEG), a PEG derivative, water, Vitamin E, and triethyl citrate. 8. The polymeric eye insert of claim 6 or 7, wherein the plasticizer or softener is present in an amount of from about 2% to about 30% w/w, about 5% to about 25% w/w, about 5% to about 20% w/w, or about 5% to about 15% w/w of the polymeric eye insert. 11. The polymeric eye insert of any one of the preceding claims, wherein the insert is comprised of approximately 40% HP guar, approximately 10% PVP, approximately 40% sodium hyaluronate, and approximately 10% PEG. Claim 34 teaches the insert having a thickness of about 50-250 microns which overlaps with the claimed range.
The reference claims teach a film composition comprising approximately 40% HP guar, approximately 10% polyvinyl pyrrolidone PVP, approximately 40% sodium hyaluronate, and approximately 10% polyethylene glycol PEG which meets the limitations of claims 1-9. The film is capable of being used according to instant claims 1 and 11-13.
The reference claims do not expressly teach the film having a contact lens shape and is about 11 mm to about 13 mm in diameter.
However, the skilled artisan understood the claimed dimensions are within the effective ranges for mucoadhesive films for drug delivery to the eye.
For example, Wirostko teaches a film for placement on the surface of the eye, wherein the film has a circular shape with a diameter from about 2 mm to about 20mm, e.g., from about 2 mm to about 16 mm, wherein the film has a thickness ranging from about 0.05 mm to about 3 mm (Wirostko, e.g., 0048). For drug delivery, Wirostko teaches inserts may be placed in the cul-de-sac of the eye or on the surface of the cornea (Wirostko, e.g., 0076).
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
The claimed ranges for diameter are within the range suggested by Wirostko as effective for placement of topical mucoadhesive films on the surface of the eye.
It would have been obvious before the effective filing date of the presently claimed invention to optimize the dimensions of films understood from the reference claims using dimensions known from the prior art as effective for placing on the surface of the eye such as a diameter from about 2 mm to about 20 mm, e.g., from about 2 mm to about 16 mm taught by Wirostko with a reasonable expectation of success. The skilled artisan would have been motivated to optimize the film dimensions within the range suggested by Wirostko to achieve predictable results depending on the size of the eye being treated, and desired film placement and/or need for specific drug delivery location, e.g., cul-de-sac or cornea as taught in Wirostko. The skilled artisan would have had a reasonable expectation of success because both references teach mucoadhesive films for placing on the surface of the eye.
Accordingly, the presently claimed invention is an obvious variant of the subject matter of the reference claims.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM CRAIGO/Examiner, Art Unit 1615
/SUSAN T TRAN/Primary Examiner, Art Unit 1615