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 .
Notice of Pre-AIA or AIA Status
DETAILED ACTION
Status of the Claims
Claims 13, 17 and 19 are cancelled. Claims 1-12, 14-16, 18 and 20 are pending and under examination.
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 .
Priority
The instant application claims priority to US provisional application 63/477,112 filed on 12/23/2022.
Information Disclosure Statement
The information disclosure statement filed on 04/02/2024 has been considered by the examiner.
Objections and Rejections Withdrawn
The objection over claim 5 is withdrawn per applicant’s amendment to claim 5.
The objection over claim 6 is withdrawn per applicant’s amendment to include an “and” between the scleroglucan and poloxamer (suggestion was a comma), which does differentiate them as items. However, it does introduce another recitation of “and” in the Markush claim and brings up an issue under USC 112(b).
The objection over claim 10 is withdrawn per applicant’s amendment to claim 10.
The objection over claim 13 is withdrawn as applicant has cancelled this claim.
The objections over claim 17 are withdrawn as applicant has cancelled this claim.
The objection over claim 15, 16, 17 and 19 is withdrawn per applicant’s amendments and claims cancellations.
The objection over claims 16 and 19 is withdrawn per applicant’s amendment and claim cancellation.
The rejection under USC 112(a) for “PEG derivative” is withdrawn per applicant’s deletion of this recitation in claim 10.
The rejection under USC 112(b) over claim 3 for “ammonium” is withdrawn per applicant’s deletion of this recitation.
The rejection under USC 112(b) over claim 8 and claims 9-12 is withdrawn per applicant’s amendment to provide for “million” in front of other numbers in the claim.
The rejection under USC 112(b) over claims 9 and 12 and claims 10 and 11 for “the sodium alginate” is withdrawn per applicant’s amendments.
The rejection under USC 112(b) over claims 9, 11 and 12 and claim 10 for “other components may not listed above is 100% w/w.” is withdrawn per applicant’s amendments.
The rejection under USC 112(b) over claims 9, 11 and 12 and claim 10 for "the humectant agents" is withdrawn per applicant’s amendments.
The rejection under USC 112(b) over claim 10 and claims 11 and 12 for “PEG derivative” is withdrawn per applicant’s deletion of this phrase.
The rejection under USC 112(b) over claim 13 is withdrawn as applicant has cancelled the claim, however claims 14-16 have issues due to the cancellation of claim 13 without updating claim 13’s dependent claims 14-16 accordingly.
The rejection under USC 112(b) over claim 18 for “the second monovalent alginate further comprises” is withdrawn per applicant’s amendment to add “layer”, however, this claim is still dependent on clam 17, which has now been cancelled by the applicant.
The rejection under USC 112(d) over claim 19 is withdrawn per applicant’s cancellation of the claim.
As these objections and rejections are withdrawn, applicant’s arguments toward the objections and rejections are now moot.
Maintained and New Rejections under USC 112(b) – New Rejection Necessitated by Amendments
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.
Claims 6, 9-12, 14-16 and 18 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.
This rejection is maintained. Claims 9, 11 and 12 recite the limitation “the %w/w of mucoadhesive polymers” in lines 4-5 of the claim where the prior recitations are “one or more mucoadhesive polymers”. As there may be first, second, third or other mucoadhesive polymers in the “one or more”, it would be unclear which the applicant is referring to for the %w/w. There is insufficient antecedent basis for this limitation in the claim. Applicant may rewrite the recitation as “the % w/w of the one or more mucoadhesive polymers”.
Claim 10 is rejected as being dependent on an indefinite claim.
New Rejections – As Necessitated by Applicant’s Amendments and Claim Cancellations
Claim 6 is indefinite for the applicant’s addition of the word “and” in the middle of the Markush group between “scleroglucan” and “poloxamer”. As a Markush claim uses the structure “selected from the group consisting of…..and….” for the group of options, it is unclear if the group should end with “and poloxamer” or if “scleroglucan and poloxamer” is an option and the group should extend to “and combinations thereof”. If applicant means “scleroglucan and poloxamer” to be a combination agent, then applicant might recite “…..(HP guar), a polymer combination of scleroglucan and poloxamer, poly(galacturonic) acid,……” It is noted that dependent claim 7 currently corrects the issue by limiting the group of “one or more mucoadhesive polymers” and that claims 8-12 are dependent from claim 7.
Claim 14 is indefinite for being dependent on a cancelled claim after applicant’s cancellation of claim 13, and it did not correct the previous issue that was previously noted for claim 13 (and claim 14 was rejected for being dependent thereon), which was whether the first monovalent alginate further comprises the one or more humectant (the alginate comprises the humectant) or if applicant means that “the first monovalent alginate layer comprises one or more humectant.” For the purpose of compact prosecution, the examiner will read the claim as being dependent on claim 1 and as “the first monovalent alginate layer comprises…” Applicant should change the dependency of claim 14 to a previous claim which fits best and should insert the word “layer” between recitations of “alginate” and “further” in the claim.
Claim 15 is rejected as being dependent on an indefinite claim.
Claim 16 is rejected as being dependent on a cancelled claim, making it unclear where claim 16 is meant to add a limitation to. For the purpose of compact prosecution, the examiner will read the claim as being dependent on claim 1.
Claim 18 is rejected as being dependent on a cancelled claim, making it unclear where claim 18 is meant to add a limitation to. For the purpose of compact prosecution, the examiner will read the claim as being dependent on claim 1.
Maintained Rejection – Modified As Necessitated by Amendments
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 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.
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 1-12, 14, 16, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Higuchi US 3993071, Ketelson WO2020222195A1 (published 11-5-2020) and Chiu EP2711028A1.
“Substantially free” is read as less than 0.005% w/w as provided by applicant’s definition in paragraph 29 of the specification.
“Prepared by a co-extrusion process” in claim 1 is a product by process limitation (MPEP 2113) that will be read as multiple layers are being formed together. Thus, if the prior art teaches a product with at least two layers, then it will be read as the structure that co-extrusion would provide.
Higuchi teaches an ocular insert that bioerodes in the environment of the eye to dispense drug (abstract). Figures 3 and 4 of Higuchi provide for a core layer surrounded on both sides by layers. Higuchi teaches “When lamination is employed to fabricate the insert, the device may comprise a sheet of inner core material sandwiched between two sheets of outer layer material.” (column 23, lines 40-45). Higuchi teaches “in FIG. 3, the inner core 20 of the ocular insert is made from a non-release rate controlling matrix material having the drug dispersed therethrough” (column 23, lines 4-8). Higuchi teaches “and release characteristics for the drug being used. Materials suitable for forming the inner core are those which are compatible and highly permeable to the drug used and relatively rapidly bioerodible, exemplary of which are glycerinated gelatin, collagen, gum acacia, polyvinyl alcohol, polyvinyl pyrrolidone, alginic acid
and alkali metal salts of alginic acid, starch phosphate, starch and gelatin, linear polyacrylamides and polymethacrylamides or the like” (column 23, lines 10-20). Higuchi notes that other materials can be employed for the matrix material and consistent with comments made for selection of this material as related to the outer release rate controlling membrane material (column 23, lines 18-24). The comments made for selection of the material are found in columns 17-22 and include anionic polyelectrolytes (3, in columns 18-21) like hyaluronic acid and others (column 19). Polyvalent metal cations are provided in relation to polyelectrolyte materials (see columns 19-20) and include copper, zinc, ferric ion, ferrous ion, calcium, magnesium and others. An anion like chloride or sulfate can be associated with this metal cation (see column 20, lines 24-26). Thus, this is a salt. Hyaluronic acid is a polymer that is seen as used with a polyvalent salt (column 19, lines 55-66). Higuchi allows for other bioerodible materials including guar and algin (algin aka alginic acid/alginate) (5. Other bioerodible materials, starts in column 22). These various bioerodible materials are seen as useful for the membrane and/or matrix materials (column 17, lines 39-45). Example 2 teaches a sodium alginate ocular insert (columns 26-27). Example 1 provides for zinc alginate which would be a multivalent salt. Thus, there can be layers of monovalent sodium alginate and also layers that have multivalent salts like zinc alginate in teachings of Higuchi. Importantly, Higuchi teaches the structure of an ocular insert with layers where either one or both of the outer membranes or inner core would be allowed the option of having polyelectrolytes and polyvalent salts including those with calcium or other polyvalent metals, while layers are also able to contain materials like algin (alginate). Examples of Higuchi provide for films being formed. Thus, film is a structure associated with Higuchi. Higuchi teaches poly (ethylene glycol) as a conventional additive (column 24) and poly(vinyl pyrrolidone) as another bioerodible material (column 22).
Although Higuchi teaches layers for a bioerodible/dissolvable eye insert, it does not provide for the monovalent alginate layer substantially free of multivalent salt and the multivalent salt layer substantially free of monovalent alginate. However, these options could occur through teachings of various options in Higuchi (Higuchi allowing different polymer options for the inner core matrix and outer membrane and one of the polymer options being polyelectrolyte where a polyvalent salt can be included and other polymer options being hyaluronic acid or guar), but are not directed to. Higuchi does not provide for amounts of agents of the claims.
Ketelson teaches “These inserts may contain one or more polymers as well as a softener/plasticizer so that, when inserted into the eye, they may absorb tears, and dissolve and slowly release lubricant into the tear film to lubricate and protect the ocular surface for an extended duration of time.” (abstract). Ketelson teaches the insert comprising one or more mucoadhesive polymers which may be “hyaluronic acid or salts thereof, hydroxypropylmethylcellulose (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.” (claims 1 and 2 of Ketelson). Ketelson narrow to HP guar, hyaluronic acid or sodium hyaluronate (claim 3 of Ketelson). Ketelson teaches the plasticizer or softener is “polyethylene glycol (PEG), a PEG derivative, water, Vitamin E, and triethyl citrate” and as PEG (claims 6 and 8 of Ketelson). Ketelson teaches “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.” (claim 4 of Ketelson). Ketelson teaches “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.” (claim 7 of Ketelson). Ketelson teaches “wherein the insert is comprised of approximately 40% HP guar, approximately 10% PVP, approximately 40% sodium hyaluronate, and approximately 10% PEG” (claim 9 of Ketelson). Ketelson teaches “the insert shape is a film, a rod, a sphere, an annulus, or an irregular shape having a maximum size in any single dimension of 5-6 mm” (claim 17 of Ketelson). Example 2 of Ketelson provides for various polymer formulations including “HA/PEG, HA/PVP/PEG, HA/PVP, HA/HP-Guar/PEG, HP-Guar/P VP/PEG, HA/HP-Guar/PVP/PEG, HA/HP-Guar/PAA/PEG, HA/HP-
Guar/HPMC/PEG”. Ketelson teaches a molecular weight of hyaluronic acid/hyaluronate being 1.5 to 2 M Daltons or 0.1 to 2 million daltons while HP guar is 2 to 4 million daltons (claim 20 of Ketelson).
Chiu teaches film containing alginate membrane layer (title and abstract). Chiu teaches layer of alginate with sodium alginate or potassium alginate at a certain percent that is coated with a layer of salt water solution with a certain percent of divalent metal ions (abstract). Thus, Chiu allows a layer of monovalent alginate that has a layer/coat of divalent metal ion salt. Chiu teaches “Then crosslinking occurs between the alginate in the alginate solution and the divalent metal ions in the salt solution on the surface of the film carrier” (abstract). Chiu teaches 0.01 to 20% by weight of sodium or potassium alginate (claim 19 of Chiu). Chiu teaches calcium chloride in salt water solution (claim 21 of Chiu). Chiu teaches 1 to 10 wt% of divalent metal ions (claim 23 of Chiu). Chiu teaches alginate membrane separated from the film carrier (claim 25 of Chiu). Chiu teaches a layer of salt water solution is coated over the layer of alginate solution (claim 26 of Chiu). Chiu sees the utility for drug solutions and bioactives (claim 30 of Chiu and paragraph 22). Chiu sees the film carrier as soaked with the alginate solution before applying the coat of salt solution (paragraph 16). Chiu also teaches ammonium alginate (paragraph 2). It should be noted that once the calcium/polyvalent cation crosslinking of alginate occurs in Chiu, there would be substantially less monovalent alginate in this layer. Chiu sees its teachings as improving the performance and applications of the film (paragraph 4).
One of ordinary skill in the art before the time of filing would see that a coating/layer of polyvalent salt on a layer of monovalent alginate is a useful way to form an improved alginate film product by teachings of Chiu and Ketelson’s ocular film inserts made up of mucoadhesive polymers and softeners/humectants allow extended release of lubricants to the eye (field of disclosure in Ketelson), which would prompt one of ordinary skill in the art to provide for layers having mucoadhesive polymers and softeners (humectants) while providing a layer of monovalent alginate adjacent to a layer of polyvalent salt in a layered film insert for the eye of Higuchi which provides for the bioerodible (dissolvable) ocular insert structures having forms with polysaccharide polymers (includes alginate and hyaluronic acid) and polyvalent salts in order to improve performance and application characteristics of the bioerodible film inserts and alter release rates of drugs and/or lubricants from the inserts. As the prior art teaches overlapping and near ranges to those of applicant’s claims for its components and the use for making films including eye inserts, one of ordinary skill in the art before the time of filing would have worked with such ranges to produce better film eye inserts (MPEP 2144.05). Thus, there was a reasonable expectation of success in combining the teachings of the prior art and achieving an eye insert film that would allow for controlled agent release and improved performance for its application.
Response to Arguments and Withdrawal of Rejection under USC 103 over claim 15
In regards to the rejections under USC 112(b), claims 9, 11 and 12 still had the issue of “%w/w of mucoadhesive polymers” which needs to be “%w/w of the one or more mucoadhesive polymers” to properly refer back to that limitation.
The examiner is withdrawing the rejection under USC 103 for claim 15, which provides for “the multivalent salt layer further comprises the one or more mucoadhesive polymer” which is dependent on claim 14 which carries the limitation of “the first monovalent alginate “layer” further comprises the one or more humectant”.
In regards to the rejection under USC 103, applicant argues there wasn’t a proper prima facie case of obviousness as the rejection does not provide for the limitation of “multivalent salt layer is sandwiched between the first monovalent alginate layer and the second monovalent alginate layer”. However, the prior art allows for conventional inserts with multiple layers and conventional agents to form a product including monovalent alginate and multivalent salt layers, and Chiu sees that a layer of multivalent salt on the monovalent alginate layer will cause more crosslinking in the monovalent alginate containing layer that maintains the structure and function of the product. Thus, there is a reasonable expectation of success in producing the sandwiched form through routine layering of the prior art and known functionality of the multivalent salt layer, where both monovalent alginate layers would be desired to be in contact with the multivalent salt layer as it will be operational for this crosslinking effect with both adjacent alginate layers. It was noted that the layer of multivalent salt layer in Chiu is not seen as a mucoadherent liquid/substance, and thus, there is no substantial motivation to add mucoadhesive polymer(s) in this layer. Thus, it was reconsidered in terms of further agents that the insert would have in the particular layers and it was not well motivated to combine the “one or more mucoadhesive polymers” into the multivalent salt layer. Thus, if limitation of claim 15 with any necessary corrections are imported into claim 1, then applicant will have an allowable claim. Applicant should amend dependent claims accordingly to any changes made to the claims they depend on.
If applicant desires to import the limitation of claim 15 into claim 1 and corrects other issues without introducing new issues, then applicant may have allowable claims. Applicant might consider an after final response to make such changes.
The examiner attempted to contact applicant regarding the above issues, but did not receive a return phone call or other message.
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613
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