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
Restriction/Election
Applicant’s election of Group I , claims 1-2, 4, 8, 10-11, 14-15, 17-20 and 27 in the reply filed on 05/26/26 is acknowledged.
Applicant’s election of Species 1 - a combination of hydroxypropyl methylcellulose, hydroxyethyl cellulose, and hydroxypropyl cellulose as the species of cellulose polymer; Species 2 - a combination of polyethylene glycol, propylene glycol, and a copolymer of ethyl acrylate, methyl methacrylate and methacrylic acid ester as the species of non-cellulose polymer; Species 3 - a combination of hydroxypropyl methylcellulose, hydroxyethyl cellulose, and hydroxypropyl cellulose, polyethylene glycol, propylene glycol, and a copolymer of ethyl acrylate, methyl methacrylate and methacrylic acid ester as the polymers of the first layer; Species 4-ethyl cellulose as the polymer of the second layer; Species 5-ethyl cellulose as the polymer of the third layer; and Species 6- 4'-Ethynyl-2-fluoro-2'-deoxyadenosine (EFdA) as the species of antiviral drug is also acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 3, 6, 16, 21-24 and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/species there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/26/26.
Claims 1-2, 4, 8, 10-11, 14-15, 17-20 and 27 are under prosecution.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rohan et al. ( US PG Pub. 2020/0253885A1).
Rohan et al. teaches a bioerodible film (Para [0049] "While as noted previously a desirable trait of the film is long term stability for extended shelf life films that lack such long term stability may nevertheless be desirable. In such aspects a pre film solution can include PVP-K90" and Para [0051]. "The film composition described herein dissolves in vivo and may be administered for a period of time or at intervals, ranging from as needed to hourly") and comprising one or more cellulose polymers (Para [0049] "Hydroxypropyl methylcellulose...6") one or more non-cellulose polymers (Para [0035] "In some aspects, the non-cellulose polymer is polyvinyl pyrrolidone (PVP)" and Para [0049] "PVP - K90...2")), and a therapeutic composition (Para [0003]; [0049] "Active agent solubilizing / alkalinizing agent", active agent with solubilizing agent is reasonably understood as a therapeutic composition).
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 2, 4, 8, 10-11, 14-15, 17-20 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Rohan et al. ( US PG Pub. 2020/0253885A1) in view of Lindquist et al. (US PG Pub. 2016/0129165 A1).
Rohan et al. teaches a bioerodible film (Para [0049] "While as noted previously a desirable trait of the film is long term stability for extended shelf life films that lack such long term stability may nevertheless be desirable. In such aspects a pre film solution can include PVP-K90" and Para [0051]. "The film composition described herein dissolves in vivo and may be administered for a period of time or at intervals, ranging from as needed to hourly") and comprising one or more cellulose polymers (Para [0049] "Hydroxypropyl methylcellulose...6") one or more non-cellulose polymers (Para [0035] "In some aspects, the non-cellulose polymer is polyvinyl pyrrolidone (PVP)" and Para [0049] "PVP - K90...2")), and a therapeutic composition (Para [0003]; [0049] "Active agent solubilizing / alkalinizing agent", active agent with solubilizing agent is reasonably understood as a therapeutic composition). Use of dapivirine is taught in claim 5. The reference teaches the dissolvable film, wherein the one or more cellulose polymers are three cellulose polymers, wherein the three cellulose polymers comprise hydroxyethyl cellulose, hydroxypropyl methyl cellulose, and carboxymethyl cellulose, wherein the three cellulose polymers comprise 1.5 to 7% wt. hydroxyethyl cellulose, 1.5 to 8% wt. hydroxypropyl methyl cellulose, and 0.5 to 6% wt. carboxymethyl cellulose, see claims 6-9.
Rohan et al. teaches the bioerodible film, wherein the therapeutic composition is an antiviral composition (Para [0003] "The present invention relates to pharmaceutical vehicles for use in delivering therapeutic compositions to patients. More particularly the present invention relates to films for the delivery of antiviral compositions to patients" and Para [0032]. "Therapeutic compositions/active ingredients useful in the thin films described herein can include but are not limited to...( e.g. 4-Ethynyl-2-fluoro-2- deoxyadenosine EFdA )", this is an antiviral ,also claimed in instant claim 14).
Rohan et al. teaches the bioerodible film, wherein the antiviral composition is 4'-ethynyl-2-fluoro-2'- deoxyadenosine (EFdA) (Para [0032]. "Therapeutic compositions/ active ingredients useful in the thin films described herein can include but are not limited to...( e.g. 4-Ethynyl-2-fluoro-2 deoxyadenosine EFdA and/or a salt, prodrug, or derivative thereof. Rohan et al. teaches the bioerodible film, further comprising levonorgestrel (LNG) (Para [0032] "Therapeutic compositions/active ingredients useful in the thin films described herein can include but are not limited to ...levonorgestrel"). Rohan et al. teaches the bioerodible film, further comprising etonogestrel (ENG) (Para [0032] "Therapeutic compositions/active ingredients useful in the thin films described herein can include but are not limited to...etonogestrel"). Rohan et al. teaches the bioerodible film, further comprising LNG (Para [0032] "Therapeutic compositions/active ingredients useful in the thin films described herein can include, but are not limited to levonorgestrel"). Rohan et al. teaches the bioerodible film, further comprising ENG (Para [0032] "Therapeutic compositions/active ingredients useful in the thin films described herein can include but are not limited to.etonogestrel"). Rohan et al. teaches the bioerodible film, further comprising a mucoadhesive (Para [0049] "Hydroxyethyl cellulose this second polymer would be able to engage with mucosa via hydrogen bonding and therefor behave as a mucoadhesive). Rohan et al. teaches the bioerodible film further comprising a plasticizer (Para [0037] "In addition to the polymer base of the film matrix, a film as described herein can include one or more additional components for example and without limitation a plasticizer"). Rohan et al. teaches a method of delivering a therapeutic to a patient, comprising administering the bioerodible film to the patient (Para [0028] "As used herein the treatment or treating of a wound or defect means administration to a patient by any suitable dosage regimen procedure and/or administration route an amount of a composition device or structure effective to and with the object of achieving a desirable clinical/medical end-point, including attracting progenitor cells, healing a wound correcting a defect, etc." and (Para [0051] "The film composition described herein dissolves in vivo and may be administered for a period of time, or at intervals ranging from as needed to hourly daily weekly monthly or yearly including increments there between such as from one to six times per day daily every other day weekly bi weekly monthly bi-monthly quarterly etc. An appropriate dosing schedule can be determined by a person of ordinary skill, such as a physician"). Various therapeutic agents can be used in [0032]. Therefore, any active agent can be used for the treatment of diseases and conditions.
Rohan et al. teaches wherein the bioerodible film is inserted into the patient' S vagina (Para [0007] "Accordingly provided herein is a dissolvable film for intravaginal delivery of an active agent for example an antiretroviral composition e.g. for treatment or prophylaxis of HIV or an antiviral composition e.g. for treatment of a herpes virus such as a HSV e.g. HSV-1 and/or HSV").
Rohan et al. teaches the bioerodible film, but does not disclose wherein the film comprises a plurality of layers.
Lindquist et al. discloses a bioerodible film comprised of multiple layers (para [0014]-[0015], (claim 1, "A medical device comprising: a Substrate; and a bioerodible polymeric layer disposed over the substrate, the bioerodible polymeric layer including poly(lactic acid) or poly(lactic acid-co-glycolic acid) and a plasticizer selected from glycolic acid, an oligomer comprising glycolic acid, and combinations thereof"). Lindquist teaches that in certain embodiments of the invention, polymeric layers for use in the medical devices of the invention may contain, for example, (a) from 50 wt % or less to 60 wt % to 70 wt % to 80 wt % to 90 wt % to 95 wt % to 97.5 wt % to 99 wt % or more of one or more types of biodegradable polymers, (b) from 1 wt % or less to 2.5 wt % to 5 wt % to 10 wt % to 20 wt % to 30 wt % or more of one or more types of therapeutic agent and (c) from 0 wt % to 1 wt % to 2.5 wt % to 5 wt % to 10 wt % to 20 wt % to 30 wt % to 40 wt % to 50 wt % or more of one or more types of plasticizers, see [0015].
It would have been obvious to one of skill in the art to combine these references design the film wherein the film comprises a plurality of layers to provide more substrate in layer form by routine experimentation as Lindquist provides use of bioerodible film with multiple layers to be used with various therapeutic agents for treatment of diseases. Manipulation of the amounts will be within skill of an artisan by performing experimental manipulations for optimum release of the active ingredients.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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