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 . Claims included in the prosecution are claims 1-17.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/12/2025 has been entered.
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.
1. Claims 1, 3 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Bandyopadhyay et al. (US 2002/0107238, Aug. 8, 2002) (hereinafter Bandyopadhyay) (of record) in view of Full et al. (US 2010/0196512, Aug. 5, 2010) (hereinafter Full) (of record).
Bandyopadhyay discloses a pharmaceutical composition suitable for topical administration to an eye, the composition comprising as active agent at least one oxazolidinone antibacterial drug, and at least one ophthalmically acceptable excipient ingredient that reduces a rate of removal of the composition from the eye by lacrimation such that the composition has an effective residence time in the eye of about 2 to about 24 hours. The composition is an in situ gellable solution (i.e., liquid) (abstract). The composition may be an in situ gellable aqueous solution (i.e., aqueous medium) comprising about 1% to about 50% of a water-soluble film-forming polymer such as methylcellulose and cyclodextrin (¶ [0106]). The solution is preferably viscous and contains a viscosity enhancer (¶ [0097]). The oxazolidinone antibacterial drug can be reversibly loaded on to ion exchange resin particles to extend the duration of release of the drug to the treated eye (¶ [0120]). The composition may additionally comprise one or more antibacterial drugs other than oxazolidinone in a concentration effective for treatment and/or prophylaxis of a gram-negative bacterial infection of the eye (¶ [0125]).
Bandyopadhyay differs from the instant claims insofar as not disclosing wherein the composition comprises 0.005% to about 10% (w/w) chlorine dioxide.
However, Full discloses administering chlorine dioxide for the alleviation of non-oral biological tissue infections (abstract). The non-oral mucosa infection can be urethritis or conjunctivitis (¶ [0010]). The causative pathogen for urethritis may be Escherichia coli (gram negative bacteria) (¶ [0073]). Pink eye (conjunctivitis) is an inflammation or infection of the transparent membrane (conjunctiva mucosa) that lines the eyelid and part of the eyeball. Viral conjunctivitis and bacterial conjunctivitis may affect one or both eyes (¶ [0075]). The composition comprises about 1 to about 1000 ppm (about 0.0001% to about 0.1%) chlorine dioxide (claim 2). Chlorine dioxide is known to be a disinfectant. The bactericidal properties of chlorine dioxide are also well known (¶ [0004]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Bandyopadhyay discloses wherein the composition may comprise one or more antibacterial drugs for the treatment and/or prophylaxis of a gram-negative bacterial infection. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated about 1 to about 1000 ppm (about 0.0001% to about 0.1%) chlorine dioxide into the composition of Bandyopadhyay since about 1 to about 1000 ppm (about 0.0001% to about 0.1%) chlorine dioxide is a known and effective antibiotic effective against gram-negative bacteria (e.g. E.coli) and which may be administered to the eye as taught Full.
In regards to instant claim 15 reciting wherein the composition comprises cyclodextrin and methylcellulose, since Bandyopadhyay discloses the use of various water-soluble film-forming polymers individually, the use of the individual species in combination would have been obvious since it is prima facie obvious to combine two compositions, each of which is taught by Bandyopadhyay to be useful for the same purpose, in order to form a third composition to be used for the very same purpose; the idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06.
In regards to instant claim 16 reciting wherein the methylcellulose has a concentration of about 0.05% to about 5%, Bandyopadhyay discloses wherein the amount of water-soluble film-forming polymers is about 1% to about 50%. Therefore, it would have been obvious to one of ordinary skill in the art to have formulated the composition to comprise an amount of methylcellulose and an amount of cyclodextrin wherein the total amount is within the range of about 1% to about 50%. The amount of methylcellulose obtained may overlap with the claimed range. 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 A.
Response to Arguments
Applicant argues that Bandyopadhyay nor Full teach or fairly suggest that combining chlorine dioxide with dextrin or cyclodextrin results in chlorine dioxide/dextrin or cyclodextrin complexes that dissociate upon administration producing sustained release of chlorine dioxide over a period of up to 24 hours. As evidenced by the Declaration, chlorine dioxide/α-cyclodextrin and chlorine dioxide/γ-cyclodextrin unexpectedly precipitate out of an aqueous solution, illustrating that the cyclodextrins in the claimed invention do not act as solubilizing agents in the context of Applicant’s claimed invention. The Declaration further evidences that the chlorine dioxide/dextrin or cyclodextrin complexes dissociate at nearly linear rate when suspended in an aqueous solution.
The Examiner does not find Applicant’s argument to be persuasive. Independent claim 1 does not recite a chlorine dioxide/dextrin or cyclodextrin complex. A composition comprising chlorine dioxide and dextrin or cyclodextrin does not mean that the two ingredients are complexed with one another. Therefore, Applicant’s argument that a chlorine dioxide/dextrin or cyclodextrin complex is unexpected is not persuasive since the independent claim does not recite a chlorine dioxide/dextrin or cyclodextrin complex. Furthermore, even if the independent claim was to recite a complex, Applicant’s argument would still be unpersuasive. Bandyopadhyay discloses in paragraph [0110] wherein the solubilizing agent is for solubilizing the oxazolidinone antibacterial drug. Therefore, one of ordinary skill in the art would not expect cyclodextrin to be a solubilizing agent for chlorine dioxide such that finding out that it is not a solubilizing agent for chlorine dioxide would have been unexpected. Moreover, the claimed subject matter must be compared with the closest prior art to be effect to rebut a prima facie case of obviousness. See MPEP 716.02(e). Bandyopadhyay discloses in paragraph [0127] wherein the extended residence time is at least in part due to the presence in the composition of an in-situ gelling polymer system. Bandyopadhyay discloses in paragraph [0106] wherein the in-situ gelling polymer system comprises cyclodextrin. Thus, it was known in the art that cyclodextrin contributes to release rate. Applicant has not shown wherein a chlorine dioxide/dextrin or cyclodextrin complex is more advantageous than an in-situ gelling polymer system comprising cyclodextrin in terms of release of chlorine dioxide. As such, Applicant’s argument of unexpected results is unpersuasive.
2. Claims 4, 5, 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Bandyopadhyay et al. (US 2002/0107238, Aug. 8, 2002) (hereinafter Bandyopadhyay) (of record) in view of Full et al. (US 2010/0196512, Aug. 5, 2010) (hereinafter Full) (of record), and further in view of Chauhan et al. (US 2004/0241207, Dec. 2, 2004) (hereinafter Chauhan) (of record).
The teachings of Bandyopadhyay and Full are discussed above. Bandyopadhyay and Full do not disclose wherein the active agents are encapsulated within nanoparticles.
However, Chauhan discloses a drug delivery system comprising a contact lens having dispersed therein as nanoparticles an ophthalmic drug nanoencapsulated in a material from which said ophthalmic drug is capable of diffusion into and migration through said contact lens and into the post-lens tear film when said contact lens is placed on the eye (claim 1). The drug delivery rates can be controlled by manipulating the size, concentration, and structure of the nanoparticles (¶ [0090]). The drug-laden nanoparticles are generally less than about 50 nm to 200 nm (¶ [0022]). Nanoparticles suitable for encapsulating drugs include chitosan nanoparticles (CS) (¶ [0025]), liposomes (¶ [0032]), and polymeric nanoparticles (claim 8). Suitable ophthalmic drugs include antibiotics (claim 6).
Bandyopadhyay discloses wherein the antibacterial drugs may be loaded onto particles to extend the duration of release of the drug. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have encapsulated the antibacterial drugs into the nanoparticles of Chauhan since it is a known and effective controlled release delivery vehicle for ophthalmic drugs as taught by Chauhan.
Response to Arguments
Applicant argues that Chauhan fails to cure the deficiencies of Bandyopadhyay and Full.
The Examiner submits that arguments regarding Bandyopadhyay and Full have been discussed above and are unpersuasive. Therefore, the rejection is maintained.
3. Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Bandyopadhyay et al. (US 2002/0107238, Aug. 8, 2002) (hereinafter Bandyopadhyay) (of record) in view of Full et al. (US 2010/0196512, Aug. 5, 2010) (hereinafter Full) (of record), and further in view of Yu (US 2005/0228046, Oct. 13, 2005) (of record).
The teachings of Bandyopadhyay and Full are discussed above. Bandyopadhyay and Full do not disclose wherein the composition comprises a chlorine dioxide-containing complex.
However, Yu discloses a multi-purpose contact lens care solution having high activity against fungi and certain bacteria (abstract). Chlorine dioxide containing complexes such as complexes of chlorine dioxide with carbonate and chloride dioxide with bicarbonate are suitable antimicrobial components for the composition (¶ [0034]).
As discussed above, it would have been obvious to have incorporated chlorine dioxide as an antibacterial drug. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated chlorine dioxide containing complexes such as complexes of chlorine dioxide with carbonate and complexes of chloride dioxide with bicarbonate into the composition of Bandyopadhyay since chlorine dioxide containing complexes are known and effective types of antibiotic chlorine dioxide suitable for administration to the eye as taught by Yu.
Response to Arguments
Applicant argues that Yu fails to cure the deficiencies of Bandyopadhyay and Full.
The Examiner submits that arguments regarding Bandyopadhyay and Full have been discussed above and are unpersuasive. Therefore, the rejection is maintained.
4. Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Bandyopadhyay et al. (US 2002/0107238, Aug. 8, 2002) (hereinafter Bandyopadhyay) (of record) in view of Full et al. (US 2010/0196512, Aug. 5, 2010) (hereinafter Full) (of record), Chauhan et al. (US 2004/0241207, Dec. 2, 2004) (hereinafter Chauhan) (of record), and further in view of Popov et al. (US 2013/0323179, Dec. 5, 2013) (hereinafter Popov) (of record).
The teachings of Bandyopadhyay, Full, and Chauhan are discussed above. Bandyopadhyay, Full, and Chauhan do not disclose wherein the composition comprises mucous penetrating particles.
However, Popov discloses a mucus penetrating particle (abstract). The composition may be administered to the eye for application to the ophthalmic mucous membrane (¶ [0148]). The core of the particle comprises a pharmaceutical agent. The pharmaceutical agent constitutes at least about 80% of the core particle. A coating comprising a surface-altering agent surrounds the core particle. The surface-altering agent comprises a hydrophilic block-hydrophobic block-hydrophilic block configuration, wherein the hydrophobic block has a molecular weight of at least about 2 kDa and the hydrophilic block constitute at least about 15 wt. % of the triblock copolymer. The surface-altering agent has a density of at least about 0.001 molecules per nanometer squared. The coated particles have a relative velocity of greater than 0.5 in mucus (claim 1). The core may be at least about 50 nm (¶ [0062]). The coating may have an average thickness of about least about 1 nm (¶ [0093]).
As discussed above, polymeric nanoparticles are effective controlled release delivery vehicle for ophthalmic drugs as taught by Chauhan. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated the antibacterial drugs of Bandyopadhyay into the mucus penetrating particles of Popov since the mucus penetrating particles are known and effective polymeric nanoparticles for delivering pharmaceutical agents to the eye as taught by Popov.
Response to Arguments
Applicant argues that Popov fails to cure the deficiencies of Bandyopadhyay, Full, and Chauhan.
The Examiner submits that arguments regarding Bandyopadhyay, Full, and Chauhan have been discussed above and are unpersuasive. Therefore, the rejection is maintained.
5. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Bandyopadhyay et al. (US 2002/0107238, Aug. 8, 2002) (hereinafter Bandyopadhyay) (of record) in view of Full et al. (US 2010/0196512, Aug. 5, 2010) (hereinafter Full) (of record), Chauhan et al. (US 2004/0241207, Dec. 2, 2004) (hereinafter Chauhan) (of record), and further in view of Hofland et al. (US 2004/0224010, Nov. 11, 2004) (hereinafter Hofland) (of record).
The teachings of Bandyopadhyay, Full, and Chauhan are discussed above. Bandyopadhyay, Full, and Chauhan do not disclose wherein the composition comprises a liposome comprising phosphatidylcholine and cholesterol.
However, Hofland discloses a liposome-based ophthalmic drug delivery (¶ [0007]). The liposome may comprise a neutral lipid as well as a cationic lipid. Suitable neutral lipids include phosphatidyl choline and suitable cationic lipids include DC-cholesterol (¶ [0010]). The liposomes may have diameters within the range of 25 nm to 4 µm (¶ [0027]).
As discussed above, it would have been obvious to have incorporated nanoparticles in the form of liposomes into the composition of Bandyopadhyay as taught by Chauhan et al. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated the liposomes of Hofland into the composition of Bandyopadhyay since the liposomes are known and effective ophthalmic liposomes as taught by Hofland.
Response to Arguments
Applicant argues that Hofland fails to cure the deficiencies of Bandyopadhyay, Full, and Chauhan.
The Examiner submits that arguments regarding Bandyopadhyay, Full, and Chauhan have been discussed above and are unpersuasive. Therefore, the rejection is maintained.
6. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Bandyopadhyay et al. (US 2002/0107238, Aug. 8, 2002) (hereinafter Bandyopadhyay) (of record) in view of Full et al. (US 2010/0196512, Aug. 5, 2010) (hereinafter Full) (of record), Chauhan et al. (US 2004/0241207, Dec. 2, 2004) (hereinafter Chauhan) (of record), and further in view of Li et al. (Liposome coated with low molecular weight chitosan and its potential use in ocular drug delivery, Jun. 25, 2009) (hereinafter Li) of record).
The teachings of Bandyopadhyay, Full, and Chauhan are discussed above. Bandyopadhyay, Full, and Chauhan do not disclose wherein the liposomes are coated with chitosan.
However, Li discloses wherein liposomes coated with low molecular weight chitosan displayed a prolonged in vitro drug release profile, improved physiochemical stability in a 30-day storage period, significantly prolonged retention compared with non-coated liposome, and potential penetration enhancing effect for transcorneal delivery of a drug. The low molecular weight coating significantly modified the properties of the liposome and brought a series of notable advantages for ocular drug delivery (abstract).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have coated the liposomes of Chauhan with chitosan motivated by the desire to modify the properties of the liposome to bring about a series of notable advantages for ocular drug delivery as taught by Li.
Response to Arguments
Applicant argues that Li fails to cure the deficiencies of Bandyopadhyay, Full, and Chauhan.
The Examiner submits that arguments regarding Bandyopadhyay, Full, and Chauhan have been discussed above and are unpersuasive. Therefore, the rejection is maintained.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,925,894 in view of Bandyopadhyay et al. (US 2002/0107238, Aug. 8, 2002) (hereinafter Bandyopadhyay) (of record). The pending claims and conflicting claims differ in that the conflicting claims recite methylcellulose and do not recite cyclodextrin. However, Bandyopadhyay discloses a pharmaceutical composition suitable for topical administration to an eye (abstract). The composition may be an in situ gellable aqueous solution (i.e., aqueous medium) comprising about 1% to about 50% of a water-soluble film-forming polymer such as methylcellulose and cyclodextrin (¶ [0106]). Accordingly, it would have been obvious to one of ordinary skill in the art to have included cyclodextrin into the pending claimed composition since it is an alternative to methylcellulose as taught by Bandyopadhyay.
Response to Arguments
Applicant argues that dextrin and cyclodextrin do not act as solubilizing agents in the context of independent claim 1 and are not alternatives for methylcellulose.
The Examiner does not find Applicant’s argument to be persuasive. The patented claims do not require methylcellulose to perform a particular function. Since it was known in the art as taught by Bandyopadhyay that both methylcellulose and cyclodextrin are water-soluble film forming polymers for ophthalmic compositions, it would have been obvious to one of ordinary skill in the art that the methylcellulose of the patented claims is a water-soluble film forming polymer, which may be substituted with another water-soluble film forming polymer, such as cyclodextrin. As such, Applicant’s argument is unpersuasive.
Response to Declaration
Declarant’s arguments have been addressed above and are unpersuasive.
Conclusion
Claims 1-17 are rejected.
Claims 18-24 have been withdrawn.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614