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
Status of 19/412,192
Claims 1-20 are currently pending.
Priority
Instant application 19/412,192, filed 12/8/2025, claims priority as follows:
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Support for the instant claims is found in the provisional dated 4/27/2023.
Information Disclosure Statement
All references from the IDS submitted on 5/27/2026 have been considered unless marked with a strikethrough.
Objection to the Abstract
The abstract of the disclosure is objected to for insufficient length, as it is less than 50 words. The abstract should generally be within the range of 50 to 150 words in length, and chemical abstracts in particular should provide the structure of the compound of a formula thereof in addition to methods of use. Furthermore, the abstract contains minor grammatical informalities. Specifically, the abstract states, “comprising of lidocaine”, but should read, “comprising lidocaine”. See MPEP § 608.01. Appropriate correction is required.
Election/Restriction
Applicant’s election of Group I, claims 1-19, drawn to a pharmaceutical composition comprising lidocaine and halobetasol propionate, without traverse, in the reply filed 5/27/20026, is acknowledged. Applicant’s election of Formula 1 – Halobetasol Suspension Formulation:
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In the same reply, is also acknowledged.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and prior art was identified. See the 103 rejection below. The full scope of the claims has not yet been searched in accordance with Markush search practice. Claims 1-19 read on the elected species. Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
Claim Interpretation
Claims 16-19 recite functional limitations of the pharmaceutical composition of claim 1. If a composition meets the structural limitations previously recited in claim 1, the claim from which 16-19 depend, then the functional limitations recited in claims 16-19 would flow from embodiments meeting the structure.
Claim Objections
Claim 4 is objected to for a minor informality. Claim 4 recites, “further comprises propylene glycol”, but should read, “further comprising propylene glycol”. Appropriate correction is required.
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 5, 10, 11, 14, and 15 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 5 recites the phrase "such as", which renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Dependent claims 10 and 11 do not resolve this limitation and are therefore also rejected.
Claim 5 and 14 contains the trademark/trade names Sepineo® P600 and Transcutol-P. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade names are used to identify/describe chemicals and, accordingly, the identification/description is indefinite.
Claim 14 recites an instance of parentheses in reference to the chemical diethylene glycol monoethylether. The term is indefinite because it is unclear if the phrase within the parentheses is required, or just examples of what is required. Dependent claim 15 does not resolve this issue and is therefore also rejected. Appropriate correction is required.
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 1-4, 6-9, 12-13, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Citius (https://web.archive.org/web/20211206012815/https://citiuspharma.com/pipeline/halo-lido/default.aspx, Dec 6th, 2021. Accessed June 5, 2026., cited in the IDS of 5/27/2026) further in view of Janowska (Janowska, A. et. al. Journal of Investigative Surgery. 2022, 35(1), 49-52.) and Dr. Reddy’s Laboratories, LTD. (WO 2011/026076 A2, herein after “Dr. Reddy’s”). This rejection applies to the elected species.
Determining the scope and contents of the prior art
The reference Citius teaches the topical formulation of halobetasol and lidocaine to provide anti-inflammatory and anesthetic relief to individuals suffering from hemorrhoids, which helps teach claim 1, and dependent claims thereof.
The reference Janowska teaches a 5% lidocaine hydrochloride cream to treat wound pain relief (title, abstract), which helps teach claims 1 and 2, and the dependent claims thereof.
The reference Dr. Reddy’s teaches topical compositions comprising a steroid to treat diseases and disorders of the skin (title, abstract). Specifically, Dr. Reddy’s teaches Example 6 (page 30):
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Which contains 0.05 wt. % of halobetasol propionate, which satisfies the limitation in claim 1 of halobetasol propionate in an amount of about 0.02% to about 0.07% by weight of the total composition and the limitation of claim 3 where the halobetasol is present in an amount of about 0.05% by weight of the total composition (page 30). This helps teach claims 1 and 3, and dependent claims thereof.
Regarding claims 4, 8, and 9, Example 6 teaches propylene glycol in an amount of 7.5% (page 30).
Regarding claims 6, 12, and 13, Dr. Reddy’s teaches hydroxypropyl methylcellulose as a suitable polymer in the formulations (page 13). Further, in Example 6, Dr. Reddy’s teaches the cellulose polymer in a concentration of 0.1% (page 30).
With respect to claim 7, Dr. Reddy’s teaches water in a concentration of 76.3%.
Ascertaining the differences between the prior art and the claims at issue
The reference Citius fails to teach the concentrations recited by the instant claims of lidocaine and halobetasol, and fails to include the additional ingredients in the pharmaceutical composition.
The reference Janowska fails to teach halobetasol propionate in a concentration of 0.02% to 0.07%, and fails to include the additional ingredients in the pharmaceutical composition.
The reference Dr. Reddy’s fails to teach lidocaine or lidocaine hydrochloride in a concentration of 5% in the composition.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of compositions comprising lidocaine and halobetasol propionate. An artisan possess the technical knowledge necessary to make adjustments to the compositions to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of compositions comprising lidocaine and halobetasol propionate and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (A), it would have been prima facie obvious to combine the teachings of Citius, Janowska, and Dr. Reddy’s because one of ordinary skill in the art would expect the combination of ingredients taught for the same purpose to be successful in treating anorectal disorders. A skilled artisan would be motivated before the effective filing date of the claimed invention to test combinations of compounds taught for the same purpose to improve the overall activities of the compositions to treat anorectal disorders and would readily predict success in light of the teachings of Citius, Janowska, and Dr. Reddy’s.
With respect to claims 1, 8, 9, 12, and 13 , it would have been prima facie obvious to one having ordinary skill in the art to arrive at the concentrations of halobetasol propionate, propylene glycol, and hydroxypropyl methylcellulose recited in the instant claims because it is considered well within the capabilities of one of ordinary skill in the art to optimize the concentrations of individual ingredients of the formulation to provide optimal pharmaceutical compositions for anorectal disorders. The concentration of each individual ingredient in the formulation is a result effective parameter that will affect the physical properties of the final composition. The amount of propylene glycol in a composition is clearly a result effective parameter that a person of ordinary skill would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the ratios of halobetasol propionate, propylene glycol, and hydroxypropyl methylcellulose, disclosed by Janowska and Dr. Reddy’s above, provide a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal ratio of halobetasol propionate, propylene glycol, and hydroxypropyl methylcellulose to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. See MPEP § 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Claims 1-13 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Citius (https://web.archive.org/web/20211206012815/https://citiuspharma.com/pipeline/halo-lido/default.aspx, Dec 6th, 2021. Accessed June 5, 2026., cited in the IDS of 5/27/2026) further in view of Janowska (Janowska, A. et. al. Journal of Investigative Surgery. 2022, 35(1), 49-52.), Dr. Reddy’s Laboratories, LTD. (WO 2011/026076 A2, herein after “Dr. Reddy’s”), and Badruddoza (Badruddoza, A.Z.M. et. al. International Journal of Pharmaceutics. 2022, 621, 121824). This rejection applies to the elected species.
Determining the scope and contents of the prior art
The references Citius, Janowska, and Dr. Reddy’s teach as disclosed above, and at least those teachings are incorporated herein.
The reference Badruddoza teaches acrylamide/sodium acryloyldimethyl taurate copolymer, also known as the trademark name Sepineo® P600, as a gelling agent in compositions with lidocaine (abstract). Furthermore, Badruddoza teaches the concentration in the composition ranging from 0.5% to 5% w/w (page 2, left handed column), and teaches an exemplary embodiment at 3% w/w (page 2, Table 1).
Ascertaining the differences between the prior art and the claims at issue
The references Citius, Janowska, and Dr. Reddy’s fail to teach as disclosed above, and at least those failures are incorporated herein.
Additionally, Citius, Janowska, and Dr. Reddy’s fail to teach the presence of acrylamide sodium/acryloyldimethyl taurate copolymer, also known as Sepineo ® P600, in the compositions, whereas Badruddoza fails to teach the composition comprising lidocaine and halobetasol propionate in the concentrations of 5% and 0.02% to 0.07%, respectively
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of compositions comprising lidocaine and halobetasol propionate. An artisan possess the technical knowledge necessary to make adjustments to the compositions to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of compositions comprising lidocaine and halobetasol propionate and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (A), it would have been prima facie obvious to combine the teachings of Citius, Janowska, Dr. Reddy’s, and Badruddoza because one of ordinary skill in the art would expect the combination of ingredients taught for the same purpose to be successful in treating anorectal disorders. A skilled artisan would be motivated before the effective filing date of the claimed invention to test combinations of compounds taught for the same purpose to improve the overall activities of the compositions to treat anorectal disorders and would readily predict success in light of the teachings of Citius, Janowska, Dr. Reddy’s, and Badruddoza.
With respect to claims 10 and 11, it would have been prima facie obvious to one having ordinary skill in the art to arrive at the concentration of acrylamide sodium/acryloyldimethyl taurate copolymer, also known as Sepineo ® P600, recited in the instant claims because it is considered well within the capabilities of one of ordinary skill in the art to optimize the concentrations of individual ingredients of the formulation to provide optimal pharmaceutical compositions for anorectal disorders. The concentration of each individual ingredient in the formulation is a result effective parameter that will affect the physical properties of the final composition. The amount of acrylamide sodium/acryloyldimethyl taurate copolymer, also known as Sepineo ® P600, in a composition is clearly a result effective parameter that a person of ordinary skill would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the ratio of acrylamide sodium/acryloyldimethyl taurate copolymer, also known as Sepineo ® P600, disclosed by Badruddoza above, provide a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal ratio acrylamide sodium/acryloyldimethyl taurate copolymer, also known as Sepineo ® P600, to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. See MPEP § 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Claims 1-4, 6-9, 12-15, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Citius (https://web.archive.org/web/20211206012815/https://citiuspharma.com/pipeline/halo-lido/default.aspx, Dec 6th, 2021. Accessed June 5, 2026., cited in the IDS of 5/27/2026) further in view of Janowska (Janowska, A. et. al. Journal of Investigative Surgery. 2022, 35(1), 49-52.), Dr. Reddy’s Laboratories, LTD. (WO 2011/026076 A2, herein after “Dr. Reddy’s”), and C.B. Fleet Company, Incorporated (US 2017/0056332 A1, herein after “C.B.”). This rejection applies to the elected species.
Determining the scope and contents of the prior art
The references Citius, Janowska, and Dr. Reddy’s teach as disclosed above, and at least those teachings are incorporated herein.
Regarding claims 14 and 15, Dr. Reddy’s teaches propylene glycol in an amount of 7.5% as stated above, diethylene glycol monoethylether in a concentration of 5% in Example 6 (page 30), and further teaches hydroxypropyl cellulose (page 13) as a possible component in the composition.
The reference C.B. teaches topical hemorrhoid compositions (abstract, para [0082]) and specifically teaches glycerin as a hydrophilic skin protectant (para [0048]) in exemplary compositions (Tables 1-3).
Ascertaining the differences between the prior art and the claims at issue
The references Citius, Janowska, and Dr. Reddy’s fail to teach as disclosed above, and at least those failures are incorporated herein.
Additionally, Citius, Janowska, and Dr. Reddy’s fails to teach the presence of glycerin in the composition, whereas C.B. fails to teach the composition comprising lidocaine and halobetasol propionate in the concentrations of 5% and 0.02% to 0.07%, respectively.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of compositions comprising lidocaine and halobetasol propionate. An artisan possess the technical knowledge necessary to make adjustments to the compositions to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of compositions comprising lidocaine and halobetasol propionate and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (A), it would have been prima facie obvious to combine the teachings of Citius, Janowska, Dr. Reddy’s, and C.B. because one of ordinary skill in the art would expect the combination of ingredients taught for the same purpose to be successful in treating anorectal disorders. A skilled artisan would be motivated before the effective filing date of the claimed invention to test combinations of compounds taught for the same purpose to improve the overall activities of the compositions to treat anorectal disorders and would readily predict success in light of the teachings of Citius, Janowska, Dr. Reddy’s, and C.B.
With respect to claim 15, it would have been prima facie obvious to one having ordinary skill in the art to arrive at the concentration of propylene glycol recited in the instant claims because it is considered well within the capabilities of one of ordinary skill in the art to optimize the concentrations of individual ingredients of the formulation to provide optimal pharmaceutical compositions for anorectal disorders. The concentration of each individual ingredient in the formulation is a result effective parameter that will affect the physical properties of the final composition. The amount of propylene glycol in a composition is clearly a result effective parameter that a person of ordinary skill would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the ratio of propylene glycol disclosed by C.B. above, provides a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal ratio propylene glycol to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. See MPEP § 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-19 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-15 and 24-27 of copending Application No. 18/647,921 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
Claims 1-19 are rejected. Claim 20 is withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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