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 .
Formal Matters
Applicant’s claim amendments and arguments in the reply filed on 30 December 2025 are acknowledged and have been fully considered. Claims 14-31 are pending. Claims 14-31 are under consideration in the instant office action. Claims 1-13 are cancelled. Applicant’s claim amendments and arguments did not overcome the rejections under 35 USC 112 and 103 for reasons set forth in the previous office action and herein below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 30 December 2025 is noted and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. A signed copy is attached herein.
Withdrawn Objections/Rejections
Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.
Objections and Rejections Maintained
Claim Objections
Claim 23 is objected to because of the following informalities: Independent claims start recitations using the articles “A” or “An” and dependent claims start with the proposition “The”. Claim 23 is starts the limitation awkwardly reciting “In a method of treating a subject with Rifaximin,”. Appropriate correction is required.
Response to Arguments
Applicant's arguments filed 30 December 2025 have been fully considered but they are not persuasive.
Applicant argues Because claim 23 meets all three of the requirements under Rule 75(e), this claim is a proper Jepson format. Accordingly, the objection to claim 23 for informalities should be withdrawn.
The above assertions are not found persuasive because the use of Jepson format does not automatically satisfy all formalities since objections for improper claim phrasing even in Jepson format claims when the overall presentation fails to adhere to accepted drafting practices. Applicant has not proposed an amendment to place the claim in proper form (for example, by rephrasing to a more conventional Jepson structure such as “A method of treating a subject having a condition…..” or an equivalent that aligns with standard independent claim introductory language while preserving the Jepson intent. Such an amendment would resolve the objection without altering the substantive scope.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 14-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of hepatic encephalopathy and traveler’s diarrhea, does not reasonably provide enablement for a method of treating a subject in need of rifaximin treatment as recited in claim 14 and In a method of treating a subject with rifaximin providing improvement as recited in claim 23. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to the claimed method being used to any subject in need of rifaximin treatment, the invention commensurate in scope with these claims. Claims 14 and 23 broadly encompass treatments of any subject in need of rifaximin which will include a wide variety of conditions (e.g., hepatic encephalopathy, traveler’s diarrhea, irritable bowel syndrome, and others). The specification does not provide sufficient description or representative examples to enable a person of ordinary skill in the art to practice the invention across the entire breadth of the claims. The specification may describe rifaximin in relation to particular indications, but it does not demonstrate or reasonably predict efficacy for all possible diseases and conditions where rifaximin might be useful., Absent such disclosure , one of ordinary skill in the art would need to engage in undue experimentation to determine how, or whether, rifaximin could be used effectively for each encompassed condition. Without limitations to specific therapeutic indications, dosing regimens, or subject populations, the claims read on an unpredictable number of methods of treatments. The disclosure does not enable the full scope of these potential generic treatments.
Response to Arguments
Applicant's arguments filed 30 December 2025 have been fully considered but they are not persuasive.
Applicant argues because the specification teaches how to make the pharmaceutical composition and how to use the pharmaceutical composition in treating conditions known to be treatable with rifaximin such as the two conditions disclosed in the specification traveler’s diarrhea, hepatic encephalopathy, and 10 other conditions disclosed by the 10 exhibits provided by Applicant, the skilled person would have recognized at the time of the effective filing date of the instant invention that the treatment of any other conditions treatable with rifaximin could be carried out using the disclosed pharmaceutical composition without undue experimentation.
The above assertions are not found persuasive because the independent claims encompass the composition applied across the entire genus of rifaximin treatable conditions known and potentially later identified ones without limitation to any particular indication, dosing regimen, patient subpopulation, or therapeutic context. Enablement requires the specification to teach one of ordinary skill in the art how to make and use the full scope of the claimed subject matter without undue experimentation. See MPEP 2164; Amgen Inc. v Sanofi, 598 U.S. 594 (2023); In re Wanda, 858 F.2d 731 (Fed. Cir. 1988). Applicant’s arguments fail to address the critical distinction while rifaximin itself may be known for certain uses, the claimed invention is method of using the polymorphic mixture. The specification’s lack of working examples except the mention of the two conditions hepatic encephalopathy and traveler’s diarrhea coupled with general references to known rifaximin utilities, do not demonstrate that this particular polymorphic mixture reliably provides therapeutically effective treatment or the asserted improvement in the case of claim 23 across the full breadth of the genus. Different conditions can involve distinct physiological environments, dosing requirements, bioavailability needs, formulation interactions, and safety profiles to mention a few. The polymorphic mixture’s properties (e.g., solubility, dissolution rate, stability, or bioavailability) may vary unpredictably across indications, potentially requiring condition specific studies and optimizations, clinical validation, or other adjustments not disclosed in the specification. The examiner takes the position that applying the Wands factors confirms undue experimentation would be required given the breadth of the claims is extremely broad covering any and all rifaximin treatable conditions (gastrointestinal, hepatic, etc.). Furthermore, pharmaceutical methods of treatment claims involving specific formulations or polymorphs are highly unpredictable. Polymorphs can significantly alter key pharmaceutical parameters, and efficacy/safety across disparate disease states is not routine or predictable without targeted data, see MPEP 2164.03. Only two conditions are mentioned or disclosed in the specification as conditions that can be treated with rifaximin not even in a working example showing the use of the polymorphic mixtures indeed can treat the two conditions. General knowledge of rifaximin’s uses and the ability to make the composition do not bridge the gap to using the specific polymorphic mixture effectively for the full genus. One of ordinary skill in the art would need to undertake significant trial and error efforts including formulation testing, pharmacokinetic studies, dose ranging, efficacy trials, and safety assessments for each additional condition to confirm therapeutic effectiveness and any improvement from administering the polymorphic mixture containing pharmaceutical composition. This constitutes undue experimentation. The examiner takes the position that mere knowledge in the prior art that rifaximin treats certain conditions as mentioned in exhibits I-X does not enable the claimed treatment or improvement using the recited polymorphic mixtures for all conditions treatable by rifaximin administration. None of the exhibits I-X are drawn to the claimed pharmaceutical composition comprising the recited polymorphic mixtures. The specification must enable the claimed invention commensurate in scope with the claims (see MPEP2164.08. Applicant has not provided a representative number of credible and exemplary species, a general quality running through the genus, or sufficient correlation between polymorphic mixture containing composition and effectiveness or efficacy across the full breadth of claims.
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 23-31 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 23 recites the limitation "the improvement". The phrase was not previously recited in claim 23. There is insufficient antecedent basis for this limitation in the claim.
Claims 14-31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: Instant claim 14 recites “A method of treating a subject having a condition that is treatable by rifaximin administration comprising selecting a subject having the condition that is treatable by rifaximin administration….”. Instant claim 23 recites “In a method of treating a subject having a condition that is treatable by Rifaximin administration, the improvement comprising: administering to the subject a Rifaximin polymorphic mixture that comprises a and b Rifaximin polymorphs in a a/b relative ratio of 85/15±3 to treat the condition, wherein the Rifaximin polymorphic mixture is characterized by an X-Ray spectrum with characteristic 2theta values at about: 5.32, 5.78, 6.50, 7.24, 7.82, 8.80, 10.50, 11.02, 11.58, 13.08, 14.42, 17.32, 17.68, 18.58, 19.52, 21.04, 21.60, and 21.92.” Both claims 14 and 23 do not provide specific condition or disease that is treated using the Rifaximin polymorphic mixture that comprises a and b Rifaximin polymorphs in a a/b relative ratio of 85/15±3, wherein the Rifaximin polymorphic mixture is characterized by an X-Ray spectrum with characteristic 2theta values at about: 5.32, 5.78, 6.50, 7.24, 7.82, 8.80, 10.50, 11.02, 11.58, 13.08, 14.42, 17.32, 17.68, 18.58, 19.52, 21.04, 21.60, and 21.92. The dependent claims thereof do not clarify the issue.
Response to Arguments
Applicant's arguments filed 30 December 2025 have been fully considered but they are not persuasive.
Applicant argues that the claim is properly written in Jepson format therefore the recitation “the improvement” in claim 23 is permissible and the rejection should be withdrawn.
The above assertions are not found persuasive because while the claim attempts to invoke Jepson style claiming, the specific language used does not overcome the indefiniteness problem. A Jepson claim typically takes the form of reciting known or conventional elements in the preamble, followed by a transitional phrase “wherein the improvement comprising,” or “the improvement comprising” with the body then reciting the novel elements that constitute the asserted improvement over the prior art (see MPEP 2129; In re Xencor (and related Appeal Review Panel Decisions, e.g., Chamberlain). The preamble in proper Jepson claim is limiting and provides context for the improvement. In the instant case the phrase “the improvement” appears without any prior recitation of “an improvement”, “said improvement”, or other antecedent in the claim. This renders the term indefinite because it is unclear what specific “improvement” is being referred to, or how the recited polymorphic mixture specifically improves upon the base method of rifaximin administration recited in the preamble. One of ordinary skill in the art reading the claim would not have a clear understanding of the metes and bounds of the claimed subject matter , particularly where the preamble describes a broad, conventional method of treatment without identifying any particular deficiency or baseline that the “improvement” is addressing. The use of the Jepson format does not automatically immunize the claim from antecedent basis requirements under 35 USC 112(b). The transitional phrase itself must be supported by clear antecedent basis, and the overall claim still particularly point out and distinctly claim the invention. The mere invocation of “the improvement comprising” does not inherently supply the missing antecedent; it presupposes that “the improvement” has already been introduced is unambiguously defined by the preamble and the body of the claim. Here, it is not since the claim fails to clearly link the polymorphic mixture to a specific identifiable improvement in the treatment method (e.g. improved efficacy, stability, bioavailability, or other property) leaving the scope indeterminate. Applicant has not amended the claim to correct the lack of antecedent basis for the phrase (e.g. by changing to “wherein the improvement comprises…” with proper support or by redrafting to provide explicit antecedent basis. Nor has Applicant demonstrated that the specification provides clear corresponding disclosure that would resolve the ambiguity for one of ordinary skill in the art.
Applicant argues with regard to the rejection for the claim omitting essential elements reciting a specific condition or disease that is treated using the pharmaceutical composition comprising the rifaximin polymorphic mixture that the claim is properly recites “a condition that is treatable by rifaximin administration”. Therefor, the rejection should be withdrawn.
The above assertions are not found persuasive because in both claims 14 and 23 the phrase “a condition that is treatable by Rifaximin administration” is vague, functional limitation that does not identify any particular disease, indication, or therapeutic context. This leaves the claim unclear to one of ordinary skill in the art. The claim omits any recitation of specific condition or disease (or other narrowing features that would define the essential elements of the method) rendering the scope of indeterminate. The phrase encompasses administration of the polymorphic mixture for any known or future rifaximin treatable condition without providing any objective standard determining what falls within the scope of the claim (see MPEP 2173.05(b) (functional language or relative terminology that fails to provide a clear standard for ascertaining the scope of the claim can render it indefinite); Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910, 110 USPQ2d 1688, 1693 (2014) (a patent must inform, with reasonable certainty those skilled in the art about the scope of the invention). The mere reference to conditions “treatable by Rifaximin administration” does not cure the indefiniteness because the set of such condition is not fixed or clearly delineated in the claim or specification, and the claim does not tie the “improvement” for instance in claim 23 to the specific polymorphic mixture or to any identifiable baseline deficiency in the prior art method for a defined condition. One of ordinary skill in the art would not be able to determine with reasonable certainty whether a particular treatment method for a given condition infringes the claim.
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.
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.
Note: For prior art rejection purpose the examiner read claims 14 and 23 to mean a method of treating hepatic encephalopathy as per applicant’s election.
Claims 14-31 are rejected under 35 U.S.C. 103 as being unpatentable over Viscomi et al. (US20120059023, IDS reference of 04/04/23) in view of Jahagirdar et al. (EP2011486, IDS reference of 04/04/23).
Applicant Claims
Applicant claims a method of treating hepatic encephalopathy comprising selecting a subject and administering to said subject a pharmaceutical composition comprising a rifaximin polymorphic mixture of /polymorphs in a relative ration of 85/15 ± 3 , wherein the Rifaximin polymorphic mixture is characterized by an X-Ray spectrum with characteristic 2theta values at about: 5.32, 5.78, 6.50, 7.24, 7.82, 8.80, 10.50, 11.02, 11.58, 13.08, 14.42, 17.32, 17.68, 18.58, 19.52, 21.04, 21.60, and 21.92. Dependent claims thereof recite other features of the pharmaceutical composition used in the treatment.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Viscomi et al. disclose as follows on claim 1:
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Viscomi et al. teach provided herein are methods of treating, preventing, or alleviating bowel related disorders comprising administering to a subject in need thereof an effective amount of one or more of a Form α, Form β, or Form γ polymorph of rifaximin. Bowel related disorders include one or more of irritable bowel syndrome, diarrhea, microbe associated diarrhea, Clostridium difficile associated diarrhea, traveler’s diarrhea, small intestinal bacterial overgrowth, Crohn's disease, chronic pancreatitis, pancreatic insufficiency, colitis, hepatic encephalopathy, or pouchitis (paragraph 0148). The invention also provides pharmaceutical compositions, comprising an effective amount of a rifaximin polymorph (e.g., Form α, Form β, and/or Form γ) described herein and a pharmaceutically acceptable carrier. In a further embodiment, the effective amount is effective to treat a bacterial infection, e.g., small intestinal bacterial overgrowth, Crohn's disease, hepatic encephalopathy, antibiotic associated colitis, and/or diverticular disease (paragraph 0158). In combination therapy treatment, both the compounds of this invention and the other drug agent(s) are administered to mammals (e.g., humans, male or female) by conventional methods. The agents may be administered in a single dosage form or in separate dosage forms. Effective amounts of the other therapeutic agents are well known to those skilled in the art. However, it is well within the skilled artisan's purview to determine the other therapeutic agent's optimal effective-amount range. In one embodiment of the invention in which another therapeutic agent is administered to an animal, the effective amount of the compound of this invention is less than its effective amount in case the other therapeutic agent is not administered. In another embodiment, the effective amount of the conventional agent is less than its effective amount in case the compound of this invention is not administered. In this way, undesired side effects associated with high doses of either agent may be minimized. Other potential advantages (including without limitation improved dosing regimens and/or reduced drug cost) will be apparent to those skilled in the art (paragraph 0198).
Viscomi et al. teach in another embodiment, the composition is formulated for selected coated and uncoated tablets, hard and soft gelatine capsules, sugar-coated pills, lozenges, wafer sheets, pellets and powders in sealed packet (paragraph 0034). The invention provides pharmaceutical compositions comprising one or more of a Form .alpha., Form .beta., or Form .gamma. polymorph of rifaximin and a pharmaceutically acceptable carrier. That is, formulations may contain only one polymorph or may contain a mixture of more than one polymorph. Mixtures may be selected, for example on the basis of desired amounts of systemic adsorption, dissolution profile, desired location in the digestive tract to be treated, and the like. The pharmaceutical composition further comprises excipients, for example, one or more of a diluting agent, binding agent, lubricating agent, disintegrating agent, coloring agent, flavouring agent or sweetening agent. Composition may be formulated for selected coated and uncoated tablets, hard and soft gelatin capsules, sugar-coated pills, lozenges, wafer sheets, pellets and powders in sealed packet. For example, compositions may be formulated for topical use, for example, ointments, pomades, creams, gels and lotions (paragraph 0160). In certain embodiments, these pharmaceutical compositions are suitable for topical or oral administration to a subject. In other embodiments, as described in detail below, the pharmaceutical compositions of the present invention may be specially formulated for administration in solid or liquid form, including those adapted for the following: (1) oral administration, for example, drenches (aqueous or non-aqueous solutions or suspensions), tablets, boluses, powders, granules, pastes; (2) parenteral administration, for example, by subcutaneous, intramuscular or intravenous injection as, for example, a sterile solution or suspension; (3) topical application, for example, as a cream, ointment or spray applied to the skin; (4) intravaginally or intrarectally, for example, as a pessary, cream or foam; or (5) aerosol, for example, as an aqueous aerosol, liposomal preparation or solid particles containing the compound (paragraph 0162). The phrase "pharmaceutically-acceptable carrier" includes pharmaceutically-acceptable material, composition or vehicle, such as a liquid or solid filler, diluent, excipient, solvent or encapsulating material, involved in carrying or transporting the subject chemical from one organ, or portion of the body, to another organ, or portion of the body. Each carrier must be "acceptable" in the sense of being compatible with the other ingredients of the formulation and not injurious to the patient. Some examples of materials which can serve as pharmaceutically-acceptable carriers include: (1) sugars, such as lactose, glucose and sucrose; (2) starches, such as corn starch and potato starch; (3) cellulose, and its derivatives, such as sodium carboxymethyl cellulose, ethyl cellulose and cellulose acetate; (4) powdered tragacanth; (5) malt; (6) gelatin; (7) talc; (8) excipients, such as cocoa butter and suppository waxes; (9) oils, such as peanut oil, cottonseed oil, safflower oil, sesame oil, olive oil, corn oil and soybean oil; (10) glycols, such as propylene glycol; (11) polyols, such as glycerin, sorbitol, mannitol and polyethylene glycol; (12) esters, such as ethyl oleate and ethyl laurate; (13) agar; (14) buffering agents, such as magnesium hydroxide and aluminum hydroxide; (15) alginic acid; (16) pyrogen-free water; (17) isotonic saline; (18) Ringer's solution; (19) ethyl alcohol; (20) phosphate buffer solutions; and (21) other non-toxic compatible substances employed in pharmaceutical formulations (paragraph 0164). In solid dosage forms of the invention for oral administration (capsules, tablets, pills, dragees, powders, granules and the like), the active ingredient is mixed with one or more pharmaceutically-acceptable carriers, such as sodium citrate or dicalcium phosphate, and/or any of the following: (1) fillers or extenders, such as starches, lactose, sucrose, glucose, mannitol, and/or silicic acid; (2) binders, such as, for example, carboxymethylcellulose, alginates, gelatin, polyvinyl pyrrolidone, sucrose and/or acacia; (3) humectants, such as glycerol; (4) disintegrating agents, such as agar-agar, calcium carbonate, potato or tapioca starch, alginic acid, certain silicates, and sodium carbonate; (5) solution retarding agents, such as paraffin; (6) absorption accelerators, such as quaternary ammonium compounds; (7) wetting agents, such as, for example, acetyl alcohol and glycerol monostearate; (8) absorbents, such as kaolin and bentonite clay; (9) lubricants, such as talc, calcium stearate, magnesium stearate, solid polyethylene glycols, sodium lauryl sulfate, and mixtures thereof; and (10) colouring agents. In the case of capsules, tablets and pills, the pharmaceutical compositions may also comprise buffering agents. Solid compositions of a similar type may also be employed as fillers in soft and hard-filled gelatin capsules using such excipients as lactose or milk sugars, as well as high molecular weight polyethylene glycols and the like (paragraph 0174). A tablet may be made by compression or molding, optionally with one or more accessory ingredients. Compressed tablets may be prepared using binder (for example, gelatin or hydroxypropylmethyl cellulose), lubricant, inert diluent, preservative, disintegrant (for example, sodium starch glycolate or cross-linked sodium carboxymethyl cellulose), surface-active or dispersing agent. Molded tablets may be made by molding in a suitable machine a mixture of the powdered active ingredient moistened with an inert liquid diluent (paragraph 0175). The tablets, and other solid dosage forms of the pharmaceutical compositions of the present invention, such as dragees, capsules, pills and granules, may optionally be scored or prepared with coatings and shells, such as enteric coatings and other coatings well known in the pharmaceutical-formulating art. They may also be formulated so as to provide slow or controlled release of the active ingredient therein using, for example, hydroxypropylmethyl cellulose in varying proportions to provide the desired release profile, other polymer matrices, liposomes and/or microspheres. They may be sterilized by, for example, filtration through a bacteria-retaining filter, or by incorporating sterilizing agents in the form of sterile solid compositions which can be dissolved in sterile water, or some other sterile injectable medium immediately before use. These compositions may also optionally contain opacifying agents and may be of a composition that they release the active ingredient(s) only, or preferentially, in a certain portion of the gastrointestinal tract, optionally, in a delayed manner. Examples of embedding compositions which can be used include polymeric substances and waxes. The active ingredient can also be in micro-encapsulated form, if appropriate, with one or more of the above-described excipients (paragraph 0176). Viscomi et al. further teach generally, out of one hundred %, this amount will range from about 1% to about ninety-nine % of active ingredient, preferably from about 5% to about 70%, most preferably from about 10% to about 30%.The examiner for instance assuming form alpha is incorporated in amounts of from about 1% to about 99% and while the form is incorporated from about 10% to about 30% one of ordinary skill in the art can easily calculate a ratio of 1-99%/10-30% which clearly overlaps with the claimed range (paragraph 0167).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.012)
Viscomi et al. teach the ratio of /in an obviousness or overlapping manner. Viscomi et al. teach solid dosage forms of the invention for oral administration (capsules, tablets, pills, dragees, powders, granules and the like), the active ingredient is mixed with one or more pharmaceutically-acceptable carriers, such as sodium citrate or dicalcium phosphate, and/or any of the following: (1) fillers or extenders, such as starches, lactose, sucrose, glucose, mannitol, and/or silicic acid; (2) binders, such as, for example, carboxymethylcellulose, alginates, gelatin, polyvinyl pyrrolidone, sucrose and/or acacia; (3) humectants, such as glycerol; (4) disintegrating agents, such as agar-agar, calcium carbonate, potato or tapioca starch, alginic acid, certain silicates, and sodium carbonate; (5) solution retarding agents, such as paraffin; (6) absorption accelerators, such as quaternary ammonium compounds; (7) wetting agents, such as, for example, acetyl alcohol and glycerol monostearate; (8) absorbents, such as kaolin and bentonite clay; (9) lubricants, such as talc, calcium stearate, magnesium stearate, solid polyethylene glycols, sodium lauryl sulfate, and mixtures thereof; and (10) colouring agents, Viscomi et al. do not specifically teach red iron oxide as a coloring agent. This deficiency is cured by the teachings of Jahagirdar et al. (EP 2011486).
Jahagirdar et al. teach a rifaximin containing pharmaceutical composition comprises a rifaximin, or its salt, enantiomer or polymorph(s), release controlling agent(s) and excipient(s) (see abstract). See the use of iron oxide red as a coloring agent in paragraph 0086.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to modify the teachings of Viscomi et al. by utilizing iron oxide red as coloring agent because Jahagirdar et al. (EP 2011486) teach a rifaximin containing pharmaceutical composition comprises a rifaximin, or its salt, enantiomer or polymorph(s), release controlling agent(s) and excipient(s) (see abstract). See the use of iron oxide red as a coloring agent in paragraph 0086. The selection of a known material or method based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). One of ordinary skill in the art would have had a reasonable chance of success in combining the teachings of Viscomi et al. and Jahagirdar et al. (EP 2011486) because both references teach tablet compositions of rifaximin.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 30 December 2025 have been fully considered but they are not persuasive.
Applicant argues in Viscomi of the amount of active ingredient does not constitute a
disclosure of a ratio of α and ß polymorphs, let alone the polymorphic mixture of α/ß form in a
relative ratio of 85/15±3 as recited in independent claims 14 and 23 of the present application. It
is this specific ratio of α/ß form that has produced unexpected stability during dry granulation
and tableting steps used to prepare the form used for administration. See Present Application at
page 3, line 25 to page 4, line 2. The rifaximin α/ß mixture in a relative ratio of 85/15±3 of the
present invention, when prepared into film coated tablets using a dry granulation and tableting
procedure produced no sensible modification of the relative ratio between the α and ß polymorphic forms. See Present Application at page 4, lines 3-8. Additionally, Jahagirdar does not overcome the above-noted deficiencies of Viscomi.
The above assertions are not found persuasive because "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle."Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ."Id. at 418, 82 USPQ2d at 1396. Viscomi et al. clearly teach the amount of each of the polymorphic forms in the mixture in ranges. One of ordinary skill in the art can easily calculate a ratio by picking amounts from each disclosed ranges of amounts. Furthermore, in the case where the claimed ranges for amount of active ingredients or ratios “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). Additionally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). The ratio is a result effective parameter which is optimizable absent a showing of criticality.
Conclusions
THIS ACTION IS MADE FINAL. 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 TIGABU KASSA whose telephone number is (571)270-5867. The examiner can normally be reached on 8 AM-5 PM.
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/TIGABU KASSA/Primary Examiner, Art Unit 1619
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