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 .
Response to Arguments
Applicant's arguments filed 2 December 2025 have been fully considered but they are not persuasive. The rejections of record have been maintained for the following reasons.
Cancellation of claim 13 rendered the rejection of record moot.
(Old) Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 106038523 (hereafter CN’523) in view of Parsons (US Pub. 2019/00321391) or Montalbetti et al.
Applicant argues that CN’523 does not render the claimed invention obvious because the composition disclosed therein contains potassium and is therefore allegedly unsuitable for treating IC/BPS, and that the claimed potassium-free composition represents a non-obvious therapeutic advance.
This argument is not persuasive.
As presently drafted, claim 1 is not limited to a second medical use claim, nor does it recite any structural or functional limitation requiring a newly discovered therapeutic effect. Instead, claim 1 broadly recites a pharmaceutical composition suitable for use in the treatment of IC/BPS.
CN’523 expressly discloses sustained-release oral compositions suitable for the treatment of IC/BPS (see CN’523, paragraph [0008] and examples). Therefore, CN’523 squarely addresses the same therapeutic context as the claimed invention.
B. Potassium Avoidance Is Explicitly Taught in the Art
Applicant further contends that knowledge of dietary potassium avoidance does not render obvious the preparation of a potassium-free oral pharmaceutical composition.
However, US’391 and Montalbetti et al. expressly contradict this position.
US’391 teaches that potassium intake worsens IC/BPS symptoms and that potassium exposure should be avoided to prevent symptom exacerbation.
Montalbetti et al. teaches that urinary potassium promotes pain and irritative voiding symptoms in IC/BPS patients and explicitly states that urinary potassium levels should be controlled by dietary and pharmacological means.
Thus, the prior art does not merely suggest avoiding potassium in food, but affirmatively teaches pharmacological control of potassium exposure, directly motivating the skilled person to eliminate potassium from drug formulations intended for IC/BPS.
C. Substitution of Citrate Salts Is a Predictable Modification
Applicant argues that replacing potassium citrate with magnesium citrate is not obvious.
This argument is unavailing. Citrate salts such as potassium citrate, sodium citrate, and magnesium citrate are well-known, functionally interchangeable alkalinizing agents in pharmaceutical compositions. Substituting one known citrate salt for another to avoid a known adverse effect constitutes a predictable substitution using known alternatives, yielding no unexpected result.
Such substitutions fall squarely within routine pharmaceutical formulation practice and do not require inventive skill.
D. No Evidence of Unexpected Results
Applicant has not provided comparative data or experimental results demonstrating that the claimed potassium-free composition provides an unexpected improvement over the compositions of CN’523. The application itself contains no working examples demonstrating effective urine alkalinization or improved IC/BPS outcomes attributable to the absence of potassium (see specification pages 12–13 and 16–17).
In the absence of evidence of a surprising or unexpected results the alleged advantage of potassium avoidance does not overcome the prima facie case of obviousness.
Accordingly, Applicant’s arguments fail to overcome the rejection of claims 1–13 as obvious over CN’523 in view of US’391 and/or Montalbetti et al.
Claim(s) 1-13 is/are rejected under 35 U.S.C. 103 as being unpatentable JP 2006/045200 (hereafter JP’200) in view of Parsons (US Pub. 2019/00321391) or Montalbetti et al.
Applicant similarly argues that JP’200 does not render the claimed invention obvious, asserting that the claimed potassium-free formulation represents a non-obvious departure from the prior art.
This argument is likewise not persuasive.
A. JP’200 Is Directed to the Same Disease State
JP’200 discloses oral tablet compositions for the treatment of IC/BPS, comprising citric acid, sodium citrate, and potassium citrate. Thus, JP’200 addresses the same disease state and same therapeutic purpose as the claimed invention.
B. Motivation to Eliminate Potassium Is Explicit
As discussed above, US’391 and Montalbetti et al. teach that potassium aggravates IC/BPS symptoms and should be avoided or controlled, including through pharmacological intervention. A person of ordinary skill in the art would therefore have been motivated to modify the potassium-containing composition of JP’200 to eliminate potassium.
C. Use of Magnesium Citrate Is an Obvious Alternative
Replacing potassium citrate with magnesium citrate represents nothing more than the selection of a known alternative citrate salt to achieve the same known function (alkalinization) while avoiding a known disadvantage (potassium irritation). Such substitution is well within the ordinary skill in the art and yields predictable results.
Claims 2–13 recite additional formulation parameters, excipients, dosage ranges, or intended results that constitute routine optimization or properties inherently achieved by the obvious compositions. Applicant has not identified any limitation in these claims that confers patentable distinction or produces an unexpected technical effect.
Claim Rejections - 35 USC § 112
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 1, 3-4, 8-10, 13 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.
A. Replacement of Trade Names with Excipients Lacks Support
The originally filed application recited specific commercial trade names to define excipients in claim 1. In the presently pending claims, those trade names have been replaced with generic excipient definitions. However, the application as originally filed does not provide a clear and unambiguous basis for equating the originally claimed trade names with the newly recited excipients.
Trade names, by their nature, do not reliably define a fixed chemical composition, as the formulation of commercial products may change over time. As a result, it cannot be directly and unambiguously determined that the presently claimed excipients correspond to the specific products originally identified by trademark.
This deficiency is illustrated by the present record. Document ANONYMOUS defines Avicel® DG as a co-processed excipient comprising microcrystalline cellulose (85%) and guar gum (15%) (page 8). In contrast, ANONYMOUS characterizes Avicel® DG as microcrystalline cellulose co-processed with dicalcium phosphate (page 2). These inconsistent definitions demonstrate that a trade name does not uniquely and unambiguously identify a specific excipient composition.
Accordingly, the application as filed does not provide written description support for replacing the originally claimed trade names with the presently recited excipients.
B. Broadening of Claim Scope
Additionally, the originally filed claims attempted—albeit unclearly—to define specific commercial products with specific properties. Replacing those trade names with broad, generic excipient definitions impermissibly broadens the scope of the claims beyond what was originally disclosed, contrary to 35 U.S.C. §112(a).
C. Non-Existent Excipient
Furthermore, the excipient recited as “microcrystalline hydroxypropyl-methylcellulose” does not appear to exist as a recognized material in the art. The specification does not describe such an excipient, nor does it provide any guidance enabling the skilled artisan to understand its structure or properties.
D. Claims 8–10
With respect to claims 8–10 and the corresponding passages on description pages 1–2, the same deficiencies apply. The excipients replacing the trade names in those passages likewise lack a clear and unambiguous basis in the application as originally filed.
Claims 3 and 4 are redundant: they refer to mandatory features in claim 1. By repeating these features, it gives the impression that the features are optional in claim 1, thereby rendering said claims unclear
Conclusion
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 DEBORAH D CARR whose telephone number is (571)272-0637. The examiner can normally be reached Monday-Friday (10:30 am -7:00 pm).
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/DEBORAH D CARR/ Primary Examiner, Art Unit 1691