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 .
Status of the Claims
Claims 22-43 are pending. Claims 22-33 are withdrawn. Claims 34-43 are rejected.
Priority
This is a 35 U.S.C. 371 National Stage Filing of International Application No.
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, which claims priority under 35 U.S.C. 119(a-d) to
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. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d).
Information Disclosure Statement
The Information Disclosure Statements (IDS’s) submitted on 8/21/2024, 1/5/2026 and 9/16/2026 were considered by the Examiner.
Election/Restrictions
Applicant's election with traverse of Group III (claims 34-43) in the reply filed on 8/21/2026 is acknowledged. The traversal is on the ground(s) that Damman, 2013 disclose topical effect of salicylates in general and the instant claims are drawn to oral administration. Applicant further states that “none of the claimed metabolites is mentioned in Damman, 2013” (see p. 2 of response). This is not found persuasive because:
Oral administration of salicylic acid has been found obvious below, over Katanic et al., Steenkamp et al, Bekersky et al., Farber et al. and Kiss et al.
The metabolite salicyluric acid is intrinsically formed from the metabolism of salicylic acid, as discussed below.
The requirement is still deemed proper and is therefore made FINAL.
Claims 22-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/21/2026.
Claim Objections
Claim 42 is objected to because of the following informalities: the following limitation is repetitive as claim 42 depends from claim 34: “wherein said metabolite is a metabolite formed in vivo after ingestion of salicylic acid”. Appropriate correction is required.
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 34-43 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 34 recites the limitation: “wherein said metabolite is a metabolite formed in vivo after ingestion of salicylic acid” in lines 4-5 referring directly to an administered metabolite by oral route. It is unclear how a subject can both administer a metabolite by oral route and the metabolite be something formed after ingestion of another drug (salicylic acid).
Claim 34 additionally recites the limitation “or pharmaceutical compositions thereof” in lines 3 to 4; it is unclear if this is claiming pharmaceutical compositions containing the salicylic acid or metabolite or that the salicylic acid or metabolite are a pharmaceutical composition. Examiner recommends amending to clarify these discrepancies. Claims 35-43 are additionally rejected for depending on claim 34 and failing to remedy its deficiencies.
Claim 39 recites the limitation "the urinary tract infection" in line 1. There is insufficient antecedent basis for this limitation in the claim because claim 34 just refers to “a urinary infection”, not “tract”.
Claim 42 is unclear regarding what is the additional active step or explicit additional limitation. It recites the amount of SA and incorporates at least one pharmaceutically or cosmetically acceptable carrier, diluent or excipient thereof, but the overall grammar of the claim renders it confusing as to what the intentions of the limitations are.
Claim 43 recites the limitation "the formulation" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 43 depends from claim 34, which does not recite the limitation of “the formulation”.
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.
Claim(s) 34, 35, 37-38 and 42-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katanic et al. (Journal of Ethnopharmacology, 193, 2016, 627-636) in view of Bekersky et al. (Drug Metabolism and Disposition, 1980, 8(5), 319-324), and further in view of Farber et al. (The Journal of Urology, 1993, 149, 667-670).
Katanic et al. teach Filipendula ulmaria (F. ulmaria) has been traditionally used in most European countries for the treatment of inflammatory diseases due to its antipyretic, analgesic, astringent, and anti-rheumatic properties (see abstract). F. ulmaria is also used in the treatment of urinary tract infections and includes salicylic acid as a phenolic constituent (see p. 628, top left column). The study aimed to reveal the anti-inflammatory activity of methanolic extracts of F. ulmaria, both in in vitro and in vivo conditions, using two doses in rats: 100 and 200 mg/kg, suspended in normal saline [a cosmetically acceptable diluent] (see abstract and section 2.8.1) [for a 0.5 kg rat, this equates to 50-100 mg total weight, embraced by range of instant claim 43]. The administration route to the animals was oral (see section 2.8.1). Katanic concluded that F. ulmaria extracts, which include salicylic acid, were demonstrated to have anti-inflammatory activity and were useful in treating various conditions as traditionally done (see abstract).
Katanic fails to disclose specifically the following:
salicyluric acid, a metabolite formed in vivo after ingestion of salicylic acid, to prevent and/or treat a urinary infection;
the instantly claimed “effective amount” of salicylic acid or a metabolite thereof.
Bekersky studied the metabolism of salicylic acid in the rat kidney, wherein salicylic acid was metabolized to salicyluric acid (see abstract).
Regarding the limitation of the instant claims “an effective amount of salicylic acid or a metabolite thereof” the instant specification recites “a formulation comprising from about 0.1 to about 50 mg of salicylic acid [SA]” (see p. 14, lines 3-6) or about “0.75 ug to 2.6 mg of SA” (see p. 7, lines 1-3). Farber et al. teach that catheter-related urinary tract infections continue to be a major cause of morbidity in hospitalized patients. “During the pathogenesis of these infections, bacteria migrate along a biofilm into the bladder. Biofilms may form on a wide variety of medical polymers including silicone, polyvinyl chloride and Teflon-coated latex” (see p. 667, left column). Farber et al. additionally teach that the “use of salicylic acid to coat urinary or other medical devices may provide a novel approach in attempt to decrease the incidence of infection” (see p. 669, right column, first full para.). See Farber Table 2 for specific amounts, wherein 5 mM demonstrated 79% inhibition:
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[5 mM, molar mass of salicylic acid = 138.12 g/mol, equates to 0.69 mg of salicylic acid in a 1 mL sample].
Regarding instant claims 34-35, 37-38, and 42-43, it would have been obvious to a PHOSITA to prevent and/or treat a urinary infection by administering salicylic acid (SA) or a metabolite formed in vivo thereof (such as salicyluric acid), orally to a subject in need thereof, prior to the effective filing date of the instant claims and modify the teachings of Katanic with Bekersky and Farber. (Examiner would like to note that “prevention” of urinary infections embraces all subjects who could possibly acquire a urinary infection.) A skilled artisan would have been motivated to do so because of the following:
The prior art teaches that F. ulmaria is used to treat urinary tract infections and includes salicylic acid (see Katanic, p. 628, top left column);
The prior art teaches oral administration of F. ulmaria extracts (see Katanic, section 2.8.1);
The prior art discloses an effective amount of salicylic acid (within the range of the instant claims) that effectively inhibits E. coli, which causes urinary tract infections (see Farber et al. Table 2);
Salicyluric acid is intrinsically formed from the metabolism of salicylic acid;
Traditional uses, such as urinary tract treatment, of F. ulmaria were confirmed effective by the prior art study (see Katanic abstract).
Upon oral administration of F. ulmaria, which includes salicylic acid and intrinsically the metabolite salicyluric acid, a PHOSITA would have had a reasonable expectation of success in the effective treatment of a urinary infection.
Claim(s) 36, 39-40 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katanic et al. (Journal of Ethnopharmacology, 193, 2016, 627-636) in view of Bekersky et al. (Drug Metabolism and Disposition, 1980, 8(5), 319-324) and Farber et al. (The Journal of Urology, 1993, 149, 667-670), as applied to claims 34, 35, 37-38 and 42-43 above, and further in view of Steenkamp et al. (Journal of Ethnopharmacology, 103, 2006, 71-75) and Kiss et al. (Phytomedicine, 18, 2011, 557-560).
The 103 rejection over Katanic, Bekersky, and Farber of claims 34, 35, 37-38 and 42-43 supra is incorporated herein by reference.
Katanic, Farber, and Bekersky fail to disclose the inclusion of oenothein B, an Epilobium parviflorum extract, from the instantly claimed method. Additional dependent limitations will be addressed below.
Steenkamp et al. teach that urinary tract infections are usually caused by E. coli (reads on instant claim 39) and urinary tract infections cause acute bacterial prostatitis (a prostate disorder) (see Introduction, p. 71). Steenkamp additionally teaches the following: “Epilobium parviflorum has been reported to have a high antioxidant capacity….oenothein B, isolated from the aqueous extract has been identified as the compound responsible for the activity of the extract in the treatment of prostate disorders…” (see p. 74, left column, middle para.). Steenkamp is silent on specific amounts of oenothein B used to treat prostate disorders, caused by urinary tract infections.
Kiss et al. additionally teach oenothein B as an extract from Epilobium parviflorum, see Table 1:
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. Kiss teaches oenothein B having an IC50 of 1.1 uM against the enzyme hyaluronidase (see abstract). Kiss discloses that the strong inhibition of hyaluronidase of oenothein B particularly might explain the use of Epilobium species as a wound healing factor (see p. 559, left column).
Instant claims 36 and 41 require oenothein B [claim 36, part of a Epilobium parviflorum extract] and a “generic” Epilobium parviflorum extract (claim 41), respectively, used in combination with salicylic acid, in which both salicylic acid and oenothein B (found within E. parviflorum) have been demonstrated to treat urinary tract infections or ailments associated with urinary tract infections (i.e. prostate infections). “Absent a showing of unexpected results, one of ordinary skill in the art would be motivated to combine both of the therapeutic agents which are taught for the same purpose in order to treat said diseases.” In re Susi, 58 CCPA 440 169 USPQ 423, 426 (1971); In re Crokett, 47 CCPA 126 USPQ 186,188 (1960). "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072. See MPEP 2144.06(I). It would have been obvious to one of skill in the art to modify the teachings of Katanic, Farber, and Bekersky (oral administration of salicylic acid) by adding the oenothein B of Steenkamp and Kiss with a reasonable expectation of success in preventing and/or treating a urinary infection. Prior to the effective filing date, both salicylic acid and oenothein B were effectively used in urinary infection related treatments. Regarding instant claim 39, the prior art teaches that urinary tract infections are usually caused by E. coli (reads on instant claim 39) and urinary tract infections cause acute bacterial prostatitis (a prostate disorder) (see Steenkamp, Introduction, p. 71).
Regarding instant claim 40, Kiss teaches oenothein B having an IC50 of 1.1 uM against the enzyme hyaluronidase (see abstract). While Kiss does not specifically teach a composition with 15 ug to about 65 mg of oenothein B, 1.1 uM of oenothein is equivalent to 1.73 mg/ml (molar mass of oenothein B = 1569.1 g/mol). For example, if the composition was 1 ml, it would include 1.73 mg of oenothein B to achieve the IC50 for hyaluronidase, which falls within the instantly claimed range. A skilled artisan would have been motivated to explore administering effective amounts of oenothein B, related to important IC50 values, concomitantly with salicylic acid, with a reasonable expectation of treatment success because of the following reasons:
Both salicylic acid and oenothein B are linked to effective treatments of urinary tract related infections;
Known IC50 values against a “wound healing” related enzyme are embraced by amounts of the instant claims;
“Wound healing” is a broad ailment that would encompass most other diseases and infections, especially a urinary tract infection that may cause tissue damage to a subject.
One of ordinary skill in the art would have had a reasonable expectation of success in preventing and/or treating a urinary infection with the combination of salicylic acid and oenothein B because both were taught to be beneficial for related ailments and could enhance one another’s treatment efficacy.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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/MEGHAN C HEASLEY/Examiner, Art Unit 1626
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
