DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Preliminary amendment filed on 02/06/2024 has been entered. Claim 32 is new. Claims 1-32 are pending in this application. Claims 5-14, 16, 18, 19, and 21-32 are withdrawn. Claims 1-4, 15, 17, and 20 are currently under examination.
Priority
This application is a 371 of PCT/US22/41757 filed on 08/26/2022 and claims benefit of US PRO 63/237,811 filed on 08/27/2021.
Election/Restrictions
Applicant's election with traverse of Group I invention (claims 1-13, 15-18, and 20) and species (
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, wherein X is H and wherein NT is O-linked Serotonin) in the reply filed on 07/13/2026 is acknowledged. Claims 5-14, 16, 18, 19, and 21-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Thus, claims 1-4, 15, 17, and 20 are currently under examination.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 07/18/2024 has been considered.
Claim Objections
Claims 1, 2, 15, 17, and 20 are objected to because of the following informalities: In claim 1, insert the missing preposition “for” immediately before the recitation “treating” (line 1); spell out abbreviated “MOGLs” (line 4) to “modular glucosides (MOGLs)”; and insert the missing element “H,” immediately after the recitations “G2 is” (line 10) and “G6 is” (line 18) because the G2 or G6 of the VIII-b, VIII-c, and VIII-d in dependent claim 2 requires hydrogen. In claims 2 and 17, change the incorrect recitation “, where the” (line 1 of claims 2 and 17) to “, wherein the” to become proper dependent claim format; also in claim 17, insert the missing verb “is” immediately before the recitation “selected from” (line 3). In claim 15, insert the missing phrase “in need thereof” immediately after the recitation “mammal” (line 2) because only those in need require the therapeutic composition; and insert the missing element “H,” immediately after the recitations “G2 is” (line 10) and “G6 is” (line 15) because the G2 or G6 of the VIII-b, VIII-c, and VIII-d in dependent claim 17 requires hydrogen. In claim 20, insert the missing word “further” immediately after the recitation “pharmaceutical composition” (line 3) because the preceding Formula I is also required. Appropriate correction is required.
Claims 1, 2, 15, and 17 are objected to because they include reference characters which are not enclosed within parentheses. Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m). Applicant is advised to add parenthesis to the symbols “I”, “VIII-a”, “VIII-b”, “VIII-c”, and “VIII-d” right next to the corresponding chemical structures.
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 2-4, 15, and 17 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 pre-AIA the applicant regards as the invention.
Claims 2-4 and 17 recite “a derivative”, which is not specifically defined and thus its scope is not clear. Applicant is advised to insert the word “structural” immediately before the recitation “derivative”.
Regarding claim 15, the phrase “e.g.”, equivalent to "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). To advance the prosecution, the broad recitation before the recitation “e.g.” is examined here.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 15, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kleeb et al. (J. Med. Chem. 2016, 59, 3163−3182, hereinafter referred to as Kleeb ‘2016).
With regard to structural limitations “a method comprising administering to a patient in need thereof a therapeutically effective amount of a composition comprising one or more MOGLs (which is not specifically defined and thus is broadly interpreted as any glycoside, including mannose) of Formula I:
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wherein: G1 is -OR10, G2 is H, X is metal M+ or Z+ comprising nitrogen-based cation; G6 is H; R10 is optionally substituted aryl (or further comprising a pharmaceutically acceptable excipient” (claims 1, 15, and 20):
Kleeb ‘2016 disclosed syntheses and pharmacokinetic evaluation of phosphate prodrugs, which show an improved aqueous solubility of up to 140-fold. The synthesis of 3-phosphate 6b (Scheme 2):
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. The synthesis of 3-phosphate 7b (Scheme 6):
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The in vivo application of phosphate prodrugs led to a substantially increased Cmax and prolonged availability of FimH antagonists in urine. In vivo studies in a mouse disease model confirmed the therapeutic potential of biaryl mannosides for an oral treatment of Urinary tract infection . In vivo pharmacokinetics: Compounds were diluted in PBS and applied using an oral gavage (page 3163, Abstract; right col., para. 2; page 3164, right col., para. 2; page 3165, left col., para. 1; page 3166, Scheme 2; page 3168, Scheme 6; page 3180, left col., para. 2).
Thus, these teachings of Kleeb ‘2016 anticipate Applicant’s claims 1, 15, and 20.
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.
Claims 1-4, 15, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kleeb et al. (J. Med. Chem. 2016, 59, 3163−3182, hereinafter referred to as Kleeb ‘2016) in view of Servillo et al. (LWT - Food Science and Technology 73 (2016) 117e122, hereinafter referred to as Servillo ‘2016). Claims 1, 15, and 20 are rejected here because they have been rejected by the primary reference under 102 above. Thus, the above disclosure of Kleeb ‘2016 is incorporated by reference in its entirety here.
Kleeb ‘2016 did not explicitly disclose the limitations “a neurological disease”, and “the MOGL is
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(or wherein X is H and wherein NT is a neurotransmitter linked to the glucose; or the -NT is a monoamine neurotransmitter or O-linked Serotonin, elected)”, required by claims 2-4 and 17.
Servillo ‘2016 disclosed serotonin 5-O-ß-glucoside:
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. Serotonin 5-O-ß-glucoside occurs at similar levels in beans of all varieties of Robusta and Arabica coffee species. Serotonin (5-hydroxytryptamine, 5-HT) is a tryptophan derived neurotransmitter involved in the regulation of important physiological functions in humans and animals such as mood, sleep and maintenance of energetic balance. The serotonin action starts with the binding to specific cell receptors able to modify cerebral and peripheral mechanisms involved in the control of food intake and satiety (page 121, left col., Fig. 2b; page 117, Abstract and left col., para. 1).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to substitute the starting biaryl mannosides material in Scheme 2 or 6 of Kleeb ‘2016 with the Serotonin 5-O-ß-glucoside in view of Servillo ‘2016 and proper protection of other reactive sites to synthesize Serotonin 5-O-ß-glucoside 3-phosphate because the 3-phosphate glycoside compound shows highly improved bioavailability in vivo as described above. Thus, one of skill in the art would have a reasonable expectation that by substituting the starting biaryl mannosides material in Scheme 2 or 6 of Kleeb ‘2016 with the Serotonin 5-O-ß-glucoside in view of Servillo ‘2016 and proper protection of other reactive sites to synthesize Serotonin 5-O-ß-glucoside 3-phosphate, one would achieve Applicant’s claims 1-4, 15, 17, and 20. "Exemplary rationales that may support a conclusion of obviousness include: (B) Simple substitution of one known element for another to obtain predictable results". See MPEP § 2143 [R-01.2024] [I].
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YIH-HORNG SHIAO whose telephone number is (571)272-7135. The examiner can normally be reached Mon-Thur, 08:30 am to 07:00 pm EST.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691
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