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 .
Claim Objections
Claims 2-5, 12-14, 16-19, 21, 25, 27-28, and 30-31 are objected to because of the following informalities:
Claims 2-5, 12-14, 16-19, 25, 27-28, 30-31 recite the language “characterised in that”. Examiner suggests amending to “wherein” for clarity.
Claim 3 recites “an PNP enzyme inhibitor”. This should read “a PNP enzyme inhibitor”.
Claim 13 recites “hybrid of hadacidin and hydantocidin 5’-phosphate”. This should read “a hybrid of hadacidin and hydantocidin 5’-phosphate”.
Claim 21 recites “(c) bismuth salt”. Examiner suggests amending to “(c) a bismuth salt” for consistency.
Claim 25 recites “characterised in that it is additionally administered in combination with an additional antibiotic”. The claim recites the administration of the inhibitor in combination with an antibiotic, therefor the use of ‘”it”, referring to a singular element, reads as awkward. Examiner suggests amending “it” to a term that would refer to both compounds.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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 1-5, 12-17, 19, 21 and 25-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The instant claims recite the prevention of disease associated with H. pylori infection. While the term “prevent” does not necessarily mean that something is kept from ever occurring, such an interpretation is available to the Examiner that falls under the “broad and reasonable” standard for claim interpretation as set form in MPEP 2111 and thus is proper.
Claims 1-5, 12-17, 19, 21 and 25-31 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for treating H. pylori infection, does not reasonably provide enablement for prevention of diseases associated with H. pylori infection. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: These include: (1) breadth of the claims; (2) nature of the invention; (3) state of the prior art; (4) amount of direction provided by the inventor; (5) the level of predictability in the art; (6) the existence of working examples; (7) quantity of experimentation needed to make or use the invention based on the content of the disclosure; and (8) relative skill in the art. All of the factors have been considered with regard to the claim, with the most relevant factors discussed below: While all of the factors have been considered, only those required for a prima facie case are set forth below.
(1 & 2) The breadth of the claims and nature of the invention: Claim 1 and its dependents are broadly directed to a method of treating H. pylori infection and/or treating or preventing a disease associated with H. pylori infection.
(3) The state of the prior art: While there are publications that discuss treating H. pylori infection and diseases associated with H. pylori infection, there is no evidence in the prior art the claimed method and compositions would prevent diseases associated with H. pylori infection, such as neurological disorders and cancer, from ever occurring.
(4 & 6) The amount of direction provided by the inventor and the existence of working examples: Applicant has not provided examples that demonstrate that the claimed method is effective at preventing diseases associated with H. pylori infection, such as cancer or neurological disorders. The instant specification has demonstrated that the method can inhibit the growth of H. pylori cultures. Applicant has not demonstrated that administration of the claimed method would prevent associated diseases from occurring.
(5) The level of predictability in the art: The prior art does not teach a method of preventing H. pylori associated diseases by administering a therapeutic composition. Although some methods may aid in the treatment of H. pylori infection, there is nothing in the prior art that indicates that complete prevention of diseases associated with such infection is possible. Furthermore, there is no evidence to show that development of such a disease can be prevented, even with successful eradication or absence of H. pylori infection.
(7) The quantity of experimentation: An undetermined number of experimental factors utilizing a broad range of compounds and a method for preventing diseases associated with H. pylori infection would have to be resolved by the practitioner for the following reasons: the factors are not sufficiently discussed in the specification to provide guidance to utilize the invention as claimed.
(8) The level of skill in the art: The level of skill in the art would be high, mostly likely at the Ph.D. /MD level.
Claims 1-4, 12-13, 15-17, 21, 25-31 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 treating h. pylori infection with immucillin, 6-methylformycin A, 2-chloro-6-benzyloxypurine, 2-chloro-6-benzylthiopurine, 2-chloro-6-benzylthiopurine-2’-deoxy-9-ribofuranoside, 6-benzylthiopurine, and 2,6-dichloropurine, pyridoxal 5’-phosphate, pyridoxal (PI-h), mefloquine and quinine, does not reasonably provide enablement for all possible inhibitors of PNP and AdSS, including compounds that meet the criteria of Formulas I, II and III. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: These include: (1) breadth of the claims; (2) nature of the invention; (3) state of the prior art; (4) amount of direction provided by the inventor; (5) the level of predictability in the art; (6) the existence of working examples; (7) quantity of experimentation needed to make or use the invention based on the content of the disclosure; and (8) relative skill in the art. All of the factors have been considered with regard to the claim, with the most relevant factors discussed below: While all of the factors have been considered, only those required for a prima facie case are set forth below.
(1 & 2) The breadth of the claims and nature of the invention: Claim 1 and its dependents are broadly directed to a method of treating H. pylori infection and/or treating or preventing a disease associated with H. pylori infection.
(3) The state of the prior art: While there are publications that discuss treating H. pylori infection and diseases associated with H. pylori infection, there is no evidence in the prior art that all the compounds as claimed would be effective for such purpose.
(4 & 6) The amount of direction provided by the inventor and the existence of working examples: Applicant has provided data regarding the aforementioned enabled compounds; however, applicant has not demonstrated that all of inhibitors of PNP and AdSS, including those of Formulas I, II, and III, would treat H. pylori infection and diseases associated with H. pylori infection.
(5) The level of predictability in the art: The prior art does not teach that all inhibitors of PNP and ADSS , nor the compounds of formulas I, II, and III would treat H. pylori infection and diseases associated with H. pylori infection. Applicant’s own specification discusses the unpredictability in the art, wherein, for example, hadacidin is a known inhibitor of AdSS but does not penetrate into the H. pylori cell interior, and thus is ineffective at inhibiting H. pylori growth [instant Specification pg. 4]. Furthermore, an example of a compound that meets the criteria of Formula I would be ATP. ATP is required for bacterial life, and thus likely would not be effective in treating H. pylori infection.
(7) The quantity of experimentation: An undetermined number of experimental factors utilizing a broad range of compounds and a method for preventing/treating H. pylori infection and diseases associated with H. pylori infection would have to be resolved by the practitioner for the following reasons: the factors are not sufficiently discussed in the specification to provide guidance to utilize the invention as claimed.
(8) The level of skill in the art: The level of skill in the art would be high, mostly likely at the Ph.D. /MD level.
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 1-5, 12-17, 19, 21 and 25-31 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 1 recites “the helicobacter pylori (H. pylori) cell purine nucleotide salvage pathway (reserve) enzyme”. There is insufficient antecedent basis for this limitation in the claim. It is unclear which purine nucleotide salvage pathway enzyme is being referred to in this claim. Furthermore, “(reserve)” renders the cell claim indefinite. It is unclear what the term means in the context of the claim and whether the term in parentheses is a required part of the invention. For purposes of compact prosecution, the limitation is being interpreted to read “a helicobacter pylori (H. pylori) cell purine nucleotide salvage pathway enzyme”.
Claim 1 also recites “a disease associated with H. pylori infection”. This renders the claim indefinite because it is unclear what “associated with” means. For example, “associated with” could refer to an instance of disease directly caused by H. pylori infection, or a disease for which H. pylori infection is generally known to be a risk factor, regardless of whether the etiology of a specific instance of disease is related to H. pylori infection. It is therefore unclear if the patient or subject is meant to already have an H. pylori infection with regards to treating the disease associated with H. pylori infection. The instant specification does not provide a clear definition for “associated with” and thus it is unclear how far removed a disease or instance of disease could be from H. pylori infection and still be considered to be “associated with” such infection. For purposes of compact prosecution, a disease that is generally known in the art to be connected with H. pylori infection will be considered to meet the claim limitation of “associated with”.
Claims 2-5, 12-17, 19, 21 and 25-31 depend from parent claim 1 and do not cure the deficiencies of claim 1. Therefore, claims 2-5, 12-17, 19, 21 and 25-31 inherit the deficiencies of claim 1.
Claim 2 recites “the enzyme selected from”. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending the limitation to recite language such as “wherein the inhibitor is an inhibitor of a Helicobacter pylori (H. pylori) cell purine nucleotide salvage pathway enzyme selected from purine nucleoside phosphorylase (PNP) and adenylosuccinate synthetase (AdSS)”. For purposes of compact prosecution, this limitation is being interpreted as the suggested amendment above.
Claim 4 recites “(Formula I)”, “(Formula II)”, and “(Formula III)”. This renders the claim indefinite because it is unclear if the parenthetical recitations are part of the claimed invention. Furthermore, the formulas are not defined in the claims, thus is unclear which compounds are embraced by the claimed formulas. For example, it is unclear if Formula I embraces any and all substituted purines, or only a defined subset of substituted purines (and if so, which substituent groups are claimed). Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
For purposes of compact prosecution, the instant claim is being interpreted to read “the method of claim 3, wherein the inhibitor is selected from substituted purines of Formula I, substituted 9-deaza-purines of Formula II, substituted 8-aza-9-deaza-purines of Formula III, mefloquine, and quinine”, wherein Formulas I, II, and III are defined according to page 15 of the instant specification. Examiner suggests amending the claims to include the structures of the claimed formulas and their substituent groups.
Claim 5 recites the phrases “preferably” and “more preferably”. This renders the claim indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. MPEP 2173.05(d). For purposes of compact prosecution, the language that comes after said phrases is being interpreted as optional.
The parenthetical recitations of formula IIa, Formula IV, Formula V, Formula VI, Formula VII, and Formula VIII also render the claim indefinite because it is unclear whether the recitations in parentheses are part of the claimed invention. Furthermore, the formulas are not defined in the claims, thus it is unclear which compounds are embraced by the claimed formulas. For example, it is unclear from the claims alone if Formula IV refers to only 6-benzyloxy-2-chloropurine, or if Formula IV is a general formula that embraces a wider group of compounds. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim.
For purposes of compact prosecution, the instant claim is being interpreted as “The method of claim 5, wherein the inhibitor is: …. (b) immucillin, (c) a substituted purine selected from 6-benzyloxy-2-chloropurine, 6-benzylthio-2-chloropurine, 2-chloro-6-benzylthiopurine-2’-deoxy-9-ribofuranoside, 6-benzylthiopurine, and 2,6-dichloropurine”. Examiner suggests amending the claims to include the structures of the claimed formulas and their substituent groups.
Claims 13 and 14 recite the phrase “preferably”. This renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For purposes of compact prosecution, the language that comes after “preferably” is being interpreted as optional.
The parenthetical recitation of “(vitamin B6)” also renders the claim indefinite because it is unclear whether the recitation in parentheses is part of the claimed invention. Since vitamin B6 embraces more compounds than pyridoxal 5’-phosphate, the parenthetical casts confusion on the scope of the claim. For purposes of compact prosecution, pyridoxal 5’-phosphate and other variations of vitamin B6 will be considered to read on the instant claim limitation.
Claim 17 recites the phrase “preferably”. This renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For purposes of compact prosecution, the language that comes after “preferably” is being interpreted as optional.
Claim 19 recites the phrases “i.e.” and “preferably”. This renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. MPEP 2173.05(d). Furthermore, it is unclear what ”PI-h” refers to, as there is no clear definition in the claims nor the specification. It is unclear if PI-h is equivalent to pyridoxal hydrochloride (see instant specification page 12, line 11), pyridoxal (see instant specification, example 10), or a subtype of pyridoxal (see instant specification, pg. 8 line 12). Furthermore, a cursory search indicates that “PIH” is used to refer to pyridoxal isonicotinoyl hydrazone, which is absent from the instant specification. For purposes of compact prosecution, the limitation will be interpreted to read “selected from pyridoxal 5’-phosphate (PLP) and its precursors”.
Claim 21 recites “cell purine nucleotide salvage pathway (reserve) enzyme”. It is unclear what the term “(reserve)” means in the context of the claim and whether the term in parentheses is a required part of the invention. For purposes of compact prosecution, the limitation is being interpreted to read “cell purine nucleotide salvage pathway enzyme”.
Claim 21 also recites the phrases “in particular”, “especially”, and “preferably”. This renders the claim indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. MPEP 2173.05(d). For purposes of compact prosecution, the language that comes after “preferably” is being interpreted as optional.
Claim 21 also recites a list of elements (a) through (d) without the use of a conjunction such as “and” or “or”. This renders the scope of the claim indefinite as it is unclear if all the listed elements are required, if only one is required, or if any combination is acceptable.
For purposes of compact prosecution, the instant limitations will be interpreted to read:
“selected from the group consisting of metronidazole … and rifabutin;”
“selected from the group consisting of omeprazole … and pantoprazole;”
“bismuth salt; or”
“an antibiotic, …. ; and any combination thereof.”
Claim 25 recites “the helicobacter pylori (H. pylori) cell purine nucleotide salvage pathway (reserve) enzyme”. It is unclear what the term “(reserve)” means in the context of the claim and whether the term in parentheses is a required part of the invention. For purposes of compact prosecution, the limitation is being interpreted to read “the helicobacter pylori (H. pylori) cell purine nucleotide salvage pathway enzyme”.
Claim 25 also recites the phrases “preferably”. This renders the claim indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. MPEP 2173.05(d). For purposes of compact prosecution, the language that comes after “preferably” is being interpreted as optional.
Claim 27 recites the phrase “in particular”. This renders the claim indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. MPEP 2173.05(d). For purposes of compact prosecution, the language that comes after “in particular” is being interpreted as optional.
Claim 28 recites the phrases “in particular” and “preferably”. This renders the claim indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. MPEP 2173.05(d). For purposes of compact prosecution, the language that comes after said phrases is being interpreted as optional.
Claims 29 and 30 recites the phrase “in particular”. This renders the claim indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. MPEP 2173.05(d). For purposes of compact prosecution, the language that is modified by “in particular” is being interpreted as optional.
Examiner's Comments
The examiner has cited particular columns and line numbers, paragraphs, or figures in the references as applied to the claims for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant, in preparing the responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 and 16 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Schramm et al. (WO 2014/025842 A1, published 2/13/2014, cited on the 10/14/2024 IDS).
Regarding claims 1-5, Schramm teaches methods of treating infections due to Helicobacter pylori (H. pylori) comprising administering inhibitors of MTAN (5'-methylthioadenosine nucleosidase) to the subject [Abstract; claim 18]. Schramm teaches that one such inhibitor is butyl-thio-DADMe-Immucillin A (BuT-DADMe-ImmA) [pg. 45 Table 1; claim 18], which has the following structure (see also pg. 46 Table 2; Figure 1C):
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BuT-DADMe-ImmA is a substituted 9-deazapurine according to Formula II of the instant application. (See also claims 1 and 2, wherein V = CH2; W = NR; X = CH2; Z = SQ, wherein Q = C4 alkyl; and G = CH2; and claims 16 and 20.) Even though Schramm characterizes BuT-DADMe-ImmA as a MTAN inhibitor, “[p]roducts of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Thus, BuT-DADMe-ImmA reads on an inhibitor of purine nucleoside phosphorylase (PNP).
Regarding claim 16, Schramm teaches the administration of BuT-DADMe-ImmA to a subject with gastric ulcer and duodenal ulcer [claim 27].
Claims 1-2, 12-14, 26, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pozueta Romero et al. (WO 2014/102432, published 7/3/2014).
Regarding claims 1-2, 12-14, 26, and 28, Pozueta Romera teaches the use of a compound for prevention and treatment of bacterial infection in humans [claims 3-4], wherein the compound is pyridoxal phosphate (PLP) [claims 1-2] and the bacteria is helicobacter pylori [claim 6]. The compound may be formulated as a pharmaceutical composition that further comprises a pharmaceutically acceptable adjuvant and/or vehicle (reads on excipient) [claim 7]. Pozueta teaches that PLP is a regulator that increases the activity of ADPG-pyrophosphorylase through the stimulation of GlgC, GlgA, and GlgS [see, e.g. 0010; 0027]. However, “[p]roducts of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Thus, PLP meets the limitation of an inhibitor of adenylosuccinate synthetase (Adss) despite not being explicitly characterized as such an inhibitor by Pozueta Romero.
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.
Claims 1-5, 16-17, 21, 26-27, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Schramm et al. (WO 2014/025842 A1, published 2/13/2014, cited on the 10/14/2024 IDS).
Regarding claims 1-5, Schramm teaches methods of treating infections due to Helicobacter pylori (H. pylori) comprising administering inhibitors of MTAN (5'-methylthioadenosine nucleosidase) to the subject [Abstract; claim 18]. Schramm teaches that one such inhibitor is butyl-thio-DADMe-Immucillin A (BuT-DADMe-ImmA) [pg. 45 Table 1; claim 18]. BuT-DADMe-ImmA is a substituted 9-deazapurine according to Formula II of the instant application. (See also claims 1 and 2, wherein V = CH2; W = NR; X = CH2; Z = SQ, wherein Q = C4 alkyl; and G = CH2; and claims 16 and 20.) Even though Schramm characterizes BuT-DADMe-ImmA as a MTAN inhibitor, “[p]roducts of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Thus, BuT-DADMe-ImmA reads on an inhibitor of purine nucleoside phosphorylase (PNP).
Regarding claim 16, Schramm teaches the administration of BuT-DADMe-ImmA to a subject with gastric ulcer and duodenal ulcer [claim 27].
Regarding claim 17, Schramm teaches that antibiotic resistance is an increasingly prevalent problem in treatment of H. pylori infection [0005]. Schramm further teaches that compounds such as BuT-DADMe-ImmA indicate a narrow spectrum antibiotic that may address current issues of antibiotic resistance [0093]. Schramm demonstrated that BuT-DADMe-ImmA was more effective at inhibiting H. pylori growth than an equivalent amount of amoxicillin, and equivalent amounts of metronidazole or tetracycline gave no growth inhibition (reads on antibiotic-resistant strain) [0089]. Thus, it would be obvious to a skilled artisan, before the effective filing date of the claimed invention, to treat infections of antibiotic-resistant H. pylori with BuT-DADMe-ImmA due to its increased effectiveness compared to commonly used antibiotics [0089].
Regarding claim 21, Schramm teaches that amoxicillin is effective in inhibiting H. pylori growth [0089]. "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 (CCPA 1980). Thus, it would be obvious to administer BuT-DADMe-ImmA in combination with amoxicillin since both compounds are known in the art to be useful for treating H. pylori.
Regarding claims 26 and 27, Schramm teaches that BuT-DADMe-ImmA may be formulated as a pharmaceutical composition comprising a pharmaceutically acceptable carrier (reads on excipient) [0036; claim 31], such as phosphate buffered saline, water, and oil/water emulsions [0036].
Regarding claims 29 and 30, Schramm makes obvious the combined administration of BuT-DADMe-ImmA and amoxicillin (reads on antibiotic) (discussed above in the rejection of claim 21). Schramm further teaches that a pharmaceutical composition comprising a pharmaceutically acceptable carrier/excipient (discussed above in the rejection of claims 26 and 27). It would be obvious to formulate the pharmaceutical composition of Schramm further comprising an excipient with amoxicillin as taught by Schramm, for the administration to a subject for treating H. pylori infection, as combining equivalents known for the same purpose is prima facie obvious.
Claim 15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Schramm et al. (WO 2014/025842 A1, published 2/13/2014, cited on the 10/14/2024 IDS), in view of Pozueta Romero et al. (WO 2014/102432, published 7/3/2014).
Regarding claim 15, Schramm does not explicitly teach the instantly claimed method wherein a PNP inhibitor and an AdSS inhibitor are both administered. As discussed, Schramm teaches the administration of BuT-DADMe-ImmA (reads on PNP inhibitor) [claim 18], and Pozueta Romero teaches the administration of pyridoxal phosphate (PLP) (reads on AdSS inhibitor) [claims 1-7]. Both references teach the administration of these compounds for the purpose of treating H. pylori infection. It is prima facie obvious to combine equivalents known for the same purpose. MPEP 2144.06.
Regarding claim 19, Schramm makes obvious the administration of BuT-DADMe-ImmA to an antibiotic-resistant strain of H. pylori (see rejection of claim 17), but does not explicitly teach the claimed method wherein the inhibitor is either a PNP inhibitor comprising quinine or mefloquine or an AdSS inhibitor comprising PLP. Pozueta Romero teaches the administration of PLP [claims 1-7]. Both references teach the administration of these compounds for the purpose of treating H. pylori infection. It is prima facie obvious to combine equivalents known for the same purpose. MPEP 2144.06. Thus, it would be obvious to modify the teachings of Schramm with that of Pozueta to administer a composition comprising BuT-DADMe-ImmA and PLP to treat an antibiotic-resistant strain of H. pylori.
Claims 21, 25, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Schramm et al. (WO 2014/025842 A1, published 2/13/2014, cited on the 10/14/2024 IDS), further in view of Dore et al. (2016).
Regarding claims 21 and 25, Schramm does not explicitly teach administering an inhibitor of an H. pylori cell purine nucleotide salvage pathway enzyme in combination with an antibiotic, proton pump inhibitor, or bismuth salt. Dore teaches that the addition of bismuth to a triple therapy comprising a proton-pump inhibitor (PPI), amoxicillin, and a third drug such as clarithromycin, metronidazole, fluoroquinolone or rifabutin improves treatment outcomes of H. pylori infection in antibiotic resistant infections [Abstract; Introduction]. "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 (CCPA 1980). Thus, it would be prima facie obvious to administer BuT-DADMe-ImmA, as taught by Schramm, in combination with the triple therapy plus bismuth, as taught by Dore, because are known in the art to be useful for treating H. pylori, particularly antibiotic-resistant strains.
Regarding claim 31, claim 31 depends from claim 30 which has been made obvious by Schramm in a previous rejection, and recites the additional limitation of a proton pump inhibitor and/or a bismuth salt. Dore teaches that the addition of bismuth to a triple therapy comprising a proton-pump inhibitor (PPI), amoxicillin, and a third drug such as clarithromycin, metronidazole, fluoroquinolone or rifabutin improves treatment outcomes of H. pylori infection in antibiotic resistant infections [Abstract; Introduction]. Dore further teaches that commonly used bismuth preparations include bismuth citrate, bismuth subsalicylate, and bismuth nitrate (reads on bismuth salt) [pg. 874]. It is prima facie obvious to combine equivalents known in the art to be useful for the same purpose. MPEP 2144.06.
Conclusion
No claims are allowed.
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/AMANDA LYNN CHI/ Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
