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 .
Election/Restrictions
Acknowledgement is made to Applicant’s response filed 06/01/2026.
Claims 1-17 are pending.
Claims 7-15 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/01/2026.
Claims 1-6 and 16-17 are currently under consideration to the extent that they read upon Applicant’s elected species.
NOTE: Applicant elected –
compound that alters iron homeostasis: Applicant elects an iron chelator
iron chelator: Applicant elects deferoxamine (DFO)
iron supplement: Applicant elects ferric ammonium citrate (FAC)
Bacterium: Applicant elects E. coli.
Upon further search and examination the species election over iron chelator is broadened to include quercetin, curcumin, epigallocatechin gallate, phytic acid, deferasirox, deferiprone, and desferrithiocin. The iron supplement is broadened to include ferrous sulfate, ferrous bisglycinate, ferrous gluconate, ferrous citrate, ferric sulfate, iron dextran, iron sucrose, ferric gluconate. As well as the bacterium is broadened to include P. aeruginosa, Streptococcus pyogenes, and Klebsiella pneumoniae.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/07/2024 are being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
Claim Objections
Claim 5 is objected to because of the following informalities: line 2 is missing a comma after aeruginosa. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claim 17 is 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.
The term “specific level” in claim 17 is a relative term which renders the claim indefinite. The term “specific level” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. This renders the claim indefinite as to what “level” satisfies the limitation the synergistic effect takes place.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6 and 16-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions (i.e., product of nature, a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The claims recite a composition comprising a composition containing 3-hydroxyanthanilic acid (3HAA) and an iron chelator, which is a natural phenomenon or law of nature.
Every claimed invention must be examined to determine whether the claimed invention complies with 35 U.S.C. 101, particularly whether the claimed invention falls within a 35 U.S.C. 101 judicial exception of non-patentable subject matter (e.g. an abstract idea, law of nature, natural phenomenon, natural product etc.). Phenomena of nature, though just discovered, natural products, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work. See MPEP 2106. In accordance with the 2019 Revised Patent Subject Mater Eligibility Guidance (aka 2019 PEG), the following revised flowchart found in MPEP §2106(III), is used when considering whether or not a claimed invention recites eligible subject matter:
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The invention recited in claims 1 is drawn to a composition of matter, in this case, a composition comprising a composition containing 3-hydroxyanthanilic acid (3HAA) and an iron chelator. Step 1 is satisfied.
Step 2 has now been broken out into a two-prong analysis:
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Step 2A first asks whether or not the claimed invention is directed to a judicial exception such as a natural phenomenon (e.g., product of nature). Here, the answer is yes, since the only compositional requirements which are set forth are that the composition comprises 3-hydroxyanthanilic acid (3HAA) (is a natural product per instant claim 16) and an iron chelator (naturally occurring quercetin, curcumin, epigallocatechin gallate).
The second leg of the analysis evaluates whether the claim recites additional elements that integrate the established judicial exception into a practical application of the exception. Based on the recitations provided in claims 1-6 and 16-17, the answer is no. At most, the claims recite a composition which comprises 3-hydroxyanthanilic acid (3HAA) and an iron chelator and nothing which else which would be considered an “element.” The applications recited in claim 5 are directed to intended uses of the recited composition.
Lastly, Step 2B asks if the claim recites additional elements that amount to “significantly more” than the judicial exception. Asked another way, do the claims recite anything additional demonstrating that the recited composition provides an inventive concept? Here, again, the answer is no because the claims simply do not recite anything else, compositionally or structurally, which provides an inventive concept. The claims recite a composition which is composed of 3-hydroxyanthanilic acid (3HAA) and an iron chelator. As this is considered to be a product of nature with no additional elements recited, the Examiner concludes that claims 1-6 and 16-17 fail to recite subject matter which is patent eligible.
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.
Claim(s) 1-5 and 16-17 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by YOSHIDA et al (JP 2009107970).
YOSHIDA discloses an agent for enhancing the expression of an iron metabolism-related gene of macrophage comprises a compound having an NF-E2-related factor 2 (hereinafter referred to as “Nrf2”) activation action as an active ingredient (see entire document, for instance, abstract). YOSHIDA teaches that reducing oxidative stress is useful for preventing or delaying progression of various chronic diseases (arteriosclerosis, diabetes, cranial nerve degenerative diseases, skin diseases, eye diseases, asthma, etc.) (page 6). YOSHIDA discloses Nrf2 activator enhances the expression of iron metabolism-related genes in macrophages (page 7). In addition, based on the nature of the Nrf2 activator, the present inventors have a potential to promote the cooperative increase from the degradation of aging erythrocytes to the elimination of iron and the suppression of the growth of pathogenic microorganisms (page 7). YOSHIDA teaches compounds having Nrf2 activation action include 3-hydroxyanthranilic acid, curcumin (an iron chelator per instant specification), quercetin (an iron chelator per instant specification) (page 7). YOSHIDA discloses these having an iron release promoter stored in macrophages, containing as an active ingredient the expression enhancer, an agent for suppressing the growth of infectious microorganisms (gram-negative and positive) and viruses that grow in macrophages, comprising the expression enhancer, as well as an inflammatory iron deficiency improving agent comprising the expression enhancer (page 7). YOSHIDA teaches that functional iron deficiency can be improved because the release of iron stored in macrophages can be promoted by enhancing the expression of iron metabolism-related genes (page 8). Therefore, the agent for enhancing the expression of an iron metabolism-related gene of the is effective as an agent (page 8). YOSHIDA discloses the expression enhancer for iron metabolism-related genes of the present invention is effective as an agent for preventing or treating infectious diseases because it has an effect of suppressing the growth of infectious microorganisms and viruses as a result of the enhanced expression of iron metabolism-related genes (page 8). YOSHIDA teaches ferrous sulfate included in its invention (page 9). YOSHIDA teaches the expression enhancer of the present invention is an agent for prevention of infection of pathogenic bacteria, and therapeutic results and prognosis It is considered effective for improvement (page 9).
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.
Claim(s) 1-5 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over YOSHIDA et al (JP 2009107970).
YOSHIDA discloses an agent for enhancing the expression of an iron metabolism-related gene of macrophage comprises a compound having an NF-E2-related factor 2 (hereinafter referred to as “Nrf2”) activation action as an active ingredient (see entire document, for instance, abstract). YOSHIDA teaches that reducing oxidative stress is useful for preventing or delaying progression of various chronic diseases (arteriosclerosis, diabetes, cranial nerve degenerative diseases, skin diseases, eye diseases, asthma, etc.) (page 6). YOSHIDA discloses Nrf2 activator enhances the expression of iron metabolism-related genes in macrophages (page 7). In addition, based on the nature of the Nrf2 activator, the present inventors have a potential to promote the cooperative increase from the degradation of aging erythrocytes to the elimination of iron and the suppression of the growth of pathogenic microorganisms (page 7). YOSHIDA teaches compounds having Nrf2 activation action include 3-hydroxyanthranilic acid, curcumin (an iron chelator per instant specification), quercetin (an iron chelator per instant specification) (page 7). YOSHIDA discloses these having an iron release promoter stored in macrophages, containing as an active ingredient the expression enhancer, an agent for suppressing the growth of infectious microorganisms (gram-negative and positive) and viruses that grow in macrophages, comprising the expression enhancer, as well as an inflammatory iron deficiency improving agent comprising the expression enhancer (page 7). YOSHIDA teaches that functional iron deficiency can be improved because the release of iron stored in macrophages can be promoted by enhancing the expression of iron metabolism-related genes (page 8). Therefore, the agent for enhancing the expression of an iron metabolism-related gene of the is effective as an agent (page 8). YOSHIDA discloses the expression enhancer for iron metabolism-related genes of the present invention is effective as an agent for preventing or treating infectious diseases because it has an effect of suppressing the growth of infectious microorganisms and viruses as a result of the enhanced expression of iron metabolism-related genes (page 8). YOSHIDA teaches ferrous sulfate included in its invention (page 9). YOSHIDA teaches the expression enhancer of the present invention is an agent for prevention of infection of pathogenic bacteria, and therapeutic results and prognosis It is considered effective for improvement (page 9).
It is noted that YOSHIDA et al teaches the instantly claimed components, wherein it is further noted that anticipation is the greatest form of obviousness. Additionally, it would be obvious at the time the invention was filed to rearrange the components of YOSHIDA and obtain additional embodiments of the invention as claimed. A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. Where, as here, the specific combination of features claimed is disclosed within the broad teachings of the reference but the reference does not disclose the specific combination of variables (for example, molar ratio between 3HAA and iron chelator), in a specific embodiment or in a working example, “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
However, "when a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious". KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). "[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious", the relevant question is "whether the improvement is more than the predictable use of prior art elements according to their established functions." (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that "[a] person of ordinary skill is ... a person of ordinary creativity, not an automaton." Id. at 1742.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to rearrange the disclosed elements and embodiments of YOSHIDA et al., to include a molar ratio between 3HAA and iron chelator, to prepare the claimed composition. Such a rearrangement by a person of ordinary skill in the art who is not an automaton to yield the instantly claimed compositions and methods is within the purview of the ordinary skilled artisan upon reading YOSHIDA et al., as cited above, and would yield predictable results.
Claim(s) 1-6 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over YOSHIDA et al (JP 2009107970) as applied to claims 1-5 and 16-17 above, and further in view of SCHOFIELD et al (WO 2009063241 A1; as submitted on IDS of 05/07/2024) and NEWMAN et al (US 20170283763 A1; as submitted on IDS of 05/07/2024).
The teachings of YOSHIDA et al have been set forth above. However, they do not expressly disclose including molar ratio between 3HAA and iron chelator as well as the species of gram-negative and positive organisms. SCHOFIELD discloses treating a subject an infection comprising administering to the subject a therapeutically effective amount of 3 hydroxyanthranilic acid or a pharmaceutically acceptable salt thereof (see entire document, for instance, title). SCHOFIELD teaches 0.1 to 20%, of 3 -hydroxy anthranilic acid or a pharmaceutically acceptable salt thereof and chelating agents (page 5). NEWMAN discloses compounds and compositions that in several embodiments are suitable for reducing antibiotic resistance and/or survivability of bacteria (see entire document, for instance [0006]). NEWMAN teaches the term “chelator” as used herein refers to a molecule capable of binding a metal ion (e.g. iron) by forming multiple bonds to the metal ([0100] - [0101]. Chelators can be biological molecules (siderophores such as deferoxamine, deferiprone, deferasirox or organic chelators such as (tachpyr), and others identifiable to a skilled person) ([0100] - [0101]. NEWMAN discloses the composition comprises an Fe (II) chelator and an Fe (III) chelator ([0120]). NEWMAN teaches the Fe (II) chelator is Ferrozine® and is comprised in the composition in an amount ranging between about 10 and about 1000 μM ([0120]). NEWMAN discloses Fe (III) chelation has been shown to dramatically improve antibiotic effectiveness against the opportunistic pathogen Pseudomonas aeruginosa ([0291]).
Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the composition as described by YOSHIDA with the composition of SCHOFIELD and NEWMAN et al. There would be a reasonable expectation of success because YOSHIDA teaches the presence of gram-negative and positive bacterium in compositions wherein SCHOFIELD and NEWMAN et al teaches that chelation has been shown to dramatically improve antibiotic effectiveness against the opportunistic pathogen such as Pseudomonas aeruginosa.
Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the composition as described by YOSHIDA with the composition of SCHOFIELD and NEWMAN et al. It would be within the purview of the skilled artisan to manipulate amounts of active ingredients within said ranges by routine experimentation, with a reasonable expectation of success. It is noted that MPEP 2144.05 states: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature 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).” In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). In this case, it would be within the purview of the ordinarily skilled artisan to select amounts of each active ingredients from within the disclosed ranges, including amounts instantly claimed, by routine experimentation, with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET JOSEPH whose telephone number is (571)270-1372. The examiner can normally be reached Monday and Thursday 0730-1730 Eastern.
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/JANET JOSEPH/Patent Examiner, Art Unit 1611
/TREVOR LOVE/Primary Examiner, Art Unit 1611
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