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 Claims
Claims 1-16 are pending in the instant application.
Domestic Benefit
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C> 119€ or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more of the conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C> 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting Inc., 38, F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/705,475, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C> 112, first paragraph for one or more claims of this application.
Regarding Claims 1-16, insufficient support is provided in the prior-filed provisional application ‘475, as no working example demonstrating the efficacy of the disclosed compositions in protecting against or treating a pathogenic infection. No data are provided which would be found to enable the protection against or treatment of a pathogenic infection as broadly as is claimed.
U.S. Patent Application No. 18/003,706 is a national stage entry of PCT/US2021/039722, filed June 29th, 2021.
Information Disclosure Statement
Applicant has submitted no Information Disclosure Statement (IDS) with this application. Applicant is reminded per 37 CFR 1.56, “Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability …”
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which Applicant may become aware of in the specification.
Claim Rejections - 35 USC § 112
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 1-16 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 claims contain 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.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the invention:
The invention is drawn to a method for protecting against, or treating a subject with, a pathogenic infection.
Breadth of the invention:
The scope of the claimed invention is very broad, as it is drawn to the protection against or treatment of any pathogenic infection, which could include any pathogenic infection known today or protection against or treatment of pathogenic infections that are not yet known, but discovered at a future date.
State of the prior art and predictability in the art:
The administration of cellular energy inhibitors as broadly claimed for the protection against or treatment of pathogenic infections is speculative as disclosed in the instant specification. At Page 6, Lines 27-30 of the instant specification cellular energy inhibitor is defined as a drug that inhibits, reduces, or stops ATP production in a cell. With respect to inhibiting the production of ATP in a cell as a mechanism by which to treat bacterial infection, Mackieh et. al. (“Inhibitors of ATP Synthase as New Antibacterial Canddiates,” Antibiotics, 12, 650, 2023) represents the state of the art. As Mackieh was published after the effective filing date of the instant application, its representation of the speculative nature underscoring the lack of predictability in administering a cellular energy inhibitor for the protection against or treatment of pathogenic infections as broadly claimed would have been true at the time of filing.
At Page 1, under Introduction, Mackieh teaches ATP synthase is the last enzyme in the pathway that triggers ATP synthesis, and that bacterial ATP synthases have a simpler subunit structure than their mitochondrial counterparts.
At Page 4, under Therapeutical Applications, Mackieh teaches ATP synthase has emergered as a prospective therapeutic target to treat infections by resistant bacteria.
At Page 4, under Resveratrol, Mackieh teaches administration of resveratrol, a polyphenolic ATP synthase inhibitor improves the effectiveness of aminoglycosides against Staphylococcus aureus.
At Page 4, under Piceatannol, Mackieh teaches both resveratrol and piceatannol, a polyphenolic inhibitor of ATP synthase, inhibited both ATP synthase activity and ATP synthesis, and that administration of piceatannol in combination with other inhibitors established an inhibitory effect on Streptococcus mutans.
At Page 5, under Bedaquiline, Mackieh teaches Bedaquiline is an ATP synthase inhibitor against multidrug-resistant tuberculosis, but had only limited or no direct antibacterial effect against other pathogenic bacteria such as Gram-positive nocardia, Corynebacterium, and others.
At Page 6, under Tomatidine, Mackieh teaches tomatidine is an inhibitor of ATP synthase exhibiting bacteriostatic activity toward S. aureus small colony variants, and Mackieh speculates that tomatidine “may eventually be used in combination therapy with other conventional antibiotics to get rid of S. aureus strains that are tenacious”.
At Page 6, under Oligomycin A, Mackieh teaches “oligomycin A is non-selective and blocks ATP synthase in mitochondria, which limits its clinical use.”
Beginning at Page 8, Mackieh summarizes the activity of a variety of ATP Synthase Inhibitors and the bacteria in which they have shown inhibitory activity.
At Page 11, under Conclusions, Mackieh teaches “with an ever rising need for novel antibiotics due to the phenomenon of antibiotic resistance, serious research into creative workarounds for this problem is highly encouraged, and as this review has made clear, one of the promising therapies is the ATP synthase inhibitors. Many ATP synthase inhibitors have shown a prominent and selective effect against certain bacterial species. Their use offers an unprecedented efficacy and selectivity,” and “Emphasis should be placed on counteracting the lack of specificity of certain inhibitors such as oligomycin A and venturicidin A … to obtain sufficient efficacy, “and further, “The rational design of novel, selective inhibitors of bacterial ATP synthases may someday benefit from improved understanding of the activity of this important enzyme across species.”
With respect to the administration of 3-bromopyruvate, a compound of formula I, as recited at instant Claim 2, in treating the pathogenic infection tuberculosis, Kratky et. al. (“Advances in Mycobacterial Isocitrate Lysase Targeting and Inhibitors”, Current Medicinal Chemistry, 19, 36, 2012; hereinafter referred to as Kratky) represents the state of the prior art.
At Page 6135, Second Paragraph under Conclusions, Kratky teaches 3-bromopyruvate cannot be used in the treatment of tuberculosis infection due to high biotoxicity and no specific effect.
Taken together, Kratky teaches 3-bromopyruvate, a cellular energy inhibitor is not suitable for the treatment of a specific pathogen due to high biotoxicity and lack of specificity. Mackieh establishes, as taught with the example of oligomycin A, that inhibition of ATP synthesis is not viable due to lack of specificity. Mackieh speculates that inhibition of ATP synthesis is a viable route for treatment of specific pathogenic infections if the lack of specificity is counteracted.
Together, this demonstrates the lack of predictability in the efficacy of the administration of cellular energy inhibitors as broadly claimed for treating any pathogenic infection. The administration of cellular energy inhibitors for the treatment of pathogenic infections is known in the art to be predictable for the treatment of specific pathogens. Nothing in the prior art, however, suggests that the inhibition of ATP synthesis is predictable for the protection against or treatment of any pathogenic infection.
Level of ordinary skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems.
The amount of direction provided and working examples:
No examples have been provided that demonstrate the efficacy of any of the disclosed compositions in protecting against or treating a pathogenic infection.
With respect to compounds of formula I, Applicant provides the following formula:
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In the examples beginning at Page 29 of the instant specification, Applicant states the cellular energy inhibitor of formula I can be a 3-halopyruvate selected from 3-fluoropyruvate, 3-chloropyruvate, 3-bromopyruvate, and 3-iodopyruvate. No examples are provided in which a compound of formula I is disclosed where X is not halogen and R is not OH.
Further, beginning at Page 29, Applicant discloses a variety of examples of compositions that could be formulated consistent with the limitations recited at instant Claim 1. No example is provided in which Applicant demonstrates a composition has actually been made, much less employed in an efficacious manner for the protection against or treatment of a pathogenic infection.
Applicant provides speculation on a pathway by which the proposed compositions could treat a pathogenic infection, for example at Page 11 of the instant specification, under “Primary Infections” or at Page 12 of the instant specification, under “Secondary Infections”. Sufficient disclosure has not been provided, however, that would allow a person having ordinary skill in the art to readily understand for which pathogenic infections a composition according to the instantly recited limitations would be useful for the protection against or treatment thereof.
Quantity of experimentation needed to use the invention based on the content of the disclosure:
The quantity of experimentation needed is undue experimentation. As referenced above, a person having ordinary skill in the art would not readily understand for which pathogenic infections administration according to the instantly claimed method would be efficacious in protecting against or treating. Therefore, a person having ordinary skill in the art would need not only to identify and/or develop metrics to determine the efficacy of the instantly claimed method of protection against or treatment of a pathogenic infection, but then to employ these methods with no assurance of success in protecting against or treating the pathogenic infection.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation.
Genentech Inc. v Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person having ordinary skill in the art would have to engage in undue experimentation to determine the efficacy of the instantly claimed method of protecting against or treating a pathogenic infection, with no assurance of success.
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.
Claim 16 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.
Claim 16 recites the limitation " the hexokinase inhibitor" in the first line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Conclusion
Claims 1-16 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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/D.J.B./ Examiner, Art Unit 1624
/JEFFREY H MURRAY/ Supervisory Patent Examiner, Art Unit 1624