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
Applicant’s election of Group 1, claims 1, 3, 6, 8-9, 13-15, and 17-19 in the reply filed on 8/11/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 22, 24-26, 28-29, 39, and 41-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/11/25.
Priority
Application claims priority to 62/002,611 provisional application with an effective filing date of 3/31/20. Claims of the instant application are supported by the provisional application and thus have a priority date of 3/31/20.
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, 3, 6, 8-9, 13-15, and 17 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 the specific bacterial species recited in claims 18 and 19 does not reasonably provide enablement for the administration of any agent that increases the amount of bacteria which are capable of breaking down smoke to any subject. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to carry out the invention commensurate in scope with these claims.
Whether a disclosure satisfies the enablement requirement is assessed with respect to the factors set forth in In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988); MPEP 2164.01 (a). These factors include: breadth of the claims, nature of the invention, state of the prior art, level of one of ordinary skill, level of predictability in the art, amount of direction provided by the inventor, existence of working examples and quantity of experimentation needed to make or use the invention.
All of the Wands factors have been considered with respect to the instant claims, and the most relevant factors are discussed in detail below.
Breadth of the claims/Nature of the invention
The elected species of the invention currently under examination is directed any agent capable of increasing bacteria in any subject to treat or prevent a disease associated with smoke residue. The phrasing of the claim indicates that the bacteria capable of breaking down smoke could be found in the subject. Thus, carrying out the invention requires a identifying a vast number prebiotics, antibiotics, other bacterial species and any subject capable of harboring bacteria.
State of the prior art/Level of predictability
The prior art indicates that 700 species of bacteria are in the mouth (p1) (Mouth microbes, retrieved from https://newsinhealth.nih.gov/2019/05/mouth-microbes). The prior art indicates that there numerous classes of prebiotics with different structures and functions (whole document) (Bamigbade, Gafar Babatunde, et al. "An updated review on prebiotics: insights on potentials of food seeds waste as source of potential prebiotics." Molecules 27.18 (2022): 5947). The prior art indicates that there are 100s of different antibiotics (whole document) (https://www.nhs.uk/medicines/antibiotics/#:~:text=There%20are%20hundreds%20of%20different,be%20classified%20into%206%20groups.&text=Other%20antibiotics%20include%20chloramphenicol%20(used,used%20for%20urinary%20tract%20infections). One of ordinary skill in the arts understands that every living creature harbors bacteria. As evidenced by CDC, smoking harms nearly every organ in the body.
Amount of direction provided/Existence of working examples
The instant specification discloses only the four bacteria recited in claims 18 and 19. Instant specification has not shown any evidence in even one organ tissue that could be benefited by the increase in bacteria capable of breaking down smoke. The specification does not provide any additional agents, subjects or prebiotics that could impact the level of bacteria, nor any structure-function relationship or other guidance that would allow one skilled in the art to determine such information.
Quantity of experimentation needed to make or use the invention
The claimed invention requires extremely wide genus of agents, subjects, and bacteria. As such, one of ordinary skill in the art would be required to undertake undue experimentation to carry out the claimed method. Further, each organ has different cellular compositions and therefore will respond differently both to the smoke producing bacteria and the smoke.
Claims1, 3, 6, 8-9, 13-15, and 17 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1, 3, 6, 8-9, 13-15, and 17, the claims require any agent that increases the amount of bacteria which are capable of breaking down smoke to any subject. As discussed above, this could entail 100s of antibiotics, entire classes of prebiotics with different structures and functions, and any living organisms that harbors bacteria. Applicants have only reduced the 4 bacterial species found in claims 18 and 19 to practice and therefore are not in possession of the broad genus of any agent or any subject as no structure-function relationship is provided for in the specification.
Regarding claim 14, the claim requires the genetic modification of a bacteria to express a protein that increases the degradation of smoke. No such proteins are identified in the specification, no guidance on how to identify such proteins, or structure function relationship is provided in the specification. MPEP 2163.II.A.3.(a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention”.
For claims drawn to a genus, MPEP § 2163 states the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. The claims are lacking written description support as specification does not provide any of the correlations required by MPEP 2163.
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.
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, 3, 6, 13-14, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Atherton (Engineering the Human Lung Microbiome to Degrade Inhaled Carcinogens, as cited in applicants IDS).
Regarding claim 1, Atherton teaches administering a probiotic E. coli (agent increasing amount of bacteria) capable of degrading benzine into the lungs (abstract). As evidenced by instant specification [0142], benzine is found in smoke. Atherton teaches benzine is cariogenic (treating or preventing a disease associated with smoke residue). Atherton expects their invention to be used in firefighters to prevent repercussions from the inhaled toxins (administered to a subject to prevent smoke residue related disease) (“conclusion”).
Atherton does not explicitly teach the administration of the bacteria to a subject.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the bacteria to a subject as suggested by Atherton. One of ordinary skill in the art would be motivated to do so because Atherton teaches the invention should be administered to subjects, e.g. firefighters. There would be a reasonable expectation of success as Atherton states that their invention is intended to be administered to subjects, and shows that the probiotic E. coli can be successfully preserved and delivered to the lungs via a nebulizer (Atherton, p. 10, last para. To p. 11, last para.).
Regarding claim 3, Atherton teaches the bacteria can be delivered to the lungs (respiratory system) (abstract).
Regarding claim 6, Atherton teaches benzine is found in forest fire smoke and cigarette (tobacco) smoke (p2-4 “introduction”).
Regarding claims 13-14 and 17-19, Atherton teaches the E. coli is genetically engineered (abstract).
Claims 1, 3, 6, 8-9, 13-15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Szibor (WO2014096437A1) and Thisted ("Optimization of a nicotine degrading enzyme for potential use in treatment of nicotine addiction." BMC biotechnology 19.1 (2019): 56)
Regarding claims 1, 3, 13-14 Szibor teaches an oxidase that prevents smoking associated lung damage (respiratory system) (title). Szibor teaches their method prevents or treats diseases or conditions caused by inhalation of smoke (abstract). Szibor teaches their method relates to a non-toxic host cell carrying a vector expressing the oxidase (agent increasing the amount of bacteria) comprising the oxidase (abstract).
Szibor does not explicitly teach the bacteria breaking down the smoke residue.
Thisted teaches an enzyme for degrading nicotine for treating nicotine addiction (title). Thisted teaches that nicotine is found in the blood (smoke residue) (p2 background). Thisted teaches that NicA2 was optimized for its nicotine degrading activity (abstract). Thisted teaches that their invention can be incorporated into other therapies for treating cravings and withdrawals (p9 left column).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a NicA2 protein taught by Thisted in the bacteria of Sziebor. One of ordinary skill in the art would be motivated to do so because Thisted teaches that their invention can be incorporated into other therapies. One of ordinary skill in the art would be motivated to do so because these enzymes have been successfully used to degrade nicotine, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. There would be a reasonable expectation of success as both Sziebor and Thisted are in the same field of endeavor of treating diseases from smoking.
Regarding claim 6, Szibor teaches the smoke can be from cigarettes (tobacco smoke) (p5 lines 1-9).
Regarding claim 8, Thisted teaches that the enzyme was tested against mice dosed with nicotine levels equivalent to >30 cigarettes a day (“Pilot chronic toxicology testing indicates that NicA2 in the presence of nicotine is well-tolerated” section)
Regarding claim 9, Szibor teaches the disease to be prevented is cancer (subject is not diagnosed with cancer as the cancer is being prevented) (claim 6).
Regarding claim 15, Szibor teaches the host cell can naturally express the oxidase (p22 lines 20-22). Thisted teaches the NicA2 enzyme naturally occurs in bacteria (“background” section).
Regarding claims 17-19, Sizbor teaches that the host can be E. coli (p22 lines 23-25).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR KANE/ Examiner, Art Unit 1657
/ROBERT J YAMASAKI/ Primary Examiner, Art Unit 1657