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 I, claims 40-50 in the reply filed on 11/18/25 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)).
Applicant’s election of the species of complement C3 agonist in claim 48 in the reply filed on 11/18/25 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Claims 51-58 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.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 11/18/25.
Priority
Application claims priority to 62/084,204 provisional application with an effective filing date of 9/28/20. Claims of the instant application are supported by the provisional application and thus have a priority date of 9/28/20.
Information Disclosure Statement
The IDS filed on 4/23/24 has been fully considered except where references have been lined through.
Drawings
The drawings are objected to because the figures are not properly labeled.
37 CFR 1.84 (u)(1) states “The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear.”
In the instant case, the view numbers for Figures are preceded by the word "Figure" instead of the abbreviation "FIG.".
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The use of the term MiSeq (PGPUB [0153]), AdipoGen ([0167]), pGEM ([0172]), FACSCelesta ([0181]). FloJo ([0181]), and GraphPad ([0182]) which is a trade name or a mark used in commerce, has been noted in this application. The above list may not be exhaustive. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 40-50 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 claim 40, the claim requires a “modified AIEC”. As evidenced by Nash ("Genome sequence of adherent-invasive Escherichia coli and comparative genomic analysis with other E. coli pathotypes." BMC genomics 11.1 (2010): 667), the AIEC genome is 4.7 mb and comprises 4431 genes. Instant specification only provides support for the mutation of a wzy gene. This is insufficient to claim the broad genus of a “modified AIEC” as there are 4430 other genes that could be modified in various ways including truncation, deletion, duplication, SNPs, and other ways. Applicant has not provided any information on what genes or methods of modifications are able to result in a AIEC capable of preventing, treating or ameliorating intestinal inflammation, and therefore no structure-function relationship has been disclosed by applicant and applicant is not in possession of the entire claimed genus.
Regarding claim 42-43, the claims requires a “greater sensitivity to the complement system” and “greater susceptibility to engulfment and/or killing by phagocytes”. While applicant has support for a wzy mutant with these properties, there is no other reference in the specification as to what other of the 4431 genes could impact the claimed phenotype. No additional structure function relationship to genes outside the wzy mutants capable of exhibiting the claimed phenotype were disclosed and therefore applicant is not in possession of the claimed genus.
Claim 40-50 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 a method of treating or ameliorating intestinal inflammation does not reasonably provide enablement for preventing intestinal inflammation. 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.
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 a method of preventing intestinal inflammation. The claim is extremely broad as the claimed prevention via administration of AIEC can be performed on any cause of intestinal inflammation.
State of the prior art/Level of predictability
Per the CDC, causes of inflammatory bowel disease are not well known and complicated, but several factors including, lifestyle, genetics, drug use, infections, gut bacteria, and over 200 genetic markers are linked to IBD (p2).
Amount of direction provided/Existence of working examples
The instant specification discloses only treatment of induced colitis in mice, not the prevention of the inflammatory bowel disease via administration of the AIEC. The specification does not provide any additional information, 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 knowledge of dosing levels of AIEC to prevent inflammatory diseases, how long the administration needs to be conducted, how the many different causes of inflammation respond to the treatment with AIEC, and the quantity of AIEC needed to treat each of the disparate causes of inflammation. Such information is not available in the prior art, as such, one of ordinary skill in the art would be required to undertake undue experimentation to carry out the claimed method
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 42-43 and 49 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.
Regarding claims 42 and 43, both claims refer to “said mutant AIEC” in reference to claim 41. Claim 41 contains three instances of a mutant AIEC. Therefore, it is unclear which of the three mutant AIECs claims 42 and 43 are referring to.
Regarding claim 49, the claim requires a “normal microbiota”. No explicit definition is provided for this term in the specification. As evidenced by Shanahan, ("The healthy microbiome—what is the definition of a healthy gut microbiome?." Gastroenterology 160.2 (2021): 483-494) there is no specific definition for what constitutes a healthy/normal microbiome as there are far too many variables and therefore the metes and bounds of the claim are unclear (whole document, especially “whats in a word” section).
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 40-46 and 49-50 are rejected under 35 U.S.C. 103 as being unpatentable over Gibson (US20200069747A1) and Dreux (of record in applicants IDS).
Regarding claim 40-41, Gibson teaches probiotics that reduce inflammation and increase colonization/persistence in the digestive tract (intestinal inflammation in a subject) (abstract). Gibson teaches that the probiotic can be E. coli ([0057]). Gibson teaches the probiotic is recombinant (modified) ([0009]). Gibson teaches that the probiotic is coupled with a pharmaceutically acceptable carrier ([0219]). Gibson teaches the probiotic should be administered in an effective quantity ([0221]).
Gibson does not explicitly teach the use of mutant AIEC
Dreux teaches point mutations in AIEC (title) Dreux teaches the findings can be useful for therapeutics for Crohn’s disease (abstract). Dreux constructs a variety of AIEC mutants (modified) (fig 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the modified AIEC of Dreux in the probiotic treatment of Gibson. One of ordinary skill in the art would be motivated to do so because Dreux teaches their findings can be used for therapeutics. There would be a reasonable expectation of success as both Gibson and Dreux are in the same field of endeavor of treating Crohn’s disease.
Regarding claims 42-43, while these claimed phenotypes are not measured by Dreux or Gibson, “Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable”. See MPEP 2112. Further, as discussed above this phenotype is only supported in the specification via the wzy mutants but no other structure function relationship is disclosed and therefore it can be inferred that the mutant of Dreux exhibits the same phenotypes.
Regarding claim 44, Gibson teaches that the illness treated can include colitis, and Crohn’s ([0188]).
Regarding claim 45, Gibson teaches the probiotic can be administered orally ([0220]).
Regarding claim 46, Gibson teaches Crohn’s disease can be treated ([0188]). As evidenced by Marks, Crohn’s is an immunodeficiency disease (immunocompromised) (abstract).
Regarding claim 49-50, Dreux teaches that AIEC are found more often in patents with Crohn’s disease than samples without Crohn’s disease (introduction).
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Gibson (US20200069747A1) and Dreux (of record in applicants IDS), as applied to claims 40-46 and 49-50 above, and further in view of Prantera “An antibiotic regimen for the treatment of active Crohn's disease: a randomized, controlled clinical trial of metronidazole plus ciprofloxacin." The American journal of gastroenterology 91.2 (1996): 328-332.
Regarding claim 47, Gibson and Dreux do not explicitly teach administration of an antibiotic.
Pranteria studies antibiotics and Crohn’s disease (title). Prantera teaches antibiotic can be effective in treating Crohn’s disease (“conclusions”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Gibson and Dreux above by adding an antibioticas taught by Pranteria. One of ordinary skill in the art would be motivated to do so because Pranteria teaches that Crohn’s can be treated with antibiotics. Further, would be motivated to do so because these antibiotics have been successfully used to treat Crohn’s 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 Gibson, Dreux and Pranteria are in the same field of endeavor of Crohn’s disease
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Gibson (US20200069747A1) and Dreux (of record in applicants IDS), as applied to claims 40-46 and 49-50 above, and further in view of Nielsen ("Complement activation in plasma before and after infliximab treatment in Crohn disease." Scandinavian journal of gastroenterology 38.10 (2003): 1050-1054).
Regarding claim 48, Gibson and Dreux do not explicitly teach administration of a complement C3 agonist.
Nielsen teaches complement activation in plasma before and after infliximab treatment in Crohn disease (title). Nielsen teaches C3 activation is decreased after infliximab treatment (abstract). Nielsen teaches that symptoms are improved upon treatment (results and table 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Gibson and Dreux above by adding a complement C3 agonist as taught by Nielsen. One of ordinary skill in the art would be motivated to do so because Nielsen teaches that symptoms of Crohn are improved. Further, would be motivated to do so because these agonists have been successfully used to treat Crohn’s 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 Gibson, Dreux and Nielsen are in the same field of endeavor of Crohn’s disease.
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, Louise Humphrey can be reached at 571-272-5543. 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