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 with traverse of Group I, good prognosis and poor prognosis, Firmucutes and Bacteriodetes, (i) in claim 6, and indoxylsulfate in the reply filed on 11/11/2025 is acknowledged. The traversal is on the ground(s) that a technical feature links the groups. This is not found persuasive for the reasons made of record in the previous office action.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9, 10, and 14 are withdrawn from consideration as being directed to non-elected species or inventions. An action on the merits of claims 1-8, 11-13 and 15 is set forth below.
Duplicate Claim Warning
Applicant is advised that should claim 13 be found allowable, claim 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 1-8, 11-13, and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural correlation/law of nature and an abstract idea without significantly more. This judicial exception is not integrated into a practical application and the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106. The unpatentability of abstract ideas was confirmed by the U.S. Supreme court in Bilski v. Kappos, 561 U.S. 593, 601 (June 28, 2010) and Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014). See also Myriad v Ambry, CAFC 2014-1361, -1366, December 17, 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 71 (2012). “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable. Dia-mond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S. at 601 (2010).
Claims Analysis:
As set forth in MPEP 2106, the claims have been analyzed to determine whether they are directed to one of the four statutory categories (STEP 1).
The instant claims are directed to methods and therefore are directed to one of the four statutory categories of invention.
The claims are then analyzed to determine if they recite a judicial exception (JE) (STEP 2A, prong 1) [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)].
The claimed invention recites a method of assessing whether a subject in need of a complementation of the gastrointestinal tract with live microorganisms would benefit from the complementation by measuring the abundance of bacteria associated with a good prognosis and a poor prognosis, determining weighted sums of the abundance of each and calculating a score equal to the ratio of the weighted sum values. This recitation is a natural correlation between the abundance levels of the bacteria and treatment efficacy which is a natural correlation. With regard to the natural correlation, as in Mayo, the relationship is itself a natural process that exists apart from any human action. The claimed invention also recites mathematical formulas and computations including determining weighted sums and calculating a score, as well as mental steps such as comparing values. These recitation are directed to abstract ideas. It is therefore determined that the claims are directed to judicial exceptions.
The claims are then analyzed to determine whether they recite an element or step that integrates the JE into a practical application (STEP 2A, prong 2) [Vanda Pharmaceuticals Inc., v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018)].
The claims recite steps of measuring bacteria abundance, however this does not integrate the JE into a practical application because it is a mere data gathering step to use the correlation and does not add a meaningful limitation to the method. While claims 13 and 15 recite administering an FMT (fecal microbiota transplant) to subjects indicated likely to benefit, this recitation is dependent on claim 1, which does not require determining that a subject is likely to benefit from complementation with live microorganisms. Accordingly, this conditional limitation does not integrate the JEs into a practical application.
In the absence of steps or elements that integrate the JE into a practical application, the additional elements/steps are considered to determine whether they add significantly more to the JE either individually or as an ordered combination, to “’transform the nature of the claim’ into a patent eligible application” [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)] (STEP 2B).
In the instant situation, the step of measuring bacteria abundance do not provide any particular reagents that might be considered elements that transform the nature of the claims into a patent eligible application because no specific elements/steps are recited. This step is not only a mere data gathering step, but the general recitation of detection of known nucleic acids is well understood, routine, and conventional activity (See MPEP 2106.05(d)(II)). Applicant is reminded that in Mayo, the Court found that “[i]f a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Further "conventional or obvious" "[pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law”. Flook, 437 U. S., at 590; see also Bilski, 561 U. S., at ___ (slip op., at 14) (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by’ . . . adding ‘insignificant post-solution activity’” (quoting Diehr, supra, at 191–192)). The Court also summarized their holding by stating “[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.” Therefore these limitations/steps do not “‘transform the nature of the claim’ into a patent-eligible application.’” Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297).
When viewed as an ordered combination, the claimed limitations are directed to nothing more than the determination that a natural correlation/phenomena exists. Any additional element consists of using well understood, routine and conventional activity, and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.
Accordingly, it is determined that the instant claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 112
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.
Claims 1-8, 11-13, and 15 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Claim 1 lists what appears to be Markush groups of alternatively usable bacteria, however it is not clear what the alternative embodiments are. The use of the term “and” occurs throughout the listing in a1 and b1 such that it is not clear what the demarcation is between the alternatively usable species. It is also not clear if some of the recitations are meant to be grouped together, or alternatively usable. For example, does claim 1 require Bacilli and Actinobacteria classes or is it meant to require Bacilli or Actinobacteria classes. This issue occurs throughout the claim.
The use of the term “corresponding” in steps a2 and b2 of claim 1 are vague and unclear because the relationship between the value G or B, and the weighted sum is not clear. If the value is equal to the weighted sum of the abundances, it is suggested that the claim be amended to clearly recite this. Additionally, the score recited in step c of claim 1 is unclear as it uses a number of characters whose meaning is not defined. It is not clear if the score calculated in step c is the ratio of the weighted sum of the abundances of the good bacteria to the weighted sum of the abundances of the bad bacteria.
The use of the terms “superior” and “inferior” in step d of claim 1 is unclear. First it is noted that these are relative terms, where the claims do not make clear how to ascertain if a score is superior or inferior. Additionally, it is not clear if these terms refer to levels. For example, does the term “superior” indicate that the score is higher than a reference, or does the term “superior” simply refer to the fact that the score is “better”. This issue also arises in claim 11, as not only does it use the term, but the claim does not make clear how the additional markers are used in the score to assess patients for complementation response.
The recitation of bacteria in claim 6 is indefinite because it is not clear if this refers to phylum, order, genus, etc. Some of the bacteria are listed several times in claim 1, in some cases to an order and a phylum. As such, the terms in many cases appear to lack sufficient antecedent basis.
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 1-8, 11-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kusakabe (Kusakabe et al; British Journal of Hematology, vol 188, pages 438-449, 30 September 2019; cited in the IDS filed 10/14/2022).
With regard to claims 1 and 6, Kusakabe teaches (see whole document) a method of assessing the gut microbiota of patients receiving hematopoietic stem cell transplantation, including those with GvHD complications (claims 3-5). Kusakabe teaches analysis of Firmicutes and Bacteroidetes (figure 1), as well measuring the relative abundances of bacteria (figure 3) in different fecal samples (claim 2) and controls (comparing to a reference value). Kusakabe teaches use of 16S rRNA gene sequencing (claim 7). Kusakabe teaches disruptions in abundances of bacteria are associated with a poor prognosis in patients receiving HCT. Kusakabe teaches that FMT can prevent dysbiosis and also teaches that the safety and efficacy of FMT has been studied in patients receiving HSCT. Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to have assessed the efficacy of FMT in patients receiving HSCT by analysis of the gut microbiome because Kusakabe suggests to do so. It would have further been prima facie obvious to one of ordinary skill in the art to have treated patients with FMT who were determined to benefit from it.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to examiner Jehanne Sitton whose telephone number is (571) 272-0752. The examiner is a hoteling examiner and can normally be reached Mondays-Fridays from 8:00 AM to 2:00 PM Eastern Time Zone.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Winston Shen, can be reached on (571) 272-3157. The fax phone number for organization where this application or proceeding is assigned is (571) 273-8300.
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/JEHANNE S SITTON/Primary Examiner, Art Unit 1682