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 .
DETAILED ACTION
Status of claims
The amendment filed on Feb. 6, 2026 is acknowledged. Claims 1-40 have been canceled and new claims 41-54 are added. Claims 46-54 have been withdrawn. Claims 41-45 are under examination in the instant office action.
Applicants' arguments, filed on Feb. 6, 2026, have been fully considered but they are moot in view of new ground of rejection which are necessitated by the amendments (new claims with new limitations). Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 41-45 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. All dependent claims are included.
New independent claim 41 is drawn to a method for treatment and/or prevention of enteritis and/or hepatitis in a patient, comprising: determining enteritis and/or hepatitis based on the amount of a free D-amino acid in the body of the patient; and when enteritis and/or hepatitis are/is determined, administering an effective dose of the free D-amino acid or a pharmaceutically acceptable salt thereof to the patient, and thereby inhibiting development of symptoms or alleviating symptoms of enteritis and/or hepatitis in the patient.
The claim 41 encompasses two embodiments: one embodiment where enteritis and/or hepatitis are/is determined, administering an effective dose of the free D-amino acid or a pharmaceutically acceptable salt thereof to the patient is required (embodiment A) and the other one where enteritis and/or hepatitis are/is not determined, the administering step is not required (embodiment B). For the embodiment B, the claimed method includes just determining step only and do nothing. Thus, this embodiment is not directed to patent-eligible subject matter as explained below, and since the claims include at least one ineligible embodiment, they are also rejected.
See MPEP 2111.04 II. The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent is not met. Also, See Ex parte Schulhauser, Appeal 2013-007847 (PTAB April 28, 2016): "[t]he Examiner did not need to present evidence of the obviousness of the method steps of claim 1 that are not required to be performed under a broadest reasonable interpretation of the claim (e.g., instances in which the electrocardiac signal data is not within the threshold electrocardiac criteria such that the condition precedent for the determining step and the remaining steps of claim 1 has not been met);" however to render the claimed system obvious, the prior art must teach the structure that performs the function of the contingent step along with the other recited claim limitations. Schulhauser at 9, 14.
The claimed invention falls within a statutory category (Step 1: YES). The claim recites a series of steps or acts. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claims are directed to a judicial exception (Step 2A: YES).
The claims purports to apply natural laws or natural phenomenon describing the relationships between D-amino acid levels in the body of the patient and enteritis/hepatitis. The examiner must determine, below, whether the claimed processes have transformed these unpatentable natural laws into patent eligible applications of those laws. As analyzed in Mayo Collaborative Services v. Prometheus Labs., Inc., 566 U.S. -__ (2012), 132 S. Ct. 1289.
The determining step could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams).
And the step of “determining whether a patient has enteritis and/or hepatitis based on the level of D-amino acid in the body of the patient” simply refer to the measurements of a natural phenomenon through whatever process the doctor or laboratory wishes to use. At most this adds a suggestion that he should take those laws into account when treating his patient. When recited at this high level of generality, there is no meaningful limitation in this step that distinguishes it from well-understood, routine, conventional data gathering activity previously engaged in by scientists in the field prior to applicant’s invention, and at the time the application was filed. Accordingly, the claim (the embodiment B) does not include additional elements that are sufficient to amount to significantly more than the judicial exception (STEP 2B).
Accordingly, the claims are not directed to patent-eligible subject matter.
See Mayo Collaborative Services v. Prometheus Laboratories, Inc., 101 USPQ2d 1961 (U.S. 2012). In Mayo v. Prometheus it was found that the correlation between concentrations of certain biomarkers in the blood and the response to a drug is directed towards unpatentable subject matter. “The relation is a consequence of the ways in which thiopurine compounds are metabolized by the body—entirely natural processes. And so a patent that simply describes that relation sets forth a natural law… Because methods for making such determinations were well known in the art, this step simply tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists in the field. Such activity is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law.”
Claim Rejections - 35 USC § 112 (b)
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 41-45 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 pre-AIA the applicant regards as the invention.
New independent claim 41 recites “determining enteritis and/or hepatitis based on the amount of a free D-amino acid in the body of the patient”. It is unclear how enteritis and/or hepatitis is determined based on the amount of a free D-amino acid in the body of the patient. First, the claim does not particularly point out how much amount of free D-amino acid should be present in the body for a patient to be determined to have enteritis and/or hepatitis. Also, it does not specify whether a decrease or an increase in the amount of free D-amino acids in the body of a patient is an indicator for determining enteritis and/or hepatitis? In addition, the amount of free amino acids varies depending on which body part and what assay method are used to measure the level of D-amino acid. The claim does not specify what assay conditions and which body part are used for determining step. Thus, one of ordinary skill in the art would not ascertain the scope of the patient population to whom the free D-amino acid is administered because it is vague and confusing how to perform the determining step. Further, the preamble of claim 41 recites prevention of enteritis and/or hepatitis but the active step recites “administering an effective dose of the free D-amino acid or a pharmaceutically acceptable salt thereof to the patient when enteritis and/or hepatitis are/is determined”. Thus, administering step only occurs when the patient is determined to have enteritis and/or hepatitis. It is unclear how prevention can be done by administering D-amino acid when the patient already has the condition. Clarification is required.
For examination purpose, it is treated as if it recites “A method for treatment and/or prevention of enteritis and/or hepatitis in a patient, comprising: determining the amount of a free D-amino acid in the body of the patient” and administering an effective dose of the free D-amino acid or a pharmaceutically acceptable salt thereof to the patient, and thereby inhibiting development of symptoms or alleviating symptoms of enteritis and/or hepatitis in the patient.
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 41-45 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2010/027344 (hereafter, BAUER; cited in IDS filed on 1/23/2023) in view of Sasabe et al. (Nat Microbiol 1(10): 16125, 1-17, 2016; cited in the IDS filed on 1/23/2023) and US 2012/0165262 (hereafter, POLK, prior art of record).
BAUER teach administering extracts from Lactobacillus bacteria, which have immunomodulatory effects, for treating colitis and inflammatory bowel diseases in subjects (abstract, [080], and claims 18 and 22).
BAUER disclose that the extracts include D-amino acids such as D-Ala, D-Pro, D-Asp D-Ser, and D-met (Examples 3.1-3.5). BAUER further disclose that D-amino acids can be beneficial in increasing the time of effectiveness of the extracts, as they are not efficiently digested in the mammalian gut and D-amino acids may also protect smaller peptides and proteins from degradation during digestion ([014]).
As to claim 45, IBD symptoms include inflammation of the intestine and resulting in abdominal cramping and persistent diarrhea as evidenced by POLK ([0202]). Thus, inhibiting or alleviating symptoms of IBD such as diarrhea necessarily occurs when the composition comprising the same D-amino acid is administered to the same patient as taught by the prior art. It is noted that products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). When the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Alternately, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). 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. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
While BAUER teaches the use of a composition comprising free D-amino acids for treating colitis and IBD, BAUER does not specifically teach determining enteritis and/or hepatitis based on the amount of a free D-amino acid in the body of the patient and ulcerative colitis as IBD.
Sasabe et al. teach that free D-amino acids are produced in the intestine tract by intestinal microbiota of mammal and oxidative deamination of intestinal D-amino acid by D-amino acid oxidase (DAO), which yields antimicrobial product, hydrogen peroxide, protects the mucosal surface in the small intestine from the cholera pathogen, which causes cholera and enteritis (p1, para 1, p2, para 3, p3, para 3, and Fig. 1). Sasabe et al. disclose the effects of DAO supplemented with/without exogenous D-amino acid such as D-Pro or D-Ala on common enteric pathogens (p3, para 3). Also, Sasabe et al. disclose that while the Vibrio cholerae was susceptible to DAO alone because of the substantial amounts of D-amino acid it releases, an amino acid racemase-deficient mutant strain, which release less D-amino acid than the wild strain and therefore generates less hydrogen peroxide in the presence of exogenous DAO, shows reduced susceptibility to DAO toxicity in the absence of exogenous D-amino acid (p3, para 3 and Supplementary Fig, 7g). Sasabe et al. suggest that DAO can exert bactericidal effects on several enteric pathogen through production of hydrogen peroxide from oxidation of D-amino acid and D-amino acid and DAO are mediators of microbe-host interplay and homeostasis on the epithelial surface of the small intestine (p2, para 1 and p3, para 3). In addition, Sasabe et al. teach determination of D-amino acid level in cecal luminal contents (p6, last para and Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine the amount of free D-amino acids in the intestinal tract of a patient before administering the composition of BAUER comprising D-amino acids in the treatment of colitis and inflammatory bowel diseases to identify the intrinsic level of D-amino acids in the patient because the level of D-amino acids could indicates the state of intestinal microbiota of the patients and the presence of enteric pathogens which release D-amino acids as evidenced by Sasabe et al. The skilled artisan would have been motivated to do so for identifying a patient who would benefit from administering the D-amino acid composition of BAUER.
As to claims 44-45, it was well-known in the art that IBD includes ulcerative colitis and the treatment for IBD is also used for ulcerative colitis as evidenced by POLK ([0202] and claim 33). POLK teaches that IBD is characterized by inflammation of at least part of the gastrointestinal tract and may include inflammation of the intestine and resulting in abdominal cramping and persistent diarrhea, and include ulcerative colitis (UC) ([0202]). POLK further teaches that ulcerative colitis is a disease that causes inflammation and sores, called ulcers, in the lining of the large intestine and the most common symptoms of ulcerative colitis are abdominal pain and bloody diarrhea ([0204] and [0206]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the same composition useful for IBD for treating ulcerative colitis because ulcerative colitis is a subtype of IBD and has the same underlying causes and symptoms as evidenced by POLK. Thus, one of ordinary skill in the art would have been motivated to do so on the reasonable expectation that the same composition useful for IBD would be similarly effective for treating ulcerative colitis.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONG-SOOK BAEK whose telephone number is 571-270-5863. The examiner can normally be reached 9:00AM-6:00PM Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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