DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendments
1) Acknowledgment is made of Applicants’ claim set filed 06/23/26.
Election
2) Acknowledgment is made of Applicants’ election filed 06/23/26 in response to the restriction and the species election requirement mailed 04/29/26. Applicants have elected, without traverse, invention I, and the Lactobacillus gallinarum bacterial species and the indole-3-carboxylic acid (ICA) species; and the ICA further element species.
Status of Claims
3) Claims 1-18 are pending.
Claims 2 and 8-18 of are withdrawn from consideration as being directed to a non-elected invention or species. See 37 CFR 1.142(b) and M.P.E.P § 821.03.
Claims 1 and 3-7 are examined on the merits.
Drawings
4) Acknowledgment is made of Applicants’ color drawings photographs filed 05/03/24. Applicants’ petition for color drawings has been granted on 07/10/24.
Priority
5) The instant AIA application, filed 05/03/24, which claims priority to the provisional application 63/464,325 filed 05/05/2023.
Objection(s) to Specification & Claim(s)
6) The specification is objected to for the following reason(s):
(a) The use of trademark recitations in the instant specification has been noted. For example, see Alexa Fluor 488” at section [0118]. All trademark recitations should be CAPITALIZED wherever they appear, or where appropriate, should include a proper symbol indicating use in commerce such as TM, SM, or ® following the term. See M.P.E.P 608.01(v) and Appendix l. Although the use of trademarks is permissible in patent applications, the propriety 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 trademarks. It is suggested that Applicants examine the whole specification to make similar corrections to trademark recitations, wherever such recitations appear.
(b) MPEP 601.01 (g) states "if the drawings show Figures 1A, 1 B, and 1C and the Brief Description of the drawings refers only to Figure 1, this is an error in the specification which must be corrected."
In the instant application, several Figures include multiple panels. See Figures 1-3, 5-8, 10-13, 15-17, 19, 20 and 22-25. However, the “Brief Description of the Drawings” of these Figures in the specification does not refer to these Figures, for example, as --Figure 1A-1G-- at line one of section [0009] and as --Figure 2A-2F at line 1 of section [0010], and so on. Appropriate amendments to the Brief Description of the Drawings’. References to these Figures throughout the specification should be amended accordingly.
(c) The notation “:” ‘within the limitation “of:” in line 1 of claims 4 and 5 is unnecessary and should be deleted.
(d) The notation “:” ‘within the limitation “of:” in line 4 of claim 4 is unnecessary and should be deleted.
Rejection(s) under 35 U.S.C § 101
7) 35 U.S.C § 101 states:
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.
8) Claims Claims 1 and 3-7 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.
The claims are drawn to a composition comprising Lactobacillus gallinarum and a pharmaceutically acceptable excipient, for example inert water. Because the claimed Lactobacillus gallinarum and the water excipient are composed of matter, at least one embodiment encompassed within the broadest reasonable interpretation (BRI) of the instant claim is directed to a statutory category, i.e., a composition of matter (Step 1: YES). Lactobacillus gallinarum is a naturally occurring probiotic and water is naturally occurring and the two are judicial exceptions (JE). MPEP 2106.04(c)(II)(C) (“Thus, in order to be markedly different, applicant must have caused the claimed product to possess at least one characteristic that is different from that of the [closest naturally occurring] counterpart.”). Supreme Court has made it clear in Myriad that eligibility requires the creation of something not naturally occurring, which is markedly different from what exists in nature. Unlike the Chakrabarty bacterium, which was new “with markedly different characteristics from any found in nature” 447 U.S., at 310, 100 S. Ct. 2204, 65 L. Ed. 2d 144, due to the multiple additional plasmids and resultant “capacity for degrading oil”, there is no indication that the instantly claimed strain is genetically manipulated or structurally modified in any marked or significant way such that the structural difference results in change of properties of the strain. Note that in Chakrabarty and Myriad, the marked difference inquiry was focused on the structural characteristics of the product, not how it was used or how it was made. The naturally occurring L. gallinarum is merely present in a concentrated or desired number in the composition of claims 3-7. StepA: Prong One. While indole-3-carboxylic acid (ICA) in claim 4 is optional, claim 5 adds indole-3-carboxylic acid (ICA), which is also an element that occurs naturally in a variety of biological sources from common plants, vegetables to exotic marine life. See BENCHCHEM, pages 1-17, May 2026. This additional JE element does not integrate the Lactobacillus gallinarum into a practical application since both elements occur in natural sources such as stomach or intestinal contents comprising Lactobacillus gallinarum and ICA-containing vegetable from a consumed food. There is nothing that provides significantly more or that integrates the claimed naturally occurring strain and the carrier, i.e., the judicial exceptions, into a practical application. Step 2A: Prong Two. The claims as a whole do not amount to significantly more than a ‘product of nature’ (Step 2B). Therefore, the claims are not directed to a patent eligible subject matter.
The rationale for this determination is formed in view of the 2019 PEG, the 2015 Update of the 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 4618) (hereafter Interim Eligibility Guidance) dated 16 December 2014, the Life Sciences Examples issued in May 2016, and in view of Myriad v Ambry, CAFC 2014-1361, -1366, 17 December 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U. S. (June13, 2013).
Notice Re Prior Art Available under Both Pre-AIA and AIA
In the event the determination of the status of the application as subject to AIA 35 U.S.C § 102 and 35 U.S.C § 103 (or as subject to pre-AIA 35 U.S.C § 102 and 35 U.S.C § 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection would be the same under either status.
Rejection(s) under 35 U.S.C § 102
9) The following is a quotation of the appropriate paragraphs of 35 U.S.C § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
10) Claims 1, 3 and 4 are rejected under 35 U.S.C § 102(a)(1) as being anticipated by Sugimura Naoki. Lactobacillus gallinarum Protects against Colorectal Tumorigenesis through Secretion of Anti-tumor Metabolites. Ph.D. Thesis, The Chinese University of Hong Kong, pages 1-134, 2020 (Sugimura Naoki, 2020).
Sugimura Naoki (2020) taught a Lactobacillus gallinarum composition comprising 1 x 108 CFU of Lactobacillus gallinarum having CRC tumor-suppressive effect. The composition was administered by oral gavage to a mouse once daily for 8 weeks and it significantly decreased the number and size of colorectal tumors and abrogated intestinal tumorigenesis. Sugimura Naoki (2020) taught a composition comprising said Lactobacillus galli and PBS, i.e., a physiologically acceptable excipient. Sugimura Naoki (2020) taught that Lactobacillus gallinarum protects against intestinal tumorigenesis in mice. See title, pages 2-4, sections 2.1.1 on page 36, section 2.2.2 on pages 37 and 38, sections 3.1 and 3.1.1 on pages 49-50, and Figures 3.3, 3.4, 3.5, 3.6 and 3.7.
Claims 1, 3 and 4 are anticipated by Sugimura Naoki (2020).
Rejection(s) under 35 U.S.C § 103
11) 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 claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 148 USPQ 459, 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 unobviousness.
12) Claim 7 is rejected under 35 U.S.C § 103 as being unpatentable over Sugimura Naoki. Lactobacillus gallinarum Protects against Colorectal Tumorigenesis through Secretion of Anti-tumor Metabolites. Ph.D. Thesis, The Chinese University of Hong Kong, pages 1-134, 2020 (Sugimura Naoki, 2020) as applied to claim 1 above.
The teachings of Sugimura Naoki, 2020 are set forth supra, which are silent on the composition being formulated in a daily dosage comprising about 5 x 109 CFU of L. gallinarum per kg recipient body weight as claimed.
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to arrive at the recited daily dosage via routine standardization and optimization to produce the formulation of the instant invention. It is prima facie obvious to one of ordinary skill in the art before the effective filing date of instant application to determine all operable and optimal CFU of L. gallinarum per kg recipient body weight via routine standardization, because such is an art-recognized result-effective variable, which would have been routinely determined and optimized in the vaccine or pharmaceutical art. Further, doing so was well within the purview of one of ordinary skill in the art at the time the invention was made and lends no patentable import to the claimed invention. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). See MPEP§ 2144.05 part II. ”[I]t is not inventive to discover the optimum or workable ranges by routine experimentation.' In re Aller, 220 F.2d 454, 456 (CCPA 1955); see also In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003). ''Only if the 'results of optimizing a variable' are 'unexpectedly good' can a patent be obtained for the claimed critical range.'1 In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997) (quoting In re Antonie, 559 F.2d 618, 620 (CCPA 1977)). ''[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). As set forth in KSR Int'l Co. v. Teleflex Inc., 27 S. Ct. 1727, 1741-42, 82 USPQ2d 1385, 1397 (2007), [i]n determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under § 103".
Claim 7 is prima facie obvious over the prior art of record.
13) Claims 5 and 6 are rejected under 35 U.S.C § 103 as being unpatentable over Sugimura Naoki. Lactobacillus gallinarum Protects against Colorectal Tumorigenesis through Secretion of Anti-tumor Metabolites. Ph.D. Thesis, The Chinese University of Hong Kong, pages 1-134, 2020 (Sugimura Naoki, 2020) as applied to claim 1 above and further in view of Kuhara (JP-2020164493 A - Original and machine translation).
The teachings of Sugimura Naoki, 2020 are set forth supra, which are silent on the presence of indole-3-lactic acid in the composition formed as a food or beverage item as claimed.
However, Kuhara teaches having indole-3-lactic acid in a composition to inhibit
intestinal inflammation caused by the inflammatory cytokines such IL-1, IL-6, TNF-α in the intestinal tract. See Abstract, claim 1, and page 4/34 of the machine translation.
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 add to Sugimura Naoki’s (2020) Kuhara’s
indole-3-lactic acid to produce the instant invention. One of ordinary skill in the art would be
motivated to do so for the expected benefit of inhibiting the intestinal inflammation caused by cytokines as taught by Kuhara. Furthermore, having the resultant composition in the form of a food or beverage would have been well within the realm of routine experimentation in order to produce a composition that is convenient for consumption.
Claims 5 and 6 are prima facie obvious over the prior art of record.
Conclusion
14) No claims are allowed.
Correspondence
15) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's Supervisor, Jeffrey Stucker, can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
16) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
September, 2026
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