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
The amended claim set filed 11/20/2023 is acknowledged.
The examiner’s restriction requirement has been vacated.
Claims 1-16 will be examined on the merits herein.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, support for the claimed invention cannot be determined because the foreign priority documents provided are not in English. Applicant cannot rely upon the certified copy of the foreign priority application to overcome any prior art rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216. Failure to provide a certified translation may result in no benefit being accorded for the non-English application. Accordingly, the filing date of the PCT application of 05/16/2022 will be used for the purpose of applying prior art.
Information Disclosure Statement
The IDS filed 4/30/2025 is not accessible by the examiner as it is corrupt and thus has not been considered.
Election/Restrictions
The restriction mailed 12/16/2025 is hereby vacated. Since the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
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.
Claim 6 is 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 claim 6: Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The terms “Lactobacillus family” and “Streptococcus family” in claim 6 refer to phylogenetic genera not phylogenetic families.
In the interest of compact prosecution, the examiner will interpret “Lactobacillus family” to mean Lactobacillaceae and “Streptococcus family” to mean Streptococcaceae hereinafter. The examiner proposes the applicant should alter these terms to overcome the aforementioned rejection.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 15 and 16 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 15 is drawn to a method for predicting acid resistance of lactic acid bacteria comprising the methods according to claim 11. Claim 16 is drawn to a method for predicting viability after low temperature storage of lactic acid bacteria comprising the methods according to claim 11. Claims 15 and 16 are drawn to intended uses, and do not further limit the method of claim 11 from which they depend as they do not provide any structural or functional characteristics. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 an 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.
Claims 11-13, 15, and 16 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Sunny-Roberts et al. (2007, from IDS 2/20/2024), hereinafter Sunny.
Claims 11-13, 15, and 16 are drawn to a method for detecting live lactic acid bacteria with high carbohydrate metabolism using cFDA (carboxy-fluorescein diacetate), PI (propidium iodide) and an aldohexose which induces extrusion of cF from (carboxy-fluorescein) from the cells.
Sunny teaches a method of measuring the extrusion of intracellular accumulated cF upon energizing cells with glucose (an aldohexose) in food associated bacteria, specifically Lactobacillus rhamnosus p.183 introduction. Sunny teaches “Stationary growth phase cultures were harvested, washed twice in Ringer’s solution” this step would remove saccharide as in instant claim 12. Sunny teaches the use of the fluorescent esterase substrate cFDA incubated for 10 minutes with cells, then washing the cells and adding the cell membrane damage reagent PI and further incubating for 10 minutes on p.186 par.6. Cells were further incubated with 20mM glucose for 40 min in order to measure the performance of cells in extruding intracellular accumulated cF. Kinetic measurements were performed by withdrawing samples every 10 min for 40 min to monitor release of cF from glucose energized cells on p. 185 par. 7. In regards to claim 11, if the applicant is to argue that detection of bacteria that excrete a fluorescent substance and have no membrane damage that Sunny executed at 0 and 10 minute is not within 10 minutes, it would have been obvious for a person having ordinary skill in the art to subtract a small amount of time such as 10 seconds to be within 10 minutes and it would not significantly change the results depicted in Sunny Fig 5 and Fig 5 of the instant application.
Claims 15 and 16 recite intended use and do not further limit or add any procedure or structure to claim 11. However, if the applicant is to argue that the intended use adds any structure or procedures to the methods it would have been obvious for a person having ordinary skill in the art to make those modifications.
Therefore, the teachings of Sunny anticipate claims 11-13, 15, and 16.
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.
The factual inquiries 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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Sunny in view of He et al. (2017) The teachings of Sunny are laid out in the 102 rejections above anticipating all elements of the following claims except those addressed hereafter.
Sunny does not teach the method for detecting live lactic acid bacteria in a beverage or food as in instant claim 1.
He teaches a method of quantifying live lactic acid bacteria in yogurt in figure 3 which is a lactic acid bacteria containing food and is also a milk product as claimed in instant claim 4. He uses flow cytometry and a live stain (SYTO9) combined with PI p.4 scheme 1. He teaches absolute quantification is achieved by the addition of 200 nm beads to the samples p 3. par. 2.5 as in instant claim 9.
The teachings of Sunny are sufficient to anticipate the added limitations of dependent claims 2, 3 and 5-7, see above.
He also teaches the above method for detection of live Lactobacillus casei p.2 par. 2.2 and Figure 1, as in instant claim 8.
It would have been obvious for a person having ordinary skill in the art to extend the teachings of Sunny for detecting metabolically active bacteria to food products that contain probiotics because live probiotics confer health benefit on their hosts, and because lactic acid bacteria are widely used as sources of probiotics, and these bacteria are contained in foods such as yogurts and fermented milk products, see He p.1 introduction. One of ordinary skill in the art would recognize that the similar protocol using FCM would ensure a high probability of successfully applying the methods of Sunny to the analytes of He.
Claim 10 is drawn to beads set to 5-70% of the particles in the sample. It would have been obvious for a person having ordinary skill in the art to carry out routing optimization to arrive at an effective percentage of beads to particles.
Claims 14 is rejected under 35 U.S.C. 103 as being unpatentable over Sunny in view of Abe et al. (1989) The teachings of Sunny are laid out in the 102 rejections above and anticipate claim 11 from which claim 14 depends.
Claim 14 is drawn to plotting a graph of cells which have excreted cF versus time and taking area of the plotted curve to quantify live lactic acid bacteria.
Abe teaches plotting concentration of a drug versus time and taking the area under the curve to quantify total serum levels on p.31-32 and table 4. It would have been obvious for a person having ordinary skill in the art to use the method of calculating the area under the curve to obtain a measure of total amount of live lactic acid bacteria and a person having ordinary skill in the art would be motivated to do this to know total amounts of live bacteria that would be available for food production or probiotic benefits to consumers.
Conclusion
No claims are allowed.
Inquiry Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUDOLPH E. SLOUP Jr. IV Ph.D. whose telephone number is (571)272-7899. The examiner can normally be reached Monday to Friday, 9am to 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel E. Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUDOLPH E. SLOUP Jr. IV Ph.D./
Examiner, Art Unit 1645
/DANIEL E KOLKER/ Supervisory Patent Examiner, Art Unit 1645