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
Response to Amendment
Applicant’s amendment filed on 19 December 2025 is entered. Claims 3 and 7-14 are amended, claims 1-2, 4-6, and 15 are cancelled, and claims 16-22 are new.
Claims 3, 7-14, and 16-22 are pending. Claims 14 and 16-22 are withdrawn. Claims 3 and 7-13 are under examination.
Priority
Receipt is acknowledged of English language translated certified copies of papers required by 37 CFR 1.55. Applicant’s claim to the foreign priority filing date of KR10-2019-0122531 filed 02 October 2019 is perfected by filing the English translation of the certified copy.
The effective filing date is now 02 October 2019.
Claim Objections
Claims 1 and 7-13 are objected to because of the following informalities:
Claims 1 and 7-13 recite convoluted language in their preambles. The preambles of claims 3 and 7 may be amended to “An enteric-coated composition comprising…”, and the preambles to dependent claims 8-13 may be amended to “The enteric-coated composition of claim [7, 8, 11, or 12]…”.
Appropriate correction is required.
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.
(Maintained) Claims 3 and 7-13 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is apparent that biological materials Lactobacillus acidophilus KBL409, Lactobacillus paracasei KBL382, and Lactobacillus plantarum KBL396 are required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of Lactobacillus acidophilus KBL409, Lactobacillus paracasei KBL382, and Lactobacillus plantarum KBL396.
The process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the Lactobacillus acidophilus KBL409, Lactobacillus paracasei KBL382, and Lactobacillus plantarum KBL396 that are considered necessary to make and use the invention is both known and readily available to the public.
It is noted that Applicants have deposited Lactobacillus acidophilus KBL409 at KCTC under deposit number 13518BP, Lactobacillus paracasei KBL382 under deposit number 13509BP, and Lactobacillus plantarum KBL396 under deposit number 13278BP, all under the conditions of the Budapest Treaty, but there is no indication in the specification as to public availability.
Since the deposit is made under the terms of the Budapest Treaty, a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that all restrictions imposed by the depositor on the availability to the public on the deposited material will be irrevocably removed upon granting of the patent, would satisfy the deposit requirement made herein.
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.
(New necessitated by amendment) Claims 3 and 7-13 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.
Claims 3 and 7 recite the new limitation “…an extract of the strain 13518BP”. Earlier in the claims, the strain number for the claimed Lactobacillus acidophilus is KBL409 with accession number 13518BP. It is unclear if the “13518BP” is a strain number or a deposit accession number for the Lactobacillus acidophilus KBL409 strain, or if it is the strain number for a different unrecited organism.
Claims 8-13 depend from claim 7, and so are indefinite for the same reason.
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.
(Maintained) Claims 3 and 7-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of product of nature without significantly more.
Claims 3 and 7-13 are drawn to the statutory category of products (Step 1: Yes).
Claim 3 recites an enteric-coated dosage form comprising the bacterial strain Lactobacillus acidophilus KBL409 with deposit number KCTC 13518BP, a culture of the strain, a lysate of the strain or an extract of the strain. Lactobacillus acidophilus KBL409 is a naturally occurring bacterial strain isolated from fecal samples of healthy adults and infants, as evidenced by pg. 5 sent. 1 and Table 1 of Lin (Screening and evaluation of Lactobacillus spp. tightening the intestinal barrier, Master’s Thesis, Seoul National University, published August 2017). As such, the bacterial strain Lactobacillus acidophilus KBL409 with deposit number KCTC 13518BP is a naturally occurring microorganism. The culture of the strain contains the naturally occurring Lactobacillus acidophilus KBL409 bacteria and nutrients and chemical compounds that enable the strain to grow. There is no evidence of record demonstrating that the additional components of the bacterial culture are non-natural. A lysate and extract of the Lactobacillus acidophilus KBL409 strain entirely comprise of cell components and/or chemical compounds produced or found in Lactobacillus acidophilus KBL409, and so are considered to also be naturally occurring compositions. The claim term “enteric-coated dosage form” implies the existence of enteric-coating as a component in the composition. The broadest reasonable interpretation of enteric coating includes coatings comprising naturally occurring compounds, such as alginate, pectin, glyceride, and glycerol monostearate, as evidenced by the abstract of Khoder et al. (A novel natural GRAS-grade enteric coating for pharmaceutical and nutraceutical products, International Journal of Pharmaceutics 584 (2020) 119392).
Claim 7 recites an enteric-coated dosage form for preventing or treating renal disease comprising the naturally occurring bacterial strain Lactobacillus acidophilus KBL409, a culture of the strain, a lysate of the strain or an extract of the strain. As discussed with claim 3 above, the culture, lysate, and extract of the Lactobacillus acidophilus KBL409 strain entirely comprise of cell components and/or chemical compounds naturally produced or found in Lactobacillus acidophilus KBL409, and so are considered to also be naturally occurring compositions, and the implied enteric-coating structural component is also directed to naturally occurring compounds. The limitation that the composition is “for preventing or treating renal disease” does not recite any additional components or structures of the composition but rather recites an intended use of the composition.
Dependent claims 8-10 further limit the anti-renal disease abilities of claim 7’s intended use limitation, but also do not recite any additional components or structures of the composition.
Claim 11 recites that the enteric-coated dosage form of claim 7 further comprises an additional probiotic strain, or a culture, lysate, or extract thereof. Probiotics are live bacteria that provide beneficial health effects to the host. The BRI of the term probiotic includes many naturally occurring bacteria found in nature. Dependent claims 12-13 limit this additional probiotic to be Lactobacillus paracasei KBL382 with accession number KCTC13509BP and/or Lactobacillus plantarum KBL396 with accession number KCTC13278BP. Both of these probiotic strains are also naturally occurring bacterial strains isolated from fecal samples of healthy adults and infants, as evidenced by pg. 5 sent. 1 and Table 1 of Lin (Screening and evaluation of Lactobacillus spp. tightening the intestinal barrier, Master’s Thesis, Seoul National University, published August 2017). As such, the additional probiotic strains Lactobacillus paracasei KBL382 and/or Lactobacillus plantarum KBL396 are naturally occurring microorganisms.
Claims 3 and 7-13 do not recite any additional non-natural compounds or structures of the compositions, thus the claims recite a judicial exception of a product of nature (Step 2A Prong One: Yes).
This judicial exception is not integrated into a practical application, nor do the claims include additional elements that are sufficient to amount to significantly more than the judicial exception, because the claims are drawn to the statutory category of products, and the claims do not recite any applications of the products. Although claims 7-13 recite that the product of nature compositions can be used to prevent or treat renal diseases and have anti-renal disease properties, these limitations do not integrate the claimed compositions into a practical application because the claims do not require any active steps be performed such that the product of nature compositions are required to be used or applied in some way to achieve these anti-renal disease properties. Thus, the instant invention is directed to the judicial exception of a product of nature (Step 2A Prong Two and Step 2B: No).
Therefore, the instant invention is directed to a product of nature without significantly more and is not patent eligible subject matter under 35 USC §101.
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.
(New necessitated by amendment) Claims 3 and 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Lin (Screening and evaluation of Lactobacillus spp. tightening the intestinal barrier, Master’s Thesis, Seoul National University, published August 2017) in view of Lam et al. (WO 2011079282 A1, published 30 June 2011).
Regarding claim 3, Lin teaches the microorganism Lactobacillus acidophilus KBL409 (Lin Table 1). Lin also teaches that Lactobacillus acidophilus KBL409 caused a positive change in transepithelial/transendothelial electrical resistance (TEER) relative to the control group, indicating that the strain strengthens the intestinal barrier (Lin Table 2).
However, Lin does not teach the microorganism Lactobacillus acidophilus KBL409 is in the form of an enteric-coated dosage form.
Lam teaches enteric coating compositions comprising Lactobacillus acidophilus species, and that enteric coating a composition prevents the release of the composition before reaching the small intestine, thereby providing control over the location where the composition is released (Lam [31] and [51]-[53]).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to formulate Lin’s Lactobacillus acidophilus KBL409 as an enteric coated composition as taught by Lam so that the Lactobacillus acidophilus KBL409 can be effectively delivered to the small intestine so that it can provide the therapeutic effect of strengthening the intestinal barrier. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Lam teaches that formulating compositions comprising Lactobacillus acidophilus species prevents the release of the composition before reaching the small intestine, thereby providing control over the location where the composition is released. Thus, one of ordinary skill in the art would reasonably expect that enteric coating Lin’s Lactobacillus acidophilus KBL409 would allow the Lactobacillus acidophilus KBL409 to traverse the stomach acid and be selectively delivered to the intestines, so that it can provide its therapeutic effect.
Regarding claims 7-10, claim 7 recites an enteric-coated dosage form for preventing or treating renal disease, and claim 8 recites that the prevention or treatment of renal disease is due to a decrease in renal inflammation, a decrease in blood concentration of uremic toxin, a decrease in proteinuria, a restoration of renal mitochondrial function and/or an inhibition of renal fibrosis. Claim 9 limits the uremic toxin recited in claim 8 to blood urea nitrogen, blood creatinine and/or blood p-cresol. Claim 10 limits the renal disease recited in claim 7 to be selected from a group consisting of uremia, chronic renal failure, acute renal failure, subacute renal failure, renal fibrosis, glomerulonephritis, pyelonephritis, interstitial nephritis, proteinuria, diabetic nephropathy, hypertensive nephropathy, malignant neurosis, lupus nephritis, thrombotic microangiopathy, transplant rejection, glomerulopathy, renal hypertrophy, renal hyperplasia, contrast agent induced nephropathy, toxin induced kidney injury, oxygen free-radical mediated nephropathy, polycystic renal disease and nephritis. These limitations are interpreted as being an intended use and desired properties of the claimed composition, but do not add any new structural limitations to the composition; thus, if a composition in the prior art teaches all of the structural limitations of the claimed composition, instant claims 7-10 will be considered to be obvious.
Regarding claims 11-12, Lam teaches that the enteric coated composition may comprise multiple probiotic strains, including strains of Lactobacillus paracasei and Lactobacillus plantarum (Lam [51]-[53]).
Regarding claim 13, Lin also teaches the bacterial strains Lactobacillus paracasei KBL382 and Lactobacillus plantarum KBL396 (Line Tables 1 and 2), and that these strains also caused a positive change in transepithelial/transendothelial electrical resistance (TEER) relative to the control group, indicating that these strains are also useful for strengthen the intestinal barrier, just as strain Lactobacillus acidophilus KBL409 is (Lin Table 2).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to combine Lin’s three bacterial strains Lactobacillus acidophilus KBL409, Lactobacillus paracasei KBL382, and Lactobacillus plantarum KBL396 into a single enteric coated composition to stabilize the intestinal barrier of a subject in need thereof. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Lin teaches that Lactobacillus acidophilus KBL409, Lactobacillus paracasei KBL382, and Lactobacillus plantarum KBL396 strengthen the intestinal barrier of a subject, and Lam teaches that formulating compositions comprising Lactobacillus acidophilus, Lactobacillus paracasei, and Lactobacillus plantarum prevents the release of the composition before reaching the small intestine, thereby providing control over the location where the composition is released. Thus one of ordinary skill in the art would reasonably predict that enteric coating Lin’s combination of Lactobacillus acidophilus KBL409, Lactobacillus paracasei KBL382, and Lactobacillus plantarum KBL396 would allow those strains to traverse stomach acid and be selectively delivered to the intestines so that it can provide its therapeutic effect.
Response to Arguments
Applicant’s arguments with respect to the 102 and 103 rejections of claim 3 and 7-13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 19 December 2025 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments that biological deposit receipts for the claimed Lactobacillus strains have been provided and are sufficient to meet the requirements set forth in the Office action (Remarks pg. 6 paras. 1-2), the deposit receipts have been provided, but no statement that “all restrictions imposed by the depositor on the availability to the public on the deposited material will be irrevocably removed upon granting of the patent” has been provided in the disclosure. See MPEP § 2410.01. The statement is necessary to satisfy the requirements for the biological deposits.
Regarding Applicant’s arguments that the amended claims are now directed to an enteric-coated dosage form, so the claims are now patent eligible because the enteric dosage form transforms the bacterial strain (Remarks pg. 7 paras. 1-3), the claim term “enteric-coated dosage form” implies the existence of an enteric-coating as a component in the composition. The broadest reasonable interpretation of enteric coating includes coatings comprising naturally occurring compounds, such as alginate, pectin, glyceride, and glycerol monostearate, as evidenced by the abstract of Khoder et al. (A novel natural GRAS-grade enteric coating for pharmaceutical and nutraceutical products, International Journal of Pharmaceutics 584 (2020) 119392). As such, the claimed composition is still directed to a product of nature and is not patent eligible under 35 USC §101.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander M Duryee whose telephone number is (571)272-9377. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/Alexander M Duryee/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657