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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 26 August 2026 has been entered.
DETAILED ACTION
Applicant’s amendment filed on 26 August 2026 is entered. Claim 7 is amended. Claims 3 and 14 are cancelled. Claims 7-13 and 16-22 are pending. Claims 16-22 are withdrawn. Claims 7-13 are under examination.
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 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 7-13 are drawn to the statutory category of products (Step 1: Yes).
Claim 7 recites an enteric-coated composition for preventing or treating renal disease comprising a core encapsulated within an enteric coating, wherein the core comprises bacterial strain Lactobacillus acidophilus KBL409, 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 composition” and “encapsulated within an enteric coating” 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). 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 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.
Claims 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 7, 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 encapsulated in an enteric coating.
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 filed 26 August 2026 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments against the rejection under 35 U.S.C. 101 that the amended claims combine a coating and a core therapeutic dosage form of Lactobacillus, and Lactobacillus is not encapsulated in nature, and that the Office Action fails to recognize the combination of core and coating transforms the claims into something more than materials from natural sources (Remarks pg. 6), 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). Applicant has not presented any evidence or working examples demonstrating that coating the naturally occurring Lactobacillus acidophilus KBL409 strain with a naturally occurring enteric coating results in the claimed composition gaining any markedly different characteristics as compared to the natural counterpart such as to make the invention patent eligible under 35 USC §101. Rather, Applicant has only asserted through arguments that the combination of the naturally occurring enteric coating and Lactobacillus acidophilus KBL409 strain results in a composition with a non-natural structure. No evidence has been presented to support Applicant's conclusion of patent eligibility. As such, the claimed composition is still directed to a product of nature and is not patent eligible under 35 USC §101.
Regarding Applicant's argument that Claim 5 of the Example 11 "amazonic acid" example in the USPTO's Patent Eligibility guidance establishes that a physical integration constitutes patent eligible structural differentiation, and that the Office Action has not provided a reason why the analysis of Example 11 is not applicable to the instant claims (Remarks pg. 6), the previous Advisory Action mailed 06 July 2026 did provide a reason why the analysis of Example 11 is not applicable to the rejection of the instant claims. Notably, the background information for Example 11 of the USPTO's Patent Eligibility guidance states that "Applicants disclose an example of a solid pharmaceutical composition demonstrating that when a core of amazonic acid is enveloped by a layer of a natural polymeric material, the resulting manufacture does not release the amazonic acid until it reaches the colon. This colonic release greatly improves the bioavailability of amazonic acid, and is particularly advantageous in the treatment of colon cancer". Example 11's Applicant also provided a specific definition for "natural polymeric material" as being a naturally occurring polymer that is not easily digestible by human enzymes, so that it passes through most of the human digestive system intact until it reaches the colon, and provides specific examples of natural polymeric material suitable for this purpose, shellac and inulin. Thus, Example 11's Applicant provides evidence within a working example showing that when the naturally occurring amazonic acid is coated with their specific naturally occurring polymeric materials, their resulting coated composition has the markedly different effect of not releasing the amazonic acid until it reaches the colon, which greatly improves the bioavailability of amazonic acid. Example 11's Applicants provided sufficient examples and evidence demonstrating how their naturally occurring polymeric coatings were able to produce the markedly different, non-natural effect that gives their composition patent eligibility.
On the contrary, the present Applicant has not presented any evidence or working examples demonstrating that coating the naturally occurring Lactobacillus acidophilus KBL409 strain with a naturally occurring enteric coating results in any markedly different characteristics in the claimed composition as compared to the natural counterpart such as to make the invention patent eligible under 35 USC §101. Rather, Applicant has only asserted through arguments that the combination of the naturally occurring enteric coating and Lactobacillus acidophilus KBL409 strain results in a composition with a non-natural structure. No evidence has been presented to support Applicant's conclusion of patent eligibility.
Regarding Applicant’s argument against the rejection under 35 U.S.C. 103 that Lin and Lam do not disclose or suggest the novel therapeutic effects of Lactobacillus acidophilus KBL 409 as shown in Examples 1 through 3 in the specification (Remarks pg. 7-9), the claims are drawn to a composition, not a therapeutic intervention. The only limitation that mentions therapeutic effects is the limitation of claim 7: "for preventing or treating renal disease." This limitation is interpreted as an intended use of the composition, but does not limit the composition to any sort of administration or use in a therapeutic intervention.
Conclusion
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
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