DETAILED ACTION
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 .
The response and amendment to the claims have been entered.
Status of Claims
Claims 2-5, 9, 17, 19-20, 27-28 and 30-33 have been canceled. Claims 1, 6-8, 10-16, 18, 21-26, 29 and 34 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restriction
Applicant’s election of species Lactiplantibacillus plantarum (Lp-115, Lp12418 and/or Lp12407 in the reply filed on 2-6-2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Information Disclosure Statement
The information disclosure statement filed 3-27-2025 has been entered into the record.
Claim Interpretation
As noted in the Written Opinion of the International Searching Authority:
“Lactiplantibacillus plantarum Lp115” and “L. plantarum Lp-115” are all synonymous with the strain which has been deposited under deposit numbers [ATCC] SD5209, DGCC 4715, PTA-4799, DSM22266. Additionally, the term “Lactobacillus plantarum is basionym for the term “Lactiplantibacillus plantarum” as set forth in the NSBI Taxonomy Browser.
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.
Claims 1, 6-8, 10, 11-16, 21-26 and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated Rask et al (Clinical and Experimental Immunology 172:321-332, 2012).
Rask et al teach the administration of Lactobacillus plantarum strain 299v (DSM9843) in humans. The 299v strain was dosed at 1010 bacteria per day. Bacteria were manufactured and packaged together with skimmed milk powder in 1-g lots in aluminum bags. The studies participants were instructed to take the study product once daily by mixing the content of one aluminum bag with a cold drink or sour milk. For L. plantarum, there was a washout followed by a 5 week intervention period of administration (see in particular page 322, column 2, materials and methods, subjects and trial criteria). Rask et al teach that L. plantarum 299V was associated with immune activation as demonstrated by increased expression of DC25, HLA-DR on both CD4+ and CD8+ cells, increased NK Tcell numbers and increased phagocytosis. L. plantarum induced high concentrations of the bioactive form of IL-12 (see page 326, column 2). L. plantarum was also demonstrated to increase the expression of activation markers on cells participated in acquired cell-mediated immunity and appears to be the result of broad activation function on antigen-presenting cells leading to broadly enhanced T cell activity (see page 328-29, bridging paragraph). The immune modulating properties and methods of stimulating the immune modulating properties are inherent to the bacterium administered. As such, the claims are anticipated. Although the reference is silent about the specific mechanisms and immune properties, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories 58 USPQ2d 1508 (CAFC 2001). {i}t is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable. In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). The mechanism of action does not have a bearing on the patentability of the invention if the invention was already known or obvious. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145.
Claims 1, 6-8, 10, 11-16, 21-26, 29 and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated Paineau et al (FEMS Immunol Med Microbiol 53:107-113, 2008).
Paineau et al teach the immunomodulatory effects of probiotic L. plantarum Lp-115 on specific immune responses. Paineau et al teach that healthy volunteers consumed 2 x 1010 bacteria over 3 weeks (see abstract) Subjects consumed two capsules per day of the test product between days zero and 21. Each active capsule contained 1 x 1010 CFU of bacteria in a maltodextrin carrier. Control groups received capsules contained only maltodextrin. All treatment packages were identical in presentation ( see page 108, column 2, Bacterial Strains). The oral vaccine was given at days 7 and 14 (see 109, Figure 1). L. plantarum Lp-115 tended to increase in specific serum IgG. Paineau et al teach that the pilot indicates that probiotic strains may modulate the immune response to oral vaccination and induce a faster increase in serum IgG concentrations. (see page 113, paragraphs 4 and 5). The immune modulating properties and methods of stimulating the immune modulating properties are inherent to the L. plantarum Lp-115 bacterium administered. As such, the claims are anticipated. Although the reference is silent about the specific mechanisms and immune properties, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories 58 USPQ2d 1508 (CAFC 2001). {i}t is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable. In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). The mechanism of action does not have a bearing on the patentability of the invention if the invention was already known or obvious. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145.
Claims 1, 6-8, 10, 11-16, 21-26, 29 and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated Zhang et al (Hepatobiliary Surg. Nutr. 2(3):142-147, 2013).
Zhang et al teach the use of a probiotic composition in preventing postoperative infection in liver transplant patients (see Abstract and Study methods). Zhang et al teach that a symbiotic composition of prebiotics and probiotics were administered twice daily via the feeding tube or orally. Each capsule contains 6 different probiotic strains and 27 billion organisms of beneficial bacteria:
• Lactobacillus Acidophilus (LA-14) 15.5 Billion;
• Lactobacillus Plantarum (LP-115) 5.0 Billion;
• Bifidobacterium Lactis (BL-04) 2.0 Billion;
• Lactobacillus Casei (LC-11) 1.5 Billion;
• Lactobacillus Rhamnosus (LR-32) 1.5 Billion; and
• Lactobacillus Brevis (LBr-35) 1.5 Billion.
(page 143, column 2, Group A). Zhang et al teach that the mixture significantly reduced the incident of bacterial nosocomial infections following liver transplantation (see page 146, column1, second paragraph). As such, Zhang et al anticipate the instantly claimed invention. Although the reference is silent about the specific mechanisms and immune properties, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories 58 USPQ2d 1508 (CAFC 2001). {i}t is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable. In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). The mechanism of action does not have a bearing on the patentability of the invention if the invention was already known or obvious. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 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.
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 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 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 1, 6-8, 10, 11-16, 21-26, 29 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Paineau et al (FEMS Immunol Med Microbiol 53:107-113, 2008) in view of Rask et al (Clinical and Experimental Immunology 172:321-332, 2012) and the admitted commercial availability of the L. plantarum strains (page 8, lines 6-8) DuPont Nutrition Biosciences ApS.
The teachings of Paineau et al and Rask et al are set forth supra. The claims are alternatively drawn Lp-115 in combination with other deposited strains of L. plantarum or alternatively the other deposited strains (Lp12418 and/or Lp12407).
It would have been prima facie obvious to add or substitute any additional L. plantarum strains including the commercially available GRAS strains L. plantarum Lp12418 and/or Lp12407 to the administered composition of Paineu et al for the modulation of immune responses as evidenced by Rask et al because Rask et al teach L. plantarum strains modulate the immune responses and Paineau et al Lp-115 also modulate specific immune responses. As such, the use of the additional deposited strains are prima facie obvious over the Lp-115 of Paineau and the 299v strain of Rask et al because the L. plantarum strains have the same property. Additionally, the combination has not been demonstrated to have any unexpected properties.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Patricia Duffy whose telephone number is (571)272-0855. The examiner can normally be reached 8:00 am - 4 pm.
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/Patricia Duffy/Primary Examiner, Art Unit 1645
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