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 .
Applicant’s response filed 5/27/2025 has been received and entered into the case. Claims 1, 6-12, 15, 16, 18 are pending. Claims 7 and 10 are withdrawn. Claims 1, 6, 8, 9, 11, 12, 15, 16, 18 have been considered on the merits. All arguments and amendments have been considered.
The following objections and rejections are withdrawn in light of applicants claim amendments, Claim 16 is objected to, Claims 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, Claims 1, 2, 5, 6, 8, 9, 13-16 are rejected under 35 U.S.C. 101, Claim(s) 1, 13, 14, 15, 16 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO2018050623 A1.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 1, 6, 8, 9, 15, 16 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO2018/050650 (IDS).
WO’650 teaches a probiotic composition comprising a mixture of (up to 10) bacterial strains (p. 11, lines 13-20) including Lactobacillus acidophilus NCFM, Lactobacillus rhamnosus HN001, Bifidobacterium lactis HN019, Bifidobacterium lactis Bi-07, Bifidobacterium lactis BI-04, Lactobacillus plantarum Lp-115, Lactobacillus paracasei Lpc-37, Lactobacillus rhamnosus Lr-32, Lactobacillus rhamnosus GG, Bifidobacterium lactis Bb-12, Lactobacillus rhamnosus GR-1, Lactobacillus rhamnosus Rosell-11, Lactobacillus rhamnosus HA-11 , Lactobacillus plantarum HA-119 (p. 3, lines 26-p. 4, lines 1-10). The reference specifically teaches a probiotic composition which comprises Lactobacillus acidophilus NCFM, Bifidobacterium lactis HN019, Bifidobacterium lactis Bi-07, Bifidobacterium lactis BI-04, and Lactobacillus paracasei Lpc-37 and one or more of L. rhamnosus GG, L. rhamnosus HN001, L. plantarum Lp-115, (p. 12, lines 5-30, claim 7). WO’650 teaches the composition to comprise additional ingredients including microcrystalline cellulose and magnesium stearate, for example (p. 19, lines 34-p. 20, lines 1-10). WO’650 teaches the composition may in tablet and capsule form (p. 19, lines 8-10, 23-25, 30-p. 20, lines 5-21).
The microorganisms are present in the composition in amounts of 106-1012 CFU of bacteria/microorganism/dose (p. 13, lines 9-30).
Regarding claims 1, 15 and 16, the reference teaches the composition is administered to a subject to enhance intestinal mucosal immunity, increase probiotic and indigenous lactobacilli, treat urogenital and gastrointestinal disorders (p. 2, lines 30-37, p. 5, lines 25-p. 6, lines 1-6). The probiotic composition is used in the treatment of a gastrointestinal disorder. “As used herein, the term "gastrointestinal disorder" includes any disease or disorder relating to the gastrointestinal tract. The disorder may, for example, be one that is known to be associated with an altered composition and diversity of the GIT microbiota. The gastrointestinal disorder may be inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), Crohn's disease, ulcerative colitis, constipation or diarrhea” (p. 18, lines 33-37), thereby improving gut health.
Regarding applicants newly added limitations to claim 1 of “for improving gut health” and “wherein consumption of the probiotic composition improves…”, the intended use and function of the claimed substrate does not patentably distinguish the composition, per se, since such undisclosed use and function is inherent in the reference composition. In order to be limiting, the intended use and function must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use and function fails to create a structural difference, thus, it is not limiting. Please note that when applicant claims acomposition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Moreover, the claimed function must be inherent to the reference composition. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new. Thus, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (see MPEP 2112)
II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) ("[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention."); Abbott Labs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319, 51 USPQ2d 1307, 1310 (Fed.Cir.1999) ("If a product that is offered for sale inherently possesses each of the limitations of the claims, then the invention is on sale, whether or not the parties to the transaction recognize that the product possesses the claimed characteristics."); Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1348-49, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999) ("Because ‘sufficient aeration’ was inherent in the prior art, it is irrelevant that the prior art did not recognize the key aspect of [the] invention.... An inherent structure, composition, or function is not necessarily known."); SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343-44, 74 USPQ2d 1398, 1406-07 (Fed. Cir. 2005) (holding that a prior art patent to an anhydrous form of a compound "inherently" anticipated the claimed hemihydrate form of the compound because practicing the process in the prior art to manufacture the anhydrous compound "inherently results in at least trace amounts of" the claimed hemihydrate even if the prior art did not discuss or recognize the hemihydrate); In re Omeprazole Patent Litigation, 483 F.3d 1364, 1373, 82 USPQ2d 1643, 1650 (Fed. Cir. 2007) (The court noted that although the inventors may not have recognized that a characteristic of the ingredients in the prior art method resulted in an in situ formation of a separating layer, the in situ formation was nevertheless inherent. "The record shows formation of the in situ separating layer in the prior art even though that process was not recognized at the time. The new realization alone does not render that necessary [sic] prior art patentable.").
MPEP 2112 Requirements of Rejection Based on Inherency; Burden of Proof [R-08.2012]
The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 and 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.5.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983).
lll. A REJECTION UNDER 35 U.S.C. 102/103 CAN BE MADE WHEN THE PRIOR
ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THE PRIOR ART IS
SILENT AS TO AN INHERENT CHARACTERISTIC
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C.103 and for anticipation under 35. U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102/103 rejection is appropriate for these types of claims as well as for composition claims.
Thus, the reference anticipates the claimed subject matter.
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
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.
Claim(s) 1, 6, 8, 9, 11, 12, 15, 16, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2018050623 A1 in view of each of AU2016100865A4 (IDS) and WO2018/050650 (IDS).
WO’623 teaches a probiotic composition comprising Lactobacillus acidophilus NCFM, Bifidobacterium lactis Bl-04, HN019 and Bi-07, and Lactobacillus paracasei Lpc-37 to treat gastrointestinal disorder (abstract, p. 2, lines 30-p. 3, lines 1-9, p. 5, lines 5-12, claim 9). The probiotic strains improve microbial colonization of the GI tract, block adhesion and invasion of pathogenic microbe (p. 2, lines 30-p. 3, lines 1-9, ). The composition comprises up to 10 bacterial strains in combination with additional bacterial strains (p. 4, lines 5-7, p. 10, lines 19-11, lines 1-19 ) and includes all 5 of Lactobacillus acidophilus NCFM, Bifidobacterium lactis Bl-04, HN019 and Bi-07, and Lactobacillus paracasei Lpc-37 (p. 11, lines 20-23, p. 20 , lines 9-11, claim 9). The additional bacterial strains may be selected from L. rhamnosus and L. plantarum (p. 11, lines 5-18). The reference teaches a dosage of about 106-1012 CFU of microorganism/dose (p. 12, lines 10-25). The composition may be formulated as a capsule or tablet (p. 13, lines 5-7, p. 18, lines 8-10, 15) and may contain additional ingredients including microcrystalline cellulose and magnesium stearate, for example (p. 18, lines 19-31).
Regarding claims 15 and 16, the composition is administered to treat gastrointestinal disorders including IBD, IBS, Crohn’s disease, ulcerative colitis, constipation and diarrhea (p. 17, lines 19-23)
WO’623 teaches a probiotic composition comprising Lactobacillus acidophilus NCFM, Bifidobacterium lactis Bl-04, HN019 and Bi-07, and Lactobacillus paracasei Lpc-37 and may further comprise additional probiotic bacteria including L. rhamnosus and L. plantarum (p. 11, lines 5-18); however, the reference does not teach all the claimed strains and the specific L. plantarum and L. rhamnosus strains and limitations of 1, 6, 8, 9, 11, 12, 18.
Regarding claims 1, 6, 8, 9, WO’650 teaches a probiotic composition comprising a mixture of (up to 10) bacterial strains (p. 11, lines 13-20) including Lactobacillus acidophilus NCFM, Lactobacillus rhamnosus HN001, Bifidobacterium lactis HN019, Bifidobacterium lactis Bi-07, Bifidobacterium lactis BI-04, Lactobacillus plantarum Lp-115, Lactobacillus paracasei Lpc-37, Lactobacillus rhamnosus Lr-32, Lactobacillus rhamnosus GG, Bifidobacterium lactis Bb-12, Lactobacillus rhamnosus GR-1, Lactobacillus rhamnosus Rosell-11, Lactobacillus rhamnosus HA-11 , Lactobacillus plantarum HA-119 (p. 3, lines 26-p. 4, lines 1-10). The reference specifically teaches a probiotic composition which comprises Lactobacillus acidophilus NCFM, Bifidobacterium lactis HN019, Bifidobacterium lactis Bi-07, Bifidobacterium lactis BI-04, and Lactobacillus paracasei Lpc-37 and one or more of L. rhamnosus GG, L. rhamnosus HN001, L. plantarum Lp-115 (p. 12, lines 5-30, claim 7).
AU2016100865A4 (IDS) teaches a multi-strain probiotic composition for re-colonizing microbiota and treating dysbiosis in a subject, thus improving gut health (abstract, 0012, 0013, 0017, 0028, 0047). Dysbiosis is linked to IBS, allergies, diabetes, obesity and can be caused by chronic stress, infection, diet, environmental insults, medications, and antibiotics, for example (0005, 0007) The composition comprises at least 8 probiotic bacterial strains (abstract, 0001, 0013) and wherein the composition comprises a total amount of greater than 100 billion to 1 trillion CFU (0014-0019, 0032) according to new claim 18. The bacterial strains are selected from Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis, Lactobacillus plantarum, Lactobacillus paracasei (0020, 0021, 0058, 0059) and according to claims 1, 6, 8, specifically include Lactobacillus acidophilus (NCFM), Bifidobacterium lactis (Bl-04, HN019, and Bi-07) , Lactobacillus rhamnosus (GG and HN001), Lactobacillus plantarum (Lp-115 and 299v), and Lactobacillus paracasei (Lpc-37) and any strain that has similar characteristics and in any combination (0020-0022, 0024, 0025, 0049). The composition is said to comprise 1-10 strain of each of Lactobacillus and Bifidobacteria, specifically 8 strains of Lactobacillus and 3 strains of Bifidobacteria (0025, 0058, for example). The composition may be in tablet or capsule form (0034).
The composition comprises at least 2 different strains of L. rhamnosus (Table 5-active ingredients, Ex. 3, 4, 0058, 0059).
Regarding claim 6, the composition comprises L. plantarum ATCC5209 (Lp-115) (0020-0022, 0024, 0025, 0049).
Regarding claims 11, 12, 18, the composition is disclosed to contain B. lactis (ATCC 5219 Bi-04) in amounts of 220 billion CFU, B. lactis (ATCC 5674 HN109) in amounts of 30 billion CFU, L. acidophilus in amounts of 50 billion CFU, L. plantarum (ATCC 5209 Lp-115) in amounts of 30 billion CFU, L. rhamnosus (ATCC 5675 HN001) in amounts of 10 billion CFU, L. rhamnosus (Lr-32) in amounts of 5 billion CFU and a teaching of L. rhamnosus in amounts ranging from 0-40 billion CFU (p. 35, Ex. 3, 4), and L. paracasei (ATCC 5275 Lpc-37) in amounts of 50 billion CFU (Table 5-Active ingredients, 0058, Ex. 3, 0059, Ex. 4). While the reference teaches and exemplifies amounts of B. lactis, L. acidophilus, L. plantarum, and L. paracasei and L. rhamnosus meeting applicants claimed amounts of claim 12, the amount of L. rhamnosus ATCC7017 (GG) is taught be administered in amounts ranging from 0-40 billion CFU (p. 35, Ex. 3, 4). Thus, the amount of L. rhamnosus ATCC7017 (GG) is taught to meet applicants at least 20 billion, as up to 40 billion CFU may be present in the composition. AU865 teaches that the composition comprising at least 8 probiotic strains has a total amount of from 100 billion to 1 trillion CFU and the amounts are optimizable so long as they do not exceed the upper limit (0013-0019, 0032), thus meeting the limitation of claim 18.
Therefore, before the effective filing date of the claimed invention, it would have been obvious to formulate a probiotic composition comprising Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis, Lactobacillus plantarum, and Lactobacillus paracasei, specifically comprising the claimed probiotic strains of Lactobacillus acidophilus (NCFM), 3 strains of Bifidobacterium lactis (Bl-04, HN019, and Bi-07) , Lactobacillus rhamnosus (GG and HN001), Lactobacillus plantarum (Lp-115), and Lactobacillus paracasei (Lpc-37) in amounts claimed because the art teaches probiotic compositions comprising the claimed strains, suggesting mixtures and the claimed amounts of the claimed probiotic bacteria of up to 10 strains to treat gastrointestinal disorders and dysbiosis of the gut. Therefore, one of ordinary skill in the art would have been motivated to combine to claimed strains disclosed by the art to be used in probiotic compositions and with a reasonable expectation of successfully treating at least gastrointestinal disorders and dysbiosis of the gut.
Regarding applicants newly added limitations to claim 1 of “for improving gut health” and “wherein consumption of the probiotic composition improves…”, the intended use and function of the claimed substrate does not patentably distinguish the composition, per se, since such undisclosed use and function is inherent in the reference composition. In order to be limiting, the intended use and function must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use and function fails to create a structural difference, thus, it is not limiting. Please note that when applicant claims acomposition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Moreover, the claimed function must be inherent to the reference composition. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new. Thus, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (see MPEP 2112)
II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) ("[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention."); Abbott Labs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319, 51 USPQ2d 1307, 1310 (Fed.Cir.1999) ("If a product that is offered for sale inherently possesses each of the limitations of the claims, then the invention is on sale, whether or not the parties to the transaction recognize that the product possesses the claimed characteristics."); Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1348-49, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999) ("Because ‘sufficient aeration’ was inherent in the prior art, it is irrelevant that the prior art did not recognize the key aspect of [the] invention.... An inherent structure, composition, or function is not necessarily known."); SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343-44, 74 USPQ2d 1398, 1406-07 (Fed. Cir. 2005) (holding that a prior art patent to an anhydrous form of a compound "inherently" anticipated the claimed hemihydrate form of the compound because practicing the process in the prior art to manufacture the anhydrous compound "inherently results in at least trace amounts of" the claimed hemihydrate even if the prior art did not discuss or recognize the hemihydrate); In re Omeprazole Patent Litigation, 483 F.3d 1364, 1373, 82 USPQ2d 1643, 1650 (Fed. Cir. 2007) (The court noted that although the inventors may not have recognized that a characteristic of the ingredients in the prior art method resulted in an in situ formation of a separating layer, the in situ formation was nevertheless inherent. "The record shows formation of the in situ separating layer in the prior art even though that process was not recognized at the time. The new realization alone does not render that necessary [sic] prior art patentable.").
MPEP 2112 Requirements of Rejection Based on Inherency; Burden of Proof [R-08.2012]
The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 and 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.5.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983).
lll. A REJECTION UNDER 35 U.S.C. 102/103 CAN BE MADE WHEN THE PRIOR
ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THE PRIOR ART IS
SILENT AS TO AN INHERENT CHARACTERISTIC
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C.103 and for anticipation under 35. U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102/103 rejection is appropriate for these types of claims as well as for composition claims.
Claim(s) 1, 6, 8, 9, 11, 12, 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over AU2016100865A4 (IDS) in view of each of Airaksinen et al. (Beneficial Microbes, online July 2019, vol. 10, p. 617-627), WO2018050623, and WO2018/050650 (IDS).
AU2016100865A4 (IDS) teaches a multi-strain probiotic composition for re-colonizing microbiota and treating dysbiosis in a subject, thus improving gut health (abstract, 0012, 0013, 0017, 0028, 0047). Dysbiosis is linked to IBS, allergies, diabetes, obesity and can be caused by chronic stress, infection, diet, environmental insults, medications, and antibiotics, for example (0005, 0007) The composition comprises at least 8 probiotic bacterial strains (abstract, 0001, 0013) and wherein the composition comprises a total amount of greater than 100 billion to 1 trillion CFU (0014-0019, 0032) according to new claim 18. The bacterial strains are selected from Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis, Lactobacillus plantarum, Lactobacillus paracasei (0020, 0021, 0058, 0059) and according to claims 1, 6, 8, specifically include Lactobacillus acidophilus (NCFM), Bifidobacterium lactis (Bl-04, HN019, and Bi-07) , Lactobacillus rhamnosus (GG and HN001), Lactobacillus plantarum (Lp-115 and 299v), and Lactobacillus paracasei (Lpc-37) and any strain that has similar characteristics and in any combination (0020-0022, 0024, 0025, 0049). The composition is said to comprise 1-10 strain of each of Lactobacillus and Bifidobacteria, specifically 8 strains of Lactobacillus and 3 strains of Bifidobacteria (0025, 0058, for example). The composition may be in tablet or capsule form (0034).
The composition comprises at least 2 different strains of L. rhamnosus (Table 5-active ingredients, Ex. 3, 4, 0058, 0059).
Regarding claim 6, the composition comprises L. plantarum ATCC5209 (Lp-115) (0020-0022, 0024, 0025, 0049).
Regarding claims 11, 12, 18, the composition is disclosed to contain B. lactis (ATCC 5219 Bi-04) in amounts of 220 billion CFU, B. lactis (ATCC 5674 HN109) in amounts of 30 billion CFU, L. acidophilus in amounts of 50 billion CFU, L. plantarum (ATCC 5209 Lp-115) in amounts of 30 billion CFU, L. rhamnosus (ATCC 5675 HN001) in amounts of 10 billion CFU, L. rhamnosus (Lr-32) in amounts of 5 billion CFU and a teaching of L. rhamnosus in amounts ranging from 0-40 billion CFU (p. 35, Ex. 3, 4), and L. paracasei (ATCC 5275 Lpc-37) in amounts of 50 billion CFU (Table 5-Active ingredients, 0058, Ex. 3, 0059, Ex. 4). While the reference teaches and exemplifies amounts of B. lactis, L. acidophilus, L. plantarum, and L. paracasei and L. rhamnosus meeting applicants claimed amounts of claim 12, the amount of L. rhamnosus ATCC7017 (GG) is taught be administered in amounts ranging from 0-40 billion CFU (p. 35, Ex. 3, 4). Thus, the amount of L. rhamnosus ATCC7017 (GG) is taught to meet applicants at least 20 billion, as up to 40 billion CFU may be present in the composition. AU865 teaches that the composition comprising at least 8 probiotic strains has a total amount of from 100 billion to 1 trillion CFU and the amounts are optimizable so long as they do not exceed the upper limit (0013-0019, 0032), thus meeting the limitation of claim 18.
Regarding claims 15 and 16, the composition is administered to a subject to maintain the balance of the microbiota of the intestine (recolonizing intestinal microbiota) and to treat dysbiosis (0026-0028).
Regarding applicants’ limitation of claims 1, 8, and 12, drawn to the composition comprising at least 3 strains of B. lactis and specifically strains Bi-07, Bl-04 and HN019, AU865 teaches that strains Bi-07, Bl-04 and HN019 can be used in the composition, and while they exemplify only 2 strains of B. lactis (Bi-07 and Bl-04), the reference teaches that any combination of the disclosed strains can be used in the probiotic composition. The reference does not teach the additional inactive ingredient of claim 1.
Further, Airaksinen teach a probiotic composition comprising Lactobacillus acidophilus NCFM (1010 CFU), Lactobacillus paracasei Lpc-37 (2.5x109 CFU), Bifidobacterium animalis subsp. lactis B1-04 (2.5x109 CFU), Bi-07 (2.5x109 CFU) and HN109 (1010 CFU) to treat gastrointestinal disorders including bloating, flatulence, and constipation (abstract). The composition is administered to subjects to treat constipation and bloating associated with irritable bowel syndrome, as well as relieving irregularity, improving stool consistency and increasing microbial abundance (p. 618-619, Study design section, p. 619, last parag.-p. 620, 1st parag., Fig. 3, 4).
WO2018050623 teach a probiotic composition comprising Lactobacillus acidophilus NCFM, Bifidobacterium lactis Bl-04, HN019 and Bi-07, and Lactobacillus paracasei Lpc-37 to treat gastrointestinal disorder (abstract, p. 2, lines 30-p. 3, lines 1-9, p. 5, lines 5-12, claim 9). The composition may be formulated as a capsule or tablet (p. 13, lines 5-7, p. 18, lines 8-10, 15) and may contain additional ingredients including microcrystalline cellulose and magnesium stearate, for example (p. 18, lines 19-31).
WO2018/050650 (IDS) teaches a probiotic composition which comprises Lactobacillus acidophilus NCFM, Bifidobacterium lactis HN019, Bi-07, and BI-04, and Lactobacillus paracasei Lpc-37 (claim 7) to treat gastrointestinal disorders. WO’650 teaches the composition to comprise additional ingredients including microcrystalline cellulose and magnesium stearate, for example (p. 19, lines 34-p. 20, lines 1-10). WO’650 teaches the composition may in tablet and capsule form (p. 19, lines 8-10, 23-25, 30-p. 20, lines 5-21).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to formulate a probiotic composition comprising Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis, Lactobacillus plantarum, and Lactobacillus paracasei, specifically comprising the claimed probiotic strains of Lactobacillus acidophilus (NCFM), 3 strains of Bifidobacterium lactis (Bl-04, HN019, and Bi-07) , Lactobacillus rhamnosus (GG and HN001), Lactobacillus plantarum (Lp-115), and Lactobacillus paracasei (Lpc-37) because the art teaches probiotic compositions comprising the claimed strains, suggesting mixtures of the claimed probiotic bacteria of up to 10 strains, including 3 different strains of B. lactis to treat gastrointestinal disorders and dysbiosis of the gut. Therefore, one of ordinary skill in the art would have been motivated to combine to claimed strains disclosed by the art to be used in probiotic compositions and with a reasonable expectation of successfully treating at least gastrointestinal disorders and dysbiosis of the gut.
Regarding applicants newly added limitations to claim 1 of “for improving gut health” and “wherein consumption of the probiotic composition improves…”, the intended use and function of the claimed substrate does not patentably distinguish the composition, per se, since such undisclosed use and function is inherent in the reference composition. In order to be limiting, the intended use and function must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use and function fails to create a structural difference, thus, it is not limiting. Please note that when applicant claims acomposition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Moreover, the claimed function must be inherent to the reference composition. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new. Thus, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (see MPEP 2112)
II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) ("[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention."); Abbott Labs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319, 51 USPQ2d 1307, 1310 (Fed.Cir.1999) ("If a product that is offered for sale inherently possesses each of the limitations of the claims, then the invention is on sale, whether or not the parties to the transaction recognize that the product possesses the claimed characteristics."); Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1348-49, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999) ("Because ‘sufficient aeration’ was inherent in the prior art, it is irrelevant that the prior art did not recognize the key aspect of [the] invention.... An inherent structure, composition, or function is not necessarily known."); SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343-44, 74 USPQ2d 1398, 1406-07 (Fed. Cir. 2005) (holding that a prior art patent to an anhydrous form of a compound "inherently" anticipated the claimed hemihydrate form of the compound because practicing the process in the prior art to manufacture the anhydrous compound "inherently results in at least trace amounts of" the claimed hemihydrate even if the prior art did not discuss or recognize the hemihydrate); In re Omeprazole Patent Litigation, 483 F.3d 1364, 1373, 82 USPQ2d 1643, 1650 (Fed. Cir. 2007) (The court noted that although the inventors may not have recognized that a characteristic of the ingredients in the prior art method resulted in an in situ formation of a separating layer, the in situ formation was nevertheless inherent. "The record shows formation of the in situ separating layer in the prior art even though that process was not recognized at the time. The new realization alone does not render that necessary [sic] prior art patentable.").
MPEP 2112 Requirements of Rejection Based on Inherency; Burden of Proof [R-08.2012]
The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 and 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.5.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983).
lll. A REJECTION UNDER 35 U.S.C. 102/103 CAN BE MADE WHEN THE PRIOR
ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THE PRIOR ART IS
SILENT AS TO AN INHERENT CHARACTERISTIC
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C.103 and for anticipation under 35. U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102/103 rejection is appropriate for these types of claims as well as for composition claims.
Claim(s) 11, 12, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2018/050650 (IDS) as applied to claims 1, 6, 8, 9, 15, 16 above, and further in view of AU2016100865A4 (IDS).
WO’650 teaches a probiotic composition comprising a mixture of (up to 10) bacterial strains (p. 11, lines 13-20) including Lactobacillus acidophilus NCFM, Lactobacillus rhamnosus HN001, Bifidobacterium lactis HN019, Bifidobacterium lactis Bi-07, Bifidobacterium lactis BI-04, Lactobacillus plantarum Lp-115, Lactobacillus paracasei Lpc-37, Lactobacillus rhamnosus Lr-32, Lactobacillus rhamnosus GG, Bifidobacterium lactis Bb-12, Lactobacillus rhamnosus GR-1, Lactobacillus rhamnosus Rosell-11, Lactobacillus rhamnosus HA-11 , Lactobacillus plantarum HA-119 (p. 3, lines 26-p. 4, lines 1-10). The reference specifically teaches a probiotic composition which comprises Lactobacillus acidophilus NCFM, Bifidobacterium lactis HN019, Bifidobacterium lactis Bi-07, Bifidobacterium lactis BI-04, and Lactobacillus paracasei Lpc-37 and one or more of L. rhamnosus GG, L. rhamnosus HN001, L. plantarum Lp-115, (p. 12, lines 5-30, claim 7). WO’650 teaches the composition to comprise additional ingredients including microcrystalline cellulose and magnesium stearate, for example (p. 19, lines 34-p. 20, lines 1-10). WO’650 teaches the composition may in tablet and capsule form (p. 19, lines 8-10, 23-25, 30-p. 20, lines 5-21).
The microorganisms are present in the composition in amounts of 106-1012 CFU of bacteria/microorganism/dose (p. 13, lines 9-30).
Regarding claims 1, 15 and 16, the reference teaches the composition is administered to a subject to enhance intestinal mucosal immunity, increase probiotic and indigenous lactobacilli, treat urogenital and gastrointestinal disorders (p. 2, lines 30-37, p. 5, lines 25-p. 6, lines 1-6). The probiotic composition is used in the treatment of a gastrointestinal disorder. “As used herein, the term "gastrointestinal disorder" includes any disease or disorder relating to the gastrointestinal tract. The disorder may, for example, be one that is known to be associated with an altered composition and diversity of the GIT microbiota. The gastrointestinal disorder may be inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), Crohn's disease, ulcerative colitis, constipation or diarrhea” (p. 18, lines 33-37), thereby improving gut health.
WO’650 does not teach the limitations of claims 11, 12, and 18.
AU2016100865A4 (IDS) teaches a multi-strain probiotic composition for re-colonizing microbiota and treating dysbiosis in a subject (abstract, 0012, 0013, 0017, 0047). The composition comprises at least 8 probiotic bacterial strains (abstract, 0001, 0013) and wherein the composition comprises a total amount of greater than 100 billion to 1 trillion CFU (0014-0019, 0032),thus meeting the limitations of claim 18. The bacterial strains are selected from Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis, Lactobacillus plantarum, Lactobacillus paracasei (0020, 0021, 0058, 0059) and according to claims 1, 2, 5-8, specifically include Lactobacillus acidophilus (NCFM), Bifidobacterium lactis (Bl-04, HN019, and Bi-07) , Lactobacillus rhamnosus (GG and HN001), Lactobacillus plantarum (Lp-115 and 299v), and Lactobacillus paracasei (Lpc-37) and any strain that has similar characteristics and in any combination (0020-0022, 0024, 0025, 0049). The composition is said to comprise 1-10 strain of each of Lactobacillus and Bifidobacteria, specifically 8 strains of Lactobacillus and 3 strains of Bifidobacteria (0025, 0058, for example).
Regarding claims 11 and 12, the composition is disclosed to contain B. lactis (ATCC 5219 Bi-04) in amounts of 220 billion CFU, B. lactis (ATCC 5674 HN109) in amounts of 30 billion CFU, L. acidophilus in amounts of 50 billion CFU, L. plantarum (ATCC 5209 Lp-115) in amounts of 30 billion CFU, L. rhamnosus (ATCC 5675 HN001) in amounts of 10 billion CFU, L. rhamnosus (Lr-32) in amounts of 5 billion CFU and a teaching of L. rhamnosus in amounts ranging from 0-40 billion CFU (p. 35, Ex. 3, 4), and L. paracasei (ATCC 5275 Lpc-37) in amounts of 50 billion CFU (Table 5-Active ingredients, 0058, Ex. 3, 0059, Ex. 4). While the reference teaches and exemplifies amounts of B. lactis, L. acidophilus, L. plantarum, and L. paracasei and L. rhamnosus meeting applicants claimed amounts of claim 12, the amount of L. rhamnosus ATCC7017 (GG) is taught be administered in amounts ranging from 0-40 billion CFU (p. 35, Ex. 3, 4). Thus, the amount of L. rhamnosus ATCC7017 (GG) is taught to meet applicants at least 20 billion, as up to 40 billion CFU may be present in the composition. AU865 teaches that the composition comprising at least 8 probiotic strains has a total amount of from 100 billion to 1 trillion CFU and the amounts are optimizable so long as they do not exceed the upper limit (0013-0019, 0032).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to formulate a probiotic composition comprising the claimed strains taught by the art in the amounts according to claims 11, 12, and 18 because AU865 teaches and exemplifies amounts of B. lactis, L. acidophilus, L. plantarum, and L. paracasei and L. rhamnosus meeting applicants claimed amounts of claim 12, and the amount of L. rhamnosus ATCC7017 (GG) is taught be administered in amounts ranging from 0-40 billion CFU (p. 35, Ex. 3, 4). AU865 teaches that the composition comprising at least 8 probiotic strains has a total amount of from 100 billion to 1 trillion CFU and the amounts are optimizable so long as they do not exceed the upper limit (0013-0019, 0032).
Therefore, the art suggests the claimed amounts present in a probiotic composition comprising the claimed strains and thus one of ordinary skill in the art could have pursued known options within his or her technical grasp with a reasonable expectation of success.
Regarding applicants newly added limitations to claim 1 of “for improving gut health” and “wherein consumption of the probiotic composition improves…”, the intended use and function of the claimed substrate does not patentably distinguish the composition, per se, since such undisclosed use and function is inherent in the reference composition. In order to be limiting, the intended use and function must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use and function fails to create a structural difference, thus, it is not limiting. Please note that when applicant claims acomposition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Moreover, the claimed function must be inherent to the reference composition. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new. Thus, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (see MPEP 2112)
II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) ("[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention."); Abbott Labs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319, 51 USPQ2d 1307, 1310 (Fed.Cir.1999) ("If a product that is offered for sale inherently possesses each of the limitations of the claims, then the invention is on sale, whether or not the parties to the transaction recognize that the product possesses the claimed characteristics."); Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1348-49, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999) ("Because ‘sufficient aeration’ was inherent in the prior art, it is irrelevant that the prior art did not recognize the key aspect of [the] invention.... An inherent structure, composition, or function is not necessarily known."); SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343-44, 74 USPQ2d 1398, 1406-07 (Fed. Cir. 2005) (holding that a prior art patent to an anhydrous form of a compound "inherently" anticipated the claimed hemihydrate form of the compound because practicing the process in the prior art to manufacture the anhydrous compound "inherently results in at least trace amounts of" the claimed hemihydrate even if the prior art did not discuss or recognize the hemihydrate); In re Omeprazole Patent Litigation, 483 F.3d 1364, 1373, 82 USPQ2d 1643, 1650 (Fed. Cir. 2007) (The court noted that although the inventors may not have recognized that a characteristic of the ingredients in the prior art method resulted in an in situ formation of a separating layer, the in situ formation was nevertheless inherent. "The record shows formation of the in situ separating layer in the prior art even though that process was not recognized at the time. The new realization alone does not render that necessary [sic] prior art patentable.").
MPEP 2112 Requirements of Rejection Based on Inherency; Burden of Proof [R-08.2012]
The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 and 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.5.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983).
lll. A REJECTION UNDER 35 U.S.C. 102/103 CAN BE MADE WHEN THE PRIOR
ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THE PRIOR ART IS
SILENT AS TO AN INHERENT CHARACTERISTIC
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C.103 and for anticipation under 35. U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102/103 rejection is appropriate for these types of claims as well as for composition claims.
Response to Arguments
Applicant's arguments filed 5/27/2025 have been fully considered but they are not persuasive.
Applicants arguments directed at each of WO’650 are that the reference does not teach the specific combination of probiotics but a laundry list of probiotics to be in the composition. Applicants argue that the reference teaches the composition for urogenital disorders and the claimed composition now claims improves intestinal microbiome diversity, Firmicutes/Bacteroides ratio, and/or encourages growth of beneficial microbiota not in the probiotic composition itself. Applicants argue that the microbiota not contained in the probiotic composition itself. Applicants state that “For the sake of argument, even if WO’650 were to teach or suggest the now claimed composition, which it does not, the fact that a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic. In re Rijckaert, 9 F.3d 1531, 1534, 28 USPQ2d 1955, 1957 (Fed. Cir. 1993). Plus, “In relying upon the theory of inherency, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art.” Ex parte Levy, 17 USPQ2d 1461, 1464 (Bd. Pat. App. & Inter. 1990).”
It is the Examiners position that WO’650 specifically teaches a probiotic composition which comprises Lactobacillus acidophilus NCFM, Bifidobacterium lactis HN019, Bifidobacterium lactis Bi-07, Bifidobacterium lactis BI-04, and Lactobacillus paracasei Lpc-37 and one or more of L. rhamnosus GG, L. rhamnosus HN001, L. plantarum Lp-115, (p. 12, lines 5-30, claim 7), wherein the composition comprises additional ingredients including microcrystalline c