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 3/12/2026 has been received and entered into the case. Claims 3, 4, 9-11, 17, 18, 22-25 are pending and have been considered on the merits. All arguments and amendments have been considered.
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) 3, 4, 9-11, 17, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2019/129807 (IDS).
Regarding claims 3, 4, 17, WO’807 teaches a method comprising administering a composition comprising a therapeutically effective amount serpin protein producing B. longum strain CNCM I-2628 (NCC2705) to an individual in need thereof, wherein said individual has celiac disease and gluten-related/gluten-sensitivity disorders triggered by gluten (p. 1, lines 6-11, 21-p. 2, lines 1-6, p. 4, lines 29-31, p. 9, lines 26-p. 12, whole page). Celiac disease is triggered by the digestion of wheat gluten and other cereal proteins from rye and barley, for example (p. 1, lines 24-25). B. longum CNCM I-2618 is disclosed to be used in the treatment or prevention of conditions related to gluten sensitivity or involving reduced activity of serine protease inhibitors (p. 9, lines 26-28) including specifically celiac disease (p. 10, lines 2, 6, 7). Serine protease inhibitors are known to play a role in gluten-related disorders as having potent inhibitory capacity of elastases and proteinases, and having a role in celiac disease by inhibiting transglutaminase 2, thus inhibiting deamidation of a 33-mer gliadin peptide (this activity is in itself glutenasic activity), which is a trigger of the adaptive immune response in celiac disease. The serpin protein of B. longum NCC2705 display similar antiprotease activity (p. 2, lines 10-30).
WO’807 teaches that “Clinical evidence shows class Il human leukocyte antigens (HLA-DQII), which strongly relate with celiac disease pathology, are expressed in about 95% of celiac disease patients. In the intestinal lumen, gluten proteins are partially digested, forming proteolytic-resistant 33-mer gluten peptides. After crossing the small intestinal barrier, they are deamidated by transglutaminase 2 (TG2) with negative charges (Sollid, 2000, Annual review of immunology, 18(1), 53-81), which then bind to the positively charged binding sites of HLA-DQ2.5/8 (Dieterich et al., 1997, Nature medicine, 3(7), 797-801). HLA-DQ2.5/8 displaying those specific gluten peptides signals to helper T cells and other immune cells causing further damage in the small intestine. Antibodies against gluten proteins and autoantibodies to connective tissue components (TG2) also associated with celiac disease progression (Alaedini & Green, 2005, Annals of internal medicine, 142(4), 289-298)” (p. 10, lines 19-28).
Regarding claim 4, 17, WO’807 teaches that gluten contains the cytotoxic protein gliadin as well as other proteins/peptides which contribute to symptoms of gluten-related disorders including celiac disease. Serine protease inhibitors (serpins) have been shown to have potent inhibitory role in gluten-related disorders including potent antiprotease activity and B. longum subsp longum NCC2705 contains serpins having antiprotease activity and protect against proteases in the GI tract, which improve gluten induced pathophysiology in the mouse model of gluten sensitivity and thus is a solution for gluten related disorders (p. 2, lines 2-21, 27-31, p. 3, lines 1-6, Ex. 2 p. 15-16).
Regarding claims 9 and 10, WO’807 teach the composition comprising B. longum strain CNCM I-2628 (NCC2705) to be in the form of a food, medical food, nutritional supplement or pharmaceutical composition, a powder, a tablet, a capsule, and a lozenge (p. 4, lines 8-31, p. 5, lines 21-30, p. 7, lines 9-10).
Regarding claim 11, the composition comprises between 106-1010 cfu of B. longum NCC2705 per dose (p. 7, lines 20-23). Further, the reference teaches that the ideal dose will depend on the subject to be treated, which will vary but can be easily determined by those of skill in the art.
The claimed invention is drawn to a single method step of administering a composition comprising therapeutically effective amount of a serpin producing B. longum strain CNCM I-2628 (NCC2705) to an individual in need, wherein said individual in need thereof has celiac disease.
WO’807 teaches the single method step of administering a composition comprising therapeutically effective amount of a serpin producing B. longum strain CNCM I-2628 (NCC2705) to an individual in need (those having gluten-related disorders), wherein said individual in need thereof has celiac disease. The reference teaches that serine protease inhibitors (serpins) have been shown to have potent inhibitory role in gluten-related disorders including potent antiprotease activity and B. longum subsp longum NCC2705 contains serpins having antiprotease activity and protect against proteases in the GI tract, which improve gluten induced pathophysiology in the mouse model of gluten sensitivity and thus is a solution for gluten related disorders (p. 2, lines 2-21, 27-31, p. 3, lines 1-6, Ex. 2 p. 15-16). It is important to note that applicants state that the presence of serpin in the duodenum may confer advantageous properties such as reduced digestion of gluten by reduction of gluten-related proteolytic activity (0133, 0135).
While the cited reference does not teach that their composition is used in a method of inhibiting digestion of gluten, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition 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. (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.").
Further, applicants’ amendments to claims 3 and 22 drawn to “wherein the administering of the composition reduces duodenal glutenasic activity in the individual with celiac disease by at least 40%” and “wherein administration of the composition increases serpin concentration in the individual with celiac disease by at least 40%” are taken to necessarily be happening when administering the same composition to the same patient population, i.e. a result on the process step of administering. The whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d. 1614, 1620 (Fed. Cir. 2003)). The only method step is administering, and thus the reduction of activity and increase in serpin concentration are only intended results of administering the composition, as well as a function of the preparation. The method of WO’807 is drawn to the same method as claimed, i.e. a B. longum CNCM I-2628 (NCC2705) composition administered to the same celiac subjects. Thus, it is the Examiners position that these results are inherent to the administration step taught by WO’807. One would necessarily expect to achieve the same results when practicing the method of WO’807, which is the same as applicants claimed method.
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).
WO’807 does not teach administration twice a day according to claims 3 and 17, WO’807 does however teaches that the ideal dose will depend on the subject to be treated, which will vary but can be easily determined by those of skill in the art (p. 7, lines 16-19). Thus, before the effective filing date of the claimed invention, determining dosing and administration would be well within the purview of one of ordinary skill in the art and would be a result effective variable optimizable by one of ordinary skill in the art.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2019/129807 (IDS) as applied to claims 3, 4, 9-11, 17, 22 above, and further in view of Otten B. ( Safety of Bifidobacterium longum NCC 2705 and production of its serpin in patients with celiac disease and non-celiac gluten sensitivity. UEG Week Virtual Symposium 2020, abstract OP174 (https://www.esanum.com/today/posts/probiotic-provides-a-potential-adjuvant-treatment-to-gluten-free-diet, 2/11/2020) and Olivares et al. (Br. J. Nutr., 2014).
The teachings of WO’807 are found above.
WO’807 does not teach a double-blinded placebo-controlled study according to claim 18.
Regarding claim 18, double-blinded placebo-controlled studies are routine and well-known in the art, specifically when studying the effects of probiotic administration in celiac patients. See Otten who teach a double-blinded placebo study and Olivares who teach a double-blinded randomized control trial wherein celiac patients receive a placebo or B. longum capsule to study effects (abstract).
Therefore, before the effective filing date of the claimed invention, one of ordinary skill in the art could have pursued known options within his or her technical grasp to study probiotic effects in celiac patients with a reasonable expectation of success.
Claim(s) 3, 4, 9-11, 17, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCarville (Appl. And Env. Microb., 2017, IDS) in view of WO2019/129807.
McCarville teach a method of treating gluten/gliadin-related immunopathology comprising orally administering the serpin producing Bifidobacterium longum strain NCC2705 to gliadin-sensitized NOD/DQ8 mouse model of gluten sensitivity/celiac disease (abstract, p. 2, last parag.-p. 3, . McCarville discloses “ We have previously shown that expression of the human serine protease inhibitor (serpin) elafin is decreased in the duodenum of patients with active CeD (celiac disease). Recombinant Lactococcus lactis expressing elafin (L. lactis-elafin) has been shown (i) to be protective in several murine colitis models and (ii) to prevent gluten immunopathology in the NOD/DQ8 mouse model of gluten sensitivity…Although eukaryotic serpins such as elafin are known to possess anti-inflammatory properties, bacterially produced serpins have not been explored for their therapeutic capacity in vivo. The infant-derived commensal probiotic strain Bifidobacterium longum NCC2705 (B. longum srp+) produces a serpin (Srp) encoded by the BL0108 (srp) gene in a nonconstitutive manner. Expression of srp is induced in the murine intestinal tract, and Srp may exhibit anti-inflammatory properties as it inhibits both pancreatic elastase and neutrophilic elastase in vitro. We tested the hypothesis that administration of the commensal B. longum srp+ prevents immunopathology in the NOD/DQ8 mouse model of gluten sensitivity.
We show that both the wild-type B. longum srp+ strain and a recombinant strain constitutively expressing srp [B. longum srp(Con)] prevent gliadin-induced immunopathology in NOD/DQ8 mice, whereas an srp knockout strain (B. longum Δsrp) does not. These results clearly suggest that the beneficial effect of B. longum srp+ is mediated by Srp” (p. 2, 1st and 2nd full parag.).
McCarville teach that the administration of the serpin producing strain NC2705 to a gluten-sensitive mouse model prevented inflammation induced by gliadin and effectively inhibit serine proteases (elastase) in the mouse model and protected mice from developing gliadin-induced immunopathology; therefore, having immunomodulating capacity treating gastrointestinal inflammatory conditions and gluten-related disorders (p. 6, last parag.-p. 9, p. 10, Mucosal delivery section).
The claimed invention is drawn to a single method step of administering a composition comprising therapeutically effective amount of a serpin producing B. longum strain CNCM I-2628 (NCC2705) to an individual in need, wherein said individual in need thereof has celiac disease.
McCarville teaches the single method step of administering a composition comprising therapeutically effective amount of a serpin producing B. longum strain CNCM I-2628 (NCC2705) to an individual in need (those having gluten-related disorders), wherein said individual in need thereof is a celiac disease model mouse. The reference teaches that serine protease inhibitors (serpins) have been shown to have potent inhibitory role in gluten-related disorders including potent antiprotease activity and teach that the administration of the serpin producing strain NC2705 to a gluten-sensitive mouse model prevented inflammation induced by gliadin and effectively inhibit serine proteases (elastase) in the mouse model and protected mice from developing gliadin-induced immunopathology; therefore, having immunomodulating capacity treating gastrointestinal inflammatory conditions and gluten-related disorders.
While the cited reference does not teach that their composition is used in a method of inhibiting digestion of gluten, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition 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. (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.").
Further, applicants’ amendments to claims 3 and 22 drawn to “wherein the administering of the composition reduces duodenal glutenasic activity in the individual with celiac disease by at least 40%” and “wherein administration of the composition increases serpin concentration in the individual with celiac disease by at least 40%” are taken to necessarily be happening when administering the same composition to the same patient population, i.e. a result on the process step of administering. The whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d. 1614, 1620 (Fed. Cir. 2003)). The only method step is administering, and thus the reduction of activity and increase in serpin concentration are only intended results of administering the composition, as well as a function of the preparation. The method of WO’807 is drawn to the same method as claimed, i.e. a B. longum CNCM I-2628 (NCC2705) composition administered to the same celiac subjects. Thus, it is the Examiners position that these results are inherent to the administration step taught by WO’807. One would necessarily expect to achieve the same results when practicing the method of WO’807, which is the same as applicants claimed method.
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).
McCarville does not teach the composition forms of claims 9-10, nor the dosing of claims 3, 11, and 17.
WO’807 teaches a method comprising administering a composition comprising a therapeutically effective amount of B. longum strain CNCM I-2628 (NCC2705) to an individual in need thereof, wherein said individual has celiac disease and gluten-related/gluten-sensitivity disorders triggered by gluten (p. 1, lines 6-11, 21-p. 2, lines 1-6, p. 9, lines 26-p. 12).
Regarding claims 9 and 10, WO’807 teach the composition comprising B. longum strain CNCM I-2628 (NCC2705) to be in the form of a food, medical food, nutritional supplement or pharmaceutical composition, a powder, a tablet, a capsule, and a lozenge (p. 4, lines 8-31, p. 5, lines 21-30, p. 7, lines 9-10).
Regarding claim 11, the composition comprises between 106-1010 cfu of B. longum NCC2705 per dose (p. 7, lines 20-23).
Thus, before the effective filing date of the claimed invention, it would have been obvious to formulate the composition of McCarville comprising B. longum NC2705 for administration to a subject in need thereof, specifically having celiac disease, in the dosage forms as taught by WO’807 because the reference teaches treating celiac disease patients with B. longum NC2705 compositions which can be formulated as claimed. Therefore, a person of ordinary skill in the art has good reason to pursue the known options within his or her technical grasp with a reasonable expectation of success.
WO’807 does not teach administration twice a day according to claims 3 and 17, WO’807 does however teach that the ideal dose will depend on the subject to be treated, which will vary but can be easily determined by those of skill in the art (p. 7, lines 16-19). Thus, before the effective filing date of the claimed invention, determining dosing and administration would be well within the purview of one of ordinary skill in the art and would be a result effective variable optimizable by one of ordinary skill in the art.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCarville (Appl. And Env. Microb., 2017, IDS) in view of WO2019/129807 as applied to claims 3, 4, 9-11, 17, 22 above, and further in view of further in view of Otten B. ( Safety of Bifidobacterium longum NCC 2705 and production of its serpin in patients with celiac disease and non-celiac gluten sensitivity. UEG Week Virtual Symposium 2020, abstract OP174 (https://www.esanum.com/today/posts/probiotic-provides-a-potential-adjuvant-treatment-to-gluten-free-diet, 2/11/2020) and Olivares et al. (Br. J. Nutr., 2014).
The teachings of McCarville in view of WO’807 are found above.
McCarville does not teach a double-blinded placebo-controlled study according to claim 18.
See Otten who teach a double-blinded placebo study and Olivares who teach a double-blinded randomized control trial wherein celiac patients receive a placebo or B. longum capsule to study effects (abstract).
Therefore, before the effective filing date of the claimed invention, one of ordinary skill in the art could have pursued known options within his or her technical grasp to study probiotic effects in celiac patients with a reasonable expectation of success.
Claim(s) 3, 4, 9-11, 17, 18, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Otten, B. (Safety of Bifidobacterium longum NCC 2705 and production of its serpin in patients with celiac disease and non-celiac gluten sensitivity. UEG Week Virtual Symposium 2020, abstract OP174 (https://www.esanum.com/today/posts/probiotic-provides-a-potential-adjuvant-treatment-to-gluten-free-diet, 2/11/2020) in view of WO2019/129807.
Otten teaches a placebo-controlled, cross-over trial wherein B. longum NC2705 is administered to celiac patients as a treatment to protects from accidental gluten intake.
The claimed invention is drawn to a single method step of administering a composition comprising therapeutically effective amount of a serpin producing B. longum strain CNCM I-2628 (NCC2705) to an individual in need, wherein said individual in need thereof has celiac disease.
Otten teaches the single method step of administering a composition comprising therapeutically effective amount of a serpin producing B. longum strain CNCM I-2628 (NCC2705) to an individual in need (those having gluten-related disorders), wherein said individual in need thereof has celiac disease.
While the cited reference does not teach that their composition is used in inhibiting production of toxigenic and/or immunogenic peptides from gluten, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition 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. (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.").
Further, applicants’ amendments to claims 3 and 22 drawn to “wherein the administering of the composition reduces duodenal glutenasic activity in the individual with celiac disease by at least 40%” and “wherein administration of the composition increases serpin concentration in the individual with celiac disease by at least 40%” are taken to necessarily be happening when administering the same composition to the same patient population, i.e. a result on the process step of administering. The whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d. 1614, 1620 (Fed. Cir. 2003)). The only method step is administering, and thus the reduction of activity and increase in serpin concentration are only intended results of administering the composition, as well as a function of the preparation. The method of WO’807 is drawn to the same method as claimed, i.e. a B. longum CNCM I-2628 (NCC2705) composition administered to the same celiac subjects. Thus, it is the Examiners position that these results are inherent to the administration step taught by WO’807. One would necessarily expect to achieve the same results when practicing the method of WO’807, which is the same as applicants claimed method.
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
Otten does not teach the composition forms of claims 9-10, nor the dosing of claims 3 and 11.
WO’807 teaches a method comprising administering a composition comprising a therapeutically effective amount of B. longum strain CNCM I-2628 (NCC2705) to an individual in need thereof, wherein said individual has celiac disease and gluten-related/gluten-sensitivity disorders triggered by gluten (p. 1, lines 6-11, 21-p. 2, lines 1-6, p. 9, lines 26-p. 12).
Regarding claims 9 and 10, WO’807 teach the composition comprising B. longum strain CNCM I-2628 (NCC2705) to be in the form of a food, medical food, nutritional supplement or pharmaceutical composition, a powder, a tablet, a capsule, and a lozenge (p. 4, lines 8-31, p. 5, lines 21-30, p. 7, lines 9-10).
Regarding claim 11, the composition comprises between 106-1010 cfu of B. longum NCC2705 per dose (p. 7, lines 20-23).
Thus, before the effective filing date of the claimed invention, it would have been obvious to formulate the composition of Otten comprising B. longum NC2705 for administration to a subject in need thereof, specifically having celiac disease, in the dosage forms as taught by WO’807 because the reference teaches treating celiac disease patients with B. longum NC2705 compositions which can be formulated as claimed. Therefore, a person of ordinary skill in the art has good reason to pursue the known options within his or her technical grasp with a reasonable expectation of success.
WO’807 does not teach administration twice a day according to claims 3 and 17, WO’807 does however teach that the ideal dose will depend on the subject to be treated, which will vary but can be easily determined by those of skill in the art (p. 7, lines 16-19). Thus, before the effective filing date of the claimed invention, determining dosing and administration would be well within the purview of one of ordinary skill in the art and would be a result effective variable optimizable by one of ordinary skill in the art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 3, 4, 9, 10, 17, 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6 of U.S. Patent No. 11590181. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed inventions are drawn to methods of treating those having celiac disease comprising administering a composition comprising B. longum CNCM I-2618 (NCC2705), which would those in need of inhibiting the digestion of gluten or production of toxigenic/immunogenic gluten peptides. The compositions are administered enterally, encompassing orally administered formulations according to instant claims 9-10. The inventions differ in that the composition of reference patent claim 1 includes a sugar; however, the composition and methods of instant claims include the open-ended language “comprising” and thus the composition or administration of a sugar with B. longum is not excluded from the instant claims.
Further, applicants’ amendments to claims 3 and 22 drawn to “wherein the administering of the composition reduces duodenal glutenasic activity in the individual with celiac disease by at least 40%” and “wherein administration of the composition increases serpin concentration in the individual with celiac disease by at least 40%” are taken to necessarily be happening when administering the same composition to the same patient population, i.e. a result on the process step of administering. The whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d. 1614, 1620 (Fed. Cir. 2003)). The only method step is administering, and thus the reduction of activity and increase in serpin concentration are only intended results of administering the composition, as well as a function of the preparation. The method of WO’807 is drawn to the same method as claimed, i.e. a B. longum CNCM I-2628 (NCC2705) composition administered to the same celiac subjects. Thus, it is the Examiners position that these results are inherent to the administration step taught by WO’807. One would necessarily expect to achieve the same results when practicing the method of WO’807, which is the same as applicants claimed method.
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
Therefore, the examined claims would be obvious over the reference patent claims.
Claims 3, 4, 17, 19, 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 and 15 of copending Application No. 17597304 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed inventions are drawn to methods of treating those having celiac disease comprising administering a composition comprising B. longum CNCM I-2618 (NCC2705), which would those in need of inhibiting the digestion of gluten or production of toxigenic/immunogenic gluten peptides. The inventions differ in that the composition of reference claim 14 includes a sugar; however, the composition and methods of instant claims include the open-ended language “comprising” and thus the composition or administration of a sugar with B. longum is not excluded from the instant claims. Therefore, the examined claims would be obvious over the reference claims.
Further, applicants’ amendments to claims 3 and 22 drawn to “wherein the administering of the composition reduces duodenal glutenasic activity in the individual with celiac disease by at least 40%” and “wherein administration of the composition increases serpin concentration in the individual with celiac disease by at least 40%” are taken to necessarily be happening when administering the same composition to the same patient population, i.e. a result on the process step of administering. The whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d. 1614, 1620 (Fed. Cir. 2003)). The only method step is administering, and thus the reduction of activity and increase in serpin concentration are only intended results of administering the composition, as well as a function of the preparation. The method of WO’807 is drawn to the same method as claimed, i.e. a B. longum CNCM I-2628 (NCC2705) composition administered to the same celiac subjects. Thus, it is the Examiners position that these results are inherent to the administration step taught by WO’807. One would necessarily expect to achieve the same results when practicing the method of WO’807, which is the same as applicants claimed method.
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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
New rejection of record necessitated by filing of Application NO. 19447621
Claims 3, 4, 17, 19, 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-7 of copending Application No. 19447621 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed inventions are drawn to methods of treating those having celiac disease comprising administering a composition comprising B. longum CNCM I-2618 (NCC2705), which would those in need of inhibiting the digestion of gluten or production of toxigenic/immunogenic gluten peptides. The inventions differ in that the composition of reference claim 4 includes a fructose disaccharide, FOS or combinations thereof; however, the composition and methods of instant claims include the open-ended language “comprising” and thus the composition or administration of a fructose disaccharide, FOS or combinations thereof with B. longum is not excluded from the instant claims. Therefore, the examined claims would be obvious over the reference claims.
Further, applicants’ amendments to claims 3 and 22 drawn to “wherein the administering of the composition reduces duodenal glutenasic activity in the individual with celiac disease by at least 40%” and “wherein administration of the composition increases serpin concentration in the individual with celiac disease by at least 40%” are taken to necessarily be happening when administering the same composition to the same patient population, i.e. a result on the process step of administering. The whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d. 1614, 1620 (Fed. Cir. 2003)). The only method step is administering, and thus the reduction of activity and increase in serpin concentration are only intended results of administering the composition, as well as a function of the preparation. The method of WO’807 is drawn to the same method as claimed, i.e. a B. longum CNCM I-2628 (NCC2705) composition administered to the same celiac subjects. Thus, it is the Examiners position that these results are inherent to the administration step taught by WO’807. One would necessarily expect to achieve the same results when practicing the method of WO’807, which is the same as applicants claimed method.
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).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 3/12/2026 have been fully considered but they are not persuasive.
Applicant argues that the references alone and in combination fail to render the claims obvious as the references do not teach or suggest the inhibition of duodenal glutenasic activity in an individual with celiac disease let alone a 40% reduction.
As cited above, applicants’ amendments to claims 3 and 22 drawn to “wherein the administering of the composition reduces duodenal glutenasic activity in the individual with celiac disease by at least 40%” and “wherein administration of the composition increases serpin concentration in the individual with celiac disease by at least 40%” are taken to necessarily be happening when administering the same composition to the same patient population, i.e. a result on the process step of administering. The whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d. 1614, 1620 (Fed. Cir. 2003)). The only method step is administering, and thus the reduction of activity and increase in serpin concentration are only intended results of administering the composition, as well as a function of the preparation. The method of WO’807 is drawn to the same method as claimed, i.e. a B. longum CNCM I-2628 (NCC2705) composition administered to the same celiac subjects. Thus, it is the Examiners position that these results are inherent to the administration step taught by WO’807. One would necessarily expect to achieve the same results when practicing the method of WO’807, which is the same as applicants claimed method.
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
Applicants also argue that these results are superior as the specification demonstrates superior glutenasic activity inhibition in CD patients compared to NCGS and that in both CD and NCGS subject, the serpin concentration Cmax was significantly higher compared to placebo after administration of the composition.
First, applicants’ arguments directed against CD vs. NCGS subjects are not persuasive as the prior art cited is directed to celiac patients, thus, the composition is administered to the claimed subject population. Additionally finding that serpin concentration is significantly higher in subjects administered a serpin producing microbe compared to a placebo is not surprising or unexpected.
Regarding Duboux, applicant argues that the reference focuses on increasing serpin activity and teaches elastase inhibition, not glutenasic activity inhibition.
It is the Examiners position that Duboux teaches that serine protease inhibitors (serpins) have been shown to have potent inhibitory role in gluten-related disorders including potent antiprotease activity and B. longum subsp longum NCC2705 contains serpins having antiprotease activity and protect against proteases in the GI tract, which is itself glutenasic activity.
Regarding McCarville, applicants again argue the mouse model and that the reference does not demonstrate development or reversal of severe villous atrophy or modulation of anti-TG2 autoimmunity.
As previously addressed by the Examiner, first, the claims are not drawn to limitations directed towards development or reversal of severe villous atrophy or modulation of anti-TG2 autoimmunity, and regarding NOD/DQ8 mice being an inappropriate model to support celiac disease, this mouse model relates to mice which carry the HLA-DQ8 gene, a major celiac susceptibility factor, predisposing them to autoimmune conditions. Further, when these mice are fed gluten, they develop celiac related intestinal changes and damage to the intestinal lining, i.e. villous atrophy.
Support is provided by Murray https://mayoclinic.elsevierpure.com/en/projects/a-hla-mouse-model-for-gluten-sensitivity-and-enteropathy-10/#:~:text=DQ8%20mouse%2C%20once%20sensitized%20to,new%20prevention%20or%20treatment%20strategies, and Galipeau who teach that CD is a common autoimmune disease caused by the ingestion of gluten composed of the proteins gliadin and glutenin and carry HLA-DQ8 contributing to disease susceptibility by presenting toxic gliadins and glutenins to CD4+ T lymphocytes (p.1 1st parag.-p. 2, 1st parag.). The NOD/DQ8 mouse model develop activation of the innate and adaptive arms of the immune system and gliadin induced mucosal dysfunction and enteropathy (p. 5, Results gliadin-sens section) as well as developed anti-gliadin and anti-Tg (transglutaminase) antibodies (p. 6, 1st 3 parag., p. 9, Discussion section, 1st parag.) is a gliadin-sensitized mouse which develops moderate enteropathy, lymphocytosis, barrier dysfunction and which confers susceptibility to celiac disease by presenting toxic gliadins and glutenins to CD4+ T lymphocytes (abstract, p..). Thus, the NOD/DQ8 models is one which develops gluten-sensitive enteropathy and anti-TG2 antibodies.
It is the Examiners position that one of ordinary skill in the art would appreciate that the NOD/DQ8 model is and was known to be a model of celiac disease and one which at least reflects a model of gluten-related disorders (all triggered by gluten) in which the administration of a serpin-producing B. longum strain effectively prevented gliadin (toxigenic/and or immunogenic peptides from gluten) immunopathology when challenged with gliadin, thus inhibiting digestion of gluten and production of peptides from gluten as claimed.
Applicants also argue that because they have claimed a quantified reduction of activity and recited a therapeutically effective amount, that the claims create a structural difference from that of the compositions of the cited art.
It should be noted that the effective amount claimed is taught by the prior art of record and thus, the compositions fail to provide a structural difference as argued.
It is the Examiners position that a prior art reference teaching administering a serpin protein producing B. longum strain to an individual with celiac disease would anticipate the claimed invention as it teaches the single method step of administering a composition comprising therapeutically effective amount of a serpin producing B. longum strain CNCM I-2628 (NCC2705) to an individual having celiac disease. The patient population is the same, as is the composition. Each of WO’807, McCarville and Otten specifically teach administering a serpin-producing B. longum to treat a patient with celiac disease.
WO’807 teaches treating celiac disease comprising administering a composition comprising a serpin-producing B. longum strain NCC2705 (p. 4, lines 26-30, for example). Celiac disease is triggered by the ingestion or digestion of gluten, with gliadin being the main cytotoxic antigen of gluten. Serpins are encoded and produced by B. longum NCC2705 which improve gluten induced pathophysiology (p. 1-3) and used to treat or prevent condition related to gluten sensitivity (p. 9, lines 25-p. 10, lines 1-7).
Serpin, serine protease inhibitors, are taught to play an important role in gluten-related disorders as they inhibit elastases and proteinase and inhibit transglutaminase 2, thus inhibiting the deamidation of the 33-mer gliadin peptide, which is a trigger in the adaptive immune response in celiacs disease (p. 2, lines 21). The activity of serpin is in itself glutenasic activity. B. longum NCC2705 serpin production improves gluten induced pathophysiology in a mouse model gluten sensitivity, thus a solution for gluten related disorders (p. 3, lines 3-6).
McCarville teaches that the serpin producing B. longum NCC2705 demonstrates immune-modulating properties to treat gluten-related disorders. Celiac disease is a chronic enteropathy caused by ingestion of gluten-containing cereals in genetically susceptible individuals and celiac patients have a noted depletion of Bifidobacteria (intro) and a decrease of serpin in patients with active celiac (p. 2, 1st full parag.) Gliadin is a gluten protein which causes severe adverse reactions including autoimmune enteropathy celiac disease and non-celiac gluten sensitivity (p. 5, discussion section). The oral administration of the srp+ B. longum strain prevents gliadin induced inflammation in a genetically susceptible model, NOD/DQ8, which demonstrate a severe gluten immunopathology (p. 5-8, discussion section). The reference teaches that serpin-producing B. longum (srp+) prevent gliadin-induced immunopathology in the NOD/DQ8 mouse model. B. longum srp+ treated mice had lower CD3+ lymphocyte counts in the small intestine, inhibited human neutrophil elastase activity thus having anti-inflammatory properties, prevented gliadin (toxigenic/and or immunogenic peptides from gluten) immunopathology when challenged with gliadin.
Otten specifically discloses that in a mouse model of celiac disease, B. longum NCC2705 was shown to ameliorate gluten immunopathology though the production of serpin. In human placebo-controlled, cross-over trial, celiac patients were administered NCC2705, wherein serpin concentrations were increased in the duodenum and can be used as an adjuvant treatment to gluten-free diet to protect from accidental gluten intake.
Thus, each prior art reference teaches the amelioration of gluten/gliadin immunopathology when administering serpin-producing B. longum. Thus, one would have a reasonable expectation is inhibiting gluten or the production of toxigenic/immunogenic peptides from gluten in a celiac patient when administering the same claimed strain to a subject in which gliadin is a causes severe adverse reactions including autoimmune enteropathy celiac disease, and wherein glutenasic activity is decreased while increasing serpin activity.
The art as a whole teaches that the administration allows for the presence of B. longum and/or serpin in the duodenum which confers properties such as reduced digestion of gluten by reduction of gluten directed proteolytic activity and manage symptoms due to accidental gluten intake in patients with wheat allergy or celiac disease.
Applicants wish to hold the ODP rejections in abeyance until allowable subject matter is indicated.
Allowable Subject Matter
Claims 23-25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 TIFFANY MAUREEN GOUGH whose telephone number is (571)272-0697. The examiner can normally be reached M-Thu 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIFFANY M GOUGH/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
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