DETAILED ACTION
The present application is a domestic application filed 16 December 2022, which is a continuation of US Application No. 17/093,337 (now US Patent No. 11,529,364), filed 09 November 2020, and is a continuation of US Application No. 15/104,794 (now US Patent No. 10,828,313), filed 15 June 2016, which is a national stage entry of PCT/DK2015/050385, filed 08 December 2015, and claims foreign priority to DKPA 2014 70768, filed 08 December 2014.
Claims 1-20 are pending in the current application and are examined on the merits herein.
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 .
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) 1-7 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Newburg et al. (US Patent Application Publication No. 2012/0294840, cited in IDS submitted 02 March 2023) in view of Jung et al. (Korean J. Fam Med, vol. 34, no. 2, pp. 80-89, cited in PTO-892) and further in view of Strowski et al. (Gut, 2009, vol. 58, no. 8, pp. 1044-1045, cited in PTO-892).
Newburg et al. is concerned with the use of synthetic human milk oligosaccharides (HMOs) as prebiotics (abstract). Newburg et al. teach a method for stimulating the growth of a probiotic bacteria or bacteria in a gastrointestinal tract (GI tract) of a mammalian subject, comprising administering to said subject a composition comprising a purified 2’-fucosyllactose (2’-FL), 3-fucosyllactose (3-FL), or lactodifucotetraose (LDFT), (claims 1 and 15). The 2’-FL, 3-FL and LDFT can be administered together (para [0013]). The composition is intended to stimulate the growth if Bifidobacterium (claim 7). The composition comprises between 0.01-10 g 2’-FL per gram of composition, (claim 9). The composition further comprises fructooligosaccharide (FOS). The composition can be administered to infants, children, and adults (para [0012]). The composition can be in the form of a tablet, capsule, powder or infant formula (claim 11).
Newburg et al. do not expressly disclose treating an obese human (present claim 1).
Jung et al. teach administering a composition comprising BNR17 to obese or overweight adults (p.81, 1.Study Design). BNR17 capsules contained 1010 cfu of Lb. gasseri BNR17 and filler powder (50% trehalose, 25% skim milk, and 25% fructooligosaccharide), (p.82, 2. Preparation of Samples and Treatment). The subjects were instructed to take 6 capsules per day for 12 weeks. They found the composition was effective in reducing body weight in obese or overweight patients (p.87, last para). Administration of BR17 also reduced coliform bacterial counts, suggesting it suppresses the proliferation of harmful bacteria in the gut (p.87, fifth para). They also observed a reduction in white adipose tissue weight in high-fat diet-fed rats (p.87, fifth para). In another study, BNR17 reduced fasting blood glucose, 2-hour postprandial blood sugar (2PPBS), and improved tolerance to oral glucose (p.87, third para). In another study, supplementation of the high-fat diet with oligofructose resulted in increased concentration of Bifidobacteria, normalized concentration of serum lipopolysaccharides (LPS), improved glucose tolerance and insulin sensitivity (p. 87, seventh para).
Strowski et al. report on the effects of feeding prebiotics to leptin-deficient ob/ob mice, an animal model of obesity and type 2 diabetes mellitus (p.1044, fourth para). It has been found that a prebiotic diet can reduce the expression of proinflammatory cytokines and oxidative stress markers in ob/ob mice. Prebiotics increased the relative abundance of Bifidobacterium. These changes were accompanied by reduced intestinal permeability, improved intestinal tight junction integrity and barrier function, decreased circulating proinflammatory cytokines, and increased levels of butyrate (which contribute to an enhanced intestinal barrier). Strowski et al. also report prebiotics stimulated proglucagon gene expression, and the synthesis of GLP-1 and GLP-2 in ob/ob mice (p.1045, first para). Strowski et al. conclude prebiotic nutrients are able to alleviate systematic inflammation processes, thereby enhancing peripheral insulin action and preventing further weight gain.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer 2’-FL and/or 3-FL to obese non-infant humans to increase the relative abundance of Bifidobacteria, and reduce a precursor condition for a metabolic disorder associated with the development of obesity-induced pre-diabetes and type 2 diabetes.
From the combined teaching of the prior art, the ordinary artisan would have known prebiotics not only improve the relative abundance of Bifidobacteria in the GI tract, but they are also effective in reducing body weight in obese or overweight patients, improving glucose tolerance and insulin sensitivity, reducing body fat percentage, reducing proinflammatory cytokines and oxidative stress markers, reducing intestinal permeability, stimulating proglucagon gene expression, and increasing the synthesis of GLP-1 and GLP-2.
While Newburg et al. teach administering the HMO-based prebiotics to an infant, child or adult, Newburg et al. do not expressly disclose administering the HMO-based prebiotics to an obese non-infant human. The ordinary artisan would have known from Jung et al. and Strowski et al. that prebiotics are effective in obese subjects, including those with type 2 diabetes, and not an infant.
Newburg et al. teach administering anywhere between 0.01 and 10 g HMO. Jung et al. teach administering prebiotics six times a day, for 12 weeks. The ordinary artisan would have been motivated to administer anywhere between 0.01 and 10 g HMO one to six times a day for 12 weeks. These dosages overlap with the amounts recited in claim 5. Since “an initial treatment phase” and “maintenance phase” are not defined, they are broadly and reasonably interpreted to include the beginning of treatment, and the rest of treatment.
While the prior art is silent about increasing the relative abundance of Bifidobacterium adolescentis, Newburg et al. found the HMOs increased the relative abundance of Bifidobacterium in the GI microbiome. Furthermore, the prior art teach administering an amount of HMO that overlaps with the amounts presently claimed. And the prior art provides motivation to administer it to the claimed patient population. Administering the claimed amount of HMOs to the claimed patient population will necessarily be effective for increasing the relative abundance of B. adolescentis and reducing a precursor condition for a metabolic disorder associated with development of one or more of obesity-induced pre-diabetes and type 2 diabetes.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claim(s) 8-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mills et al. (US Patent No. 8,197,872, cited in PTO-892) in view of Jung et al. (cited above) and further in view of Strowski et al. (cited above).
Mills et al. teach a prebiotic composition comprising a first oligosaccharide selected from lacto-N-tetraose (LNT) and lacto-N-neotetraose (LNnT) to increase the amount of bifidobacteria (claim 2). The composition can be formulated as a powder, tablet, food product or supplemented beverage (col. 2:61-67). The composition can further include lacto-N-fucopentaose I (col.3:61-65). The dosage will vary depending on whether the composition will be administered to an infant vs adult, and reasons for loss of beneficial gut bacteria (co.11:58-67). The amount ranges from 1 g/L to 10 g/L (col.12:1-15).
Mills et al. do not expressly disclose treating an obese human (present claim 8).
Jung et al. teach as discussed above.
Strowski et al. teach as discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer LNT and/or LNnT to obese non-infant humans to increase the relative abundance of Bifidobacteria, and reduce a precursor condition for a metabolic disorder associated with the development of obesity-induced pre-diabetes and type 2 diabetes.
From the combined teaching of the prior art, the ordinary artisan would have known prebiotics not only improve the relative abundance of beneficial bacteria including bifidobacteria in the GI tract, but they are also effective in reducing body weight in obese or overweight patients, improving glucose tolerance and insulin sensitivity, reducing body fat percentage, reducing proinflammatory cytokines and oxidative stress markers, reducing intestinal permeability, stimulating proglucagon gene expression, and increasing the synthesis of GLP-1 and GLP-2.
While Mills et al. teach administering the HMO-based prebiotics to any age group, Mills et al. do not expressly disclose administering the HMO-based prebiotics to an obese non-infant human. The ordinary artisan would have known from Jung et al. and Strowski et al. that prebiotics are effective in obese subjects, including those with type 2 diabetes, and not an infant.
Mills et al. teach administering anywhere between 1 g/L to 10 g/L HMO. Jung et al. teach administering prebiotics six times a day, for 12 weeks. The ordinary artisan would have been motivated to administer anywhere between 1 g/L to 10 g/L HMO one to six times a day for 12 weeks. These dosages overlap with the amounts recited in claims 14 and 20. Since “an initial treatment phase” and “maintenance phase” are not defined, they are broadly and reasonably interpreted to include the beginning of treatment, and the rest of treatment.
While the prior art is silent about increasing the relative abundance of Bifidobacterium adolescentis, Mills et al. found the HMOs increased the relative abundance of Bifidobacterium in the GI microbiome. Furthermore, the prior art teach administering an amount of HMO that overlaps with the amounts presently claimed. And the prior art provides motivation to administer it to the claimed patient population. Administering the claimed amount of HMOs to the claimed patient population will necessarily be effective for increasing the relative abundance of B. adolescentis and reducing a precursor condition for a metabolic disorder associated with development of one or more of obesity-induced pre-diabetes and type 2 diabetes.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Newburg et al. (cited above), Mills et al. (cited above) in view of Jung et al. (cited above) and further in view of Strowski et al. (cited above).
Newburg et al. and Mills et al. teach as discussed above.
Neither Newburg et al. nor Mills et al. expressly disclose treating an obese human (present claims 1, 8 and 14).
Jung et al. and Strowski et al. teach as discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer 2’-FL, 3-FL, LNT and/or LNnT to obese non-infant humans to increase the relative abundance of Bifidobacteria, and reduce a precursor condition for a metabolic disorder associated with the development of obesity-induced pre-diabetes and type 2 diabetes.
From the combined teaching of the prior art, the ordinary artisan would have known prebiotics not only improve the relative abundance of Bifidobacteria in the GI tract, but they are also effective in reducing body weight in obese or overweight patients, improving glucose tolerance and insulin sensitivity, reducing body fat percentage, reducing proinflammatory cytokines and oxidative stress markers, reducing intestinal permeability, stimulating proglucagon gene expression, and increasing the synthesis of GLP-1 and GLP-2.
While Newburg et al. and Mills et al. teach administering the HMO-based prebiotics to an infant, child or adult, Newburg et al. do not expressly disclose administering the HMO-based prebiotics to an obese non-infant human. The ordinary artisan would have known from Jung et al. and Strowski et al. that prebiotics are effective in obese subjects, including those with type 2 diabetes, and not an infant.
Newburg et al. teach administering anywhere between 0.01 and 10 g HMO, and Mills et al. teach administering anywhere between anywhere between 1 g/L to 10 g/L HMO. Jung et al. teach administering prebiotics six times a day, for 12 weeks. The ordinary artisan would have been motivated to administer anywhere between 0.01 and 10 g HMO or anywhere between 1 g/L to 10 g/L HMO one to six times a day for 12 weeks. These dosages overlap with the amounts recited in claim 5. Since “an initial treatment phase” and “maintenance phase” are not defined, they are broadly and reasonably interpreted to include the beginning of treatment, and the rest of treatment.
While the prior art is silent about increasing the relative abundance of Bifidobacterium adolescentis, Newburg et al. and Mills et al. found the HMOs increased the relative abundance of Bifidobacterium in the GI microbiome. Furthermore, the prior art teach administering an amount of HMO that overlaps with the amounts presently claimed. And the prior art provides motivation to administer it to the claimed patient population. Administering the claimed amount of HMOs to the claimed patient population will necessarily be effective for increasing the relative abundance of B. adolescentis and reducing a precursor condition for a metabolic disorder associated with development of one or more of obesity-induced pre-diabetes and type 2 diabetes.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior 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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,696,921 in view of Jung et al. (cited above) and Strowski et al. (cited above).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patent are directed towards increasing the relative abundance B. adolescentis, comprising administering to a non-infant human a composition comprising one or more of 2’-FL, 3-FL, LNT and LNnT (claim 1). The composition further comprises LNFP-I (claim 3). The non-infant human is an adult (claim 5).
The claims do not expressly disclose treating an obese non-infant human.
Jung et al. and Strowski et al. teach as discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer 2’-FL, 3-FL, LNT and/or LNnT to obese non-infant humans to increase the relative abundance of Bifidobacteria, and reduce a precursor condition for a metabolic disorder associated with the development of obesity-induced pre-diabetes and type 2 diabetes.
From the combined teaching of the prior art, the ordinary artisan would have known prebiotics not only improve the relative abundance of Bifidobacteria in the GI tract, but they are also effective in reducing body weight in obese or overweight patients, improving glucose tolerance and insulin sensitivity, reducing body fat percentage, reducing proinflammatory cytokines and oxidative stress markers, reducing intestinal permeability, stimulating proglucagon gene expression, and increasing the synthesis of GLP-1 and GLP-2.
While the reference Patent is directed towards administering the HMO-based prebiotics to a non-infant, the claims do not expressly disclose administering the HMO-based prebiotics to an obese non-infant human.
The ordinary artisan would have known from Jung et al. and Strowski et al. that prebiotics are effective in obese subjects, including those with type 2 diabetes, and not an infant.
From the combined teaching of the prior art, the ordinary artisan would have known prebiotics not only improve the relative abundance of Bifidobacteria in the GI tract, but they are also effective in reducing body weight in obese or overweight patients, improving glucose tolerance and insulin sensitivity, reducing body fat percentage, reducing proinflammatory cytokines and oxidative stress markers, reducing intestinal permeability, stimulating proglucagon gene expression, and increasing the synthesis of GLP-1 and GLP-2.
Thus, the claimed invention as a whole is prima facie obvious over the claims of the reference Patent in view of Jung et al. and Strowski et al.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,751,354 in view of Jung et al. (cited above) and Strowski et al. (cited above).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patent are directed towards increasing the relative abundance B. adolescentis, comprising administering to a non-infant human a composition comprising one or more of 2’-FL, 3-FL, LNT and LNnT (claim 1). The composition further comprises LNFP-I (claim 3). The non-infant human is a child, teenager or adult (claim 5).
The claims do not expressly disclose treating an obese non-infant human.
Jung et al. and Strowski et al. teach as discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer 2’-FL, 3-FL, LNT and/or LNnT to obese non-infant humans to increase the relative abundance of Bifidobacteria, and reduce a precursor condition for a metabolic disorder associated with the development of obesity-induced pre-diabetes and type 2 diabetes.
From the combined teaching of the prior art, the ordinary artisan would have known prebiotics not only improve the relative abundance of Bifidobacteria in the GI tract, but they are also effective in reducing body weight in obese or overweight patients, improving glucose tolerance and insulin sensitivity, reducing body fat percentage, reducing proinflammatory cytokines and oxidative stress markers, reducing intestinal permeability, stimulating proglucagon gene expression, and increasing the synthesis of GLP-1 and GLP-2.
While the reference Patent is directed towards administering the HMO-based prebiotics to a non-infant, the claims do not expressly disclose administering the HMO-based prebiotics to an obese non-infant human.
The ordinary artisan would have known from Jung et al. and Strowski et al. that prebiotics are effective in obese subjects, including those with type 2 diabetes, and not an infant.
From the combined teaching of the prior art, the ordinary artisan would have known prebiotics not only improve the relative abundance of Bifidobacteria in the GI tract, but they are also effective in reducing body weight in obese or overweight patients, improving glucose tolerance and insulin sensitivity, reducing body fat percentage, reducing proinflammatory cytokines and oxidative stress markers, reducing intestinal permeability, stimulating proglucagon gene expression, and increasing the synthesis of GLP-1 and GLP-2.
Thus, the claimed invention as a whole is prima facie obvious over the claims of the reference Patent in view of Jung et al. and Strowski et al.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,835,544 in view of Jung et al. (cited above) and Strowski et al. (cited above).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patent are directed towards increasing the relative abundance B. adolescentis, comprising administering to a non-infant human having a metabolic disorder and being diagnosable with one or more of obesity, obesity-induced pre-diabetes, and type 2 diabetes, a composition comprising one or more of 2’-FL, 3-FL, LNT, LNnT, LNFP-I, and DFL (claim 1). The non-infant human is a child, teenager or adult (claim 5).
The claims do not expressly disclose reducing a precursor condition as recited in claim 1.
Jung et al. and Strowski et al. teach as discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer 2’-FL, 3-FL, LNT, LNnT, LNFP-I, and DFL to obese non-infant humans to increase the relative abundance of Bifidobacteria, and reduce a precursor condition for a metabolic disorder associated with the development of obesity-induced pre-diabetes and type 2 diabetes.
From the combined teaching of the prior art, the ordinary artisan would have known prebiotics not only improve the relative abundance of Bifidobacteria in the GI tract, but they are also effective in reducing body weight in obese or overweight patients, improving glucose tolerance and insulin sensitivity, reducing body fat percentage, reducing proinflammatory cytokines and oxidative stress markers, reducing intestinal permeability, stimulating proglucagon gene expression, and increasing the synthesis of GLP-1 and GLP-2.
The reference Patent teaches administering a composition comprising the same HMOs to the same/similar patient population as the present claims. Performing the positively recited steps will necessarily result in reducing any one of the claimed precursor conditions.
Thus, the claims of the reference Patent anticipate the present claims.
And if the reduction in precursor conditions is not inherent, they are obvious over the claims of the reference Patent in view of Jung et al. and Strowski et al.
The following are additional rejections on the ground of nonstatutory double patenting, having the same or similar fact patterns as the above US Patents. Namely, the following US Patents are similarly directed towards antibacterial chitosan derivatives having the same structure as those recited in the instant claims. For the sake of brevity, these have been summarized as below:
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,890,293 in view of Jung et al. and Strowski et al.;
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,881,674 in view of Jung et al. and Strowski et al.;
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,291,677 in view of Jung et al. and Strowski et al.;
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,278,558 in view of Jung et al. and Strowski et al.;
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,529,364 in view of Jung et al. and Strowski et al.;
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,278,558 in view of Jung et al. and Strowski et al.;
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,828,313 in view of Jung et al. and Strowski et al.;
Thus, the instant claims are prima facie obvious over the claims of the reference Patent.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699