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 .
DETAILED ACTION
Claims 1-17 are pending.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. See Fig. 3. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites Lactobacillus plantarum ECGC 13110402. However, the strain is deposited at European Collection of Cell Cultures (specification page 52), which appears to be a shortened name of the acronym European Collection of Authenticated Cell Cultures (ECACC). Therefore, it is unclear what the acronym ECGC means.
Claim 8 recites the limitation, wherein the Lactobacillus plantarum ECGC 13110402 is administered at a daily dose of about 200 mg to 300 mg of the active strain providing about 2.6 109 cells. The claim combines a broad range (200 mg to 300 mg of the active strain) with a narrow range (about 2.6 109 cells), thus rendering the claim indefinite.
Claims 11-13 each recite the limitation "the GOS" in line 1. There is insufficient antecedent basis for this limitation in these claims.
Claim 11 is further indefinite for the limitation “wherein the GOS is specific to the growth of Lactobacillus plantarum EGGC 13110402.” The claim has multiple reasonable interpretations, rendering the claim indefinite. In one interpretation, Lactobacillus plantarum EGGC13110402 is capable of utilizing the GOS. In a second interpretation, Lactobacillus plantarum EGGC 13110402 produces the GOS.
Claim 12 is further indefinite for the limitation “wherein the GOS is capable of being produced by Lactobacillus plantarum EGGC 13110402.” It is unclear whether the GOS is the prebiotic and if so, whether the claim scope is limited to GOS that are produced by Lactobacillus plantarum EGGC 13110402.
Claim 13 is further indefinite for the limitation “wherein the GOS is produced by Lactobacillus ECGC 13110402. It is unclear whether the method further comprises culturing Lactobacillus ECGC 13110402 to produce GOS prior to administering the Lactobacillus ECGC 13110402 and GOS.
Claims 2-17 are rejected for depending from a rejected base claim and not rectifying the source of indefiniteness discussed above.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-17 rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claims contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is apparent that Lactobacillus plantarum ECGC 13110402 is required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the Lactobacillus plantarum ECGC 13110402;.
It is not apparent if the biological materials considered necessary to make and use the invention is both known and readily available to the public. It is noted that Applicants have deposited biological material (see specification page 52, “Biological Deposits”) but there is no indication as to public availability. There is no repeatable method set forth in the specification by which the public could obtain the strain.
This rejection will be withdrawn if a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, is made that clearly indicates that all restrictions imposed by the depositor on the availability to the public of the deposited material (Lactobacillus plantarum ECGC 13110402 deposited at the European Collection of Cell Cultures, a Budapest Treaty depository) will be irrevocably removed upon the granting of the patent. See 37 C.F.R. 1.808; MPEP 2404.01. In the alternative, Applicant may convincingly show that there indeed exists a repeatable method to obtain the strain.
Claims 1-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for managing or treating hypertension or hypercholesterolemia, does not reasonably provide enablement for preventing hypertension or hypercholesterolemia. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Per MPEP 2164.01(a), the following eight factors should be considered when determining whether the person of ordinary skill in the art would face undue experimentation to make and/or use the invention: (1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. While it is not essential that every factor be examined in detail, those factors deemed most relevant should be considered.
Nature of the invention. Claim 1 is drawn to a method of managing, treating, or preventing hypertension or hypercholesterolemia comprising administering to an individual in need thereof a composition comprising Lactobacillus plantarum ECGC 13110402, and one or more lipid modifying active ingredients selected from the group consisting of statins, stanols, sterols, monacolin K, fatty acids, niacin, potassium, soluble fibers, and/or prebiotics.
Breadth of the claims. The method encompasses managing, treating, or preventing hypertension or hypercholesterolemia.
State of the prior art and unpredictability. Farmer (WO 9949877 A2) teaches a composition for decreasing serum cholesterol in a patient comprising Lactobacillus plantarum, a cholesterol-reducing agent, and a bifidogenic oligosaccharide (Farmer claims 1-2 and 5). In a preferred embodiment, the cholesterol-reducing agent in the composition is fluvastatin, pravastatin, or simvastatin (Farmer claim 20, paragraph bridging pages 14-15). Statins reduce both cholesterol and blood pressure (i.e. treats hypertension), as evidenced by Strazzullo (Abstract and page 792, left column, paragraph 1). Farmer teaches that niacin is a preferred additional component of the composition (line 5 on page 22).
O'Hara (WO 2015/067948 A1) teaches compositions for the treatment of high cholesterol comprising Lactobacillus plantarum 2830 (ECGC 13110402)and a cholesterol modifying agent (see O’Hara claim 3 on page 30).
Thus, the prior art teaches managing/treating hypertension and hypercholesterolemia but does not teach preventing hypertension or hypercholesterolemia.
Guidance in the specification and working examples. Example 1 of the specification describes a human volunteer study to establish the safety, compliance, and extent of cholesterol reduction and hypertension control by administering a composition comprising Lactobacillus plantarum ECGC 13110402 in 49 mildly hypercholesterolemic adults (lines 20-22 on page 17). Tables 5-7 summarize the results of the study: Total cholesterol from baseline to 12 weeks was reduced in all groups compared to the placebo group (lines 1-2 on page 25).
Amount of experimentation necessary. No amount of experimentation would enable the claimed method of preventing hypertension or hypercholesterolemia by administering Lactobacillus plantarum ECGC 13110402, and one or more lipid modifying active ingredients selected from the group consisting of statins, stanols, sterols, monacolin K, fatty acids, niacin, potassium, soluble fibers, and/or prebiotics.
Taking these factors into account, undue experimentation would be required by one of ordinary skill in the art to practice the full scope of the claimed invention. Thus, the claims are not fully enabled by the disclosure.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-2, 5-10, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Farmer et al. (WO 9949877 A2) in view of O’Hara et al. (WO 2015/067948 A1).
Farmer teaches a method for decreasing serum cholesterol (i.e. treating hypercholesteremia) in a patient comprising administering a composition comprising Lactobacillus plantarum, a cholesterol-reducing agent, and a bifidogenic oligosaccharide (Farmer claims 1-2 and 5). In a preferred embodiment, the cholesterol-reducing agent in the composition is fluvastatin, pravastatin, or simvastatin (Farmer claim 20, paragraph bridging pages 14-15). Farmer teaches that the composition is encapsulated (Farmer page 25, line 3). Farmer teaches that niacin is a preferred additional component of the composition (line 5 on page 22).
Farmer does not teach that the composition comprises Lactobacillus plantarum ECGC 13110402.
O'Hara teaches compositions for the treatment of high cholesterol comprising Lactobacillus plantarum 2830 (ECGC 13110402) and a cholesterol modifying agent (see O’Hara claim 3 on page 30). This is the same bacterial species with the same accession number as recited in instant claim 1.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the composition of Farmer with the composition of O’Hara and to administer the composition to the patient to treat hypercholesterolemia. Both compositions are art-recognized equivalents for the same purpose (treating high cholesterol), thus the person of ordinary skill in the art would have had a reasonable expectation of success. See MPEP 2144.06 part (I).
Regarding claim 2, Farmer teaches that the cholesterol-reducing agent in the composition is fluvastatin, pravastatin, or simvastatin (Farmer claim 20, paragraph bridging pages 14-15),
Regarding claim 4, Farmer does not exemplify administering a composition comprising β-glucan, glucomannan, or psyllium. However, Farmer teaches fibrins such as oat bran (comprises β-glucan), konjak flour (glucomannan), and psyllium bind cholesterol in the form of free cholic acid and thereby remove them from bioavailability (lines 25-32 on page 18).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate any of the fibrins taught by Farmer, including β-glucan, glucomannan, or psyllium into the composition of Farmer modified by O’Hara in order to further enhance the cholesterol-lowering activity of the composition. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Regarding claim 5, Farmer teaches that the composition comprises fructo-oligosaccharides (Farmer claim 39).
Regarding claims 6-7, Farmer teaches that the composition comprises in one gram dosage from 2 x 105 to 1010 CFU of viable lactic acid producing bacteria (lines 13-15 on page 20), which overlaps with the instant claimed range of 2×105 cells to 2×1012 cells (claim 6) and 2×108 cells to 2×1012 cells (claim 7). Farmer teaches that the composition is taken daily (lines 15-16 on page 31).
Regarding claim 8, Farmer teaches two to four dosages of the composition are administered per day, each comprising about 0.1 g to 5 g per dosage (lines 12-13 on page 25). Farmer teaches that the composition comprises in one gram dosage from 2 x 105 to 1010 CFU of viable lactic acid producing bacteria (lines 13-15 on page 20). Thus, for two dosages of 0.1 g (total daily dosage of 0.2 g or 200 mg), Farmer teaches administering 4 x 104 to 2 x 109 CFU. The claimed value of about 2.6 x 109 is approaching Farmer’s range.
Regarding claims 9-10, Farmer teaches administering 50 mg to 10 g of fructooligosaccharides per day (lines 24-26 on page 25), which overlaps with the claimed range of 5 to 15 g (claim 9) and up to 5 g (claim 10).
Regarding claim 14, Farmer teaches the composition is encapsulated (page 25, lines 1-33).
Regarding claim 15, Farmer does not teach administering freeze-dried Lactobacillus plantarum ECGC 13110402.
O’Hara teaches that Lactobacillus plantarum B2830 (synonym for ECGC 13110402 ) has a freeze-drying survival rate of 40% in sucrose (Fig. 12).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to freeze-dry and administer the freeze-dried Lactobacillus plantarum ECGC 13110402 in the composition of Farmer modified by O’Hara. The person of ordinary skill in the art would have been motivated by the greater stability of freeze-dried bacteria. The person of ordinary skill in the art would have had a reasonable expectation of success.
Regarding claim 16, Farmer teaches that the composition further comprises vitamins or minerals (Farmer claim 29).
Regarding claim 17, Farmer teaches that the composition is encapsulated (Farmer page 25, line 3) and the active agents are combined with a carrier that is physiologically compatible with the gut tissue of a human or animal to which it is administered (page 22, lines 19-21). Carriers can be solid-based dry materials for formulations in tablet, capsule or powdered form, and can be liquid or gel-based materials for formulations in liquid or gel forms, which forms depend, in part, upon the routes of administration (page 23, lines 1-5).
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Farmer et al. (WO 9949877 A2) in view of O’Hara et al. (WO 2015/067948 A1), as applied to 1-2, 5-10, and 14-17 above, further in view of Micallef et al. (The Journal of nutritional biochemistry 20.12 (2009): 927-939).
See discussion of Farmer and O’Hara above, which is incorporated into this rejection as well.
Farmer and O’Hara do not teach that the composition includes omega-3 polyunsaturated fatty acids or sterols.
Micallef teaches administering both phytosterols and omega-3 polyunsaturated fatty acids, alone or in combination with statins, for the treatment or management of dyslipidemia (Title and Abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate phytosterols and omega-3 fatty acids into the composition of Farmer modified by O’Hara and to administer the composition in order to treat hypercholesterolemia. The person of ordinary skill in the art would have been motivated by the teaching of Micallef, who suggests combining both phytosterols and omega-3 fatty acids with statins. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Farmer et al. (WO 9949877 A2) in view of O’Hara et al. (WO 2015/067948 A1), as applied to 1-2, 5-10, and 14-17 above, as evidenced by Iqbal et al. (Carbohydrate research 345.10 (2010): 1408-1416).
See discussion of Farmer and O’Hara above, which is incorporated into this rejection as well.
Claims 11-13 are interpreted as requiring that the composition further comprises GOS.
Claim 11 is interpreted as requiring that the GOS specifically induces growth of L. plantarum ECGC 13110402, which is an inherent property of the bacteria.
Regarding claims 11-13, O’Hara teaches that L. plantarum ECGC 13110402 produces β-galactosidases (O’Hara claims 6 and 18), which produce galactooligosaccharides (GOS) as evidenced by Iqbal (Abstract, page 1408, left column, paragraph 1, page 1409, left column, paragraph 1).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 4, and 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 9-10 12, and 14-15 of U.S. Patent No. 10,898,528 (hereafter ‘528). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 1, 4, and 11-17 are obvious over claims 7, 9-10 and 14-15 of ‘528.
Claim 10 of ‘528 recites the composition further comprises one or more of statins, sterols and/or stanols. Claim 10 of ‘528 depends from claim 1 of ‘528, which recites “A composition comprising Lactobacillus plantarum 2830, deposited at the European Collection of Cell Cultures under Accession Number 13110402, for use in the management or treatment of elevated total cholesterol (TC) and low density lipoprotein cholesterol (LDL-C) levels […] and the composition is encapsulated.”
Claim 10 of ‘528 does not recite administering the composition to an individual in need thereof.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the composition to an individual with hypercholesterolemia per the intended use of the composition. The person of ordinary skill in the art would have had a reasonable expectation of success.
Claim 15 of ‘528 recites a composition comprising Lactobacillus plantarum 2830 deposited at the European Collection of Cell Cultures under Accession Number 13110402 for use in a method of treating or modulating hypercholesterolemia in an individual, wherein the Lactobacillus plantarum 2830 is formulated for oral administration in an amount in the range of 1×105 to 1012 cells once or twice a day and optionally the composition further comprises one or more cholesterol lowering agents.
Claim 15 of ‘528 does not recite administering the composition further comprises one or more of statins, sterols and/or stanols or administering the composition to an individual in need thereof.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the composition with statins, sterols, and/or stanols, as recited in claim 10 of ‘528, and to administer the composition per its intended use. The person of ordinary skill in the art would have had a reasonable expectation of success.
Instant claim 4 is obvious over claim 9 of ‘528.
Instant claim 11 is obvious over claim 14 of ‘528.
Instant claims 12-13 is obvious over claims 12 and 14 of ‘528.
Instant claims 14-15 and 17 are obvious over claim 10 of ‘528 because claim 10 of ‘528 depends from claim 1, which requires the composition is encapsulated or concentrated and the bacteria are freeze-dried.
Instant claim 16 is obvious over claim 7 of ‘528. Although claim 7 of ‘528 does not recite administering the composition, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the composition per its intended use and the person of ordinary skill in the art would have had a reasonable expectation of success in doing so.
Claims 2 and 5-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 and 14-15 of U.S. Patent No. 10,898,528 (hereafter ‘528) in view of Farmer (WO1999049877 A2).
See discussion of claims 10 and 15 of ‘528 above, which is incorporated into this rejection as well.
Regarding instant claim 2, claim 10 of ‘528 does not recite the composition further comprises fluvastatin; pravastatin; simvastatin; atorvastatin and rosuvastatin.
Farmer teaches a method for decreasing serum cholesterol in a patient comprising administering a composition comprising Lactobacillus plantarum, a cholesterol-reducing agent, and a bifidogenic oligosaccharide (Farmer claims 1-2 and 5). In a preferred embodiment, the cholesterol-reducing agent in the composition is fluvastatin, pravastatin, or simvastatin (Farmer claim 20, paragraph bridging pages 14-15).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to specifically incorporate fluvastatin, pravastatin, or simvastatin in the composition of claim 10 of ‘528 and to administer the composition to treat hypercholesterolemia per the teachings of Farmer. The person of ordinary skill in the art would have had a reasonable expectation of success.
Instant claim 5 is obvious over claim 14 of ‘528, which requires that the composition further comprise a galacto-oligosaccharide.
Regarding instant claims 6-7, claim 15 of ‘528 recites the Lactobacillus plantarum 2830 (synonym for ECGC 13110402) is formulated for oral administration in an amount in the range of 1×105 to 1012 cells once or twice a day, which overlaps with the claimed ranges.
Regarding instant claim 8, claims 10 and 15 of ‘528 do not recite administering a daily dose in the range of about 200 mg to 300 mg of the active strain providing about 2.6 x 109 cells.
Farmer teaches two to four dosages of the composition are administered per day, each comprising about 0.1 g to 5 g per dosage (lines 12-13 on page 25). Farmer teaches that the composition comprises in one gram dosage from 2 x 105 to 1010 CFU of viable lactic acid producing bacteria (lines 13-15 on page 20). Thus, for two dosages of 0.1 g (total daily dosage of 0.2 g or 200 mg), Farmer teaches administering 4 x 104 to 2 x 109 CFU. The presently claimed value of about 2.6 x 109 is approaching Farmer’s range.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to formulate the composition of claims 10 or 15 of ‘528 per the teachings of Farmer since the compositions comprise bacteria for the same intended use (treating hypercholesterolemia). The person of ordinary skill in the art would have had a reasonable expectation of success.
Regarding instant claims 9-10, claims 10 and 15 of ‘528 do not recite administering a daily dose of fructooligosaccharides in the range of 5 to 15 g.
Farmer teaches administering 50 mg to 10 g of fructooligosaccharides per day (lines 24-26 on page 25), which overlaps with the presently claimed range of 5 to 15 g (claim 9) and up to 5 g (claim 10).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the composition of claims 10 and 15 of ‘528 by incorporating 50 mg to 10 g of fructooligosaccharide into the composition per the teaching of Farmer and to administer the composition per its intended use. The person of ordinary skill in the art would have had a reasonable expectation of success.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 and 15 of U.S. Patent No. 10,898,528 (hereafter ‘528) in view of Micallef et al. (The Journal of nutritional biochemistry 20.12 (2009): 927-939).
See discussion of claims 10 and 15 of ‘528 above, which is incorporated into this rejection as well.
Claims 10 and 15 of ‘528 do not recite administering omega-3 polyunsaturated fatty acids.
Micallef teaches administering omega-3 fatty acids, alone or in combination with statins, for the treatment or management of dyslipidemia (Title and Abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate omega-3 polyunsaturated fatty acids into the composition of claims 10 or 15 of ‘528 modified by Farmer in order to treat hypercholesterolemia. The person of ordinary skill in the art would have been motivated by the teaching of Micallef, who suggests combining omega-3 polyunsaturated fatty acids with statins. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Claims 1, 5-8, 11-13, and 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 7, and 10-11 of U.S. Patent No. 11,413,317 (hereafter ‘317). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 1 and 15 are anticipated by claim 11 of ‘317 and instant claims 5-8, 11-13, and 16-17 are obvious over claims 1, 3-5, 7, and 10 of ‘317.
Claim 11 of ‘317 recites administering the composition of claim 1 to an individual with hypertension. Claim 11 of ‘317 depends from claim 1 of ‘317, which recites a composition comprising Lactobacillus plantarum 2830 deposited at the European Collection of Cell Cultures under Accession Number 13110402 for use in the treatment of hypertension, wherein the composition further comprises an oligosaccharide prebiotic growth medium which is specific to Lactobacillus plantarum 2830 and was produced by Lactobacillus plantarum 2830 by an enzyme reaction, wherein the enzyme is capable of catalyzing the reverse of the reaction which produced the oligosaccharide prebiotic growth medium, and wherein the Lactobacillus plantarum 2830 is freeze-dried.
Therefore, instant claims 1 and 15 are anticipated by claim 11 of ‘317.
Although claim 1 of ‘317 does not recite administering the composition to an individual with hypertension, instant claims 1 and 15 are also obvious over claim 1 of ‘317 since it would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to administer the composition for its intended use and the person of ordinary skill in the art would have had a reasonable expectation of success in doing so.
Instant claim 5 is obvious over claim 10 of ‘317.
Instant claim 6-7 are obvious over claims 4-5 of ‘317 because the presently claimed range of 2×105 to 2×1012 (instant claim 6) and the presently claimed range of 2×108 to 2×1010 (instant claim 7) overlap with the range recited in claim 4 of ‘317 and claim 5 of ‘317 recites a daily dose.
Instant claim 8 is also obvious over claims 4-5 of ‘317 because 2×109 cells is within the range recited in claim 4 of ‘317 and claim 5 of ‘317 recites a daily dose.
Instant claims 11-13 are obvious over claims 1 and 10 of ‘317.
Instant claim 16 is obvious over claim 7 of ‘317.
Instant claim 17 is obvious over claim 3 of ‘317.
Claims 2, 4, 9-10, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 11,413,317 (hereafter ‘317) in view of Farmer et al. (WO 9949877 A2) as evidenced by Strazzullo et al. (Hypertension 49.4 (2007): 792-798; Abstract and page 792, left column, paragraph 1).
Claim 18 of ‘317 recites the composition is administered in combination with one or more of statins, sterols and/or stanols. Claim 18 of ‘317 depends from claim 11 of ‘317. See discussion of claim 11 of ‘317 above, which is incorporated into this rejection as well.
Regarding instant claim 2, claim 18 of ‘317 does not recite that the statins are selected from fluvastatin; pravastatin; simvastatin; atorvastatin and rosuvastatin.
Farmer teaches a composition for decreasing serum cholesterol in a patient comprising Lactobacillus plantarum, a cholesterol-reducing agent, and a bifidogenic oligosaccharide (Farmer claims 1-2 and 5). In a preferred embodiment, the cholesterol-reducing agent in the composition is fluvastatin, pravastatin, or simvastatin (Farmer claim 20, paragraph bridging pages 14-15). Statins reduce both cholesterol and blood pressure, as evidenced by Strazzullo (Abstract and page 792, left column, paragraph 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of claim 18 of ‘317 by incorporating any of the statins taught by Farmer, such as fluvastatin, pravastatin, or simvastatin in order to further enhance the ability of the composition to treat hypertension. The person of ordinary skill in the art would have had a reasonable expectation of success.
Regarding instant claim 4, claim 18 of ‘317 depends from claim 17 of ‘317, which recites the composition further comprises cholesterol-lowering agents.
Claim 18 of ‘317 does not recite including β-glucan, glucomannan, or psyllium in the composition.
Farmer teaches fibrins such as oat bran (comprises β-glucan), konjak flour (glucomannan), and psyllium bind cholesterol in the form of free cholic acid and thereby remove them from bioavailability (lines 25-32 on page 18).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of claim 18 of ‘317 by incorporating any of the fibrins taught by Farmer, including β-glucan, glucomannan, or psyllium in order to further enhance the cholesterol-lowering effect of the composition. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Regarding instant claims 9-10, claim 18 of ‘317 does not recite the composition further comprises fructo-oligosaccharides.
Farmer teaches administering 50 mg to 10 g of fructooligosaccharide per day (lines 24-26 on page 25), which overlaps with the claimed range of 5 to 15 g (claim 9) and up to 5 g (claim 10).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Farmer’s fructooligosaccharides into the composition administered in claim 18 of ‘317 per the teachings of Farmer. The person of ordinary skill in the art would have had a reasonable expectation of success.
Regarding instant claim 14, claim 18 of ‘317 does not recite the composition is encapsulated.
Farmer teaches the composition is encapsulated (page 25, lines 1-33).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to encapsulate the composition of claim 18 of ‘317 prior to administering the composition. The person of ordinary skill in the art would have been motivated to provide a means for oral administration of the composition and the person of ordinary skill in the art would have had a reasonable expectation of success in doing so.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 11,413,317 (hereafter ‘317) in view of
Micallef et al. (The Journal of nutritional biochemistry 20.12 (2009): 927-939).
Claim 11 of ‘317 does not teach administering omega-3 polyunsaturated fatty acids.
Micallef teaches administering omega-3 fatty acids, alone or in combination with statins, for the treatment or management of dyslipidemia (Title and Abstract). Micallef teaches that these fatty acids could play a key role in the management of hypertension and hyperlipidemia (page 931, right column, bottom paragraph, 3.2 Mechanism of action).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition administered in the method of claim 11 of ‘317 by including omega-3 polyunsaturated fatty acids in order to treat hypertension. The person of ordinary skill in the art would have been motivated by the teaching of Micallef, who suggests omega-3 fatty acids could play a key role in the management of hypertension. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Claims 1, 5, 9-10, 14, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 6 of U.S. Patent No. 11,622,980 (hereafter ‘980) in view of O’Hara.
Claim 1 of ‘980 is drawn to a probiotic composition comprising Lactobacillus plantarum 2830 (synonym for Lactobacillus plantarum ECGC 13110402) and a prebiotic comprising galactooligosaccharides.
Claim 2 of ‘980 recites the composition comprises up to 1 g galactooligosaccharides.
Claim 6 of ‘980 recites the composition is the form of capsules.
Claim 1 of ‘980 does not recite the composition is administered to an individual to treat hypercholesterolemia.
O'Hara teaches compositions for the treatment of high cholesterol comprising a Lactobacillus plantarum 2830 (ECGC 13110402) and a cholesterol modifying agent (see O’Hara claim 3 on page 30).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the composition of claims 1, 2, or 6 of ‘980 in order to treat high cholesterol in an individual in need thereof. The person of ordinary skill in the art would have been motivated by the teaching of O’Hara. The person of ordinary skill in the art would have had a reasonable expectation of success.
Instant claim 5 is obvious over claim 1 of ‘980 in view of O’Hara.
Regarding instant claim 9, claim 2 of ‘980 recites the composition comprises up to 1 g galactooligosaccharides rather than 10 to 15 g.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize by routine experimentation the amount of GOS in the composition. The person of ordinary skill in the art would have had a reasonable expectation of success.
Instant claim 10 is obvious over claim 2 of ‘980 because the range of up to 10 g GOS overlaps with the claimed range of up to 1 g GOS.
Instant claims 14 and 17 are obvious over claim 6 of ‘980 in view of O’Hara.
Claims 1 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,622,980 (hereafter ‘980) in view of O’Hara and Micallef et al. (The Journal of nutritional biochemistry 20.12 (2009): 927-939).
See discussion of claims 1 of ‘980 and O’Hara above, which is incorporated into this rejection as well.
Claim 1 of ‘980 does not recite that the composition further comprises omega-3 polyunsaturated fatty acids or sterols.
Micallef teaches administering both phytosterols and omega-3 fatty acids, alone or in combination with statins, for the treatment or management of dyslipidemia (Title and Abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate phytosterols and omega-3 polyunsaturated fatty acids into the composition of claim 1 of ‘980 modified by O’Hara and to administer the composition in order to treat hypercholesterolemia. The person of ordinary skill in the art would have been motivated by the teaching of Micallef. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Claims 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,622,980 (hereafter ‘980) in view of O’Hara et al. (WO 2015/067948 A1), as applied to 1, 5, 9-10, 14, and 17 above, as evidenced by Iqbal et al. (Carbohydrate research 345.10 (2010): 1408-1416).
See discussion of claim 1 of ‘980 and O’Hara above, which is incorporated into this rejection as well.
Regarding claims 11-13, O’Hara teaches that L. plantarum ECGC 13110402 produces β-galactosidases (O’Hara claims 6 and 18), which necessarily synthesizes galactooligosaccharides as evidenced by Iqbal (Abstract, page 1408, left column, paragraph 1, page 1409, left column, paragraph 1).
Claims 2, 4, 6-8, and 15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of US 11,622,980 (hereafter ‘980) in view of O’Hara and Farmer.
See discussion of claim 1 of ‘980 and O’Hara above, which is incorporated into this rejection as well.
Regarding instant claim 2, claim 1 of ‘980 does not recite the composition further comprises fluvastatin, pravastatin, or simvastatin.
Farmer teaches a composition for decreasing serum cholesterol in a patient comprising Lactobacillus plantarum, a cholesterol-reducing agent, and a bifidogenic oligosaccharide (Farmer claims 1-2 and 5). In a preferred embodiment, the cholesterol-reducing agent in the composition is fluvastatin, pravastatin, or simvastatin (Farmer claim 20, paragraph bridging pages 14-15).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate fluvastatin, pravastatin, or simvastatin into the composition of claim 1 of ‘980 modified by O’Hara and to administer the composition in order to further enhance the cholesterol-treating effect of the composition. The person of ordinary skill in the art would have had a reasonable expectation of success in this modification.
Regarding instant claim 4, claim 1 of ‘980 does not recite the composition further comprises β-glucan, glucomannan, or psyllium.
Farmer teaches fibrins such as oat bran (comprises beta-glucan), konjak flour (glucomannan), and psyllium bind cholesterol in the form of free cholic acid and thereby remove them from bioavailability (lines 25-32 on page 18).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate any of the fibrins taught by Farmer, including β-glucan, glucomannan, or psyllium together into the composition in the method of claim 1 of ‘980 modified by O’Hara in order to further enhance the cholesterol-lowering effect of the composition. The person of ordinary skill in the art would have had a reasonable expectation of success in the modification.
Regarding instant claims 6-8, claim 1 of ‘980 does not recite the daily dosage of Lactobacillus plantarum ECGC 13110402 administered to treat high cholesterol.
Regarding claims 6-7, Farmer teaches that the composition comprises in one gram dosage from 2 x 105 to 1010 CFU of viable lactic acid producing bacteria (lines 13-15 on page 20), which overlaps with the instant claimed range of 105 cells to 1012 cells (claim 6) and 108 cells to 1012 cells (claim 7).
Regarding claim 8, Farmer teaches two to four dosages of the composition are administered per day, each comprising about 0.1 g to 5 g per dosage (lines 12-13 on page 25). Farmer teaches that the composition comprises in one gram dosage from 2 x 105 to 1010 CFU of viable lactic acid producing bacteria (lines 13-15 on page 20). Thus, for two dosages of 0.1 g (total daily dosage of 0.2 g or 200 mg), Farmer teaches administering 4 x 104 to 2 x 109 CFU. The claimed value of about 2.6 x 109 is approaching Farmer’s range.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to formulate the daily dosage of Lactobacillus plantarum ECGC 13110402 administered in the method of claim 1 of ‘980 and O’Hara per the teachings of Farmer. The person of ordinary skill in the art would have had a reasonable expectation of success.
Regarding instant claim 15, claim 1 of ‘980 does not recite freeze-drying Lactobacillus plantarum ECGC 13110402.
O’Hara teaches that Lactobacillus plantarum B2830 (synonym for ECGC 13110402) has a freeze drying survival rate of 40% in sucrose (Fig. 12).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to freeze dry and administer the freeze-dried Lactobacillus plantarum ECGC 13110402 in the method of claim 1 of ‘980 modified by O’Hara. The person of ordinary skill int eh art would have been motivated by the greater stability of freeze-dried bacteria. The person of ordinary skill in the art would have had a reasonable expectation of success.
Regarding instant claim 16, claim 1 of ‘980 does not recite the composition further comprises vitamins or minerals.
Farmer teaches that the composition further comprises vitamins or minerals (Farmer claim 29).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Farmer’s vitamins or minerals into the composition in the method of claim 1 of ‘980 modified by O’Hara and Farmer. The person of ordinary skill in the art would have had a reasonable expectation of success given that both compositions are intended to treat high cholesterol.
Claims 1, 5-8, 11-13 and 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 11, 13, 15-17, and 19 of US 11,903,979 (hereafter ‘979). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 1 and 15 are anticipated by claims 19 of ‘979. Instant claims 5-8, 11-13, 16-17 is obvious over claims 3, 11, 13, 15-17, and 19 of ‘979.
Claim 19 of ‘979 recites the composition is administered in combination with one or more of statins, sterols and/or stanols. Claim 19 of 979 depends from claim 14 of ‘979, which recites a method of treating an individual with hypertension comprising administering the composition comprising freeze-dried Lactobacillus plantarum 2830 (synonym for ECGC 13110402).
Instant claims 1 and 15 are anticipated by claim 19 of ‘979.
Instant claim 5 is obvious over claims 13 and 19 of ‘979.
Instant claims 6-8 are obvious over claims 15-16 and 19 of ‘979.
Instant claim 11-13 are obvious over claims 11, 13, and 19 of ‘979.
Instant claim 16 of ‘979 is obvious over claims 17 and 19 of ‘979. Claim 17 of ‘979 does not recite that the composition further comprises statins, sterols and/or stanols. However, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the statins, sterols, and/or stanols into the composition of claim 17 of ‘979 given that both the composition of claim 17 of ‘979 and the composition of claim 19 of ‘979 treat hypertension.
Instant claim 17 of ‘979 is obvious over claims 3 and 19 of ‘979.
Although claim 19 of ‘979 does not recite administering the composition as a liquid, claim 3 of ‘979 recites the composition is incorporated into a drinkable liquid.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to formulate the composition of claim 19 of ‘979 as a liquid given that claim 3 of ‘979 recites a composition comprising Lactobacillus plantarum 2830 incorporated into a drinkable liquid.
Claims 2, 4, 9-10, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 19 of US 11,903,979 (hereafter ‘979) in view of Farmer et al. (WO 9949877 A2)
Claim 2 of ‘979 recites the composition is for use in the treatment of hypertension in an individual having hypercholesterolemia. See above for the recitation of claim 19 of ‘979, which is incorporated into this rejection as well.
Regarding instant claim 2, claim 19 of ‘979 does not recite that the statins are selected from fluvastatin; pravastatin; simvastatin; atorvastatin and rosuvastatin.
Farmer teaches a composition for decreasing serum cholesterol in a patient comprising Lactobacillus plantarum, a cholesterol-reducing agent, and a bifidogenic oligosaccharide (Farmer claims 1-2 and 5). In a preferred embodiment, the cholesterol-reducing agent in the composition is fluvastatin, pravastatin, or simvastatin (Farmer claim 20, paragraph bridging pages 14-15).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition in the method of claim 19 of ‘979 by incorporating any of the statins taught by Farmer, such as fluvastatin, pravastatin, or simvastatin. The person of ordinary skill in the art would have had a reasonable expectation of success.
Regarding instant claim 4, claim 19 of ‘979 does not recite including β-glucan, glucomannan, or psyllium in the composition.
Farmer teaches fibrins such as oat bran (comprises β-glucan), konjak flour (glucomannan), and psyllium bind cholesterol in the form of free cholic acid and thereby remove them from bioavailability (lines 25-32 on page 18).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition in the method of claim 19 of ‘979 by incorporating any of the fibrins taught by Farmer, including β-glucan, glucomannan, or psyllium in order to enhance the cholesterol-lowering effect of the composition. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Regarding instant claims 9-10, claim 19 of ‘979 does not recite the composition comprises fructo-oligosaccharides.
Farmer teaches administering 50 mg to 10 g of fructooligosaccharide per day (lines 24-26 on page 25), which overlaps with the claimed range of 5 to 15 g (claim 9) and up to 5 g (claim 10).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Farmer’s fructooligosaccharides into the composition administered in the method of claim 19 of ‘979. The person of ordinary skill in the art would have been motivated by the teachings of Farmer. The person of ordinary skill in the art would have had a reasonable expectation of success in this modification.
Regarding instant claim 14, claim 19 of ‘979 does not recite the composition is encapsulated.
Farmer teaches the composition is encapsulated (page 25, lines 1-33).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to encapsulate the composition administered in the method of claim 19 of ‘979. The person of ordinary skill in the art would have been motivated to provide a means for oral administration of the composition and the person of ordinary skill in the art would have had a reasonable expectation of success in doing so.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of US 11,903,979 (hereafter ‘979) in view of
Micallef et al. (The Journal of nutritional biochemistry 20.12 (2009): 927-939).
Claim 19 of ‘979 does not teach that the composition administered further comprises omega-3 polyunsaturated fatty acids.
Micallef teaches administering omega-3 polyunsaturated fatty acids, alone or in combination with statins, for the treatment or management of dyslipidemia (Title and Abstract). Micallef teaches that these fatty acids could play a key role in the management of hypertension and hyperlipidemia (page 931, right column, bottom paragraph, 3.2 Mechanism of action).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition administered in the method of claim 19 of ‘979 by including omega-3 polyunsaturated fatty acids. The person of ordinary skill in the art would have been motivated by the teaching of Micallef, who suggests omega-3 polyunsaturated fatty acids could play a key role in managing hypertension. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Claims 1 and 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 5 of US 12,673,076 (hereafter ‘076). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 1 and 11-17 are obvious over claims 1, 3, and 5 of ‘076.
Claim 1 of ‘076 recites a composition comprising a strain of Lactobacilli having an elevated bile salt hydrolase activity and a galactooligosaccharide; wherein the strain is Lactobacillus plantarum 2830 (ECGC 13110402), wherein the galactooligosaccharide is produced by the strain by reverse beta-galactosidase reaction, and wherein the composition further comprises an excipient and/or carrier compound; the composition is in the form of a food stuff or a food additive; the Lactobacillus plantarum 2830 is freeze-dried; the composition further comprises at least one selected from: vitamins, minerals, phytochemicals and/or antioxidants; or a combination thereof.
Claim 3 of ‘076 recites the composition is for treatment of high cholesterol.
Claim 5 of ‘979 of ‘076 recites the composition is encapsulated.
Regarding instant claims 1 and 15, although claim 1 of ‘076 does not recite administering the composition to an individual to treat hypercholesterolemia, claim 3 of ‘076 recites the composition is for treatment of high cholesterol.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the composition of claim 1 of ‘076 to an individual in order to treat hypercholesterolemia per its intended use (recited in claim 3 of ‘079) and the person of ordinary skill in the art would have had a reasonable expectation of success in doing so.
Instant claims 11-13 are obvious over claims 1 and 3 of ‘076.
Instant claim 16 is obvious over claim 1 and 3 of ‘076
Instant claims 14 and 17 are obvious over claims 3 and 5 of ‘076.
Claims 2, 4, and 6-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of US 12,673,076 (hereafter ‘076) n view of Farmer et al. (WO 9949877 A2)
See discussion of claim 3 of ‘076 above, which is incorporated into this rejection as well.
Regarding instant claim 2, claim 3 of ‘076 does not recite that the composition further comprises a statin are selected from fluvastatin; pravastatin; simvastatin; atorvastatin and rosuvastatin.
Farmer teaches a composition for decreasing serum cholesterol in a patient comprising Lactobacillus plantarum, a cholesterol-reducing agent, and a bifidogenic oligosaccharide (Farmer claims 1-2 and 5). In a preferred embodiment, the cholesterol-reducing agent in the composition is fluvastatin, pravastatin, or simvastatin (Farmer claim 20, paragraph bridging pages 14-15).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of claim 3 of ‘076 by incorporating any of the statins taught by Farmer, such as fluvastatin, pravastatin, or simvastatin into the composition of claim 3 of ‘076 and to administer the composition to treat high cholesterol per its intended use. The person of ordinary skill in the art would have had a reasonable expectation of success.
Regarding instant claim 4, claim 3 of ‘076 does not recite including β-glucan, glucomannan, or psyllium in the composition.
Farmer teaches fibrins such as oat bran (comprises β-glucan), konjak flour (glucomannan), and psyllium bind cholesterol in the form of free cholic acid and thereby remove them from bioavailability (lines 25-32 on page 18).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of claim 3 of ‘076 by incorporating any of the fibrins taught by Farmer, including β-glucan, glucomannan, or psyllium in order to further enhance the cholesterol-lowering effect of the composition. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Regarding instant claims 6-8, claim 3 of ‘076 does not recite the daily dose of Lactobacillus plantarum ECGC 13110402.
Regarding instant claims 6-7, Farmer teaches that the composition comprises in one gram dosage from 2 x 105 to 1010 CFU of viable lactic acid producing bacteria (lines 13-15 on page 20), which overlaps with the instant claimed range of 105 cells to 1012 cells (claim 6) and 108 cells to 1012 cells (claim 7).
Regarding instant claim 8, Farmer teaches two to four dosages of the composition are administered per day, each comprising about 0.1 g to 5 g per dosage (lines 12-13 on page 25). Farmer teaches that the composition comprises in one gram dosage from 2 x 105 to 1010 CFU of viable lactic acid producing bacteria (lines 13-15 on page 20). Thus, for two dosages of 0.1 g (total daily dosage of 0.2 g or 200 mg), Farmer teaches administering 4 x 104 to 2 x 109 CFU. The claimed value of about 2.6 x 109 is approaching Farmer’s range.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to formulate the composition of claim 3 of ‘076 per the dosages suggested by Farmer, given that Lactobacillus plantarum ECGC 13110402 is a strain of bacteria that is part of the broader specie of Lactobacillus plantarum that Farmer teaches in a composition for reducing cholesterol (Farmer claim 5). The person of ordinary skill in the art would have had a reasonable expectation of success in this modification.
Regarding instant claims 9-10, claim 3 of ‘076 does not recite the composition further comprises fructo-oligosaccharides.
Farmer teaches administering 50 mg to 10 g of fructooligosaccharide per day (lines 24-26 on page 25), which overlaps with the presently claimed range of 5 to 15 g (instant claim 9) and up to 5 g (instant claim 10).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Farmer’s fructooligosaccharides into the composition administered in the method of claim 3 of ‘076. The person of ordinary skill in the art would have been motivated by the teachings of Farmer. The person of ordinary skill in the art would have had a reasonable expectation of success.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of US 12,673,076 (hereafter ‘076) in view of
Micallef et al. (The Journal of nutritional biochemistry 20.12 (2009): 927-939).
See discussion of claim 3 of ‘076 above, which is incorporated into this rejection as well.
Claim 3 of ‘076 does not teach administering omega-3 polyunsaturated fatty acids.
Micallef teaches administering omega-3 fatty acids, alone or in combination with statins, for the treatment or management of dyslipidemia (Title and Abstract). Micallef teaches that these fatty acids could play a key role in the management of hypertension and hyperlipidemia (page 931, right column, bottom paragraph, 3.2 Mechanism of action).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of claim 3 of ‘076 by including omega-3 fatty acids in order to treat hypertension. The person of ordinary skill in the art would have been motivated by the teaching of Micallef, who suggests combining omega-3 fatty acids with statins. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Claims 1, 6-8, 14, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-4 of US 10,463,704 (hereafter ‘704). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claim 1 is anticipated by claim 4 of ‘704. Instant claims 6-8, 14 and 17 are obvious over claims 2-4 of ‘704.
Claim 4 of ‘704 recites a method of treating an individual with elevated cholesterol serum levels by administering a composition comprising Lactobacillus plantarum ECGC 1311402, wherein the strain is mixed with a prebiotic composition.
Instant claim 1 is anticipated by claim 4 of ‘704.
Instant claims 6-8 are obvious over claim 2 of ‘704. Claim 2 of ‘704 recites the amount of cells/g administered but does not recite the total daily dose or the grams administered.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize by routine experimentation the total daily dose and grams of the composition administered and the person of ordinary skill in the art would have had a reasonable expectation of success in doing so.
Instant claims 14 and 17 are obvious over claims 3-4 of ‘704 since although claim 3 of ‘704 does not recite the composition further comprises a prebiotic, claim 4 of ‘704 recites the strain is mixed with a prebiotic, thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to encapsulate both the strain and prebiotic and to administer the composition. The person of ordinary skill in the art would have had a reasonable expectation of success in this modification.
Claims 2, 4-5, 9-10, and 15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of US 10,463,704 (hereafter ‘704) in view of Farmer et al. (WO 9949877 A2).
Claim 4 of ‘704 recites the strain is mixed with a prebiotic.
Farmer teaches a composition for decreasing serum cholesterol in a patient comprising Lactobacillus plantarum, a cholesterol-reducing agent, and a bifidogenic oligosaccharide (Farmer claims 1-2 and 5). In a preferred embodiment, the cholesterol-reducing agent in the composition is fluvastatin, pravastatin, or simvastatin (Farmer claim 20, paragraph bridging pages 14-15). Farmer teaches that the composition is encapsulated (Farmer page 25, line 3). Farmer teaches that niacin is a preferred additional component of the composition (line 5 on page 22).
Regarding instant claim 2, claim 4 of ‘704 does not recite the composition further comprises fluvastatin, pravastatin, or simvastatin.
Farmer teaches that the cholesterol-reducing agent in the composition is fluvastatin, pravastatin, or simvastatin (Farmer claim 20, paragraph bridging pages 14-15),
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine fluvastatin, pravastatin, or simvastatin with the composition administered in the method of claim 4 of ‘704 in order to further enhance the cholesterol-treating ability of the composition. The person of ordinary skill in the art would have had a reasonable expectation of success.
Regarding instant claim 4, claim 4 of ‘704 does not recite the composition further comprises β-glucan, glucomannan, or psyllium.
Farmer teaches fibrins such as oat bran (comprises beta-glucan), konjak flour (glucomannan), and psyllium bind cholesterol in the form of free cholic acid and thereby remove them from bioavailability (lines 25-32 on page 18).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate any of the fibrins taught by Farmer, including β-glucan, glucomannan, or psyllium into the composition administered in the method of claim 4 of ‘704 in order to further enhance the cholesterol-lowering effect. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Regarding instant claim 5 and 9-10, claim 4 of ‘704 does not recite the composition further comprises fructo-oligosaccharides.
Farmer teaches that the composition comprises fructo-oligosaccharide (Farmer claim 39).
Regarding instant claims 9-10, Farmer teaches administering 50 mg to 10 g of fructooligosaccharide per day (lines 24-26 on page 25), which overlaps with the presently claimed range of 5 to 15 g (instant claim 9) and up to 5 g (instant claim 10).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the prebiotic fructo-oligosaccharides into the composition administered in the method of claim 4 of ‘704 per the teaching of Farmer and the person of ordinary skill in the art would have had a reasonable expectation of success in doing so.
Regarding instant claim 15, claim 4 of ‘704 does not recite that the Lactobacillus plantarum 2830 is freeze-dried.
Farmer teaches freeze-drying bacteria (lines 5-7 on page 31).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to freeze-dry and administer the freeze-dried Lactobacillus plantarum ECGC 13110402. The person of ordinary skill int eh art would have been motivated by the greater stability of freeze-dried bacteria. The person of ordinary skill in the art would have had a reasonable expectation of success.
Regarding instant claim 16, claim 4 of ‘704 does not recite that the composition further comprises vitamins or minerals.
Farmer teaches that the composition further comprises vitamins or minerals (Farmer claim 29).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate vitamins or minerals into the composition administered in the method of claim 4 of ‘704. The person of ordinary skill in the art would have been motivated by the teaching of Farmer and the person of ordinary skill in the art would have had a reasonable expectation of success in this modification.
Claims 1 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of US 10,463,704 (hereafter ‘704) in view of Micallef et al. (The Journal of nutritional biochemistry 20.12 (2009): 927-939).
Claim 4 of ‘704 does recite the composition administered further comprises omega-3 polyunsaturated fatty acids or sterols.
Micallef teaches administering both phytosterols and omega-3 fatty acids, alone or in combination with statins, for the treatment or management of dyslipidemia (Title and Abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer phytosterols and omega-3 fatty acids in combination with the composition of claim 4 of ‘704 in order to treat hypercholesterolemia. The person of ordinary skill in the art would have been motivated by the teaching of Micallef, who suggests combining both phytosterols and omega-3 fatty acids for the treatment of hypercholesterolemia (a type of dyslipidemia). The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Claims 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of US 10,463,704 (hereafter ‘704) as evidenced by O’Hara et al. (WO 2015/067948 A1) and by Iqbal et al. (Carbohydrate research 345.10 (2010): 1408-1416).
Regarding claims 11-13, L. plantarum ECGC 13110402 produces β-galactosidases as evidenced by O’Hara (O’Hara claims 6 and 18), which necessarily produces galactooligosaccharides as evidenced by Iqbal (Abstract, page 1408, left column, paragraph 1, page 1409, left column, paragraph 1).
Claims 1-2 and 4-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of US 11,173,170 (hereafter ‘170) in view of Farmer et al. (WO 9949877 A2).
Claim 4 of ‘170 recites the composition is for use in the management of cholesterol or in the treatment of high cholesterol. Claim 4 of ‘170 depends from claim 1 of ‘170, which recites a composition comprising Lactobacillus plantarum ECGC 13110402 and a galactooligosaccharide produced by the strain and selective for the strain, wherein the composition is encapsulated, in the form of a liquid, further comprises an additional active ingredient, or the strain is freeze-dried.
Regarding instant claim 1, claim 4 of ‘170 does not recite administering the composition or that the composition further comprises statins (instant claim 1). Claim 4 of ‘170 does recite that the composition comprises fluvastatin, pravastatin, or simvastatin (instant claim 2).
Farmer teaches a method for decreasing serum cholesterol in a patient comprising administering a composition comprising Lactobacillus plantarum, a cholesterol-reducing agent, and a bifidogenic oligosaccharide (Farmer claims 1-2 and 5). In a preferred embodiment, the cholesterol-reducing agent in the composition is fluvastatin, pravastatin, or simvastatin (Farmer claim 20, paragraph bridging pages 14-15).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate any of the statins selected from fluvastatin, pravastatin, and simvastatin into the composition of claim 4 of ‘170 in order to further enhance the activity of the composition in treating high cholesterol. It would have been further obvious to administer the composition to an individual in need thereof per its intended use (managing or treating high cholesterol). The person of ordinary skill in the art would have had a reasonable expectation of success.
Regarding instant claim 4, claim 4 of ‘170 does not recite that the composition further comprises β-glucan, glucomannan, or psyllium.
Farmer teaches fibrins such as oat bran (comprises beta-glucan), konjak flour (glucomannan), and psyllium bind cholesterol in the form of free cholic acid and thereby remove them from bioavailability (lines 25-32 on page 18).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate any of the fibrins taught by Farmer, including β-glucan, glucomannan, or psyllium into the composition administered in the method of claim 4 of ‘170 modified by Farmer in order to further enhance the cholesterol-lowering effect. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Regarding instant claim 5, claim 4 of ‘170 recites the composition comprises galacto-oligosaccharides.
Regarding instant claims 6-8, claim 4 of ‘170 does not recite the daily dosage of Lactobacillus plantarum ECGC 13110402.
Regarding instant claims 6-7, Farmer teaches that the composition comprises in one gram dosage from 2 x 105 to 1010 CFU of viable lactic acid producing bacteria (lines 13-15 on page 20), which overlaps with the presently claimed range of 105 cells to 1012 cells (instant claim 6) and 108 cells to 1012 cells (instant claim 7).
Regarding instant claim 8, Farmer teaches two to four dosages of the composition are administered per day, each comprising about 0.1 g to 5 g per dosage (lines 12-13 on page 25). Farmer teaches that the composition comprises in one gram dosage from 2 x 105 to 1010 CFU of viable lactic acid producing bacteria (lines 13-15 on page 20). Thus, for two dosages of 0.1 g (total daily dosage of 0.2 g or 200 mg), Farmer teaches administering 4 x 104 to 2 x 109 CFU. The claimed value of about 2.6 x 109 is approaching Farmer’s range.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to formulate the daily dosage of the composition administered in the method of claim 4 of ‘170 per the teachings of Farmer. The person of ordinary skill in the art would have had a reasonable expectation of success.
Regarding instant claims 9-10, claim 4 of ‘170 does not recite that the composition further comprises fructooligosaccharides.
Farmer teaches administering 50 mg to 10 g of fructooligosaccharide per day (lines 24-26 on page 25), which overlaps with the claimed range of 5 to 15 g (claim 9) and up to 5 g (claim 10).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate 50 mg to 10 g of fructooligosaccharides into the composition administered in the method of claim 4 of ‘170 modified by Farmer. The person of ordinary skill in the art would have been motivated to include an additional prebiotic to support the growth of the bacteria. The person of ordinary skill in the art would have had a reasonable expectation of success.
Instant claims 11-13 are obvious over claim 4 of ‘170 in view of Farmer.
Instant claim 14-15 and 17 are obvious over claim 4 of ‘170 in view of Farmer.
Regarding instant claim 16, claim 4 of ‘170 does not recite the composition further comprises vitamins or minerals.
Farmer teaches that the composition further comprises vitamins or minerals (Farmer claim 29).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate vitamins or minerals into the composition of claim 4 of ‘170 modified by Farmer. The person of ordinary skill in the art would have been motivated by the teaching of Farmer and the person of ordinary skill in the art would have had a reasonable expectation of success given that both the composition of Farmer and the composition of claim 4 of ‘170 are intended to treat high cholesterol.
Claims 1 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of US 11,173,170 (hereafter ‘170) in view of Micallef et al. (The Journal of nutritional biochemistry 20.12 (2009): 927-939).
Claim 4 of ‘170 does not recite that the composition further comprises fatty acids (instant claim 1) or omega-3 polyunsaturated fatty acids or sterols (instant claim 3).
Micallef teaches administering omega-3 fatty acids, alone or in combination with statins, for the treatment or management of dyslipidemia (Title and Abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition administered in the method of claim 4 of ‘170 by incorporating omega-3 polyunsaturated fatty acids in order to treat high cholesterol. The person of ordinary skill in the art would have been motivated by the teaching of Micallef, who suggests that administering omega-3 fatty acids helps treat dyslipidemia (which includes high cholesterol). The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Conclusion
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/CANDICE LEE SWIFT/Examiner, Art Unit 1657
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