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 .
Claims 1-18 are pending in this application and are being examined.
Objection(s):
Claim(s):
Claims 4, 12 and 17 are objected to because of the following informalities:
In claim 4, line 2, replace “functional bowel disorders” with –a functional bowel disorder--, and line 3, replace “functional duodenal disorders” with --a functional duodenal disorder--.
In claim 12, last line, replace “a flatoxin” with -- aflatoxin--.
In claim 17, line 2, replace “histamine type-2 receptor antagonists” with –a histamine type-2 receptor antagonist--.
Appropriate correction is required.
Specification:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, for example, paragraphs [0005], [0021], [0062], [0111], [0112], [0288], [0464] and [0486].
Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejection - 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 1-18 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.
In claim 1 the phrase “an effective amount” is indefinite because the claim fails to state the function to be achieved and there are more than one effect implied from the specification, for example, starch digestion, treatment of individual having congenital sucrase isomaltase syndrome, among others (Also, see paragraph [0027]). As such, the effective amount is not clearly defined and the metes and bounds of the claim is not exactly set forth.
Suggestion to obviate the rejection: provide a numerical value for the effective amount.
In claim 2 the phrase “a dosage that is equal to or greater than 10,000 unit …” is indefinite because the specific amount of amyloglucosidase in the composition and claimed method is not exactly clear. A indicated in MPEP, “a patentee or applicant is free to be his or her own lexicographer, a patentee or applicant may use terms in a manner contrary to or inconsistent with one or more of their ordinary meanings if the written description clearly redefines the terms.” (Also see MPEP 2173.02(a)). In this case, “dose” refers to a specified amount of medication taken at one time, while “dosage” refers to a specific amount, number, and frequency of doses over a specified period of time. In this case, there are no specific amount, number, and frequency of doses over a specified period of time, for the claimed amyloglucosidase composition in claim 36. Moreover, there is no special definition in the specification for a dosage. It should be noted that the phrase “… releases of one gram of glucose per hour” relates to definition of amyloglucosidase unit and not to a specific amount, number, and frequency of doses over a specified period of time. As such, the metes and bounds of the claim is not exactly set forth.
Suggestion to obviate the rejection: define the dosage, i.e., a specific amount, number, and frequency of doses over a specified period of time.
In claim 4 the Markush group “congenital sucrase isomaltase syndrome, functional bowel disorders, functional bowel syndrome, functional duodenal disorders, small bowel bacterial overgrowth, radiochemotherapy- induced mucositis and/or short-gut syndrome” is indefinite because the Markush grouping is not a closed group of alternatives.
Suggestion to obviate the rejection: for example, in claim 4, line 2, after of, insert “a condition selected from the group consisting of--, and line 5, replace “and/or” with –or--.
In claim 12 the Markush group “a mycotoxin, a ochratoxins, and/or a flatoxin” is indefinite because the Markush grouping is not a closed group of alternatives.
Suggestion to obviate the rejection: for example, in claim 12, last line, replace “and/or” with –or--.
In claim 18 the Markush group “congenital sucrase isomaltase syndrome, functional bowel disorders, functional bowel syndrome, functional duodenal disorders, small bowel bacterial overgrowth, radiochemotherapy- induced mucositis and/or short-gut syndrome” is indefinite because the Markush grouping is not a closed group of alternatives.
Suggestion to obviate the rejection: for example, in claim 18, line 2, replace “and/or” with –or--.
Claim Rejection - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-5, 7-11, 14-16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Global Healing (The health Benefits of Glucoamylase, Written by Dr. Group, DC Founder, 2014, 5 pages of PDF, retrieved from explore.globalhealing.com, which is also cited in IDS filed on 11/26/2024), as evidenced by NIH Dietary Supplement label database (NIH Dietary Supplement label database, Product: VeganZyme[Symbol font/0xD2], retrieved from National Institute of Health, Office of Dietary Supplements database on 09/17/2026, 7 pages of PDF).
Regarding claim 1, Global Healing disclose health benefits of administering a composition comprising amyloglucosidase (VeganZyme[Symbol font/0xD2] comprising AGU or glucoamylase or amyloglucosidase units) for treating irritable bowel syndrome and digesting glucose from food, etc. (See pages 2-4).
Regarding claim 3, Global Healing inherently disclose the composition is provided to the individual orally (since VeganZyme[Symbol font/0xD2] formula is a systemic formula) (see p. 4 1st paragraph). Also, as evidenced by NIH Dietary Supplement label database showing Supplement Form: capsule (See p. 2 product classification, Supplement form).
Regarding claim 4, Global Healing disclose individual is in need of treatment or prevention of congenital sucrase isomaltase syndrome, functional bowel disorders, functional bowel syndrome, functional duodenal disorders, small bowel bacterial overgrowth, radiochemotherapy-induced mucositis and/or short-gut syndrome (glucoamylase eases effects of IBS, etc.) (See for example, p. 2-3 paragraphs 1 and 2).
Regarding claim 5, Global Healing disclose the providing step occurs daily, weekly, monthly, or yearly, as evidenced by NIH Dietary Supplement label database showing take 2 capsules twice daily (See p. 5 “Suggested Use”).
Regarding claim 7, Global Healing disclose the individual is an infant, child, adolescent, teenager, or adult, as evidenced by NIH Dietary Supplement label database showing targeted Groups adults and children (See p. 5 “Target Groups”).
Regarding claim 8, Global Healing disclose the composition is formulated in a comestible or beverage, as evidenced by NIH Dietary Supplement label database showing Supplement Form: capsule (See p. 2 product classification, Supplement form).
Regarding claim 9, Global Healing disclose the composition is a food supplement, as evidenced by NIH Dietary Supplement label database showing Supplement Form: capsule (See p. 2 product classification, Supplement form).
Regarding claim 10, Global Healing disclose the composition is in the form of a solid, liquid, or gel, as evidenced by NIH Dietary Supplement label database showing Supplement Form: capsule (See p. 2 product classification, Supplement form).
Regarding claim 11, Global Healing disclose the composition is a capsule, tablet, pill, film, lozenge, powder, or combination thereof. As evidenced by NIH Dietary Supplement label database showing Supplement Form: capsule (See p. 2 product classification, Supplement form).
Regarding claim 14, Global Healing disclose composition further comprises one or more other therapeutic agents, as evidenced by NIH Dietary Supplement label database showing enzyme blend including invertase (See p. 3 list of ingredients).
Regarding claim 15, Global Healing disclose the one or more other therapeutic agents comprise an agent that facilitates digestion of biological molecules other than starch, as evidenced by NIH Dietary Supplement label database showing enzyme blend including invertase and lipase (See p. 3 list of ingredients).
Regarding claim 16, Global Healing disclose the therapeutic agent is invertase sucrase, lactase, xylose isomerase, beta-galactosidase, or a combination thereof, as evidenced by NIH Dietary Supplement label database showing enzyme blend including invertase and lactase, etc. (See p. 3-4 list of ingredients).
Regarding claim 18, Global Healing disclose no added buffers, amino acids, and/or carbohydrates are in the composition (no buffer), as evidenced by NIH Dietary Supplement label database list of ingredients (See p. 4 list of other ingredients).
Global Healing therefore anticipate the claimed method of optimizing starch or fructans digestion in an individual.
Claim Rejection - 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.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Global Healing as evidenced by NIH Dietary Supplement label database (VeganZyme[Symbol font/0xD2]) as applied to claims 1, 3-5, 7-11, 14-16 and 18 above, and further in view of Friss et al. (U.S. Patent No. 9,695,406) and Eisenstein et al. (US 2008/0213320 A1).
The teaching of Global Healing and NIH Dietary Supplement label database (VeganZyme[Symbol font/0xD2]) with respect to the limitations of claims 1, 3-5, 7-11, 14-16 and 18 were discussed above in detail.
Global Healing does not teach the composition comprises amyloglucosidase in a dosage that is equal to or greater than 10,000 unit releases of one gram of glucose per hour (claim 2), the individual is malnourished (claim 6), the composition comprises amyloglucosidase and a reduced level of a toxin with reference to an amyloglucosidase composition that has not been subjected to an extraction/purification step, wherein the toxin is a mycotoxin, a ochratoxins, and/or aflatoxin (claim 12), and the one or more therapeutic agents is histamine type-2 receptor antagonists, benzimidazole derivative, or a combination thereof (claim 17).
However, regarding claim 12, before the effective filing date of the invention, Friis et al. teach a composition comprises amyloglucosidase (AMG) and a reduced level of a toxin with reference to an amyloglucosidase composition that has not been subjected to an extraction/purification step, wherein the toxin is a mycotoxin, a ochratoxins, and/or aflatoxin (enzyme product comprising purified glucoamylase collected by spray drying, etc.), the AMG can be combined by other therapeutic agents including invertase, beta-galactosidase, and AMG activity in AGU (See for example, column 34 lines 45-64, column 51 lines 65-66-Continued on column 52 lines 1-12, column 35 lines 11-20, and column 54 lines 63-67-Continued on column 55 Table 3 lines 1-10). Therefore, a person of ordinary skill in the art before the effective filing date of the invention would have been capable of substituting the amyloglucosidase (AMG) taught by Friis et al. for the amyloglucosidase being administered in the method taught by Global Healing (substituting equivalents) with a reasonable expectation of success in providing the claimed subject matter of claim 12.
Moreover, regarding claim 17, before the effective filing date of the invention, Eisenstein et al. teach therapeutic agents including histamine type-2 receptor antagonists (H2 blockers), and further teach digestive enzymes including lactase to treat digestive disorders, etc. (see p. 1 paragraphs [0005], [0006] and [0011]). Therefore, a person of ordinary skill in the art before the effective filing date of the invention, knowing that therapeutic agents including histamine type-2 receptor antagonists and digestive enzymes including lactase were being used to treat digestive disorders, would have motivated to combine teachings of prior art and the method taught by Global Healing, by including therapeutic agents including histamine type-2 receptor antagonists and digestive enzymes in the composition being administered in the method taught by Global Healing with a reasonable expectation of success to provide the method of claim 17.
In addition, regarding claim 2 and 6, the amount of amyloglucosidase in a dosage that is equal to or greater than 10,000 unit releases of one gram of glucose per hour (AGU), and the subject/individual in the claimed method taught by Global Healing would have been optimized by a person of ordinary skill in the art before the effective filing dated of the invention. Because Global Healing teach the composition helps the digestion, and defines amount of glucoamylase in one unit of AGU (See p. 3 “how t oread the Units …” and p. 4 1st paragraph).
Double Patenting Rejection:
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.
A)
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. U.S. Patent No. 11,690,392 B2. Although the claims at issue are not identical, they are not patentably distinct from each other in view of the side by side comparison (see below table) of the limitations of claimed method of instant application and the method of claims 1-9 of U.S. Patent No. 11,690,392 B2.
Claims 1-9 of U.S. Patent No. 11,690,392 B2:
Claims 1-11 instant Application:
1. A method for optimizing starch or fructans digestion in an individual, comprising the step of providing to the individual an effective amount of an amyloglucosidase composition produced by the method of extracting a crude amyloglucosidase composition in the presence of an immiscible solvent, and separating a purified amyloglucosidase composition from the immiscible solvent, wherein the composition comprises amyloglucosidase in a dose that is equal to or greater than 10,000 unit releases of one gram of glucose per hour (AGU).
1. A method of optimizing starch or fructans digestion in an individual, comprising the step of providing to the individual an effective amount of a composition comprising amyloglucosidase.
2. The method of claim 1, wherein the composition comprises amyloglucosidase in a dosage that is equal to or greater than 10,000 unit releases of one gram of glucose per hour (AGU).
2. The method of claim 1, wherein the individual is in need of treatment or prevention of a condition selected from the group consisting of congenital sucrase isomaltase syndrome, functional bowel disorders, functional bowel syndrome, functional duodenal disorders, small bowel bacterial overgrowth, radiochemotherapy-induced mucositis and short-gut syndrome.
4. The method of claim 1, wherein the individual is in need of treatment or prevention of congenital sucrase isomaltase syndrome, functional bowel disorders, functional bowel syndrome, functional duodenal disorders, small bowel bacterial overgrowth, radiochemotherapy-induced mucositis and/or short-gut syndrome.
3. The method of claim 1, wherein the providing step occurs daily, weekly, monthly, or yearly.
5. The method of claim 1, wherein the providing step occurs daily, weekly, monthly, or yearly.
4. The method of claim 1, wherein the individual is malnourished.
6. The method of claim 1, wherein the individual is malnourished.
5. The method of claim 1, wherein the individual is an infant, child, adolescent, teenager, or adult.
7. The method of claim 1, wherein the individual is an infant, child, adolescent, teenager, or adult.
6. The method of claim 1, wherein the composition is formulated in a comestible or beverage.
8. The method of claim 1, wherein the composition is formulated in a comestible or beverage.
7. The method of claim 6, wherein the composition is a food supplement.
9. The method of claim 8, wherein the composition is a food supplement.
8. The method of claim 1, wherein the composition is in the form of a solid, liquid, or gel.
10. The method of claim 1, wherein the composition is in the form of a solid, liquid, or gel.
9. The method of claim 1, wherein the composition is a capsule, tablet, pill, film, lozenge, powder, or combination thereof.
3. The method of claim 1, wherein the composition is provided to the individual orally.
Note: capsule, tablet, pill are orally administered.
11. The method of claim 1, wherein the composition is a capsule, tablet, pill, film, lozenge, powder, or combination thereof.
Regarding the limitations of claims 12 and 13 not explicitly disclosed by claims of U.S. Patent No. 11,690,392 B2, i.e., the composition comprises amyloglucosidase and a reduced level of a toxin with reference to an amyloglucosidase composition that has not been subjected to an extraction/purification step, wherein the toxin is a mycotoxin, a ochratoxins, and/or a flatoxin (claim 12), and the amyloglucosidase composition comprises 10, 20, 30, 40, 50, 60, 70, 80, 90, 91, 92, 94, 95, 96, 97, 98, or 99% lower amount of toxin than the reference amyloglucosidase composition (claim 13), the specification of U.S. Patent No. 11,690,392 B2 define the amyloglucosidase composition as “toxin-free”, i.e., has reduced by a level that is 10, 20, 30, 40, 50, 60, 70, 80, 90, 91, 92, 92, 94, 95, 96, 97, 98, or 99%, and (See paragraph 28). As such, the limitations of claims 12 and 13 are inherently present.
Therefore, in view of the side by side comparison of claimed methods as indicated above, it the method of claims 1-9 of U.S. patent No. 11,690,392 B2 anticipates the claimed method of claims 1-13 of instant application.
B)
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,690,392 B2 in view of Eisenstein et al. (US 2008/0213320 A1).
The teachings of 1-9 of U.S. Patent No. 11,690,392 B2 with respect to the limitations of claims 1-13 of instant application were discussed above in detail.
Regarding claims 14-18, Eisenstein et al. teach therapeutic agents including histamine type-2 receptor antagonists (H2 blockers), and further teach digestive enzymes including lactase to treat digestive disorders, etc. (see p. 1 paragraphs [0005], [0006] and [0011]).
Therefore, a person of ordinary skill in the art before the effective filing date of the invention, knowing that therapeutic agents including histamine type-2 receptor antagonists and digestive enzymes including lactase were being used to treat digestive disorders, would have motivated to combine teachings of prior art and the method as disclosed by claims 1-9 of U.S. patent No. 11,690,392 B2, by including therapeutic agents including histamine type-2 receptor antagonists and digestive enzymes in the composition being administered in the method taught by claims of U.S. patent No. 11,690,392 B2, with a reasonable expectation of success to provide the method(s) as disclosed by claims 1-18 of instant application.
Conclusion(s):
No claim(s) is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KADE ARIANI whose telephone number is (571)272-6083. The examiner can normally be reached IFP, Monday - Friday, 8:00 AM -4:00 PM EST.
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/KADE ARIANI/Primary Examiner, Art Unit 1651
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