DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
The instant application is a 371 of PCT/CA2021/051485 filed on 10/21/2021, which claims domestic benefit to US provisional application no. 63/109,140 filed on 11/03/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/02/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
The preliminary amendments filed on 05/02/2023 is acknowledged. Claims 1, 3-4, 8, 10-11, and 13 are amended.
Accordingly, claims 1-13 are pending and being examined on the merits herein.
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.
Claim 7 is 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 7 recites “The use of montbretin A as an ingredient in a cooked food product for human consumption for limiting polysaccharide processing in a human.”
The recitation of “the use of” is suggestive of a method, however the claim does not recite a use without setting forth any steps involved in the use. See MPEP 2173.05(q).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 7 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim is not drawn to one of the four statutory categories. MPEP 2173.05(q) recites “"Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101”
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.
Claim(s) 1-5, 7-8, and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Skop et al. (US20060147565A1 in PTO-892) in view of US‘541 (US8431541B2 in IDS filed on 05/02/2023)
Skop et al. discloses a purified amylase inhibitor obtained by a superior process that includes extracting ground beans with supercritical carbon dioxide (see Abstract). Skop et al. discloses that their amylase inhibitor can be administered to a mammal for improving post-prandial glucose tolerance in a diabetic mammal (see Abstract). Skop et al. discloses that amylase inhibitors are derived from various sources, including vegetable albumins and leguminous plants (paragraph 0004) and further discloses that current methods for purification of amylase inhibitors, which includes concentrating and drying beans, include the use of heat treatments and/or solvents (paragraph 0005). However, Skop et al. discloses that the use of heat treatments and/or solvents has several drawbacks such as degradation and a decrease in stability and potency (paragraph 0005). Skop et al. discloses that amylase inhibitors are often added to food products for consumption but the impurities and contaminants that remain from conventional extraction methods are associated with negative flavors that render such food products unappetizing (paragraph 0008). Therefore, Skop provides a method for a purer and more potent amylase inhibitor derived from beans, and a more sophisticated process for obtaining the same (paragraph 0010). Skop et al. discloses that amylase inhibitors are glycoproteins that inhibit the enzyme responsible for breaking down carbohydrates, namely, amylase (paragraph 0015). Skop et al. discloses that their produced amylase inhibitor is superior to other amylase inhibitors because it is of a higher degree of purity than amylase inhibitors obtained by conventional extraction methods, i.e. heat and chemical, and due to the high degree of purity, the amylase inhibitor exhibits improved stability and potency in vitro and in vivo over amylase inhibitors of the prior art (paragraph 0016). Skop et al. discloses that their amylases inhibitors remain stable at elevated temperatures, such as, for example, 120-200° F, and that such heat stability allows the amylase inhibitor to be utilized in, for example, food products that are cooked, without losing the beneficial, starch-blocking effects (paragraph 0017). Skop et al. discloses that their amylase inhibitor is stable under baking temperatures, and be effectively added to baking mixes such as pancakes, waffles, breads, biscuits, or cookies (paragraph 0051).
The difference between Skop and the claimed invention is that Skop does not teach montbretin A.
US’541 discloses the use of certain glycosylated acyl-flavonols as mammalian pancreatic and salivary α-amylase inhibitors and exemplifies montbretin A and B (see column 3 lines 35-51). US’541 discloses their compounds can be isolated from Crocosmia, a genus of perennial plants of the Iridaceae family (see column 3 lines 35-51). US’541 discloses in Fig. 1 a process of extracting montbretins from this plant using a solvent based extraction. US’541 discloses their montbretin compounds are shown to be useful in controlling starch digestion, which meets the limitation “limiting polysaccharide processing” recited in claims 1 and 8. US’541 further exemplifies that the controlling of starch digestion is to manage postprandial glycemia in pre-diabetic or diabetic subjects and/or for management of obesity in any subject, and that the subject may be a human or other mammal (see column 3 lines 35-51). US’541 discloses their montbretin compounds are used as an α-amylase inhibitor for the treatment of pre-diabetes, diabetes, or obesity (see column 4 lines 62-67). US’541 discloses their montbretin compounds can be administered by including an α-amylase inhibiting effective amount in a food, beverage, candy, or other “treat”, nutritional supplement, or the like, which is intended to be ingested by a subject (see column 11 lines 56-63).
It would have been prima facie obvious to combine Skop with US’541 before the effective filing date of the claimed invention by substituting the amylase inhibitor extracted from beans with the montbretin A extracted from Crocosmia plants and further incorporate the extracted montbretin A into a baking mix to make baked bread as disclosed in Skop to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to make these modifications with a reasonable expectation of success because Skop et al. provides guidance of an extraction method to obtain a similar amylase inhibitor such as the montbretin A amylase inhibitor disclosed in US’541. Furthermore, Skop et al. discloses several advantages of their extraction method over conventional methods (ex. the solvent extraction method disclosed in US’541) such as a higher purity and better stability at baking temperatures for use in baking mixes to form baked food products such as bread. Therefore, an ordinary skilled artisan would have been motivated to improve the extraction of montbretin A for better stability as an amylase inhibitor in baked food products, and could have predictably applied the extraction method of Skop to achieve this.
In regards to instant claims 7-8, it would have also been prima facie to use the modified baked bread comprising montbretin A as suggested by the combined teachings of Skop and US’541 for limiting polysaccharide processing in a human subject as disclosed in US’541. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because US’541 provides guidance that montbretin A are shown to be useful in controlling starch digestion, and further discloses that monebretin A can be administered to a human as a food product.
In regards to instant claim 10, it would have also been prima facie to use the modified baked bread comprising montbretin A as suggested by the combined teachings of Skop and US’541 for managing prostprandial glycemia in a pre-diabetic, diabetic, or obese human subject as disclosed in US’541. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because US’541 provides guidance that montbretin A can be administered to a human to manage postprandial glycemia in pre-diabetic or diabetic subjects and/or for management of obesity in any subject, and that the subject may be a human or other mammal.
In regards to instant claim 11-12, it would have also been prima facie to use the modified baked bread comprising montbretin A as suggested by the combined teachings of Skop and US’541 for inhibiting mammalian alpha-amylase in a human subject as disclosed in US’541. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because US’541 provides guidance that montbretin A can be administered to a human as mammalian pancreatic and salivary α-amylase inhibitors.
In regards to instant claim 13, it would have also been prima facie to use the modified baked bread comprising montbretin A as suggested by the combined teachings of Skop and US’541 for treating diabetes in a human subject as disclosed in US’541. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because US’541 provides guidance that montbretin A can be administered to a human as an α-amylase inhibitor for the treatment of pre-diabetes, diabetes, or obesity.
Claim(s) 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Skop et al. (US20060147565A1 in PTO-892) in view of US‘541 (US8431541B2 in IDS filed on 05/02/2023), as applied to claims 1 and 8 above, and further in view of JP’117 (JP2007077117A in PTO-892, an English translation is provided in PTO-892 and used as the basis for this rejection)
The combination of Skop and US’541 teaches the cooked food product of claim 1 and the method of claim 8 as described above.
The difference between the combination of Skop and US’541 and the claimed invention is that the combination of Skop and US’541 do not disclose wherein the montbretin A is present in the cooked food product in an amount from about 0.1 to about 1.0 milligram per gram of the cooked food product.
JP’117 discloses a novel α-amylase inhibitor, which is useful in particular as an active ingredient in foods, beverages and pharmaceuticals that are effective in preventing, ameliorating and treating diseases such as diabetes, obesity and hyperlipidemia (see paragraph 0001). JP’117 discloses their α-amylase inhibitor is characterized by containing dicaffeoylquinic acid, which is extracted from plants (see paragraph 0009 and 0011). JP’117 discloses that the content of the α-amylase inhibitor in a food or beverage is preferably 0.01 to 50 parts by weight or more, more preferably 0.1 to 10 parts by weight per 100 parts by weight of the food (see paragraph 0030). JP’117 discloses that an effective dosage of their active ingredient is preferably about 0.01 to 100 mg/kg (see paragraph 0037). JP’117 exemplifies several foods that can include the α-amylase inhibitor such as bread, various cooked foods, and among other food types (see paragraph 0029). JP’117 further discloses that the method for producing the food and beverage product include cooking, processing, and production using commonly used food and beverage production methods, as long as the α-amylase inhibitor is contained, added, or diluted in the produced food and beverage product (see paragraph 0028).
It would have been prima facie obvious to combine Skop and US’541 with JP’117 before the effective filing date of the claim invention such that the montbretin A in the modified cooked food product as suggested by the combined teachings of Skop and US’541 is 0.01 to 50 parts by weight (converts to 0.001 mg to 5 mg per gram) of the cooked food product as disclosed in JP’117 and would be further obvious to arrive at the claimed weight ratio amount based on this overlapping range disclosed in JP’117. See MPEP 2144.05 section I.
In regards to instant claim 9, it would have also been prima facie obvious that the modified cooked food product as suggested by the combined teachings of Skop and US’541 can be administered at an effective amount from about 0.1 gram to 2 grams food product per kg human subject based on the teachings of JP’117 to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because JP’117 provides guidance that an effective amount for the use of a similar α-amylase inhibitor is preferably about 0.01 to 100 mg/kg and can also be in 0.01 to 50 parts by weight (converts to 0.001 mg to 5 mg per gram) of a cooked food product. Therefore, an ordinary skilled artisan could have predictably optimized the effective amount of the modified cooked food product as suggested by the combined teachings of Skop and US’541 based on the amounts taught in JP’117 of a similar α-amylase inhibitor in the same food composition with the same uses. See MPEP 2144.05 section II.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 7-8, and 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 8,431,541 (US’541) in view of US‘541 (US8431541B2 in IDS filed on 05/02/2023) and Skop et al. (US20060147565A1 in PTO-892) JP’117 (JP2007077117A in PTO-892, an English translation is provided in PTO-892 and used as the basis for this rejection) and as evidenced by ThermoPro (ThermoPro website, 2018 in PTO-892).
Claim 1 of ‘541 recites an isolated compound that is not montbretin A or montbretin B. Claim 8 of ‘541 recites the compound is present at an effective amount in a food for the inhibition of salivary or pancreatic α-amylase in a mammalian subject. Claim 10 of ‘541 recites method of managing postprandial glycemia in a subject in need thereof, wherein said subject is pre-diabetic, has diabetes or is obese, the method comprising administration of an effective amount of a compound or physiologically acceptable salt thereof as defined by claim 1 to manage said postprandial glycemia.
The difference between the claims of ‘541 and the claimed invention is that the claims of ‘541 do not recite montbretin A and a cooked food product.
The independent teachings of US’541 and Skopare as discussed above. Furthermore, US’541 incorporates all of the limitations in the claims of US‘541 as seen in columns 3-10.
It would have been prima facie obvious to combine the claims of US’541 with US’541 and Skop before the effective filing date of the claimed invention by substituting the isolated compound recited in the claims of US‘541 with the monbretin A disclosed in US’541 and further extracting the monbretin A using the extraction process taught in Skop and incorporating into a bake mix to form baked bread as disclosed in Skop to arrive at the claimed invention. One of ordinary skill in the art would have made these modifications with a reasonable expectation of success because the disclosure of US’541 discloses all of the same uses of monbretin A as recited for the compound in the claims of US‘541. Furthermore, US’541 provides guidance of adding monbretin A as an α-amylase inhibitor into food products, and Skop et al. provides guidance of an extraction method to obtain a similar amylase inhibitor such as the montbretin A amylase inhibitor disclosed in US’541 for use in baking mixes to form baked food products. Additionally, Skop et al. discloses several advantages of their extraction method over conventional methods (ex. the solvent extraction method disclosed in US’541) such as a higher purity and better stability at baking temperatures. Therefore, an ordinary skilled artisan would have been motivated to improve the extraction of montbretin A for better stability as an amylase inhibitor in baked food products, and could have predictably applied the extraction method of Skop to achieve this.
Claims 1, 6, and 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 8,431,541 (US’541) in view of US‘541 (US8431541B2 in IDS filed on 05/02/2023), Skop et al. (US20060147565A1 in PTO-892), and JP’117 (JP2007077117A in PTO-892, an English translation is provided in PTO-892 and used as the basis for this rejection).
The claims of US‘541 are as described above.
The difference between the claims of US‘541 and the claimed invention is that the claims of US‘541 do not recite wherein the montbretin A is present in the cooked food product in an amount from about 0.1 to about 1.0 milligram per gram of the cooked food product.
The independent teachings of US’541, Skop, and JP’117 are as described above.
It would have been prima facie obvious to combine the claims of US‘541 with US’541, Skop, and JP’117 before the effective filing date of the claimed invention such that the montbretin A in the modified cooked food product as suggested by the combination of the claims of US‘541 and the teachings of US’541 and Skop described above can contain is 0.01 to 50 parts by weight (converts to 0.001 mg to 5 mg per gram) of the cooked food product as disclosed in JP’117 and would be further obvious to arrive at the claimed weight ratio amount based on this overlapping range disclosed in JP’117. See MPEP 2144.05 section I.
In regards to instant claim 9, it would have also been prima facie obvious that the modified cooked food product as suggested by the combination of the claims of US‘541 and the teachings of US’541 and Skop described above can be administered at an effective amount from about 0.1 gram to 2 grams food product per kg human subject based on the teachings of JP’117 to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because JP’117 provides guidance that an effective amount for the use of a similar α-amylase inhibitor is preferably about 0.01 to 100 mg/kg and can also be in 0.01 to 50 parts by weight (converts to 0.001 mg to 5 mg per gram) of a cooked food product. Therefore, an ordinary skilled artisan could have predictably optimized the effective amount of the modified cooked food product as suggested by the combination of the claims of US‘541 and the teachings of US’541 and Skop described above based on the amounts taught in JP’117 of a similar α-amylase inhibitor in the same food composition with the same uses. See MPEP 2144.05 section II.
Conclusion
No claim is found allowable.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693