Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
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.
Previously presented rejection of claim(s) 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Sakuma JP2003306692: Takase JP2003160794: Koike JP2002138297; KoikeM, JP2002138296 (see IDS 06/02/2023, not included herewith) and Hosoya US 20100267681. Hosoya is new and added to augment the rejection.
Applicants arguments and affidavit filed are considered.
Hosoya teaches a fat or oil composition comprising diacylglycerols, omega-3 fatty acids (e.g., α-linolenic acid) and vitamin C at contents and ratios that overlap the contents and ratios recited in claims (see Hosoya abstract; paragraphs [0017], [0018] and [0045]-[0047]). Hosoya claim 1:
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Hosoya claim 13:
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As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Applicants argument points out that the instant working Example 4 has favorable low sensory evaluation score, with respect to odor evaluation. Taken together the teaching Sakuma and Takase (Koike and KoikeM teaching being silent), Applicant argues that there is no suggestion for the instant 0.15 mass % to 6.0 mass% of a hydroxy acid or a salt.
This is not persuasive, because as the components of the composition (and modifying their ratios) as result effect variables is known the art in the cited references. For example, the odor appears 16 times in the disclosure of Hosoya. Also see page 5 previous action (see below). As previously noted, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Again, the invention is a selective combination of the inventions by the prior arts done in a manner obvious to one of ordinary skill in the art. Patent for the combination of known elements wherein their functions remain the same withdraws “what is already known into field of its monopoly and diminishes resources available to skilled men”. Sakraida v. Ag Pro, Inc.189 USPQ 449, 425 US 273, (1976).
Following is from previous action:
Sakuma teaches a powdery oil-and-fat containing a diglyceride and having excellent taste, flavor, palatability, storage stability, dispersibility in water and dispersing power of powder such as proteins and carbohydrates and provide an oil-and-fat processed food containing the powdery oil-and-fat.
The above powdery oil/fat powder comprising (A) 15-79.9% by weight of a glyceride mixture containing 5-84.9% by weight of triglycerides, 0.1-5% by weight of monoglycerides and 15-94.9% by weight of diglycerides, with 50% by weight or more of all fatty acids constituting the glyceride mixture being unsaturated fatty acids, (B) 20-84.9% by weight of one or two or more powder-forming bases selected from carbohydrates, proteins and peptides and (C) 0.1-5% by weight of water. Sakuma also indicates that the oil/fat powder further comprises 0.01-5 parts by weight of an antioxidant relative to 100 parts by weight of the component (A) and comprises 0.1-20 parts by weight of an emulsifier with an HLB of 7 or more relative to 100 parts by weight of the component (A), with 50% or more of all fatty acids constituting the glyceride mixture of the component (A) being unsaturated fatty acids which are preferably oleic acid, linoleic acid, or linolenic acid, the antioxidant preferably being tocopherol, L-ascorbyl fatty acid ester or the like, and the oil/fat powder preferably comprising 0.001-0.5 parts by weight of hydroxycarboxylic acid having 2-8 carbon atoms in order to improve flavor and storage stability. Sakuma also indicates, for instance in the examples, that oil/fat composition I comprising 0.04 parts by weight of L-ascorbyl palmitate relative to 100 parts by weight of oil/fat f (glyceride composition: 84.8% diglyceride with 55.2% a-linolenic acid in the diglycerides and triglycerides) and 25 ppm of citric acid was produced, and that water, sucrose stearate ester and the like were further added to prepare an emulsion.
Although the above example comprises 25 ppm of citric acid, Sakuma indicates, as stated above, that 0.001-0.5 parts by weight of hydroxycarboxylic acid or the like having 2-8 carbon atoms is preferably included, and it would not be particularly difficult to adjust the content of the hydroxycarboxylic acid having 2-8 carbon atoms by taking flavor and storage stability into account.
Takase teaches an oil-and-fat composition which keeps a good taste and stability against discoloration and exhibits excellent hydrolysis resistance, oxidation resistance and emulsion stability even when exposed to severe conditions of high-temperature long-time heating and can therefore find wide utility in pharmaceutical preparations, food and feed, and has an excellent effect of suppressing deposition of fat in the body.
The above an oil/fat composition comprising (A) 15-70% by weight of diglycerides, with less than 15% by weight of the fatty acids constituting the diglycerides being w3 unsaturated fatty acids and (B) 30-85% by weight of triglycerides, with 15% by weight or more of the fatty acids constituting the triglycerides being w3 unsaturated fatty acids. Takase also indicates that the oil/fat composition further comprises 0.004-5% by weight of an antioxidant, the antioxidant is preferably vitamin C or derivatives thereof, or
vitamin E, etc. in terms of antioxidative properties, the oil/fat composition preferably comprises 0.001-0.2% of hydroxycarboxylic acid because hydrolysis is further suppressed, and the oil/fat composition may be used in the form of an emulsion or the like. Takase also teaches, for instance in the examples, that product 1 of the present invention comprising 0.1 parts of vitamin E and 0.02 parts of citric acid relative to 100 parts of oil/fat (glyceride composition: 21.9% diglyceride with 8% a-linolenic acid in the diglycerides and 25% a- linolenic acid in the triglycerides) was produced and that water and an emulsifier were further added to prepare an emulsion.
In the above example, the antioxidant used was vitamin E. However, Takase indicates, as stated above, that vitamin C is equally preferable to vitamin E in terms of antioxidative properties, and it would not be particularly difficult to use vitamin C as the antioxidant. Further, although the above example comprises 0.02 parts of citric acid, Takase indicates, as stated above, that 0.001-0.2% of hydroxycarboxylic acid or the like is preferably included, and it would not be particularly difficult to adjust the content of the hydroxycarboxylic acid by taking suppression of hydrolysis into account.
As such, the active components A, B and C in the base claim 1 and in the dependent claims are found in the above noted references. These teachings also include how to make emulsified composition containing alpha- linolenic.
The difference is in the amounts of the A, B and C in these references and the oil-in-water composition of the instant claims
As admitted by the applicant, at [0002] (and cited art thereafter), alpha- linolenic composition and issues such as (oxidative) stability, odor etc. are within the purview of one of skill in the art. These A, B and C are result-effective variables for making linolenic composition. As to disclosure in the specification with regards to secondary consideration: At page 13 (PgPub), Reference Examples 1 and 2 and at page 9, Comparative Examples 1 to 6 onwards, different compositions of A. B and C are disclosed. At page 10, column A, [0165], it is disclosed that Example 4 obtained by blending 0.015% of VCP had less fish odor and fishy odor, which were each at such a level as to cause no problem, but had low oxidative stability; at page 12, [0174], it is disclosed the oxidative stability was also satisfactory as compared to Comparative Example 3 to 5. However the specific % amounts of A, B and C in these specific working examples that do provide for desirable properties are also found in the cited references.
Since all the claimed elements were known in the prior art, one of skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions to arrive at the instantly claimed composition. As per Examination guidelines, where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least
one examined application claim is not patentably distinct from the reference claim(s)
because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Previously presented rejection of claim(s) 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12089610 and over the claims of pending Application No. 18255776 in view of Sakuma JP2003306692: Takase JP2003160794: Koike JP2002138297; KoikeM, JP2002138296 (see IDS 06/02/2023, not included herewith) and Hosoya US 20100267681. Hosoya is new added to support the previously presented arguments.
Applicant’s argues that the
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overlooks the rationale invoked as per page 8 of previous action in obviousness analysis
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Hosoya teaches a fat or oil composition comprising diacylglycerols, omega-3 fatty acids (e.g., α-linolenic acid) and vitamin C at contents and ratios that overlap the contents and ratios recited in claims (see Hosoya abstract; paragraphs [0017], [0018] and [0045]-[0047]). Hosoya claim 1:
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Hosoya claim 13:
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As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Applicants argument points out that the instant working Example 4 has favorable low sensory evaluation score, with respect to odor evaluation. Taken together the teaching Sakuma and Takase (Koike and KoikeM teaching being silent), Applicant argues that there is no suggestion for the instant 0.15 mass % to 6.0 mass% of a hydroxy acid or a salt.
This is not persuasive, because as the components of the composition (and modifying their ratios) as result effect variables is known the art in the cited references. For example, the odor appears 16 times in the disclosure of Hosoya. Also see page 5 previous action (see below). As previously noted, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Again, the invention is a selective combination of the inventions by the prior arts done in a manner obvious to one of ordinary skill in the art. Patent for the combination of known elements wherein their functions remain the same withdraws “what is already known into field of its monopoly and diminishes resources available to skilled men”. Sakraida v. Ag Pro, Inc.189 USPQ 449, 425 US 273, (1976).
Sakuma teaches a powdery oil-and-fat containing a diglyceride and having excellent taste, flavor, palatability, storage stability, dispersibility in water and dispersing power of powder such as proteins and carbohydrates and provide an oil-and-fat processed food containing the powdery oil-and-fat.
The above powdery oil/fat powder comprising (A) 15-79.9% by weight of a glyceride mixture containing 5-84.9% by weight of triglycerides, 0.1-5% by weight of monoglycerides and 15-94.9% by weight of diglycerides, with 50% by weight or more of all fatty acids constituting the glyceride mixture being unsaturated fatty acids, (B) 20-84.9% by weight of one or two or more powder-forming bases selected from carbohydrates, proteins and peptides and (C) 0.1-5% by weight of water. Sakuma also indicates that the oil/fat powder further comprises 0.01-5 parts by weight of an antioxidant relative to 100 parts by weight of the component (A) and comprises 0.1-20 parts by weight of an emulsifier with an HLB of 7 or more relative to 100 parts by weight of the component (A), with 50% or more of all fatty acids constituting the glyceride mixture of the component (A) being unsaturated fatty acids which are preferably oleic acid, linoleic acid, or linolenic acid, the antioxidant preferably being tocopherol, L-ascorbyl fatty acid ester or the like, and the oil/fat powder preferably comprising 0.001-0.5 parts by weight of hydroxycarboxylic acid having 2-8 carbon atoms in order to improve flavor and storage stability. Sakuma also indicates, for instance in the examples, that oil/fat composition I comprising 0.04 parts by weight of L-ascorbyl palmitate relative to 100 parts by weight of oil/fat f (glyceride composition: 84.8% diglyceride with 55.2% a-linolenic acid in the diglycerides and triglycerides) and 25 ppm of citric acid was produced, and that water, sucrose stearate ester and the like were further added to prepare an emulsion.
Although the above example comprises 25 ppm of citric acid, Sakuma indicates, as stated above, that 0.001-0.5 parts by weight of hydroxycarboxylic acid or the like having 2-8 carbon atoms is preferably included, and it would not be particularly difficult to adjust the content of the hydroxycarboxylic acid having 2-8 carbon atoms by taking flavor and storage stability into account.
Takase teaches an oil-and-fat composition which keeps a good taste and stability against discoloration and exhibits excellent hydrolysis resistance, oxidation resistance and emulsion stability even when exposed to severe conditions of high-temperature long-time heating and can therefore find wide utility in pharmaceutical preparations, food and feed, and has an excellent effect of suppressing deposition of fat in the body.
The above an oil/fat composition comprising (A) 15-70% by weight of diglycerides, with less than 15% by weight of the fatty acids constituting the diglycerides being w3 unsaturated fatty acids and (B) 30-85% by weight of triglycerides, with 15% by weight or more of the fatty acids constituting the triglycerides being w3 unsaturated fatty acids. Takase also indicates that the oil/fat composition further comprises 0.004-5% by weight of an antioxidant, the antioxidant is preferably vitamin C or derivatives thereof, or
vitamin E, etc. in terms of antioxidative properties, the oil/fat composition preferably comprises 0.001-0.2% of hydroxycarboxylic acid because hydrolysis is further suppressed, and the oil/fat composition may be used in the form of an emulsion or the like. Takase also teaches, for instance in the examples, that product 1 of the present invention comprising 0.1 parts of vitamin E and 0.02 parts of citric acid relative to 100 parts of oil/fat (glyceride composition: 21.9% diglyceride with 8% a-linolenic acid in the diglycerides and 25% a- linolenic acid in the triglycerides) was produced and that water and an emulsifier were further added to prepare an emulsion.
In the above example, the antioxidant used was vitamin E. However, Takase indicates, as stated above, that vitamin C is equally preferable to vitamin E in terms of antioxidative properties, and it would not be particularly difficult to use vitamin C as the antioxidant. Further, although the above example comprises 0.02 parts of citric acid, Takase indicates, as stated above, that 0.001-0.2% of hydroxycarboxylic acid or the like is preferably included, and it would not be particularly difficult to adjust the content of the hydroxycarboxylic acid by taking suppression of hydrolysis into account.
As such, the active components A, B and C in the base claim 1 and in the dependent claims are found in the above noted references. These teachings also include how to make emulsified composition containing alpha- linolenic.
The difference is in the amounts of the A, B and C in these references and the oil-in-water composition of the instant claims
As admitted by the applicant, at [0002] (and cited art thereafter), alpha- linolenic composition and issues such as (oxidative) stability, odor etc. are within the purview of one of skill in the art. These A, B and C are result-effective variables for making linolenic composition. As to disclosure in the specification with regards to secondary consideration: At page 13 (PgPub), Reference Examples 1 and 2 and at page 9, Comparative Examples 1 to 6 onwards, different compositions of A. B and C are disclosed. At page 10, column A, [0165], it is disclosed that Example 4 obtained by blending 0.015% of VCP had less fish odor and fishy odor, which were each at such a level as to cause no problem, but had low oxidative stability; at page 12, [0174], it is disclosed the oxidative stability was also satisfactory as compared to Comparative Example 3 to 5. However the specific % amounts of A, B and C in these specific working examples that do provide for desirable properties are also found in the cited references.
Since all the claimed elements were known in the prior art, one of skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions to arrive at the instantly claimed composition. As per Examination guidelines, where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
The art made of record and not relied upon is considered pertinent to applicant's disclosure.
Feldman, Understanding ‘Evergreening’ : Making Minor Modifications Of Existing
Medications To Extend Protections, Health Affairs June 2022 41:6, 801-804.
Dwivedi, Evergreening: A deceptive device in patent rights, Technology in Society 32 (2010) 324–330.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625