DETAILED ACTION
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 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/23/2025 and 05/10/2024 have been considered by the examiner.
Status of the Claims
The response and amendment filed 07/21/2026 is acknowledged.
Claims 1-5, 7-10, and 21-46 are pending.
Applicant’s election of Group I, claims 1-5, 7-10, and 21-31, in the reply filed on 07/21/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 32-46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/21/2026.
Claims 1-5, 7-10, and 21-31 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
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 23 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 pre-AIA the applicant regards as the invention.
There is a lack of antecedent basis for “the inulin” in claim 23.
Claim 1 is silent to inulin.
Clarification is required.
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 7-9, 21, and 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over Bertelsen, US 20090068268 and Suzuki, JP H11196779 A (cited previously).
Bertelsen teaches mixtures comprising a binder and filler and hydrophobic active agent (Bertelsen, e.g., 0101 table, and vitamin D at 0144-0158). The terms filler and binder are semantic distinctions in a product claim, and there are a variety of pharmaceutical excipients which the skilled artisan would consider both a filler and a binder, e.g., see Bertelsen, e.g., 0101 and 0112 listing various specific excipients, including sugar alcohols, polymers, and polysaccharides which may be present in the mixture as either a binder or a filler. See also Bertelsen, e.g., 0025 teaching that sugar alcohols have binder properties. From this, the skilled artisan understood mannitol, lactose, xylitol, sorbitol, isomalt, and/or polysaccharides may be considered both a binder and a filler.
Bertelsen teaches mixtures containing 0.1-40% binder and 0.1-40% filler (Bertelsen, e.g., 0101). Bertelsen exemplifies mixtures containing combinations of sugar alcohols (Bertelsen, e.g., examples 1-2), and claim 7 listing sugar alcohols isomalt, mannitol, sorbitol, xylitol, inositol, erythritol, lactitol, maltitol, and mixtures thereof.
Bertelsen exemplifies combinations of sugar alcohols having a ratio of 1:1 (Bertelsen, e.g., examples 1-2). Melting point of isomalt (145-150°C) is close to the claimed range. Melting point of mannitol (165-170°C) is within the claimed range. Melting point of inositol (222-227°C) is within the claimed range. Melting point of maltitol (144-152°C) overlaps with the claimed range. Melting point of lactitol (146°C) is close to the claimed range.
Thus, in addition to teaching mixtures containing sorbitol (MP below the claimed range), isomalt (MP abutting the claimed range), xylitol (below the claimed range), and mannitol (MP within the claimed range), Bertelsen exemplifies sorbitol/xylitol mixtures and clearly teaches mannitol/xylitol mixtures (Bertelson, e.g., 0175). Bertelsen also shows a preference for isomalt, mannitol, sorbitol, and xylitol (Bertelsen, e.g., 0179). Further, of the sugar alcohols recited in claim 7, five of the eight listed have a melting point close to, overlapping with, or within the claimed MP for the “filler” as claimed while sorbitol and xylitol fillers/binders are exemplified. Selection of a clearly disclosed combination in Bertelsen, e.g., mannitol/xylitol, would have led the skilled artisan to a mixture of filler and binder meeting the claimed melting temperature limitations.
On this basis, the skilled artisan would have, more likely than not, found it obvious to select a combination of binder/fillers meeting the melting temperature limitations as claimed before the filing date of the presently claimed invention with a reasonable expectation of success.
In the case where the claimed ranges “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). MPEP 2144.05. Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). MPEP 2144.05.
Here, the fillers/binders taught by Bertelsen, including those having a melting point close to or abutting the claimed range, would clearly have the same properties since they are all taught for the same purpose as fillers or binders to form pharmaceutical mixtures which are, e.g., capable of processing into dosage forms including powders for sachets, capsules, or by compression into tablets (Bertelsen, e.g., 0079).
It would have been obvious before the effective filing date of the presently claimed invention to formulate mixtures taught by Bertelsen by combining sugar alcohols having higher and lower melting temperatures as claimed and in a ratio of 1:1 with a reasonable expectation of success. Since Bertelsen claims mixtures containing combinations of sugar alcohols, e.g., mannitol and sorbitol, mannitol/xylitol, and expressly teaches combinations meeting the melting temperature range recited, the skilled artisan would have found it obvious to combine, e.g., mannitol/xylitol to arrive at a composition comprising a ratio of binder to filler, e.g., 1:1 as expressly suggested in Bertelson which is within the claimed ratio range and meets the melting temperature limitations for filler as claimed with a reasonable expectation of success.
Bertelsen does teach the mixture containing vitamin D (Bertelsen, e.g., 0144-0158 and claim 19). Bertelsen further teaches vitamin D is subject to degradation and may be formulated in a protective matrix to improve stability (Bertelsen, e.g., 0090).
However, Bertelsen does not expressly teach the mixture containing microcapsules.
Suzuki teaches similar formulations wherein oil-based physiologically active substances such as oil soluble vitamins which are susceptible to deterioration or decomposition are formulated in microcapsules for improved stability when formulating the mixture as tablets (Suzuki, e.g., 0002-0003). Vitamin D is named (Suzuki, e.g., 0005). Suzuki teaches granulation mixtures containing microcapsules in an amount of 12.5%. For example, Suzuki teaches 3kg microcapsules in a granulation mixture of 24kg which works out to 12.5% by weight based on the total weight of the granular composition obtained. This amount is within the claimed range.
It would have been obvious before the effective filing date of the presently claimed invention to improve Bertelsen’s formulation mixtures containing degradable vitamin D using microencapsulation techniques known from Suzuki to improve the formulation mixture in the same way with a reasonable expectation of success. The skilled artisan would have seen this as the use of a known technique to improve similar formulation mixtures in the same way. Since Bertelsen recognizes vitamin D is subject to degradation and should be administered in a protective matrix, the skilled artisan would have been motivated to encapsulate the vitamin D in microcapsules as the protective matrix using techniques known from Suzuki to reduce degradation in Bertelsen’s mixtures in the same way with a reasonable expectation of success. The skilled artisan would have had a reasonable expectation of success because both references teach granulated mixtures to formulate degradable vitamins for oral administration.
Applicable to claim 2-4, 21, 24, 25: Bertelsen teaches the filler may include polysaccharide, e.g., agar, dextran, cellulose, dextrin, maltodextrin, hydroxypropylcellulose, starch (Bertelsen, e.g., 0112). At least agar and cellulose may be called dietary fiber. Mannitol, xylitol, sorbitol, and isomalt are sugar alcohols.
Applicable to claims 7-9 and 26-28: Bertelsen teaches the mixture comprising one or more fat soluble vitamins and actives, e.g., various forms of vitamin D, vitamin K, phospholipids, bile salts, fatty acids, fatty alcohols, etc. (Bertelsen, e.g., 0032, 0083-0085, 0124-0125, 0131). Bertelsen and Suzuki do not expressly teach mixtures comprising at least two, three, four, or five fat soluble active agents. However, Suzuki teaches oil based physiologically active substances include oil soluble vitamins, e.g., vitamin A, E, and K in addition to vitamin D as well as lutein, polyunsaturated fatty acids, higher alcohols, phospholipids and the like (Suzuki, e.g., 0005). It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to combine oil soluble nutrients and vitamins, e.g., vitamin A, E, and K in addition to vitamin D as well as other nutrients including lutein, polyunsaturated fatty acids, and phospholipids into a single mixture with a reasonable expectation of success. Since Suzuki teaches a number of oil-soluble vitamins and nutrients may be encapsulated in microcapsules for stability, and since Bertelsen teaches the mixtures may contain a number of nutrients such as vitamin D, the skilled artisan would have found it obvious to formulate the mixture with a number of oil soluble nutrients and vitamins as named by the references in microcapsules for improved stability.
Accordingly, the subject matter of claims 1-4, 7-9, 21, and 24-28 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 1, 5, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Bertelsen, US 20090068268 and Suzuki, JP H11196779 A (cited previously) as applied to claims 1-4, 7-9, 21, and 24-28 above, and further in view of Harel, US 20190194259.
The teachings of Bertelsen and Suzuki enumerated above apply here. The combined teachings of Bertelsen and Suzuki teach a mixture according to claim 1, wherein the mixture comprises sorbitol but do not expressly teach the mixture comprising inulin.
Harel teaches pharmaceutical formulations for protecting bioactive materials, wherein the bioactive materials comprise vitamins (Harel, e.g., 0044, 0049, example 8, 0098-0099, claim 3). Inulin is a named stabilizing agent and alternative to filler/binders reported in Bertelsen for dry mixutres (Harel, e.g., 0045, 0054, 0064, example 1, 0082-0083, example 14, example 15, and claim 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify a mixture as understood from the combined teachings of Bertelsen and Suzuki by formulating the mixture with inulin with a reasonable expectation of success. The skilled artisan may have viewed this modification as a substitution of, or combination of, one known pharmaceutical filler for/with another to achieve improved stability of the vitamins present in the formulation. Since Bertelsen teaches the fillers and binders in the mixture may be granulated, the skilled artisan would have found it obvious to formulate the mixture with granulated inulin. The skilled artisan would have had a reasonable expectation of success because Herel teaches improving dry mixtures comprising vitamins.
Accordingly, the subject matter of claims 1, 5, and 22-23 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 1, 10 and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Bertelsen, US 20090068268 and Suzuki, JP H11196779 A (cited previously) as applied to claims 1-4, 7-9, 21, and 24-28 above, and further in view of Diguet, US 8597642 B2.
The teachings of Bertelsen and Suzuki enumerated above apply here. The combined teachings of Bertelsen and Suzuki teach a mixture according to claim 1 but do not expressly teach wherein the mixture comprises less than 10%wt water.
Diguet teaches formulations of lipophilic health ingredients wherein the composition has a residual moisture content of less than or equal to 6.5%wt based on the total weight of the formulation, which formulations offer improved stability of the lipophilic health ingredients (Diguet, e.g., Abstract, ¶ spanning, C7-C8, and claim 16). The low moisture content improves the stability of the fat-soluble active agents in the formulation (Diguet, e.g., c2:33-37, c12:1-8, c14:1-12). The technique is suggested to improve stability of fat-soluble actives including vitamins A, D, E, K, CoQ10, fatty acid esters thereof, lutein, polyunsaturated fatty acids, and triglycerides (Diguet, e.g., c2:43-c3:10).
In the case where the claimed ranges “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). MPEP 2144.05. The claimed ranges share values with the prior art range. The narrower claimed ranges are entirely within the prior art range, and the art teaches minimizing the amount of water.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify a mixture suggested by the combined teachings of Bertelsen and Suzuki by drying the mixture such that the moisture content is less than 6.5wt% as suggested by Diguet to improve the mixture in the same way with a reasonable expectation of success. The skilled artisan would have been motivated to dry the mixture to a water content suggested by Diguet with a reasonable expectation of improved active stability. The skilled artisan would have had a reasonable expectation of success since Diguet teaches the technique is effective to improve stability of the same fat-soluble actives discussed in Bertelsen and Suzuki.
Accordingly, the subject matter of claims 1, 10, and 29-31 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 1-5, 7-10, and 21-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-17, and 19-24 of 18709330 in view of Bertelsen, US 20090068268 and Suzuki, JP H11196779 A and Harel, US 20190194259.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims teach a mixture for continuous melt granulation comprising a filler, a binder and at least one active ingredient, wherein the mixture comprises from 5 weight-% to 15 weight-% of a binder, based on the total weight of the mixture, and wherein the filler and the binder are present in a the weight ratio of the filler to the binder of 4:1 to 10:1, and wherein the filler has a melting temperature of 151°C to 240°C, and wherein the binder has a melting temperature that is lower than the melting temperature of the filler. Sorbitol found in claim 6. Less than 10wt% water is found in claim 12. The mixture is for formulating vitamins (claim 11).
The reference claims do not expressly teach the mixture comprising microcapsules and fat-soluble active ingredients.
However, as enumerated above, Bertelsen and Suzuki teach modifying vitamin and nutrient containing mixtures with fat-soluble actives including various forms of vitamin D, vitamin K, phospholipids, bile salts, fatty acids, fatty alcohols, etc. (Bertelsen, e.g., 0032, 0083-0085, 0124-0125, 0131), and vitamin A, E, and K in addition to vitamin D as well as lutein, polyunsaturated fatty acids, higher alcohols, phospholipids and the like (Suzuki, e.g., 0005). Bertelsen teaches fat soluble vitamins may be formulated in a protective matrix for stability (Bertelsen, e.g., 0090). Suzuki teaches fat soluble actives may be encapsulated in microcapsules for improved stability when formulating the mixture into pharmaceutical compositions (Suzuki, e.g., 0002-0003).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify a mixture for formulating vitamins as understood from the reference claims by including microcapsules containing fat soluble vitamins and nutrients with a reasonable expectation of success. Since the reference claims are directed to mixtures for formulating vitamins, the skilled artisan would have found it obvious to include additional vitamins and nutrients including fat soluble vitamins and nutrients as suggested by Bertelsen and Suzuki, e.g., to arrive at a mixture comprising additional vitamins and nutrients which is useful for the same purpose. The skilled artisan would have further been motivated to formulate the fat-soluble vitamins and nutrients in microcapsules to improve their stability in the same way suggested by Suzuki with a reasonable expectation of success.
The reference claims do not expressly teach the mixture comprising inulin. However, the teachings of Harel enumerated above cures this defect.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify a mixture suggested by the reference claims, Bertelsen, and Suzuki by including inulin in the mixture with a reasonable expectation of success. The skilled artisan may have viewed this modification as a substitution of, or combination of, one known pharmaceutical filler for/with another to achieve improved stability of the vitamins present in the formulation. Since Bertelsen teaches the fillers and binders in the mixture may be granulated, the skilled artisan would have found it obvious to formulate the mixture with granulated inulin. The skilled artisan would have had a reasonable expectation of success because Herel teaches improving dry mixtures comprising vitamins.
Accordingly, the subject matter of claims 1-5, 7-10, and 21-31 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim(s) 1-5, 7-10, and 21-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-13 and 26-30 of 18710029 in view of Bertelsen, US 20090068268 and Suzuki, JP H11196779 A.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims are directed to a continuous melt granulation mixture comprising, based on total weight of the mixture: at least 50 weight-% of an active ingredient, at least 10 weight-% of a polysaccharide filler having a melting temperature of at least 155°C, a binder, and less than 5 weight-% water, wherein the active ingredient has a melting temperature that is higher than a melting temperature of the binder, and wherein the melting temperature of the binder is lower than the melting temperature of the polysaccharide filler. The active is a nutrient and/or vitamin (claims 5-7). The amounts of binder and filler are within or overlapping with the claimed ranges (claims 8-9 and 26-30). The filler is inulin (claim 10). The binder is a sugar alcohol, e.g., sorbitol (claims 11-12).
The reference claims do not expressly teach the mixture comprising microcapsules or fat-soluble active agents.
However, the teachings of Bertelsen and Suzuki enumerated above cures this defect.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify a mixture for formulating vitamins and nutrients as understood from the reference claims by including microcapsules containing fat soluble vitamins and nutrients with a reasonable expectation of success. Since the reference claims are directed to mixtures for formulating vitamins and nutrients, the skilled artisan would have found it obvious to include additional vitamins and nutrients including fat soluble vitamins and nutrients as suggested by Bertelsen and Suzuki, e.g., to arrive at a mixture comprising additional vitamins and nutrients which is useful for the same purpose. Since Bertelsen teaches the fillers and binders in the mixture may be granulated, the skilled artisan would have found it obvious to formulate the mixture with granulated inulin. The skilled artisan would have further been motivated to formulate the fat-soluble vitamins and nutrients in microcapsules to improve their stability in the same way suggested by Suzuki with a reasonable expectation of success.
Accordingly, the subject matter of claims 1-5, 7-10, and 21-31 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
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