DETAILED ACTION
Amendments made October 16, 2025 have been entered.
Claims 1, 7, 8, 11-13, and 18-21 remain pending.
Claims 13 and 18-21 have been withdrawn.
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.
Specification
The previous objection to the disclosure has been withdrawn in light of applicant’s amendments made October 16, 2025.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 2, 11, and 12 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joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention has been withdrawn in light of applicant’s amendments made October 16, 2025.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1, 7, 8, 11, and 12 under 35 U.S.C. 102(a)(1) as being anticipated by Beck et al (US 2008/0299209 A1) has been withdrawn in light of applicant’s amendments made October 16, 2025; specifically, because Beck is not specific to the vitamin as selected from vitamin A acetate or vitamin A palmitate as recited in amended claim 1.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 7, 8, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Beck et al (US 2008/0299209 A1) in view of Diguet et al (WO 2009/000404).
Regarding claims 1, 7, and 8, Beck et al (Beck) teaches pharmacologically effective formulations containing by weight:
0.1-90%, preferably 0.1-80% of fat-soluble active ingredients, preferably selected from a group including vitamin A (abstract, paragraphs 19 and 27, and claims 5 and 12); and
10-90%, preferably 20-75% protective colloid, including mixtures of modified food starch, i.e. at least one emulsifier, and sugar selected from the group including trehalose, i.e. at least one non-reducing sugar, in a ratio of 500:1 to 1:100, preferably 20:1 to 1:10, more preferably 10:1 to 1:10 (abstract, paragraphs 28, 29, 31, 32, 37 and 58, and claims 12 and 15).
Regarding the product as solid particles, as Beck teaches that the formulation is a powder (paragraphs 38-41, 45, 53, 54, and 81), and powder is defined as a solid substance of loose particles, the teachings of Beck encompass solid particles as instantly claimed.
Regarding the non-reducing sugar as trehalose present in an amount of 10-50% and the at least one emulsifier as modified starch or gum acacia present in an amount of 20-70% as recited in claim 1, as discussed above Beck teaches the composition comprises 10-90% protective hydrocolloid, including mixtures of modified food starch, i.e. at least one emulsifier, and sugar selected from the group including trehalose, i.e. at least one non-reducing sugar, in a ratio of more preferably 10:1 to 1:10 (abstract, paragraphs 28, 29, 31, 32, 37 and 58, and claims 11, 12, and 15). Thus, at 10% by weight colloid and a ratio of 1:10 to 10:1, the starch would be at about 0.9-9.1% weight, and the non-reducing sugar, trehalose, would be at about 0.9-9.1% weight. At 90% by weight colloid and a ratio of 1:10 to 10:1, the starch would be at about 8.2-81.8% weight, and the non-reducing sugar would be at about 8.2-81.8% weight. Thus, Beck teaches about 0.9-81.8% of at least one emulsifier including modified starch, and about 0.9-81.8% of at least one non-reducing sugar including trehalose which encompasses the claimed ranges.
Beck is not specific to the vitamin as selected from vitamin A acetate or vitamin A palmitate as recited in claim 1.
Diguet et al (Diguet) teaches fortified foods containing sugar, starch, and fat-soluble vitamins, wherein vitamin A and/or retinyl esters including retinyl palmitate and retinyl acetate are especially preferred (abstract, page 3 lines 5-9, and page 4 lines 18-24)
Regarding the vitamin as selected from vitamin A acetate or vitamin A palmitate, it would have been obvious to one of ordinary skill in the art for the vitamin A nutrient as taught by Beck to be retinyl A palmitate or retinyl A acetate as Diguet teaches that they are especially preferred nutrients. Furthermore, to use a known type of vitamin A wherein vitamin A was disclosed would have been an obvious suggestion of the prior art.
Regarding the solid particles as having a Dv90 size of 50-1000um as recited in claim 11, preferably 100-800um as recited in claim 12, Beck teaches the powder has a mean particle size of 50-1000um, preferably 80-700um, more preferably 100-500um (paragraph 57). Beck does not disclose the particle size in Dv90. However, the claimed ranges are considered obvious because it has been held that changes in size are prima facie obviousness. MPEP 2144.04 IV. A. As discussed above, Beck discloses solid particles have a mean particle size of 50-1000um. As such, particles with a Dv90 between 50-1000um (claim 11), and between 100-800um (claim 12) is obvious. For 90% of the particles to fall within the disclosed range would have been an obvious suggestion of the prior art.
Alternatively, claims 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Beck et al (US 2008/0299209 A1) in view of Diguet et al (WO 2009/000404), further in view of van Lengerich (US 8,828,432).
Regarding claims 11 and 12, as discussed above, Beck teaches pharmacologically effective formulation powders with a mean particle size of 50-1000um, preferably 80-700um, more preferably 100-500um (paragraph 57). Beck does not disclose the particle size in Dv90. However, the claimed ranges are considered obvious because it has been held that changes in size are prima facie obviousness. MPEP 2144.04 IV. A. As discussed above, Beck discloses solid particles have a mean particle size of 50-1000um. As such, particles with a Dv90 between 50-1000um (claim 11), and between 100-800um (claim 12) is obvious. For 90% of the particles to fall within the disclosed range would have been an obvious suggestion of the prior art.
Alternatively, van Lengerich teaches of solid particles comprising starch and with biologically active compounds, including vitamins, wherein the particle size is varied to control the surface to volume ratio for achieving a desired control release during passage through a consumer mouth, stomach, and intestine (abstract, column 7 lines 48-49 and 55, column 9 lines 13-15 and 26- 28, column 16 lines 44-67, and column 17 lines 1-19). In the alternative, it would have been obvious to adjust the size of the vitamin particle of Beck based on the desired release in the consumer as taught by van Lengerich.
Terminal Disclaimer
The terminal disclaimer filed on October 16, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. patent 11,696,594 and any patent granted on U.S. Patent Application No. 18/921,898 has been reviewed and is accepted. The terminal disclaimer has been recorded.
The rejection of claims 1, 7, 8, 11, and 12 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,696,594 has been withdrawn in light of the terminal disclaimed filed October 16, 2025.
The provisional rejection of claims 1, 7, and 8 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 18/921,898 (‘898) (reference application) has been withdrawn in light of the terminal disclaimed filed October 16, 2025.
The provisional rejection of claims 11 and 12 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 18/921,898 (‘898) (reference application), further in view of Diguet et al (WO 2009/000404) has been withdrawn in light of the terminal disclaimed filed October 16, 2025.
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, 7, 8, 11 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10 of U.S. Patent No. 10,966,934 (‘934) in view of Beck et al (US 2008/0299209 A1) and Diguet et al (WO 2009/000404).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim solid particles comprising: at least 20% of a fat-soluble vitamin, including vitamin A; at least one emulsifier; and at least one non-reducing sugar (claims 1 and 10).
Regarding the reducing sugar as present from 10-50% as recited in claim 1, as discussed above ‘924 claims a composition comprising at least 20% of a fat-soluble vitamin; at least one emulsifier; and at least one non-reducing sugar (claims 1 and 10). Although ‘924 is silent to the reducing sugar as present from 10-50%, in forming the solid particles claimed by ‘924 it would have been obvious to form the product with the claimed components within the claimed ranges, without unnamed ingredients, and thus, it would have been obvious for the at least one non-reducing sugar to include an amount of about 80% or less (100% - at least 20% vitamin - the emulsifier), which encompasses the claimed ranges.
Regarding the at least one emulsifier as from 20-70% as recited in claim 1, as discussed above ‘924 claims a composition comprising at least 20% of a fat-soluble vitamin; at least one emulsifier; and at least one non-reducing sugar (claims 1 and 10). Although ‘924 is silent to, it would have been obvious to form the product with the claimed components within the claimed ranges, without unnamed ingredients, and thus it would have been obvious for the at least one emulsifier to include an amount of about 80% or less (100% - at least 20% vitamin – the at least one non-reducing sugar), which encompasses the claimed range.
Regarding claims 7 and 8, the claimed range of at least 20% fat soluble vitamin (claim 1 of ‘934), encompasses or at least makes obvious the instantly claimed ranges of 20-75% recited in claim 7 and 20-70% as recited in claim 8.
It would have been obvious to one of ordinary skill in the art to select any portions of the claimed ranges including the instantly claimed ranges from the ranges claimed in the reference patent, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
‘934 does not claim that the non-reducing sugar is trehalose, the vitamin A is vitamin A acetate or vitamin A palmitate, or the at least one emulsifier as modified food starch or acacia gum as recited in claim 1, or the solid particles as having a size of 50-1000um as recited in claim 11, preferably 100-800um as recited in claim 12.
Beck et al (Beck) teaches pharmacologically effective particles comprising: a fat-soluble active ingredient, preferably selected from a group including vitamin A (abstract, paragraphs 19 and 27, and claims 5 and 12); in combination with a protective colloid, specifically including mixtures of modified food starch, i.e. at least one emulsifier, and sugar selected from the group including sucrose and trehalose, i.e. at least one non-reducing sugar (abstract, paragraphs 28, 29, 31, 32, 37 and 58, and claims 12 and 15).
Diguet et al (Diguet) teaches fortified foods containing sugar, starch, and fat-soluble vitamins, wherein vitamin A and/or retinyl esters including retinyl palmitate and retinyl acetate are especially preferred (abstract, page 3 lines 5-9, and page 4 lines 18-24). Diguet teaches that the composition comprises emulsifiers including starches and acacia gum (page 7 lines 11-14), and that modified food starch and acacia gum are preferred ingredients within the nutritional composition (page 3 lines 5-9). Diguet teaches that the preferred product form was a beadlet with a mean size of 50-1000um (page 6 lines 19-27).
Regarding the non-reducing sugar is trehalose as recited in claim 1, it would have been obvious to one of ordinary skill in the art for the at least one non-reducing sugar as claimed by ‘934 to be one which was known and disclosed for use with fat-soluble vitamin compositions, i.e. nutraceutical compositions. Thus, it would have been obvious to use trehalose as the non-reducing sugar claimed by ‘934 in view of Beck. To use a known type of non-reducing sugar wherein non-reducing sugar was claimed would have been an obvious suggestion of the claims.
Regarding the vitamin as selected from vitamin A acetate or vitamin A palmitate as recited in claim 1, it would have been obvious to one of ordinary skill in the art for the vitamin A nutrient as claimed by ‘934 to be retinyl A palmitate or retinyl A acetate as Diguet teaches that they are especially preferred nutrients. To use a known type of vitamin A wherein vitamin A was claimed would have been an obvious suggestion of the claims.
Regarding the at least one emulsifier as modified food starch or acacia gum as recited in claim 1, it would have been obvious to one of ordinary skill in the art for the at least one emulsifier as claimed by ‘934 to be one which was known and disclosed for use with fat-soluble vitamin/sugar compositions, i.e. nutraceutical compositions. Thus, it would have been obvious to use food starch or acacia gum as the emulsifier claimed by ‘934 in view of Diguet. Furthermore, one would have been particular motivated to use acacia gum or modified food starch as Diguet teaches they are particularly preferred ingredients. To use a known emulsifier wherein an emulsifier was claimed would have been an obvious suggestion of the claims.
Regarding the solid particles as having a size of 50-1000um as recited in claim 11, preferably 100-800um as recited in claim 12, as discussed above, ‘934 claims solid vitamin/sugar particles. It would have been obvious for the vitamin/sugar particle claimed by ‘934 to have a size of 5-1000um as Diguet teaches that is a preferred size/form for vitamin/sugar particles. It would have been obvious to one of ordinary skill in the art to select any portions of the claimed ranges including the instantly claimed ranges from the ranges claimed in the reference patent, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05. Diguet does not disclose the particle size in Dv90. However, the claimed ranges are considered obvious because it has been held that changes in size are prima facie obviousness. MPEP 2144.04 IV. A. As discussed above, Diguet discloses solid particles have a mean particle size of 50-1000um. As such, particles with a Dv90 between 50-1000um (claim 11), and between 100-800um (claim 12) is obvious. For 90% of the particles to fall within the disclosed range would have been an obvious suggestion of the prior art.
Response to Arguments
Applicant's arguments filed October 16, 2025 regarding the remaining rejections have been fully considered but they are not persuasive.
Applicant argues that the principal problem addressed in the claimed invention is the ability to provide compressible solid particles with increased vitamin A. This argument is not convincing as it is not commensurate in scope with the claims which recite solid particles and not compressed tablets. Similarly, applicant’s arguments that Beck includes gelatin, and that the use of trehalose is critical as seen in Fig 3A of the specification is not convincing as it is not commensurate in scope with the claims. First it is noted that the evidence cited is specific to a compressed product and not solid particles as claimed, and furthermore, is limited to a single composition, neither of which represent the scope of the claims. The arguments are not convincing as they are not commensurate in scope with the claims which recite solid particles and not compressed tablets or compositions without gelatin.
Applicant argues that just because vitamin A acetate or vitamin A palmitate were known does not mean that it would have been obvious for the claimed composition to comprise them. This argument is not convincing. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, as the primary references teaches the use of vitamin A, the use of known vitamin A forms would have been a direct and obvious suggestion of the prior art. It would have been even further obvious to use said elements as they were taught by the secondary, Diguet as preferred forms. As stated previously, and above, it would have been obvious to one of ordinary skill in the art for the vitamin A nutrient as taught by Beck to be retinyl A palmitate or retinyl A acetate as Diguet teaches that they are especially preferred nutrients. To use a known type of vitamin A wherein vitamin A was disclosed would have been an obvious suggestion of the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KELLY BEKKER whose telephone number is (571)272-2739. The examiner can normally be reached Monday-Friday 8am-3:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KELLY BEKKER
Primary Patent Examiner
Art Unit 1792
/KELLY J BEKKER/Primary Patent Examiner, Art Unit 1792