DETAILED ACTION
Amendments made May 14, 2026 have been entered.
Claims 1, 7, 8, 11-13, and 18-21 remain pending.
Claims 13 and 18-21 have been withdrawn.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 14, 2026 has been entered.
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.
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.
Claims 1, 7-8, and 11-12 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.
Claim 1 recites “under the compression force sufficient to form a compressed particulate product”. It is unclear as to if “the compression force” refers to the compression force of between 5-40kN as recited in the preamble, or if it encompasses any force sufficient to form a particulate product.
Claim 1 recites “compared to a similar compressed product of particles not containing the trehalose”. It is unclear as to what would and would not be considered a “similar” product. For example, it is unclear as to if the composition is identical with the exception of the trehalose, or if other variations may be present.
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) and Ohtake et al (“Trehalose: Current Use and Future Applications” Wiley Online Library February 18, 2011, pages 2020-2053).
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 which is not derived from an animal source, 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). Beck teaches that the material may be pressed into tablets (abstract and paragraph 67).
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 sugar as trehalose as recited in claim 1, as discussed above, Beck teaches of a powder comprising sugar selected from the group comprising trehalose, and thus, the use of trehalose would have been encompassed by the teachings of Beck. Furthermore, Ohtake et al (Ohtake) teaches that trehalose has unique properties different from other sugars (abstract). Ohtake teaches trehalose has a unique ability to sustain and preserve a wide array of biological materials (abstract), and has exceptional stability and is effective to stabilize a wide variety of compounds (page 2020, column 2 last paragraph, page 2021 column 1 Unique Properties of Trehalose paragraph 1 and 3, page 2024, Mechanism of Stabilization, Table 2). Ohtake teaches that trehalose may have an advantage over other sugars when used in tablet formation, resulting in tablets of reduced stickiness and enhanced stability (page 2022 column 1 paragraph 2). Ohtake also teaches trehalose has been used as a stabilizer and its several unique qualities may enhance its use as an ingredient in solid dosage forms (page 2038, paragraph 1), that it is a bulking agent and binder in a number of tablet applications due to its stability toward high temperature and hydrolysis and moldability which makes it a superior choice (page 2038 paragraphs 2 and 3), and that it yields high tablet reproducibility (page 2038 paragraph 3). Ohtake teaches that trehalose may help protect and preserve foods (page 2039-2041, Food Preservation paragraph 1 and Table 5, and page 2042, column 2 paragraph 2), and results in suppression of starch aging (page 2041, column 2 paragraph 1). Thus, it would have been specifically obvious to one of ordinary skill in the art for the sugar in the compressible powder of Beck to specifically be trehalose for its unique properties and many benefits including stabilization, preservation, and reduced stickiness as taught by Ohtake.
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.
Regarding the solid particles as compressible between a force of 5-40kN and as forming a product with a greater fat-soluble vitamin retention compared to a similar compressed product of particles not containing trehalose after storage in a closed brown-glass bottle at room temperature for 35 days as recited in claim 1, as discussed above the claimed limitations are unclear. Regardless, the claimed limitation is intended use and only requires the ability of the product to perform; the claim is directed to solid compressible particles, and not the compressed product itself. As the prior art teaches of a composition that is the same as that claimed and disclosed, including the same type and amount of emulsifier and sugar, one of ordinary skill in the art would expect that the product of the prior art be able to perform in the manner claimed. The position is further supported as Beck teaches that the material may be pressed into tablets (abstract and paragraph 67). It is additionally noted that the claims do not exclude additional materials, such as coatings and/or preservatives from being present on the compressed tablet. Applicant is reminded that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
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) and Ohtake et al (“Trehalose: Current Use and Future Applications”), 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.
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.
The rejection of claims 1, 7, 8, 11 and 12 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) has been withdrawn in light of applicant’s amendments made May 14, 2026 which require a compressible particle. Specifically, the rejection has been withdrawn in view of the amendment which requires the ability of the particles to be compressed in combination with the claimed composition.
Response to Arguments
Applicant's arguments filed May 14, 2026 regarding the remaining rejections have been fully considered but they are not persuasive.
Applicant’s arguments regarding the newly added limitations are not convincing as said limitations are considered to be encompassed or obvious over the prior art for the reasons stated above.
Applicant argues that the claimed composition provides for unexpected results in terms of improved retention of fat-soluble vitamins when using trehalose as compared to maltodextrin, both of which are disclosed by the primary reference Beck, and thus the claimed particles should be allowable. Specifically, applicant refers to the Examples and Figures 1-3. This argument is not convincing.
First it is noted that the evidence is limited to 47.31% and 48.31% modified food starch in combination with 18.19% trehalose (see tables 1 and 2) which does not represent the breadth of the claims of 20-70% modified food starch or gum acacia and 10-50% trehalose, such that the argued result would be expected to present across the claimed scope. Additionally, it is further unclear as to if the argued result would be present across the claimed scope because the claims recite “modified starch” and the examples do not disclose what type of modified starch is used, and there are a variety of modifications, and thus different starches and starch properties which may be encompassed by the claimed invention (see instant specification page 5 paragraph 4). Thus, it is further unclear as to if the argued result would be present across the claimed scope and the argument is not convincing.
Second, as stated above, the prior art Belk specifically teaches the use of trehalose in the compressible particle, and Ohtake further teaches the benefits of trehalose compared to other sugars. Thus, the product as claimed is specifically obvious over the teachings of the prior art. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Third, the argued result does not appear unexpected in view of the teachings of Ohtake which show that trehalose is unique compared to other sugars and provides for stabilization and preservation (see teachings of Ohtake noted above).
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
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.
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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
Prosecution Insights