DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on December 18, 2024 and September 19, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Status
Claims 1 – 133 are cancelled.
Claims 134 – 156 are examined here-in.
Claim Interpretation
Regarding the interpretation of dependent claim 140:
At present, claim 134’s recitation for “a third type of particle in an amount of 1 -10% by weight of the population of particles separate from the first and second type of particles, the third type of particles comprising a flavor” is interpreted to mean that the third type of particle is present in an amount of 1 – 10% by weight and the third type of particle comprises a flavor.
Claim 140’s recitation for “wherein the third type of particle has a load of flavor in a range of 5 – 25%” is interpreted to mean that 5 – 25% of claim 134’s recitation of 1 – 10% by weight, i.e. 0.5 to 2.5% by weight of the population is a flavor.
“Load of flavor” is referenced on page 19 of the instant specification, however, no specific definition or further clarifying language is present.
If this interpretation of the claims differs from what Applicant intended, Applicant should clarify this matter in response or amend the claims as necessary.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 134 – 156 are rejected under 35 U.S.C. 103 as being unpatentable over Wittorff (US 2021/0346295 A1).
Wittorff teaches a flowpack comprising a population of particles and one or more active ingredients, wherein the population of particles includes at least two different types of particle (abstract, paragraph 0011).
Wittorff teaches that at least one of the two different types of particle is a sugar alcohol particle comprising granulated sugar alcohol particles (paragraph 0011). Wittorff teaches that inclusion of more than one type of sugar alcohol particle leads to improved delivery of active ingredients and improved mouthfeel (paragraphs 0012 – 0015).
Wittorff teaches that in addition to the granulated sugar alcohol particles, another population of particles should be non-directly compressible (non-DC) sugar alcohol particles (paragraph 0016). Wittorff teaches that the inclusion of non-DC sugar alcohol particles results in improved melting sensation, flavor sensation, cooling sensation, and off-not sensation associated with the active ingredient (paragraph 0017).
Wittorff teaches that it may also be advantageous to include directly compressible (DC) sugar alcohol particles (paragraph 0018). ). Wittorff teaches that the inclusion of DC sugar alcohol particles results in improved melting sensation, salivation, flavor sensation, and off-not sensation associated with the active ingredient (paragraph 0019).
Wittorff teaches that the combination of an active ingredient and three types of particles (granulated sugar alcohol particles, non-DC sugar alcohol particles, DC sugar alcohol particles) can improve mouthfeel, generation of saliva, cooling sensation, melting sensation, flavor sensation, and off-note sensation associated with the active ingredient (paragraph 0020 – 0021, 0156). In other words, Wittorff teaches that the three-way combination is advantageous because it combines each of the benefits associated with the different types of particles (paragraph 0156).
Wittorff teaches that the powder is dry and flowable (paragraphs 0023, 0030 – 0031, 0043, 0176).
Wittorff teaches granulated sugar alcohol particles may be granulated particles of xylitol, maltitol, isomalt, mannitol, erythritol, lactitol, dextrose, or combinations thereof (paragraph 0119). Wittorff teaches that granulated sugar alcohol particles may also include a binder such as carboxymethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethylcellulose, and polyvinyl pyrrolidone, among others (paragraph 0117).
Wittorff teaches non-DC sugar alcohol particles are selected from xylitol, maltitol, isomalt, mannitol, erythritol, lactitol, or combinations thereof (paragraph 0131).
Wittorff teaches DC sugar alcohol particles that are not granulated sugar alcohol particles may comprise sorbitol or dextrose (paragraphs 0139 – 0141, 0144). Wittorff teaches sorbitol or dextrose particles may have an average particle size less than 250, 210, 180, or 150 microns (paragraph 0144).
Wittorff teaches the flowpack comprises one or more flavoring agents and one or more high-intensity sweeteners (paragraphs 0157 – 0158). Wittorff teaches that the encapsulation of sweetener is beneficial to prolong sweetness and flavor perception through controlled release (paragraphs 0158, 0231).
Wittorff teaches 0.1 to 10% by weight of the formulation may be flavor, and that the flavor may be in the form of a powder (paragraphs 0160 - 0162).
Wittorff teaches the inclusion of a dissolution modifier (paragraphs 0163 – 0164).
Wittorff teaches the active ingredient may be diphenhydramine, cetirizine, loratadine, chlorpheniramine maleate, dextromethorphan, phenylephrine, famotidine, omeprazole, doxylamine succinate, melatonin, fexofenadine, dimenhydrinate, pseudoephedrine, aspirin, caffeine, guaifenesin, calcium carbonate, magnesium hydroxide, acetaminophen, ibuprofen, and naproxen sodium, among others (paragraphs 0184, 0236 – 0237, 0240, 0248, 0255, 0324). Wittorff shows the inclusion of active pharmaceutical ingredients in the particle composition in amounts ranging from 25 to 540 mg for 1500 mg sugar alcohol particles (Table 14A) which is approximately a range of 1.6 to 26% by weight of the total formulation.
Wittorff does not teach a specific embodiment having each of the claimed elements, however, claims 134 – 156 are rendered prima facie obvious over the teachings of Wittorff, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results (MPEP 2143(i)(a)). In the instant case, all the claimed elements (e.g., flowpacks, particles, DC and non-DC sugar alcohols, flavors, binders, active pharmaceutical ingredients) were known in the prior art (e.g., oral delivery of active ingredients) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (e.g., a flowpack with multiple types of particles and an active pharmaceutical ingredient that includes the benefits of each different type of particle) to one of ordinary skill in the art.
Wittorff’s teaching for a flowpack comprising an active pharmaceutical ingredient and three types of flowable particles (granulated sugar alcohol particles, non-DC sugar alcohol particles, DC sugar alcohol particles) and the inclusion of 0.1 to 10% by weight of a flavor (abstract, paragraphs 0011, 0020 – 0021, 0023, 0030 – 0031, 0043, 0160 -0162, 0176) reads on instant claims 134, 155, and 156.
Wittorff’s teaching for 0.1 to 10% by weight of a flavor in the composition (paragraphs 0160 – 0162) overlaps on the instantly claimed amount of 1 to 10% by weight as recited in instant claims 134, 155, and 156. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Wittorff’s teaching for the inclusion of active pharmaceutical ingredients in the particle composition in amounts ranging from 25 to 540 mg for 1500 mg sugar alcohol particles (Table 14A) which is approximately a range of 1.6 to 26% by weight of the total formulation overlaps on the instantly claimed amount of 20 to 70% by weight of active pharmaceutical ingredients as recited in claim 134. Although Wittorff’s teaching for an approximate range of 1.6 to 26% by weight of a pharmaceutical ingredient does not overlap on the claimed range of 40 to 60% by weight as recited in instant claim 155, a person of ordinary skill in the art would be motivated to include more than 26% by weight (the maximum amount exemplified by Wittorff) in order to have increased pharmaceutical effects. For example, it is well-known that 1,000 mg acetaminophen is an established dosage for adults. A person of ordinary skill in the art would be motivated to include 1,000 mg acetaminophen rather than 325 mg acetaminophen in case 165 D shown in Table 14A in order to create a formulation with increased analgesic and anti-pyretic activity for adults. For case 165 D, 1,000 mg acetaminophen, 5 mg phenylephrine, 10 mg dextromethorphan and 200 mg guaifenesin would be a total of 1,215 mg active pharmaceutical ingredients to 1500 mg sugar alcohol particles, or 45% by weight active ingredient. Therefore, through routine experimentation a person of ordinary skill in the art would be motivated to include an amount such as 45% by weight, which is an amount between 40 and 60% by weight, as recited in instant claim 155. Routine optimization is prima facie obvious according to MPEP 2144.05(ii)(a). Instant claim 156 does not recite an amount of active pharmaceutical ingredient, just the inclusion of some active pharmaceutical ingredient, therefore Wittorff’s teachings read on instant claim 156.
Wittorff’s teaching for particles of granulated sugar alcohol, non-DC sugar alcohol, or DC sugar alcohol (paragraph 0020 – 0021) reads on the limitation “particles comprising at least 95% by weight of one or more sweeteners” as recited in claims 134, 155, and 156. For Wittorff’s examples with particle compositions including active pharmaceutical ingredients in amounts ranging from 25 to 540 mg and sugar alcohol particles in the amount of 1500 mg (Table 14A), the particles make up 74 to 98.4% by weight of the total formulation. The amount of 74 to 98.4% by weight of particles containing a sweetener overlaps on the claimed range of 30 – 95% by weight as recited in instant claim 134, 155, and 156.
Wittorff’s teaching that the powder delivery system is dry and includes free-flowing particles (paragraph 0043) reads on instant claim 135.
Wittorff’s teaching for non-DC sugar alcohol particles that are selected from xylitol, maltitol, isomalt, mannitol, erythritol, lactitol, or combinations thereof (paragraph 0131) reads on instant claims 136 and 137.
Wittorff’s teaching for dextrose particles (paragraphs 0139 – 0141, 0144) reads on instant claim 138.
Wittorff’s teaching for flavor in the form of a powder (paragraphs 0160 -0162) reads on instant claim 139.
As discussed above, claim 140’s recitation for “wherein the third type of particle has a load of flavor in a range of 5 – 25%” is interpreted to mean that 5 – 25% of claim 134’s recitation of 1 – 10% by weight, i.e. 0.5 to 2.5% by weight of the population is a flavor. Wittorff’s teaching that 0.1 to 10% by weight of the formulation may be flavor (paragraphs 0160 -0162) overlaps on the instantly claimed range of 0.5 to 2.5% by weight as recited in claim 140. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Several of Wittorff’s examples with three types of particles have each type of particle in a 1:1:1 ratio (paragraphs 0307 – 0310, 0315 – 0326), which is the first type of particle in an amount of 33% by weight of the population of particles, thus overlapping on the instantly claimed range of 30 – 60% by weight as recited in claim 141.
Wittorff’s teaching for active ingredients such as diphenhydramine, cetirizine, loratadine, chlorpheniramine maleate, dextromethorphan, phenylephrine, famotidine, omeprazole, doxylamine succinate, melatonin, fexofenadine, dimenhydrinate, pseudoephedrine, aspirin, caffeine, guaifenesin, calcium carbonate, magnesium hydroxide, acetaminophen, ibuprofen, and naproxen sodium, among others (paragraphs 0184, 0236 – 0237, 0240, 0248, 0255, 0324) reads on instant claims 142, 143, and 145.
As discussed above, Wittorff teaches the inclusion of active pharmaceutical ingredients in the particle composition in amounts ranging from 25 to 540 mg for 1500 mg sugar alcohol particles (Table 14A) which is approximately a range of 1.6 to 26% by weight of the total formulation. Wittorff’s teaching for active pharmaceutical ingredient in an amount of 26% by weight overlaps on the instantly claimed range of 20 – 40% by weight as recited in claim 144. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i). Although Wittorff’s teaching for an approximate range of 1.6 to 26% by weight of a pharmaceutical ingredient does not overlap on the claimed range of 30 to 70% by weight as recited in instant claim 146, a person of ordinary skill in the art would be motivated to include more than 26% by weight (the maximum amount exemplified by Wittorff) in order to have increased pharmaceutical effects. For example, it is well-known that 1,000 mg acetaminophen is an established dosage for adults. A person of ordinary skill in the art would be motivated to include 1,000 mg acetaminophen rather than 325 mg acetaminophen in case 165 D shown in Table 14A in order to create a formulation with increased analgesic and anti-pyretic activity for adults. For case 165 D, 1,000 mg acetaminophen, 5 mg phenylephrine, 10 mg dextromethorphan and 200 mg guaifenesin would be a total of 1,215 mg active pharmaceutical ingredients to 1500 mg sugar alcohol particles, or 45% by weight active ingredient. Therefore, through routine experimentation a person of ordinary skill in the art would be motivated to include an amount such as 45% by weight, which is an amount between 30 and 70% by weight, as recited in instant claim 146. Routine optimization is prima facie obvious according to MPEP 2144.05(ii)(a).
Wittorff’s example 16A, shown in Table 14A includes six samples with three populations of particles each, where the particles have a total weight of 1500 mg and various amounts of active pharmaceutical ingredients (paragraphs 0325 – 0326, Table 14A) reads on instant claim 147. Wittorff reports “an exact and equal amount” of each type of particle was measured out, implying the relative standard deviation is below 10%.
Wittorff’s teaching that sorbitol or dextrose particles may have an average particle size less than 250, 210, 180, or 150 microns (paragraph 0144) overlaps on the instantly claimed amount of “at most 200 microns” as recited in claim 148.
Wittorff teaches that the encapsulation of sweetener is beneficial to prolong sweetness and flavor perception through controlled release (paragraphs 0158, 0231), with this in mind, a person of ordinary skill in the art would be motivated to encapsulated the active pharmaceutical ingredients for controlled release, reading on instant claim 149.
The instant claim 150 recites “wherein the one or more active pharmaceutical ingredients is granulated with the carrier”. The limitation that the active pharmaceutical ingredients is granulated with the carrier is interpreted as a product-by-process limitation. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps according to MPEP 2113.
Even though product-by-process claims are written as defined by the process, the determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In the instant case, Wittorff’s teaching for a flowpack comprising an active pharmaceutical ingredient and three types of flowable particles (granulated sugar alcohol particles, non-DC sugar alcohol particles, DC sugar alcohol particles) wherein the powder delivery system is dry and flowable (abstract, paragraphs 0011, 0020 – 0021, 0023, 0030 – 0031, 0043, 0160 -0162, 0176) reads on the instantly claimed flowpack where the active pharmaceutical ingredients is granulated with the carrier because active pharmaceutical ingredient granulated with carrier implies the active pharmaceutical ingredient is in particle or powder form, which Wittorff teaches. As such, the patentability of the instant composition does not depend on its method of production, and the Applicant’s limitation regarding the process where active pharmaceutical ingredient is granulated with the carrier is not patentable under 35 U.S.C. 103, in view of Wittorff.
Wittorff teaches granulated sugar alcohol particles include a binder such as microcrystalline cellulose or starch (paragraph 0117). Wittorff’s teaching for granulated sugar alcohol particles comprising microcrystalline cellulose or starch with active pharmaceutical ingredients (paragraphs 0117, 0239) read on instant claim 151.
Wittorff’s teaching that the active pharmaceutical ingredient is released from the powder (paragraph 0239), wherein the powder comprises granulated sugar alcohol particles of xylitol, maltitol, isomalt, mannitol, erythritol, lactitol, dextrose, or combinations thereof (paragraph 0119), or non-DC sugar alcohol particles are selected from xylitol, maltitol, isomalt, mannitol, erythritol, lactitol, or combinations thereof (paragraph 0131), or DC sugar alcohol particles (that are not granulated sugar alcohol particles) are sorbitol or dextrose (paragraphs 0139 – 0141, 0144) reads on instant claim 152.
Wittorff’s teaching that particles may include a binder such as carboxymethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethylcellulose, and polyvinyl pyrrolidone, among others (paragraph 0117) reads on instant claim 153.
Wittorff’s teaching for the inclusion of a dissolution modifier (paragraphs 0163 – 0164) reads on instant claim 154’s recitation for a disintegrant.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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.
Double Patenting over U.S. Patent No. 12,551,439
Claims 134 – 156 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1 – 28 of U.S. Patent No. 12,551,439.
Although the claims at issue are not identical, they are not patentably distinct from each other because: instant claim 134 is drawn to a flowpack for oral delivery of active pharmaceutical ingredients comprising a flowable population of particles comprising a first type of particles with a content of 20 to 70% by weight active pharmaceutical ingredients, a second type of particles in an amount of 30 – 95% by weight comprising one or more sweeteners, and a third type of particles in an amount of 1 – 10% by weight comprising a flavor.
Independent claim 155 is drawn to a flowpack for oral delivery of active pharmaceutical ingredients comprising a flowable population of particles comprising a first type of particles with a content of 40 to 60% by weight active pharmaceutical ingredients, a second type of particles in an amount of 30 – 95% by weight comprising one or more sweeteners, and a third type of particles in an amount of 1 – 10% by weight comprising a flavor.
Independent claim 156 is drawn to a flowpack for oral delivery of active pharmaceutical ingredients comprising a flowable population of particles comprising a first type of particles with active pharmaceutical ingredients, a second type of particles in an amount of 30 – 95% by weight comprising one or more sweeteners, and a third type of particles in an amount of 1 – 10% by weight comprising a flavor.
Conflicting claim 1 is drawn to a flowpack for oral delivery of active ingredients, the flowpack comprising an outer package material enclosing a dissolvable unstamped powder delivery system comprising a population of particles and one or more active ingredients, wherein the population of particles includes at least two types of sugar alcohol particles that are flowable, wherein at least one of said two types of sugar alcohol particles comprises granulated sugar alcohol particles in an amount of at least 20% by weight, wherein the particles have a size below 500 microns and a Hausner ratio between 1.00 and 1.45.
The instant and conflicting claims differ because instant claims 134, 155, and 156 recite the population of particles in the flowpack comprises three types of particles, whereas conflicting claim 1 recites the population of particles includes at least two types of particles. The conflicting claim’s recitation for “at least two” is an amount that overlaps on the instant claims’ recitation for three, because three is “at least two”. Furthermore, the instant and conflicting claims differ because conflicting claim 1 recites the particles have a size below 500 microns and a Hausner ratio between 1.00 and 1.45.
Instant claim 148 recites the particles have an average particle size of at most 200 microns, which overlaps with the conflicting claim’s recitation for a size below 500 microns.
Although instant claim 134 does not recite a Hausner ratio, instant claim 135 recites the particles are a free-flowing population of particles, which is consistent with a Hausner ratio between 1.00 and 1.45 as recited in conflicting claim 1.
Conflicting claims 2, 4 – 6, 9, 11, 13, 15, and 17 recite at least one of the two types of particles are non-directly compressible sugar alcohol particles, reading on instant claim 136.
Conflicting claims 14 and 15 recite particles are xylitol maltitol, isomalt, mannitol, erythritol, lactitol, dextrose, or combinations thereof, reading on instant claims 137, 138, and 152.
Conflicting claim 18 recites the one or more active ingredients is selected from diphenhydramine, acetaminophen, ibuprofen, phenylephrine, dextromethorphan, guaifenesin and combinations thereof, reading on instant claims 142, 143, and 145.
Conflicting claims 24 and 25 recite Hausner rations between 1.00 and 1.34 and 1.00 and 1.25, reading on instant claim 135’s recitation for “free-flowing”.
Independent conflicting claims 26 and 28 read on instant claims 134, 55, and 156 as conflicting claim 1, which is described in detail above.
Conclusion
All claims are rejected. No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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