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 statement (IDS) submitted on May 10, 2024 and May 21, 2026 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Claims 19 – 24 are withdrawn.
Claims 1 – 17 are examined herein.
Claim Objections
Claim 7 – 9 and 15 are objected to because of the following informalities:
In claims 7 – 9, the spellings “2’-O-fucosyllactose” and “2’ O-fucosyllactose” are both used. Please change so the spellings are consistent across the claims.
In line 2 of claim 15 “particles” should be “particle”.
Appropriate correction is required.
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1 – 17, in the reply filed on May 21, 2026 is acknowledged.
Claims 19 – 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Group 2.
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.
Claim 15 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 15 recites the broad recitation “median particle size D50”, and the claim also recites in parentheses “volume based” which appears to be the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Further “mass median particle size” seems to conflict with “volume based” because it is unclear if the D50 is weight-based or volume-based, or optionally either.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 – 6, and 10 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Gandhi (US 2009/0208576 A1).
Gandhi teaches orally disintegrating tables (title, abstract). Gandhi teaches an orally disintegrating table formulation with at least one active agent, mannitol, and at least one other excipient (paragraphs 0022 – 0025).
Gandhi teaches tablets produced with 160 grams of mannitol, 20 grams of sorbitol, and 20 grams of calcium silicate (Example 3, paragraph 0060). Gandhi teaches mannitol and sorbitol are water soluble excipients suitable for inclusion in the composition (paragraphs 0034). Gandhi’s teachings anticipate instant claims 1 – 6, which recite a mixture comprising a filler, a binder, and an active ingredient, wherein the filler is mannitol and the binder is sorbitol.
Gandhi’s teaching for 160 grams of mannitol, 20 grams of sorbitol, and 20 grams of calcium silicate (Example 3, paragraph 0060) is a weight ratio of mannitol to sorbitol of 8:1, which falls within the claimed range of 4:1 and 10:1 as recited in claim 1 and within the ratio of 7:1 to 9:1 as recited in claim 10. A specific example in the prior art which is within a claimed range anticipates the range according to MPEP 2131.03(i).
Gandhi’s teaching for 160 grams of mannitol, 20 grams of sorbitol, and 20 grams of calcium silicate (Example 3, paragraph 0060) is 10 weight% sorbitol, which falls within the claimed range of 5 to 15 weight % as recited in claim 1.
However, in the event that the previous does not have sufficient specificity to rise to anticipation, claims 1 - 6, and 10 are also rejected under 35 U.S.C. 103 below.
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 1 – 6, 10 – 14, 16, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gandhi (as cited above).
For the purposes of this ground of rejection only, and purely arguendo, the examiner will take the position that Gandhi does not teach a specific embodiment (i.e., preferred embodiment, working example, etc.) having all of the claimed elements arranged as required by claims 1 – 6, 10, and 11 without resorting to some “picking and choosing” within the prior art disclosure. That being said, although Gandhi thus would not be anticipatory by this interpretation of the facts, it nevertheless does fairly suggest the claimed invention, as shown below.
Gandhi teaches an orally disintegrating table formulation with at least one active agent, mannitol, and at least one other excipient (paragraphs 0022 – 0025).
Gandhi teaches mannitol and sorbitol are water soluble excipients suitable for inclusion in the composition (paragraphs 0034). Gandhi teaches tablets produced with 160 grams of mannitol, 20 grams of sorbitol, and 20 grams of calcium silicate (Example 3, paragraph 0060). Gandhi teaches the composition may include vitamin B1, B2, B16, or B12 as active ingredients (paragraph 0042, claim 21).
In Examples 12 – 19, Gandhi teaches the active ingredient of the composition included in various amounts (paragraphs 0072 – 0088). The amount of active ingredient relative to the total weight of the composition is shown in the table below.
Amount active ingredient (grams)
Total weight of composition (grams)
Weight percent active ingredient per total weight of the composition
Example 12: clonazepam
0.5
90
0.55 %
Example 12:
loratadine
10
90
11.1 %
Example 13:
taste-masked tramadol
108
210
51.4%
Example 14: taste-masked donepezil
45
150
30%
Example 15: taste-masked paracetamol
200
405
49.4%
Example 16: taste-masked aripiprazole
30
130
23.1%
Example 17: taste-masked ropinirole
10
100
10%
Example 18: enteric-coated esomeprazole
35
250
14%
Example 19: taste-masked memantine
40
210
19%
For the purposes of this rejection, as discussed above, Gandhi does not teach a specific embodiment having each of the claimed elements, however, claims 1 – 6, 10 – 14, 16, 17 are rendered prima facie obvious over the teachings of Gandhi, 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., mannitol, sorbitol, active ingredients) were known in the prior art (e.g., disintegrating tablets) 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 disintegrable table with mannitol, sorbitol, and an active ingredient) to one of ordinary skill in the art.
Gandhi’s teaching for orally-disintegrable tablets produced with 160 grams of mannitol, 20 grams of sorbitol, and 20 grams of calcium silicate (Example 3, paragraph 0060) reads on instant claims 1– 6 which recite a mixture comprising a filler, a binder, and an active ingredient, wherein the filler is mannitol and the binder is sorbitol.
Claim 1’s recitation of “for continuous melt granulation” is an intended use limitation. Gandhi’s teaching for a mixture of mannitol, sorbitol, and calcium silicate (Example 3, paragraph 0060) appears to be capable of meeting the intended use of suitability for continuous melt granulation.
Gandhi’s teaching for 160 grams of mannitol, 20 grams of sorbitol, and 20 grams of calcium silicate (Example 3, paragraph 0060) is a weight ratio of mannitol to sorbitol of 8:1, which falls within the claimed range of 4:1 and 10:1 as recited in claim 1 and within the ratio of 7:1 to 9:1 as recited in claim 10. Claimed ranges that overlap or lie within the prior art are prima facie obvious according to MPEP 2144.05(i).
Gandhi’s teaching for 160 grams of mannitol, 20 grams of sorbitol, and 20 grams of calcium silicate (Example 3, paragraph 0060) is 10 weight% sorbitol, which falls within the claimed range of 5 to 15 weight % as recited in claim 1.
Sorbitol and mannitol are non-identical polyols, non-identical sugar alcohols, and stereoisomers of each other, reading on instant claims 2 – 4.
Gandhi’s teaching that the composition may include vitamin B1, B2, B16, or B12 as active ingredients (paragraph 0042, claim 21) and relative amounts of active ingredient shown in Examples 12 - 19 (paragraphs 0072 – 0088) ranging from 0.55% to 51% as shown in the table above, reads on instant claim 11. Gandhi’s taught range of 0.55% to 51% overlaps on the instantly claimed range of 0.1 to 10 weight% as recited in instant claim 11. Claimed ranges that overlap or lie within the prior art are prima facie obvious according to MPEP 2144.05(i).
Gandhi’s examples 12 – 19 do not include water, reading on claim 12’s limitation of “wherein the mixture comprises less than 10 weight % water”.
The instant specification describes a granule as “preferably a unit formed of numerous particles (page 4 lines 26 – 27). As such, the orally disintegrable table of Gandhi (which is a solid made of various ingredients) reads on granule of the instant claims. Therefore, Gandhi’s teachings for an orally disintegrable table with mannitol, sorbitol, and an active ingredient read on instant claim 13. Further, Gandhi teaches that tablets and granules are both solid dosage forms, and the components of a tablet may also be used to form granules (paragraph 0051).
Gandhi’s teaching for a composition with mannitol, sorbitol, and calcium silicate (Example 3, paragraph 0060) reads on instant claim 14, with mannitol as filler, sorbitol as binder, and calcium silicate as active ingredient. The term “active ingredient” is not explicitly defined in the instant specification, therefore active ingredient is broadly interpreted to include calcium silicate.
Gandhi teaches the tablets can be made via extrusion or melt granulation (0051), reading on instant claim 16. Notably, the limitation “obtained by continuous melt granulation of the mixture” is 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, Gandhi’s teaching for an orally disintegrable composition with mannitol, sorbitol, and calcium silicate (title, abstract, Example 3, paragraph 0060) reads on the claimed granules. As such, the patentability of the instant composition does not depend on its method of production, and the Applicant’s limitation “obtained by continuous melt granulation of the mixture” is not patentable under 35 U.S.C. 103, in view of Gandhi.
Gandhi teaches the tablets are orally disintegrable (title, abstract), which suggests they dissolve in the aqueous environment of saliva in the mouth, reading on claim 17’s recitation of water-soluble or water-dispersible.
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Gandhi (as cited above) in view of Goston (US 2013/0165406 A1).
Gandhi’s teachings are discussed above. Notably, Gandhi teaches inclusion of a water-soluble excipient in the composition, such as lactose (paragraph 0034, claim 5). Gandhi suggests that the identity of water-soluble excipient used in the composition impacts properties such as moisture content, porosity, and disintegration time, among others (paragraph 0041).
Gandhi does not teach the filler comprises 2’ O-fucosyllactose, crystalline fucosyllactose, or difucosyllactose.
Goston teaches the missing element of Gandhi.
Goston teaches 2’-O-fucosyllactose for use in pharmaceutical or nutritional compositions (abstract).
Goston teaches 2’-O-fucosyllactose is an oligosaccharide found in human milk, which potentially has prebiotic, antibacterial, and antiviral properties, among others (paragraphs 0002 – 0003).
Goston teaches the crystalline form of 2’-O-fucosyllactose may have different physical, electrical, mechanical, and optical properties which may be advantageous for use in product development (paragraph 0006).
The combination of Gandhi and Goston’s teachings renders claims 7 and 9 prima facie obvious for the following reasons. Gandhi teaches that the water-soluble excipient of the composition can influence properties such as moisture content, porosity, and disintegration time, among others (paragraph 0041). Gandhi teaches the most preferred water-soluble excipient is mannitol, but that lactose would be an acceptable alternative (paragraph 0034). 2’-O-fucosyllactose is a derivative of lactose, and Goston teaches that this oligosaccharide has desirable prebiotic, antibacterial, and antiviral properties (paragraphs 0002 – 0003). A person of ordinary skill in the art would be motivated to substitute 2’-O-fucosyllactose for lactose in the composition of Gandhi because 2’-O-fucosyllactose has desirable prebiotic, antibacterial, and antiviral properties. The substitution of a known element for another (in this case, lactose for 2’-O-fucosyllactose) to obtain predictable results (i.e. a tablet composition that includes 2’-O-fucosyllactose and potentially associated properties) is prima facie obvious according to MPEP 2143(i)(b).
The combination of Gandhi’s teaching for orally-disintegrable tablets produced with mannitol, sorbitol, and an active ingredient (title, abstract, paragraphs 0042, 0060), substituting mannitol for lactose (as Gandhi teaches is acceptable), then lactose for 2’-O-fucosyllactose because Goston teaches 2’-O-fucosyllactose has desirable prebiotic, antibacterial, and antiviral properties (paragraphs 0002 – 0003) reads on instant claim 7.
Goston’s teaching that the crystalline form of 2’-O-fucosyllactose may have different physical, electrical, mechanical, and optical properties which may be advantageous for use in product development (paragraph 0006) would lead a person of ordinary skill in the art to use crystalline 2’-O-fucosyllactose in an effort to modulate physical, electrical, mechanical, and optical properties of the composition, reading on instant claim 9.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gandhi (as cited above) in view of Goston (as cited above) and further in view of Phipps (Phipps, K.R., et al. “Safety evaluation of a mixture of the human-identical milk oligosaccharides 2’-fucosyllactose and difucosyllactose” Food and Chemical Toxicology, 2018, 120: 552 – 565).
Gandhi and Goston’s teachings are discussed above.
The combination of Gandhi and Goston does not teach the filler comprises difucosyllactose.
Phipps teaches the missing element of the combination of Gandhi and Goston.
Phipps teaches 2’-fucosyllactose and difucosyllactose are oligosaccharides that are always present together in human milk (abstract) and suggests that the combination of these two oligosaccharides has increased health benefits than an oligosaccharide alone (abstract, page 553 column 1).
The combination of Gandhi, Goston, and Phipps’ teachings renders claim 8 prima facie obvious for the following reasons. Gandhi teaches that the water-soluble excipient of the composition can influence properties such as moisture content, porosity, and disintegration time, among others (paragraph 0041). Gandhi teaches the most preferred water-soluble excipient is mannitol, but that lactose would be an acceptable alternative (paragraph 0034). 2’-O-fucosyllactose is a derivative of lactose, and Goston teaches that this oligosaccharide has desirable prebiotic, antibacterial, and antiviral properties (paragraphs 0002 – 0003). A person of ordinary skill in the art would be motivated to substitute 2’-O-fucosyllactose for lactose in the composition of Gandhi because 2’-O-fucosyllactose has desirable prebiotic, antibacterial, and antiviral properties. The substitution of a known element for another (in this case, lactose for 2’-O-fucosyllactose) to obtain predictable results (i.e. a tablet composition that includes 2’-O-fucosyllactose and potentially associated properties) is prima facie obvious according to MPEP 2143(i)(b). Further, a person of ordinary skill in the art would be motivated to include difucosyllactose with 2’-O-fucosyllactose because Phipps’ teaches these oligosaccharides occur naturally together and suggests that they have increased health benefits when combined (abstract, page 553 column 1). As such, Phipps’ teachings would lead a person of ordinary skill in the art to include difucosyllactose with 2’-O-fucosylklactose in the combination of Goston and Gandhi. Teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill in the art to modify the prior art reference to arrive at the claimed invention is prima facie obvious according to MPEP 2143(i)(g).
The combination of Gandhi’s teaching for orally-disintegrable tablets produced with mannitol, sorbitol, and an active ingredient (title, abstract, paragraphs 0042, 0060), substituting mannitol for lactose (as Gandhi teaches is acceptable), then lactose for 2’-O-fucosyllactose because Goston teaches 2’-O-fucosyllactose has desirable prebiotic, antibacterial, and antiviral properties (paragraphs 0002 – 0003) and finally combining difucosyllactose with 2’-O-fucosyllactose because Phipps’ suggest the combination has increased health benefits (abstract, page 553 column 1) reads on instant claim 8.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gandhi (as cited above) in view of Upadhye (US 10,786,459 B2).
Gandhi’s teachings are discussed above.
Gandhi does not teach granules have a median particle size D50 from 0.5 mm to 6 mm.
Upadhye teaches the missing element of Gandhi.
Upadhye teaches methods for producing granules that are easy to handle and transport with improved flowability and compressibility of ingredients (column 1 lines31 – 32). Upadhye teaches granules with a particle size distribution of 89% falling within the size range of 0.5 mm to 1.4 mm (column 30 lines 10 – 12). Upadhye teaches that a size between 0.5 mm and 1.4 mm is desirable for producing tablets with favorable compressibility (column 30 lines 60 – 67), and medium sized granules have improved flowability (column 32 lines 58 – 60).
The combination of Gandhi and Upadhye’s teachings renders claim 15 prima facie obvious as combining prior art elements according to known methods to yield predictable results (MPEP 2143(i)(a)). A person of ordinary skill in the art would have been motivated to make Gandhi’s granules in the size of 0.5 mm to 1.4 mm as taught by Upadhye because Upadhye teaches that granules of this size range have improved flowability and produce tables with good compressibility (column 30 lines 60 – 67, column 32 lines 58 – 60). Therefore, it would have been obvious before the filing date of the instant invention to modify Gandhi’s granules with Upadhye’s teachings for granules of a size between 0.5 mm and 1.4 mm, which is prima facie obvious according to MPEP 2143(i)(a).
The combination of Gandhi’s teaching for orally-disintegrable tablets produced with mannitol, sorbitol, and an active ingredient (title, abstract, paragraphs 0042, 0060) with Upadhye’s teaching for more than 50% of particles having a size between 0.5 and 1.4 mm (column 30 lines 10 – 12) reads on instant claim 15. A person of ordinary skill in the art would have been motivated to make Gandhi’s granules in the size range taught by Upadhye because Upadhye teaches that granules of this size range have improved flowability and produce tables with good compressibility (column 30 lines 60 – 67, column 32 lines 58 – 60).
Although Upadhye does not teach the particles are measured via dynamic image analysis, Upadhye’s particles fall within the claimed size range. Furthermore, Upadhye’s technique for measuring particles via sieve analysis would be expected to characterize particle size such that particles are comparable with those characterized by dynamic image analysis, in other words, the particle size would be approximately the same regardless of the technique used to measure it. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i)(a).
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. Application 18/709,316
Claims 1 – 17 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1 – 20 of copending Application No. 18/709,316.
Although the claims at issue are not identical, they are not patentably distinct from each other because: instant claim 1 is drawn to a mixture comprising a filler, a binder, and at least one active ingredient, wherein the binder is in an amount from 5 to 15 weight %; the filler and binder are in a weight ratio of 4:1 to 10:1; wherein the filler has a melting temperature of 151 to 240 °C; and wherein the binder has a melting temperature that is lower than that of the filler.
Conflicting claim 1 is drawn to a mixture comprising a filler, a binder, and microcapsules, wherein the mixture comprises 0.1 to 55 weight % microcapsules; wherein the mixture comprises 5 to 15 weight % binder; wherein the weight ratio of filler to binder is from 4:1 to 10:1; wherein the melting temperature of the filler is from 151 to 240 °C; and wherein the binder has a melting temperature that is lower than that of the filler.
The instant and conflicting claims differ because conflicting claim 1 recites the inclusion of microcapsules, whereas instant claim 1 recites the inclusion of at least one active ingredient. Dependent claims 8 and 9 (of the conflicting application) recite the microcapsules encapsulate fat soluble active ingredients, reading on the active ingredient of instant claim 1.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Double Patenting over U.S. Application 18/710,029
Claims 1 – 17 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1 – 13 and 26 – 30 of copending Application No. 18/710,029.
Although the claims at issue are not identical, they are not patentably distinct from each other because: instant claim 1 is drawn to a mixture comprising a filler, a binder, and at least one active ingredient, wherein the binder is in an amount from 5 to 15 weight %; the filler and binder are in a weight ratio of 4:1 to 10:1; wherein the filler has a melting temperature of 151 to 240 °C; and wherein the binder has a melting temperature that is lower than that of the filler.
Conflicting claim 1 is drawn to a mixture comprising at least 50 weight % of an active ingredient, at least 10 weight % 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 the melting temperature of the binder; and wherein the melting temperature of the binder is lower than the melting temperature of the polysaccharide filler.
The instant and conflicting claims differ because conflicting claim 1 recites the filler is a polysaccharide filler and the composition has less than 5 weight % water. The polysaccharide filler reads on the general filler of instant claim 1. Dependent claim 12 (of the instant application) recites the mixture comprises less than 10 weight % water. The instant range of less than 10% water overlaps on the conflicting claimed range of less than 5 weight % water.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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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