DETAILED ACTION
Claims 1-3, 5-9, 12, and 14-24 of J. Martin, US 17/450,414 (July 7, 2025) are pending: claims 1, 6-7, 12, 14-16, and 21 are amended, claims 4, 10-11 and 13 are canceled, and claims 17-20 are withdrawn. Claims 1-3, 5-9, 12, 14-16, and 21-24 are rejected.
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 .
Priority
Acknowledgment is made of Applicant's claim for domestic benefit of provisional application 63/090156 filed on 10/09/2020.
Election/Restrictions
Applicant previously elected, with traverse, the invention of Group I (now claims 1-3, 5-12, 14-21) drawn to an intraorally absorbable composition, in the reply filed on January 31, 2023. Claims 17-20 to the non-elected inventions of Groups (II) and (III) are maintained as withdrawn from further consideration. The restriction is maintained as FINAL.
Withdrawn Claim Rejections
The following rejection is withdrawn in view of Applicant’s amendment to the claims: The rejection of claims 1-3, 5-9, 12, 14-16, 21 and 22-24 under 35 U.S.C. 103 as being unpatentable over J. Piene et.al. CA 2349565C (2000) (“Piene”) in view of Ewing 20190350240-A1 (“Ewing”). The rejection is withdrawn in view of Applicant’s amendments to the claim. A new rejection is set forth and discussed below.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Regarding claim 1, the claim recites the term, “… active ingredient…”. As it relates to this term, the p. 4 of the Specification defines the term as:
As used herein, the term "active ingredient" refers to any pharmaceutical agents, therapeutic substances and/or nutritional substances that may be delivered orally and/or intraorally. Examples of suitable active ingredients include but are not limited to pharmaceutical agents, nutraceutical agents, and nutrients.
Furthermore, Specification page 5 defines “nutrients” as follows:
[0019] As used herein, the term "nutrients" refers to any substance that either provide energy, act as building blocks for growt.h and/or repair, and/or act to regulate chemical processes in a subject. Examples of suitable nutrients include but are not limited to carbohydrates, lipids and fatty acids, proteins and amino acids, vitamins, minerals and electrolytes, stimulants, herbal products, and combinations thereof, whether prepared naturally, artificially, or synthetically.
which includes “carbohydrates”, that one of skill in the art would interpret as including sugars, sugar derivatives, sugar substitutes, and sugar alcohols, such as glucose, dextrose, lactose and isomalt.
As it relates to the term, “sweeteners …” in claim 1, the specification provides the following definitions on p. 6, paragraphs [0022] and [0024] as:
[0024] As used herein, the term "sweetener" refers to sugars, sugar derivatives, sugar substitutes, and sugar alcohols, including natural and synthetic non-sugar sweeteners. Examples of suitable sweeteners that have been identified include but are not limited to glucose, dextrose, maltose, and lactose, mannitol, sorbitol, xylitol, erythritol, maltitol, isomalt, and sucralose.
[0022] Examples of excluded binders include but are not limited to …
… sugars (e.g., glucose, dextrose, and lactose); sugar alcohols (e.g., mannitol, sorbitol, xylitol, erythritol, maltitol, and isomalt);
As disclosed above, claim 1’s elements of “active ingredients” and “sweeteners” overlap such that a sugar could be interpreted as a nutrient and not a sweetener; thus, isomalt may be interpreted as a nutrient. Such an interpretation is supported by the Examples 4 and 5 of the specification wherein dextrose is included as a nutrient and not as a sweetener.
It is noted from the above definitions “sugar alcohols” is separate from “sugar derivatives”, and thus are interpreted as different alternatives. For example, isomalt is identified as a “sugar alcohol” and not a “sugar derivative”.
Therefore, claim 1’s elements of “active ingredients” and “sweeteners” overlap such that sugars, sugar derivatives, sugar substitutes, and sugar alcohols could be interpreted as a nutrient and not a sweetener. Thus, isomalt may be interpreted as a nutrient.
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 nonobviousness.
Claims 1-3, 5-9, 12, 14-16, 21 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Dam et al., US Patent No. 8,858,984 B2 (“Dam”), in view of Piene et al. CA 2349565C (2000) (“Piene”) and in further view of Ewing US PG-PUB 2019/0350240-A1 (“Ewing”).
Claim 1 recites:
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Regarding claim 1, Dam teaches a lozenge formulation for buccal drug delivery, that comprises a combination of i) at least one gum, and ii) at least one non-crystallizing sugar or non-crystallizing sugar alcohol in a matrix designed for controlled buccal delivery of a drug. Dam’s Abstract. The lozenge also contains water and optional components selected from flavorings, taste masking agents, colorings, buffer components, pH adjusting agents, excipients, stabilizers and sweeteners. In col. 4, ll. 31-32, Dam teaches dextrose as a suitable active ingredient. In col. 2, ll. 36-38, Dam also discusses the amounts: “Preferably such lozenges are characterized in that 50-0.90 wt. %, more preferably 55-85 wt. %, and most preferably 60-80 wt. % of component (ii) consists of: A. at least one non-crystallizing Sugar, B. at least one non-crystallizing Sugar alcohol, or C. a mixture of at least one non-crystallizing Sugar and at least one non-crystallizing Sugar alcohol.”.
Several lozenge examples are discussed throughout the disclosure, but Dam also discloses a general lozenge formulation in col. 10 where each component is either an active ingredient or an excipient:
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Regarding pH stability, Dam also teaches that the formulation comprises a pH buffer system in col. 16, ll. 50-56: “The phosphate buffers used were one or a combination of two or more of sodium dihydrogen phosphate, di-sodium hydrogen phosphate, potassium dihydrogen phosphate, dipotassium hydrogen phosphate, sodium hydroxide, potassium hydroxide, trisodium phosphate and other alkali earth metal phosphate salts and hydrated salts.
As noted in col. 3, ll. 1-3, Dam also teaches that “As the non-crystallizing sugars and/or sugar alcohols are sweet, it is not necessary for additional sweetening agents (such as sucrose) to be used…”, and in col. 6, ll. 30-35 discloses that: “Sweeteners may include artificial sweeteners such as aspartame and sodium saccharin, sugars and sugar alcohols as previously listed. It is preferred that sugars or sugar alcohols used as sweeteners be non-crystallizing or be treated to impart non-crystallizing properties and that sucrose is absent.” See also claims 1-8 of Dam.
Dam however does not teach an excipient blend comprising a lubricant and a binder as claimed.
Piene teaches a similar lozenge formulation, where calcium carbonate tablets used as a source of calcium, especially for patients suffering from or at risk of osteoporosis. Piene at page 1. Piene teaches an orally administrable calcium composition comprising 60.5-96% of calcium compound as the active ingredient. Piene at page 4, lines 33-36. Piene teaches that the composition can be compressed into lozenge form, Piene at page 15, Example 3; page 17, Examples 6-10, line 1-6.
Piene teaches that the orally administrable calcium composition also comprises a water-soluble diluent. Piene at page 2, line 17-18. Piene also teaches that the water-soluble diluent can be saccharide-based diluents include sucrose, fructose and the maltodextrins. Piene at page 5, line 8-10.
More specifically, in Example 9, Piene teaches the following composition for a chewable tablet and a lozenge. See, Piene at page 17; and at page 18.
Piene, Example 9, Chewable Tablet and Lozenge (total tablet weight is 1738 mg)
Ingredient
Claim 1 element
Piene’s Purpose
Weight (mg)
Weight %
CaCO3
active
active
1250
72%
inulin
binder
binder1
24
1.4%
magnesium stearate
Lubricant
lubricant
8
0.5 %
lemon flavor
-
flavor agent
52.6
3%
vitamin D3
active
nutrient
4.4
0.3%
isomalt
- 4
sweetener/diluent 2
390
22%
Malic acid
-
flavor enhancer 3
8
0.46%
aspartame
-4
sweetener
1
0.05%
1 See Piene at page 17, EXAMPLES 6 TO 10, line 7-9.
2 See Piene at page 5, lines 4-6.
3 See Piene at page 10, lines 27-30.
4 See claim interpretation of sweetener above.
Piene’s Example 9 calcium carbonate as an active ingredient at 72% also meets claim 1 limitation (a) of “50-90% of active ingredients”. The remaining Example 9 ingredients meet claim 1, limitation (b) “10-50% of an excipient blend comprising a lubricant and a binder selected from . . . inulin”, where magnesium stearate is the lubricant and inulin is the binder. Furthermore, Piene’s Example 9 inulin at 1.4% meets the claim 1 limitation (b) recitation of:
. . . a binder selected from chicory root, a chicory root extract, inulin, or combinations thereof; and devoid or substantially devoid of any other binder, wherein the binder is present in an amount from 2 wt.% to 8 wt.% of the composition . . .
The claim also recites 2 wt.% to 8 wt.% for the binder. However, because the proportion of 1.4% is so close to 2 wt.%, and there is no showing of criticality of the claimed range, “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.” MPEP § 2144.05(I). The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
As it relates to the limitation:
. . . one or more sweeteners, wherein the one or more sweeteners is present in an amount less than 5 wt.% of the composition,
Piene teaches aspartame and isomalt in the composition of Example 9 as elements that add “sweetness” (p. 5, ll. 1-2). Isomalt, while labeled by Piene as a diluent (see, for e.g., p. 5 ll. 4-5), is present in an amount of 22%, and aspartame is present at 0.05%.
As disclosed in the claim interpretation, claim 1’s elements of “active ingredients” and “sweeteners” overlap such that a sugar, sugar derivatives, sugar substitutes, and sugar alcohols could be interpreted as a nutrient and not a sweetener. Thus, isomalt may be interpreted as a nutrient. Such an interpretation is supported by the Examples 4 and 5 of the specification wherein dextrose is included as a nutrient (i.e., active ingredient) and not as a sweetener.
Aspartame, a potent synthetic non-sugar sweetener, used to “enhance sweetness” as disclosed by Piene on p. 10, ll. 22-26:
Extra sweeteners, e.g., artificial sweeteners such as aspartame, acesulfame K, saccharin, sodium saccharin, neohesperidine hydrochloride, taumatin and sodium cyclamate may be used to enhance the sweetness of the granulate.
Thus, reads on the claimed limitation “… wherein the one or more sweeteners is present in an amount less than about 5 wt.% of the composition…”.
Therefore, while both isomalt and aspartame are present in the formulation, and adds “sweetness” to the formulation, isomalt may be interpreted as a nutrient and aspartame as a LOW sweetener, considering that it is present at 0.05 wt.%.
As disclosed in Applicant’s specification on p. 11:
[0039] For example, the embodiments disclosed herein can include active ingredients at significantly higher amounts and density, the excipient content can be substantially reduced, the need for sugars, sugar derivatives, sugar substitutes, and sugar alcohols can be eliminated, manufacture and administration can be completed more conveniently and efficiently, and enhanced bioavailability can be achieved.
As it relates to what is considered “less than 5 wt. %”, the specification discloses on p. 34 paragraph [0085] that, “In various embodiments, the methods include increasing absorption of one or more active ingredients of an oral formulation of the compositions that may include an amount of at least about 0.01 wt.% of one or more sweeteners…”. This value of 0.01 wt.. % appears to be the minimum acceptable amount of “sweetener” required which is “substantially absent” or substantially zero. One would be motivated to modify Piene’s Example 9, with reasonable expectation of success, as the elements of aspartame and isomalt both already add “sweetness” to the formulation. Aspartame at 0.05 wt..% is broadly interpreted to be substantially absent, and thus, the formulation may be interpreted as “sugar-free” while still maintaining “sweetness”.
While Piene teaches the above, Piene fails to teach the amended limitation wherein the active ingredients comprise dextrose, potassium, and sodium as required claim 1. However, as discussed above, Dam teaches wherein the active ingredients for a lozenge formulation comprises dextrose, potassium, and sodium.
Consistent with this reasoning, Dam in view of Piene, in combination, teach the full scope of the claimed invention, and also in the recited amounts.
Moreover, Ewing, also in the field of dietary formulations, teaches that intensity remains an important and unmet criterion for high-potency sweeteners, such as sucralose and aspartame for example, para. [0067]. At low does, high potency sweeteners elicit mild sweetness, but in high doses, they tend to elicit bitterness, and other off-flavors.
Ewing also teaches that specific dosage levels of dietary potassium and sodium have been discovered to correct the flavor deficits of existing high potency sweeteners, related to off-flavor, after-taste, thin mouth-feel, and loss of sweetness at high doses (Abstract). Ewing further teaches that these dietary electrolyte salts are used to enhance the sugar-like flavor of natural low-calorie sweetener compositions, Para. [0046], and can be used on packaged edible product that includes hard candy, cough drops, etc., Ewing, claim 13. In paragraphs [0210]-[0211], Ewing also teaches that carbohydrate compositions are included in sweetener compositions to enhance the flavor with often negligible calories, and that in a preferred embodiment, dextrose and cane sugar, were discovered to provide the best flavor enhancement, moisture stability, and dissolving properties for sweetener powder compositions, which is in line with Applicant’s Specification at para. [00103].
To one of ordinary skill in the art of lozenge formulations, it would be prima facie obvious, before the effective filing date of the instant invention, to take Dam’s lozenge formulation, modify it in view of Piene’s formulation, by substituting one active ingredient for another, i.e., CaCO3 for dextrose as a carbohydrate nutrient (c.f., claim interpretation), wherein dextrose also serves “to provide the best flavor enhancement, moisture stability, and dissolving properties for sweetener powder compositions” (Ewing at para. [00103]). One of skill in the art would also be further motivated to include potassium and sodium as electrolyte salts, which may also be used to correct any flavor deficits of existing high potency sweeteners such as sucralose and/or aspartame (Ewing, Abstract); thus, arriving at the claimed invention.
Both Dam and Piene teach an intraorally absorbable composition, comprising a. 50-90% of one or more active ingredients. Dam teaches the active ingredients to comprise dextrose, potassium, and sodium. Piene especially teaches an intraorally absorbable composition, comprising a. 50-90% of one or more active ingredients (see, for e.g., Piene at page 4, lines 33-36); and b. 10-50% of an excipient blend comprising a lubricant; an inulin binder (see, for e.g., p. 6, ll. 11-12); and devoid or substantially devoid of any other binder, wherein the binder is present in an amount from 2 wt.. % to 8 wt.. % of the composition (see, for e.g., p. 18, Example 9); wherein the composition is in a lozenge form (see, for e.g., p. 17, Examples 6-10, line 1-6), and one or more sweeteners (see, for e.g., p. 5, ll. 1-6; p. 10, ll. 22-26). As it relates “wherein the one or more sweeteners is present in an amount less than 5 wt.. % of the composition, Piene teaches aspartame is present at 0.05% in Example 9 above. Ewing teaches that intensity remains an important and unmet criterion for high-potency sweeteners, such as sucralose and aspartame for example, para. [0067], and that specific dosage levels of dietary potassium and sodium have been discovered to correct the flavor deficits of existing high potency sweeteners, related to off-flavor, after-taste, thin mouth-feel, and loss of sweetness at high doses (Abstract). Ewing also teaches that these dietary electrolyte salts are used to enhance the sugar-like flavor of natural low-calorie sweetener compositions, Para. [0046], and those carbohydrates such dextrose and cane sugar, were discovered to provide the best flavor enhancement, moisture stability, and dissolving properties for sweetener powder compositions, which is in line with Applicant’s Specification at para. [00103]. Furthermore, the comprising language of the active ingredients and the overall composition do not preclude the addition of other actives or ingredients in the formulation. Thus, Dam in view of Piene and Ewing teach obtaining the predicable result of a sweet tasting tablet/lozenge in the claimed amount.
In addition, the specific combination of features claimed is disclosed within the formulations taught by the references, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have selected various combinations of the various disclosed ingredients in Piene such as LOW aspartame and a LOW inulin binder for example, in view of Ewing, to arrive at compositions yielding no more than one would expect from such an arrangement as disclosed above.
Here Applicant’s claims are directed to a known combination of known elements, differing from the prior art only in the identity of the “sweetener”. The obviousness rational is thus a simple substitution of one known element for another to obtain predictable results. MPEP § 2143(I)(B). The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results; and when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result. MPEP § 2141(I) (citing the rational used in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)). Furthermore, it is within the skill of an artisan to adjust the amount of a component in a composition and it is routine to obtain the claimed invention. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) which states, "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05, "II. Optimization of Ranges".
The additional limitations of claims 2-3, 5-6, 8, 9 are met by the modification of Dam’s general formula, with Piene Example 9 above (see p. 18, of Piene), and in further view of Ewing (as discussed above):
Claim 2, “The composition of claim 1, wherein the one or more active ingredients is present in an amount of at least 60 wt.% of the composition.” – CaCO3 at 72 wt. %. (i.e., the substitution of one active for another with dextrose).
Claim 3, “The composition of claim 1, wherein the one or more active ingredients is present in an amount of at least 70 wt.% of the composition.” – CaCO3 at 72 wt. %. (i.e., the substitution of one active for another with dextrose).
Claim 5, “The composition of claim 1, wherein the composition is in compressed, powdered lozenge form.” – Piene p. 17, Example 9, “lozenge”.
Claim 6, “The composition of claim 1, wherein the lubricant is present in an amount from about 0.5 wt.% to about 5 wt.% of the composition.” – magnesium stearate at 0.5 wt. %
Claim 8, “The composition of claim 1, wherein the lubricant is magnesium stearate, stearic acid, or combinations thereof.” – magnesium stearate at 0.5 wt. %
Claim 9, “The composition of claim 1, wherein the excipient blend further comprises one or more flavoring agents.” – lemon flavor.
Claim 7 recites, “The composition of claim 1, wherein the lubricant is present in an amount from about 2 wt.% to about 4 wt.% of the composition.”
The limitations of claim 7 are met by the proposed modification of Piene Example 9 (where magnesium stearate is present in 0.5%) because 0.5 wt.% is considered to meet “about 2 wt.% to about 4 wt.%”. See specification at page 4, [0014] (“[a]ccordingly, a value modified by a term or terms, such as ‘about,’ ‘approximately,’ and ‘substantially,’ are not to be limited to the precise value specified unless the context clearly dictates otherwise”). Further, generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. MPEP § 2144.05(II)(A) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) ("[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”).
Here, there is no evidence that the lubricant concentration is critical. Further, Piene teaches that magnesium stearate is generally preferred as a lubricant and that such a lubricant will generally make up 0.3 to 1.5%. Piene at page 11, lines 3-4. Here the lower claim 7 lubricant limit (about 2 wt.%) meets, or is at least close to, the Piene upper limit of 1.5%. As discussed above, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. MPEP § 2144.05(I). Claim 7 is obvious in view of the above discussion because one of ordinary skill is motivated to optimize within the claim 7 lubricant range.
Claim 12 recite: “The composition of claim 1, wherein the binder and the lubricant are present in a combined amount from 3 wt.% to 10 wt.% of the composition” respectively. The limitations of claim 12 is met because the wt.% sum of inulin (binder, 1.4%) plus magnesium stearate (lubricant, 0.5%) equals 1.9 wt.%, which meets claim 12 limitations of “from about 3 wt.% to about 10 wt.% of the composition”, for the same reasons discussed above. Given that 1.9 wt.% is very close to the lower limit of 3 wt.%, and in the absence of evidence demonstrating the criticality of the claimed range, a prima facie case of obviousness is established. According to MPEP § 2144.05(I), obviousness may be found where the claimed ranges do not overlap with the prior art but are merely close. Since the proportions are sufficiently similar, one skilled in the art would reasonably expect them to exhibit the same properties. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Regarding claim 14, the claim recites, “The composition of claim 1, wherein the one or more sweeteners is present from 0 wt.% to 4.9 wt.% of the composition”. As disclosed above, and in the specification on p. 34 paragraph [0085], the value of 0.01 wt.. % appears to be the minimum acceptable amount of “sweetener” required which is “substantially absent” or substantially zero.
Piene teaches aspartame and isomalt in the composition of Example 9 as elements that add “sweetness” (p. 5, ll. 1-2). Isomalt, while labeled by Piene as a diluent (see, for e.g., p. 5 ll. 4-5), is present in an amount of 22%, and aspartame is present at 0.05%.
As disclosed in the claim interpretation, claim 1’s elements of “active ingredients” and “sweeteners” overlap such that a sugar, sugar derivatives, sugar substitutes, and sugar alcohols could be interpreted as a nutrient and not a sweetener. Thus, isomalt while still present, may be interpreted as a nutrient. Such an interpretation is supported by the Examples 4 and 5 of the specification wherein dextrose is included as a nutrient and not as a sweetener.
Aspartame, a potent synthetic non-sugar sweetener, used to “enhance sweetness” as disclosed by Piene on p. 10, ll. 22-26:
Extra sweeteners, e.g., artificial sweeteners such as aspartame, acesulfame K, saccharin, sodium saccharin, neohesperidine hydrochloride, taumatin and sodium cyclamate may be used to enhance the sweetness of the granulate.
Thus, reads on the claimed limitation “… wherein the one or more sweeteners is present in an amount less than about 5 wt.% of the composition…”, and meets each and every limitation of claim 14.
Regarding claims 15-16, the limitations of claims 15 and 16 are met by Dam’s general lozenge formula combined with Piene Example 9 composition, in view of Ewing as discussed above.
Dam teaches in col. 3, ll. 45-59:
The release profile of the active agent or the dissolution profile of the lozenge is governed by the matrix composition and lozenge size and can be varied according to the nature of the active agent and the desired effect. Thus, the dissolution profile can be altered, whilst retaining the same amount of the active agent, by varying the lozenge size and/or the proportion of gum in the lozenge. A smaller overall lozenge size will result in faster dissolution. Similarly, a reduced gum content will result in faster lozenge dissolution. A suitable dissolution profile for lozenges of the invention is such that after 20 minutes approximately 35-65% of the lozenge has dissolved, after 40 minutes, approximately 60-90% of the lozenge has dissolved, and after 60 minutes more than 70% of the lozenge has dissolved.
Piene also teaches that “[t]he disintegration time is typically between 3 and 6 min. It is also a characteristic feature of the tablet that it disintegrates into the primary crystals of calcium carbonate which ensures a rapid exposure of calcium carbonate for dissolution”. Piene at page 15, lines 1-5. Thus, the disintegration properties are highly related to the primary crystals making up the tablet. Therefore, the modified Dam in combination with Piene Example 9 composition, and in view of Ewing, using dextrose as the primary active ingredient, would necessarily result in the claimed disintegration properties. MPEP § 2112(IV).
Regarding claim 21, the limitations are also met for the reasons given above. Moreover, Applicant’s current amendment disclosing
Regarding claims 22 and 24, Dam and Piene in view of Ewing teach the composition of claims 1 and 21. Claims 1 and 21 narrows scope and the range of active ingredients to dextrose at 95% and sodium and potassium at 5% combined total.
Dam, Piene and Ewing in combination teach that one active may be substituted for another depending on the purpose/desirability of the formulation as discussed above. In the instant case, the active ingredients disclosed by Dam, include Applicant’s claimed Dextrose, Sodium and Potassium as discussed and applied above to claims 1 and 21 in the claimed amounts, which overlap in scope with the claimed invention. Piene on the other hand discusses another active, 1250 mg CaCO3 for treating osteoporosis (i.e., 99.6% = ((1250 mg)/(1250 mg + 4.4 mg))) and Vitamin D at 4.4 mg (c.f., Piene page 8 and Example 9 composition) (i.e., 0.4% = ((4.4 mg)/(1250 mg + 4.4 mg))), where the amounts also overlap in scope with the claimed invention.
Dam, Piene and Ewing teach dextrose as an active ingredient, along with potassium and sodium, “wherein dextrose comprises about 95% of the active ingredients, and potassium and sodium together comprise a combined total of about 5% of the active ingredients. Moreover, in the absence of evidence demonstrating the criticality of the claimed range, a prima facie case of obviousness is established. Since the proportions are sufficiently similar, one skilled in the art would reasonably expect them to exhibit the same properties. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Applicant’s Specification in para. [0014] states that, “…a value modified by a term or terms, such as "about” are not to be limited to the precise value specified unless the context clearly dictates otherwise. Claims 22 and 24 are therefore also obvious over Dam, and Piene, in further view of Ewing.
Regarding claim 23, to a composition comprising the same active ingredients as claim 1, further narrows the potassium salt and the sodium salt to potassium citrate and Himalayan rock salt. Dam, and Piene in view of Ewing teaches the composition of claim 1 comprising potassium and sodium. One of ordinary skill in the art would have considered a pharmaceutical composition as taught by Dam and Piene, in further view of Ewing, using the optimized salt forms of potassium and sodium based on desirability as shown by Ewing in paragraphs [0083]-[0140].
Therefore, while Dam and Piene in further view of Ewing do not expressly teach potassium citrate and Himalayan rock salt as claimed, one of ordinary skill would have readily considered other forms of potassium and sodium salts based on routine optimization. Moreover, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). Claim 23 is therefore also obvious over the prior arts cited.
Applicant’s Arguments
Applicant argues context and scope, emphasizing that dextrose may have multiple use, and that the office should consider purpose and context. Applicant’s Remarks pp. 7-8. In particular, Applicant argues that dextrose is used as a sweetening agent, and not an active ingredient on page 7. Applicant argues that there would be no reason to replace Piene’s CaCO3 with a sweetener as the active ingredient. Applicant argues that one of ordinary skill in the art would at best substitute one sweetener in Piene for another sweetener. Applicant also argues substituting Piene’s CaCO3 for dextrose would change Piene’s principle of operation which is centered around treating osteoporosis using CaCO3. Applicant further argues the disintegration time, and contends that Piene’s CaCO3 is different from the claimed dextrose active ingredient; thus, although the formulations are both lozenges, the rejection is improper. Applicant’s Remarks page 10.
Response to Applicant’s Arguments
The Examiner acknowledges the Applicant’s arguments; however, they are moot in light of the new rejection discussed above. Claims 1-3, 5-9, 12, 14-16, 21 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Dam et al., US Patent No. 8,858,984 B2 (“Dam”), in view of Piene et.al. CA 2349565C (2000) (“Piene”), and in further view of Ewing US PG-PUB 2019/0350240-A1 (“Ewing”).
Conclusion
No claims are allowed.
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.
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/C A/ Examiner, Art Unit 1622 May 28, 2026
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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