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 .
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 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.
Restriction Requirement
Restriction - Groups
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-19 and 21-22, drawn to an orodispersible tablet comprising KVD900, or a pharmaceutically acceptable salt and/or solvate thereof.
Group II, claim 20, drawn to a method of manufacturing the orodispersible tablet of claim 1.
Group III, claims 23-28, drawn to a method for treating bradykinin mediated angioedema on-demand comprising: administering one or more orodispersible tablets according to claim 1 to a patient in need thereof on-demand.
As set for the in Rule 13.1 of the Patent Cooperation Treaty (PCT), “the international application shall relate to one invention only or to a group of inventions so linked as to from a single general inventive concept.” Moreover, as stated in PCT Rule 13.2, “where a group of inventions is claimed in one and the same international application, the requirement of unity of invention referred to in Rule 13.1 shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features." Furthermore, Rule 13.2 defines “special technical features” as “those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.”
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
The special technical feature of Group I is an orodispersible tablet comprising KVD900. This composition is not novel in view of Beaton (WO 2017/208005 A1; cited on IDS dated 7/19/2023), as evidenced by Dey (“Orodispersible tablets: A new trend in drug delivery,” Journal of Natural Science, Biology and Medicine, July 2010, Vol 1, Issue 1, 2-5). Beaton discloses the compound KVD900 as a plasma kallikrein inhibitor (Abstract) and that the compound can be administered orally in the form of tablets, syrups, or powders (paragraph bridging pages 26-27). Beaton discloses that inhibitors of plasma kallikrein have been shown to treat hereditary angioedema (HAE) by preventing the release of bradykinin (suggesting that HAE is mediated by bradykinin and reading on treatment of bradykinin mediated angioedema) (page 1: 8-10 and 33-34).
Beaton teaches orally administered forms of KVD600 may be formulated as “fast-dissolving, fast-disintegrating dosage forms” (pg 27: 26-28).
The evidentiary art of Dey discloses: “Orodispersible tablets are also called as orally disintegrating tablets, mouth-dissolving tablets, rapid dissolving tablets, fast-disintegrating tablets, fast-dissolving tablets.” See pg 2, Introduction.
As such, Group I does not share a special technical feature with the instant claims of Groups II and III. Therefore, the claims are not so linked within the meaning of PCT Rule 13.2 so as to form a single inventive concept, and unity between Groups I-III is broken.
Inventorship
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Rejoinder
The examiner has required restriction between product and process claims. Where applicant elects claims directed to the product, and the product claims are subsequently found allowable, withdrawn process claims that depend from or otherwise require all the limitations of the allowable product claim will be considered for rejoinder. All claims directed to a nonelected process invention must require all the limitations of an allowable product claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product are found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product claim will not be rejoined. See MPEP § 821.04(b). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product claims. Failure to do so may result in a loss of the right to rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Telephonic Election
During a telephone conversation with Joshua McCoy on June 18, 2026, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-19 and 21-22. Affirmation of this election must be made by applicant in replying to this Office action. Claims 20 and 23-28 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Status
Claims 1-28 are pending.
Claims 20 and 23-28 are withdrawn.
Claims 1-19 and 21-22 are examined on the merits in this prosecution.
CLAIM REJECTIONS
Indefiniteness Rejections
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.
Claims 7, 9, 16, and 19 are 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, or for pre-AIA the applicant regards as the invention.
The recitation “lactose or a derivative thereof" in claim 7 renders the claim indefinite. The recitation of a “derivative” is not clearly defined in the specification, and therefore does not set forth the metes and bounds of the terms “derivative”. The Merriam-Webster' s Online Dictionary defines “derivative” as “a chemical substance related structurally to another substance and theoretically derivable from it” (citation provided). Hence, one of ordinary skill in the art could not ascertain and interpret the metes and bounds of the patent protection desired as to “derivative”. One of ordinary skill in the art would clearly recognize that a "derivative" would read on those compounds having any widely varying groups that could be used to substitute the compound. Any significant structural variation to a compound would be reasonably expected to alter its properties; e.g. physical, chemical, physiological effects and functions. It is also noted that the examples of derivatives of lactose in the Specification (pg 19), “e.g. lactose monohydrate, spray dried lactose, anhydrous lactose,” are not generally considered chemical derivatives since they have not undergone a chemical transformation. Thus, it is unclear and indefinite as to how the “derivative” herein is encompassed thereby.
Claims 7 recites the parenthetical term “e.g.” four times. The phrase "e.g.”, considered the equivalent of “for example," renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 7 recites the trademark name “Mannogem EZ®” twice. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b). See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a form of mannitol and, accordingly, the identification/description is indefinite.
Claims 9, 16, and 19 recite the parenthetical term “e.g.”. The phrase "e.g.”, considered the equivalent of “for example," renders the claim indefinite, as discussed above.
Claims 16 and 19 recite the trademark name “Mannogem EZ®”. As discussed above, where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b).
Anticipation Rejection
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.
1) Claims 1 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beaton (WO 2017/208005 A1; cited on IDS dated 7/19/2023), as evidenced by Dey (“Orodispersible tablets: A new trend in drug delivery,” Journal of Natural Science, Biology and Medicine, July 2010, Vol 1, Issue 1, 2-5).
Beaton discloses the compound of Figure A, shown below, identical to KVD900, as a plasma kallikrein inhibitor (Abstract) and that the compound can be administered orally in the form of tablets, syrups, or powders (paragraph bridging pages 26-27). Beaton discloses that inhibitors of plasma kallikrein have been shown to treat hereditary angioedema (HAE) by preventing the release of bradykinin (suggesting that HAE is mediated by bradykinin and reading on treatment of bradykinin mediated angioedema) (page 1: 8-10 and 33-34).
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Beaton teaches the orally administered active ingredient is swallowed so that the compound enters the gastrointestinal tract, and/or is administered buccally, lingually, or sublingually by which the compound enters the blood stream directly from the mouth (pg 27: 6-8). Beaton also teaches orally administered forms may be formulated as “fast-dissolving, fast-disintegrating dosage forms” (pg 27: 26-28).
The evidentiary art of Dey discloses: “Orodispersible tablets are also called as orally disintegrating tablets, mouth-dissolving tablets, rapid dissolving tablets, fast-disintegrating tablets, fast-dissolving tablets.” See pg 2, Introduction.
For claim 17, the limitation of “the orodispersible tablet is debossed” is interpreted as a product-by-process limitation since the debossing occurs during the tableting process; furthermore, the debossing is not considered to alter or effect the KVD900 composition described in claim 1. Therefore, as set forth in MPEP 2113(I), “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."
Obviousness Rejections
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
1) Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Beaton (cited above), as evidenced by Dey (cited above).
The teachings of Beaton regarding anticipation are discussed above.
In addition, for claim 2, Beaton teaches the amount of drug administered is between 10 mg and 1000 mg, depending on the mode of delivery (pg 26: 13-15). Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
For claim 3, one of ordinary skill in the formulation art is able to determine the percentage of active agent required for in vivo activity in a formulation as described by Beaton. As set forth in MPEP 2144.05(II), "[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 the instant case, Beaton teaches the amount, in milligrams, of the active agent KVD900.
Quoting again from MPEP 2144.05(II),
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."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.")
As such, routine optimization of Beaton’s fast-dissolving, fast-disintegrating dosage form of KVD900 would have led to the claimed range of about 26% to about 40% of the agent because Beaton teaches a range of 0.1 mg to 10,000 mg (pg 26: 13-14) as the effective range in a dosage form.
2) Claims 4-11, 16, 18-19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Beaton (cited above), in view of Park (US 9,526,789), as evidenced by Dey (cited above).
The teachings of Beaton regarding anticipation and obviousness are discussed above.
Beaton does not teach the disintegrants recited in claims 4 and 5; the fillers recited in claims 6, 7, and 16; the binders recited in claims 8 and 9; and the flow enhancer recited in claims 10 and 11.
Park teaches the missing elements of Beaton.
Park teaches a fast-disintegrating tablet oral formulation which disintegrates quickly in the oral cavity, alternative referred to as an “orodispersible tablet” (Abstract; col 1: 44-46). Park teaches numerous classes of active agents may be formulated as orodispersible tablets (col 9: 4 to col 11: 37).
For claims 4 and 5, Park teaches disintegrating agents such as sodium starch glycolate and crospovidone in an amount of 7% or less (col 7: 49-56), overlapping the claimed range.
For claims 6, 7, and 16, Park teaches a spray-dried mannitol such as Mannogem™ as a filler in an amount of 30-95% (col 5: 16-39), overlapping the claimed range
For claims 8 and 9, Park teaches a binder such as microcrystalline cellulose or silicified microcrystalline cellulose in an amount of 0.1% to 50%, more preferably 30%, and even more preferably 15% by weight or less (col 6: 4-18), overlapping the claimed range.
For claims 10 and 11, Park teaches a flow enhancer, such as silicon dioxide, characterized by Park as a lubricant, in a preferable amount of 1.5% by weight or less, based on total weight of the tablet (col 7: 57-67), overlapping the claimed range.
For claims 18 and 19, as discussed in detail above, one of ordinary skill in the art is able to determine the effective dose of KVD900 utilizing the teachings of Beaton, and Park teaches the claimed amounts of filler, binders, and disintegrants.
For claims 20 and 21, one of ordinary skill in the art is able to determine the effective dose of KVD900 utilizing the teachings of Beaton. It is further noted that one of ordinary skill in the art would have been motivated to prepare a kit comprising the same composition because the preparation of a kit comprising a pharmaceutical composition is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It is further noted that a claimed kit comprising two or more tablets does not represent an alteration of the ingredients set forth in claim 1.
The skilled artisan would have expected success in adding Park's disintegrating agents, sodium starch glycolate and/or crospovidone; spray-dried mannitol such as Mannogem™ as a filler; a binder such as microcrystalline cellulose or silicified microcrystalline cellulose; and a flow enhancer/lubricant such as silicon dioxide, each within the claimed range, because Beaton teaches administration of KVD900 in an orodispersible formulation and Park teaches that disintegrating agents, fillers, binders, and a flow enhancer/lubricant are common and necessary ingredients in an orodispersible formulation in order to provide the rapid disintegration of the tablet.
3) Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Beaton (cited above), in view of Park (cited above) and Kohr (US 2015/0283067 A1; cited on IDS dated 9/17/2025), as evidenced by Dey (cited above).
The teachings of Beaton, Park, and Dey are discussed above. It is noted that Park teaches the addition of a flavoring agent and a sweetening agent to the orodispersible tablet composition (col 5: 66 to col 6: 1).
The combination of Beaton, Park, and Dey does not teach the sweeteners and flavorings recited in claims 12-15.
Kohr teaches the missing elements of the combination of Beaton, Park, and Dey.
Kohr teaches an orodispersible film composition comprising a therapeutically effective amount of at least one active pharmaceutical ingredient, at least one flavoring agent selected from natural citrus fruit derived oil or a mixture of two or more natural citrus fruit derived oils, and a sweetening agent (Abstract; pg 2, [0023]).
For claims 12 and 13, Kohr teaches the sweetener may be monosaccharides, disaccharides, polysaccharides, maltodextrin, sucralose, sorbitol, xylitol, saccharin, aspartame, acesulfame, maltitol or mixtures thereof, in an amount of from 0% to 20% (pg 2, [0027] and [0029]), overlapping the claimed range.
For claims 14 and 15, Kohr teaches the flavoring agent may be lemon, orange and/or grapefruit oil, or mixtures thereof, in an amount of from 0.05% to 0.5% (pgs 2-3, [0017] and [0018]), within the claimed range.
The skilled artisan would have expected success in adding a flavoring and a sweetener to the composition of Beaton and Park since Park teaches the addition of a flavoring agent and a sweetener and Kohr teaches the preferred species and amounts of each useful for increasing the palatability of an orodispersible formulation. One of ordinary skill would be motivated to utilize the flavoring and sweetening elements taught by Kohr as useful in an orodispersible film for the orodispersible tablet of the combination of Beaton and Park since both the film and tablet are formulated to disperse rapidly in the mouth and Kohr teaches flavorings are useful for masking unpleasant or bitter tasting active ingredients (pg 1, [0005]).
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612
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