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 view of applicant’s statements (shown in their REMARKS) that “the base is a medium in which the corresponding active ingredient is dissolved or dispersed.” and that the term “base” as in “gelatin shell base” refers to a compositional component forming the gelatin-shell, previous 112(b) rejection on claims 1-15 (as addressed on Paragraph 8 of the last Office Action) is hereby withdrawn.
In view of the amendment, previous 112(b) rejection on claim 6, previous 112(b) rejection on claim 9, previous 112(b) rejection on claims 9 and 10, previous 112(b) rejection on claim 10 and previous 112(b) on claim 15 are hereby withdrawn.
In response to the previous 102(a)(1) and 103 rejections over Cho et al (KR 10-2015-0033405), applicant argue that in Cho’s Example 5 (which teaches a combination preparation containing atorvastatin and omega-3 fatty acid in the form of a soft capsule where poloxamer 188 was used to form micelles with atorvastatin so as to prevent contact with the omega-3 fatty acid, thereby creating two separate phases which do not overlap with each other), the poloxamer 188 functions as a surfactant and thus argue that Cho does not teach the amended claim 1 which requires the continuous first and second phases in the capsule being present as separate phases without an additional surfactant. Based on applicant’s such argument, previous 102(a)(1) and 103 rejections over Cho et al (KR’405) are hereby withdrawn.
Due to a newly cited prior art, the following rejections are made non-final.
Claim Objections
Claim 18 is objected to because of the following informalities: on line 4 and line 5, and on the last line, applicant need to change “or” to --- and ---. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: on lines 1-2, applicant need to change “comprises (1)” to --- satisfies the condition (1) ---. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: on lines 1-2, applicant need to change “comprises (2)” to --- satisfies the condition (2) ---. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: on lines 1-2, applicant need to change “comprises (3)” to --- satisfies the condition (3) ---. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 5, 6, 8-15 and 18-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In both claims 1 and 22, applicant recite that the continuous first and second phases in the capsule are present as separate phases without “an additional surfactant” and the presence of a physical layer. The term “an additional surfactant” renders the scope of claims 1 and 22 indefinite because the term “additional” means that “a” surfactant already exists somewhere in the capsule formulation, yet the claims do not recite “a surfactant” included in the capsule formulation. Didn’t applicant mean to recite “a surfactant” instead of “an additional surfactant”? Also, by the phrase “wherein the continuous first and second phases in the capsule are present as separate phases without an additional surfactant”, what exactly are applicant excluding? Are they excluding any surfactant in the formulation? Appropriate correction and clarification are required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8 recites that the first liquid phase or the first suspension is not miscible with the second liquid phase or the second suspension, since ingredients of the base of the first liquid phase or the first suspension are different from ingredients of the base of the second liquid phase or the second suspension, and physical properties of the first liquid phase or the first suspension are different from physical properties of the second liquid phase or the second suspension. However, the amended claim 1 (from which claim 8 depends) already requires that the first phase and the second phase are present as separate phases from each other and that an existence region of the first phase and an existence region of the second phase do not overlap (with) each other. Thus, instant claim 8 which recites that the first liquid phase or the first suspension is not miscible with the second liquid phase or the second suspension (the rest of the claim merely explains the reason why they are not miscible) fails to further limit the subject matter of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 9 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claim 9 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: although claim 9 recites “wherein the water-soluble base comprises at least one selected from the group consisting of polyethylene glycol, . . . and a combination thereof”, not all members listed are water-soluble (at least, polymethylacrylate, glycerol monostearate and glycerol monocaprylocaprate are not water-soluble).
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 6, 8-10, 18, 19 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mori et al (JP2000-239159A and its English translation).
Mori teaches ([0005]-[0006]) a capsule preparation comprising a capsule and a drug (two or more active ingredients) filled in the capsule, characterized in that the drug is separated into a plurality of component phases, where the separation state is visible from outside the capsule preparation. Mori teaches ([0008]) that preferably, the plurality of the component phases are all liquids and separated into layers. Mori further teaches that preferably, at least one component phase consists of a hydrophilic liquid and one component phase consists of a hydrophobic liquid and teaches that the drug (i.e., two or more active ingredients) is separated into multiple component phases by utilizing the difference in properties of these component phases (such as density).
Specifically, in Example 3 ([0059]-[0062]), Mori teaches a composition in which benzalkonium chloride (a hydrophilic medicinal component – see [0016]) was mixed into a solution containing PEG 400 (instant water soluble base of claim 9) and an aqueous solution of Blue dye No.1 to form a hydrophilic component phase. Camphor (a hydrophobic medicinal component – see [0017]) was mixed and dissolved with corn oil (instant plant oil of claims 10 and 18) and peppermint oil to form a hydrophobic component phase. The hydrophilic component phase and hydrophobic component phase were injected into a soft gelatin capsule (see [0054] and [0061]) and were left to stand overnight. Mori further states that it was easy to see from the outside that PEG 400 containing benzalkonium chloride colored blue located in the lower layer and transparent corn oil containing the camphor was located in the upper layer.
Thus, Mori’s Example 3 teaches instant capsule formulation of claim 1 comprising a continuous first phase of a first liquid phase comprising a water-soluble base (PEG 400 – instant water-soluble base of claim 9) in which a first pharmaceutical active ingredient (benzalkonium chloride) is dissolved or dispersed; and a continuous second phase of a second liquid phase comprising a fat-soluble base (corn oil – instant fat-soluble base which is a plant oil of claims 10 and 18) in which a second pharmaceutical active ingredient (camphor) is dissolved, wherein the first phase and the second phase are present as separate phases from each other (the water-soluble phase being the bottom layer, and the fat-soluble phase being the top layer), wherein the firs phase and the second phase are present as continuous phases, and an existence region of the first phase and an existence region of the second phase do not overlap each other, wherein the continuous first and second phases in the capsule are present as separate phases without an additional surfactant and the presence of a physical layer, and wherein the capsule formulation satisfies the condition (1) the first liquid phase or the first suspension contains a water-soluble base, and the second liquid phase or the second suspension contains a fat-soluble base.
Thus, Mori teaches instant claims 1, 6, 8-10, 18, 19 and 22 (instant claim 6 is a product-by-process claim. Since Mori already teaches instant capsule formulation of claim 1, Mori also teaches instant claim 6 – see MPEP 2113(I)).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 11-15, 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al (JP2000-239159A and its English translation).
With respect to instant claim 11, Mori teaches ([0016]) that medicinal components that dissolve in hydrophilic liquids can be antipyrine (instant NSAID of claim 11), sodium salicylate (instant NSAID of claim 11), guaifenesin (instant influenza medicinal ingredient of claim 11), dextromethorphan hydrobromide (instant influenza medicinal ingredient of claim 11), water-soluble vitamins or benzalkonium chloride. It would be obvious to one skilled in the art to replace benzalkonium chloride used in Mori’s Example 3 with one of the other medicinal components listed above with a reasonable expectation of success. Thus, Mori renders obvious instant claim 11.
With respect to instant claim 12, Mori teaches ([0017]) that medicinal components that dissolve in hydrophobic liquids can be cod liver oil (a source of omega-3 fatty acid), fat-soluble vitamins and camphor. Thus, it would be obvious to one skilled in the art to replace camphor used in Mori’s Example 3 with cod liver oil or fat-soluble vitamins with a reasonable expectation of success. Thus, Mori renders obvious instant claim 12.
With respect to instant claim 13, as another example of medicinal component that dissolves in hydrophilic liquids, Mori teaches acetaminophen. It would be obvious to replace benzalkonium chloride used in Mori’s Example 3 with acetaminophen with a reasonable expectation of success. Thus, Mori renders obvious instant claim 13.
With respect to instant claims 14 and 15, as discussed above, Mori teaches that the hydrophilic component phase and hydrophobic component phase of its capsule formulation were injected into a soft gelatin capsule. Further in [0031]-[0032], Mori teaches that glycerin is added to the gelatin in order to give the gelatin appropriate flexibility. It would be obvious to one skilled in the art to add glycerin (instant plasticizer of claims 14 and 15) to the gelatin so as to give the gelatin capsule more flexibility. Thus, Mori renders obvious instant claims 14 and 15.
With respect to instant claims 20 and 21, Mori states ([0001] and [0005]) that the purpose of its invention is to provide two or more types of active ingredients that are filled into a capsule where the two or more types of active ingredients separate into multiple component phases and this separated state is made visible from outside of the capsule, thereby making it easy for the person taking the capsule to recognize that the capsule contains multiple types of active ingredients and thus recognize that the capsule is highly effective for treatment. Although Mori teaches that the multiple component phases preferably include at lest one hydrophilic liquid component phase and one hydrophobic liquid component phase, Mori does not exclude two component phases where both of the phases are hydrophilic (water-soluble) phases or where both of the phases are hydrophobic (fat-soluble) phases. In the case where both of the two active ingredients are water-soluble, it would be obvious to one skilled in the art to have one water-soluble active ingredient in a hydrophilic phase and have another water-soluble active ingredient in a separate hydrophilic phase by utilizing the difference in properties of these two hydrophilic phases (such as difference in density or degree of hydrophilicity – see [0019] in Mori) and make this separated state visible from outside of the capsule, thereby making it easy for the person taking the capsule to recognize that the capsule contains multiple types of active ingredients and thus recognize that the capsule is highly effective for treatment. By the same logic, in the case where both of the two active ingredients are fat-soluble, it would equally be obvious to one skilled in the art to have one fat-soluble active ingredient in a hydrophobic phase and have another fat-soluble active ingredient in a separate hydrophobic phase by utilizing the difference in properties of these two hydrophobic phases (such as difference in density or degree of hydrophobicity) and make this separated state visible from outside of the capsule, thereby making it easy for the person taking the capsule to recognize that the capsule contains multiple types of active ingredients and thus recognize that the capsule is highly effective for treatment. Thus, Mori renders obvious instant clams 20 and 21.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Mori et al (JP2000-239159A and its English translation) in view of Taggart (“Building healthcare brands through recognizable capsules”, an internet article dated June 30, 2018 and found at the website: https://blog.capscanada.com/building-healthcare-brands-through-recognizable-capsules ).
Mori already teaches that its inventive composition can be separated into a plurality (two or more) of separate component phases. Furthermore, Taggart states (see the 1st paragraph) that differentiation and establishment of brand recognition are as important for drug products (as they are for consumer goods). Taggart states that when it comes to oral solid dosage forms, two-piece hard capsules provide drug makers with many opportunities to create a unique and recognizable product that encourages brand loyalty and repeat purchases. It would be obvious to one skilled in the art to one skilled in the art to make either the first or second phase of Mori’s inventive capsule formulation into multiple continuous phases that are separated from each other through the other phase in order to give the capsule a distinctive and unique look and encourage brand loyalty and repeat purchases. Besides, see MPEP 2144.04 (VI)(C) which cites In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). Thus, Mori in view of Taggart renders obvious instant claim 5.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
May 31, 2026
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