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 .
Claim Status:
Claims 18-19 are cancelled.
Claims 1-17 and 20-26 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/5/26 was filed after the mailing date of the non-FINAL Action on 8/5/25. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn rejections
Applicant's amendments and arguments filed 2/5/26 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
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 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.
Claims 1-7, 10-17 and 20-26 are rejected under 35 U.S.C. 103 as being unpatentable over Melocchi et al. (Journal of Pharmaceutical Sciences 109 (2020) 1990-1999) and Melocchi et al. (AAPS PharmSciTech (November 2018); Vol. 19, No. 8: 3343-3354; hereinafter Melocchi2018).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims, for example:
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Examiner comment: the limitation of “the unique circumferential surface of the capsule” has antecedent basis in “a unique interior circumferential surface of the capsule” because the sidewall of the divider can only engage with the interior surface of the capsule; not the exterior surface.
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a pharmaceutical capsule research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from pharmaceutical capsule design and manufacturing— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claim 1, Melocchi et al. teach capsular devices comprising 1 to 3 independent inner compartments were attained by Lego-inspired assembly of matching modular units with different wall compositions with one-, two- and three-pulse release profiles of the dietary ingredient were obtained from differently assembled devices following the breakup of the compartments occurring promptly (immediate-release), on
pH change (delayed-release) or after tunable lag times (pulsatile-release). (Abstract). Melocchi et al. teach: “Modular units were devised in the form of hollow parts (i.e.,
type A, A1, A2, B, B1, and B2) and joints (i.e., type 1 and 2), schematically
represented with dimensional details in Figure 1. Hollow parts had a closed round end and an open end. The open end was characterized by halved wall thickness to enable overlapping with matching modular units. By progressively increasing the length and diameter of type A and B hollow parts while maintaining the same nominal thickness, type A1 and B1, as well as type A2 and B2 hollow parts, were designed. These were intended to enclose capsular devices already filled and assembled. Type 1 joints were composed of 2 hollow cylinders with the same diameter, height, and thickness, grounded in a common 600 mm thick base. Type 2 joints also had the form of 2 hollow cylinders resting on opposite sides of the 600 mm thick base that closed both.
However, the 2 cylinders forming type 2 joints had different height and diameter. The open ends of type 1 and type 2 joints had halved thickness, enabling overlapping with matching parts.” (Page 1991, right column methods). Melocchi et al. show in Figure 1 dimensions of the components (See also Tables 3-4):
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Melocchi et al. show 1, 2 and 3 compartment capsules in Figure 2:
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460
976
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Consequently, Melocchi et al. teach and suggest a capsule comprising a first hollow body and a second hollow body configured to couple to the first hollow body, thereby collectively forming an interior volume of the capsule, wherein each hollow body comprises a closed end portion; a first divider, wherein the first divider comprises:
a base, a sidewall protruding from a first circumferential edge portion of the base, the
sidewall comprising an inner surface, an outer surface, and a second circumferential edge portion, the second circumferential edge portion configured to continuously engage a unique interior circumferential surface of the capsule, thereby securing the first divider within the interior volume of the capsule and forming at least two unique interior volumes of the interior volume based on a position of the first divider and the unique circumferential surface of the capsule.
Regarding claim 3, the capsules of Melocchi et al. implicitly have a line of symmetry about a longitudinal axis of the capsule as shown in the figures.
Regarding claims 4 and 20, Melocchi et al. teach: “The external dimensions (8 mm in diameter and length in the 12.5 to 21.8 mm range) were selected to be consistent with convenient oral administration, in agreement with the capsule sizes commonly used for dietary supplements (i.e., size _ commercially-available 00el hard-gelatin capsules). Like in Lego building systems, the compartments were obtained by assembling matching modular units having different geometry and polymeric composition. This way, multiple compartments having different volume and composition could be combined in a single system, which would overall increase the versatility of the delivery platform in terms of (1) type and amount of dietary ingredients that could be contained in each capsule and (2) release profiles that could be achieved.” (Page 1995, right column Discussion). Those capsule dimensions implicitly provide an interior volume is within the claimed range of about 0.1 mL to about 1.5 mL with a hypothetical example having a base radius of 4 mm and a length of 15 mm provides 1022 mm3 or 1.022 mL volume:
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Regarding claim 5, the second circumferential edge portion implicitly deforms radially.
Regarding claim 6, as shown in the Figures, the inner and/or outer surface of the sidewall of the capsule of Melocchi et al. is generally concave or generally convex.
Regarding claims 7 and 10, as shown in the Figures of Melocchi et al., the base has an upper and lower surface which are generally concave or generally convex and are parallel or substantially parallel.
Regarding claim 12, once the capsule of Melocchi et al. is assembled, the outer diameter of the second circumferential edge portion exclusively engages the unique circumferential surface of the capsule.
Regarding claims 13-14, the 3-compartment capsular device of Melocchi et al. appears to present a third circumferential edge portion (Figure 2) where the second circumferential edge portion comprises a first diameter and the third circumferential edge portion comprises a second diameter different from the first diameter (See joints 1 and 2 in Figure 1 and the 3-compartement capsular device in Figure 2).
Regarding claim 21, as shown in the Figures of Melocchi et al., the first hollow body, the second hollow body, the first divider, or a combination thereof is transparent, translucent, or opaque.
Regarding claim 22, as shown in the Figures of Melocchi et al., the divider is a monolithic body.
Regarding claims 24-25, as shown in the 3-compartment capsule components in Figure 2, the first divider is defined by a first orientation, and wherein the capsule further comprises a second divider defined by a second orientation wherein the first orientation is different from the second orientation.
Regarding claim 26, Melocchi et al. teach construction with: “Main polymeric components: hydroxypropyl cellulose (HPC, Klucel® LF, Ashland, Chatham, NJ); hydroxypropyl methylcellulose (HPMC; Affinisol™ 15cP, Dow, Pittsburg, CA); hydroxypropyl methylcellulose acetate succinate (HPMCAS; AQUOT-LG, Shin-Etsu, Tokio, J); polyvinyl alcohol of different molecular weight (PVA03 and PVA05; Gohsenol™EG 03PWand 05P, Nippon Gohsei, Tokio, J); polyvinyl alcohol-polyethylene glycol graft copolymer (KIR; Kollicoat ® IR, BASF, Ludwigshafen, D). Plasticizers: glycerol (GLY; Pharmagel, Milan, I); polyethylene glycol (PEG; PEG 400, 1500 and 8000, Clariant Masterbatches, Milan, I). Dietary ingredient tracer: caffeine (CFF; A.C.E.F., Milan, I).” (Page 1991, Materials). Melocchi et al. teach: “Based on the composition of the modular units, the delivery platform could combine multiple release kinetics for the doses of caffeine loaded into each compartment, such as immediate (KIR and PVA03-based compartments), pulsatile (HPC-, HPMC-, and PVA05-based compartments) and delayed (HPMCAS-based compartments) release.” (Page 1991, left column bottom; See also Table 1). The polymers disclosed read on wherein the first divider, the first hollow body, the second hollow body, or a combination thereof comprises a water soluble polymer, an erodible polymer, a degradable polymer, a swellable polymer, or a combination thereof.
Regarding claims 1-2 and 15-16, Melocchi2018 teach two-compartment capsular devices where the middle divider section has a frustum shape as shown in Figure 7:’
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;
and in Table 4:
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1084
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Thus, the first hollow body or the second hollow body comprises a third diameter greater than or equal to the second diameter and the third diameter is less than or equal to the first diameter; thinner vs thicker wall thickness creates different diameters.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Melochhi et al. is that Melocchi et al. do not expressly teach a capsule comprising a pharmaceutical composition wherein the plurality of pharmaceutical compositions comprises one or more liquid formulations, one or more solid formulations, one or more powdered formulations, one or more granule formulations, one or more gel formulations, or a combination thereof. However, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to fill the capsule of Melocchi et al. with plurality of pharmaceutical compositions comprises one or more liquid formulations, one or more solid formulations, one or more powdered formulations, one or more granule formulations, one or more gel formulations, or a combination thereof and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because the ordinary artisan in this art readily understands that capsule are pharmaceutical drug delivery platforms designed to hold solids, powders, liquids, granules or gels of pharmaceutical compositions. Especially when Melocchi et al. teach that the seminal work for this study was based on pulsatile release of drugs (Page 1991, left column 3rd paragraph). One of ordinary skill in the art would have a reasonable expectation of success in so doing.
The difference between the instant application and Melochhi et al. is that Melocchi et al. do not expressly teach a capsule where the first divider has a frustum shape or wherein the first hollow body or the second hollow body comprises a third diameter greater than or equal to the second diameter and wherein the third diameter is less than or equal to the first diameter or chamfer/rounded edges on circumferential edge portions. However, the same author Melocchi2018, teaches a capsule where the first divider has a frustum shape or wherein the first hollow body or the second hollow body comprises a third diameter greater than or equal to the second diameter and wherein the third diameter is less than or equal to the first diameter and thus it is merely a design choice by the ordinary artisan to do. Chamfering or rounding an edge wherein an outer diameter of the second circumferential edge portion exclusively engages the unique circumferential surface of the capsule is obvious to make the parts more easily slide over one another for assembly. The ordinary artisan would do so with a reasonable expectation of success.
The difference between the instant application and Melocchi et al. is that Melocchi et al. do not expressly teach a capsule wherein a draft angle of the sidewall is greater than zero or wherein the draft angle is in a range of from about 0.1 degrees (0) to about 5°. However, either these limitations are implicit in the capsular device of Melocchi et al. or routinely optimized by the ordinary artisan with a reasonable expectation of success.
Claims 8-9 are rejected under 35 U.S.C. 103(a) as being unpatentable over Melocchi et al. (Journal of Pharmaceutical Sciences 109 (2020) 1990-1999) and Melocchi et al. (AAPS PharmSciTech (November 2018); Vol. 19, No. 8: 3343-3354; hereinafter Melocchi2018), as applied to claims 1-7, 10-17 and 20-26 above, in further view of Momoi, K (US20070042035).
Applicant claims:
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The references of Melocchi et al. and Melocchi2018 are discussed in detail above and that discussion is incorporated by reference.
Momoi teaches that in the capsule art an anti-sticking agent coating is applied to keep the capsules from sticking (Abstract) and “capsule anti-sticking agent of the present invention can be used for coating Surfaces of various capsules which need prevention of surface sticking” [0044] for numerous capsule materials [0047].
The difference between the instant application and Melocchi et al. as modified by Melocchi et al. is that Melocchi et al. as modified by Melocchi et al. do not expressly teach a capsule further comprising a layer of a material disposed on a portion of the upper surface, the material configured to prevent the upper surface from adhering to a different surface or face other than the layer of the material wherein the material comprises a coefficient of friction in a range of from 0.1 to 0.8. However, Momoi guides the artisan to adding an anti-sticking agent coating to prevent surface sticking of the capsules. Thus, it is desirable to add the anti-sticking agent coating of Momoi to prevent the upper surface from adhering to a different surface or face other than the layer of the material with a reasonable expectation of success. It would be merely routine optimization and conventional laboratory skill to measure the coefficient of friction where a lower value would indicate less sticking for ease of manufacture by the ordinary artisan with a reasonable expectation of success.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments:
Applicant’s arguments filed on 2/5/26 have been carefully considered but are not persuasive.
Applicant discusses independent claim 1 and states: "[A] first draft angle of the outer surface of the side wall allows the first divider to easily be inserted into a respective hollow body due to a slope imparted by the first draft angle on this outer surface… In this way, the claimed invention not only has the first divider within the interior volume of the capsule to allow for consistent release rate but also having the draft angle of the side wall to allow for easy insertion, which allows for producing the capsule at scale." Applicant then asserts that: “Melocchi and Melocchi2, alone or in combination, are not cited for, and do not teach or suggest, the capsule having the interior volume formed by the first hollow body and the second hollow body configured to couple to the first hollow body, in which the sidewall of the first divider includes the second circumferential edge portion that is configured to continuously engage the unique interior circumferential surface of the capsule with the draft angle of the sidewall in the range of from about 0.1° to about 5°, as recited by the claimed invention.” On page 8 of remarks, Applicant asserts that Melochhi discloses that the “joint is used to couple two capsule compartments together. Melocchi states that, "For the assembly of two- and three-compartment capsular devices, joints to be matched with hollow parts were used." Melocchi at page 14. The joints are formed such that "Type 1 joints were composed of two hollow cylinders with the same diameter, height and thickness, [and] Type 2 joints also had the form of two hollow cylinders resting on opposite sides of the []thick base that closed both." Applicant asserts that the joints of Melocchi lack draft angle.
Respectfully, the Examiner has a different perspective. First, the remainder of the sentence cited by Applicant above is: “However, the 2 cylinders forming type 2 joints had different height and diameter. The open ends of type 1 and type 2 joints had halved thickness, enabling overlapping with matching parts.” (Page 1991, right column Design Concept of the Lego-Inspired Delivery Platform). In Figure 2, the 3 compartment device appears to utilize a divider where the side walls implicitly have a draft angle, as previously asserted by the Examiner, and shown below with a line along the sidewalls of the divider that is not horizontal but slanted indicating an angle:
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Also, the rejection is over a combination of references and the Examiner has cited Melocchi2018 for teaching dividers with the frustum shape, that inherently have a draft angle on the sidewalls as shown in Table 4 (Page 3350). Consequently, the art of record renders obvious a divider with a draft angle of the sidewall as claimed where the draft angle can be optimized to obtain the best fit. Where patentability rests upon a property of the claimed material not disclosed within the art, the USPTO has no reasonable method of determining whether there is, in fact, a patentable difference between the prior art materials and the claimed material. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Therefore, where the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the USPTO can require an applicant to prove that the prior art products do not necessarily possess the characteristics of his claimed product. Id. See MPEP 2112(V).
Respectfully, Applicant’s arguments are not persuasive.
On page 9 of remarks, Applicant argues that Melocchi2 discloses similar joints that couple two capsule compartments together that are composed of two truncated cones connected at a base. Hence, a frustum shape with draft angle side walls. Figure 8 of Melocchi2 is noted but not relevant to the rejection.
On page 10 of remarks, Applicant asserts that the references, either alone or in combination do not teach and suggest each and every limitation of claim 1. Respectfully, the Examiner does not agree because from the Examiner’s perspective both references, alone and in combination, render obvious a draft angle on the sidewall of the divider. It appears that all Applicant has done is measure the draft angle on the dividers of Melocchi and Melocchi2. That is not invention without more. “A prima facie case of obviousness is established when the teachings from the prior art itself would appear to have suggested the claimed subject matter to a person or ordinary skill in the art." In re Rinehart, 531 F.2d 1048, 1051, 189 USPQ 143, 147 (CCPA 1976). The test for obviousness is "what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 4I3, 425 (CCPA I98I) (MPEP 2145(III)). All that is required to show obviousness is that the applicant "make his claimed invention merely by applying knowledge clearly present in the prior art. Section 103 requires us to presume full knowledge by the inventor of the prior art in the field of his endeavor." In re Winslow, 365 F.2d 1017, 1020, 53 C.C.P.A. 1574, 1578 (1966); Application of Sheckler, 438 F.2d 999, 1001 (C.C.P.A. 1971). The Examiner has shown with evidence that the art teaches and suggests a capsule as claimed. Thus, does Applicant make their claimed invention merely by applying knowledge clearly present in the prior art.
On page 10 of remarks, Applicant argues the rejection of claims 8-9 separately. Applicant asserts that Momoi fails to remedy the deficiencies in Melocchi and Melocchi2, alone or in combination. For this reason, claims 8-9 are patentable over Melocchi, Melocchi2, and Momoi, either alone or in combination, for at least the same reasons as claim 1. Respectfully, the Examiner does not agree. Momoi is relied upon as characterized by the Examiner in the rejection.
All of Applicant’s arguments have been carefully considered but are not persuasive.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Y Kwon can be reached at 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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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613