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 .
DETAILED ACTION
Claims 1-17 and 20-21 are currently pending and amendment to the claims as filed 09/15/2025 is acknowledged.
Allowable Subject Matter
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Withdrawn rejections:
Applicant's amendments and arguments filed 09/15/2025 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 Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
Claim Objections
Claims 6 and 17 are objected to minor informalities under 37 CFR 1.75.
Claim 6 recites “in the _ CAPSSHELL”, but which should be corrected to “in the CAPSSHELL”.
Claim 17 recites “A CAPSSHELL”, but which would be better to “The CAPSSHELL”.
Appropriate correction is requested.
Maintained Rejection
Claim Rejections - 35 USC § 103
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.
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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-10, 12-17 and 20-21 remain rejected under 35 U.S.C. 103 as being unpatentable over Cape et al. (US2017/0281780A1) in view of Cade et al. (US2017/0087092A1, IDS of 10/20/2022).
Applicant claims the below claim 1 filed on 09/15/20252:
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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 medical/pharmaceutical research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— 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); 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)
Cape teaches a composition for the manufacture of capsule shell comprising an aqueous colloidal dispersion comprising hydroxypropyl methyl cellulose acetate succinate (HPMCAS), dispersant such as surfactant and plasticizer which reads on the claimed ADD (instant claim 9), and non-polymeric ionizable surface modifier ([0003], [0030], [0047]-[0054] and claim 1 of prior art) wherein the amount of HPMCAS is ranged from 5.0 to 45% ([0035]); the composition does not contain a gelling agent that undergoes cold gelation or thermogelling agent ([0073]); the non-polymeric ionizable surface modifier comprises calcium chloride (CaCl2) in an amount of less than 50 millimoles per liter ([0054], [0102] and Examples 1-3); the composition may comprise an optional film-forming polymers such as HPMC, MC, gelatin, starch, etc. ([0061] and [0067]) (instant claim 1, in part); the colloidal dispersion has properties conducive to manufacture of capsules using conventional dip-molding manufacturing processes, and the colloidal dispersions are capable of forming films upon continued heating, and are suitable for use in manufacture of capsules using conventional dip molding techniques ([0079]) wherein the process comprises providing a bath of the colloidal dispersion at a temperature below the gelling temperature, and molding pins pre-heated to a temperature above the gelling temperature are dipped into the colloidal dispersion, the molding pins are withdrawn, forming a film on the molding pins, the film formed on the molding pins surface can then be dried, stripped off the pins and cut to a desired length, thereby obtaining the capsule caps and bodies ([0108]) (instant claims 13-16); and the capsule shell is filled with active ingredient such as acetaminophen, ibuprofen and caffeine ([0024]-[0026]) which reads on the claimed ACTINGR (instant clam 17).
Although Cape teaches the amount of CaCl2, it does not expressly teach the ranges of 3,000-9,000, 3500-9000 or 4,000-9,000ppm of instant claims 1 and 6-7. However, the prior art amount (less than 100 millimole per liter = less than 11,098 ppm) which overlaps the said instant ranges. Further, one of ordinary artisan would have optimized the prior art range to obtain the claimed ppm amount without undue experimentation (instant claims 1 and 6-7: CaCl2 amount). MPEP 2144.05 states that [I]n the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
However, Cape does not expressly teach HPMC as shell material of instant claims 1-3; and the amount of HPMC of instant claim 8; and DPI Of instant claims 20-21. The deficiencies are cured by Cade.
Cade discloses HPMC hard capsules and process of manufacture (title) and for this, aqueous composition containing HPMC (instant claim 1 – HPMC capsule shell) wherein the HPMC has a methoxy content of 27.0-30.0 and hydroxypropoxy content of 4.0-7.5, MPEP 2144.05 above, and includes HPMC type 2096, 2910([0019] and [0109]) (instant claims 2-5); the HPMC is present in an amount of 70-99% (claims 11-12 of prior art) which overlaps the instant range of 70% or more (instant claim 8); the HPMC hard capsule can be used in the context of dry powder inhalers ([0084])(instant claims 20-21); to obtain colored capsule, pigment such as titanium dioxide can be used ([0028])(instant claim 12 – colorant); capsules manufactured by combination of HPMC with gelling agents have very poor visual quality and dissolution properties since they are sensitive to cations and to pH ([0011]), and the aqueous composition contain less than between 0% and 1%, preferably 0% based on the total weight of the aqueous composition of a gelling system, and by “gelling systems” it is meant one or more cations and/or one or more gelling agents, and typical cations are K+, Na+, Li+, NH4 +, Ca++, Mg++ and mixtures thereof and typical gelling agent(s) are hydrocoloids such as alginates, agar gum, guar gum, locust bean gum (carob), carrageenans, tara gum, gum arabic, ghatti gum, khaya grandifolia gum, tragacanth gum, karaya gum, pectin, arabian (araban), xanthan, gellan gum, konjac mannan, galactomannan, funoran, and mixtures thereof, and but as usually, gelling agents can optionally be used in combination with cations and other ingredients such as sequestering agents ([0025]), and therefore, it is taught or suggested by the prior art that the aqueous composition can be prepared without the presence of cation and gelling agent; and the composition is prepared as dried capsule shell by dip molding ([0051]-[0052]).
It would have been obvious to replace HPMCAS of Cape with HPMC of Cade in order to achieve the claimed invention. One of the ordinary artisan would have been motivated to do so because HPMCAS or HPMC would have equivalent function in providing proper hard capsule shell material and such replacement or selection would have yielded no more than the predictable result, and both references do not require gelling agent who leads to poor dissolution issue.
Although Cade does not expressly teach the subject matters of instant claims 10-11, Cade teaches HPMC, with small amount of cation e.g., calcium, and/or pigment (=colorant), without gelling agent, and therefore, one of the ordinary artisan would have designed or chosen such shell components of HPMC with cation and/or pigment, unless there are unexpected results of the capsule shell using HPMC/CaCl2 with or without pigment.
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(a).
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 have been fully considered, but are not persuasive.
Applicant argues that the secondary reference Cade discloses problems related to incorporating calcium ions and therefore actually points away from using calcium ion; the Examiner’s combination of the applied art is improper because the references are directed to solving fundamentally different technical problem while the claimed invention is directed to solving the specific problem of high powder retention in gelling-agent free HPMC capsule and small amount of CaCl2 (3000-9000ppm) to an HPMC shell in the absence of a gelling agent, resulting in significantly reduced powder retention; the primary reference of Cape is directed to an entirely different field and problem: creating capsule shells with bulk enteric properties, and the function of CaCl2 in Cape is not to reduce powder retention, but to act as a non-polymeric, ionizable surface modifier to facilitate the aggregation and film-formation of HPMCAS particles; Cape discloses HPMC is only an optional ingredient and the amount of HPMC is lower than that of HPMCAS polymer, and this is a direct instruction against using HPMC as the sole or primary polymer, as required by the instant invention, and thus there is no reasons to replace enteric-film forming polymer with a non-enteric film forming polymer; Examiner’s obvious optimization arguments as to the concentration of CaCl2 are based on hindsight because Cape does not teach or suggest CaCl2 has any effect whatsoever on powder retention, and the function of CaCl2 taught by Cape has nothing to do with when using HPMC; and the claimed specific range of CaCl2 provides unexpected technical effect of reduced powder retention in a gelling-agent-free HPMC shell constitutes.
The Examiner responds that although Cade avoids gelling system such as cation including calcium, Cade teaches such Ca++ can be present between 0 and 1%([0025]) and instant claims 1 and 11 require 3000-9000ppm (=0.3-0.9%) and 0.6- 0.65% of CaCl2, respectively, which is within the said small amount of Cade, and both Cape and Cade disclose avoiding gelling agent in the hard capsule shell; as to different solving problems, please see MPEP 2144(IV): “The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006)”; further, the claimed invention does not require “the capsule shell has reduced powder retention compared to the capsule shell without CaCl2”, and Cape also discloses using overlapping amount (0.05%-7%) of CaCl2 ([0057] of Cape) regardless of their different functions; instant claim 1 does not require the amount of HPMC, and also uses “comprising” language which does not exclude introduction of any other film forming polymer and that is, instant claim 1 using “comprising” does not require “HPMC” as a sole or primary polymer; both references disclose hypromellose as one of the capsule shell materials (see [0061] and [0067] of Cape and entire document of Cade); here, Cape discloses the combination of HPMCAS and CaCl2 without additional gelling agent for preparing a hard capsule shell, and Cade discloses HPMC and small amount of Ca++ (if present) without additional gelling agent for preparing a hard capsule shell, and even if hindsight is used, please note that “[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper.” In reMcLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971); and as to the alleged unexpected results, it is not clear if PR (powder retention) is significantly made from Fig. 3 because when the load 5-5.5, there is no big difference between CC-A** using the claimed range (7,576ppm) of CaCl2 and CC-B using the outside range (9,732ppm), and only CC-A* using the claimed range (6,353ppm) appears to be significantly low PR. Therefore, it may not be said that the criticality of CaCl2 range is proven.
In light of the foregoing, applicant’s arguments are not persuasive.
Conclusion
The instant case is not in condition for allowance.
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 KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613