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 1-20 are currently pending and an amendment to the claims filed on 11/16/2025 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/16/2025 was filed before the mailing date of the instant first action on the merits. The submission thereof is in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statement has been considered by the examiner, and signed and initialed copy is enclosed herewith.
Withdrawn rejections:
Applicant's amendments and arguments filed 12/16/2025 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 Any rejection and/or objection not specifically addressed below are herein withdrawn.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.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (CN101433526B, citation is obtained from the attached Google English translation) in view of by Scott et al. (US2005/0249676A1).
Applicant claims the below claim 1 filed on 12/16/2025:
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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 hard capsule shell research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from capsule shell 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)
Wu teaches non-gelatin enteric hard capsule shell material and production method thereof (title); the material comprises a non-gelatin hydrophilic agent, an enteric material, a pH regulator, water, and optional ingredient such as flocculation aid, and binder (abstract) wherein the hydrophilic agent includes high acetylation gellan gum and low acetylation gellan gum in an amount of 0.01 to 18% (page 5 – non-gelatin hydrophilic agent), and although Wu does not expressly teach each amount of high acyl gellan gum and low acyl gellan gum, Wu teaches the said gellan gum agent can be used in an amount of 0.01 to 18% and thus the each amounts (0.2 to 0.5% and 0.1 to 0.5% or 0.25 to 0.45 and 0.15 to 0.45% or 0.3 to 0.4 and 0.2 to 0.4%) of two acyl gellan agents are within the prior art range and thus it would be routinely optimized in the absence of evidence to the contrary; the enteric material includes acetylated pullulan in an amount of 20-97% (bridging paragraphs on pages 5-6) that overlaps the instant range of 95-98.7% or 95-98.4, or 95-98.3%, or at least 95%; the flocculation aid includes potassium chloride in an amount of 0-5% which overlaps the instant range of 1-2% or 1.2 to 1.8% or 1.2 to 1.6% (page 6 – (E) flocculation aid); and the binder pullulan in an amount of 0-80 parts (page 8 – (G)) (instant claims 1 and 6-7, in part, and instant claim 15); the composition does not contain gelatin (instant claim 2); the shell material comprises NaHCO3 (sodium bicarbonate) as a pH adjuster in an amount of 0.01 to 25% (page 6 – (C) pH regulator agent) that overlaps the instant range of 0.02 to 0.06% (instant claims 12-13); and the shell material is prepared by dipping cast (Embodiment 2) (instant claim 16). The prior art teaches overlapping amounts as noted above. In this regard, please see MPEP 2144.05: “In 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, Wu does not expressly teach specific selection of pullulan among various film forming enteric materials without the necessity of other film forming agents of instant clams 1-5, 14, 18 and 19; active agent of instant claim 17; and sucrose or sorbitan monolaurate of instant claims 8-11, 14 and 20. The deficiencies are cured by Scott.
Scott discloses a hard capsule comprising pullulan in an amount of 85% to 90% by weight, potassium chloride in an amount of 1.0% to 1.5% by weight, carrageenan in an amount of 0.1% to 0.4% by weight, one or more surfactants in an amount of 0.1% to 0.2% by weight, and water in an amount of 10% to 15% by weight (claim 1 of prior art); and the capsule further comprises gellan as setting agent ([0081]-[0084]) in an amount of 0.01 to 5% or 0.1 to 4% ([0085]-[0086]); the pullulan films provide an improved chemical stability, e.g., no cross-linking as provided in gelatin capsules, and pullulan provides desired dissolution profile which is not affected during a longer time of storage ([0028]); Scott teaches surfactant to improve the pullulan film surface gliding performance ([0098]-[0100]) such as sorbitan fatty acid ester or sorbitan ester such as sorbitan laurate and sugar esters in an amount of 0.01 to 3% ([0109], [0132] and Example 3) which overlaps the instant range of 0.01 to 0.05% or 0.05 to 0.25% (instant claims 8, 10, 11, 14 and 20); Scott does not teach HPMC, PVA, modified starch, HPMCAS, CAP, polyacrylic acid copolymers as other film-forming material (see entire document); and the pullulan compositions is for use in pharmaceutical, veterinary, food, cosmetic or other products ([0001]-[0002]), and capsule filled with acetaminophen which reads on the claimed active agent (instant claim 17).
It would have been obvious to specifically select pullulan among various enteric materials because the pullulan films provide an improved chemical stability, e.g., no cross-linking as provided in gelatin capsules, and pullulan provides desired dissolution profile which is not affected during a longer time of storage as taught by Scott. Further it would be a matter of choice or design to exclude other film forming polymers because Wu teaches pullulan as a main film forming polymer and overlapping higher amount of pullulan, and acyl gellans and thus, one of the ordinary artisan would design or choose pullulan without necessity of other film forming agent.
Further, it would have been obvious to modify the teachings of Wu with addition of surfactant in order to improve the pullulan surface properties as taught by Scott.
Further Wu in view of Scott teaches/suggests pullulan without requiring any other film forming polymers, and but does not disclose specific embodiments as claimed. However, one of ordinary skill would be motivated to do this because a reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. Where, as here, the specific combination of features claimed is disclosed within the broad teachings of the reference but the reference does not disclose the specific combination of elements in a specific embodiment or in a working example, “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, "when 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.
Here, the applied art of Wu and Scott teaches selection of pullulan, KCl, high/low gellans, surfactants of sorbitan monolaurate or sucrose ester along with overlapping amounts thereof. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange the disclosed elements and embodiments of the cited reference to prepare the instantly claimed composition. Such a rearrangement by a person of ordinary skill in the art who is not an automaton to yield the instantly claimed invention is within the purview of the ordinary skilled artisan upon reading the cited reference and would yield predictable results.
It would be obvious to fill the capsule of the Wu with active agent of Scott because the capsule contains active agent therein.
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 have been fully considered, but are not persuasive.
Applicant argues that since Wu requires acetyl pullulan as an enteric material and thus, its initial disintegration time is longer because capsule will deliver payload to the intestine and Scott requires pullulan and its initial disintegration occurs quickly in the stomach, on average within 9 minutes post-dose, and thus a person of ordinary skill in the art would not combine Wu and Scott because they concern capsules with opposing properties.
The Examiner responds that what the Examiner relied on Scott for disclosing “pullulan” itself as a suitable material for forming hard capsule shell; Wu teaches various enteric solubility materials in the hard capsule shell and acetylated pullulan is one of them, and also pullulan itself as a binding agent can be contained in a capsule shell material; and Scott teaches pullulan itself is a suitable material for forming hard capsule shells. Because the acetylated pullulan is derived from pullulan and both materials are used for the same purpose, i.e., forming hard capsule shells, and thus a person of ordinary skill in the art would have recognized pullulan as a known alternative capsule shell polymer to the acetylated pullulan of Wu. It would accordingly have been obvious to substitute the pullulan of Scott for the acetylated pullulan of Wu in order to produce a pullulan-based capsule shell using a known capsule shell material, particularly where Scott demonstrates pullulan forms stable hard capsules suitable for encapsulation and such substitution of one know material for another closely related material used for the same function would have been a predictable variation. Further Wu discloses pullulan derivatives may be used to form capsules with modified dissolution characteristics such as enteric performance, and therefore, an ordinary artisan would have recognized that acetylated pullulan is a derivative of pullulan and represents a modification of the known pullulan capsule shell material as taught by Scott to alter its dissolution properties. However, the difference in dissolution behavior (enteric vs. stomach disintegration) reflects a modification of the pullulan material rather than an incompatibility between the teachings of the references of Wu and Scott. Further US7,267,718 (IDS of 09/06/2023) discloses pullulan ester can be used as a film or coating agent (see background section: US3,871,892) and the pullulan ester includes pullulan acetate, and therefore, it is also well known that modified pullulan can be used as a hard capsule shell as well.
Therefore, Wu in view of Scott would be combinable.
Further, “enteric property” is not a structural of the claimed limitation, and the claimed invention does not require “short disintegration time”.
Please note that pullulan itself is well known hard capsule materials as disclosed in e.g., IDS documents of 12/16/2025 including US2008/0254111, US2018/0154327, WO2012/095746A1, regardless of quick disintegration time.
In light of the foregoing, applicant’s arguments are not persuasive.
Conclusion
All examined claims are rejected.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S 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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/KYUNG S CHANG/Primary Examiner, Art Unit 1613