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 .
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 2-13 and 15-20 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.
Claims 2-13 and 16-20 recites the limitation "the hard capsule" (in some of these claims, the hard capsule is mentioned twice). There is insufficient antecedent basis for this limitation in the claim. Applicant need to change the limitation to --- the hard capsule shell ---. Also, in claim 10, lines 2, applicant need to change “hard capsule components,” to --- hard capsule shell components, ---; in claim 15, line 1, applicant need to change “hard capsule” to --- hard capsule shell ---; in claim 19, on the last line, applicant need to change “hard capsule components,” to --- hard capsule shell components, ---.
Claims 16-20 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.
Claim 16 recites the limitation "the gelling aid" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 5, 7 and 9 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.
Applicant need to make it clear whether it is the hard capsule shell or the film that comprises a gelling agent. Also, applicant need to change “comprises” to --- further comprises ---.
Claim 6 is 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 claim 6, it is unclear whether the H atoms of -OH groups of cellulose are being replaced with alkyl group (only) or alkyl methylcellulose (the whole compound); or hydroxyalkyl group (only) or hydroxyalkyl methylcellulose (the whole compound).
Claims 8 and 10 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.
Applicant need to make it clear whether it is the hard capsule shell or the film that further comprises a gelling aid.
Claims 18-20 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.
Applicant need to make it clear whether it is the hard capsule shell or the film that further comprises a gelling agent and a gelling aid. Applicant also need to change “comprises” on line 2 of claim 18 to --- further comprises ---.
Claims 19-20 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.
Claim 19 recites the limitation "the aqueous solution" on the last line. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 is 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.
The way claim 14 is currently written is confusing and indefinite. Applicant need to change last two lines of claim 14 to state --- wherein the suspension is for the preparation of a hard capsule shell comprising a film comprising (1) a water-soluble film forming compound . . . , (2) ZnO and (3) CaCO3, wherein the ZnO and CaCO3 are in a suitable amount to provide a white color to the film. --- (see claim 1).
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 5-8, 14 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al (CN 113209041 A and its English translation).
Liu teaches ([0001]-[n0001]) a formulation of hydroxypropyl methylcellulose empty capsule (i.e., a hard capsule shell formulation) that contains zinc oxide, magnesium oxide, calcium salts and barium salts as light-blocking agents (opacifiers). Liu teaches (see [n0002]) that although currently titanium dioxide is used as the light-blocking agent in capsules, due to safety concerts, there is a demand not to use titanium dioxide as the light-blocking agent. Liu teaches ([n0005]) that its hydroxypropyl methylcellulose (HPMC) empty capsule formulation contains: 5.0-35.0 wt.% of HPMC (instant water-soluble film forming compound, instant water-soluble cellulose compound as well as instant water-soluble cellulose ether (of claim 6) in which one or more H atoms of -OH groups of cellulose are replaced with hydroxyalkyl methylcellulose); 0.1-5.0 wt.% of gellan gum (instant gelling agent of claim 7); 0.1-1.0 wt.% of Tween 80; 0.1-1.0 wt.% of sodium caseinate; 0.5-1.0 wt.% of low-substituted hydroxypropyl cellulose; 0-1.0 wt.% of pigment; 0.05-9.0 wt.% opacifier; and water (as the remainder). Specifically, in its Example 2 (see [n0022]), Liu teaches a HPMC empty capsule formulation (i.e., a HPMC hard capsule shell formulation) containing zinc oxide, calcium carbonate and magnesium oxide as its opacifiers. As to instant limitation of claim 1 “wherein ZnO and CaCO3 are in a suitable amount to provide a white color to the film”, as evidenced by present specification (pg.1, lines 22-24), zinc oxide (ZnO) and calcium carbonate (CaCO3) are white colorants that provide white color to the hard capsule film in order to provide a light-shielding capacity for the hard capsule shell. Liu also teaches ([n0002]) that its light-blocking agent (opacifier) is used to achieve light-protecting effects to ensure the stability of photosensitive drugs. Thus, Liu impliedly teaches that its opacifiers (including zinc oxide and calcium carbonate) must be used in a sufficient amount to provide a white color to its HPMC empty capsule (so as to achieve light-protecting effects and ensure the stability of photosensitive drugs).
Thus, Liu teaches instant claims 1 and 5-7.
With respect to instant claim 8, Liu teaches ([n0005]) that its HPMC empty capsule composition contains 0.1-1.0 wt.% of sodium caseinate (instant gelling aid capable of generating sodium ions in an aqueous solution). Thus, Liu teaches instant claim 8.
With respect to instant claim 15, Liu teaches that the light-blocking agents that are added to its HPMC empty capsule composition are for ensuring the stability of photosensitive drugs (see [n0002] and [n0017]). Thus, Liu impliedly teaches instant capsule product comprising a TiO2 free hard capsule as defined in claim1 filled with a formulation comprising an active ingredient. Thus, Liu teaches instant claim 15.
With respect to instant claim 14, Liu teaches ([n0013]-[n0015]) that the opacifying solution comprising zinc oxide, calcium carbonate, magnesium oxide and water is added to a melted HPMC adhesive solution comprising HPMC and deionized water to form the empty capsule. Thus, Liu teaches instant claim 14.
Claim Rejections - 35 USC § 103
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.
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 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 3, 4, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (CN 113209041 A and its English translation).
With respect to instant claim 3, Liu’s Example 2 contains 1000 pbw of melted HPMC adhesive solution, 150 pbw of opacifier solution (containing zinc oxide, calcium carbonate, magnesium oxide and water), 11 pbw in total of pigments (brilliant blue, carmine and lemon yellow), which means that the total weight of the composition is 1161 pbw. (i) Since Liu teaches ([n0005[) that its HPMC empty capsule formulation contains 5.0-35.0 wt.% of HPMC, this means that there is 58.05-406.35 pbw of HPMC (5.0 wt.% of 1161 pbw is 58.05 pbw and 35.0 wt.% of 1161 pbw is 406.35 pbw) as calculated by the Examiner. (ii) Since Liu’s opacifier solution contains 160 parts of zinc oxide, 40 parts of calcium carbonate, 20 parts of magnesium oxide and 1000 parts of water (see the 1st two lines in [n0022]), this means that in Liu’s opacifier solution, there is 13.11 wt.% of zinc oxide, 3.2 wt.% of calcium carbonate, 1.64 wt.% of magnesium oxide (as an example, 160 parts of zinc oxide divided by 1220 parts (the sum of zinc oxide, calcium carbonate, magnesium oxide and water) gives 13.11 wt.% of zinc oxide) as calculated by the Examiner. This means that Liu’s Example 2 composition contains 19.67 pbw of zinc oxide (13.11 wt.% of 150 pbw of the opacifier solution (containing zinc oxide, calcium carbonate, magnesium oxide and water) is 19.67 pbw) and 4.92 pbw of calcium carbonate as calculated by the Examiner. Thus, the zinc oxide and calcium carbonate together are present in the amount of 24.59 pbw, which converts to 5.7- 29.8 wt.% of zinc oxide and calcium carbonate together based on 100 wt.% of HPMC, zinc oxide and calcium carbonate (24.59 divided by (24.59 + 58.05) gives 29.8 wt.%, and 24.59 divided by (24.59 + 406.35) gives 5.7 wt.%). The range 5.7-29.8 wt.% for the zinc oxide and calcium carbonate together overlaps with instant range 1-22 wt.%, thus rendering instant range prima facie obvious. IN the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Thus, Liu renders obvious instant claim 3.
With respect to instant claim 4, as discussed above, Liu’s Example 2 composition contains 24.59 pbw of zinc oxide and calcium carbonate together. Since there is 19.67 pbw of zinc oxide, this gives 80 wt.% of zinc oxide based on the total amount of zinc oxide and calcium carbonate. Although 80 wt.% of zinc oxide does not meet instant range of 33-64 wt.% or 50-76 wt.%, the opacifying solution in Liu’s Example 2 contains magnesium oxide (in addition to zinc oxide and calcium carbonate). Furthermore, since Liu teaches the equivalence of magnesium oxide and calcium carbonate ([n0006]-[n0007]), it would be obvious to one skilled in the art to replace magnesium oxide with more of calcium carbonate in Liu’s opacifying solution of its Example 2 with a reasonable expectation of success. Since there is 2.46 pbw of magnesium oxide in the opacifying solution of Liu’s Example 2, this would give 27.05 pbw for the sum of zinc oxide and calcium carbonate. This would give 72.7 wt.% of zinc oxide (which falls within instant range of 50-76 wt.%) based on the total amount of zinc oxide and calcium carbonate. Thus, Liu renders obvious instant claim 4.
With respect to instant claim 9, Liu’s Example 2 composition contains a total weight of 1,161 pbw (as calculated by the Examiner). Liu further teaches that the gellan gum (instant gelling agent of claim 7) can be used in the amount of 0.1-5 wt.% (see [n0005]). This means that the gellan gum (instant gelling agent) would be present in the amount of 1.16-58.05 pbw. This gives 0.27-41.3 wt.% of the gellan gum based on 100 wt.% of HPMC, gelling agent, zinc oxide and calcium carbonate (as calculated by the Examiner). The range 0.27-41.3 wt.% for the amount of gellan gum overlaps with instant range 0.05-2 wt.% for the amount of the gelling agent, thus rendering instant range prima facie obvious. In Wertheim, supra. Thus, Liu renders obvious instant claim 9.
With respect to instant claim 10, as already discussed above (in relation to instant claim 8), Liu teaches ([n0005]) that its HPMC empty capsule composition contains 0.1-1.0 wt.% of sodium caseinate (instant gelling aid capable of generating sodium ions in an aqueous solution). As calculated by the Examiner, Liu’s Example 2 composition contains the following ingredients in the following amounts: HPMC (58.05 – 406.35 pbw); gellan gum (1.16-58.05 pbw); tween 80 (1.16-11.61 pbw); sodium caseinate (instant gelling aid) (1.16-11.61 pbw); low substituted hydroxypropyl cellulose (5.8-11.61 pbw); pigments (brilliant blue, carmine and lemon yellow) (11 pbw); zinc oxide (19.67 pbw); calcium carbonate (4.92 pbw); and magnesium oxide (2.46 pbw). Thus, the amount of the sodium caseinate (instant gelling aid) would be 0.22-10 wt.% based on the total HPMC empty capsule composition of Liu’s Example 2 (excluding water (aqueous solution)). The range 0.22-10 wt.% overlaps with instant range 0.2-1 wt.%, thus rendering instant range prima facie obvious. In re Wertheim, supra. Thus, Liu renders obvious instant claim 10.
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (CN 113209041 A and its English translation) in view of Lee et al (WO 2017/160106 A2).
Liu does not teach the use of starch in its HPMC empty capsule composition. However, it is well known in the art, as evidenced by Lee et al ([0048], [0049] and [0051]), low-substituted hydroxypropyl cellulose (which is used in Liu’s Example 2 as a disintegrant – see [n0034]) and starch are equivalently or interchangeably used as disintegrants in capsule or tablet formulation. Thus, it would be obvious to one skilled in the art to use starch instead of the low-substituted hydroxypropyl cellulose in Liu’s Example 2 with a reasonable expectation of success. Thus, Liu in view of Lee renders obvious instant claim 12.
With respect to instant claim 13, since Liu teaches (see [n0005]) using low-substituted hydroxypropyl cellulose in the amount of 0.5-1.0 wt.%, it would be obvious to one skilled in the art to use starch in the same amount with a reasonable expectation of success. Since the total weight of Liu’s Example 2 composition is 1,161 pbw (as discussed above), this means that there is to be 5.80-11.61 pbw of starch in Liu’s Example 2 composition. Since there is total of 24.59 pbw for the zinc oxide and calcium carbonate together, this means that the amount of the starch based on 100 wt.% of the total amount of zinc oxide, calcium carbonate and the starch would be 19.1-32.1 wt.% (as calculated by the Examiner). Such range falls within instant range 1-34 wt.%. Thus, Liu renders obvious instant claim 13.
Claims 2, 11 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (CN 113209041 A and its English translation) in view of Palangetic et al (US 2021/0052505 A1).
With respect to instant claim 2, although Liu does not explicitly teach that its calcium carbonate is precipitated calcium carbonate, as evidenced by Palangetic et al (Table 1 in [0129] and [0130]), it is known in the art that when calcium carbonate is used as an opacifier (instead of TiO2) in HPMC and gellatin-based capsule formulation, encapsulated calcium carbonate and ground calcium carbonate give a hard capsule with less mechanical strength than precipitated calcium carbonate. Thus, it would be obvious to one skilled in the art to use precipitated calcium carbonate in Liu’s HPMC empty capsule composition with a reasonable expectation of improving the mechanical strength of the empty capsule. Thus, Liu in view of Palangetic renders obvious instant claims 2 and 16-19 (the subject matter of instant claims 16-19 were already discussed above in relation to the rejections of instant claims 3-5 and 8-10).
With respect to instant claim 11, Liu does not teach the use of gelatin. However, as evidenced by Palangetic et al ([0033], claim 1, claim 4), it is known in the art that gelatin and HPMC are equivalently or interchangeably used as film-forming agents in hard shell capsules. Thus, it would be obvious to one skilled in the art to use gelatin instead of HPMC (as the empty capsule forming agent) in Liu with a reasonable expectation of success. Thus, Liu in view of Palangetic renders obvious instant claim 11.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (CN 113209041 A and its English translation) in view of Palangetic et al (US 2021/0052505 A1) as applied to claim 19 above, and further in view of Lee et al (WO 2017/160106 A2).
Liu in view of Palangetic does not teach the use of starch in its HPMC empty capsule composition. However, it is well known in the art, as evidenced by Lee et al ([0048], [0049] and [0051]), low-substituted hydroxypropyl cellulose (which is used in Liu’s Example 2 as a disintegrant – see [n0034]) and starch are equivalently or interchangeably used as disintegrants in capsule or tablet formulation. Thus, it would be obvious to one skilled in the art to use starch instead of the low-substituted hydroxypropyl cellulose in Liu’s Example 2 with a reasonable expectation of success. As to instant amount for the starch, the Examiner already established above (in relation to the rejection of instant claim 13) that the amount of the starch based on 100 wt.% of the total amount of zinc oxide, calcium carbonate and the starch would be 19.1-32.1 wt.% (as calculated by the Examiner). Such range falls within instant range 1-34 wt.%. Thus, Liu in view of Palangetic, and further in view of Lee renders obvious instant claim 20.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov . Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice .
/SIN J LEE/
Primary Examiner, Art Unit 1613
August 22, 2026
Prosecution Insights