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 .
Acknowledgement of Receipt
Applicant's response filed on 04/23/2025 to the Office Action mailed on 01/23/2025 is acknowledged.
Claim Status
Claims 1-12 and 14 are pending.
Claims 1, 6, 9, 11, and 14 are currently amended.
Claim 13 was previously canceled.
Claims 1-12 and 14 have been examined.
Claims 1-12 and 14 are rejected.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/22/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Modified 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.
Claim 10 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.
Claim 10 recites the limitation “as measured by the test for immediate- release preparations (plain tablets) described in 6.09 Disintegration Test of the General Tests, Processes and Apparatus section of the Japanese Pharmacopoeia.” The claim is indefinite since it is unclear how to arrive at the claimed disintegration time based on the test disclosed. Testing parameters may be modified at will as scientific findings and technology advances. There is nothing in the claim to limit the testing parameters to the version of the of the 6.09 Disintegration Test that was in effect when Applicant filed their application. Thus, the claims are indefinite since the scope of the claimed disintegration test is unclear.
Response to Applicant’s Arguments
The objection to claims 6 and 11 are withdrawn in view of amendments to the claims.
The rejection of claims 9 and 11-12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph has been withdrawn in view of amendments to the claims.
With regard to the rejection of Claim 10 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph:
Applicant argues that the specific recitation of "the test for immediate-release preparations (plain tablets) described in 6.09 Disintegration test of the General Tests, Process and Apparatus section of the Japanese Pharmacopoeia" the tablet has "a disintegration time of 70 seconds or less . . . ." renders the claim definite because the tablet of the invention must have the recited disintegration time according to that specific method. Applicant’s argument has been fully considered but found not to be persuasive. A claim is indefinite when the metes and bounds of the claimed invention cannot be determined. In the instant case, it is unclear if infringement would occur in compositions developed before the specified test method because they could not have been tested according to the parameters of the test since it was not available. Accordingly, the metes and bounds of claim 10 are indefinite.
For the foregoing reasons the rejection is maintained.
New 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 (i.e., changing from AIA to pre-AIA ) 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, 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.
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.
Claims 1-4, 6-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Inoue (US 2016/0158227A1, June 9, 2016) (hereinafter Inoue) (cited by examiner on Form 892 01/23/2025) in view of Fukushima et al., (US20110105615A1, May 05, 2011) (hereinafter Fukushima).
Inoue discloses a tablet comprising an uncoated tablet containing 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one (i.e. brexpiprazole) or a salt thereof, excipients, disintegrants such as low-substituted hydroxypropylcellulose, binders, and lubricants; and further comprising a coating layer containing talc (Abstract). Suitable excipients include D-mannitol and microcrystalline cellulose ([0055]). The excipients may be used singly or in a combination of two or more. Examples of binders include partially pregelatinized starch ([0060]). Examples of lubricants include magnesium stearate, talc, and sodium stearyl fumarate, which may be used singly or in a combination of two or more ([0069]). The tablet of the present invention may be used as an orally disintegrating tablet ([0049]). The amount of microcrystalline cellulose may be 5 to 20% by weight ([0113]). Compound (I) (i.e. 7-[4-(4-Benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one) treats central nervous system diseases (in particular, schizophrenia) ([0003]). The tablet can be produced by a step of forming into a tablet a mixture containing Compound (I) or a salt thereof, an excipient, a binder, a disintegrant, and a lubricant ([0188]). Examples of the tablet forming methods include tableting, such as direct compression tableting and external lubrication tableting ([0190]). The coated tablet can be produced by mixing a coating agent, a colorant, and a liquid medium; spraying the obtained liquid mixture on the surface of the uncoated tablet; and successively drying it ([0191]). Suitable coating agents include talc ([0076]). The tablet may have a hardness of 4.7 Kp (equivalent to 46.09 N) and a disintegration time of 69 seconds (Table 2). The measurement of disintegration was performed using water as a test liquid according to the disintegration test of the Japanese Pharmacopeia ([0201]). The hydroxypropoxyl groups content of the hydroxypropylcellulose is 10.0 to 12.9% ([0197]).
The prior art differs from the instant claims insofar as not disclosing wherein the partially pregelatinized starch is a partially pregelatinized starch having a degree of pregelatinization of 70% or less and a water-soluble component content of 10% or less.
However, Fukushima discloses a tablet which is rapidly disintegrated in an oral cavity containing an active ingredient, mannitol and corn-derived pregelatinized starch mixed with at least one disintegrant such as carmellose and/or crospovidone (abstract). The “corn-derived pregelatinized starch” is a starch wherein a part or all of cornstarch is pregelatinized and the degree of pregelatinization of the partly pregelatinized starch is less than 30% ([0114]). Specific examples of the partly pregelatinized starch include commercially available PCS-PC-10 ([0016]). The partly pregelatinized starch used in the rapidly disintegrating tablet was trade name: PCS-PC-10, Asahi Kasei Corporation ([0088]). The tablet is rapidly disintegrated in an oral cavity containing an active ingredient at a high concentration, and having both good disintegrability in the oral cavity and tablet strength ([0089]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Inoue discloses wherein the tablet comprises partially pregelatinized starch. It would have been obvious to one of ordinary skill in the art to have incorporated partially pregelatinized starch having a degree of pregelatinization of 70% or less into the tablet of Inoue since this is a known and effective partially pregelatinized starch for oral disintegrating tablets as taught by Fukushima.
Regarding claim 3 reciting an internal lubricant and an external lubricant, as discussed above, Inoue discloses wherein the uncoated tablet contains a lubricant and wherein the coating layer comprises talc (see Abstract). Inoue discloses wherein talc is a lubricant (see [0069]). Therefore, the tablet of Inoue comprises an internal lubricant (i.e., lubricant in the uncoated tablet) and an external lubricant (i.e., talc in the coating layer).
Regarding claim 4 reciting wherein the external lubricant comprises magnesium stearate, as discussed above, Inoue discloses wherein tablet forming methods include external lubrication tableting and discloses wherein magnesium stearate is a suitable lubricant. Accordingly, it would have been obvious to one of ordinary skill in the art that the external lubricant may comprise magnesium stearate if magnesium stearate is used as the lubricant in the external lubrication tableting process.
Regarding claim 6 reciting wherein the partially pregelatinized starch (C) is a partially pregelatinized starch having a water-soluble component content of 10% or less, the instant specification discloses that PCS PC-10; Asahi Kasei Corporation was the partially pregelatinized starch used in Example 3-1 and has a water-soluble component content of 3% or less ([0060-0061]). As discussed above, the partly pregelatinized starch used in the rapidly disintegrating tablet of Fukushima was trade name: PCS-PC-10, Asahi Kasei Corporation. Accordingly, the partially pregelatinized starch of Fukushima has a water-soluble component content of 10% or less.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Inoue (US 2016/0158227A1, June 9, 2016) (cited by examiner on Form 892 01/23/2025) (hereinafter Inoue) in view of Fukushima et al., (US20110105615A1, May 05, 2011) (hereinafter Fukushima) further in view of Yoshinari et al. (US 2001/0001106A1, May 10, 2001) (cited by examiner on Form 892 01/23/2025) (hereinafter Yoshinari).
The teachings of Inoue and Fukushima are discussed above. Inoue and Fukushima do not teach wherein the D-mannitol has a 50% particle diameter ranging from 10 µm to 100 µm, and the D-mannitol is present in non-needle-like crystalline form in the tablet.
Yoshinari teaches a D-mannitol that shows improved compressibility and is useful as an excipient (abstract). When used as an excipient, D-mannitol is preferably in the state of granules of crystalline aggregate, especially whose average size is about 0.05 to about 5.0 mm in diameter (equal to 50 µm to 5000 µm. The forms of the crystalline aggregate are not specifically limited and any form of crystalline aggregate may be used such as net-like or thin plate-like ones ([0023]). The D-mannitol exhibits excellent compressibility, which can be used as an excipient for direct compression. The mannitol can be used as a good excipient in the fields of pharmaceutical and food products ([0030]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Inoue discloses wherein the tablet comprises D-mannitol. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated the D-mannitol of Yoshinari into the composition of Inoue since it is a known and effective D-mannitol that provides additional benefits such as exhibiting excellent compressibility as taught by Yoshinari.
Response to Applicant’s Arguments
The rejection of claims 1-4, 7-12, and 14 under 35 U.S.C. 103 as being unpatentable over Inoue (US 2016/0158227A1, June 9, 2016) (hereinafter Inoue) has been withdrawn in view of amendments to the claims.
The rejection of claim 5 under 35 U.S.C. 103 as being unpatentable over Inoue (US 2016/0158227A1, June 9, 2016) (hereinafter Inoue)in view of Yoshinari et al. (US 2001/0001106A1, May 10, 2001) (hereinafter Yoshinari) has been withdrawn in view of amendments to the claims.
The rejection of claim 6 under 35 U.S.C. 103 as being unpatentable over Inoue (US 2016/0158227A1, June 9, 2016) (hereinafter Inoue) in view of Matsuoka et al. (US 2014/0300025A1, Oct. 9, 2014) (hereinafter Matsuoka) has been withdrawn in view of amendments to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Samantha J Knight whose telephone number is (571)270-3760. The examiner can normally be reached Monday - Friday 8:30 am to 5:00 pm ET.
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/S.J.K./ Examiner, Art Unit 1614
/ALI SOROUSH/ Supervisory Patent Examiner, Art Unit 1614