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
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-7, in the reply filed on 8/5/25 is acknowledged. Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected apparatus, there being no allowable generic or linking claim.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in India (IN) on 6/27/2023. It is noted, however, that applicant has not filed a certified copy of the Indian application as required by 37 CFR 1.55.
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 1-7 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.
It is not clear if the claim 1 limitation “dispersed droplets of a feed solution” refers back to the previously recited feed solution or a different feed solution. The examiner will assume for the purposes of this action the limitation refers to the previously recited feed solution.
Claim 1 recites the limitation “desirable output product”. The term “desirable” is indefinite because it’s subjective. The difference between a “desirable” output product and a non-desirable output product is entirely unclear.
Claim 2 recites “automizer”. This term is unclear and should be replaced with “atomizer”.
In claim 4, “into dry particles” does not properly refer back to the previously recited dry particles.
In claim 5, the limitation “content uniformity” is unclear. What physical property does “content” represented and what is the standard for determining the “content” to be “uniform” or “not uniform”.
The claim 5 limitation reciting “stickiness” is indefinite as it’s not clear what stickiness represents. The term is not a term of art, and it’s entirely unclear what “stickiness” represents.
Claim 6 recites the limitation “suitable excipient”. This limitation is entirely unclear. What is the standard between “suitable” and “not suitable”.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 3-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wanatanbe et al. (EP 1161940).
Based on the specification, the limitation “critical quality attributes” is interpreted by the examiner as meaning any physical property.
As to claim 1, Wantanbe discloses a method for transforming a liquid-solid suspension feed solution into a desirable output product, the method comprising: obtaining, at a controller device 111 (fig 13, para 208-209) of a drying chamber 11/71 (para 153, 117-124 – hot air introduced and material “then dried”, fig 2c), a first input associated with one or more properties (disintegration time – para 35, 142, 143, 437, fig 13), of the desirable output product; obtaining, at the controller device, a second input associated with one or more critical quality attributes (CQAs) (density – para 230-234, fig 13) of the desirable output product; obtaining, at the controller device, a third input associated with one or more operational process variables (OPVs) (feed flow rate, para 228, 255, 267-276, 413, fig 13) of the drying chamber to generate the desirable output product (tablet, Tc, Tc, t, formed in tablet with the rotary machine such as in fig 13-22, see figs 3a para 117-124, 201-235, 250); receiving, in the drying chamber, dispersed droplets of a feed solution (fluidized particles - para 117-119, fig 2c), wherein the dispersed droplets are generated based on the one or more obtained properties, the one or more obtained CQAs, and the one or more obtained operational process variables (fig 2a-3a, 13-22, para 35, 117-124, 142, 143, 201-234, 255-276, 413-437); transforming, in the drying chamber, the dispersed droplets into dry particles by drying the dispersed droplets by supplying a continuous flow of the air for drying (fig 2a-3a, 117-124), wherein the dry particles are generated based on the one or more obtained properties, the one or more obtained CQAs, and the one or more obtained operational process variables; and wherein the controller device controls the operations of the drying chamber to obtain the desirable output product (fig 2a-3a, 13-22, para 35, 117-124, 142, 143, 201-234, 255-276, 413-437).
Note specifically that para 124 discloses the method of para 111-124, figs. 2(a)-3(a) is used with the rotary tableting machine later disclosed. This machine is disclosed in figs 13-22 and includes controller 111 as extensively detailed in para 208-413.
As to claim 3, Watanabe discloses the continuous flow of the air for drying is supplied by an air distribution system (fig 2c, para 118) coupled to the drying chamber, and wherein the air distribution system directs the flow of the drying air into the drying chamber with a uniform temperature and a uniform velocity (para 118, fig 2c figs 13-15, para 201-235).
As to claim 4, Watanabe discloses the method wherein the continuous flow of the air for drying, entering into the drying chamber, is heated at a pre-determined temperature so that the heated air entering the drying chamber generates a heated gas atmosphere inside the drying chamber to transform the dispersed droplets into dry particles (para fig 2a-3a, 117-124 figs 13-15, para 201-235).
.
As to claim 5, Watanabe discloses the one or more properties are associated with at least one of a hardness, a disintegration time, a friability, and a content uniformity; the one or more critical quality attributes (CQAs) are associated with at least one of a moisture content, a particle size distribution, a stickiness, a bulk density, and a flowability index; the one or more operational process variables are associated with at least one of a feed flow rate, an inlet air temperature of hot air, a feed flow rate of the feed solution, a feed concentration of the feed solution, and an atomiser speed generating the dispersed droplets (see citations in discussion of claim 1 above).
As to claim 6, Watanabe discloses the method wherein the output product is a solid unit dosage form of medication with suitable excipients ((tablet, Tc, Tc, t, para 1, 250).
As to claim 6, Watanabe discloses the method wherein the method further includes: obtaining, at an outlet of the drying chamber, the dry particles along with the air for drying (para 118-121 153-157); collecting, at a collection chamber connected to the drying chamber, the obtained dry particles and allowing the obtained air for drying into atmosphere (para 118, para 118-121 153-157, item 11bm figures 2a-3a, 6a-c) .
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 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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watanabe, as applied to claim 1 above, and further in view of Nielsen (US 20150246333).
Watanabe is silent as to the dispersed droplets of the feed solution being obtained from an automizer fluidly coupled to the drying chamber.
Nielsen discloses a method of forming dispersed droplets from an atomizer, the atomizer4 coupled to a drying chamber 1 (para 48-52, fig 1). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify the method of Watanabe such that the dispersed droplets of the feed solution being obtained from an automizer fluidly coupled to the drying chamber as taught by Nielsen above as such provides even wetting and optimal agglomeration (para 16).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER T SCHATZ whose telephone number is (571)272-6038. The examiner can normally be reached Monday through Friday, 9-6.
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/CHRISTOPHER T SCHATZ/Primary Examiner, Art Unit 1746