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, 4-5, 8-13 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.
With regard to claim 4, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation the pharmaceutical product is an amorphous material produced by spray drying or any known drying technology, and the claim also recites preferably wherein the pharmaceutical product is an amorphous material produced by spray drying which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 4 also recites a limitation of any known drying technology. This limitation renders the claim vague and indefinite. It is unclear what the claimed any known drying technology is.
With regard to claim 8, the recited open-ended limitation of “at least 0.4 kg/h of gas per 1 kg of product” without upper limit renders the claim vague and indefinite because it is unclear what the claimed metes and bounds are.
With regard to claim 9, the recited open-ended limitation of “at least 0.05 cm/s” without upper limit renders the claim vague and indefinite because it is unclear what the claimed metes and bounds are.
With regard to claim 11, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation wherein the gas pressure is periodically changed, from vacuum to pressure up to 10 bar, and the claim also recites preferably wherein the gas pressure is between 2-10 bar and is periodically changed which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 12 recites “PP, PVDE, PCTE”. It is unclear what the claimed PP, PVDE, PCTE are.
Claims 2, 5, 8-10 and 13 are method claims. Method claims shall be defined by positive, actively steps. However, claims 5, 8-10 and 13 recite only structural limitations.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 recites in paragraph (ii) the permeable element is replaced by a sintered metal or polymer plate. Replacing sintered metal or polymer plate for the permeable element failed to further limit the subject matter of the claimed permeable element. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 (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 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.
Claims 1-7, 10 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taceb (RU 118730 U1).
With regard to claim 1, Taceb discloses a method for drying the residual solvent content of a pharmaceutical product in the form of a powder (translation, page 1, Description, first paragraph), comprising: i) feeding the pharmaceutical powder into a drying chamber 1 (Figure, by nozzle 3); ii) feeding a gas stream across a powder bed in the drying chamber 1 (Fig. 1, from top of drying chamber 1); and iii) providing a permeable element 5 to support the powder bed, wherein the gas stream flows, first through the powder bed and then the permeable element, downwards, upwards or radially (Figure).
With regard to claim 2, Taceb discloses the pharmaceutical powders are sprayed into the dryer chamber 1 by spray nozzle 3 (figure). As the current application discloses in page 7, paragraph four that the pharmaceutical powders (D.sub.V50<100 μm and with low bulk density <0.6 g/ml) is produced by a spray dryer unit, the spray nozzle 3 of Taceb would produce the powder has a Dv50 of < 100 pm and a bulk density of < 0.6 g/ml as well).
With regard to claim 3, Taceb discloses wherein the gas stream flows downwards through the powder bed (see gas flow arrow in Figure).
With regard to claim 4, Taceb discloses wherein the pharmaceutical product is an amorphous material produced by spray drying (Figure, sprayed by nozzle 3) or any known drying technology, and preferably wherein the pharmaceutical product is an amorphous material produced by spray drying.
With regard to claim 5, Taceb discloses wherein the permeable element comprises a filter or a porous membrane (see figure for porous membrane 5).
With regard to claim 6, Taceb discloses wherein:(i) the gas stream is heated prior to feeding it into the drying chamber (translation, page 2, last paragraph, line 2, already heated); and/or (ii) the drying chamber surface is heated to the target drying temperature.
With regard to claim 7, Taceb discloses wherein the gas stream is fed at a flowrate sufficient to cause the powder bed to be pushed against the permeable element to maximize relative velocity between the gas and the powder (translation, page 2, last three lines).
With regard to claim 10, Taceb discloses wherein:(i) the temperature of the gas stream is between the room temperature and the melting temperature or the glass transition temperature of the pharmaceutical product; and/or (ii) the gas is selected from a group consisting of: nitrogen (N2), carbon-dioxide (CO2), air and mixtures thereof (translation, last paragraph, air heater).
With regard to claim 14, Taceb discloses wherein the method is a batch process, using a single unit, a semi-continuous process by combining at least two units in parallel, or a fully continuous process (See sole figure for a single unit).
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.
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 12 is rejected under 35 U.S.C. 103 as being unpatentable over Taceb (RU 118730 U1) in view of Naunapper (DE 3204690 A1).
The method of Taceb as above includes all that is recited in claim 12 except for wherein: (i) the permeable element is made of a material selected from the group consisting of: PTFE (Teflon), PP, PVDF, PCTE and combinations thereof; (ii) the permeable element is supported or replaced by a sintered metal or polymer plate; and/or (iii) the method further comprises vibrating or agitating the drying chamber to mitigate clogging of the powder in the permeable element. Naunapper discloses a method for drying pharmaceutical power comprising vibrating the drying chamber to mitigate clogging of the powder in the permeable element 11 (abstrate, Fig. 1, vibrating device 20). Therefore, it would have been obvious to someone with ordinary skill in the art before the effective filing date of the invention to modify the method of Taceb to include vibrating or agitating the drying chamber to mitigate clogging of the powder in the permeable element as taught by Naunapper in order to improve the drying efficiency.
Allowable Subject Matter
Claims 8-9, 11, 13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA J YUEN whose telephone number is (571)272-4878. The examiner can normally be reached Monday-Friday 9am-5pm.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL G HOANG can be reached at (571) 272-6460. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jessica Yuen/
Primary Examiner
Art Unit 3762
JY