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 Status
The Preliminary Amendment filed on 18 March 2024 has been entered; claims 1-18 remain pending.
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 and 11 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 respect to claims 2 and 11, the limitations are rendered indefinite, as it is unclear how the first preset pressure, which when exceeded results in venting, can be lower than the second preset pressure, which when not met by the pressure in the reservoir, results in raising the pressure according to the methods of claims 1 and 10. For the purposes of examination, the Examiner will interpret the limitations of claims 2 and 11 as though they recited “wherein the first preset pressure is higher than the second preset pressure”.
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.
Claims 1, 2, 4-11, and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Vetter et al. (U.S. Patent Publication # 2020/0290044) in view of WO 2016/095685 A1 and Gerfroh et al. (U.S. Patent Publication # 2017/0157566), hereinafter “Vetter”, “WO (‘685)” and “Gefroh”.
With respect to claims 1, 4, 10, and 13, Vetter teaches a method for providing a constant pressure to a filter apparatus 406 independent of a feed stream flow rate (see Fig. 4; Paragraphs [0091-0100]), said method comprising:
a) providing i) a feed vessel (“reservoir”) comprising inlets 402, 420, and 424 (“one or more fluid feed stream inlets”) and an outlet at the bottom left of vessel 402 leading to conduit 404 (“one or more fluid feed stream outlets”) (Fig. 4; Paragraphs [0091, 0092]) and ii) a pressure source for providing and maintaining pressure in the reservoir while in operation, said pressure source comprising air 422 (“pressurized gas supply”) in fluid connection with said reservoir 402 through inlet 424 (Paragraph [0092]);
b) wherein the fluid feed stream 416 enters the reservoir via inlet 414 and fluid feed stream 426 enters the reservoir via inlet 420 (inlets 414 and 420 being “the one or more fluid feed stream inlets”) at a flow rate (Paragraph [0092]; Fig. 4);
c) wherein the reservoir is pressurized from gas 422 supplied by the pressure source (Fig. 4; Paragraph [0092]);
e) wherein said fluid feed stream exits the reservoir via the one or more fluid feed stream outlets along conduit 404 (Paragraph [0091]; Fig. 4) at approximately the same flow rate as when it enters the reservoir (Paragraph [0091]);
f) wherein said fluid feed stream is delivered at a constant pressure (Fig. 4; Paragraphs [0067, 0091] to filter unit 406 (“one or more filters located downstream of the one or more reservoir outlets”) (Paragraph [0092; Fig. 4).
With respect to claim 10, in addition to the above disclosures, Vetter also teaches that the feed stream is partially directed from filter 406 (Paragraph [0092]; “upstream process step”).
Vetter does not specifically teach step d) of claim 1 or step c) of claim 10.
WO (‘685) teaches an emptying valve 13 within an air inlet conduit in communication with a constant pressure vessel 10 (see Abstract; Fig. 1), while Gefroh teaches a pressure regulator located between a pressurized air source and a pressure vessel (Paragraph [0105]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the pressurized gas 422 and its delivery through inlet 424 of pressure vessel/reservoir 402 with the pressure regulator and valve as taught by WO (‘685) and Gefroh, in order to gain the advantage of delivering compressed gas if the pressure in vessel 402 is below a second preset pressure or emptying compressed gas from the air delivery line into vessel 402 of Vetter if the pressure is above a first preset pressure, as Vetter teaches a constant pressure system (Paragraphs [0067, 0091]), as does WO (‘685) (see Abstract) and Gefroh (see Paragraph [0105]).
With respect to claims 2 and 11, reference combination Vetter in view of WO (‘685) and Gefroh necessarily teaches allowing gas to enter the vessel 402 (“reservoir”) if the pressure is lower than a threshold pressure (“second preset pressure”) and to bleed off excess gas if the pressure is higher than a threshold pressure (“first preset pressure”) in order to maintain constant pressure in the vessel/reservoir, a goal shared by all three references.
With respect to claims 5 and 14, it is submitted that the defining of the first or second pressure to be within the recited range is well within the skill of the ordinary artisan. There is no evidence indicating such first and second pressures are critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With respect to claim 6-8 and 15-17, Vetter in view of WO (‘685) and Gefroh teaches wherein said filter 406 is a virus filter (see Vetter: Abstract; Paragraph [0092]), wherein filter 406 produces product stream 428 with little or no viral load (considered to be consistent with sterilizing the fluid feed stream”) and retentate 432, a concentrated portion of feed stream (Paragraph [0092]; Fig. 4).
With respect to claims 9 and 18, Vetter in view of WO (‘685) and Gefroh teaches wherein the fluid feed stream entering the reservoir is continuous (see flow arrows in Vetter: Fig. 4; Paragraphs [0047, 0091-0100]).
Claims 3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Vetter et al. (U.S. Patent Publication # 2020/0290044) in view of WO 2016/095685 A1 and Gerfroh et al. (U.S. Patent Publication # 2017/0157566) as applied to claims 1 and 10 above, and further in view of Pralong et al. (U.S. Patent Publication # 2013/0319944), hereinafter “Vetter”, “WO (‘685)”, “Gefroh”, and “Pralong”.
With respect to claims 3 and 12, Vetter in view of WO (‘685) and Gefroh does not specifically teach that the gas supply is sterile.
Pralong teaches a sterile gas source (Paragraph [0077]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the pressurized gas 422 source with the sterile gas obtained from filtration of the gas as taught by Pralong in order to gain the advantage of not introducing additional pathogens to the feed stream by the pressurized gas of Vetter, which would also prolong the life of filter 406 of Vetter. The Examiner additionally notes that Pralong is directed to a pneumatic cell separator filter system (Abstract), a similar biological particle filter system as disclosed by Vetter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CLARE M PERRIN whose telephone number is (571)270-5952. The examiner can normally be reached 9AM-6PM EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bob Ramdhanie can be reached at (571) 270-3240. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CLARE M. PERRIN/
Primary Examiner
Art Unit 1779
/CLARE M PERRIN/ Primary Examiner, Art Unit 1779 20 August 2026
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