DETAILED CORRESPONDENCE
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-17 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No.11,565,196 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the limitations of claims 1-17 and 20 are anticipated by the claims of the Patent and because anticipation is the epitome of obviousness.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
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 5-6, 8, 16 and 19-20 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. The claims are indefinite because of the following reasons:
The following terms lack antecedent basis: “the pump holding device” (claim 5).
Regarding claims 16 and 19-20, the phrases "for example" or “optionally” render the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention (for application of art, the limitations are not required by the claims). See MPEP § 2173.05(d).
The balance of the listed claims are also rejected since claims suffer the same defects as the claims from which they depend.
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.
Claims 1-4, 7, 10 and 12-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weissenbach et al. (U.S. 2012/0031510 A1), hereinafter “W”.
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As for claim 1, W teaches a base station for a bioprocess system comprising a frame or housing (easily deduced from figure 2), wherein said frame or housing comprises a number of valves (e.g. valves 125A to 125W or 718-721) for controlling fluid flow in a disposable tubing set (disposable flexible piping 13A-Q) during run of the bioprocess system, such that at least one inlet (13J) of the disposable tubing set is connectable to at least one outlet (13K) of the disposable tubing set via a bioprocess separation device (406) of the bioprocess system; and wherein a wall of said housing comprises an inlet valve access opening through which access to at least one inlet valve positioned within the frame or housing is achieved (the actuator of the valve is positioned in the recess of figure 3 [0169].
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As for claim 2, the opening is provided in a bottom part of the frame or housing close to a movable pump holding device (cart 2) when the movable pump holding device is provided inside the frame or housing.
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As for claim 3, the discrete movable pump holding device comprises at least one pump main body, said pump main body comprising a fluid connection (e.g. at 11C) configured to be releasably connectable to a pump connection part of the disposable tubing set 13C.
As for claim 4, the movable pump holding device comprises a trolley on wheels 47 and wherein said frame or housing comprises a void in a bottom part of the frame or housing for receiving said movable pump holding device (e.g. the void defined between 1 and 3).
As for claim 7, The base station according to claim 1, wherein at least five separation device valves (e.g. 125M-Q of figure 14) are provided for receiving the disposable tubing set for controlling feeding of a fluid in the disposable tubing set in either upflow or downflow separation directions or bypass of the bioprocess separation device when connected to the disposable tubing set.
As for claim 10, The base station according to claim 1, wherein at least one of said valves are pinch valves (e.g. pinch valves 125A to 125W [0169]).
As for claim 12, as shown above W teaches a bioprocess system comprising a base station according to claim 1, and a disposable tubing set.
As for claim 13, the bioprocess system of claim 12, further comprising a movable pump holding device 2 operably connected thereto.
As for claim 14, W teaches a disposable tubing set (as shown above) for use with the base station of claim 1 note that the phrase “for use with the base station of claim 1” is an intended use for the tubing set that fails further modify the structure thereof.
As for claim 15, W teaches components including: at least one inlet tube (e.g. 13C or 13S); at least one outlet tube 13B; at least one pump connection part connected to the inlet tubing and configured for being connected to a pump main body; at least one air trap 402; and two separation device connection points (connected to the top and bottom of device 406 shown in figure 4) for connection to a bioprocess separation device 406, wherein said components are fluidically interconnected between the at least one outlet tube and the at least one inlet tube.
As for claim 16, W teaches wherein said air trap 402 is a disposable air trap.
As for claim 17, W teaches wherein all of the components of the disposable tubing set are fluidically interconnected and the disposable tubing set can be removed from the base station in one piece (as deduced from e.g. figure 4).
As for claim 18, W teaches wherein the disposable tubing set comprises two separation device connection points, and wherein the disposable tubing is branched such that one branch of the tubing comprises one of the separation device connection points and another branch comprises the other separation device connection point (as deduced from figures 4 and 14).
As for claim 19, W teaches a bypass branch provided in between the other two branches, and optionally wherein the three branches are collected into one tubing before and after the separation device connection points (see e.g., the branched tubing involving valves 125M through 125R of figure 14).
As for claim 20, W teaches one or more of: a filter cartridge 401; at least one inlet tubing 13C; at least one outlet tubing; at least one disposable pump 413 etc.
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 that are applied 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 5-6, 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over W.
As for the additional limitations of claims 5-6, 8 and 11, as shown in e.g. figures 7-10, W teaches a frame or housing that is essentially a box and that comprises at least four walls that include valves. Which walls include which valves and the relative heights of the valves and the number of valves is considered to be within ordinary skill that would depend upon the needs at the environment of use and the type of bioprocess to be effected.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over W in view of Sword et al. (U.S. 5,846,224), hereinafter “Sword”.
As for claim 9, W teaches a disposable bubble trap 402 that is mounted to the frame [0172]. Though he shows the trap above the valves (figure 4), he doesn’t specify a holder for the trap.
However, Sword teaches a holder 180 (figure 1) on his base for a bubble trap. It is considered that it would have been obvious to one ordinarily skilled in the art before the effective filing date of the invention to have the bubble trap holder of Sword on the frame of W for the benefit of retaining the bubble trap in its proper orientation during use, but that can be easily removed when desired (col. 13, lines 29-39).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mr. TERRY K CECIL whose telephone number is (571)272-1138. The examiner can normally be reached Normally 7:30-4:00p M-F.
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 repeated attempts to reach the examiner by telephone are unsuccessful (including leaving a voice message), the examiner’s supervisor, Bobby Ramdhanie can be reached on (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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/TERRY K CECIL/Primary Examiner, Art Unit 1779
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