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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/21/2023 and 12/12/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant's election with traverse of group I, claims 1-18 in the reply filed on 05/18/2026 is acknowledged. The traversal is on the ground(s) that it would not be unduly burdensome for the examiner to search and examine all of the claims presented. This is not found persuasive because the present application is filed under 35 U.S.C. § 371 and no showing of serious burden is required. Further, a search burden is not a threshold in a PCT application.
Claims 19-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/18/2026.
The requirement is still deemed proper and is therefore made FINAL.
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 1-18 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.
Regarding claim 1, the phrase “predefined” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(c).
Claim 1 also contains conditional language that renders the claims indefinite, since it is not clear whether or not the necessary condition has actually been met. Claim 1 discloses “when the device is assembled as intended, a first liquid stream containing a target protein is introducible into the device through the first fluid inlet and is combinable in a precisely predefined volume ratio with a second, virus-inactivating liquid stream introducible into the device through the second fluid inlet to form a third, reactive liquid stream which is conducted through the first mixer for mixing in order to generate predefined, virus-inactivating conditions”. If the device is not assembled, then the necessary condition of claim 1 does not occur and is effectively void.
Claims 2-18 are dependent on independent claim 1 and are therefore rejected for the same reasons.
Claim 2 contains conditional language that renders the claims indefinite, since it is not clear whether or not the necessary condition has actually been met. Claim 2 discloses “when the device is assembled as intended, the third, reactive liquid stream is combinable with a fourth, neutralizing liquid stream introducible through the third fluid inlet to form a fifth, resultant liquid stream in order to neutralize the virus-inactivating conditions”. If the device is not assembled, then the necessary condition of claim 1 does not occur and is effectively void.
Claim 6 recites the limitation “the inlet head part” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation “the respective residence time level” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “the components” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 1-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Parker et al. (hereinafter Parker) WO 2020/076681 A1 cited in the IDS filed 09/21/2023.
Regarding claim 1, Parker discloses a device for continuous virus inactivation during a protein production process, comprising: a first and a second fluid inlet shown in Fig. 1 reproduced below, each configured to introduce a liquid stream into the device, a first mixer (static mixer 40), configured to mix a liquid stream, and a fluid outlet shown in Fig. 1 reproduced below, configured to discharge a liquid stream from the device, wherein, wherein the device comprises a head part (vertical turn 116 and/or connector 118 and/or flange 120) for combination of two liquid streams [0052-0054], one of which is the liquid stream containing the target protein, wherein the device comprises, downstream of the first mixer and upstream of the fluid outlet, a residence time arrangement (CVI reactor 100) fluidically connected to the head part for provision of a minimum residence time of the third [0044-0045], reactive liquid stream within the device, wherein the head part and the residence time arrangement are rigidly fastened to each other [0052 and 0054-0055], and wherein the head part is arranged on an end face of the residence time arrangement as shown in Fig. 2D. Also see whole document.
As to the intended use limitations i.e., when the device is assembled as intended, a first liquid stream containing a target protein is introducible into the device through the first fluid inlet and is combinable in a precisely predefined volume ratio with a second, virus-inactivating liquid stream introducible into the device through the second fluid inlet to form a third, reactive liquid stream which is conducted through the first mixer for mixing in order to generate predefined, virus-inactivating conditions, the device disclosed by Parker is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Parker is capable of providing the operating conditions as listed in the intended use section of the claim in view of paragraphs [0027 and 0044] and Fig.1.
Further, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
PNG
media_image1.png
791
676
media_image1.png
Greyscale
Regarding claim 2, Parker discloses wherein the device comprises, downstream of the first mixer and the residence time arrangement, a third fluid inlet shown in Fig, 1 reproduced above, configured to introduce a liquid stream into the device.
As to the intended use limitations i.e., when the device is assembled as intended, the third, reactive liquid stream is combinable with a fourth, neutralizing liquid stream introducible through the third fluid inlet to form a fifth, resultant liquid stream in order to neutralize the virus-inactivating conditions, the device disclosed by Parker is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Parker is capable of providing the operating conditions as listed in the intended use section of the claim in view of paragraphs [0027 and 0044] and Fig.1.
Further, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 3, Parker discloses wherein the device comprises, downstream of the third fluid inlet, a second mixer (static mixer 60), configured to mix the fifth, resultant liquid stream [0044].
Regarding claim 4, Parker discloses wherein the head part (each layer 114 can be connected to its adjacent lower layer 114 by a 180° vertical turn 116; connector 118 can be connected to each tubular flow path 112; and flange 120) is an inlet head part for generation of the third, reactive liquid stream and in that the inlet head part is arranged at one end of the residence time arrangement in order to generate the virus-inactivating conditions shown in Figs. 1, 2C and 2D; and discussed in at least [0052 and 0055].
Regarding claim 5, Parker discloses wherein the head part is an outlet head part (each layer 114 can be connected to its adjacent lower layer 114 by a 180° vertical turn 116, connector 118 can be connected to each tubular flow path 112; and flange 120) for generation of the fifth, resultant liquid stream and wherein the outlet head part is arranged at the other end of the residence time arrangement in order to neutralize the virus- inactivating conditions shown in Figs. 1, 2C and 2D; and discussed in at least [0052 and 0055].
Regarding claim 6, Parker discloses wherein the first and/or the second fluid inlet and/or the first mixer is integrated into the inlet head part, and/or wherein the third fluid inlet and/or the second mixer is integrated into the outlet head part as shown in Figs.1 and 2D.
Regarding claim 7, As to the intended use limitations i.e., wherein the first liquid stream containing a target protein and the second, virus-inactivating liquid stream are combined upstream of the first mixer or in the first mixer, and/or wherein the third, reactive liquid stream and the fourth, neutralizing liquid stream are combined upstream of the second mixer or in the second mixer, the device disclosed by Parker is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Parker is capable of providing the operating conditions as listed in the intended use section of the claim in view of paragraphs [0027 and 0044] and Fig.1.
Further, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 8, Parker discloses wherein the residence time arrangement (CVI reactor 100) is in the form of a one-piece body shown in Figs. 1 and 2C.
Regarding claim 9, Parker discloses wherein the residence time arrangement comprises an internal channel system (tubular flow path and/or a first layer 114) which is arranged at least which is arranged at least largely transversely to the longitudinal axis of the residence time arrangement [0052-0054]. Also see Fig. 2D.
Regarding claim 10, Parker discloses wherein the internal channel system (tubular flow path) which is arranged at least largely transversely to the longitudinal axis of the residence time arrangement comprises one or more residence time levels (layers 114), each of which comprises at least one residence time level channel arranged transversely to the longitudinal axis of the residence time arrangement shown in Fig. 2D.
Regarding claim 11, Parker discloses wherein the respective residence time level is in the form of a preassembled (Fig. 2D) or one-piece component as shown in (Figs. 2A).
Regarding claim 12, Parker discloses wherein the residence time arrangement is sealingly connected via an interlocking, frictional and/or bonded connection to the head part (The connector 118 can be connected to each tubular flow path 112 or flange 120 by a clamp 122, as shown in Fig. 2D, or by other fastener devices, such as a screw, an adhesive, etc.) [0055].
Regarding claim 13, Parker discloses wherein the device comprises at least one sensor (FlowVPE (C Technologies. Inc. New Jersey, NY) flow cell unit and/or surface monitor ) for measurement of a parameter of the third, reactive liquid stream and/or at least one sensor for measurement of a parameter of the fifth, resultant liquid stream [0057 and 0059].
Regarding claim 14, Parker discloses wherein the at least one sensor is integrated into the head part and the at least one sensor is arranged downstream of the first mixer and/or wherein the at least one sensor is integrated into the outlet head part and the at least one sensor is arranged downstream of the second mixer (The absorbance of the tracer at the outlet was measured using a FlowVPE (C Technologies. Inc. New Jersey, NY) flow cell unit…; A surface monitor at the outlet of the reactor recorded the mass-weigh ted molar concentration of the tracer at the outlet at each time step.) [0057 and 0059].
Regarding claim 15, Parker discloses wherein the device comprises a separate inlet intermediate plate (gasket) between the inlet head part and the residence time arrangement and/or a separate outlet intermediate plate (gasket) between the residence time arrangement and the outlet head part for the respective specific transfer of the third, reactive liquid stream [0055].
Regarding claim 16, as best as can be understood, claim 16 has been interpreted as requiring the device of claim 1 to be in the form of preassembled or one-piece unit.
Parker discloses wherein the components of the device at least necessary for the intended function, is in the form of a preassembled as shown in Fig. 1.
Regarding claim 17, as best as can be understood, claim 17 has been interpreted as requiring the device of claim 16 to comprise a single device for virus inactivation or a plurality of parallelly and/or serially arranged devices for virus inactivation fluidically connected to one another. Parker discloses wherein the device comprises only a single device for virus inactivation. See whole document.
Regarding claim 18, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production (i.e., wherein the residence time arrangement, the head part, the inlet intermediate plate and/or the outlet intermediate plate are produced in a plastics injection-molding process or in a 3D printing process). If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP §2113.
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.
Claims 16 and 17 are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Parker WO 2020/076681 A1 as applied above to claims 1-18.
Regarding claim 16, as best as can be understood, claim 16 has been interpreted as requiring the device of claim 1 to be in the form of preassembled or one-piece unit.
Parker does not expressly state that viral inactivation device is in the form of a one-piece unit. However, absent unexpected results, it would have been prima facie obvious to one of ordinary skill in the art to provide a one-piece unit, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. See MPEP §2144.04 (V-B).
Regarding claim 17, as best as can be understood, claim 17 has been interpreted as requiring the device of claim 16 to comprise a single device for virus inactivation or a plurality of parallelly and/or serially arranged devices for virus inactivation fluidically connected to one another.
Parker does not expressly state that viral inactivation device comprises a plurality of parallelly and/or serially arranged devices for virus inactivation fluidically connected to one another. However, absent unexpected results, it would have been prima facie obvious to one of ordinary skill in the art to provide a plurality of parallelly and/or serially arranged devices for fluid inactivation fluidically connected to one another, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See MPEP §2144.04 (VI-B).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Wednesday 08:00-18:00 EST.
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, Curtis Mayes can be reached on 571-272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LYDIA EDWARDS/Primary Examiner, Art Unit 1796
Prosecution Insights