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 .
Priority
Applicant’s claim for the benefit of a prior-filed application (PRO 63/039,541, filed 16 June 2020; 371 of PCT/US2021/036917, filed 11 June 2021) under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
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.
(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) 20-25 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by RANSOHOFF et al. (US 2013/0260419 A1).
Regarding Claim 20, RANSOHOFF discloses a continuous processing method for biological products (abstract); the method generally comprises a series of unit operations 3, 4, 5 wherein the unit operations are directly connected to each other via tubing/flowpath lines 2 and product flow is driven by a pump 1 (i.e., flowing the non-uniform feed stream through a flow path, said flow path comprising… a pump; p0103, FIG. 1). The method processes the output from a cell culture bioreactor (i.e., processing a non-uniform feed stream; p0089).
RANSOHOFF further discloses a bypass collection receptacle 21 that allows for diverting flow from any unit operation (p0112; FIG. 3); such unit operations include chromatography columns with ideal plug flow (i.e., a plug flow reactor; p0151). As described in p0112:
“the transmission conduits (20) [make] it possible to divert the flow from any unit operation (UO) so that the partially processed product is not lost if transfer of the flow to the next intended unit operation is not possible… a bypass collection receptacle (21) provides a means of rescuing a product that has undergone partial processing in one or more unit operations…” (emphasis added)
Although RANSOHOFF is deficient in explicitly disclosing the claimed limitation of “diverting a percentage of the non-uniform feed stream from a first location inside the PFR to a second location within the flow path”, the disclosures by the prior art that the transmission conduits divert flow “from any unit operation” and that the bypass system “provides a means of rescuing a product that has undergone partial processing in one or more unit operations” imply the transmission conduits 20 are located such that they directly withdraw product from a unit operation to capably withdraw any partially processed product (i.e., a plug flow reactor bypass line; diverting a percentage of the non-uniform feed stream from a first location inside the PFR to a second location within the flow path). RANSOHOFF further discloses a separate return line and pump to provide for the return of any product collected in the bypass receptacle to any point in the unit operation cascade (i.e., circulating the non-uniform feed stream through the flow path; p0112). Finally, RANSOHOFF discloses that there is sufficient mixing provided in the receptacles of each unit operation to ensure solution homogeneity (i.e., homogenizing the non-uniform feed stream; p0040-0044).
[AltContent: textbox (Pump)][AltContent: textbox (Collection Receptacle)][AltContent: textbox (Transmission Conduit)]
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Regarding Claim 21, RANSOHOFF discloses the method of Claim 20. RANSOHOFF further discloses the biological product includes proteins (i.e., wherein the non-uniform feed stream comprises a protein or product of interest; p0087).
Regarding Claim 22, RANSOHOFF discloses the method of Claim 20. RANSOHOFF further discloses the unit operations are directly connected to each other via tubing/flowpath lines 2 (i.e., wherein the flow path is in-line between a first process step and a second process step; p0103, FIG. 1; see also FIG. 2A of in-line process steps).
Regarding Claims 23 and 24, RANSOHOFF discloses the method of Claim 22. RANSOHOFF discloses that an initial unit operation is an affinity chromatography process (p0121), commonly a chromatography column packed with Protein A media (i.e., the first process step is a Protein A (ProA) column chromatograph (Claim 23); p0127, p0138-0139; see also p0107, FIG. 2A); a subsequent unit operation is a virus inactivation step (i.e., the second process step is a virus inactivation step (Claim 24); p0132-0133, p0138; see also p0107, FIG. 2A).
Regarding Claim 25, RANSOHOFF discloses the method of Claim 20. RANSOHOFF discloses that an initial unit operation is an affinity chromatography process (p0121), commonly a chromatography column packed with Protein A media (p0127, p0138-0139; see also p0107, FIG. 2A); a subsequent unit operation is a virus inactivation step (i.e., the method comprises a virus inactivation step; p0132-0133, p0138; see also p0107, FIG. 2A).
Response to Amendments/Arguments
Applicant’s amendments/arguments filed 12 February 2026 have been fully considered.
Regarding the Claim Objection of Claim 22, Applicant’s amendments to Claim 22 are persuasive; this objection has been withdrawn.
Regarding the rejections of Claims 20-25 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, Applicant’s amendments to Claims 20 and 25 have been fully considered and are persuasive; these rejections have been withdrawn.
Regarding the rejection of Claim 25 under 35 U.S.C. 101, Applicant’s amendments to Claim 25 have been fully considered and are persuasive; this rejection has been withdrawn.
Regarding the rejections of Claim(s) 20-25 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by RANSOHOFF et al. (US 2013/0260419 A1), Applicant’s amendments to Claim 20 and arguments have been fully considered but are not persuasive.
Applicant argues that the prior art does not disclose a PFR bypass line as claimed whereby the PFR bypass line is located at “a first location inside a plug flow reactor”; instead the prior art seems to disclose that the transmission conduits 20 “are positioned between unit operations in the flow path” as shown in FIG. 3 (pg. 8-9). As such, Applicant argues the anticipation rejection should be withdrawn.
The Examiner respectfully disagrees.
As noted by RANSOHOFF, the figures are merely schematic drawings simplified to show the general operating scheme of the disclosed unit operations (see p0075: “FIG. 3 is a schematic diagram…”. While schematic diagrams or figures are helpful in interpreting the prior art, their disclosures are merely broad representations of the disclosed inventions. The Examiner appreciates Applicant’s interpretation of FIG. 3 especially had FIG. 3 only been considered in vacuo; however, when considered with the complementary text (i.e., primarily paragraph 0112), it is evidently clear that RANSOHOFF indicates the transmission conduits 20 are not positioned between unit operations and instead are drawing directly from each unit operation. As described in p0112:
“the transmission conduits (20) [make] it possible to divert the flow from any unit operation (UO) so that the partially processed product is not lost if transfer of the flow to the next intended unit operation is not possible… a bypass collection receptacle (21) provides a means of rescuing a product that has undergone partial processing in one or more unit operations…” (emphasis added)
The disclosures by the prior art that the transmission conduits divert flow “from any unit operation” and that the bypass system “provides a means of rescuing a product that has undergone partial processing in one or more unit operations” imply the transmission conduits 20 are located such that they directly withdraw product from a unit operation to capably withdraw any partially processed product. Even if arguendo the prior art is interpreted per Applicant’s explanation, the claimed plug flow reactor is so broadly claimed such that the conduits or portions of conduits leading to and from the PFR can be considered to be part of the PFR unit, e.g., portions of or whole conduits surrounding each unit operation in RANSOHOFF’s FIG. 3 can be broadly and reasonably interpreted to be part of a unit operation.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN B HUANG whose telephone number is (571)270-0327. The examiner can normally be reached 9 am-5 pm 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, In Suk Bullock can be reached at 571-272-5954. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ryan B Huang/Primary Examiner, Art Unit 1777
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