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 .
Response to Amendment
The amendment filed on 12/16/25 has been entered and fully considered.
Claims 1-3, 5-11, 14-20 remain pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 16 recites means for releasably attaching a sample portion.
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.
Claim(s) 1-3, 5-11, 14-20 is/are rejected under 35 U.S.C. 102a1 & a2 as being anticipated by CASTILLO (WO 2019/175442).
Regarding claim 1, CASTILLO discloses a bioreactor comprising:
housing 12 having a port 22 (housing including sampling port),
a fixed bed 18 inside the housing, and
a sampler 10, extending through the port 22, the sampler having a removable/detachable sample portion 16 (releasably attached sample portion) positioned within the fixed bed (Fig 1-1a, 0055-59, 0087),
the sample portion 16 may be attached by a frangible connector (0106) or that the sample portion 16 can be connected to a cap (positioner) that it can be detached from with enough force (frangible connection) (0070-0072, fig 1e, 1f),
the connecting portion comprising three integrally formed projections 14a (at least one) that can fracture upon bending (breakaway) to detach the sample portion (Fig 1d, 0070-71).
Regarding claim 2, CASTILLO discloses the sample portion 16 may comprise a substrate which is adapted to promote cell growth (0057).
Regarding claim 3, CASTILLO discloses sampler 10 has a positioner 20 to facilitate holding the sample portion in an appropriate position in or adjacent the fixed bed (adapted for positioning the sample portion) (0057-59, Fig 1a).
Regarding claim 5, CASTILLO discloses the positioner 20 is associated with the port 22 (Fig 1).
Regarding claim 6, CASTILLO discloses a cap 14 for sealing the port 22 (Fig 1).
Regarding claim 7, CASTILLO discloses the sampler is releasable from a grip 14a/b located external to the bioreactor (Fig 1D, 1E, 1F, 0070-72)
Regarding claim 8, CASTILLO discloses a locking pin (locking engagement) on the housing for retaining the sampler (0079-80).
Regarding claim 9, CASTILLO discloses the bioreactor has a lid 24 that comprises the port 22 (Fig 1, 0058).
Regarding claim 10, CASTILLO discloses the fixed bed can have a plurality of layers with the sample portion positioned between the layers (0059, Fix 1a).
Regarding claim 11, CASTILLO discloses a sampler for sampling a cell culture associated with a fixed bed 18 in a bioreactor 12 having a port 22 (fig 1), comprising a sampler 10 including a grip 14a or 14b connected to a positioner 20, the positioner connected to a sample portion 16 for positioning the sample portion in the bioreactor adjacent the fixed bed (0106, Fig 1-1e, 0055-59, 0087), the sample portion may be removably attached to the positioner in a variety of ways including with a frame (0087-0089, Figs 10-20) and the sample portion 16 may comprise a substrate which is adapted to promote cell growth (0057).
Regarding claim 14, CASTILLO discloses a locking pin (locking engagement) on the housing for retaining the sampler (0079-80).
Regarding claim 15, CASTILLO discloses frame 50 can be releasably attached to the positioner 48 by a toothed wedge and clamp (frangible connection) (0087, Fig 15, 19-20).
Regarding claim 16, means for releasably detaching has been interpreted under 35 USC 112f as stated above to be a frangible connection [Spec 0009] and functional equivalents thereof.
CASTILLO discloses a sampler (kit) for sampling a fixed bed of a bioreactor comprising a sampler (fig 20) including a releasably attached sample portion 16 and an outer part (container) adapted to release the sample portion (0087-88, Fig 20), the releasably attaching means being a frangible connection (0106, 0070-72).
Regarding claim 17, CASTILLO discloses the outer part (container) comprises an inner part (insert) that facilitates the detaching (0088, Fig 20).
Regarding claim 18, CASTILLO discloses the sample portion 16 may comprise a substrate which is adapted to promote cell growth (0057).
Regarding claim 19, CASTILLO discloses a method of sampling a fixed bed bioreactor 12 including a sample portion (releasably attached portion) at least partially positioned in or adjacent the fixed bed to promote growth of cells on the sample portion of the sampler comprising:
providing a sampler 10, extending through the port 22, the sampler having a removable/detachable sample portion 16 (releasably attached sample portion) extending into the bioreactor (Fig 1-1a, 0055-59, 0087), the sample portion 16 may be attached by a frangible connector (0106) or that the sample portion 16 can be connected to a cap (positioner) that it can be detached from with enough force (frangible connection) (0070-0072, fig 1e, 1f),
the connecting portion comprising three integrally formed projections 14a (at least two) that can fracture upon bending (breakaway) to detach the sample portion (Fig 1d, 0070-71),
initiating a culture, allowing enough time to permit cell growth in the fixed bed and sample portion, removing the sample portion from the fixed bed (withdrawing) causing a releasing of the connection of the sample portion (detaching) (0033, 0057, 0073, 0087-0089, Claim 71).
Regarding claim 20, CASTILLO discloses detaching comprises the sample portion (releasably attached portion) inserted into an opening of an inner part 60 (insert) in an outer part 58 (container) and that releasing the connection is by flexing the inner part (using insert to break portion from sampler) (0088, Fig 20).
Response to Arguments
Applicant's arguments filed 12/16/25 have been fully considered but they are not persuasive.
In response to applicant’s arguments that the amended limitations are not taught by the cited prior art, the examiner respectfully disagrees. The amended features are addressed in the above rejections as being taught by CASTILLO. Therefore the examiner maintains the rejection as it is noted that Applicant s present no clear arguments why the cited portions of the reference does not teach these features.
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 DANIELLE B HENKEL whose telephone number is (571)270-5505. The examiner can normally be reached M-Th 11-7 EST, Alt. Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIELLE B HENKEL/Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799