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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-13, in the reply filed on 06/01/2026 is acknowledged. Claims 14-18, 30, 33 are withdrawn from further consideration pursuant of 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. This election was made without traverse in the reply filed on 06/01/2026.
Priority
Receipt is acknowledged of certified copies (PRO 63/171,371 – filed 04/06/2021) required by 37 CFR 1.78.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 11/03/2023, 02/16/2024, and 05/01/2026 have been considered and made of record.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 400 (FIG. 7A), 400a (FIG. 7B), 400b (FIG. 7B), 420 (FIG. 8A), 450 (FIG. 9A), 480 (FIG. 10). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The use of the terms “HYPERStack®” and “iCellis®”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 12 is objected to because of the following informalities:
“wherein the structurally defined surface comprises one of more fibers” should read “wherein the structurally defined surface comprises one or more fibers. Appropriate correction is required.
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 8-11 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. As noted in MPEP § 2117, claim language defined by a Markush grouping requires selection from a closed group “consisting of” the alternative members. See MPEP § 2111.03, subsection II, for a discussion of the term “consisting of” in the context of Markush groupings. Claim 8 contains an improper Markush grouping due to the present claim language “sample substrate comprises at least one of the following shapes:”. Thus, the claim is rejected under 112(b). Claims 9-11 are included in the rejection because they fail to cure the deficiencies of claim 8.
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.
Claim(s) 1-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Castillo et al. (US 20210009933 A1) (already referenced in IDS).
Regarding claim 1, Castillo et al. teaches a cell culture substrate for a fixed bed bioreactor (abstract) comprising:
a structurally defined surface for culturing cells thereon (fixed bed – See annotated FIG. 1A, element 18) for culturing cells thereon, the structurally defined defining ordered and regular array of openings through a thickness of the cell culture substrate (Castillo et al. teaches fixed bed (element 18) comprises a cell immobilization layer (non-woven material, element 18a) and spacer layer (element 18b). However, Castillo et al. further teaches that cell immobilization layer is where cells grow (para. [0060]), and this material may be non-woven or woven (para. [0066]) – hence defining an array of openings – therefore this limitation is anticipated),
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wherein at least a portion of the cell culture substrate comprises a sample substrate (sample portion – element 16), the sample substrate being defined by a separation boundary (element 18a) between the sample substrate and a remainder of the cell culture substrate (See annotated FIG. 1A)
wherein the separation boundary is configured to separate the sample substrate from the remainder of the cell culture substrate (FIG. 1A).
Regarding claim 2, Castillo et al. teaches the cell culture device of claim 1. Castillo et al. teaches “In this case the sample portion 16 may be adapted for detachment and removal from the rest of the fixed bed (such as by providing perforations or tear-away seams in the fixed bed, or pre-cutting the fixed bed or other means for separating samples to create one or more removable (detachable) portions)” (para. [0058]). Castillo et al. teaching of perforations or tear-away seams in the fixed bed anticipates the claim.
Regarding claim 3, Castillo et al. teaches the cell culture device of claim 1. Castillo et al. further teaches that “sample portion 16 may be a separate structure for positioning within the fixed bed 18 during the process of assembling the bioreactor 12 (as outlined further in the following discussion). In this case the sample portion 16 may be adapted for detachment and removal from the rest of the fixed bed” (para. [0058]). The separation boundary comprising an attachment material between the sample substrate and the remainder of the substrate is structurally the same as the sample portion being adapted for detachment and removal from the rest of the fixed bed.
Regarding the limitation “configured to release from one or both of the sample substrate and the remainder of the substrate under tension”, it has been held that 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 limitation of the claim (MPEP § 2114 II). Therefore, the cell culture substrate employed by Castillo et al. would be fully capable of achieving every intended use because Castillo et al. discloses that “sample portion 16 may be a separate structure for positioning within the fixed bed 18 during the process of assembling the bioreactor 12 (as outlined further in the following discussion). In this case the sample portion 16 may be adapted for detachment and removal from the rest of the fixed bed” (para. [0058]), and would be structurally capable of being configured to release from one or both of the sample substrate and the remainder of the substrate under tension.
Regarding claim 4, Castillo et al. teaches the cell culture substrate of claim 1. Castillo et al. further teaches “a plurality of sample portions 16 may be provided, and may be on the surface(s) of the fixed bed 18” (para. [0107]). This anticipates the claim limitation.
Regarding claim 5, Castillo et al. teaches the cell culture substrate of claim 4. Castillo et al. further teaches at least two of the plurality of sample substrates are separated from each other by a portion of the remainder of the cell culture substrate that is not one of the pluralities of sample substrates (See FIG. 42 – sample portions 16 are separated) (para. [0107]). Thus, the claim is anticipated.
Regarding claim 6, Castillo et al. teaches the cell culture substrate of claim 4. Castillo et al.’s sample portions (element) and fixed bed (element 18) anticipate the limitation of a plurality of sample substrates separated from each other by the separation boundary.
Regarding claim 7, Castillo et al. teaches the cell culture substrate of claim 1. Castillo et al. further teaches that with reference to FIG. 1C, the fixed bed 18 may comprise a plurality of concentric layers 18a that are continuous, and may be in any shape (e.g., circular, square). This anticipates the claim that cell culture substrate comprises a circular disk shape.
Regarding claim 8, Castillo et al. teaches the cell culture substrate of claim 1. Castillo et al. further teaches a sample substrate comprising a square/rectangular shape (FIG. 41 – element 16) in cell culture substrate (element 18). Thus, the limitation “the sample substrate comprises a rectangular shape” is anticipated.
Regarding claim 9, Castillo et al. teaches the cell culture substrate of claim 8. The prior art meets the limitations of Claim 8 as shown above. Further, claim 9 is drawn to further limiting limitations of Claim 8 that are presented in the alternative, such that they are not required by the claim in the presence of other alternatives. Since the other alternative recited in claim 8 has been rejected as discussed previously, Claim 9 is rejected in the same way as Claim 8.
Regarding claim 10, Castillo et al. teaches the cell culture substrate of claim 8. Castillo et al. teaches “the sample portion 16 may be positioned adjacent to and in contact with a surface of the fixed bed 18, such as a side surface (FIG. 41)” (para. [0107]). Castillo et al. further teaches that “a plurality of sample portions 16 may be provided, and may be on the surface(s) of the fixed bed 18, between layers of it, or both.” Castillo et al. teaching of inserting the sample portions into the fixed bed anticipates the claim limitation of using tapered fits, as this would allow the sample portions to be provided between the layers.
Regarding claim 11, Castillo et al. teaches the cell culture substrate of claim 8. The prior art meets the limitations of Claim 8 as shown above. Further, claim 11 is drawn to further limiting limitations of Claim 8 that are presented in the alternative, such that they are not required by the claim in the presence of other alternatives. Since the other alternative recited in claim 8 has been rejected as discussed previously, Claim 11 is rejected in the same way as Claim 8.
Regarding claim 12, Castillo et al. teaches the cell culture substrate of claim 1. Castillo et al. further teaches that the cell immobilization layer may be a woven or nonwoven material. Woven materials contain one or more fibers, therefore, the claim is anticipated by Castillo et al.
Regarding claim 13, Castillo et al. teaches the cell culture substrate of claim 12. Castillo et al. further teaches that the cell immobilization layer may be a woven or nonwoven material. Structurally, the woven material would need to comprise a plurality of woven fibers; therefore, the claim is anticipated.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIUS FRANCIS YOH whose telephone number is (571)272-3489. The examiner can normally be reached Monday-Friday: 7:30-5 PM.
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/J.F.Y./Examiner, Art Unit 1799 /William H. Beisner/Primary Examiner, Art Unit 1799
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