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 with traverse of Group I, claims 1-9, 15, and 16 and Group II, claims 10-14 in the reply filed on 09/11/2025 is acknowledged. The traversal is on the ground(s) that applicant asserts the "matrix holder has a single central opening or cavity and the matrix holder is also horizontally oriented when retained by the well strip…". This is not found persuasive because as cited in the Election/Restriction requirement mailed on 06/20/2025, the reference cited in the restriction pertained to the claim set (dated 08/05/2022) by applicant, at the time the restriction was mailed. Therefore, the reference relied upon addressed technical feature noted in the requirement and therefore, it stands and is final.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: cell culture units, transport unit, uptake unit, centering unit in claims 1, 6-9, and 16.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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.
Claim 8 is 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.
Claim 8 recites the limitation "the support rail" in line 2. There is insufficient antecedent basis for this limitation in the claim. In particular, the term “the support rail (20)” is not cited in the dependent claim 6, but rather it is cited in claim 7. Also, the term “the rail support (20)” has a different element number than the term “the rail support (22)” recite din claim 7.
Claim 8 recites the limitation "the spacer (24)" in 3. There is insufficient antecedent basis for this limitation in the claim. In particular, the term “spacer (24)” is not recited in claim 6, from which claim 8 depends on.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/05/2022 and 11/30/2022 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 6-7, 9 , and 15 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.
The term “optionally” in claims 7 and 15 is a relative term which renders the claim indefinite. The term “optionally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “approximately” in claim 9 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
Claims 1-3, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2016/0201037 A1-Tuan et al. (hereinafter Tuan).
Regarding claim 1, Tuan discloses a cell culture device (3-dimensional (3D) microsystem that models the structure and biology of tissues that are adjacent or contiguous in the body, para. [0009], lines 1-4) for three-dimensional cell culture (tissue culture, para. [0068], lines 7-8) comprising one or more cell culture units (bioreactors 100 in array 200, para. [0052], lines 1-3, Fig. 2 and shell 300 and inner body 302, para. [0053], lines 1-2, Fig. 3), wherein each cell culture unit (21) comprises: i. at least one matrix holder (12)—(shell 300 and inner body 302, para. [0053], lines 1-2, Fig. 3) with a single, central opening or cavity (13)—(cylindrical space 330, para. [0054], line 6, Fig. 3) for uptake of a matrix; ii. a support (10)—(protruding ring 320, para. [0053], line 13, Fig. 3) which is fixedly or reversibly connected to the at least one matrix holder (12);
Tuan discloses and iii. a well strip (11)—(a well strip of array 200 is shown below in annotated Fig. 2) consisting of a vessel with at least one cavity, wherein the cavity can retain at least one matrix holder (12) up to at least an upper end of the central opening (13), wherein the matrix holder (12) is vertically oriented (the matrix holder discussed above is disposed horizontally in well strip—array 200, shown in annotated Fig. 2), and wherein the matrix holder is horizontally oriented when retained by the well strip.
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Regarding claim 2, Tuan discloses wherein the central opening (13)—(cylindrical space 330, para. [0054], line 6, Fig. 3) of the matrix holder (12) is a continuous opening (13a and 13c)—(the space 320 is a continuous opening as shown in Fig. 3) or a cavity with a wall (13b), wherein the central opening (13) comprises a matrix, and wherein the matrix is a solid porous support, a hydrogel, or a combination thereof (“chondrocyte” refers to cells found in healthy cartilage, which help to produce and maintain the cartilaginous matrix, para. [0043], lines 1-3; para. [0043], lines 12-14).
Regarding claim 3, Tuan discloses wherein the matrix consists of natural, semi-synthetic or synthetic material, or a combination thereof (“matrix” can include any of various suitable biological or synthetic materials, para. [0043], lines 13-14), wherein the natural material is selected from the group consisting of collagen, fibrin, glycosamine glycans, and hyaluronic acid, and wherein the synthetic or semi-synthetic material is selected from the group consisting of polymethyl methacrylate, polylactic acid, polyglycol, polystyrene, hydroxyapatite and tricalcium phosphate (para. [0070], lines 8-10).
Regarding claim 5, Tuan discloses wherein the device comprises at least 5, or at least 10 matrix holders (12)—(shell 300 and inner body 302 can be used in array 200, which comprises 96 bioreactors 100, Fig. 3, para. [0054], lines 9-11).
Claim Rejections - 35 USC § 103
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 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 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0201037 A1-Tuan et al. (hereinafter Tuan) as applied to claim 1 above, and further in view of a different embodiment of US 2016/0201037 A1-Tuan et al. (hereinafter Tuan, referring to Fig. 5).
Regarding claim 6, Tuan teaches the invention discussed above in claim 1. Further, Tuan teaches one or more cell culture units. However, Tuan does not explicitly teach a transport unit.
For claim 6, a different embodiment of Tuan teaches a transport unit (mount 506, para. [0061], line 5), which reads on the instant claim limitation of a transport unit.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the device of Tuan and include a transport unit as taught by a different embodiment of Tuan. Further, a different embodiment of Tuan teaches mount 506 can move array 502 and mount 506 can be actuated to move plate 508 (para. [0061], lines 4-7).
Regarding claim 8, Tuan discloses wherein the well strip (11) comprises a position (25) for attachment to the support rail (20), or wherein the cell culture units are arranged in parallel in the spacer (24)—(all well strip is discussed above in annotated Fig. 2), and the culture units (bioreactors 100 are in a parallel orientation, as shown in Fig 2, further, spacer is shown in Fig. 2, where there are spaces between each bioreactor 100).
Allowable Subject Matter
Claims 4, 7, and 9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: for claim 4, the prior art fails to teach or fairly suggest wherein an interior surface of the side wall comprises: a first interior surface segment; a second interior surface segment parallel or substantially parallel to the first interior surface segment; and a third interior surface segment between the first and second interior surface segments, wherein each of the first and second interior surface segments is planar or substantially planar, and the third interior surface segment is curved in accordance with the vessel, where this is in combination with the claim as a whole.
The closet prior art is US 2016/0201037 A1-Tuan et al. (hereinafter Tuan). Tuan discloses various bioreactor devices and systems for growing cellular material, and related methods of growing cellular material. However, Tuan does not explicitly teach wherein the support comprises an element for connection with the matrix holder and the matrix holder comprises notches at its upper end, wherein the matrix holder can be reversibly connected to the element of the support by the notches.
The following is a statement of reasons for the indication of allowable subject matter: for claim 7, the prior art fails to teach or fairly suggest wherein the transport unit comprises: i. a support rail for attachment of one or more cell culture units to the transport unit, ii. an uptake unit for the support rail, iii. a cover, and iv. two spacer elements, wherein the spacer elements are optionally directly connected to each other for uptake in an orderly manner of at least two or more supports (10) of a matrix holder, v. optionally at least one identification element, the identification element being a RFID chip or a barcode, and vi. optionally a centering unit, where this is in combination with the claim as a whole.
The closet prior art is US 2016/0201037 A1-Tuan et al. (hereinafter Tuan). Tuan discloses various bioreactor devices and systems for growing cellular material, and related methods of growing cellular material. However, Tuan does not explicitly teach wherein the transport unit comprises: i. a support rail for attachment of one or more cell culture units to the transport unit, ii. an uptake unit for the support rail, iii. a cover, and iv. two spacer elements, wherein the spacer elements are optionally directly connected to each other for uptake in an orderly manner of at least two or more supports (10) of a matrix holder, v. optionally at least one identification element, the identification element being a RFID chip or a barcode, and vi. optionally a centering unit.
The following is a statement of reasons for the indication of allowable subject matter: for claim 9, the prior art fails to teach or fairly suggest wherein the transport unit comprises: i. a first plate forming the underside of the transport unit, ii. openings in the first plate for centering the transport unit on the plate, iii. openings in the first plate for screw fittings (50),iv. a second plate mounted approximately at a middle height of the transport unit, v. magnetizable metal bars, vi. a centering holder, vii. openings in the second plate for the centering holder ,viii. and a centering object, where this is in combination with the claim as a whole.
The closet prior art is US 2016/0201037 A1-Tuan et al. (hereinafter Tuan). Tuan discloses various bioreactor devices and systems for growing cellular material, and related methods of growing cellular material. However, Tuan does not explicitly teach wherein the transport unit comprises: i. a first plate forming the underside of the transport unit, ii. openings in the first plate for centering the transport unit on the plate, iii. openings in the first plate for screw fittings (50),iv. a second plate mounted approximately at a middle height of the transport unit, v. magnetizable metal bars, vi. a centering holder, vii. openings in the second plate for the centering holder ,viii. and a centering object.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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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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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799