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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group III, Claims 15-32, in the reply filed on 5/29/2026 is acknowledged.
Claims 1-14 and 33-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/29/2026.
Information Disclosure Statement
The information disclosure statement dated 8/27/2024 has been considered and made of record.
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 do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“micro-pumping mechanisms” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend 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 avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 15-32 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.
In claim 15, at line 8, “the chip” lacks clear antecedent basis. Note: Claim 15 recites that the system includes “at least one human-on-chip” and “at least one organ-on-chip”. Clarification and/or correction is requested.
In claim 15, at line 8, recitation of “valves” is considered indefinite since it is not clear if these are additional valves or part of the previously recited “at least one valving system”. Clarification and/or correction is requested.
In claim 17, “the at least one biochip” lacks clear antecedent basis. Note: Claim 15 recites that the system includes “at least one human-on-chip” and “at least one organ-on-chip”. Clarification and/or correction is requested.
In claim 17, reference to “the control system” is considered indefinite because it is not clear how a biochip, which is part of the control system, can connect to itself. Clarification and/or correction is requested.
In claims 18 and 19, “the at least two biochips” lacks antecedent basis.
In claim 20, “the at least one inlet and outlet” lacks antecedent basis.
In claim 21, “at least one duct” lacks clear antecedent basis.
In claim 22, “at least one stroma” lacks clear antecedent basis.
In claim 23, “at least one duct” and “at least one stroma” lack clear antecedent basis.
In claim 24, “at least one biochip” and “at least one measuring device” lack clear antecedent basis.
In claims 30 and 31, “at least one biochip” lacks clear antecedent basis.
Claims 16, 25-29 and 32 are indefinite because they depend from indefinite claims and fail to cure the deficiencies of the claims from which they depend.
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 15-32 are rejected under 35 U.S.C. 103 as being unpatentable over Wikswo et al. (US 2015/0004077) (IDS dated 8/27/2024) in view of Nath et al. (US 2018/0066220) (Attached PTO-892).
With respect to claim 15, the reference of Wikswo et al. discloses:
A biochip fluidic control system organ cartridge and organ chips define
a control system)(¶[0163]), the fluidic control system comprising:
at least one human-on-chip (Organ cartridge) (¶[0163]) containing at least one organ-on-chip system (Organ chip) (¶[0163]);
at least one valving system (valves)(¶[0163]-[0164]) controlling flow to each compartment (valves control flow within organ chips)(¶[0163]);
at least one micro-pumping mechanism (micropumps which is considered a functional equivalent to the disclosed micro-pumping mechanism (see 35 USC 112(f) discussion above)) (¶[0163]) that can pump and control the flow to at least one compartment (micropumps control flow within organ chips) (¶[0163]);
at least one actuator (perfusion controller) (¶[0164]-[0165]) controlling valves (valves) (¶[0163]-[0164]) controlling valves on the chip (Organ chip) (¶[0163]) and leading to the chip (the valves allow dynamic control of cartridge-to-cartridge connections and cartridge subassemblies) (¶[0164]-[0165]);
at least one actuator (perfusion controller) (¶[0164]) controlling fluid pumping to each compartment (perfusion controller controls micropumps) (¶[0164]-[0165]);
wherein the at least one valving system (valves) (¶[0163]-[0164]) could open or close and shift flow pathways to each compartment (the valves allow dynamic control of cartridge-to-cartridge connections and cartridge subassemblies) (¶[0164]-[0165]).
Claim 15 differs because the reference of Wikswo et al. fails to disclose wherein the at least one organ-on-chip system contains at least one ductal scaffold interfacing with at least one surrounding compartment.
The reference of Nath et al. discloses that organ-on-chip systems (10) (Fig. 1) are known that contain at least one ductal scaffold (HF) (11) interfacing with at least one surrounding compartment (chamber) (12) which can be integrated within microfluidic systems with multiple organ-on-chip systems with fluid management (¶[0049]).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to employ an organ-on-chip system as suggested by the reference of Nath et al. in the multiple organ system of the reference of Wikswo et al. for the known and expected result of providing an art recognized organ-on-chip system that is capable of more closely recapitulating the tissue micro-environments needed to perform complete mechanistic studies on normal tissue and cancer (¶[0004] of Nath et al.).
With respect to claim 16, the structure resulting from the combination of the references as discussed above with respect to claim 15 encompasses at least one valving system (valves) (¶[0163]-[0164]) may be at least one of pneumatically, mechanically, electrically, and fluidically actuated (perfusion controller electrically actuates valves) (¶[0163]-[0164]).
With respect to claim 17, the structure resulting from the combination of the references as discussed above with respect to claim 15 encompasses at least one valving system (valves) (¶[0163]-[0164]) connects the at least one biochip (valves connect organ chip to organ cartridge) (¶[0163]-[0164]) to the control system (the defined control system) (¶[0163]).
With respect to claim 18, the structure resulting from the combination of the references as discussed above with respect to claim 15 encompasses at least one valving system (valves) (¶ [0163]-[0164]) connects at least two biochips (organ chips) (¶[0163] and [0255]) in a human-on-chip connection plate (base substrate) (¶[0168]).
With respect to claim 19, the structure resulting from the combination of the references as discussed above with respect to claim 15 encompasses at least one valving system (valves) (¶[0163]-[0164]) controls at least two biochips (organ chips) (¶[0163]-[0165] and [0255]) in a human-on-chip connection plate (base substrate) (¶[0168]).
With respect to claim 20, the structure resulting from the combination of the references as discussed above with respect to claim 15 encompasses at least one valving system (valves) (¶[0163]-[0164]) controls at least one inlet (inlet) (¶[0067] and [0273]) and outlet (outlet) (¶[0067] and [0274]) of a biochip (valves control fluid from to and from organ chips) (¶[0163]-[0165] and [0222]).
With respect to claims 21-23, the reference of Wikswo et al. discloses the various communications that can be provided between the organ chips which includes communication between interstitial channels (¶[0069]), between microvascular channels (¶[0070]), and between the interstitial channel of one organ chip to the microvascular channel of another organ chip (¶[0071]).
In view of this teaching, it would have been obvious to one of ordinary skill in the art to connect the ducts and stroma as required of claims 21-23 as is conventional in the art as evidenced by the disclosure of the reference of Wikswo et al.
With respect to claim 24, the structure resulting from the combination of the references as discussed above with respect to claim 15 encompasses at least one valving system (valves) (¶[0163]-[0164]) connects at least one biochip (organ chip) (¶[0163]) to at least one measuring device (micro-clinical analyzers) (¶[0163]).
With respect to claim 25, if the rotary valve (¶[0275]) of the reference of Wikswo et al. is not considered a bistable valve, in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to determine the optimum valve structure to employ while maintaining the required fluid control within culture system.
With respect to claim 26, the structure resulting from the combination of the references as discussed above with respect to claim 15 encompasses at least one valving system (valves) (¶[0163]-[0164]) contains at least one open close valve (rotary valve) (¶[0275]).
With respect to claims 27-29, in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to determine the optimum valve structure to employ while maintaining the required fluid control within culture system.
With respect to claim 30, the structure resulting from the combination of the references as discussed above with respect to claim 15 encompasses at least one valving system (valves) (¶[0163]-[0164]) controls media insertion in at least one biochip (valves control delivery of fluidic samples to organ chips) (¶[0163] and [0255]).
With respect to claim 31, the structure resulting from the combination of the references as discussed above with respect to claim 15 encompasses at least one valving system which is structurally capable of controlling cell insertion in at least one biochip. Note: A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention for the prior art. If the prior art is capable of performing the intended use, it meets the claim.
With respect to claim 32, the structure resulting from the combination of the references as discussed above with respect to claim 15 encompasses at least one valving system which is structurally capable of maintaining a cell culture by media insertion. Note: A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention for the prior art. If the prior art is capable of performing the intended use, it meets the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H BEISNER whose telephone number is (571)272-1269. The examiner can normally be reached on Mon-Fri from 8am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL A MARCHESCHI, can be reached at telephone number (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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/William H. Beisner/
Primary Examiner
Art Unit 1799
WHB
Prosecution Insights