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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/11/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 05/31/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-30 in the reply filed on 02-19-2026 is acknowledged.
It should be noted that this application has been transferred to another examiner due to Applicant’s election of Group I.
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: a flow control module, a pressure control module, a force control module and an imaging module in claims 1 and 30.
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 § 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, 4-14, 16, 17, 19-26 and 29 are rejected under 35 U.S.C. 102a1 as being anticipated by Sakamoto et al. WO 2017/070392 A1 – hereafter ‘392).
‘392 discloses a system for decellularizing an isolated organ (Abstract) that includes the following limitations for claim 1:
“Apparatus for real-time in situ tissue imagining”: ‘392 discloses a decellularization chamber (Fig. 12; [0020]) that is being interpreted as the apparatus of the instant application. Furthermore, the device of ‘392 is fully capable of real-time in situ tissue imagining the apparatus. It should be noted that preamble statements reciting the purpose or intended use of the invention rather than any distinct definition of any of the claimed invention's limitations is not considered to structurally define the claimed invention over the prior art. See also MPEP 2111.02 II and 2114.
“a tissue culture chamber adapted to hold a tissue of interest”: ‘392 discloses a tissue culture chamber (Fig. 12; [0211]) that holds tissue.
“a culture medium connected to aid tissue culture chamber”: ‘392 discloses a source of culture medium connected to the chamber ([0227[).
“a flow control module configured to act on the tissue of interest”: ‘392 discloses a flow control module such as a pump (Fig. 12; [0163]) that acts on the tissue. This pump is the equivalent to the flow control module of the instant application.
“a pressure control module configured to act on the tissue of interest”: ‘392 discloses a compressor (Fig. 12; [0165]) that is used to create a pressure gradient on the tissue and is the equivalent of the pressure control module of the instant application.
“a force control module configured to act on the tissue of interest”: ‘392 discloses that a shaker is used to spread the cells int eh chamber ([0248]) where this is the equivalent to the force control module of the instant application.
“an imaging module adapted to image the tissue of interest.”: ‘392 uses an IVIS (in vivo imaging system) system ([0246]) that takes an image of the tissue and is being interpreted as the imaging module of the instant application.
For claim 4, ‘392 discloses that the tissue is a mammalian lung ([0013]).
For claim 5, the imaging system of ‘392 is fully capable of visualizing the tissue in a continuous manner in a non-destructive manner.
For claim 6, the imaging system is fully capable of monitoring the tissue at a single cell level.
For claim 7, the lung and device is fully capable of simulating mucociliary impairment in vitro.
For claim 9, the apparatus of ‘392 simulates breathing ([0164]) by regulating air flow to the lung.
For claim 10, the apparatus of ‘392 is fully capable of simulating a cough.
For claim 11, ‘392 discloses that the system of ‘392 is used for treating a disease and therefore models a disease within the tissue ([0082]).
For claim 12, ‘392 discloses that the apparatus is used for reducing disease and disorders within the tissue ([0158]) where this is being interpreted as including breathing disorders.
For claim 13, ‘392 discloses that the pharmacokinetics of drugs supplied to the tissue ([0236]) where this would include using the imaging system.
For claim 14, ‘392 discloses a drug delivery system such as syringes ([0080]). This is being interpreted as the liquid installation means of the instant application.
For claim 16, ‘392 discloses using a therapeutic agent such as genes ([0067]) where this is being interpreted as the gene therapy of the instant application.
It should be noted for claims 17, 19-21, 24-26 that the limitations are drawn to the intended use of the claimed invention and do not provide a structural limitation that defines over the prior art (see MPEP §2114) and the following rejections are based on this interpretation.
For claim 17, the imaging system is fully capable of employing fluorescent imaging as fluorescent labels are used within the device ([0160]) as part of the analytical methods since the imaging system of ‘392 is the structural equivalent of the imaging module of the instant application.
For claim 19, the pump, compressor and shaker of ‘392 are fully capable of replacing endogenous airway cells within the tissue with exogenous airway primary cells since the pump, shaker and compressor of ‘392 is the structural equivalents of the flow control module, pressure control module and the force control module of the instant application of the instant application.
For claim 20, the pump of ‘392 would be fully capable of removing cellular components in conjunction with a delivered chemical treatment since the pump of ‘392 is the structural equivalent of the flow control module of the instant application.
For claim 21, the pump of ‘392 is fully capable of delivering exogenous cells for repopulation to the tissue since the pump of ‘392 is the structural equivalent of the flow control module of the instant application.
For claims 22 and 23, ‘392 discloses that the scaffold can be made from collagen ([0098]) that is fully capable of being delivered by a hydrogel or a culture medium. Moreover, Applicant is reminded that process steps in an apparatus are not accorded patentable weight. “The patentability of a product does not depend on its method of production”. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)." Furthermore, the processing steps do not structurally define the instant application over the prior art since the claimed processing steps do not impart a distinctive structural characteristic to the final product.
For claim 24, the imaging system of ‘392 is fully capable of monitoring removal of endogenous cells and distribution of exogenous cells in in-vitro since the imaging system of ‘392 is the structural equivalent of the imaging system of the instant application.
For claim 25, this is drawn to the intended use of the claimed invention which does not structurally define the claimed invention over the prior art. See MPEP §2114.
For claim 26, the shaker of ‘392 is fully capable of modulating the frequency, amplitude and/or magnitude of an applied mechanical vibration since the shaker of ‘392 is the structural equivalent of the force control module of the instant application
For claim 29, ‘392 discloses that the systems are controlled by a computer ([0106]).
Therefore, ‘392 meets the limitations of claims 1, 4-14, 16, 17, 19-21, 24-26 and 29.
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 2, 3 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto et al. (WO 2017/070392 A1 – hereafter ‘392) in view of Hui (WO 2010/005746 A1 – hereafter ‘746).
For claim 2, ‘392 (Sakamoto) differs from the instant claim regarding the use of actuators pressure sensors, flow sensors and a valve.
‘746 (Hui) discloses an apparatus for cell culture ([004]) that for claim 2 includes using valves to selectively couple the liquid and gas source to the vessel ([008]), pressure sensors ([0106]; “Fig. 16) and flow meters ([0116]). These sensors and valves allow for managing flow dynamics within the reactor ([0116]). ‘746 further discloses using an actuator coupled to the bioreactor ([072]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the actuators, sensors and valve of ‘746 within ‘392 in order to control the flow of culture medium to the rector. The suggestion for doing so at the time would have been in order to prevent fluid flow disruptions to the system ([0116]).
For claim 3, the chamber of ‘392 is fully capable of imitating physiological microenvironments.
‘392 (Sakamoto) discloses a system for decellularizing an isolated organ (Abstract) that includes the following limitations for claim 30:
“A cough generation system”: ‘392 discloses a decellularization chamber (Fig. 12; [0020]) that is being interpreted as the apparatus of the instant application. Furthermore, the device of ‘392 is fully capable of generating a cough. It should be noted that preamble statements reciting the purpose or intended use of the invention rather than any distinct definition of any of the claimed invention's limitations is not considered to structurally define the claimed invention over the prior art. See also MPEP 2111.02 II and 2114.
“a tissue culture chamber adapted to hold a tissue of interest”: ‘392 discloses a tissue culture chamber (Fig. 12; [0211]) that holds tissue.
“a culture medium connected to aid tissue culture chamber”: ‘392 discloses a source of culture medium connected to the chamber ([0227[).
“a flow control module configured to act on the tissue of interest”: ‘392 discloses a flow control module such as a pump (Fig. 12; [0163]) that acts on the tissue. This pump is the equivalent to the flow control module of the instant application.
“a pressure control module, including a computer-controlled air compressor, configured to act on the tissue of interest”: ‘392 discloses a compressor (Fig. 12; [0165]) that is used to create a pressure gradient on the tissue and is the equivalent of the pressure control module of the instant application. Moreover, ‘392 discloses an air compressor (Fig. 12; [0165]) that is computer controlled ([0106]).
“a force control module configured to act on the tissue of interest”: ‘392 discloses that a shaker is used to spread the cells into the chamber ([0248]) where this is the equivalent to the force control module of the instant application.
“an imaging module adapted to image the tissue of interest.”: ‘392 uses an IVIS (in vivo imaging system) system ([0246]) that takes an image of the tissue and is being interpreted as the imaging module of the instant application.
‘392 differs from the instant claim regarding the use of pressure sensors, flow sensors and a valve.
‘746 (Hui) discloses an apparatus for cell culture ([004]) that for claim 30 includes using valves to selectively couple the liquid and gas source to the vessel ([008]), pressure sensors ([0106]; “Fig. 16) and flow meters ([0116]). These sensors and valves allow for managing flow dynamics within the reactor ([0116]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the sensors and valve of ‘746 within ‘392 in order to control the flow of culture medium to the rector. The suggestion for doing so at the time would have been in order to prevent fluid flow disruptions to the system ([0116]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto et al. (WO 2017/070392 A1 – hereafter ‘392) in view of Simpson et al. (US 2004/0037813 A1 – hereafter ‘813).
‘392 (Sakamoto) differs from the instant claim 15 regarding an aerosolization means.
‘813 (Simpson) discloses a system for electrodepositing collagen (Abstract) that includes using an aerosol delivered by nozzles ([0145]) as a means to suspend cells and deposit the cells onto a surface such as a scaffold ([0094]). ‘813 discloses that supplying a suspension by an aerosol is just one of many means that are familiar to one of ordinary skill in the art ([0269]).
‘813 is analogous art to the claimed invention as ‘392 provides methods for manufacturing engineered tissue and organs ([0012]) and can be used for substance delivery for testing the efficacy of pharmaceuticals ([0155]).
Therefore, it would have been obvious to one of ordinary skill in the art to employ the aerosolization means of ‘813 within ‘392 in order to supply a pharmaceutical carrier to a scaffold. The suggestion for doing so at the time would have been in order to deliver aerosol droplets to a surface or site of interest on demand ([0192]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto et al. (WO 2017/070392 A1 – hereafter ‘392) in view of Friedman (US 2003/0081499 A1 – hereafter ‘499).
‘392 (Sakamoto) discloses a shaker, but does not specifically disclose an electromagnetic shaker.
‘499 (Friedman) discloses a multidirectional shaker (Abstract) that for claim 18 includes an electromagnetically-actuated multidirectional shaker (Fig. 2; [0052]) that includes a first and second electromagnet that vibrate a platform in a horizontal direction ([0021]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the electromagnetic shaker of ‘499 within ‘392 in order to provide a mechanical force to the culture chamber. The suggestion for doing so at the time would have been in order to ensure efficient mixing of the contents of the chamber ([0012]).
Claims 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto et al. (WO 2017/070392 A1 – hereafter ‘392) in view of Grover et al. (CN 110381854 A – hereafter ‘854 and reference will be made to the enclosed machine translation).
‘392 (Sakamoto) differs from the instant claims of 27 and 28 regarding an optical fiber probe.
‘854 (Grover) discloses a method for administering substances into a body cavity (page 4, fourth paragraph) that for claim 27 includes delivering light through an optical fiber (page 18, first paragraph). This allows for light such as ultraviolet or infrared to be sent to a target (page 18, third paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the optical fiber of ‘854 within ‘392 in order to send light to the fluorescent probes. The suggestion for doing so at the time would have been in order to direct light to the desired target (page 23, eight paragraph).
For claim 28, ‘854 discloses that the diameter of the fibers can be between 200-500 microns (page 24, first paragraph). This range encompasses the claimed diameter and the diameter can be chosen based on the particular application.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the optical fiber diameter of ‘854 within ‘392 in order to send light to the fluorescent probes. The suggestion for doing so at the time would have been in order to direct light to the desired target (page 23, eight paragraph).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rouhani et al. (US 2005/0084951 A1) discloses a bioreactor for growing tissue in a three-dimensional mass.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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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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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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