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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/13/2026 has been entered.
Status of the Claims
Claims 1-9 and 11-13 are currently pending.
Claim 1 is currently amended.
Claims 10 and 14-23 have been cancelled.
Claims 1-9 and 11-13 have been considered on the merits.
New and Maintained Rejections Necessitated by Amendment
Claim Objections
Claim 2 is objected to because of the following informalities: “The method as in 1 claim 1,” should be corrected to “The method as in claim 1,” . Appropriate correction is required.
Claim 6 is objected to because of the following informalities: “The method as in claim 3 elaim3,” should be corrected to “The method as in claim 3,” . Appropriate correction is required.
35 USC § 101
A 101 rejection was considered and not made over the currently presented claims. Prong one of the Step 2A streamlined analysis asks whether the claim recites an abstract idea, law of nature, or natural phenomenon. The claim recites the phrase “prioritizing the recipe steps”, which constitutes an abstract idea. However, prong two of the Step 2A streamlined analysis asks if the claim recites additional elements that integrate the judicial exception into a practical application. In this case, the judicial exception is integrated into a practical application. The practical application of the claim as a whole is the generation of a transplantable tissue from a donor tissue, which integrates the abstract idea. Thus a 101 rejection was not made.
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 1-9 and 11-13 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.
Claim 1 contains the phrase “iteratively decellularizing and recellularizing the donor tissue until the transplantable tissue is generated”, which is indefinite. It is not clear how one may produce a transplantable tissue if after a first round of decellularization and recellularization, that exact tissue is then again decellularized, in other words stripped of cells, and recellularized. It is not clear if the subsequent rounds of decellularization are incomplete, meaning cells meant to recellularize the tissue remain attached even through subsequent decellularization treatments. Appropriate clarification is required. For the sake of compact prosecution the phrase is being interpreted to be met by any decellularizing and recellularizing so long as the transplantable tissue is generated.
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.
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 1-9 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Boland et al (WO2007009036), in view of Bodwell et al (WO2009094182A2) and Hopkins et al (US20110165676A1) (all of which are references of record).
Claim interpretation: Claim 1 contains the phrase “iteratively decellularizing and recellularizing the donor tissue until the transplantable tissue is generated”, which is rejected above for being indefinite. For the sake of compact prosecution the phrase is being interpreted to be met by any decellularizing and recellularizing so long as the transplantable tissue is generated.
With regards to claim 1, Boland teaches a method for engineering a transplantable tissue from donor tissue (abstract). The method comprises:
Accessing recipe including recipe steps ([0062]),
Receiving input from a GUI (i.e., user interface) ([0077]),
Accessing the recipe steps, GUI input, and a valve by a controller ([0074]),
Forming one controller command based on the valve recipe steps and GUI ([0074]), and
Executing one controller command to engineer the donor originated transplantable tissue (abstract, [0074]).
Boland teaches that the cartridge and graft chamber cartridge are disposable cartridges as required by claim 1 (claim 71 of Boland and [0080]). Boland teaches that the GUI and recipe is updated and controlled based on status allowing full or partial automation as required by claim 2 ([0074]/[0062]). Boland teaches the additional steps of claim 3 as follows:
Configuring at least one valve in a fluid path according to the recipe ([0074]),
Continually adjusting the fluid path by manipulating a valve based on the recipe ([0074]),
Pumping saline (i.e., water) through the fluid path past one valve to a mix cassette based on the recipe ([0074] and Claim 38 of Boland),
Pumping serum (i.e., at least one solution) through the fluid path to the mix cassette based on the recipe ([0056]/ [0074]),
Mixing the saline and serum in the mix cassette to form a medium based on the recipe ([0056]),
Pumping the medium to a reservoir based on the recipe ([0055]),
Pumping the medium from the reservoir to the bioreactor ([0055]), and
Pumping the medium from the bioreactor to a drain based on the recipe ([0047]).
Boland teaches that the water is saline (claim 38 of Boland) which is filtered (claims 44-46 of Boland) as required by claim 5. Further, Boland teaches that the saline is deaerated ([0087]) and stored in a reservoir as required by claim 5 ([0047]). Boland teaches that the serum (i.e., solution) is concentrated (Boland dilutes 1:6 ratio) as required by claim 6 ([0055]).
Boland teaches the following additional step as required by claims 1 and 7:
Housing the donor tissue in a bioreactor in communication with a cassette ([0082]),
Receiving a command from a controller to a module processor ([0062]),
Generating a module command based on the controller command to a module ([0062]),
Receiving the command to the module ([0062]),
Generating by the module a plurality of valve commands based on the module command which governs flow through a plurality of valves controlling pressure ([0062]).
Boland also teaches that the cassettes are pneumatically controlled (i.e., controlled by air) ([0087]) and disposable (see claim 38 of Boland) as required by claims 1, 8, 9, and 23. Further, Boland teaches the addition of an agent to the medium ([0058]) and the introduction of a cell culture ([0051]) as required by claim 12. Further, Boland teaches the following additional steps as required by claim 13:
Configuring a valve in the fluid path according to a recipe ([0062]),
Continually adjusting the fluid path by manipulating the at least one valve based on the recipe ([0062]),
Pumping saline though the fluid path past a valve to a mix cassette based on the recipe ([0074]/[0055]),
Pumping the serum (solution) through the fluid path past a valve to a mix cassette based on the recipe ([0074]/[0055]),
Pumping the saline and serum to mix and form a medium in the mix cassette based on the recipe ([0074]/[0055]),
Pumping the medium to a reservoir ([0074]/[0055]),
Pumping the medium through the fluid path to a bioreactor ([0074]/[0055]),
Pumping used medium to a drain (i.e., waste) ([0047]).
Although Boland teaches a graphical user interface which handles the entire procedure without user action, Boland does not explicitly state that the GUI is able to resolve conflicts in real time, wherein resolving the conflicts comprises automatically prioritizing the recipe steps over the GUI input and the default values and generating the controller command without user intervention during execution of the recipe as required by the newly amended claim 1. Boland does not teach the addition of a flexible sheet covering the pump chamber, fluid valve, and cassette as required by claims 1 and 7.
However, Bodwell teaches a similar method involving a plurality of fluid lines (abstract) and a flexible sheet (membrane) which provides a dead space between the spacers and the membrane, while minimizing any reduction to the intended stroke capacity of the pump chambers (pg.33, para 1). The user interface of Bodwell is able to resolve conflicts in real time as required by claim 1 (see Alert/Alarm Function; last para of pg. 87 spanning 90; and Fig. 56). The user interface of Bodwell performs resolving various types of conflicts including during the execution of the recipe which is termed the “therapy conditions” in Bodwell (pg. 87, last para). Bodwell teaches that the alerts/alarms relating to “Therapy conditions” are caused by a status or variable associated with the therapy going outside of allowable bounds, additionally, Bodwell explicitly states that “the responsibility for handling alerts or alarms associated with therapy conditions is also shared between the UI model and therapy subsystems…actions that may be taken in response to the system error conditions, therapy conditions, or system operation conditions described above are implemented by the subsystem (or layer) that detected the condition” (pg. 89, para 2-4). Additionally, Bodwell teaches that actions may be taken by the system such as “pausing the therapy and engaging the occluder; clearing states and timers as needed; disabling the heater; ending the therapy entirely; deactivating the safe line to close the occluder, shut off the heater, and removing power from the valves; and preventing the cycler from running therapies even after a power cycle to require the system to be sent back to service”, and Fig. 56 demonstrates a sequence diagram with various examples of both alerts/alarms that are resolved prior to escalation to a user as well as alert/alarm functions which end the process due to safety concerns (Fig. 56 and pg. 89, para 4). Thus, the alert/alarm functions of Bodwell meet the limitations of claim 1.
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the method of Boland with the flexible sheet and GUI capabilities taught by Bodwell to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Bodwell teaches that the flexible sheet provides a dead space between the spacers and the membrane, while minimizing any reduction to the intended stroke capacity of the pump chambers (pg. 33, para 1) and that the automation of the alert/alarm system is beneficial for detecting process terminations and transitions to a safe state if a process is ongoing (pg. 88, para 2-3). One of ordinary skill in the art would have a reasonable expectation of success when combining Boland with Bodwell because they are both in the field of medical instrumentation.
Boland and Bodwell do not teach that the water used is specifically deionized water as required by claim 4. Boland and Bodwell do not teach that the tissue is decellularized as required by claims 1, 7, and 11. Boland and Bodwell do not teach that the tissue is recellularized as required by claims 1 and 11.
However, Hopkins teaches a method of decellularization and recellularization. Hopkins teaches that the decellularization method comprises the use of at least one reservoir including ports/ valves, at least one bioreactor, and tubing enabling the fluidic connections ([0130]/[0140]/[0192]/[0173]. Hopkins teaches that the method of decellularization includes the use of double deionized water when reciprocating osmotic shock sequences as required by claim 4 ([0014]). Further, Hopkins discloses recellularizing ([0010]). Hopkins discloses that the method has several advantages such as removal of residual cell debris (abstract).
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the method of Boland and Bodwell with the decellularization/recellularization taught by Hopkins to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Hopkins discloses recellularizing ([0010]). Hopkins discloses that the method has several advantages such as removal of residual cell debris (abstract). One of ordinary skill in the art would have a reasonable expectation of success when combining Boland and Bodwell with Hopkins because Hopkins teaches the full method of decellularization/recellularization using a similar bioreactor system.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 03/13/2026 have been fully considered but they are not persuasive.
Applicant argues (Remarks, pg. 7) that the rejection employing Bodwell is based on impermissible hindsight reconstruction and that Bodwell does not teach “resolving conflicts in real time” nor “arbitrating between competing command sources, resolving conflicts between user input and automated recipe steps, or dynamically generating controller commands based on multiple competing instruction sources”. Applicant argues that Bodwell only demonstrates “fault detection, not command arbitration”.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant’s argument that Bodwell only demonstrates “fault detection, not command arbitration”, the argument is not found persuasive because Fig. 56 of Bodwell, cited above, does demonstrate a system which is able to auto correct for various problems prior to escalating to an alert or alarm. The user interface of Bodwell performs resolving various types of conflicts including during the execution of the recipe which is termed the “therapy conditions” in Bodwell (pg. 87, last para). Bodwell teaches that the alerts/alarms relating to “Therapy conditions” are caused by a status or variable associated with the therapy going outside of allowable bounds, additionally, Bodwell explicitly states that “the responsibility for handling alerts or alarms associated with therapy conditions is also shared between the UI model and therapy subsystems…actions that may be taken in response to the system error conditions, therapy conditions, or system operation conditions described above are implemented by the subsystem (or layer) that detected the condition” (pg. 89, para 2-4). Additionally, Bodwell teaches that actions may be taken by the system such as “pausing the therapy and engaging the occluder; clearing states and timers as needed; disabling the heater; ending the therapy entirely; deactivating the safe line to close the occluder, shut off the heater, and removing power from the valves; and preventing the cycler from running therapies even after a power cycle to require the system to be sent back to service”, and Fig. 56 demonstrates a sequence diagram with various examples of both alerts/alarms that are resolved prior to escalation to a user as well as alert/alarm functions which end the process due to safety concerns (Fig. 56 and pg. 89, para 4). Thus, the alert/alarm functions of Bodwell meet the limitations of claim 1.
Therefore, the argument is not found persuasive.
Applicant argues (Remarks, pg. 8) that the combination of arts lacks a motivation and that the rejection asserts the motivation to combine is because the arts are “both in the field of medical instrumentation”.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it appears that applicant has misinterpreted the reasoning to combine Boland with Bodwell provided in the rejection. One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the method of Boland with the flexible sheet and GUI capabilities taught by Bodwell to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Bodwell teaches that the flexible sheet provides a dead space between the spacers and the membrane, while minimizing any reduction to the intended stroke capacity of the pump chambers (pg. 33, para 1) and that the automation of the alert/alarm system is beneficial for detecting process terminations and transitions to a safe state if a process is ongoing (pg. 88, para 2-3). One of ordinary skill in the art would have a reasonable expectation of success when combining Boland with Bodwell because they are both in the field of medical instrumentation. Thus, the reason to combine Boland with Bodwell in reference to the alert/alarm function is “that the automation of the alert/alarm system is beneficial for detecting process terminations and transitions to a safe state if a process is ongoing (pg. 88, para 2-3)” and the phrase “both in the field of medical instrumentation” was provided as a reasonable expectation of success in combining Boland with Bodwell. Thus, the argument is not found persuasive.
Applicant argues (Remarks, pg. 9) that Hopkins does not teach iteratively decellularizing and recellularizing nor does Hopkins remedy the alleged deficiencies of Bodwell; further applicant argues that the references fail to teach the claimed invention as an integrated system.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response, Hopkins teaches a method of decellularization and recellularization. Hopkins teaches that the decellularization method comprises the use of at least one reservoir including ports/ valves, at least one bioreactor, and tubing enabling the fluidic connections ([0130]/[0140]/[0192]/[0173]. Additionally, Hopkins teaches recellularization of the decellularized graft ([0202]/[0010]/[0022]/[0059]). Thus, Hopkins teaches a method of decellularizing and recellularizing a donor tissue until a transplantable tissue is generated which meets the limitation of claim 1 of “iteratively decellularizing and recellularizing the donor tissue until the transplantable tissue is generated”. Therefore, the argument is not found persuasive.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632
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