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.
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 1, 3-6, 9, 15, 18-20 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Neuenfeldt et al. (US 5,964,261) in view of Gentile et al. (WO 01/08630) and Klatt (US 4,597,765).
With respect to claim 1, the reference of Neuenfeldt et al. discloses:
An engineered tissue construct transport and containment method comprising:
storing a bioreactor (container)(5) and an engineered tissue construct (implant device)(1) within a transport package (overpouch)(35)(col. 4, lines 35-60, and col. 6, lines 39-60) via an opening in the package (overpouch opening); and
sealing the opening.
While the reference of Neuenfeldt et al. discloses the use of an overpouch (35) as a transport container wherein the pouch includes a material with a plurality of pores configured to pass gaseous and/or vaporous molecules of a predetermined size into and out of the interior of the transport package, claim 1 requires that the transport package includes an opening and the opening is sealed by applying a sealing membrane across the opening, the sealing membrane including a plurality of pores configured to pass gaseous and/or vaporous molecules of a predetermined size into and out of the interior of the transport package via the opening.
The reference of Gentile et al. discloses that it is known in the art to provide biological surgical material within a transport package that can have a pouch structure (Figs. 1A-1C) or alternatively a transport package (250) including a tray structure (252) with an opening that is sealed by a sealing membrane (232).
The reference of Klatt discloses a transport package (10) that includes a tray structure (12) with an opening that is sealed by a sealing membrane (20) including a plurality of pores configured to pass gaseous and/or vaporous molecules of a predetermined size into and out of the interior of the transport package via the opening (col. 3, lines 42-49).
In view of these teachings 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 a tray structure transport package in place of the bag or pouch structure of the reference of Neuenfeldt et al. for the known and expected result of providing an alternative transport structure recognized in the art to achieve the same result. Use of the tray structure would provide a more protection during transport than a bag or pouch structure (page 12, lines 20-26, of Gentile et al.). The structure resulting from the combination of references as discussed above would result in the use of a transport package including an opening and the opening is sealed by applying a sealing membrane (plastic venting material like Tyvek)(col. 4, lines 35-60, of Neuenfeldt et al.) across the opening, the sealing membrane including a plurality of pores configured to pass gaseous and/or vaporous molecules of a predetermined size into and out of the interior of the transport package via the opening.
.
With respect to claim 3, the transport package (35) is configured for transporting the bioreactor (5) and ETC (1) contained therein to a surgical theater such that the bioreactor (5) is:
removed from the package via unsealing the opening, and
opened to remove the ETC for use in the surgical procedure (col. 4, lines 35-60, and col. 6, lines 39-60, of Neuenfeldt et al.).
With respect to claim 4, while the reference of Neuenfeldt et al. discloses transporting the ETC (1) within a bioreactor (5) including a liquid media for cellular growth (col. 1, lines 61-65), the reference does not specifically disclose that the cellular growth in the bioreactor is performed prior to storing the bioreactor (5) within the transport package (overpouch).
However, in the absence of a showing of unexpected results, it would have been well within the purview of one having ordinary skill in the art to preculture the cellular material within the bioreactor prior to packaging and transport for the known and expected result of ensuring the required cell growth is achieved prior to the use of the implant device.
With respect to claim 5, the transport package (35) is sterilized and an interior thereof including the bioreactor (5) stored therein (col. 6, lines 39-60, of Neuenfeldt et al.).
With respect to claims 6 and 9, while the reference of Neuenfeldt et al. discloses a sterilization step that includes exposing the package (35) to sterilizing medium (gas or vapor)(ETO) (col. 4, lines 35-38; col. 7, lines 44-50).
With respect to claim 15, the sealing membrane (Tyvek) includes a plurality of microscopic pores configured to pass gaseous or vaporous molecules of predetermined size out of the interior of the package and a sheet of flashspun high-density polyethylene fibers (col. 4, lines 35-60, and col. 6, lines 39-60, of Neuenfeldt et al.).
With respect to claim 18, the reference of Neuenfeldt et al. discloses:
An engineered tissue construct transport and containment method comprising:
cultivating an ETC within the interior of a bioreactor (Ex. 3);
storing a bioreactor (container)(5) and an engineered tissue construct (implant device)(1) within a transport package (overpouch)(35)(col. 4, lines 35-60, and col. 6, lines 39-60) via an opening in the transport package (overpouch opening);
sealing the opening with a sealing membrane, the membrane including a plurality of pores configured to pass gaseous or vaporous molecules of a predetermined size into and/or out of the interior of the package (col. 4, lines 35-60, and col. 6, lines 39-60); and
exposing the transport package (35) and the interior thereof, including the bioreactor, to a sterilizing substance comprising the gaseous and/or vaporous molecules (gas or vapor)(ETO) (col. 4, lines 35-38; col. 7, lines 44-50).
While the reference of Neuenfeldt et al. discloses the use of an overpouch (35) as a transport container wherein the pouch includes a material with a plurality of pores configured to pass gaseous and/or vaporous molecules of a predetermined size into and out of the interior of the transport package, claim 18 requires that the transport package includes an opening and the opening is sealed by applying a sealing membrane across the opening, the sealing membrane including a plurality of pores configured to pass gaseous and/or vaporous molecules of a predetermined size into and out of the interior of the transport package via the opening.
The reference of Gentile et al. discloses that it is known in the art to provide biological surgical material within a transport package that can have a pouch structure (Figs. 1A-1C) or alternatively a transport package (250) including a tray structure (252) with an opening that is sealed by a sealing membrane (232).
The reference of Klatt discloses a transport package (10) that includes a tray structure (12) with an opening that is sealed by a sealing membrane (20) including a plurality of pores configured to pass gaseous and/or vaporous molecules of a predetermined size into and out of the interior of the transport package via the opening (col. 3, lines 42-49).
In view of these teachings 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 a tray structure transport package in place of the bag or pouch structure of the reference of Neuenfeldt et al. for the known and expected result of providing an alternative transport structure recognized in the art to achieve the same result. Use of the tray structure would provide a more protection during transport than a bag or pouch structure (page 12, lines 20-26, of Gentile et al.). The structure resulting from the combination of references as discussed above would result in the use of a transport package including an opening and the opening is sealed by applying a sealing membrane (plastic venting material like Tyvek)(col. 4, lines 35-60, of Neuenfeldt et al.) across the opening, the sealing membrane including a plurality of pores configured to pass gaseous and/or vaporous molecules of a predetermined size into and out of the interior of the transport package via the opening.
With respect to the step of storing the package between approximately 2-40 degrees C, the reference of Neuenfeldt et al. discloses that the implant assembly device can be stored in an incubator, transported or cryopreserved (col. 2, lines 12-15).
In view of this disclosure, it would have been well within the purview of one having ordinary skill in the art to determine the optimum temperature to store the package based on the intended use of the device.
With respect to claim 19, the transport package (35) is configured for transporting the bioreactor (5) and ETC (1) contained therein to a surgical theater such that the bioreactor (5) is:
removed from the package via unsealing the opening, and
opened to remove the ETC for use in the surgical procedure (col. 4, lines 35-60, and col. 6, lines 39-60).
With respect to claim 20, while the reference of Neuenfeldt et al. discloses transporting the ETC (1) within a bioreactor (5) including a liquid media for cellular growth (col. 1, lines 61-65), the reference does not specifically disclose that the cellular growth in the bioreactor is performed prior to storing the bioreactor (5) within the transport package (overpouch).
However, in the absence of a showing of unexpected results, it would have been well within the purview of one having ordinary skill in the art to preculture the cellular material within the bioreactor prior to packaging and transport for the known and expected result of ensuring the required cell growth is achieved prior to the use of the implant device.
With respect to claim 25, the sealing membrane (Tyvek) includes a sheet of flashspun high-density polyethylene fibers (col. 4, lines 35-60, and col. 6, lines 39-60).
Claims 27-29, 31, 32, 35, 37, 38 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Neuenfeldt et al. (US 5,964,261) in view of Gentile et al. (WO 01/08630) and Klatt (US 4,597,765) taken further in view of Hill et al. (US 2005/0013726).
The combination of the references of Neuenfeldt et al., Gentile et al. and Klatt has been discussed above with respect to claim 1.
With respect to claim 27, the reference of Neuenfeldt et al. discloses:
An engineered tissue construct transport and containment method comprising:
storing a bioreactor (container)(5) and an engineered tissue construct (implant device)(1) within a transport package (overpouch)(35)(col. 4, lines 35-60, and col. 6, lines 39-60) via an opening in the package (overpouch opening); and
sealing the opening with a sealing membrane, the membrane including a plurality of pores configured to pass gaseous or vaporous molecules of a predetermined size into and/or out of the interior of the package (col. 4, lines 35-60, and col. 6, lines 39-60).
While the reference of Neuenfeldt et al. discloses the use of an overpouch (35) as a transport container wherein the pouch includes a material with a plurality of pores configured to pass gaseous and/or vaporous molecules of a predetermined size into and out of the interior of the transport package, claim 27 requires that the transport package includes an opening and the opening is sealed by applying a sealing membrane across the opening, the sealing membrane including a plurality of pores configured to pass gaseous and/or vaporous molecules of a predetermined size into and out of the interior of the transport package via the opening.
The reference of Gentile et al. discloses that it is known in the art to provide biological surgical material within a transport package that can have a pouch structure (Figs. 1A-1C) or alternatively a transport package (250) including a tray structure (252) with an opening that is sealed by a sealing membrane (232).
The reference of Klatt discloses a transport package (10) that includes a tray structure (12) with an opening that is sealed by a sealing membrane (20) including a plurality of pores configured to pass gaseous and/or vaporous molecules of a predetermined size into and out of the interior of the transport package via the opening (col. 3, lines 42-49).
In view of these teachings 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 a tray structure transport package in place of the bag or pouch structure of the reference of Neuenfeldt et al. for the known and expected result of providing an alternative transport structure recognized in the art to achieve the same result. Use of the tray structure would provide a more protection during transport than a bag or pouch structure (page 12, lines 20-26, of Gentile et al.). The structure resulting from the combination of references as discussed above would result in the use of a transport package including an opening and the opening is sealed by applying a sealing membrane (plastic venting material like Tyvek)(col. 4, lines 35-60, of Neuenfeldt et al.) across the opening, the sealing membrane including a plurality of pores configured to pass gaseous and/or vaporous molecules of a predetermined size into and out of the interior of the transport package via the opening.
Claim 27 further differs because while the reference of Neuenfeldt et al. discloses a sterilization step that includes exposing the package (35) to sterilizing medium (gas or vapor)(ETO) (col. 4, lines 35-38; col. 7, lines 44-50), the reference is silent with respect to the following steps:
placing the sealed transport package in a chamber;
providing an airflow to the chamber at an airflow rate;
maintaining the chamber at a chamber pressure;
dehumidifying the airflow so as to dehumidify the chamber, the dehumidified airflow being provided to the chamber for a dehumidification time;
after dehumidification, conditioning the airflow by first injecting a conditioning amount of a sterilizing substance into the airflow for a conditioning time;
after first injecting, second injecting of a decontamination amount of the sterilizing substance into the airflow to establish, and/or maintain a decontamination airflow entrained with the sterilizing substance within the chamber; and
exposing, within the chamber, the sealed transport package to the decontamination airflow for a decontamination time so as to decontaminate the transport packaging and the bioreactor contained herein.
The reference of Hill et al. discloses an apparatus that is structurally capable or configured to expose the package and the interior thereof, including the bioreactor, to the sterilizing medium which can be a gas or vapor (Figs 1 and 2) and includes the following steps during use:
placing the sealed transport package in a chamber (¶[0033] and [0038]);
providing an airflow to the chamber at an airflow rate (¶[0039]);
maintaining the chamber at a chamber pressure (¶[0039]);
dehumidifying the airflow so as to dehumidify the chamber, the dehumidified airflow being provided to the chamber for a dehumidification time (¶[0039]);
after dehumidification, conditioning the airflow by first injecting a conditioning amount of a sterilizing substance into the airflow for a conditioning time (¶[0040]);
after first injecting, second injecting of a decontamination amount of the sterilizing substance into the airflow to establish, and/or maintain a decontamination airflow entrained with the sterilizing substance within the chamber (¶[0041]); and
exposing, within the chamber, the sealed transport package to the decontamination airflow for a decontamination time so as to decontaminate the transport packaging and the bioreactor contained herein (¶[0041]).
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 the sterilization system of the reference of Hill et al. to sterilize the pouches of the primary reference of Neuenfeldt et al. for the known and expected result of providing an art recognized system for sterilizing medically related equipment.
With respect to claim 28, whether a single pouch or a plurality of pouches are sterilized at the same time would have been well within the purview of one having ordinary skill in the art while optimizing the method based on the number of bioreactor/pouches that need to be processed.
With respect to claim 29, the reference of Hill et al. discloses capturing the sterilizing substance contained within the exhausted decontamination airflow (¶[0042]-[0046]).
With respect to claim 31, if not intrinsic, it would have been obvious to one of ordinary skill in the art to remove the treated pouches after the sterilizing substance has reached a safe limit (¶[0043]).
With respect to claim 32, the reference of Neuenfeldt et al. discloses that the implant assembly device can be stored in an incubator, transported or cryopreserved (col. 2, lines 12-15).
In view of this disclosure, it would have been well within the purview of one having ordinary skill in the art to determine the optimum temperature to store the package based on the intended use of the device.
With respect to claim 35, in view of the steps discussed above with respect to claims 27 and 28, each bioreactor would be rendered substantially free of active biological material.
With respect to claims 37 and 38, while the reference of Hill et al. does not specifically disclose the conditioning amount and decontamination amount of the sterilizing substance, in the absence of a showing of unexpected results, it would have been well within the purview of one having ordinary skill in the art to determine the optimal amount of sterilizing substance to use through routine experimentation while considering factors such as the size of the pouches, the chamber and/or the specific sterilizing substance employed.
With respect to claim 47, the transport package (35) is configured for transporting the bioreactor (5) and ETC (1) contained therein to a surgical theater such that the bioreactor (5) is:
removed from the package via unsealing the opening, and
opened to remove the ETC for use in the surgical procedure (col. 4, lines 35-60, and col. 6, lines 39-60).
Claims 13 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Neuenfeldt et al. (US 5,964,261) in view of Gentile et al. (WO 01/08630) and Klatt (US 4,597,765) taken further in view of Smith et al. (US 2015/0351893).
The combination of the references of Neuenfeldt et al., Gentile et al. and Klatt has been discussed above with respect to claims 1 and 18.
Claims 13 and 23 differs by reciting that the implant device is an ETC that has been decellularized prior to storage within the bioreactor within the package.
The reference of Smith et al. discloses that any number of implant structures are known in the art to be sterilely stored and transported to a surgical site. The list of known tissue implant structures includes decellularized grafts (¶[0035]-[0041]).
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 provide the bioreactor chamber structure of the primary reference with a decellularized graft device as is conventional in the art as evidenced by the reference of Smith et al.
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Neuenfeldt et al. (US 5,964,261) in view of Gentile et al. (WO 01/08630) and Klatt (US 4,597,765) taken further in view of Lawson et al. (The Lancet).
The combination of the references of Neuenfeldt et al., Gentile et al. and Klatt has been discussed above with respect to claim 1.
Claim 48 differs because the reference of Neuenfeldt et al. does not disclose that the ETC is a human acellular vessel.
The reference of Neuenfeldt et al. discloses that the transport system can be used for a variety of materials used for implantation (col. 5, line 65, to col. 6, line 7.
The reference of Lawson et al. discloses that bioengineered human acellular vessels are known implant devices (See page 2026, “Summary”).
In view of these disclosures 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 the implant transport system and method encompassed by the combination of the references discussed above with respect to claim 1 to protect/store/transport human acellular vessels for implantation for while providing the benefits of the modified primary reference of Neuenfeldt et al.
Response to Arguments
Claim Rejections- 35 USC 112
The rejections of Claims 29, 32, 35, 37 and 38 under 35 U.S.C. 112(b) have been withdrawn in view of the amendments to the claims and corresponding comments on page 8 of the response dated 10/8/2025.
Claim Rejections- 35 USC 102
The rejection of Claims 1-3, 5, 11 and 15 under 35 U.S.C. 102(a)(1) as being anticipated by Neuenfeldt et al. (US 5,964,261) has been withdrawn in view of the amendments to claim 1 and corresponding comments on pages 9-10 of Applicants’ response dated 10/8/2025. Note: New grounds of rejection have been made over the combination of Neuenfeldt et al. (US 5,964,261) in view of Gentile et al. (WO 01/08630) and Klatt (US 4,597,765) to address the amendments to claim 1.
Claim Rejections- 35 USC 103
The rejections of: Claim 4 under 35 U.S.C. 103 as being unpatentable over Neuenfeldt et al. (US 5,964,261); Claims 6, 8, 9, 18-20, 25, 27-28, 31, 32, 35, 37 and 38 under 35 U.S.C. 103 as being unpatentable over Neuenfeldt et al. (US 5,964,261) in view of Hill et al. (US 2005/0013726); Claim 13 under 35 U.S.C. 103 as being unpatentable over Neuenfeldt et al. (US 5,964,261) in view of Smith et al. (US 2015/0351893); and Claim 23 under 35 U.S.C. 103 as being unpatentable over Neuenfeldt et al. (US 5,964,261) in view of Hill et al. (US 2005/0013726) and Smith et al. (US 2015/0351893) have been withdrawn in view of the amendments to claims 1, 18 and 27 and corresponding comments on pages 11-12 of Applicants’ response dated 10/8/2025. Note: New grounds of rejection have been made over the combination of Neuenfeldt et al. (US 5,964,261) in view of Gentile et al. (WO 01/08630) and Klatt (US 4,597,765) to address the amendments to claims 1 and 18; and Neuenfeldt et al. (US 5,964,261) in view of Gentile et al. (WO 01/08630) and Klatt (US 4,597,765) taken further in view of Hill et al. (US 2005/0013726) to address the amendments to claim 27.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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