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 .
Claims 13-14,16,18,21-25,27-33 are under examination.
Response to Applicants Arguments/Amendments
The examiner has considered applicants arguments and amendments. Because of the amendments made to claims 32-33, the 112b and 112d rejections are removed because the claims have been better clarified. The previous 103 rejections have been amended to address the new claim amendments. The arguments directed to the 103 rejections are addressed below the 103 rejections.
Oath
Applicants have not provided an oath. An oath must be provided in order for an application to successfully proceed to allowance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13-14,16,18,21-25,27-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention. Claims 13 and 24 (the independent claims) recite, “preserving the organ within the sealable organ container such that the pressurizer maintains fluid pressure on the organ within a desired pressure range of between about 8 cm H2O and about 50 cm H2O.” Furthermore, claims 32-33 recite the following, “wherein the desired pressure range is between 8 cm H2O and 20 cm H2O.” These amendments constitute new matter. Applicants’ specification states that the pressure is within the range of about 25 to about 50 cm H2O for its particular invention (Pages 3 and 5 of applicants’ specification) which is different than what is currently being claimed.
Pages 1-2 of the specification describe other contemporary systems by other inventors that are available . Page 1 states that many systems only provide a pressure of 0-12 cm H2O which the inventors actually state is not significant enough pressure. Applicants also discuss another system of US Patent 9,426,979 which exerts a fluid pressure on an organ of 8-20 cm H2O. The specification does not clearly establish that its system operates at these specific parameters which are now in the newly added claim amendments. The specification does not clearly provide support for a desired pressure range of between about 8 cm H2O and about 50 cmH2O.
Response to Applicants Arguments
Applicants argue the following:
PNG
media_image1.png
365
710
media_image1.png
Greyscale
Applicants argue that they are entitled to the entire pressure range of between about 8 cm H2O to about 50 cm H2O. The examiner was not persuaded by the argument. The specification is actually stating that the prior art had a pressure between 8-20 cm H2O. The specification states that the pressure of its system can be maintained at pressures greater than what was taught in the prior art (e.g. 25 to 50 cm H2O). However, the specification does not specifically state that the pressure can be maintained at the complete range of 8 to 50 cm H2O. While applicants are entitled to a pressure range of 25 to 50 cm H2O, there is no support in the specification for the entire range of 8 to 50 cm H2O.
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 13,16,18,21-24,27-33 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20120301952) in view of Scott (USPT 3,323,872)
Figure 1 of Anderson
PNG
media_image2.png
514
666
media_image2.png
Greyscale
Anderson teaches a method for storing an organ, the method comprising providing an organ storage system comprising: a sealable organ container (Figure 1, #30; paragraph 76 states that the organ storage system can be hermetically sealed) comprising a vent port (Figure 1, #38 is considered a vent port), an internal volume (Figure 1, the internal volume goes in #30), and a fill port (#34 perfusate fill port); a pressurizer in fluid communication with the sealable organ container operable to provide an increased internal volume for the sealable organ container in response to increased fluid pressure within the sealable organ container (both the membrane and the floor of #30 can jointly serve as pressurizers as discussed in Paragraphs 78 and 103); and a fluid source in fluid communication with the fill port through a fill valve (perfusate liquid fluid source goes through #34 of Figure 1 which includes a valve as discussed in paragraph 72); sealing an organ within the sealable organ container (Paragraph 76 states that the organ can be hermetically sealed); opening the vent port (Figure 1,#38 can be open initially); elevating the fluid source above the sealable organ container (the fluid source #34 is above the sealable organ container); closing the vent port upon fluid escaping therefrom (fluid is capable of emerging out port #38 which can be closed as taught in paragraph 76); energizing the pressurizer with fluid pressure from the elevated fluid source (Paragraphs 78 and 103); closing the fill valve (Paragraph 76); and disconnecting the fluid source from the fill value (in order to close the fill valve as discussed in paragraph 76, the perfusate/fluid source must be first disconnected). Anderson teaches preserving the organ within the sealable organ container such that the pressurizer maintains fluid pressure on the organ within a desired pressure range of between about 8 cm H2O and about 50 cm H2O (Paragraph 117 of Anderson) as in instant Claim 13. Anderson further teaches a method for storage of a biological sample, the method comprising: providing a biological sample storage system (Figure 1) comprising: a sealable container(Figure 1, # 30) comprising a vent port (Figure 1, #38), and internal volume (the internal volume will be inside of Figure 1, #30), and a fill port (Figure 1, #34 represents the fill port); a pressurizer in fluid communication with the sealable container operable to provide an increased internal volume for the sealable container in response to increased fluid pressure within the sealable container (Paragraphs 74,78, and 103); and a fluid source in fluid communication with the fill port through a fill valve (Figure 1, #34 and Paragraph 72), the fluid source elevated above the sealable container (Figure 1, #34) ; sealing a biological sample within the sealable container (Paragraph 76); opening the fill valve to allow fluid from the fluid source to flow into the sealable container (Paragraph 76); energizing the pressurizer with fluid pressure from the elevated fluid source (Paragraphs 74,76,78, and 103); and closing the fill valve (Paragraph 76, Figure 1, #34). Anderson teaches preserving the organ within the sealable organ container such that the pressurizer maintains fluid pressure on the organ within a desired pressure range of between about 8 cm H2O and about 50 cm H2O (Paragraph 117 of Anderson) as in instant Claim 24.
Anderson does teach a pressurizer in its container. However, Anderson does not teach a pressurizer that is composed of bellows that are spring engaged and which is disposed on an external wall of the sealable container. However, Scott teaches a pressurizer that comprises bellows which are spring-energized, and is disposed on the external wall of a sealable container (Column 2 and Figures 2 and 3 of Scott). Scott’s pressurizer/bellows passively maintains fluid pressure because it is controlled by a motor (Col. 2, lines 47-68; Col 3, lines 30-33; claims 19-22).
PNG
media_image3.png
697
458
media_image3.png
Greyscale
PNG
media_image4.png
274
495
media_image4.png
Greyscale
It would have been obvious to an artisan of ordinary skill at the time of effectively filing to have used the device taught by Scott in the process of Anderson. Anderson uses the bottom of the chamber area and the membrane in order to control pressure (Anderson Paragraphs 74,78, and 103). An artisan of ordinary skill in the art would have been motivated to have used the spring-energized bellows system taught in Scott in place of Anderson’s pressurizer since it can effectively control the pressure of vessels. Therefore, claims 13,16,18,24,27-28 would have been obvious.
Dependent Claims taught by Anderson
Anderson teaches wherein the sealable container is rigid (Paragraph 74) as in instant Claim 21. Anderson teaches wherein the sealable organ container is plastic and becomes rigid upon being filled with fluid (Paragraphs 74 and 103) as in instant Claim 22. Anderson teaches wherein the organ container comprises an elastomeric material resistant to expansion and acts as a pressurizer upon being filled with fluid (Paragraphs 74, 78, and 103) as in instant Claim 23. Anderson teaches wherein the sealable container is rigid (Paragraph 74) as in instant Claim 29. Anderson teaches wherein the sealable organ container is plastic and becomes rigid upon being filled with fluid (Paragraphs 74 and 103) as in instant Claim 30. Anderson teaches wherein the organ container comprises an elastomeric material resistant to expansion and acts as a pressurizer upon being filled with fluid (Paragraph 74,78, and 103) as in instant Claim 31.
Anderson fails to teach the use of a pressurizer with bellows and springs which is mounted to an external wall. However, Scott teaches such a pressurizing apparatus (Column 2 and Figures 2 and 3 of Scott). The ordinary skilled artisan seeking a method for complementing the invention of Anderson would have been motivated to have used the pressurizer device of Scott with the device of Anderson since it is also capable of successfully controlling the pressure. Given the teachings of the cited references and the level of skill of the artisans at the time of applicants’ invention, it must be considered absence evidence to the contrary, that the ordinarily skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.'s and Ph.D.'s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology, organ perfusion, tissue maintenance, and organ storage design. Therefore, the level of ordinary skill in this art is high.
Claims 13-14,16,18,21-25,27-33 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20120301952) in view of Scott (USPT 3,323,872) and Vries “Systems engineering the organ preservation process for transplantation” Current Opinion in Biotechnology July 4, 2019, 58: 192-201 (2019).
Anderson and Scott apply as above to teach claims 13,16,18,21-24,27-33. Anderson teaches that perfusate (the fluid source) is delivered to the device featured in Figure 1 through #34. The Anderson reference does not specifically state that the perfusion container is a certain length above the organ storage container. Vries teaches that the container containing the perfusion solution (the fluid source) is located above the actual organ storage container as shown in Figures 2a and 2c of Vries as in instant Claims 14 and 25.
PNG
media_image5.png
853
1149
media_image5.png
Greyscale
Anderson fails to teach the use of a pressurizer with bellows and springs which is mounted to an external wall. However, Scott teaches such a pressurizing apparatus (Column 2, and Figures 2 and 3 of Scott). The ordinary skilled artisan seeking a method for complementing the invention of Anderson would have been motivated to have used the pressurizer device of Scott with the device of Anderson since it is also capable of successfully controlling the pressure. It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used the design setup taught in Vries in order to deliver the perfusion solution into the organ storage container. An artisan would have been motivated to have hung the perfusate container (a bag in Vries) above the organ storage container so that the perfusate can be successfully delivered to the organ storage area. An artisan would have been motivated to have added the perfusate/fluid from a specific distance such as 50 cm from the organ container based on the size of its organ system and the location of container that holds the perfusate. This is an optimizable parameter. An artisan would have stored/contained the perfusate at a length from the organ container as needed to ensure that the perfusate fluid could be adequately delivered to the organ storage device. Because Vries teaches that this setup can successfully work (Figures 2a/2c of Vries), there would be a high expectation of success using the perfusion container setup of Vries with the system of Anderson.
Given the teachings of the cited references and the level of skill of artisans at the time of applicants’ invention, it must be considered, absence evidence to the contrary that the ordinary skilled artisan would have a reasonable expectation for success in practicing the claimed invention. All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.'s and Ph.D.'s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology, organ perfusion, tissue maintenance, and organ storage design. Therefore, the level of ordinary skill in this art is high.
Response to Applicants Arguments for the 103 Rejections
Applicants argue the following:
PNG
media_image6.png
450
706
media_image6.png
Greyscale
Applicants argue that the prior art limitation does not teach that the “pressurizer comprising a bellows configured to passively maintain fluid pressure.” The term “passively” is not more specifically defined in applicants’ specification. Therefore, “passively” will be given the broadest reasonable interpretation. According, the Merriam Webster definition, the word “passive” can mean “induced by an outside agency.” The bellows device taught by Scot is induced by an outside agent (a motor). Therefore, Scott teaches the newly added claim limitation.
Conclusion
All claims stand rejected.
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 LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
Prosecution Insights