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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-12, 15 and 16, in the reply filed on 12/1/25 is acknowledged.
Claims 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-12 and 15-16 are considered on the merits.
Information Disclosure Statement
37 CFR § 1.56 - Duty to disclose information material to patentability.
(a) A patent by its very nature is affected with a public interest. The public interest is best served, and the most effective patent examination occurs when, at the time an application is being examined, the Office is aware of and evaluates the teachings of all information material to patentability. Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section. The duty to disclose information exists with respect to each pending claim until the claim is cancelled or withdrawn from consideration, or the application becomes abandoned. Information material to the patentability of a claim that is cancelled or withdrawn from consideration need not be submitted if the information is not material to the patentability of any claim remaining under consideration in the application. There is no duty to submit information which is not material to the patentability of any existing claim. The duty to disclose all information known to be material to patentability is deemed to be satisfied if all information known to be material to patentability of any claim issued in a patent was cited by the Office or submitted to the Office in the manner prescribed by §§ 1.97(b)-(d) and 1.98. However, no patent will be granted on an application in connection with which fraud on the Office was practiced or attempted or the duty of disclosure was violated through bad faith or intentional misconduct. The Office encourages applicants to carefully examine:
(1) Prior art cited in search reports of a foreign patent office in a counterpart application, and
(2) The closest information over which individuals associated with the filing or prosecution of a patent application believe any pending claim patentably defines, to make sure that any material information contained therein is disclosed to the Office.
The information disclosure statement (IDS) submitted on 12/06/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-12 & 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bright et al. (US20150159151) and Nakamura (US20140322761).
Bright discloses a non-enzymatic (as in claim 12) method for separating a stromal vascular fraction using an ultrasonic device, wherein the stromal vascular fraction is separated from adipose tissue by using an ultrasonic device comprising a power supply unit, an ultrasonic oscillation unit and an ultrasonic vibration unit [0072]. Bright starts with adipose tissue derived from aspirates and is placed in tubes. Excess fluid is removed by centrifuge. Bright uses an ultrasonic cavitation device probe and the amplitude is set at 50%, cycle 0.4. The ultrasonic irradiation is raised and lowered for 1 minute and then for 40 seconds at two different locations in the tube (as in claim 3). The method is performed to keep the tissue temperature from about 37-43 degree C. After ultrasonication a thick solution is observed in the and is centrifuged at 800 g/5 min (as in claim 11). After centrifugation there are 3 layers--the top lipid layer, the middle floating layer containing extracellular matrix and stromal vascular cells, and a bottom layer of fluid. The top lipid layer is removed and discarded using a mixing cannula and syringe (removal of the lipid layer permits a separation of cells when isotonic fluid is added) and the remaining contents of mixed well to further disrupt the extra-cellular matrix. An isotonic washing solution (typically 0.9% saline or PBS) is added the centrifuged at 800 g/5 mins initiating the cells and extra-cellular matrix to fall out and pellet at the bottom. A large pellet is observed at the bottom of tube stromal vascular fraction comprising viable and functional stem cells. The fraction is then extracted using a mixing cannula and syringe with fluid and filtered to remove any large debris. The cell solution can be used as is, or further concentrated by a further centrifugation and removal of excess fluid.
Bright differs in that the ultrasonic device used is a probe and not a non-contact ultrasonic device however it would have been obvious to one of ordinary skill in the art at the time the invention was filed to use any available ultrasonic device in the method of Bright so long as said device could be used to apply the proper ultrasonic irradiation necessary to facilitate the separation of the stromal vascular fraction as is accomplished by Bright. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the teachings of Nakamura with Bright because Nakamura discloses that in sonication process, the skilled artisan can use a non-contact ultrasonic device (in lieu of a probe. Nakamura teaches in their process [0054] that the sonication procedure of the mixture, any existing ultrasonic generator can be used, suggesting a non-contact device which does not come in contact with a sample can also be used. The frequency of the ultrasonic wave can be appropriately selected based on the performance of the ultrasonic generator or the property of the liquid. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); >see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");< ** In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Applicant is directed to pages 12-13 of KSR v Teleflex (500 US 398 2007) “ … the Court has held that a “patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.” Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950). This is a principal reason for declining to allow patents for what is obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one(emphasis added). If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” In the instant case as it is the ultrasonic waves that are used, it is well within the purview of the skilled artisan to select a non-contact ultrasonic device as mechanical connection is not required as the energy emitted facilitates the separation desired. It is with the obvious design choice of the artisan to select the type of device to use and further the intensity and time needed. Bright teaches (as above) that the energy should be provided at different locations and angles to facilitate separation of the adipose tissue. Bright clearly teaches maintaining the tissue in containers (tubes) and thus the design of a general device to hold said tubes in useful proximity to the tubes would have also been obvious.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time the invention was made especially in the absence of evidence
to the contrary.
Claims 1-12 & 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bright et al (20150159151) and Nakamura (20140322761) & Simon (6840280).
Bright discloses a non-enzymatic (as in claim 12) method for separating a stromal vascular fraction using an ultrasonic device, wherein the stromal vascular fraction is separated from adipose tissue by using an ultrasonic device comprising a power supply unit, an ultrasonic oscillation unit and an ultrasonic vibration unit {0072]. Bright starts with adipose tissue derived from aspirates and is placed in tubes. Excess fluid is removed by centrifuge. Bright uses an ultrasonic cavitation device probe and the amplitude is set at 50%, cycle 0.4. The ultrasonic irradiation is raised and lowered for 1 minute and then for 40 seconds at two different locations in the tube (as in claim 3). The method is performed to keep the tissue temperature from about 37-43 degree C. After ultrasonication a thick solution is observed in the and is centrifuged at 800 g/5 min (as in claim 11). After centrifugation there are 3 layers--the top lipid layer, the middle floating layer containing extracellular matrix and stromal vascular cells, and a bottom layer of fluid. The top lipid layer is removed and discarded using a mixing cannula and syringe (removal of the lipid layer permits a separation of cells when isotonic fluid is added) and the remaining contents of mixed well to further disrupt the extra-cellular matrix. An isotonic washing solution (typically 0.9% saline or PBS) is added the centrifuged at 800 g/5 mins initiating the cells and extra-cellular matrix to fall out and pellet at the bottom. A large pellet is observed at the bottom of tube stromal vascular fraction comprising viable and functional stem cells. The fraction is then extracted using a mixing cannula and syringe with fluid and filtered to remove any large debris. The cell solution can be used as is, or further concentrated by a further centrifugation and removal of excess fluid.
Bright differs in that the ultrasonic device used is a probe and not a non-contact ultrasonic device however it would have been obvious to one of ordinary skill in the art at the time the invention was filed to use any available ultrasonic device in the method of Bright so long as said device could be used to apply the proper ultrasonic irradiation necessary to facilitate the separation of the stromal vascular fraction as is accomplished by Bright. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the teachings of Nakamura with Bright because Nakamura discloses that in sonication process, the skilled artisan can use a non-contact ultrasonic device (in lieu of a probe. Nakamura teaches in their process [0054] that the sonication procedure of the mixture, any existing ultrasonic generator can be used, suggesting a non-contact device which does not come in contact with a sample can also be used. The frequency of the ultrasonic wave can be appropriately selected based on the performance of the ultrasonic generator or the property of the liquid. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); >see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");< ** In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Applicant is directed to pages 12-13 of KSR v Teleflex (500 US 398 2007) “ … the Court has held that a “patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.” Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950). This is a principal reason for declining to allow patents for what is obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one(emphasis added). If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” In the instant case as it is the ultrasonic waves that are used, it is well within the purview of the skilled artisan to select a non-contact ultrasonic device as mechanical connection is not required as the energy emitted facilitates the separation desired. It is with the obvious design choice of the artisan to select the type of device to use and further the intensity and time needed. Bright teaches (as above) that the energy should be provided at different locations and angles to facilitate separation of the adipose tissue. Bright clearly teaches maintaining the tissue in containers (tubes) and thus the design of a general device to hold said tubes in useful proximity to the tubes would have also been obvious.
While the teachings of Bright & Nakamura suggest that any known sonication device would have been obvious to use to separate a stromal vascular fraction from adipose tissue, the references do not specifically discuss the use of a sonication device with a rotatable and include a horn (as in claims 4-8). However, it would have been obvious at the time the invention to use such a device because Simon teaches such a device. Simon (29-30) teaches an ultrasonic horn assembly the device being rotatable to apply ultrasonic waves in different directions. The horn being positioned to provide an area of maximum vibrational amplitude.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time the invention was made especially in the absence of evidence
to the contrary.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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/BLAINE LANKFORD/Primary Examiner, Art Unit 1657