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 .
Response to Arguments
Applicant’s arguments, see pg 6, filed 09/16/2026, with respect to abstract have been fully considered and are persuasive. The objection of 06/22/2026 has been withdrawn.
Applicant’s amendments, see pg 6, filed 09/16/2026, with respect to claims 1, 2, 3, 4, 6, 10, and 11 have been fully considered. The objection of 06/22/2026 has been withdrawn.
Applicant's arguments filed 09/16/2026 have been fully considered but they are not persuasive.
Applicant argues that there is no motivation provided to combine the first embodiment of Kyle with the third embodiment of Kyle. Examiner respectfully disagrees. The prior art reference Kyle teaches various non-limiting embodiments of the invention (para 0018). Kyle further states “any examples set forth in this specification are not intended to be limiting and merely set forth some of the many possible embodiments for the claimed invention” (para 0018). Thus, it would have been obvious to one of the ordinary skills in the art to modify the various embodiments presented by Kyle as a design choice to effectively treat a variety of medical conditions (para 0028).
Applicant further argues that the motivation to modify Kyle with a filter as taught by Dorian is not shown. Examiner respectfully disagrees. In response to applicant's argument that the motivation to modify Kyle with a filter as taught by Dorian is not shown, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Dorian recites that the filter retain the plasma during water removal process but allows that plasma to flow through when separation gravity is applied (para 0047). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teaching of Kyle with a filter as taught by Dorian for the benefit of retaining the sample during ambient gravity conditions and allowing the sample to flow through during separation gravity conditions (para 0047).
Thus, the rejection for claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17 and 18 is maintained.
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, 2, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kyle et al (US 20150157781 A1) and further in view of Dorian et al. (US 20090236297 A1).
Regarding claim 1, Kyle teaches a fluid concentrator with an upper body as an upper chamber (‘isolation chamber’, para 0067), lower body as a lower chamber (‘separation chamber’, para 0030), and a filter (‘filter unit’, para 0035). Kyle teaches the upper body comprising a valve (para 0067). Kyle teaches the lower body comprising of concentration material (‘beads’, para 0044), a valve (para 0034), and a port (“vacuum port”, para 0050).
Kyle does not teach a filter located between the upper body and the lower body; configured such that the biological fluid can flow from the lower chamber, through the filter, and into the upper chamber. Kyle also does not explicitly define the distal and proximal ends of both chambers.
However, Dorian teaches a plasma concentrator with a concentrator chamber, filter and agitator (Abstract). Dorian teaches a filter (‘Filter [24]’, para 0052) located between the upper body (concentrate chamber [40]’, para 0045) and the lower body (‘concentrating chamber [20]’, para 0041); configured such that the biological fluid can flow from the lower body, through the filter (Figure 3, Figure 7-9), and into the upper body (Figure 3, 7-9) for the benefit of retaining the sample during ambient gravity conditions and allowing the sample to flow through during separation gravity conditions (para 0047). The distal end of the lower body is the top [8] part of concentrating chamber [20] and the proximal end of the lower body is considered to be the lower end near the filter [24] (figure 3). The distal end of the upper body is the top part of concentrate chamber [40] near to the filter [24] and the proximal end of the upper body is considered to be the lower end near the depression [42] leading to the outlet port [16] (figure 3). Thus, it would be obvious to one of ordinary skill in the art before the effective filling date to modify the teaching of Kyle with the upper body and the lower body; configured such that the biological fluid can flow from the lower chamber, through the filter, and into the upper chamber as taught by Dorian for the benefit of retaining the sample during ambient gravity conditions and allowing the sample to flow through during separation gravity conditions (para 0047).
Regarding claim 2, Kyle teaches the lower body further comprises threads at the distal end of the lower body (para 0030).
Regarding claim 3, Kyle teaches the lower body further contains one or more agitator particles (para 0044).
Regarding claim 5, Kyle teaches the lower body, upper body, and filter can be screwed together or press fit together (para 0030).
Regarding claim 6, Kyle teaches the filter has pores that are sized to retain the concentration material within the lower chamber (para 0041).
Regarding claim 7, Kyle in view of Dorian teaches the biological fluid device of claim 1. Kyle teaches a method of concentrating a biological fluid comprising: inserting biological fluid into the chamber of the lower body of the biological fluid concentration device (para 0052); mixing the fluid inside the device (para 0007) and then moving the fluid into a centrifuge (para 0032); centrifuging the device such that concentrated biological fluid is collected in the upper body (para 0031); and withdrawing the concentrated biological fluid from the upper body (para 0070).
Regarding claim 8, Kyle teaches the lower body of the biological fluid concentration device comprises threads at the distal end of the lower body (para 0030).
Regarding claim 9, Kyle teaches the biological fluid is whole blood, buffy coat, and platelet poor plasma (para 0031).
Regarding claim 10, Kyle teaches the biological fluid being inserted into the chamber of the lower body of the device by screwing a device for preparation of platelet rich plasma (PRP) onto the threads at the distal end of the lower body and directly inserting the PRP into the chamber of the lower body through the valve (para 0079 and 0125).
Regarding claim 11, Kyle teaches comprising attaching a fluid extraction device to the valve of the upper body (para 0070).
Regarding claim 12, Kyle teaches injecting the concentrated biologic fluid of the chamber of the upper body into a ligament, tendon, bone, and cartilage of a patient (para 0109).
Regarding claim 13, Kyle in view of Dorian teaches the biological fluid device of claim 1. Kyle teaches a method of treatment of soft tissue damage comprising isolating plasma from a patient with soft tissue damage and placing the plasma in the chamber of the lower body (para 0052); mixing the fluid inside the device (para 0007) and then moving the fluid into a centrifuge (para 0032); centrifuging the device such that concentrated biological fluid is collected in the upper body (para 0031); withdrawing the concentrated biological fluid from the upper body (para 0070) and contacting the soft tissue damage or injury with the concentrated plasma (para 0109, para 0086).
Regarding claim 14, Kyle teaches the soft tissue damage is damage to a ligament, tendon, muscle, or joint (para 0086, para 0109).
Regarding claim 15, Kyle teaches the soft tissue damage is damage to a tendon (para 0108).
Kyle does not specify what type of tendon.
Although, Kyle does not teach the specific type of tendon, a prima facie obviousness case can be established (See MPEP 2144.08). The Kyle reference overlaps in scope and content with the instant invention as it recites a fluid concentrator used for autologous bodily fluid. The device taught by Kyle is used in the same field of endeavor which is the use of concentrated body fluids (para 0007). The Kyle reference mentions the genus “tendons” while the claimed inventions lists various types of tendons. Although various tendon are located throughout the body, they all share similar utility and composition. A person of ordinary skill in the art would understand the prior art reference to be applicable to various tendons. Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of the instant invention of claim 13 as taught by Kyle in view of Dorian and use it on a specific type of tendon with a soft tissue injury such as the Achilles tendon.
Regarding claim 16, Kyle teaches the soft tissue damage is damage to a ligament (para 0108).
Kyle does not specify what type of ligament.
Although, Kyle does not teach the specific type of ligament, a prima facie obviousness case can be established (See MPEP 2144.08). The Kyle reference overlaps in scope and content with the instant invention as it recites a fluid concentrator used for autologous bodily fluid. The device taught by Kyle is used in the same field of endeavor which is the use of concentrated body fluids (para 0007). The Kyle reference mentions the genus “ligaments” while the claimed inventions lists various types of ligaments. Although various ligaments are located throughout the body, they all share similar utility and composition. A person of ordinary skill in the art would understand the prior art reference to be applicable to various ligaments. Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of the instant invention of claim 13 as taught by Kyle in view of Dorian and use it on a specific type of ligament with a soft tissue injury such as the anterior cruciate ligament.
Regarding claim 17, Kyle teaches tissue damage or injury is tendon or ligament rupture, severance, tearing, delamination, strain, or deformation (para 0086, para 0109).
Regarding claim 18, Kyle in view of Dorian teaches the biological fluid device of claim 1. Kyle also teaches transfer syringes (para 0047). Thus, both components needed to make the kit are taught by the prior art.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kyle et al (US 20150157781 A1) in view of Dorian et al. (US 20090236297 A1) as applied to claim 1 above, and further in view of Higgins et al. (US 20090220482 A1).
Regarding claim 4, Kyle in view of Dorian teaches the concentration material is beads (para 0044).
Kyle and Dorian do not teach polyacrylamide beads specifically.
However, Higgins teaches isolating interleukin-1 receptor antagonist including incubating a liquid volume of white blood cells and platelets with polyacrylamide beads (Abstract). Higgins teaches using a concentrator assembly which uses polyacrylamide beads for the benefit of absorbing the liquid in the platelet-rich plasma (para 0045). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Kyle in view of Dorian with polyacrylamide beads in the concentration device the benefit of absorbing the liquid in the platelet-rich plasma (para 0045).
Conclusion
THIS ACTION IS MADE FINAL. 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 HENA BERA whose telephone number is (571)272-9964. The examiner can normally be reached Mon-Fri 8:00-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.R.B./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
