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 .
Specification
The abstract of the disclosure is objected to because of the inclusion of the phrase 'such The phrase ‘such as’ is indefinite. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 2, 3, 4, 6, 10 and 11 objected to because of the following informalities:
Claims 1 recites ‘the upper chamber’ and ‘the lower chamber’ in step (iii), which is inconsistent terminology. The terms can be replaced with ‘upper body’ and ‘lower body’ to be consistent.
Claim 6 recite ‘ the lower device’ which is inconsistent terminology. The term can be replaced with ‘lower body’ to be consistent.
Claims 1, 2, 3, 4, 10 and 11 are objected to because they include reference characters which are not enclosed within parentheses.
Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m).
Appropriate correction is required.
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 a chamber (‘isolation chamber’, para 0067), lower body as a 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 ambient gravity conditions for separation gravity (para 0022, para 0036). 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 ambient gravity condition for separation gravity (para 0022, para 0036).
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 chamber of the lower device (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
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/H.R.B./ Examiner, Art Unit 1798
/CHRISTINE T MUI/ Primary Examiner, Art Unit 1797
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