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 1-2, 6, 8, 13-14, in the reply filed on 05/07/2026 is acknowledged.
Claims 15-18, 21-22, 24-25, 32, 34-36, 39-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/07/2026.
Status of Claims
Claims 1-2, 6, 8, 13-18, 21-22, 24-25, 32, 34-36, 39-40 remain pending in the application, with claims 1-2, 6, 8, 13-14 being examined and claims 15-18, 21-22, 24-25, 32, 34-36, 39-40 being withdrawn pursuant to the election filed 05/07/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 6, 8, 13-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 line 6 recites “a first insert” where it is unclear if this first insert is the same or different from the first insert described on line 4.
For examination, it will be interpreted that the first insert of line 6 is the same as the one described on line 4.
It is suggested that line 6 be amended to recite “[[a]] the first insert”
Line 14 recites “a second insert” where it is unclear if this second insert is the same or different from the second insert described on line 4.
For examination it will be interpreted that they are the same insert.
It is suggested that line 14 be amended to recite “[[a]] the second insert”
It is noted that with the suggestions described above to lines 6 and 14, both the first insert and second insert will be considered to be part of the claimed system because the claim has “A system for preparing a serum comprising: a)… b)… c)… d)…” where c and d are to the first and second insert.
Claims 2, 6, 8, 13-14 are rejected by virtue of being dependent on a rejected claim.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radcliffe (US-2020/0305583-A1) in view of Ellis (US-2008/0217250-A1) and Pipelka (WO-2007/141255-A1).
Regarding claim 1, Radcliffe teaches a system comprising:
a) a containment device (bottle 16) ([0038], Figures 1-3, 4A-B);
b) a cap (cylindrical body 24) comprising an aperture (central opening 28), and a connector (annular lip 30) that can be connected to a first insert (insert molded portion 25) and to a second insert (see below) ([0041] see cap 10 is composed of a cylindrical body, [0038], Figures 2, 4A);
c) a first insert (25) comprising ([0041], Figure 2):
i) a first adaptor (aperture 12) configured to allow a fluid to flow into the containment device (16) through the first insert (25) ([0038], Figure 2);
ii) a second adaptor (aperture 13) configured to allow a fluid to flow out of the containment device (16) through the first insert (25) ([0038], Figure 2);
iv) a connector that can be connected to the cap (24) ([0042] see elastomeric material is insert molded onto cylindrical body 24 to form portion 25 and overmolds along annular lip 30, see Figure 4A where portion 25 is connected to the cylindrical body 24);
d) a second insert (apparatus 11b) comprising:
i) a connector (portion 25) that can be connected to the cap (24), and
ii) a first port (aperture 12) ([0052], Figures 7A-C, please see that there are three different apparatuses 11 that each have a cap with a different tube fixed in the cap for use with three different bottle sizes, where apparatuses 11a-c are each different inserts that will be capable of interacting with the cylindrical body 24).
Please note the limitations “A system for preparing a serum”, “a connector (420) that can be connected to a first insert and to a second insert;”, “a first adaptor (220) configured to allow fluid to flow into the containment device through the first insert;”, “a second adaptor (210) configured to allow a fluid to flow out of the containment device through the first insert;”, “a connector (230) that can be connected to the cap;”, “a connector (310) that can be connected to the cap”, and “a first port (320) that can comprise a first port cap.” are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Radcliffe and the apparatus of Radcliffe is capable of preparing a serum, the annular lip is capable of being connected to a first and second insert, the aperture 12 is capable of allowing fluid to flow into the bottle, aperture 13 is capable of allowing fluid to flow out of the bottle, the portion 25 is capable of being connected to the cylindrical body, and the aperture 12 of the other apparatus 11b is capable of comprising a first port cap. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Radcliffe (see MPEP §2114).
Please note that the serum, the fluid, nor the first port cap have been positively recited in the claim, and are therefore not part of the claimed system.
Radcliffe does not teach that the cylindrical body 24 (cap) fits within the bottle 16 (containment device) comprising a seal.
In the same problem solving area of mating a container and a cap, Ellis teaches where there may be external threads on the container that mate with internal threads of a cap, or alternatively the container threads are internal threads and the cap threads are external threads (Ellis; [0039]). Further, Ellis teaches where a cap may include one or more O ring seals between the abutting portions of the cap and container (Ellis; [0053]).
Examiner finds that the prior art contained a device/method/product (i.e., container with lid) which differed from the claimed device by the substitution of component(s) (i.e., threads on the interior surface of the cap engaging with external threads on the bottle) with other component(s) (i.e., external threads on the cap engaging with internal threads on the bottle), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., internal cap threads with external threads on the bottle for external cap threads with internal threads on the bottle), and the results of the substitution (i.e., securing the cap to the bottle) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the internal cap threads and external bottle threads of reference Radcliffe with external cap threads and internal bottle threads of reference Ellis, since the result would have been predictable.
Further, it would have been obvious to one skilled in the art to include an O ring as taught by Ellis to provide for better sealing (Ellis; [0053]).
Therefore, the cylindrical body 24 (cap) of Radcliffe will fit within the bottle 16 (containment device) and will comprise a seal (O ring).
While Radcliffe does describe air filtering device 40 that is connected to tube 15 (which is connected to aperture 13, and aperture 13 is mapped to the second adaptor), it is unclear if the air filtering device is configured to extend into the bottle 16 (Radcliffe; [0038], [0040]).
In the same problem solving area of filtering air entering and departing a hollow body, Pipelka teaches where the filtering device is fixed to a stopper (Pipelka; page 3 lines 10-12, page 4 lines 4-6).
Specifically, Pipelka teaches a hollow body 2 provided with an open top end 21 that has a stopper 3 that is joined to the top open end 21 (Pipelka; page 6 lines 9-13, Figures 1-7b). The stopper 3 has two openings 33 and 34 provided on the plane surface 31, where a filtering device 11, 12 is capable of sterilizing the air which passes from the external environment to the hollow body 2 that is placed in the first opening 33 (Pipelka; page 6 lines 22-30, page 7 lines 1-2, Figures 7a-b).
Examiner finds that the prior art contained a device/method/product (i.e., a bottle with a cap that includes a tube connected to a filtering device) which differed from the claimed device by the substitution of component(s) (i.e., filter being on the tube connected to the cap being on the outside of the container) with other component(s) (i.e., cap with a filter where the filter extends into the container), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., filter connected to the tube on the outside of the container for the filter that is connected to the cap that extends into the container), and the results of the substitution (i.e., filtering air coming into the container) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the filter that is outside of the bottle of reference Radcliffe with the filter that is on the inside of the container of reference Pipelka, since the result would have been predictable.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radcliffe (US-2020/0305583-A1), Ellis (US-2008/0217250-A1) and Pipelka (WO-2007/141255-A1), and in further view of Binder (US-2018/0243376-A1).
Regarding claim 13, modified Radcliffe teaches the system of claim 1. While Radcliffe does describe that the bottle and cap extends to a bioreactor for communication of gas or fluid where the tube is provided as a feeder line where the contents of the bottle may be transferred to the bioreactor or be collected from the bioreactor, where the bottles may hold fluidic medium (Radcliffe; [0004], [0009]), Radcliffe does not describe the specific medium provided in the bottles and therefore does not teach wherein the containment device comprises an activating material, a concentrating material, or both an activating material and a concentrating material.
In the analogous art of forming protein solutions, Binder teaches where a cell culture can be a bioreactor (Binder; [0154], [0163]).
Specifically, Binder teaches where the cell cultures can release the anti-inflammatory cytokines into culture medium naturally, or that the cultures can be induced to release the anti-inflammatory cytokines into the culture medium (Binder; [0165]). As described by [0119] of Binder, a cytokine cell suspension is incubated or otherwise contacted with a solid extraction material to produce a protein-containing liquid, where the extraction materials are useful to concentrate cytokines or other proteins in the liquid volume of white blood cells and in some embodiments activate, stimulate or otherwise increase production of cytokines. [0126] describes that the extraction material may include glass beads or polyacrylamide beads.
Radcliffe is silent with regards to specific medium supplied to a bioreactor, therefore, it would have been necessary and thus obvious to look to the prior art for conventional mediums. Binder provides this conventional teaching showing that a bioreactor can be induced to release cytokines into a culture medium, and that a solid extraction material can activate, stimulate, or otherwise increase production of cytokines. Therefore, it would have been obvious to one having ordinary skill in the art to make the medium held in the bottle of Radcliffe to be the solid extraction material as taught by Binder, because Binder teaches that the solid extraction material is effective for use with a bioreactor to activate, stimulate, or increase production of cytokines in cells (Binder; [0119], [0129]).
Regarding claim 14, modified Radcliffe teaches the system of claim 13. Binder further teaches wherein the activating material comprise glass beads or polyacrylamide beads (Binder; [0126]).
Allowable Subject Matter
Claims 2, 6, 8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 2, the closest prior art is Radcliffe in view of Ellis and Pipelka. Radcliffe is directed to a system, apparatus, and method for coding caps with tubes which can provide feeder lines for different bottle sizes, where the tubes connected to the caps are described as being a feeder line to a bioreactor (Radcliffe; [0004], [0009]). It would not be obvious to one skilled in the art to modify the bottle of Radcliffe such that it has a second opening at a distal end and comprising a second port.
Regarding claim 6 the closest prior art of record is Radcliffe in view of Ellis and Pipelka. As described in [0009] of Radcliffe, the tubes connected to the caps provide a feeder line to a bioreactor container or vessel where contents of the bottle may be transferred to the bioreactor, or be collected from the bioreactor in the bottle. It would not be obvious to one skilled in the art to modify the bottle and cap with tubes of Radcliffe such that it further comprises a device for resecting tissue fragments and fluid from a surgical site.
Regarding claim 8, similar to the reasons described for claim 6 supra, because the contents of the bottle are described to either be transferred to the bioreactor or collected form the bioreactor in the bottle, it would not be obvious to one skilled in the art to modify the bottle and cap with tubes of Radcliffe such that it further comprises a device for collecting tissue fragments and fluid from a surgical site. Additionally, claim 8 has the device for collecting tissue connected to the second adaptor, where the second adaptor of Radcliffe is mapped to aperture 13, which is connected to the air filter. Further, it would not be obvious to one skilled in the art to connect a device for collecting tissue to the aperture 13 as this would interfere with the operation of the air filter.
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Guirguis (US-6509164-B1) describes a biological fluid collection container comprising a cup, a lid, a luer lock extending from one side of the lid housing, and a hollow tube extending from the other side of the lid housing (Guirguis; abstract).
Translated Kodama (JP-2008/061524-A) teaches where cells can be cultured or grown, where the growth and function of cultured cells can be stopped and stored with polyphenols such as catechins at room temperatures, and then catechins can be removed, and by doing so the cells can be activated again (Kodama; [0015]).
Translated Zhou (CN-106475162-A) teaches where a main body 12 includes a cap 124 and a cover 126 where the opening of the cap 124 is provided with a mating protrusion along the circumference, the cap 124 being sealed to the opening of a reagent bottle (Zhou; [0041], [0042], Figure 2). The main body 12 also includes a filter 14 and an infusion tube connector 16 (Zhou; [0030], [0031], Figure 1-2).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA LYLE whose telephone number is (571)272-9856. The examiner can normally be reached 8:30-5:00 M-Th.
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
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