DETAILED ACTION
This detailed action is in response to the application filed on 10/11/2024, and any subsequent filings.
Notations “C_”, “L_” and “Pr_” are used to mean “column_”, “line_” and “paragraph_”.
Claims 1-20 are pending.
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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “200” has been used to designate both a filter press and an ion exchange chromatography system. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 6. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 20. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because of the following informalities:
Reference character 200 is used to designate both a filter press and an ion exchange chromatography system.
Reference character 6 is present in the drawings, but not described in the specification.
Reference character 20 is described in the specification, but not present in the drawings.
Appropriate correction is required.
Claim Interpretation
Claim 8 refers to “at least one fractal subsystem” in line 2 and “a filter press structured and arranged to support at least one fractal subsystem” in line 5. Claim 8 is being interpreted such that the “at least one fractal subsystem” of line 5 is the same as the “at least one fractal subsystem” in line 2.
Claims depending on independent Claim 8 are also affected by this interpretation.
Claims 7 and 14 involve “a weir”. Page 15 of the specification of the instant application describes “to prevent fluid from bypassing the resin, a (e.g., 3/8-inch) weir may be incorporated…”. The “weir” is being given its broadest reasonable interpretation as any structure or device that is capable of preventing fluid from bypassing the resin.
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 3-20 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.
Claims 3-5 refer to “the mesh screens”, whereas Claim 2, upon which Claims 3-5 depends, refers to “a pair of mesh screens”. It is unclear whether “the mesh screens” of Claims 3-5 and “a pair of mesh screens” of Claim 2 refer to the same or distinct mesh screens, rendering the claim indefinite.
Claim 6 refers to “each of the fractal packs”, whereas Claim 1, upon which Claim 6 depends, refers to “a pair of fractal packs”. It is unclear whether “each of the fractal packs” of Claim 6 and “a pair of fractal packs” of Claim 1 refer to the same or distinct fractal packs, rendering the claim indefinite.
Dependent claims not recited above require all of the limitations of Claim 6, and therefore are rejected for the same reasons set forth above.
Claim 8 is directed towards a system for purifying bioactive proteins in a fluid, then lists system components. It is unclear which of the listed system components performs the purifying of bioactive proteins in a fluid, rendering the claim indefinite.
Claim 8 refers to “at least one fractal subsystem” and “each fractal subsystem”. It is unclear whether these refer to the same or distinct fractal subsystems, rendering the claim indefinite.
Claim 8 refers to “at least one fractal subsystem” and “every other fractal subsystem”. It is unclear whether these refer to the same or distinct fractal subsystems, rendering the claim indefinite.
Dependent claims not recited above require all of the limitations of independent Claim 8, and therefore are rejected for the same reasons set forth above.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 6-9, 13-15 and 19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Publication US20170354903A1 (‘Kochergin’).
The Applicant’s claims are directed towards an apparatus.
Regarding Claims 1-2 and 6-7, Kochergin discloses a fractal subsystem (Fig. 1, [0019], fractal flow device 100) for use with an ion exchange system ([0002-0006]), the fractal subsystem comprising:
a resin chamber (Fig. 1, [0026], chamber 140 containing a fluid processing medium, such as an ion exchange resin, in opening 180); and
a pair of fractal packs (Fig. 1, [0019], fractal distributor 130 and fractal collector 150), wherein the pair of fractal packs is disposed on opposing sides of the resin chamber (Fig. 1-2).
Additional Disclosures Included:
Claim 2: the resin chamber comprises:
a frame (Fig. 2-3, [0026], chamber 140);
a plenum space through the frame for holding a resin (Fig. 2, [0026], opening 180 for containing a fluid processing medium);
a pair of mesh screens for containing the resin within the plenum space ([0026], fluid processing medium may be contained in chamber 140 by screen or filter cloth); and
a pair of resin ports adapted to at least one of introduce a fluid into the plenum space or remove a fluid from the plenum space ([0021], flow into and out of chamber 140. [0024] and [0027-0028]).
Claim 6: each of the fractal packs comprises:
a frame (Fig. 2-3, [0020]);
a plenum space through the frame (Fig. 2-3);
a fractal distributor (Fig. 3, [0022], fractal pattern 215) configured within the plenum space;
a fractal flow plate (Fig. 3, [0022], fractal plate 205c) configured within the plenum space; and
a feed material input port (Fig. 1-2, [0019], inlet 160) adapted to introduce a fluid into the plenum space.
Claim 7: a weir (Fig. 4, [0030], sealing element(s) 485 may prevent the fluid stream from leaking) is formed within the plenum space in each of the upper corners of the frame (Fig. 4).
Regarding Claims 8-9, 13-15 and 19, Kochergin discloses a system ([0017]) for purifying bioactive proteins in a fluid, the system comprising:
at least one fractal subsystem ([0017]), each fractal subsystem comprising:
a resin chamber (Fig. 1, [0026], chamber 140 containing a fluid processing medium, such as an ion exchange resin, in opening 180); and
a pair of fractal packs (Fig. 1, [0019], fractal distributor 130 and fractal collector 150), wherein the pair of fractal packs is disposed on opposing sides of the resin chamber (Fig. 1-2);
a filter press (Fig. 2 and 4, [0020], fastening element 225 may be a hydraulic press) structured and arranged to support (Fig. 4, [0030], support structures 475 have shoulders 465) at least one fractal subsystem in a horizontal arrangement (Fig. 4, [0030]) to provide a selectively adjustable bed depth ([0020], fastening element 225 may include end plates that can be adjusted to maintain pressure on fractal cells 120), wherein each fractal subsystem is in fluid communication with every other fractal subsystem ([0030]).
Additional Disclosures Included:
Claim 9: the resin chamber comprises:
a frame (Fig. 2-3, [0026], chamber 140);
a plenum space through the frame for holding a resin (Fig. 2, [0026], opening 180 for containing a fluid processing medium);
a pair of mesh screens for containing the resin within the plenum space ([0026], fluid processing medium may be contained in chamber 140 by screen or filter cloth); and
a pair of resin ports adapted to at least one of introduce a fluid into the plenum space or remove a fluid from the plenum space ([0021], flow into and out of chamber 140. [0024] and [0027-0028]).
Claim 13: each of the fractal packs comprises:
a frame (Fig. 2-3, [0020]);
a plenum space through the frame (Fig. 2-3);
a fractal distributor (Fig. 3, [0022], fractal pattern 215) configured within the plenum space;
a fractal flow plate (Fig. 3, [0022], fractal plate 205c) configured within the plenum space; and
a feed material input port (Fig. 1-2, [0019], inlet 160) adapted to introduce a fluid into the plenum space.
Claim 14: a weir (Fig. 4, [0030], sealing element(s) 485 may prevent the fluid stream from leaking) is formed within the plenum space in each of the upper corners of the frame (Fig. 4).
Claim 15: the filter press comprises:
a pair of vertical supports (Fig. 2 and 4, [0020], fastening element 225 may include end plates);
a pair of horizontal supports (Fig. 4, [0030], support structures 475) fixedly attached to the vertical supports (Fig. 4), wherein the horizontal supports are structured and arranged to support the fractal packs (Fig. 4, [0030], support structures 475 have shoulders 465); and
a filter press subsystem (Fig. 2 and 4, [0020], fastening element 225 may be a hydraulic press) that is structured and arranged to apply a compressive force to the fractal packs ([0020]).
Claim 19: the system produces laminar flow in the fluid ([0042]).
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 3-5 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication US20170354903A1 (‘Kochergin’) in view of U.S. Patent US4999098A (‘Pohl’).
The Applicant’s claims are directed towards an apparatus.
Regarding Claims 3 and 10, Kochergin discloses the fractal subsystem and system of Claims 1 and 9, except that the mesh screens comprise a 200 mesh, plain Dutch weave.
Pohl also relates to a subsystem for use with an ion exchange system (abstract) and a system for purifying in a fluid (abstract and C2/L11-16), including that the mesh screens comprise a 200 mesh (C6/L60-65, mesh on the order of 110 micron mesh size or less. The specification of the instant application states that a 200 mesh, plain Dutch weave may have nominal openings of 75 microns), plain Dutch weave (C7/L23-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the mesh screens of Kochergin to comprise a 200 mesh, plain Dutch weave, as demonstrated by Pohl, because the mesh should be relatively small to maintain chromatographic efficiency but not so small to hinder liquid flow (Pohl, C7/L42-44. Note that Kochergin is also concerned with columns, Kochergin, [0002-0003]).
Additional Disclosures Included:
Claims 4 and 11: the mesh screens have a nominal opening of 75 microns in the mesh (Pohl, C6/L60-65) (It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the mesh screens of Kochergin to have a nominal opening of 75 microns in the mesh, as demonstrated by Pohl, because the mesh should be relatively small to maintain chromatographic efficiency but not so small to hinder liquid flow (Pohl, C7/L42-44)).
Claims 5 and 12: the mesh screens have a geometric opening of 85 microns in the mesh (Pohl, C6/L60-65) (It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the mesh screens of Kochergin to have a geometric opening of 85 microns in the mesh, as demonstrated by Pohl, because the mesh should be relatively small to maintain chromatographic efficiency but not so small to hinder liquid flow (Pohl, C7/L42-44)).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication US20170354903A1 (‘Kochergin’) in view of U.S. Publication US20170095751A1 (‘Simpson’).
The Applicant’s claim is directed towards an apparatus.
Regarding Claim 16, Kochergin discloses the system of Claim 15, including a follower (Fig. 4, [0020] and [0030], end plate) and a hydraulic press (Fig. 4, [0020]), except a selectively moveable rod, wherein the follower is disposed at a distal end of the moveable rod; and the hydraulic press is disposed at a proximal end of the moveable rod.
Simpson also relates to a system for purifying in a fluid (abstract and [0033]), including that the filter press subsystem comprises:
a selectively movable rod (Fig. 3, [0022], rod 346);
a follower (Fig. 3, [0022], moveable plate 344) disposed at a distal end of the movable rod ([0022]); and
a hydraulic press (Fig. 3, [0022], end plate 342) disposed at a proximal end of the movable rod ([0022]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the filter press subsystem of Kochergin to comprise a selectively moveable rod, as demonstrated by Simpson, because both Kochergin and Simpson are concerned with separating or purifying a component or components of a multicomponent fluid stream (Kochergin, [0001]) and Simpson, [0016] and [0033]) and because Kochergin and Simpson both involve systems treating fluid streams from similar sources (Kochergin, [0038] and Simpson, [0033], applicable to water treatment, mining, renewables and petroleum industries).
Claims 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication US20170354903A1 (‘Kochergin’) in view of Publication The Fractal Pack : New Equipment for Ion Exchange Operations in the Sugar Industry (‘Peacock’, Sugar Industry 147 (2022) No. 9 468-475).
The Applicant’s claim is directed towards an apparatus.
Regarding Claim 17, Kochergin discloses the system of Claim 8, except that the selectively adjustable bed depth ranges between one (1) inch and eight (8) feet.
Peacock also relates to a system for purifying bioactive proteins in a fluid (pg. 469, right column), including that the selectively adjustable bed depth ranges between one (1) inch and eight (8) feet (pg. 469, section 2. The fractal pack).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the bed depth of Kochergin based on application (Peacock, pg. 469, left column).
Regarding Claim 20, Kochergin discloses the system of Claim 8, except that the fluid comprises a supply feed material with a fat content greater than 0.1 percent and less than five (5) percent.
Peacock also relates to a system for purifying bioactive proteins in a fluid (pg. 469, right column), including that the fluid comprises a supply feed material with a fat content greater than 0.1 percent and less than five (5) percent (pg. 469, dairy).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the fluid of Kochergin to comprise a supply feed material with a fat content greater than 0.1 percent and less than five (5) percent, as demonstrated by Peacock, because both Kochergin and Peacock are concerned with fractal pack systems applicable in food and sweetener industries (Kochergin, [0038] and Peacock, pg. 469, right column-pg. 470, left column).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication US20170354903A1 (‘Kochergin’) in view of U.S. Publication US20120097591A1 (‘Berthold’).
The Applicant’s claim is directed towards an apparatus.
Regarding Claim 18, Kochergin discloses the system of Claim 8, except that the system is capable of bidirectional flow.
Berthold also relates to a system for purifying bioactive proteins in a fluid ([0001]), including that the system is capable of bidirectional flow ([0091], change of direction).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the system of Kochergin is capable of bidirectional flow, as demonstrated by Berthold, due to deflection of liquid impinging in the direction of branching (Berthold, [0091]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BOI-LIEN THI NGUYEN whose telephone number is (703)756-4613. The examiner can normally be reached Monday to Friday, 8 am to 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bobby Ramdhanie can be reached at (571) 270-3240. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BOI-LIEN THI NGUYEN/Examiner, Art Unit 1779
/Bobby Ramdhanie/Supervisory Patent Examiner, Art Unit 1779
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