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 .
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.
Priority
The present application is filed as a continuation of application 16/618,698, filed 12/02/2019 (Patent No. 11,673,134). Acknowledgement is made of 16/618,698 as a proper National Stage (371) entry of PCT Application No. PCT/US2018/036348, filed 06/06/2018, which claims benefit under 35 U.S.C. 119(e) to provisional application No. 62/515,876, filed 06/06/2017.
Information Disclosure Statement
The information disclosure statement (IDS) filed 06/13/2023 and 03/14/2025 have been considered, initialed and are attached hereto.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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.
Claim 43 is 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 43 recites “wherein a magnetic field produced by the magnet is applied to the first chamber, transfer channel, or a second chamber when the magnet is positioned adjacent to the position first chamber, transfer channel, or second chamber, respectively”, the recited language reads as a method step; however, claim 43 depends from claim 38 which is a product invention (a device). The claim is indefinite because it is not clear what further structural feature/element the claim language is intended to impart of the device of claim 38 (what additional limitation beyond those structures/elements already recited at claim 38).
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.
Claim(s) 38 and 43 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Rhor et al., WO93/19370A1.
Rhor et al. teach a device structurally consistent with the claimed “analyte purification device” (see separation means for separating immobilized magnetically labeled reagent from free magnetically labeled reagent, end of page 3 to page 4), the device of Rhor et al. comprising: (i) first and second chambers, each of the chambers capable of containing a volume of liquid (see Example 7 at pages 33-34, separation means, constructed to include two wells); (ii) a transfer channel connecting the first and second chambers (see Example 7, wells connected by a narrow channel), (iii) a transfer surface disposed above the transfer channel and first and second chambers, the transfer surface having a proximal side oriented toward the transfer channel and first and second chambers and a distal side oriented away from the transfer channel and first and second chambers (see Example 7, particles described as migrating through the channel by way of magnet from above the well, i.e., above would be proximal side oriented toward the channel and the chambers and a distal side way from the proximal side). Example 7 describes the magnet as being above the channel, the inside of the channel on the proximal wall is considered to address the claimed “transfer surface”, i.e., the surface along which the magnetic field is applied to draw and move the magnetic particles. See further Example 7, Rhor describes a magnet configured to be positioned near or against the distal side (the outside part) of the transfer surface and capable of being moved laterally along the distal side of the transfer surface adjacent to the first chamber, transfer channel, and second chamber (see Example 7 moves along the channel from first well to the second well).
Regarding claim 43, Rhor et al. teach the device capable of receiving magnetic field produced by magnetic applicable at first chamber, transfer channel and second chamber, the device allows positioning of the magnet over each of these respectively.
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:
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.
Claim(s) 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over Rhor et al. in view of Adey et al., US PG Pub No. 2005/0019898A1, Rogalsky et al., Antimicrobial polycarbonates for biomedical applications, EPMA Journal, 5(Suppl 1), (2014), 2 pages, Ismagilov et al., CA 2870999A1, and Jang et al., Modification of polycarbonate with hydrophilic/hydrophobic coatings for the fabrication of microdevices, Sensors and Actuators B: Chemical, 193, (2014), p. 599-607.
Rhor et al. teach a device substantially as claimed (see as cited previously above).
Rhor et al. fails to teach the transfer surface (of the channel) comprises a thin film (claim 39), that the transfer surface (of the channel) comprises polycarbonate (claim 40), or that the proximal side of the thin film comprises a hydrophobic coating (claim 41).
However, the prior art recognized polycarbonate as a neutral material known in the prior art for production of assay components/devices, see for example, Adey et al., at para [0036] ( teaching it is a neutral material), see also Rogalsky et al. teaching polycarbonate is one of the most widely used engineering polymers due to its unusual combination of optical clarity, heat resistance, high impact strength and dimensional stability, as well as low water absorption, ease of sterilization and biocompatibility (see page 1, col. 1, background).
Ismagilov et al. is another example that supports the use of polycarbonate material for producing assay devices, Ismagilov is teaching an invention related to fluidic devices for preparing, processing, storing, preserving, and/or analyzing samples, Ismagilov teach producing devices via injection molding, fabricating plastic devices of polycarbonate, the parts then surface modified to render them hydrophobic.
Jang et al. teach strategy for modifying polycarbonate surfaces to make them either more hydrophilic or hydrophobic (abstract). Jang et al., similar to Rogalsky et al., recognized polycarbonate material as a substrate recognized as a suitable alternative to glass, silicon and quartz in fabrication of microfluidic devices because of its many advantages including high mechanical strength, optical transparency, low cost, ease of molding, etc. (page 599, col. 1, para 1). Jang et al. teach despite the many advantages, the material is subject to damage by organic solvents, Jang teach a solution to this issue is making the surfaces hydrophobic (see page 599, col. 2, para 2).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Rhor et al., in order to have provided the device comprising a channel (transfer surface) comprising polycarbonate material (claim 40) coated in hydrophobic thing film (claims 39 and 41). In particular, it would have been obvious to have provided the device produced of polycarbonate material, one having ordinary skill in the art would have been motivated to have relied on polycarbonate material because this was a known neutral production material used for assay device/components at the time (Adey et al. and further Ismagilov), that this material was a low cost suitable alternative to materials such as glass, silicon and quartz, that it was desirable to those having ordinary skill in the art because of its many well known advantages including optical clarity, heat resistance, high impact strength and dimensional stability, as well as low water absorption, ease of sterilization and biocompatibility (see Rogalsky and also Jang et al.). One having ordinary skill in the art further motivated to coat the material with a hydrophobic material/coating as an obvious matter of a known technique applied to a known device, see for example, Ismagilov cited above, one further motivated to modify in this way because Jang et al. recognized that such coatings make the desirable polycarbonate materials more durable/versatile by providing it with resistance to reagent such as organic solvents (Jang et al.).
One having ordinary skill int eh art would have a reasonable expectation of success relying on polycarbonate coated with hydrophobic surfacing material considering these are art recognized techniques known to those of ordinary skill in the assay art (referring to the art cited above).
Claim(s) 42 is rejected under 35 U.S.C. 103 as being unpatentable over Rhor et al. in view of Adey et al., Rogalsky et al., Ismagilov et al., and Jang et al., as applied to claim 41 above, and further in view of Esfandyarpour et al., WO2015089238A1.
Rhor et al. and the cited prior art teach a device substantially as claimed (see above). However , Rhor et al. and the cited art, also teaching hydrophobic coating, fails to teach the coating comprising a manganese oxide polystyrene nano-composite, a zinc oxide polystyrene nano-composite, precipitated calcium carbonate, a carbon nanotube-based coating, or a silica nanocoating (claim 42).
See also Esfandyarpour et al., the prior art recognized several coating materials relied on in the prior art in order to produce hydrophobic surfaces for biological analysis devices, see for example, para [0328], including Manganese oxide polystyrene nanocomposite, or Zinc oxide polystyrene nanocomposite materials.
It would have been prima facie obvious to one having ordinary skill in the art to have modified the device taught by the combination of the cited art in order to have provided a hydrophobic surface using either of Manganese oxide polystyrene nanocomposite, or Zinc oxide polystyrene nanocomposite materials, as taught by Esfandyarpour et al., as an obvious matter of a known material selected and applied for its art recognized intended purpose, namely by selecting from a finite list of known suitable materials recognized for this purpose (see for example Esfandyarpour et al.). One having ordinary skill in the art would have had a reasonable expectation off success using a known material for its art recognized purpose (recognized for creating a hydrophobic surface/coating).
Claim(s) 44-47 are rejected under 35 U.S.C. 103 as being unpatentable over Rhor et al. in view of Zilch et al., US PG Pub No. 2012/0295366A1 (IDS entered 06/13/2023).
Rhor et al. teach at Example 7 a method y substantially similar to claim 44, Rhor et al. teaching a method comprising providing a device as at claim 38 (purification device), providing paramagnetic particles within a first chamber, the particles having displayed thereon a capture agent on the surface, the capture agent with affinity for analyte of interest, the method positioning a magnet near a distal side of the surface of the channel (transfer surface) adjacent to the first chamber (on the side of the channel opposite the side of the channel above the first chamber) to pull the particles located with the chamber into dot, moving the magnet laterally along the distal side of the channel (side of the transfer surface), thereby moving the dot along the proximal side of channel (inside the channel) through the channel to a position in the second chamber. The language “dot” is considered to read on the claimed “pellet”.
However, Rhor et al. differs from the instant claims in that Rhor teach the “dot” (pellet of particles) forms on the surface of the liquid within the first well and moves above the larger well to the smaller well by migrating along the channel along the liquid surface.
Although Rhor describes movement across the air/liquid interface through the liquid in the channel, Rhor et al. does not clearly teach the particles moving along the distal side on the channel surface.
See also Zilch et al. (e.g., at the abstract and claims), teaching methods comprising moving paramagnetic particles across an air/liquid interface, Zilch et al. teach (see e.g., Figure 2), using a magnet to gather the magnetic beads (shown as 101) away from the interface, collected at the channel surface (away from the fluid zones), as a way to move the particles through various positions from zone to zone.
Although Rhor et al. teach moving magnetic capture particles by pulling particles up to a liquid/air interface and migrating particles over to the next desired chamber/zone, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date to have applied the magnetic field, pulling the particles to the surface of the channel over the chambers/zones, as in Zilch, as a simple matter of applying one known technique for facilitating movement over another. Both techniques involve using magnetic force to move particles from one desired area to another, moving the particles along a channel that connects to the two areas, the only difference between Rhor and what is presently claimed is that Rhor doesn’t teach the particles drawn up and collected at the channel surface (distal surface, referring to as the transfer surface), and rather Rhor migrates the particles at the air/liquid interface through the channel. However, the technique of pulling the particles by magnetic force through the interface to the channel surface was also known and utilized in the prior art for moving magnetic particles by channel from one area to another, see for example Zilch. One having ordinary skill could have applied the technique of Zilch to the method of Rhor and the results would have been predictable. Specifically, the results would have remained the same in that one would still expect transfer of those capture particles from the first well to the second well of Rhor.
One having ordinary skill in the art would have a reasonable expectation of success as a result of the similarity between the two techniques, both involve movement through a channel and the channel having a liquid with a liquid/air interface.
Regarding claims 45 and 46, see Rhor et al. at page 8, starting at line 13, binding member can include for example, complementary nucleotide sequences (analyte such as nucleic acids, see page 9, line 2).
Regarding claim 47, see Rhor release the particles by withdrawing the magnetic (see Example 7, removal of the magnetic field).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN J MARCSISIN whose telephone number is (571)272-6001. The examiner can normally be reached M-F 8:00am-4:30pm.
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/ELLEN J MARCSISIN/ Primary Examiner, Art Unit 1677