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.
Status of the Claims
Claims 38-42 and 44-47 are pending, claims 1-37 and 43 are cancelled, no claims are amended.
Withdrawn Objections/Rejections
The previous rejection of claim 43 under 35 U.S.C. 112(b) is withdrawn in response to Applicant’s amendments to the claims (claim 43 is cancelled).
The previous rejections of claims under 35 U.S.C. 102 and 35 U.S.C. 103, citing Rhor et al., are withdrawn. See new grounds set forth in detail below.
Maintained Objections
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).
Petition received and pending review.
New Grounds of Rejection
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 Chatterjee et al., US PG Pub No. 2016/0195523A1 (IDS entered 06/13/2023).
Chatterjee et al. teach a device/product comprising, (i) first and second chambers, each capable of containing a volume of liquid (see for example, any of those chambers at Figure 1, particularly C and D), (ii) a channel (see for example, at Figure 10, connecting across the top of the chambers) that reads on a transfer channel, the channel connecting the first and second chambers, (iii) a transfer surface disposed above the transfer channel and the first and second channel, 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 at para [0096], regarding the design of the cartridges, the cartridges having a top and a bottom, creating a closed fluidic system, the top reads on a transfer surface having a proximal side and a distal side as claimed), and a magnet configured to be positioned near or against the distal side 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 paras [0015]-[0017], particularly para [0035], position of magnet at the top of the well, moving perpendicular).
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 Chatterjee 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.
Chatterjee et al. teach a device substantially as claimed (see as cited previously above, see also para [0096], composed of plastic or polymer).
Chatterjee 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 Chatterjee et al., in order to have provided the device comprising a channel (transfer surface) comprising polycarbonate material (claim 40) coated in hydrophobic thin 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 in the 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 Chatterjee 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.
Chatterjee et al. and the cited prior art teach a device substantially as claimed (see above). However , Chatterjee 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 Chatterjee et al. in view of Zilch et al., US PG Pub No. 2012/0295366A1 (IDS entered 06/13/2023).
Chatterjee teach a method providing a device substantially as claimed (referring to 38, comprising chambers and channel, see claim 38 addressed above). Chatterjee et al. teach providing paramagnetic beads (PMP) within the first chamber, the PMP displaying a capture agent with affinity for analyte, positing magnet near side of transfer surface (i.e., above) adjacent to first chamber to pull PMPs within the first chamber together (Chatterjee teach using the magnet to concentrate the particles, which concentrate is considered to collect together, thereby reading on “pellet” as claimed) and move the PMPs laterally along to the second chamber (see e.g., paras [0015], [0035], [0068], [0103], [0105], Figures 10, 12).
However, Chatterjee et al. differs from the instant claims in that Chatterjee teach the concentrated particles (pellet of particles) moved from one chamber to the other by way of the magnetic moved along from above.
Although Chatterjee describes movement across the channel into the next chamber channel, Chatterjee 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 Chatterjee et al. teach moving magnetic capture particles by pulling particles up away from a first chamber 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. Both references teach 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 Chatterjee and what is presently claimed is that Chatterjee doesn’t clearly teach the particles drawn up and collected at the channel surface (distal surface, referring to as the transfer surface). 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 Chatterjee and the results would have been predictable and the same as in Chatterjee (achieve washing and transfer). 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 Chatterjee.
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 Chatterjee et al. at para [0018] binding agent including antibody, protein, peptide or nucleic acid.
Regarding claim 47, see Chatterjee et al. teach at paras [0011] and [0091], is teaching paramagnetic particles which exhibit strong magnetism in the magnetic field but lose all properties with removal of the field. See also paras [0109]-[0112], Chatterjee et al. describe repeated application of magnetic field, it would have been obvious to one having ordinary skill in the art that in order to subsequently apply the field, that the field be removed (the magnet drawn away) to release the particles into the subsequent chamber(s) following removal. One would have a reasonable expectation of success arriving at this conclusion because without performing this step, the particles would be maintained above the chamber at the channel).
Response to Arguments
Applicant's arguments filed 07/13/2026 have been fully considered.
Regarding the rejection of claims under 35 U.S.C. 112(b), see as indicated in detail previously above, the rejection is withdrawn in response to Applicant’s amendments to the claims (see above, claim 43 is cancelled).
Regarding the rejection of claims under 35 U.S.C. 103 (remarks pages 4-7), Applicant argues the claimed invention is distinct from Rhor. Applicant argues that claim 38 of the instant application requires "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", and further requires "a magnet configured to be positioned near or against the distal side 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."
Applicant argues that the transfer surface of claim 38 is a distinct structural element, arguing it as a surface or film that spans above the first chamber, the transfer channel and the second chamber. Applicant remarks that it serves as the platform against with the PMPs are pelleted from within he chambers and along which they are dragged laterally by an external magnet moving on the opposite (distal) side of the surface. Applicant remarks that PMPs are drawn upward against the transfer surface, collected into a pellet and then moved laterally along the transfer surface through the transfer channel from one chamber to another, all while the transfer surface separates the PMPs from the magnet.
Applicant argues that Rhor does not teach the transfer surface element of the claimed invention, that Rhor (example 7) describes two wells connected by a narrow channel, with magnet positioned above the wells (see remarks pages 5 citing Example 7). Applicant argues, that as described at Example 7, the wells and channels have open top and are not covered by a transfer surface (wells not confined by a top surface), the particles attracted by the magnetic to the surface of the liquid and not the underside of the “transfer surface” as claimed.
Applicant’s remarks are persuasive. See new grounds of rejection set forth in detail above citing Chatterjee et al. as primary reference.
The claims are rejected as indicated in detail above.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ELLEN J MARCSISIN/ Primary Examiner, Art Unit 1677
Prosecution Insights