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 .
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 1-10 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.
Regarding claims 1 and 10, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claims 2-9 are rejected as being dependent on claim 1 and failing to remove the indefiniteness.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-3, 5-8, and 10 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Gandini et al (US 20140120633).
Regarding claim 1, Gandini et al teach a method for manufacturing a biological analysis card comprising
a chamber for pretreatment of a biological sample (Para. 0011: reaction chamber) that is configured to receive a biological sample comprising biological components such as biological cells (Abstract: microbeads specific to cells), said pretreatment chamber comprising solid bodies configured to mechanically cause a separation of all or some of the components of the biological sample in order to make all or some of said components of the biological sample available for a biological analysis treatment (Para. 0011: reaction chamber with magnetic micro-beads desiccated thereon), wherein the method comprises a step of depositing the solid bodies in the pretreatment chamber in the form of a solid agglomerate (Para. 0187: microbead drops deposited in arrays on the surface of the reaction chambers), said agglomerate comprising the solid bodies and a binder which binds the solid bodies together (Para. 0187: sucrose).
Regarding claim 2, Gandini teach the binder is soluble in water (Para. 0187: rehydrated when liquid sample is added to the chamber).
Regarding claim 3, Gandini teach the solid bodies are magnetic, and are therefore adapted to be moved by a magnetic field external to the analysis card (Para. 0011: magnetic micro-bead).
Regarding claim 5, Gandini teach the binder contains mainly carbohydrates (Para. 0187: sucrose).
Regarding claim 6, Gandini teach the agglomerate comprises at least 100 solid bodies (Para. 0120: 100 micro-beads/ul using 50ul-2000ul).
Regarding claim 7, Gandini teach a preliminary step of forming the agglomerate, comprising the following steps: a) depositing a volume of mixture of solid bodies and binder on a drying surface, forming a deposit of mixture, b) drying the volume of mixture to obtain an agglomerate on the drying surface, c) removing the agglomerate from the drying surface, (Para. 0187:drops on the reaction chamber, dried in a desiccator, removed by rehydrated)
Regarding claim 8, Gandini teach wherein in step a), the mixture is deposited in the form of a drop, and the volume of mixture is less than 12 uL. (Para. 0187: nanodrops 5-10nl)
Regarding claim 10, Gandini teach a biological analysis card comprising a pretreatment chamber that is configured to receive a biological sample comprising biological components such as biological cells (Para. 0011: reaction chamber) , said pretreatment chamber comprising solid bodies configured to cause a separation of all or some of the biological components of the biological sample in order to make all or some of said components of the biological sample available for a biological analysis treatment (Para. 0011: reaction chamber with magnetic micro-beads desiccated thereon), wherein the solid bodies in the sample pretreatment chamber are present in the form of a solid agglomerate, said agglomerate comprising the solid bodies and a binder which binds the solid bodies together.(Para. 0187: microbead drops deposited in arrays on the surface of the reaction chambers; sucrose)
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gandini in view of Khattak et al US 20170248622.
Regarding claim 4, Gandini teach a magnetic core makes up the micro-beads. Gandini teach metal such as iron to create ferromagnetism. (Para. 0067). Gandini is silent to the solid bodies are metal beads.
Khattak teach microbeads made of ferromagnetic metal coated surrounded by a gold shell (Par. 0085). It is desirable to provide magnetic microbeads with metal to ensure durability and magnetism of the microbead. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the metal of Khattak to the microbeads of Gandini to provide the above advantage of ensuring durability and magnetism of the microbead.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gandini in view of Battrell et al (US 20160209431).
Regarding claim 9, Gandini teach rehydration to remove the dried reagents, but is silent in step c), the removal of the agglomerate from the drying surface is carried out by suction of the agglomerate. Battrell et al teach microfluidic cartridges using suction to draw fluid over dried reagents to rehydrate. (Para. 0018) It is desirable to provide a suction to enhance the flow of the fluids in the device. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the suction to provide the above advantage of enhancing the flow of the fluids in the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-5pm.
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, Maris R. Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Dennis White/Primary Examiner, Art Unit 1758
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