The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The disclosure is objected to because of the following informalities: The status of the parent application needs to be updated.
Appropriate correction is required.
Claims 4, 6-7 and 10-18 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. In claims 4 and 18, “the distal end of the flow passage” does not have antecedent basis. In claims 6 and 13, the scope of the “in advance” language is unclear. Does it refer to some other action? If the language refers to some action, what is the action and what structure of the biochemical reaction substrate is defined by the language or the action that is missing? With respect to claims 7 and 14, are the pair of side walls part of the flow passage? Additionally, is there a direction in which the distance between them is decreased (i.e., going from the reaction area toward the absorber in claim7)? In claim 10, It is not clear what type of flow passage structure would prevent the specimen or the like from flowing out of the reaction area when it is stirred. Additionally, “easily discharged” is a relative phrase without comparative basis. Is there some specific structure that facilitates the discharge of the reaction area so that it is easily discharged? Alternatively, what flow passage structure would make the reaction area difficult to discharge and thus outside of the scope of the language? Claims not specifically addressed above are dependent from a claim which is addressed above so that they have the problems of the claim from which they depend.
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.
Claims 1, 4 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suzuki (WO 2016/163494). Relative to claim 1 Suzuki discloses a solid-phase reaction chip comprising a rotating body (30) formed through the stacking of a first base part (31) and a second base part (32), this structure corresponds to the claimed “reaction plate”), a liquid absorption member (20, corresponding to the claimed “absorption body”) surrounding the rotating body, a storage container (12) having a bottom wall that appears to be capable of being heated (the claimed heating portion) and a cover member (11) assembled on the storage container so as to cover at least a part of the reaction plate and absorber stored in the storage container. Wherein the cover member includes an injection hole (11d) for injecting a specimen or the like into the reaction plate. The reaction plate includes a fixed area (32c, corresponding to the claimed “reaction area”) in which are fixed a plurality of binding substances that are each capable of specifically binding to a substance to be measured included in the sample liquid and a gap (30c, corresponding to the claimed "flow passage” that connects the reaction area and the absorber) formed between the first base part and second base part, and on the surface of the second base part facing the first base part. The gap 30c obviously causes the liquid absorption member 20 and fixed area 32c to be in communication with each other. Thus claim 1 is anticipated by Suzuki. With respect to claim 4, the distal (outer) end of the flow passage (gap 30c) is disposed so as to abut against the absorber. With respect to claim 9, figure 3 shows 4 sets of specific binding substance spots having a diameter of from 100 mm to 1 mm. Based on the separation between the sets in the figure and the diameter of the spots given above, the distance between the sets is anticipated by the teachings of Suzuki.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gordon (US 4,956,302). Relative to claim 1 Gordon discloses a solid-phase reaction chip characterized by comprising chromatographic medium (13) with a backing strip (17) adjacent thereto (this structure corresponds to the claimed “reaction plate”), a liquid absorption member (blotter material 19, corresponding to the claimed “absorption body”) in flow communication with the chromatographic medium (corresponding to the claimed "flow passage” that connects the reaction area and the absorber), a storage container (lower housing portion 12) having a bottom wall that appears to be capable of being heated (the claimed heating portion) and a cover member (upper housing portion 11) assembled on the storage container so as to cover at least a part of the reaction plate and absorber stored in the storage container. Wherein the cover member includes an injection hole (18) for injecting a specimen or the like into the reaction plate. The reaction plate includes a fixed area (reaction cite 16, corresponding to the claimed “reaction area”) in which are fixed a plurality of binding substances that are each capable of specifically binding to a substance to be measured included in the sample liquid. Thus claim 1 is anticipated by Gordon.
Claims 1, 4 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller (US 5,418,136). In figures 8 and 9 Miller teaches two embodiments of a biochemical reaction substrate. Figure 8 shows a reaction plate (test surface 26), an absorber (figure 8G, a thick filter pad/absorbent 60), and a storage container (lower half 34 of device 20) having a reaction plate storing portion for storing the reaction plate (pyramidal structure 28 with test surface 26, see at least figures 8E to 8G) and an absorber storing portion for storing the absorber (see at least the space defined by pyramidal structure 28 and lip portion 70 of figure 8G), wherein the reaction plate includes a reaction area in which a specific binding substance that specifically reacts with a substance to be tested in a specimen is immobilized (see at least the "Receptive Material" section; column 28, line 40 to column 31, line 31), and a flow passage that connects the absorber and the reaction area (see at least figure 8G, elements 28, 36, 43, 44 and 62; the paragraph bridging columns 36-37, "reactive test surface is mounted on a pyramidal shaped pedestal which extends above the base of the device. Rinse solution flows over the test surface and down the faces of the pedestal where it is trapped in the adsorbent pad"; and column 37, lines 38-58, "Beneath plate 36 is a thick filter pad (absorbent) 60 designed to absorb liquid passing from pyramid 28. An aperture 62 is provided within plate 36 to allow plate 36 to fit over pyramid 28. ... Aperture 43 and 44 are provided within plate 36”. Thus claim 1 is anticipated. With respect to claim 4, since fluid passes at least from the reaction plate along the slanted sides of the pyramidal structure into the absorber, the distal end of the flow path along the pyramidal structure is disposed to abut against the absorber. With respect to claim 9, figure 12 shows a device similar to that described above with respect to figure 8 with multiple test surfaces (see the description of the second configuration in the paragraph bridging columns 40-41).
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.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,085,560. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are of a scope that they completely encompass the patented claims so that one cannot practice the patented claims without also practicing the instant claims.
Examiner notes that no further art rejections are presented for other claims due to the severity of the clarity problems. Examiner reserves the right to apply additional art rejections should changes to the claims warrant such rejections.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additionally cited art relates to analysis devices having immobilized binding partners and/or absorbers used to absorb unused/excess sample and/or other fluids. The WO-2016163494-A1 patent publication was cited because examiner included a machine translation of the document that was used to explain the reference teachings for some of the claims to which it was applied above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Arlen Soderquist whose telephone number is (571)272-1265. The examiner can normally be reached 1st week Monday-Thursday, 2nd week Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached on (571)272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARLEN SODERQUIST/Primary Examiner, Art Unit 1797
