DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 11-29 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. Instant independent claim 11 and instant dependent claims 17, 18, 25 and 26 recite the limitation: “illumination” in regards to a change of an active area of a test strip. However, the active area of a test strip does not “illuminate” or provide any type of “illumination,” which is only provided by a light source. It appears, based on the instant filed specification, paragraph 0076, the correct limitation/term is “reflectivity,” since the active area is reflecting light from a light source. As such, claims 11 and 25 are rendered indefinite, since the active are is only capable of reflecting light, not providing light/illumination. Claims 2-21 are similarly rejected due to their dependency. In addition, instant independent claim 11 and instant dependent claims 17, 18, 25 and 26 recite the limitation: “opacity” in regards to a change of an active area of a test strip. It is unclear as to how the “opacity” of the active area is determined, since the opacity of a material is based on the extent to which light can pass through a substance, indicating how transparent (or translucent) it is, based on recording of an image of the active area, rendering the claims indefinite. Claims 2-21 are similarly rejected due to their dependency.
Instant independent claim 22 recites the limitation: “observing a change in one or more visual characteristics of the immunoassay strip.” The instant filed specification fails to define what exactly constitutes “visual characteristics,” and does not even employ the limitations “visual characteristics,” rendering the claim and all its dependents indefinite. In addition, it is unclear as to the metes-and-bounds of the limitation “visual characteristics,” and one of ordinary skill in the art would not be reasonably appraised of the scope of the claimed invention, further rendering the claim and its dependents indefinite.
Claim 25 recites the limitation "a light source" in line 2. However, instant independent claim 22 recites “a light source.” It is unclear if the light source is the same light source, or a different light source, rendering the claim indefinite.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim 11-13, 15-18, and 20-26 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by U.S. 2001/0034068 to Spivey et al. Spivey et al. disclose an immunoassay reader device (Fig. 3) (see entire reference) including a light source/LED (44), a recording device (CCD imager (34), CMOS image sensor (82’)) and a controller (electrical circuitry (50), CPUT (80) and EEPROM (90)) wherein the immunoassay reader device is configured to image an active area/test zone of a test strip (23) and detect a change in color, opacity or illumination in the active area (see paras 0040, 0041, 0101, 0117, 0142, 0145) (as recited in instant independent claim 11); wherein the change indicates a presence of a test sample on the test strip (see para 0040) (as recited in instant dependent claim 12); wherein the recording device includes a charge coupled device/CCD imager (34) (as recited in instant dependent claim 13); wherein the light source is configured to illuminate the active area/test zone (as recited in instant dependent claim 15); wherein the recording device is configured to record an image of the active area/test zone (see paras 0077, 0081, 0091, 0127) (as recited in instant dependent claim 16); wherein the controller is configured to determine a color or opacity of the active area/test zone (see paras 0040, 0041, 0101, 0117, 0142, 0145) (as recited in instant independent claim 17); wherein the controller is configured to detect a change in color or opacity of the active area/test zone (see paras 0142, 0145) (as recited in instant dependent claim 18); configured to accept an immunoassay cartridge (10) (see Fig. 1) (as recited in instant dependent claim 20); further inherently including a look-up table (i.e. calibration data and/or correcting algorithm with calibration data) for storing a correction (see para 0065) (as recited in instant dependent claim 21).
Spivey et al. further disclose an associated method of detecting the presence of a test sample in an active area/zone of an immunoassay strip (23) (see entire reference) including a) adding a test sample (as recited in instant dependent claim 23) to a region of the immunoassay strip; b) illuminating the immunoassay strip with a light source (44); and c) observing a change in one or more visual characteristics (color, intensity, etc.) (as recited in instant independent claim 22); wherein the test sample is a fluid sample of blood, sweat, urine or saliva (see paras 0003, 0007, 0039, 0045, 0057, 0072, 0076, 0107) (as recited in instant dependent claims 23 and 24); further comprising providing an immunoassay reader device (Fig. 3) comprising a light source (44), a recording device (34), and a controller (electrical circuitry (50), CPUT (80) and EEPROM (90)), wherein said immunoassay reader device is configured to image an active area of a test strip and detect a change in color, opacity, or illumination in the active area (see paras 0040, 0041, 0101, 0117, 0142, 0145) (as recited in instant independent claims 25 and 26); and an immunoassay strip reader device (Fig. 3) to perform the method of claim 22 (as recited in instant dependent claim 29).
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 19 and 27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. 2001/0034068 to Spivey et al. as applied to claims 11 and 22 above. Spivey et al. disclose an immunoassay reader device and method of detecting the presence of a test sample in an active area of an immunoassay strip having all of the previously recited elements and method steps. Spivey et al. does not explicitly disclose the controller is configured to record images of the active area at time intervals and monitor a feature and/or one or more visual characteristics of the immunoassay strip. However, Spivey et al. clearly disclose monitoring of a feature/visual characteristic, being a color feature/visual characteristic, and further disclose that a “kinematic analysis” can be performed to determine both rate of change in color to determine the final test result of the immunoassay (see para 0142). As such, one of ordinary skill in the art as of the effective filing date understands that any rate of change in color would require multiple images to be taken by the recording device of Spivey et al. over intervals of time to determine the rate of change in color over time color feature/visual characteristic, thus meeting the limitations recited in instant dependent claims 19 and 27.
Claim 28 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. 2001/0034068 to Spivey et al. as applied to claim 22 and 27 above, and further in view of U.S. 2005/0037511 to Sharrok. Spivey et al. disclose an immunoassay reader device and method of detecting the presence of a test sample in an active area of an immunoassay strip having all of the previously recited elements and method steps. Spivey et al. does not explicitly disclose determining the position of a fluid flow edge using the recorded images and/or the monitoring of the one or more visual characteristics of the immunoassay strip, as recited in instant dependent claim 28. Sharrok discloses method for detecting the presence of a test sample in an active area of an immunoassay strip (see entire reference); wherein the position of a flow edge/fluid front passing through an active area (zones)(see paras 0011, 0054, 0075, 0080 and 0085) of an immunoassay strip is monitored over time (see Figs. 3-5) by measuring light intensity/visual characteristic over time. It would have been obvious to modify the method of detecting the presence of a test sample in an active area of an immunoassay strip disclosed by Spivey et al., by monitoring the plurality of images over time, as taught by Sharrok, thus providing the ability to determine a flow rate, thus providing an additional control feature which would be able to determine the extent and/or rate at which the sample moved along the immunoassay strip/porous carrier and to reject those readings where the flow rate was determined to fall outside of predetermined limits, as well as providing an optimum time for reading the result can be reliably reproducibility determined (see paras 0013 and 0014 of Sharrok), thus meeting all the limitations recited in instant dependent claim 28.
Double Patenting
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 22, 27 and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 11,988,586. Although the claims at issue are not identical, they are not patentably distinct from each other because instant independent method claim 22 shares the same limitations of claim 1 of the ‘586 patent, including adding a test sample to an immunoassay strip with an active area, wherein the immunoassay strip must inherently be illuminated by a light source for observing/monitoring a visual characteristic/flow edge of the immunoassay strip, wherein the flow edge/visual characteristic is recorded in a series of images of the active area over time intervals, as recited in instant dependent claims 27 and 28 matching the limitations of claim 6 of the “586 patent. As such, claims 22, 27 and 28 are simply a broader and obvious recitation of claims 1 and 6 of the ‘586 patent.
Allowable Subject Matter
Claim 14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Applicant is invited to review PTO form 892 accompanying this Office Action listing Prior Art relevant to the instant invention cited by the Examiner.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Primary Examiner John Fitzgerald whose telephone number is (571) 272-2843. The examiner can normally be reached on Monday-Friday from 7:00 AM to 3:30 PM E.S.T. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor John Breene, can be reached at telephone number (571) 272-4107. 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. The central 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.
/JOHN FITZGERALD/Primary Examiner, Art Unit 2855
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