Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Drawings
The drawings are objected to because drawings 3-5 are not legible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 2-4 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.
Claims 2-4 are indefinite because they recite a coefficient of variation of data obtained from the microarray. The claims do not indicate what the coefficient of variation is measuring. Coefficient of variation is a measure of repeatability or the standard deviation divided by the number of replicates. While it states “of data” it is not clear if the data is a second run of the same sample of if the data is a measure of how the array performs over multiple runs of the same sample source or across all types of samples.
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1 and 5-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sundararajan et al. (US 2010/0240555 A1) in view of Rava et al. (US 5,545,531 A) and Wilson Research Group (Webpage, 2001).
Sundararajan et al. teach manufacturing biomolecule micro arrays. Sundararajan et al. teach the use of a photoactive compound to attach features to a create a microarray. [0004]. Sundararajan et al. teach the surface can comprise silicon dioxide (SiO2). [0130, 0137]. Sundararajan et al. teach the use a ligand/receptor pair and the receptor is attached to the surface including peptides, polynucleotides, nucleic acids, and proteins. (Claim 19 [0052-0060]). The receptor in Sundararajan et al. is the equivalent of a feature in instant claim 1. Sundararajan et al. teach that the photoactive compound is treated with ultraviolet light to create a photoresist on the surface. [0064-65].
Rava et al. teach biological chips with arrays of probes attached. (Col. 4, Part E). Rava et al. further describe biological chips in Col 9, part D. Rava et al. teach that the probe array of 0.25 mm2 can have at least 10, 100, 1000, 104, 105, or 106 features. (Col 9, lines 20-25). Rava et al. further teach use hybridization of a sample to the microarray. (Col. 10, lines 58-67). Rava et al. teach the biological chip is imaged on a biological chip plate reader. (Col 4 – 7 discusses the reader/imager).
Sundararajan et al. and Rava et al. both teach the creation of biological chips that can bind biological samples. Sundararajan et al. does not specifically state how many features are on a plate, however Rava et al. teaches that there can be upwards of 1,000,000 features per 0.25 mm2. Sundararajan et al. does teach that the arrays can be used to measure expression levels of up to millions of reactions simultaneously but does not provide an exact feature to area number. Sundararajan et al. and Rava et al. are both in the same field, manufacturing biological chips from silicon dioxide and one of skill in the art would create chips with the recited number of features taught by Rava et al. on the plate taught by Sundararajan et al. Furthermore, Sundararajan et al. does not teach the use of their plate, however, Rava et al. teaches binding of ligands and imagining of the resulting binding. One of skill in the art would be motivated to use the microarray taught by Sundararajan et al. after it is manufactured as that is the intended purpose of the microarray.
Sundararajan et al. and Rava et al. do not teach a water-soluble photoactive compound. Wilson Research Group teach that water soluble photoactive compounds are preferable for chip design because they are cheaper and better for the environment. Therefore, one of ordinary skill in the art would substitute the photoactive compound taught by Sundararajan et al. with a known water-soluble one to reduce costs and reduce emissions.
Regarding claims 5-12, Rava et al. teach that the microarray can be used to detect different types of samples and the array can be customized to the sample and the probe size. (Col 10, line 32 – Col 11, line6). Rava et al. discusses several types of samples such as human or pathogen. The type and size of the array will determine the amount of sample loaded onto the array and the type of sample will dictate the concentration. Therefore, it would have been obvious to one of ordinary skill in the art to create an array based on the teachings of Sundararajan et al. and Rava et al. in view of Wilson Research Group to accommodate the sample amount and concentration because the array is customizable.
Regarding claims 13-18, the detection of a specified number of ligands is dependent on the number of features available on the array. Rava et al. teach that a 0.25 mm2 area can accommodate at least 1,000,000 features. Therefore a 1 cm2 chip will contain 400,000,000 features which encompasses the number of ligands that can bind in claims 13-18. Sundararajan et al. does teach that the arrays can be used to measure expression levels of up to millions of reactions simultaneously but does not provide an exact feature to area number. Therefore, one of ordinary skill in the art would be motivated to include the number of features needed to analyze their sample and number of ligands because the arrays of both Sundararajan et al. and Rava et al. are customizable.
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 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,006,909. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are broader in scope that the claims in the 909 patent and encompass the allowed subject matter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MINDY G BROWN whose telephone number is (571)270-5605. The examiner can normally be reached Monday -Friday, 9:00 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571) 272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MINDY G BROWN/Patent Examiner, Art Unit 1683
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
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