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 .
DETAILED ACTION
Responsive to 25SEP23 claim-set
Claims pending 67-79
Claims currently under consideration 67-79
Priority
This application has a filing date of 07/08/2022 and is a CON of 16/357,099 03/18/2019 ABN
16/357,099 is a CON of
15/108,911 06/29/2016 PAT 10294510
15/108,911 is a 371 of PCT/US2015/020034 03/11/2015
PCT/US2015/020034 has PRO 61/951,461 03/11/2014
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 79 is rejected under 35 U.S.C. 102(a)(1 & 2) as being anticipated by Fu et al (US AppPub 20130116130).
Fu et al teach throughout the document and especially the abstract and paragraph 0003+, compositions and methods for stochastic labeling of samples followed by microarray analysis. More particularly and as in claim 79, Fu et al discloses in figures 1,2, and/or 9, a sample bound to target-specific binding partners, each binding partner bound to a docking strand, and at least one docking strand stably bound to a labeled imager strand.
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.
Claim 67-79 are rejected under 35 U.S.C. 103 as being unpatentable over Fu et al (US AppPub 20130116130).
Fu et al is relied upon as above regarding clam 79. Like claims 67 and 78, the claim 79 composition is made by Fu et al in a first embodiment by steps including: contacting a sample being tested for the presence of one or more targets with one or more target-specific binding partners, wherein each target-specific binding partner is linked to a docking strand, and wherein target-specific binding partners of different specificity are linked to different docking strands; contacting the sample with labeled imager strands having a nucleotide sequence that is complementary to a docking strand; removing unbound target-specific binding partners and/or labeled imager strands; imaging the sample to detect microarray bound labeled imager strands. And as second embodiment in paragraph 0176, Fu et al suggest removing labels (and thereby extinguish signal) with nucleic acid-DNA glycosylase (UDG) and a moiety cleavable thereby such enzyme. Applicant is advised the aforementioned Fu passages and/or document claims & paragraph 0092,0159 appear to read on claims 68,69,70,71,72,73,75,76,77 as well.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have added a step of UDG mediated label removal following sample microarray analysis of Fu et al and arrived at the method recited in claims 67 and 78 since one of ordinary skill in the art would have been motivated to have added a step of UDG mediated label cleavage following sample microarray analysis of Fu et al for the benefit of reusing the microarray (which are rather expensive): as interpreted in MPEP 2141 section III (C) the Supreme Court held under KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1396 (2007) the use of a known technique (UDG cleavage) to improve similar devices methods or products in the same way is obvious. One of ordinary skill in the art would have had a reasonable expectation of success in reusing Fu’s microarray by UDG mediated label cleavage in light of the enzyme being art-recognized as robust and commercial availability thereof for decades.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 67-79 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4,7-18 of U.S. Patent No. 9944972.
Although the conflicting claims are not identical, they are not patently distinct from each other because said ‘972 claims represent minor methodological variants of the techniques of making and using the very same composition recited in present claims 67-79, or else the conflicting claims alternatively overlap in scope to a large extent and consequently the overlapping claims are rendered obvious.
Moreover, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify embodiments of ‘972 that fall outside the scope of the present application to select a specifically disclosed embodiment that falls within the scope of the present application because each set of claims concern reagents and analytes with similar physiochemical properties in that they all possess a common core structure and thusbiological activities. Furthermore, one of ordinary skill in the art would have been motivated to make such a modifications because they are disclosed as “preferred” in so far as the dependent claims of ‘972 “teach toward” Applicant’s presently claimed composition made with the same methods and used in the same processes.
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 68-77 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 pre-AIA the applicant regards as the invention.
Claim 68-77 each recite the limitation "the method of claim 1" in line 1. There is insufficient antecedent basis for these limitations, since claim 1 has been cancelled, rendering the metes and bounds of claims 68-77 ascertainable.
In accordance with MPEP 2173.02: If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. See Morton Int ’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M GROSS whose telephone number is (571)272-4446. The examiner can normally be reached M-F 10-6.
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/CHRISTOPHER M GROSS/Primary Examiner, Art Unit 1684