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 Objections
Claims 1-2, 5, and 8-11 are objected to because of the following informalities:
Regarding claim 1, section b, “Isolating target” should be changed to --Isolating the target--.
Regarding claim 2, section a, “each of a plurality of n samples” should be changed to --each of a plurality of n samples, thereby providing a plurality of sample aliquots--.
Regarding claim 2, section b, “Isolating target” should be changed to --Isolating the target--.
Regarding claim 2, section b, “of the plurality” should be changed to --of the plurality of sample aliquots--
Regarding claim 2, section c, “a second sample aliquot” should be changed to --a second sample aliquot of the plurality of sample aliquots--
Regarding claim 2, section c, “and isolating target” should be changed to --and isolating the target--.
Regarding claim 5, lines 1-2, “the plurality of n samples” should be changed to --the plurality of samples--
Regarding claim 8, line 2, “contacting target” should be changed to --contacting the target--.
Regarding claim 8, lines 2-3, “by eluting bound target” should be changed to --by eluting the bound target--.
Regarding claim 9, section b, “Isolating target” should be changed to --Isolating the target--.
Regarding claim 9, section b, “isolating target bound” should be changed to --isolating the target bound--.
Regarding claim 9, section c, “isolating target bound” should be changed to --isolating the target bound--.
Regarding claim 10, section b, “Isolating target” should be changed to --Isolating the target--.
Regarding claim 10, section b, “isolating target bound” should be changed to --isolating the target bound--.
Regarding claim 10, section b, “eluting bound target” should be changed to --eluting the bound target--.
Regarding claim 10, section c, “isolating target bound” should be changed to --isolating the target bound--.
Regarding claim 10, section c, “eluting bound target” should be changed to --eluting the bound target--.
Regarding claim 11, line 1, “wherein target” should be changed to --wherein the target--.
Appropriate correction is required.
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, 8-10, and 20 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 claim 2, step (d) claims repeating step (c) n-2 times to create a pool from the plurality of sample aliquots; however, step (c) specifically states that it is only combining the first sample aliquot with a second sample aliquot. As currently claimed, step (d) would repeatedly combine only the first and second sample aliquots and it appears as though subsequent sample aliquots should be combined instead for situations where n is greater than two. It is unclear as to whether or not step (d) is intending to repeatedly combine only the first and second sample aliquots or not.
Regarding claim 4, the term “significant” is a relative term which renders the claim indefinite. The term “significant” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The limitation “does not result in a significant loss of sensitivity for detection of the target” is rendered indefinite by the usage of the term “significant”.
Regarding claim 8, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 9, it is unclear as to whether or not “a sample aliquot”, “a plurality of n samples”, “a first sample aliquot”, “a solid surface, and “a second sample aliquot” are intended to refer back to the sample aliquots from each of a plurality of samples and the solid surface(s) from claims 1 and 8, from which claim 9 depends upon, or if they are intending to provide further steps to the methods of claims 1 and 8 that manipulate another plurality of samples that are in addition to the previously claimed samples. If the claim is intending to further limit the already claimed plurality of samples, the language should be amended to reflect such further limitation. For example, instead of listing steps a-e in claim 9, the claim should recite language similar to the following: wherein the plurality of samples is a plurality of n samples, wherein isolating the target from each individual sample aliquot of comprises isolating the target from a first sample aliquot of the plurality of sample aliquots by contacting the first […], wherein pooling the sample comprises contacting a second […] and repeating, and wherein testing the pool comprises testing the solid […]. If the claim is intending to provide further steps that manipulate another plurality of samples, then the claim language should be amended to reflect the differences.
Regarding claim 9, step (d) claims repeating step (c) n-2 times; however, step (c) specifically states that it is only contacting a second sample aliquot with the bound surface and isolating the target bound to the solid surface. As currently claimed, step (d) would repeatedly contact the same singular second sample aliquot with the bound solid surface instead of a subsequent sample aliquot for situations where n is greater than two. It is unclear as to whether or not step (d) is intending to repeatedly contact a singular second sample aliquot or if step (c) should be referring to a subsequent sample aliquot of the plurality of sample aliquots. Furthermore, it is unclear as to whether the repeating of step (c) would require contacting a subsequent sample aliquot with the bound solid surface of (b) again, or to contact the bound solid surface previously created in step (c).
Regarding claim 10, it is unclear as to whether or not “a sample aliquot”, “a plurality of n samples”, “a first sample aliquot”, and “a second sample aliquot” are intended to refer back to the same named limitations the sample aliquots from each of a plurality of samples from claims 1 and 5, from which claim 10 depends upon, or if they are intending to provide further steps to the methods of claims 1 and 5 that manipulate another plurality of samples that are in addition to the previously claimed samples. If the claim is intending to further limit the already claimed plurality of samples, the language should be amended to reflect such further limitation. For example, instead of listing steps a-e in claim 10, the claim should recite language similar to the following: wherein the plurality of samples is a plurality of n samples [n has to be greater than 4 since this claim depends upon claim 5], wherein isolating the target comprises isolating the target from a first sample aliquot of the plurality of sample aliquots by contacting the first […], wherein pooling the sample comprises contacting a second […] and repeating, and wherein testing the pool comprises testing the pooled eluate […]. If the claim is intending to provide further steps that manipulate another plurality of samples, then the claim language should be amended to reflect the differences.
Regarding claim 10, step (d) claims repeating step (c) n-2 times; however, step (c) specifically states that it is only contacting a second sample aliquot with the first eluate and the solid surface, isolating the target bound to the solid surface, and eluting the bound target. As currently claimed, step (d) would repeatedly contact the same singular second sample aliquot with the first eluate and the solid surface instead of a subsequent sample aliquot for situations where n is greater than two. It is unclear as to whether or not step (d) is intending to repeatedly contact a singular second sample aliquot or whether step (c) should be referring to a subsequent sample aliquot of the plurality of samples. Furthermore, it is unclear as to whether the repeating of step (c) would require contacting a subsequent sample aliquot with the first eluate from step (b) again, or if it would require contacting the newly formed pooled eluate from step (c).
Regarding claim 20, 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).
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.
(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.
Claims 1-8, 11-14, 17-18, and 20-21 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Roth et al. (US 2017/0211058 A1) (hereinafter Roth).
Regarding claim 1, Roth teaches a method of pooling samples for detecting the presence of a target [automated processing of pooled samples; screening for presence of nucleic acid] (Para [0039], see Abstract), comprising steps of:
a) providing a sample aliquot from each of a plurality of samples, thereby providing a plurality of sample aliquots [providing samples to be analyzed] (Para [0017], see Claim 1);
b) isolating the target from each individual sample aliquot of the plurality of sample aliquots [binding the nucleic acids in the sample to the magnetic beads] (Para [0017], see Claim 1);
c) pooling the sample aliquots after the target isolation of (b) to form a pool of sample aliquots [pooling the beads by transferring the magnetic particles from at least 2 samples to a new, shared container] (Para [0017], see Claim 1); and
d) testing the pool for presence of the target, whereby identification of the presence of the target in the pool indicates presence of the target in at least one aliquot of the plurality of sample aliquots [eluting pool with elution buffer and transferring the eluted nucleic acid to one or several additional detection methods; detection of the nucleic acid of the sample pool] (Para [0017], see Claims 1 and 10).
As best understood regarding claim 2, Roth teaches a method of pooling samples for detecting the presence of a target [automated processing of pooled samples; screening for presence of nucleic acid] (Para [0039], see Abstract), comprising steps of:
a) providing a sample aliquot from each of a plurality of n samples, thereby providing a plurality of sample aliquots, wherein n is at least two [providing samples to be analyzed; combination of 2 or more individual samples] (Para [0017, 0021], see Claim 1);
b) isolating the target from a first sample aliquot of the plurality of sample aliquots [binding the nucleic acids in the sample to the magnetic beads] (Para [0017], see Claim 1);
c) combining the first sample aliquot after the target isolation of (b) with a second sample aliquot of the plurality of sample aliquots and isolating the target from the combined sample aliquots [pooling the beads by transferring the magnetic particles from at least 2 samples to a new, shared container] (Para [0017], see Claim 1);
d) repeating step (c) n-2 times to create a pool from the plurality of sample aliquots [pooling the beads by transferring the magnetic particles from at least 2 samples to a new, shared container] (Para [0017], see Claim 1); and
e) testing the pool for presence of the target, whereby identification of the presence of the target in the pool indicates presence of the target in at least one aliquot of the plurality of sample aliquots [eluting pool with elution buffer and transferring the eluted nucleic acid to one or several additional detection methods; detection of the nucleic acid of the sample pool] (Para [0017], see Claims 1 and 10).
Regarding claim 3, Roth as applied to claim 1 above teaches the claimed invention, in addition to further comprising the step of determining which of the plurality of samples contains the target, comprising testing individual sample aliquots from the plurality of samples for presence of the target [a sample is tracked with barcode label to the final result and is identifiable by the barcode] (Para [0065-0066])
As best understood regarding claim 4, Roth as applied to claim 1 above teaches the claimed invention, wherein pooling or combining the sample aliquots after the target isolation does not result in a significant loss of sensitivity for detection of the target [avoids loss of sensitivity] (Para [0022]).
Regarding claim 5, Roth as applied to claim 1 above teaches the claimed invention, in addition to wherein the plurality of samples comprises at least 4 samples (Para [0080-0092], see Figs. 1-2).
Regarding claim 6, Roth as applied to claim 5 above teaches the claimed invention, in addition to wherein the plurality of samples comprises at least 5, at least 6, at least 8, at least 10, at least 12, at least 24, at least 48, at least 96, at least 256, 4-12, 4-10, 5-10, 4-6, 6-8, 6-12, 8-12, 12-256, 24-256, 24-256, 48-256, 12-96, 24-96, or 48-96 samples (Para [0080-0092], see Figs. 1-2).
Regarding claim 7, Roth as applied to claim 1 above teaches the claimed invention, in addition to wherein the target is isolated by binding to a solid surface, such as beads, resin, or membrane [beads] (Para [0017], see Claim 1).
As best understood regarding claim 8, Roth as applied to claim 7 above teaches the claimed invention, in addition to wherein pooling is performed on the solid surface by contacting the target bound to the solid surface or by eluting the bound target from the solid surface [pooling the beads by transferring the magnetic particles from at least 2 samples to a new, shared container] (Para [0017], see Claim 1).
Regarding claim 11, Roth as applied to claim 1 above teaches the claimed invention, in addition to wherein the target is isolated by enzymatic, chemical, or mechanical means [adding a solution suited for cellular lysis together with magnetic beads suited for binding nucleic acids to the sample, binding the nucleic acids in the sample to the magnetic beads] (Para [0017], see Claim 1).
Regarding claims 12-14, Roth as applied to claim 1 above teaches the claimed invention, in addition to wherein all steps of the method are automated [method for automated processing] (Para [0021], see Claim 1).
Regarding claim 17, Roth as applied to claim 1 above teaches the claimed invention, in addition to wherein the plurality of samples comprises samples from more than one individual or source [blood donations] (see Abstract).
Regarding claim 18, Roth as applied to claim 1 above teaches the claimed invention, in addition to wherein the samples are bodily fluid samples, tissue samples, cell culture samples, DNA samples, RNA samples, or protein samples; or wherein the samples are soil or water samples [blood donations] (see Abstract).
As best understood regarding claim 20, Roth as applied to claim 1 above teaches the claimed invention, in addition to wherein the target is a biological molecule [nucleic acid] (Para [0039], see Abstract).
Regarding claim 21, Roth teaches a system for pooling samples for detecting the presence of a target [automated processing of pooled samples; screening for presence of nucleic acid] (Para [0039], see Abstract), wherein the system is capable of performing the method of claim 1 (see Rejection of Claim 1 above), wherein at least one step of the method is conducted automatically in the system [automated processing] (Para [0021], see Claim 1).
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.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Roth as applied to claim 1 above.
Regarding claim 15-16, Roth as applied to claim 1 above teaches the claimed invention, except wherein Roth fails to explicitly teach wherein the plurality of samples comprises samples from one individual or from one source, wherein the plurality of samples comprises samples obtained over a range of time; however, Roth teaches that it is known in the art to analyze a plurality of samples from a singular individual/source obtained over a range of time [blood donations; second donation after a minimum interval of 2-3 months] (Para [0005]). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Sath such that the plurality of samples comprises samples from one individual or from one source, wherein the plurality of samples comprises samples obtained over a range of time, in order to detect whether blood donations from a singular individual is safe to use or not.
Allowable Subject Matter
Claims 9-10 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 and claim objections set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 9, the primary reason for the indication of allowable subject matter is on the assumption that the claims are intended to further limit the steps (a)-(d) of claim 1 in the way described in the 35 U.S.C. 112(b) rejection above, that step (c) refers to a subsequent sample aliquot instead of a specific second sample aliquot, and that repeating of step (c) requires contacting a subsequent sample aliquot with the newly bound solid surface from step (c). Should Applicant attempt to overcome the above rejections under 35 U.S.C. 112(b) in a different manner, this indication of allowable subject matter may no longer apply.
Regarding claim 10, the primary reason for the indication of allowable subject matter is on the assumption that the claims are intended to further limit the steps (a)-(d) of claim 1 in the way described in the 35 U.S.C. 112 (b) rejection above, that step (c) refers to a subsequent sample aliquot instead of a specific second sample aliquot, and that repeating of step (c) requires contacting a subsequent sample aliquot with the newly formed pooled eluate from step (c). Should Applicant attempt to overcome the above rejections under 35 U.S.C. 112(b) in a different manner, this indication of allowable subject matter may no longer apply.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Linnen et al. (US 2018/0143115 A1) - method of pooling samples for detecting the presence of a target - also teaches claims 1-2 (Para [0007, 0017])
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/DAVID Z HUANG/ Primary Examiner, Art Unit 2855