Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Responsive to communications entered 21JUL2025
Claims Cancelled 1-23,25
Claims Pending 24,26-36
Claims Under Consideration 24,26-36
Priority
This application has a filing date of 12/17/2021 and is a CON of
15/623,134 06/14/2017 PAT 11204350
15/623,134 is a DIV of 14/777,512 09/15/2015 ABN
14/777,512 is a 371 of PCT/US2014/030584 03/17/2014
PCT/US2014/030584 has PRO 61/798,087 03/15/2013
Withdrawn Objection(s) and/or Rejection(s)
Any rejection not reiterated from the previous action is hereby withdrawn.
Maintained Claim Rejection(s) - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, 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 negatived by the manner in which the invention was made.
Claims 24,26-27 and 29-35 stand rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rohr et al (US 5998224 as cited in IDS) in view of Wang et al (US PG-Pub20120301905 as cited in IDS).
Rohr et al teach, throughout the document and especially figures 1,14 taken with columns 6-8; and/or embodiment 7 starting at column 32, ferrofluid based specific binding pair assays (e.g. immunoassays). More particularly in performing said assay, Rohr et al: suspends a plurality of non-magnetic beads bearing a antibody in a ferrofluid; mixes or otherwise exposes the ferrofluid to a plurality of particles forming a mix, such that one or more target particles of the plurality of particles bind with at least some of the non-magnetic beads; flows the mix into a microfluidic channel with an outlet; applies a magnetic field to a portion of the channel, such that the magnetic field exerts an indirect force on the non-magnetic beads to separate and extract the non-magnetic beads from the ferrofluid with a capture region via an electromagnet or permanent magnet; and finally detects captured target particles. The foregoing reads on claims 24 (in part),26,27; and 29 (in part) 31,32,33 (in part),34 and 35.
Rohr et al do not teach: a pump nor a “receptor region” such as recited in claims 24,29,30 and 33.
Similarly, Wang et al teach, throughout the document and especially the abstract, figures 6 and 8 and paragraph 0006 devices for one-step sandwich immunoassays including a “receptor region” with a second antibody mirroring figure 2 of the instant published application as well as pump like claims 24,29,30 and 33.
It would have been prima facie obvious for one of ordinary skill in the art, at the time the claimed invention was made to have performed assays of Rohr et al with a one-step device such as developed by Wang et al.
One of ordinary skill in the art would have been motivated to have performed assays of Rohr et al with a one-step device such as developed by Wang et al for the benefit of use in settings lacking sufficient wash capabilities, advantageous according to Wang et al in paragraph 0012.
One of ordinary skill in the art would have had a reasonable expectation of success in applying the apparatus of Wang et al toward the immunoassays of Rohr et al in light of the considerable technological overlap between the references.
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Please note that the above rejection has been updated from the original version to more clearly address applicants’ newly amended and/or added claims and/or arguments.
Response to Arguments
The remarks accompanying the present response argue motivation is lacking.
Applicant’s arguments have been fully considered but they are not deemed persuasive for the following reasons.
More specifically, the paragraph spanning pp 6-7 of the remarks contends Wang’s receptor region with an antibody is superfluous to Rohr, since a magnet is used to attract analyte complexes (e.g. illustrated as element 616 in Rohr figure 14), making Rohr’s device more complex or costly allegedly with no benefit.
The examiner respectfully disagrees because it is noted magnetic attraction is non-specific. That is, a receptor region with an antibody (more commonly referred to in the art as a capture antibody, cf Wang paragraph 0005) such as illustrated in Wang figure 8 provides the advantage of reducing assay false positives by enhancing assay selectivity -- especially if such capture antibody recognizes a second epitope on the same antigen different than that on the non-magnetic bead’s antibody (e.g. AB in Rohr figure 1). Accordingly, and in contrast with Applicant’s argument, the skilled artisan would have good reason to incorporate Wang’s capture antibody into Rohr’s device, even if a bit more expensive.
Additionally concerning claim 29, the third paragraph at p 7 of the remarks similarly contends Wang’s pump is superfluous to Rohr et al, who utilize capillary action for flow, likewise allegedly rendering Rohr’s device more complex or costly with no benefit.
Again, the examiner respectfully disagrees in so far as a pump provides the advantage of loading multiple samples into Rohr’s capillary. That is, in a medical clinic with many patients and in contrast with Applicant’s argument, a pump would be particularly beneficial to automate capillary loading for higher throughput and/or processing without human interaction.
New 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 28 is rejected under 35 U.S.C. 102(a)(1 & 2) as being anticipated by Koser (WO 2011/071912, aka PCT/US2010/059270– as cited in IDS).
As in claim 28, Koser teaches throughout the document and especially p 3 lines 11-21 and/or p 34 lines 7-16: a method for assaying a target particle, including steps of: suspending a plurality of non-magnetic beads in an unfunctionalized ferrofluid; mixing or otherwise exposing the unfunctionalized ferrofluid to a plurality of particles forming a mix, the plurality of particles including one or more target particles; and capturing the one or more target particles.
New Claim Rejection(s) – 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 28 and 36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection concerns new matter.
Claim 28 has been amended to now be drawn to an ‘unfunctionalized ferrofluid’ and new claim 36 is directed to a ‘magnetic field configured to drive ferrofluid in a first direction and non-magnetic beads in any direction other than the first direction’, yet the original application provides no implicit or explicit support therefor such items, nor do the remarks accompanying the current amendment indicate where such matter is presented in the original disclosure, much less in the priority documents of the current application.
Applicants are reminded that it is their burden to show where the specification supports any amendments to the disclosure. See MPEP 714.02, paragraph 5, last sentence and also MPEP 2163.06 I.
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” MPEP 2163.02 teaches that “Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application. MPEP 2163.06 further notes “When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not “new matter” is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure.
New Claim Rejection(s) – 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, 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 negatived by the manner in which the invention was made.
Claims 24,26-27 and 29-35 and 36 stand rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rohr et al (US 5998224 as cited in IDS; of record) in view of Wang et al (US PG-Pub20120301905 as cited in IDS; or record) and further in view of Koser (WO 2011/071912, aka PCT/US2010/059270– as cited in IDS)
Rohr et al in view of Wang et al is relied on as above including non-magnetic beads bound an analyte particle.
Rohr et al in view of Wang et al do not explicitly teach a magnetic field configured to drive a ferrofluid in one direction and non-magnetic beads in another per claim 36.
As in claim 36, Koser suggests, throughout the document and especially the paragraph spanning p 8 to 9, sorting of biological samples in ferrofluids. Moreover at p 34 lines 11-15 taken with p 3 lines 11-18, Koser suggests a magnetic field in various frequencies from electrode(s) in various geometries that may drive a ferrofluid and particles in different directions.
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 performed assays in a device as suggested by Rohr et al in view of Wang et al with electrodes configured in the manner of Koser.
One of ordinary skill in the art would have been motivated to have performed assays in a device as suggested by Rohr et al in view of Wang et al with electrodes configured in the manner of Koser for benefits of significantly reducing incubation times as well as increasing sensitivity, boith as noted by Koser at p 34 line 17.
One of ordinary skill in the art would have had a reasonable expectation of success in configuring electrodes as in Koser for assays in a device as suggested by Rohr et al in view of Wang et al in view of the extensive experimental protocols detailed in all three references as well as the impressive experimental results reported by Koser in the working examples.
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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached on (571)272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER M GROSS/
Primary Examiner, Art Unit 1684
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