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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/22/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-3 in the reply filed on 02/17/2026 is acknowledged.
Claims 4-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/17/2026.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Williams et al. (hereinafter Williams) US 2012/0171759.
Regarding claim 1, Williams discloses a system comprising a magnet field-generating device (heater assembly 1401 [0223]) and magnet components (magnet 1404) [0219]) to generate a magnet field, and magnet beads [0227-0228 and 0230]. Also see [0217-0235] and Figs. 26, 27 and 64.
Williams does not expressly disclose that the magnet field-generating is assembled in a 12-well culture plate. However, Williams does disclose that the heater assembly comprises 12 heater units each of which comprises a heat block. The one or more heat blocks may be fashioned from a single piece of metal or other material, or may be made separately from one another and mounted independently of one another or connected to one another in some way. Thus, the term heater assembly connotes a collection of heater units but does not require the heater units or their respective heat blocks to be attached directly or indirectly to one another. The heater assembly can be configured so that each heater unit independently heats each of the one or more process tubes 1402.
Therefore, it would have been obvious to one of ordinary skill in the art to assemble the magnet field-generating into a 12-well culture plate, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. See MPEP §2144.04 (V-B).
As to using the magnet beads to label targeting cells or tissues, or to incorporated them into agarose gel, the device disclosed by Williams is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of William is capable of providing the operating conditions.
Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 2, Williams discloses the magnet field-generating device comprises a magnet (magnet 1404) [0219]), a magnet holder (magnet 1404 is mounted on a supporting member 1505 [0232]), a culture plate (one or more process tubes 1402, [0217]); and a passive aligner (heater assembly 1401 [0223]).
Williams does not explicitly disclose that the magnet is ring-shaped however, Williams states that the magnet 1404 is not so limited in shape [0231].
The shape of a device component has been held to be a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed magnet was significant. See MPEP §2144.04 (IV)(B).
Therefore, one having ordinary skill in the art would have found it obvious to make such a change as a mere alternative and functionally equivalent magnet shape and since the same expected magnet field-generation would have been achieved. The use of alternative and functionally equivalent shapes would have been desirable to those of ordinary skill in the art based on the desired device configuration.
As to wherein the magnet and the magnet holder are assembled, and then assembled in the culture plate, applicant is reminded that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See MPEP §2113.
Regarding claim 3, Williams discloses the system of claim 1. in which. As to the target cell or tissue is prepared by using a non- integrating self-amplifying RNA (saRNA) and encapsuling with a nanoparticle based on modified iron oxide/PEI formulation, the device disclosed by Williams is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of William is capable of providing the operating conditions.
Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Claims 2 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over Williams US 2012/0171759 in view of Fayol et al. (hereinafter Fayol) US 2014/0349330.
Regarding claim 2, Williams discloses the magnet field-generating device comprises a magnet (magnet 1404) [0219]), a magnet holder (magnet 1404 is mounted on a supporting member 1505 [0232]), a culture plate (one or more process tubes 1402, [0217]); and a passive aligner (heater assembly 1401 [0223]).
Williams does not explicitly disclose that the magnet is ring-shaped.
Fayol discloses a magnet field-generating device comprising a ring-shaped magnet [0074-0075 and 0077-0078].
Since Williams discloses that the magnet 1404 it is not so limited in shape [0231]. One having ordinary skill in the art would have found it obvious to make such a change as a mere alternative and functionally equivalent magnet shape and since the same expected magnet field-generation would have been achieved. The use of alternative and functionally equivalent shapes would have been desirable to those of ordinary skill in the art based on the desired device configuration.
As to wherein the magnet and the magnet holder are assembled, and then assembled in the culture plate, applicant is reminded that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See MPEP §2113.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Wednesday 08:00-18:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached on 571-272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796
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