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 .
Drawings
Figure 1B should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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.
It is noted that this figure appears in US 2018/0017184 A1 as FIG. 1.
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 26-38 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.
Claim 26 recites the limitation "the plurality of lysing tubes" in lines 7, 8, 10 and 11-12. There is insufficient antecedent basis for this limitation in the claim. The claim only recites “a lysing tube” in line 2. Similarly, claim 26 recites the limitation “the plurality of mixing tubes” in lines 15 and 17. There is insufficient antecedent basis for this limitation in the claim. The claim only recites “a mixing tube” in lines 2-3. Appropriate correction is required.
As claims 27-38 depend directly or indirectly from claim 26, they are rejected for the same reason.
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.
Claims 26, 30, 31 and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hansen (US 6,672,458, IDS reference).
Regarding claim 26, Hansen disclosed:
A system comprising:
a receiving bay configured to receive a device comprising a lysing tube and a mixing tube aligned along each of a plurality of parallel processing axes
It is noted that the term “lysing tubes” refers to an intended use for those tubes. Similarly, the term “mixing tubes” refers to an intended use for those tubes. The term “processing axes” simply refer to the orientations of the tubes (i.e. their orientation along an “axis”). As the claims are directed to a system, the intended use does not structurally distinguish over the tubes and axes in the system of Hansen as discussed below. So long as one could use the tubes for lysing and mixing, the components in Hansen’s system meet the claims.
Hansen disclosed a “receiving bay” (102; Fig 1; col 4, ln 23-25) configured to receive a plurality of lysing tubes; the first column of tubes 120 in Fig 3 could be used for lysing the cells of a sample. Similarly, the second column of tubes 120 in Fig 3 could be used for mixing; e.g. nucleic acids extracted in the “lysing tubes” according to Hansen’s actual method of using the device could be transferred (by manual pipetting) to the “mixing tubes” and mixed with some other component, such as nucleic acid amplification reagents.
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The “processing axes” are simply axes running horizontally in the figure above through the “lysing tubes” and corresponding “mixing tubes”. As seen here, these “processing axes” are parallel:
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the receiving bay comprising: one or more first magnets aligned along a first magnet axis generally perpendicular to the plurality of processing axes, the one or more first magnets configured to move between a position below the plurality of lysing tubes to a position adjacent to the plurality of lysing tubes when the device is received in the receiving bay
Hansen’s device comprises a first magnet 166 (seen in profile in Fig 7) corresponding to the first row of tubes 120 of Fig 3 (the “lysing tubes” as illustrated above). Fig 7 illustrates the magnet in the “adjacent” position, where it can be seen attracting magnetic particles 190 to the side of the tube 120. The magnet 166 is configured to be lowered to a position below the tubes. When shoulder screws 160 are actuated to their lowest position in cam slots 158, 162 shown in Fig 12, the magnet carrier 164 and magnet 166, connected to shoulder screws 160 lies at the bottom of the receiving bay 102, below the tubes. Col 5, ln 23-60.
Note that because magnet 166 runs along the row of tubes designated as “lysing tubes” in the first captioned version of Fig 3 above, it (and thus the “first magnet axis”) would run perpendicular to the plurality of “processing axes” in the second captioned version of Fig 3 above.
the one or more first magnets configured to apply a first magnetic force to contents of the plurality of lysing tubes when the device is received in the receiving bay and the one or more first magnets are positioned adjacent to the plurality of lysing tubes
As shown in figure 7, in the adjacent position, magnet 166 applies a magnetic force to the contents of the tube, as seen by the attraction of the magnetic particles 190 to the side of the tube. Col 7, ln 43-46.
and one or more second magnets aligned along a second magnet axis generally perpendicular to the plurality of processing axes, the one or more second magnets configured to remain stationary when the plurality of mixing tubes are received in the receiving bay, the one or more second magnets configured to apply a second magnetic force to contents of the plurality of mixing tubes when the device is received in the receiving bay
Hansen’s device comprised electromagnet 178, Fig 7, which is aligned with the “mixing axis” (of the “mixing tubes”; second column of tubes in the first captioned version of Fig 3 illustrated above and illustrated in profile in Fig 7 as the tube 120 on the right). The electromagnet is configured to remain stationary (Hansen claim 2) and apply a magnetic force to contents of the mixing tubes (e.g. col 7, ln 64-67: “…the controller controls the electromagnets 178 in step 1070 to generate an AC magnetic field, which demagnetizes the particles 190 so that the particles can freely mix with the wash solution being added to the tubes 120.”).
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Note that because electromagnet 178 runs along the row of tubes designated as “mixing tubes” in the first captioned version of Fig 3 above, it (and thus the “second magnet axis”) would run perpendicular to the plurality of “processing axes” in the second captioned version of Fig 3 above.
Regarding claim 30, as shown by the placement of magnets in Fig 7, the magnetic force for each magnet would be applied “along” the processing axes.
Regarding claim 31, it is noted that the “mixing tubes”, “mixing axis”, “second magnet” and “second magnet axis” could alternatively be considered as corresponding to the last column of tubes in Hansen’s device, in which case the first magnetic force would not exert on the mixing tubes, and the second magnetic force would not exert on the lysing tubes:
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Regarding claim 38, Hansen Fig 2 shows the “device” comprising the “lysing tubes” and “mixing tubes” in the “receiving bay”; in this case the “device” corresponds to the tube rack comprising tubes, as shown in Fig 4.
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 26-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,970,692. Although the claims at issue are not identical, they are not patentably distinct from each other because, though using different wording (e.g. magnet axis “along” or “parallel” to processing lysing or mixing axis, versus perpendicular to processing axis), the claims of ‘692 describe the same invention, as can be observed from seeing how the same prior art anticipates the instant claims as the claims rejected during prosecution of the ‘692 patent.
Although a restriction was made in the ‘692 prosecution, it is noted that the claims of the instant application have been amended such that the basis of restriction has been removed. That is, claim 26 in the ‘692 patent originally stated that the second magnet axis was perpendicular to the first magnet axis. Now, however, claim 26 states that the second magnet axis is perpendicular to the plurality of processing axes. The restriction was based in part on the fact that claim 1 of the ‘692 patent originally read: “one or more second magnets aligned along a second magnet axis generally parallel to the first magnet axis”, while claim 26 of the ‘692 patent originally read: “one or more second magnets aligned along a second magnet axis generally perpendicular to the first magnet axis”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C WOOLWINE whose telephone number is (571)272-1144. The examiner can normally be reached 9am-5:30pm.
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/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681
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