DETAILED ACTION
The amendment and RCE filed on 04/15/2026 has been entered and fully considered. Claim 2 is canceled. Claims 1, 3-15 and 17-22 are pending. Claims 15 and 17-20 have been withdrawn from consideration. Claims 1, 3-14 and 21-22 are considered on merits, of which claim 1 is amended, and claim 22 is newly added.
Response to Amendment
In response to amendment, the examiner establishes 112(b) rejection and modifies rejection over the prior art established in the previous Office 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 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.
Claim 1, 3-14 and 21-22 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 1 recites the limitation "the vessel" in line 10. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim 1, 3-14 and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-10 and 16-17 of copending Application No. 17/924,950 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the currently patented claims expressly recite the same subject matter, it would have been obvious to one of ordinary skill in the art at the time the invention was made to employ both device and methods, as recited in both sets of claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-7 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belgrader et al. (US 2013/0157274) (Belgrader) in view of Renneboog (Solenoid, 2019).
Regarding claim 1, Belgrader teaches a method of preparing a sample for an analytic procedure (abstract), said sample comprising at least one molecule selected from a protein, a polypeptide and a peptide molecule inside a vessel (par [0025]), and said method comprising:
(a) fragmenting said molecule using at least one moving magnetic body (305) to produce fragments of said molecule, wherein said at least one magnetic body performs a fluctuating or oscillating motion triggered by a fluctuating or oscillating magnetic field (301) inside the vessel (303), wherein free movement of the magnetic body (305) is centered on at least three, at least four, at least five, or all six axes of translational and rotational motion inside the vessel (Fig. 3, par [0037] [0032]).
Belgrader teaches a magnetic stir element (magnetic body) moving within the sample and colliding with beads to mechanically disrupt cells (par [0032][0037]). This mechanical disruption necessarily results in fragmentation of biomolecules, including proteins and peptides, as an inherent consequence of lysis.
A varying or rotating magnetic field inherently constitutes a fluctuating magnetic field. The resulting motion (move, spin, or stirr) of the magnetic body is directly triggered by that field, satisfying the claimed limitation.
Belgrader teaches that the magnetic body is free “to move or spin or stir within the container” (par [0032]), These motions inherently involve:
translational motion, and
rotational motion
Rotation in 3D space is defined about three orthogonal axes (x, y, z). When a body is allowed to “move or spin or stir” freely in a fluid environment with bead collisions, it necessarily undergoes multi-axis rotational and translational motion, and at least three, at least four, at least five, or all six axes of translational and rotational motion.
Belgrader does not specifically teach that wherein the magnetic field is generated by an electromagnet comprising at least one coil having an opening configured to accommodate the vessel.
However, Renneboog teaches a solenoid wherein the magnetic field is generated by an electromagnet comprising at least one coil having an opening configured to accommodate the vessel (abstract). A solenoid defines an internal open space (bore) where the magnetic field is applied. This space is inherently configured to accommodate an object or vessel within the coil.
It would have been obvious to a POSITA to modify Belgrader’s magnetic field generation system to use a solenoid-type coil having an internal opening as taught by Renneboog, in order to achieve controlled magnetic field exposure.
Regarding claim 2, Renneboog teaches that wherein said magnetic field is generated by an electric current and/ or an electromagnet (abstract).
Regarding claim 3, Belgrader teaches that wherein:
(i) said fragmenting is a non-enzymatic and non-chemical process (par [0037]).
Regarding claim 4, Belgrader teaches that wherein said magnetic body collides with said molecule; and/ or at least one non-magnetic particle (50) is present, wherein said motion of said magnetic body triggers collision of said at least one non-magnetic particle with said molecule (par [0037]).
Regarding claim 5, Belgrader teaches that wherein said sample is of biological origin and comprises:
(i) a solution or suspension of said molecule (Fig. 1, par [0025]);
(ii) a cell selected from a prokaryotic and a eukaryotic cell (par [0025]); and/or
(iv) tissue (par [0025]).
Regarding claim 6, Belgrader fairly suggests that the method further comprising:
(b) exposing said sample to heat, denaturing said sample, adding
detergent to said sample, and/ or adding a chaotropic agent to said sample (par [0005]).
wherein step (b) can be performed prior to or concomitantly with step (a).
Regarding claim 7, Belgrader fairly suggests that the method further comprising:
(c) chemically modifying said molecule and/ or the fragments obtained from of said molecule (par [0039]).
Regarding claim 21, Belgrader clearly shows that the dimension of the magnetic body in Fig. 3 is significantly smaller than the dimension of the magnetic body (par [0032]).
Belgrader teaches placing a magnetic body inside a reactor/tube and move, spin or stir via a varying magnetic field (par [0032] [0037]). For such motion to occur, the magnetic body must be sufficiently smaller than the tube’s internal cross-section to permit move, spin or stir movement.
A POSITA would understand that for the permanent magnet to oscillate under the alternating magnetic field (par [0037]) and move freely within the tube, the magnet must have clearance relative to the tube interior. Selecting a magnet whose largest dimension is less than or equal to half of the tube’s smallest internal cross-section is nothing more than a predictable optimization of a parameter that the reference expressly identifies as variable. Such optimization would have been obvious to achieve the desired free oscillatory motion.
Claim(s) 8-9 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belgrader in view of Renneboog as applied to claims 1, 3-7 and 21 above, and further in view of Shin et al. (AB Sciex, 2013) (Shin).
Regarding claim 8 and 14, Belgrader does not specifically teach that wherein said analytic procedure is mass spectrometry (MS). However, Shin teaches analysing protein or peptide with mass spectrometry (page 2, par 1). It would have been obvious to one of ordinary skill in the art to analyze the fragmented molecule by mass spectrometry, the result is predictable.
Regarding claim 9, Belgrader does not specifically teach that wherein said chemically modifying said molecule and/ or the fragments of said molecule is selected from:
(ca) reducing a disulfide;
(cb) alkylating a thiol group such as a cysteine residue;
(cc) cross-linking; or
(cd) any combination of (ca), (cb) and (cc).
Shin teaches chemically modifying protein molecule and/ or the fragments of said molecule by
(ca) reducing a disulfide (page 1, par 3)
(cb) alkylating a thiol group such as a cysteine residue (page 1, par 3).
It would ahe been obvious to skill in the art to modify the protein molecule, in order to study the protein structure.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belgrader in view of Renneboog as applied to claims 1, 3-7 and 21 above, and further in view of Hughes et al. (Molecular Systems Biology, 2014) (Hughes).
Regarding claim 11, Belgrader does not specifically teach that the method further comprising:
(d) cleaning and/ or enriching the obtained fragments.
However, Hughes teaches cleaning and/ or enriching the obtained fragments (page 3, par 1). It would ahe been obvious to skill in the art to clean and/or enrich the obtained fragments, in order to increase the sensitivity.
Regarding claim 12, Hughes also teaches
(e) labeling said molecule and/ or the fragments (page 3, par 1).
Regarding claim 13, Hughes teaches reacting a functional group of said molecule with a reagent capable of forming a conjugate with said functional group, wherein said reagent capable of forming a conjugate is a tag (TMT) which is detectable by mass spectrometry (page 3, par 1).
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and file terminal disclaimer.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record does not teach or fairly suggest adding at least one of an inert viscous liquid; a polyacrylamide gel; agarose gel; an aerogel; and a zeolith to said sample.
Claim 22 is allowed.
The following is an examiner’s statement of reasons for allowance: The prior art of record does not teach or fairly suggest adding at least one of an inert viscous liquid; a polyacrylamide gel; agarose gel; an aerogel; and a zeolith to said sample.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot in view of new ground of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIAOYUN R XU, Ph. D. whose telephone number is (571)270-5560. The examiner can normally be reached M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/XIAOYUN R XU, Ph.D./Primary Examiner, Art Unit 1797
Prosecution Insights