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 .
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3,13-14 of U.S. Patent No. 10,830,681 (Fowler et al.). Although the claims at issue are not identical, they are not patentably distinct from each other because all of the claimed elements and limitations in the Instant application are claimed in the ‘681 Fowler et al. patent. Hence, the claims in the Instant application are not patentably distinct from the claims in the ‘681 Fowler et al. patent.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2,13,15-17,19 of U.S. Patent No. 12,025,483 (Fowler et al.). Although the claims at issue are not identical, they are not patentably distinct from each other because all of the claimed elements and limitations in the Instant application are claimed in the ‘483 Fowler et al. patent. Hence, the claims in the Instant application are not patentably distinct from the claims in the ‘483 Fowler et al. patent.
Claims 1-2, 6, 9-10 and 16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3,9 of copending U.S. Patent Application No. 17/932,006 (Fowler et al.). Although the claims at issue are not identical, they are not patentably distinct from each other because all of the claimed elements and limitations in the Instant application are claimed in the ‘006 Fowler et al. copending application. Hence, the claims in the Instant application are not patentably distinct from the claims in the ‘006 Fowler et al. copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-2, 6, 8-10 and 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication 2012/0060626 (Zhu et al.).
With regards to claim 1, Zhu et al. discloses a Coriolis measuring device comprising, as illustrated in Figures 1-4, a method for inspecting a lumen A,B (e.g. measuring tubes whether plugged – paragraph [0059] or free/unplugged – paragraph [0056]) comprising obtaining a flow measurement (e.g. the mass flow through tube A; paragraph [0059]) in the lumen; comparing the flow measurement (e.g. the mass flow through tube A; paragraph [0059]) to an upper test limit (e.g. predetermined limit value; paragraph [0059]) which is determined based on a representative device 2 (e.g. Coriolis flow measuring device; paragraph [0052]); determining the lumen is acceptable when the flow measurement is higher than the upper test limit (e.g. lumen is not occluded – free/unplugged; paragraph [0056],[0059]). (See, paragraphs [0052] to [0065]).
With regards to claim 2, Zhu et al. further discloses the representative device includes an occluded representative device (e.g. lumen is occluded - plugged: [0059])
With regards to claim 6, Zhu et al. further discloses rejecting the lumen (e.g. lumen is occluded – plugged; paragraph [0059]) as unsafe for patient use if the flow measurement is equal to or lower than the upper test limit (e.g. paragraph [0059] indicates "deviates significantly from the reference value to be expected, especially by more than a predetermined limit value").
With regards to claim 8, Zhu et al. further discloses the flow measurement includes a mass flow measurement (e.g. mass flow measurement; paragraph [0059]).
With regards to claim 9, the claim is directed to a method claim and is commensurate in scope with the above method claims 1,6 and is rejected for the same reasons as set forth above.
With regards to claims 10 and 15, the method claims are commensurate in scope with the above method claims 2,8 and are rejected for the same reasons as set forth above.
With regards to claim 16, the claim is directed to an apparatus claim and is commensurate in scope with the above method claim 1 and is rejected for the same reasons as set forth above. Furthermore, Zhu et al. further discloses flow measurement instrument 14,16 (e.g. oscillator sensors; paragraph [0054]) operable to obtain a flow measurement of the lumen; at least one processor (e.g. control unit performing a process control; paragraph [0025]) in communication with the flow measurement instrument.
With regards to claims 17, 18 and 19, the apparatus claims are commensurate in scope with the above method claims 8,2,6 and are rejected for the same reasons as set forth above.
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.
Claims 3-4, 7, 11-12, 14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2012/0060626 (Zhu et al.) in view of U.S. Patent 6,691,047 (Fredericks).
With regards to claims 3 and 4, Zhu et al. does not disclose the lumen is in a medical device such that the medical device includes a clinically used and reprocessed medical device.
Fredericks discloses a system for calibrating blood pumps of dialysis machine comprising, as illustrated in Figures 1-4, the lumen is in a medical device such that the medical device includes a clinically used and reprocessed medical device (e.g. blood pump; column 1, lines 25-43). (See, column 3, line 55 to column 7, line 65).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have readily recognize the advantages and desirability of employing the lumen is in a medical device such that the medical device includes a clinically used and reprocessed medical device as suggested by Fredericks to the system of Zhu et al. to have the ability to provide calibrate the pump prior to the next operation of the pump where such a modification would be a combination of prior art elements according to known methods to yield predictable results without departing from the scope of the invention - see MPEP 2143(I)(A).
With regards to claim 7, Zhu et al. does not specify such parameter, the upper test limit includes an upper boundary of a probability plot at a 95/85 confidence interval or higher, as in the claim. However, to have set such test characteristics as in the claim is considered to have been a matter of optimization and choice possibilities that would have been obvious to a skilled artisan in the art before the effective filing date of the claimed invention without departing from the scope of the invention.
With regards to claims 11, 12 and 14, the method claims are commensurate in scope with the above method claims 3,4,7 and are rejected for the same reasons as set forth above.
With regards to claim 20, the apparatus claim is commensurate in scope with the above method claims 3,4 and is rejected for the same reasons as set forth above.
Claims 5 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2012/0060626 (Zhu et al.) in view of U.S. Patent 6,691,047 (Fredericks), as applied to claim 3 above, and further in view of U.S. Patent Application 2015/0057538 (Cragg et al.).
With regards to claim 5, Zhu et al., modified by Fredericks, does not disclose the medical device includes an electrophysiology medical device.
Cragg et al. discloses a system for monitoring delivered dose comprising, as illustrated in Figures 1-13, the medical device includes an electrophysiology medical device (e.g. electrophysiology procedure; paragraph [0016]). (See, paragraphs [0033] to [0129]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have readily recognize the advantages and desirability of employing the medical device includes an electrophysiology medical device as suggested by Cragg et al. to the system of Zhu et al., as modified by Fredericks, to have the ability to provide monitor total delivered dose of an analyte of interest during an intravascular procedure, like an electrophysiology procedure, where such a modification would be a use of known technique to improve similar devices (methods, or products) in the same way without departing from the scope of the invention - see MPEP 2143(I)(C).
With regards to claim 13, the method claim is commensurate in scope with the above method claim 5 and is rejected for the same reasons as set forth above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Helen C Kwok whose telephone number is (571)272-2197. The examiner can normally be reached Monday to Friday, 7:30 to 4:00 EST.
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/HELEN C KWOK/Primary Examiner, Art Unit 2855
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