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.
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Claims 1 & 12-13 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1 & 17-18 of U.S. Patent No. 12,150,696. Although the claims at issue are not identical, they are not patentably distinct from each other:
Claims 1 & 17-18 US. Pat. No 12,150,696
Claims 1 & 12-13 of ‘097 (present claims)
insertion unit
insertion unit
bending sensing unit
displacement sensing unit
sensing insertion-related condition
sensing insertion-related condition
controller controls insertion based on sensed condition
controller controls insertion based on sensed condition
The instant claims differ principally in reciting sensing displacement of a tissue surface rather than sensing bending of the insertion unit. It would have been an obvious variation to employ tissue-surface displacement as the sensed insertion-related parameter because both represent feedback regarding tissue deformation and insertion conditions and would have predictably been used to control insertion depth and positioning of the insertion unit. Accordingly, the instant claims are not patentably distinct from the patented claims.
AND
Claims 1 & 12-13 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1 & 17-18 of U.S. Patent No. 12. Although the claims at issue are not identical, they are not patentably distinct from each other:
Claims 1 & 12-13 of ‘097 (present claims)
Claims 1 & 17-18 US. Pat. No 11,229,481
Claims 1 & 12-13 of ‘097 (present claims)
insertion unit
insertion unit
state, bending sensing unit
displacement sensing unit
sensing insertion-related condition
sensing insertion-related condition
controller controls insertion based on sensed condition
controller controls insertion based on sensed condition
The patented claims of ‘481 and the present claims both utilize sensed bending information occurring during insertion to control insertion operation. Accordingly, the instant claims are not patentably distinct from the patented claims. The claims are substantially identical in scope, not merely obvious variations.
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.
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.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allison (US 2014/0350536) in view of Freeman et al. (US 2013/0303984).
Claim 1.
Allison teaches:
a treatment apparatus including a handpiece and insertion unit configured to be inserted into tissue to perform treatment, E.G. [0013]-[0017], [0027]-[0035], [0090]-[0095]
a displacement sensing arrangement including temperature, tissue-condition and treatment monitoring sensors that detect tissue conditions associated with insertion and treatment, E.G [0061]-[0066].
a controller configured to receive sensed information and control operation of the insertion unit based on the sensed information, E.G. [0061]-[0066].
Allison does not explicitly teach:
measuring displacement of a tissue surface occurring due to insertion of the insertion unit; and
controlling insertion of the insertion unit based on the measured displacement
Freeman et al. teaches:
measuring tissue displacement, tissue tenting and actual penetration depth during insertion of a lancet into tissue, E.G. [0149]-[0150], [0213]-[0214]
sensing tissue displacement using position sensing mechanism and sensors;
comparing actual penetration characteristics with desired penetration characteristics and controlling insertion based on the measured displacement, E.G. [0150].
It would have been obvious to one having ordinary skill in the art to modify the treatment apparatus of Allison to incorporate Freeman’s displacement sensing and feedback control techniques in order to compensate for tissue deformation during insertion, thereby improving accuracy of target tissue placement, ensuring delivery of treatment at the intended depth, reducing placement error caused by tissue tenting, and improving treatment consistency and predictability. See KSR, 550 U.S. at 417, i.e. if a technique has been used to improve one device, and a person of ordinary skill would recognize that it would improve similar devices in the same way, using the technique is obvious.
Further, once tissue displacement is measured, it would have been an obvious design choice to adjust insertion depth by an amount corresponding to the measured displacement so that the insertion member reaches the intended location despite tissue deformation. Compensating insertion depth based on measured displacement merely represents the predictable use of known feedback control techniques to achieve accurate tissue penetration.
Claims 2-5
Freeman et al. teaches measuring tissue displacement and determining actual penetration depth by accounting for tissue tenting and elastic tissue deformation, E.G. [0149]-[0150], [0213]-[0214]
As discussed above, it would have been obvious to compensate insertion depth based on the measured displacement so that the insertion member reaches the desired target location despite tissue deformation.
Therefore, it would have been obvious to implement the displacement-compensation control taught by the combination.
Claim 2, additional insertion corresponds to the displacement
Claim 3, first and second insertion lengths,
Claim 4, second length corresponds to the sensed displacement and
Claim 5, calculation of the second length using the sensed displacement
Claim 6
Freeman et al. measures tissue position and displacement before, during and after insertion to determine tissue tenting and penetration characteristics, E.G. [0213]-[0214].
Claim 7.
Freeman et al. teaches a photosensor/position sensing mechanism for determining displacement of tissue and lancet position, E.G. [0150].
Claim 8.
Freeman et al. teaches a handpiece containing an insertion/treatment unit and associated sensing components positioned within the handpiece assembly, E.G. [0027]-[0035] & [0061]-[0064]
Claim 9.
Freeman et al. teaches insertion units comprising multiple needles arranged in an array, including micro-needle configuration, E.G. [0053]-[0054], [0073].
Claim 10.
Freeman et al. teaches an insertion unit configured to transfer treatment energy to target tissue after insertion, E.G, cryogenic treatment, [0013]-[0017], [0090]-[0095].
Claim 11.
Freeman et al. teaches delivery of treatment material/fluid through an inserted treatment member into target tissue, E.G. [0056]-[0060], [0067]-[0070]
Claim 12.
Allison teaches a treatment apparatus including a handpiece and an energy transfer unit configured to advance into tissue and transfer energy to a target location, E.G. [0013]-[0017], [0023]-[0027], [0090]-[0095].
Freeman et al. teaches measuring displacement of tissue resulting from insertion of an insertion member and controlling insertion depth based on the measured displacement to compensate for tissue deformation, E.G. [0150] & [0213]-[0214].
It would have been obvious to modify the treatment apparatus of Allison to incorporate Freeman’s displacement sensing and insertion control techniques in order to compensate for tissue deformation during insertion and improve treatment accuracy and target localization. See KSR.
Claim 13.
Claim 13 is rejected for substantially the same reasons discussed above with respect to claim 12, wherein Freeman et al. teaches measuring displacement of tissue caused by insertion and controlling insertion based on the measured displacement, [0150], [0213]-[0214].
Claim 14.
Claim 14 is rejected for substantially the same reasons discussed above with respect to claim 2.
Claim 15.
Claim 15 is rejected for substantially the same reasons discussed above with respect to claim 3.
Claim 16.
Claim 16 is rejected for substantially the same reason discussed above with respect to claim 5.
Claim 17.
Claim 17 is rejected for substantially the same reasons discussed above with respect to claim 7.
Claim 18.
Claim 18 is rejected for substantially the same reasons discussed above with respect to claim 10.
Claim 19.
Claim 19 is rejected for substantially the same reasons discussed above with respect to claim 11.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/ Primary Examiner, Art Unit 3796
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