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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/046,647, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. None of the applications to which the pending application claims priority, terminating in 62/046,674, disclose the use of laser knife, ultrasound knife, or electrotome.
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 2, 3, 7, 8, 9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Milkus (US 6,485,422) in view of Li (US 2011/0184684) and Milkus (US 2002/0198518), hereinafter Milkus2.
Regarding claims 2 and 3, Milkus discloses a method of planning using a transrectal ultrasound imaging probe involving the steps of calibrating and displaying a position relationship between a probe and cross-sectional image (probe 26 in fig. 3) and a sagittal image (probe 30 in fig. 2). A target is displayed on both images (fig. 4 and 6). The method further includes receiving a parameter defining contour boundaries of treatment (see discussion associated with defining the country boundaries as shown in fig. 4 and 6). It is noted that while the image limitations and parameters limitations are adjacent to each other in the claim, there is no necessary relationship between them (i.e. it is not clear if Applicant intended the angle to be in the cross-sectional image). It is also noted that the method does not recite what, exactly, is “receiving” this information or how the information is being “used.” In the case of the boundaries, both the user and the system can be considered to “receive” and “use” the boundary information as part of treating tissue of a patient (i.e. the entire purpose of Milkus). Milkus does not specifically disclose a coordinate system, although it could be argued that a coordinate system is implied based on the accurate relative positions marked on the images (e.g. figs. 8-12). However, in the interest of compact prosecution and since coordinate systems are very common in the art, there being no evidence that using a coordinate system produces an unexpected result (within the meaning of MPEP 716.02(a)), a specific coordinate system will be referenced. Li discloses a method of planning using an imaging probe which involves registering the position of a probe within a 3D coordinate system (fig. 4A, [0036]-[0037]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the method of Milkus to include the step of providing all the images with a coordinate system, such as taught by Li, that would produce the predictable result of allowing a user and/or a controls system to have specific location values to reference for respective elements on the images. Milkus also does not specifically disclose the method includes “receiving” or “using” an angle of treatment. However, where devices are inserted into tissue as discussed by Milkus, angle of treatment is directly relevant to the treatment. Milkus2, for example, discloses a similar system and teaches that various angles of treatment can be employed (fig. 1, [0003]). This includes at least a user “receiving” that angle information and using it alone or in conjunction with the system to determine treatment (e.g. [0033] which discusses maximization of iceballs from angled treatment elements). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the method of Milkus to incorporate any information commonly known to be useful for ablating tissue as Milkus does, including by incorporating a treatment angle as taught by Milkus2, that would produce the predictable result of treating tissue in a desired manner.
Regarding claims 8 and 9, the claim recites elements so generic that whatever structural elements used by Milkus (when modified as discussed above) to perform the method steps discussed above with respect to claims 2, 3 and 7 can be considered the “modules” of claim 8. Even so, Milkus, while disclosing a user interface module displays the images and receives the contour boundaries (figs. 4 and 6), does not specifically disclose the interface “receives” the angle of treatment. However, Milkus2 discloses a user interface that “receives” the angle of treatment (fig. 5) in one way or another (i.e. the angle must have been received in order to be displayed). In addition to the fact that the last clause of the claim 8 is divorced from any of the other structures recited (i.e. “treating a patient” is not performed by any module), tissue is always treated according to the parameters of the energy treatment elements, including the angle of a treatment device in tissue. In this case, both angle and boundary are directly relevant to the treatment of tissue (as discussed above). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Milkus to include a user interface which receives angle of treatment information as taught by Milkus2 to produce the predictable result of allowing a user to treat tissue in a desired manner.
Regarding claims 7 and 13, the method of Milkus does not disclose the ultrasonic probe includes an orientation sensor. However, orientation sensors are commonly used on ultrasonic probes. Li further discloses an ultrasonic probe can be provided with an orientation sensor ([0036]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the method of Milkus to include using an orientation sensor on the ultrasonic probe such as taught by Li to produce the predictable result of allowing the user and/or a control system to know the orientation of the probe.
Claims 4-6, 10-12, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Milkus, Li and Milkus2, further in view of Kim (US 2010/0249800) and Loeb (US 2005/0187537).
Regarding claims 4-6, 10-12, 14 and 15 the method/system of Milkus does not disclose automatic control of some part of a system based on the coordinate system. However, using imaging data/determined coordinates for automatically placing parts of a medical system is common in the art and there is no evidence automatic control produces an unexpected result. Kim, for example, discloses a system which uses cross-sectional and sagittal images to generate three-dimensional coordinate system for allowing a robot arm to be moved according to where a treatment site is located ([0016], [0040], [0076]). The robot arm is driven by a motion motor ([0054]). Further, Kim specifically notes that the motion can be manual or automatic ([0016]), which is a teaching of functional equivalence (MPEP 2144.06). Therefore, before the application was filed, it would have been obvious to further modify the method/system of Milkus to include the steps of converting coordinate information into a motion execution parameter for a motion motor such as taught by Kim that would produce the predictable result of automatically positioning an “execution mechanism” in a desired location based on the images. The “execution mechanism” of Milkus is not a laser knife, an ultrasound knife, a water jet “and/or” an electrotome. Rejections under 35 U.S.C 112(a)-(b) are not made for lack of written description (because the specification is totally silent about the knives and electrotome, including how they could be part of the same “mechanism”) and indefiniteness (potentially because it is not clear how all these elements would work together using singular angle/boundary data) because these elements are extremely common in the art and so using them is understood to be well within the level of ordinary skill in the art, needing no input from Applicant. Loeb similarly includes the vague suggestion that “at least one” of a rotating burr, mechanical blade, RF electrode, microwave antenna, ultrasound transducer, cryogenic source, fluid knife, incoherent or coherent light (claim 31, see also [0014]) can be used to treat a wide range of tissues including the prostate (claim 19), where any element that destroys (i.e. cuts) tissue can be considered a “knife” (see MPEP 2144.06 regarding teachings of elements being functional equivalents). Therefore, before the application was filed, it would have been obvious to include any number of commonly known “execution elements” in the method/system of Milkus, including a laser knife, ultrasound knife or water jet as taught by Loeb, and to operate those elements according to the parameters used to dictate treatment as discussed above, that would produce the predictable result of allowing a user to treat tissue in a desired manner. Note that these modifications are understood to result in a combination with the cryogenic elements present in Milkus so that an operator will be able to use the cryogenic elements in addition to the secondary treatment elements.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. It is noted in the interest of compact prosecution, however, that (1) the new claim limitations are extremely broad, possibly broader than Applicant intends (with respect to the relationship between the images and parameters, along with what those parameters actually cause to happen as it relates to “treating tissue”), and (2) Milkus would be, at best, difficult to modify to include an execution mechanism for use within the urethra (which is not a comment on what Milkus might suggest about imaging/planning a treatment procedure). Water jets for treating the prostate (which is not claimed) from within the urethra (also not claimed) do exist (e.g. US 2009/0227998 to Aljuri) and it is not clear to what extent the imaging elements of Milkus would be relevant to such references, so further search and consideration will be necessary.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
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