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.
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 4 is 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.
Regarding claim 4, there is no antecedent basis for “the ultrasound transducer” which renders the claim indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 18 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 18 recites how the ablation generator is capable of being used which does not limit the structure of the generator. That is, any generator capable of supplying ablation energy as recited in claims 1 and 17 will always and necessarily be capable of ablating any percentage of any tissue region as operated by a user. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-9, 12, 13, 16-18 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Desai (US 2003/0130575) in view of Deckman (US 2007/0249936) and McGahan (US 6,095,981).
Regarding claims 1-9, 12, 13, 16-18 and 22, Desai discloses a system including a docking device (278, fig. 16) with a proximal region (proximal end of 278), a sharp distal region (distal end of 278) and an elongate body with a lumen (“hollow” [0080]) between the regions, where a therapeutic element (282, which includes at least one RF electrode, claim 8, among other possible ablation modalities, [0089]) is slidably disposed within the lumen of the docking device (fig. 16). The docking device further includes a proximal hub (284). The system further includes a generator to supply energy to the therapeutic element (287) where the generator is “configured to” cause the therapeutic element to ablate any percentage of the ovary depending on how a user operates the system. Desai does not disclose the use of a deployment feature for translating the therapeutic element or an alignment element that interfaces with an alignment adapter having lock and partially-locked positions. However, both elements are common in the art (illustrated at least by the references cited below) and there is no evidence that their use here produces an unexpected result (within the meaning of MPEP 716.02(a)). Regarding the deployment feature, Deckman discloses a system with a docking device (an extremely broad term that can encompass any number of the various structures shown in fig. 1A) which includes a deployment feature (at least 45) for actuating a therapeutic element (14, [0034]). It has been held that the combination of known elements according to know methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system of Desai to provide the docking device with any commonly known features, including a deployment feature such as taught by Deckman, that would produce the predictable result of allowing a user to deploy the therapeutic element. Regarding the alignment adapter, McGahan discloses a system which includes an alignment adaptor (18, fig. 1) for a docking device (14), where the alignment adaptor is configured to be removably coupled to a probe (via 26a and 26B, although note that in this case 12 is an ultrasound probe, col. 3 line 3). The term “alignment element” is extremely broad and is understood to encompass any element, feature or characteristic of the proximal region of docking device that interacts with the alignment adaptor to function to maintain an alignment, including planar orientation, which includes even the size or shape of the docking device which allows sufficient force to be applied by the alignment adaptor (col. 4 lines 12-22, fig. 4). The alignment adaptor includes mechanical lock (22b) that has a fully open position to allow removal of the docking device (fig. 6) and fully locked position (fig. 4). Any of the infinite number of positions in which the lock contacts the docking device outside of the fully locked position (cf. fig. 5, and thus “not completely disengaged”) can be considered a partially-locked position, where sufficient force applied to the docking device by, for example, a user, decreasing with the amount of force applied by the lock to the docking device, would allow translation/rotation of the docking device in one or more of the partially-locked positions. The lock with various locked/partially-/unlocked positions relative to the alignment adapter produces a plurality of locked, axial (i.e. proximal/distal) positions that result in the therapeutic element being deployable in any number of “orientations” relative to a probe. 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 Desai to include a removable alignment adaptor such as taught by McGahan to produce the predictable result of allowing the docking device to be movable and lockable relative to, and removable from, a probe. It is noted that since the ultrasound probe (or transducer) is entirely hypothetical in the claim, there exists an ultrasound probe (or transducer) that, locked to the docking device and thus the therapeutic element, has a “plane” that is “aligned” with the docking device/therapeutic element (although it is noted more specifically that the entire purpose of using an ultrasound probe with a docking device is to image the docking device thus requiring the docking device to be in the plane of the probe, see e.g. [0063] and [0080] of Desai).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Desai, Deckman and McGahan, further in view of Messerly (US 2008/0275446).
Regarding claims 10 and 11, Desai as modified does not disclose that the docking device comprises a guide or that the alignment adaptor comprises a cavity between an otherwise undefined “main body” and the guide. However, aligning “docking devices” with respect to “alignment adapters” is common in the art to prevent or reduce radial movement in addition to axial movement, such as taught by Deckman which shows that one element (50, fig. 2C) is shaped within the other (59) so that rotation is prevented (if relevant, rotation is prevented relative to an ultrasonic probe 80, fig. 1B). Deckman does not disclose the use of a guide to accomplish this purpose but guides for aligning elements are also common in the art. Messerly discloses an electrosurgical system and teaches that a guide, having various configurations, can be used to assist in the aligning two parts of the system (figs. 11-15, [0035]). 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 Desai to include a guide for the docking device to ensure that the docking device, therapeutic element, alignment adapter and probe are aligned in a desired manner when the system is configured for use. Regarding the cavity, McGahan further discloses a cavity between the docking device (14, fig. 4) and a “main body” of the alignment adapter (26b). This cavity allows the docking device to be held by the adaptor and shows space around the docking device (fig. 4). 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 Desai to include the cavity as taught by McGahan to produce the predictable result of allowing the docking device to be held by the alignment adapter. When so modified, a line can be drawn between some part of the guide and some part of the “main body” of the alignment adaptor such that the cavity is on that line.
Claims 14 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Desai, Deckman and McGahan, further in view of Nasab (US 2005/0010206).
Regarding claims 14 and 19-21, the system of Desai, while discussing the use of radiofrequency energy for the therapeutic element ([0089]), does not disclose the use of two bipolar electrodes or a sensor for sensing temperature which is then used to control energy delivery, including termination of energy, when a maximum sensed temperature threshold is exceeded. However, bipolar energy and temperature-based feedback control border on ubiquitous in the art and there is no evidence that using such common elements here produces an unexpected result. Nasab discloses an ablation system and teaches that a plurality of bipolar electrodes (164, fig. 1a) and multiple temperature sensors (162) can be used in conjunction with a controller that adjusts energy based on the sensed temperature ([0027]), including termination of temperature based on threshold temperature ([0048]). The termination includes the modification of at least power, voltage and current. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system of Desai to include any commonly known therapeutic components, including at least two bipolar electrodes, and to control the RF energy supplied to those electrodes based on sensed temperature, including terminating energy delivery when a maximum temperature threshold is exceeded, all of which is taught by Nasab, to produce the predictable result of allowing a user to ablate tissue in a safe and effective manner.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Desai, Deckman and McGahan, further in view of Placek (US 2010/0222677).
Regarding claim 15, while Desai shows that some elements of the system curving (fig. 9) it is not clear whether the therapeutic element is curved. However, curved electrodes are common in the art. For example, Placek teaches that electrodes can be straight or curved, among other shapes ([0051]), which understood to be a teaching of functional equivalence (MPEP 2144.06). 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 Desai to include one or more therapeutic elements having any commonly known shape, including straight or curved as taught by Placek, that would produce the predictable result of allowing a user to interact with tissue in a desired manner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
Prosecution Insights