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 § 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 11-14 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Goodman (US 2014/0353869).
Regarding claims 11-14, Goodman discloses a generator ([0033]) with cutting and sealing stages controlled by a controller ([0033], i.e. whatever circuit elements allow the generator to output cutting and sealing signals in a controlled manner) for delivering cutting and sealing signals to sets of electrodes (fig. 3B). These sets including a sealing set (114, 124) which includes at least one electrode in common with a cutting set (130, 114, 124, [0040]). Each set of electrodes is coupled to a practically infinite number of surfaces (i.e. any arbitrarily defined surface area of a jaw which contacts an electrode) on both jaws (fig. 3B). This includes at least a first/second surface on a first jaw aligned with a third/four surface on a second jaw (respectively) when the jaws are closed (i.e. there is a line that can be drawn through these electrodes when the jaws are closed, fig. 3B). Further, the first cutting electrode is coupled with a fifth surface between the first and second surfaces (the part of the jaw contacting 130, fig. 3B). Insulative surfaces exist between each surface on a jaw including first, second and fifth, and third and fourth (fig. 3B).
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Goodman in view of Sherman (US 2014/0066913).
Regarding claim 1, Goodman discloses a generator ([0033]) with cutting and sealing stages controlled by a controller ([0033], i.e. whatever circuit elements allow the generator to output cutting and sealing signals in a controlled manner) for delivering cutting and sealing signals to sets of electrodes (fig. 3B). These sets including a sealing set (114, 124) which includes at least one electrode in common with a cutting set (130, 114, 124, [0040]). Each set of electrodes is coupled to a practically infinite number of surfaces (i.e. any arbitrarily defined surface area of a jaw which contacts an electrode) on both jaws (fig. 3B). Goodman does not disclose the phase relationship of the signals, presumably because it would be a matter for a person of ordinary skill in the art to determine. Further, there is no evidence that using a particular phase relationship between the signals produces an unexpected result (within the meaning of MPEP 716.02(a)). In fact, the prior art commonly teaches that signals applied to different sets of electrodes can have the same or different phase. Sherman, for example, discloses an ablation device and broadly teaches that signals can be in-phase or out-of-phase relative to other signals ([0008]-[0009]). This establishes both that in-phase or out-of-phase signals are known to those of ordinary skill in the art and that there is a recognized equivalence (MPEP 2144.06). Further, it has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)), where in this case in-phase and out-of-phase signals are known. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art modify the system of Goodman to have any commonly known phase relationship between signals, including in-phase or out-of-phase as taught by Sherman, that would produce the predictable result of allowing the system to seal and cut tissue.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman and Sherman, further in view of Jensen (US 2015/0088122).
Regarding claim 2, the system of Goodman does not disclose that the controller causes the generator to supply electrodes with a sealing signal based on a command from a user and a determination that tissue is disposed between the jaws. However, user commands to begin procedures are strictly necessary in this technology. Electrosurgical generators do not operate at their own. Further, since tissue cannot be treated unless it is between the jaws, detecting that tissue is between the jaws prior to treatment is common in the art. Jensen, for example, discloses a system related to Goodman (cf. fig. 2C) and teaches that sealing energy is applied only after a user command has been issued to the controller and it has been determined that tissue is between the jaws (see discussion associated with fig. 10). 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 Goodman to include the controller and sensor elements of Jensen to produce the predictable result of allowing the system to only apply energy to tissue if tissue is between the jaws.
Regarding claim 3, Goodman as modified does not disclose an impedance threshold to terminate the sealing signal. However, using impedance as a threshold to terminate sealing signals is common in the art as taught by Jensen ([0066]). 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 Goodman to use any commonly known method to determine a sealing end-point, including an impedance value as taught by Jensen, that would produce the predictable result of sealing tissue in a desired manner.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Goodman, Sherman and Jensen, further in view of Houser (US 2012/0116391).
Regarding claim 4, Goodman as modified does not disclose a dwell interval for the sealing signal. However, dwell intervals are common in the art such as taught by Houser which notes that, optionally, a dwell interval may be employed as part a sealing stage ([0108]). 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 Goodman to include a dwell interval for the sealing stage as taught by Houser that would produce the predictable result of sealing tissue in a desired manner.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman, Sherman and Jensen, further in view of Hosier (US 2010/0137854).
Regarding claim 5, Goodman as modified does not disclose that the cutting signal is applied when a tissue impedance reaches a threshold that is lower than the threshold that stops the sealing signal. However, while cutting tissue after sealing tissue is common in the art, so is starting the cutting signal while the tissue is being sealed. Hosier is an example of the latter, specifically teaching that cutting can begin when a threshold is reached during the sealing signal, leading to a “quicker and thus more effective overall process” ([0028], see also [0110]-[0111]). 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 Goodman to include an impedance threshold for starting the cutting signal during the sealing signal, as taught by Hosier, that would produce the predictable result of sealing and cutting tissue. It is noted that if the start-cutting impedance threshold occurs during the sealing stage, then the start-cutting impedance threshold will be lower than the end-sealing impedance threshold by definition.
Regarding claim 6, Goodman does not disclose that the cutting signal is stopped based on an impedance threshold that is higher than the stop-sealing impedance threshold. Using impedance as a threshold to stop cutting is common in the art such as taught by Jensen ([0068]), where the fact that Jensen does not disclose what impedance threshold is in view, or what that impedance threshold is relative to the stop-sealing impedance, is simply evidence that a person of ordinary skill in the art would be able to choose an appropriate value. Further, it has been held that choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, is an obvious modification (MPEP 2141(III)) where in this case there are exactly three options for the relative impedance thresholds: the stop-sealing impedance threshold can only be less than, equal to, or greater than, the stop-cutting threshold. Further it is noted that since the claims do not recite any magnitude of difference, even functionally negligible differences are in view. 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 Goodman to employ an impedance threshold to stop the cutting signal, such as taught by Jensen, and to further use an impedance threshold that is greater than, equal to, or less than the stop-sealing threshold, however marginally, that would produce the predictable result of terminating tissue cutting in a desired manner.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman and Sherman, further in view of Couture (US 2008/0058802).
Regarding claims 8 and 9, Goodman as modified does not disclose the use of pulses (which include intervals between the pulses by definition). However, pulsing energy is commonly known to be an effective manner of cutting tissue with RF energy, such as taught by Couture ([0083]), which also teaches that the number of pulses is based on an impedance measurement of tissue ([0083]). Therefore, before the application was filed, it would have been obvious to further modify the system of Goodman to use a pulsed cutting signal where the number of pulses is dictated by an impedance measurement of tissue, as taught by Couture, that would produce the predictable result of cutting tissue in a desired manner.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Goodman, Sherman and Couture, further in view of Kellerman (US 2011/0306959).
Regarding claim 10, Goodman as modified does not disclose that the time between pulses is based on impedance. However, time between pulses is commonly referred to as duty cycle and it is common in the art to change duty cycle for any number of reasons including tissue impedance as taught by Kellerman ([0040]). Therefore, before the application was filed, it would have been obvious to further modify the system of Goodman to include modification of any parameter commonly known to be relevant to treating tissue, including time between pulses based on impedance as taught by Kellerman, that would produce the predictable result of allowing a user to apply energy to tissue in a desired manner.
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman in view of Jensen.
Regarding claim 15, the system of Goodman does not disclose that the controller causes the generator to supply electrodes with a sealing signal based on a command from a user and a determination that tissue is disposed between the jaws. However, user commands to begin procedures are strictly necessary in this technology. Electrosurgical generators do not operate at their own whim. Further, since tissue cannot be treated unless it is between the jaws, detecting that tissue is between the jaws prior to treatment is common in the art. Jensen, for example, discloses a system related to Goodman (cf. fig. 2C) and teaches that sealing energy is applied only after a user command has been issued to the controller and it has been determined that tissue is between the jaws (see discussion associated with fig. 10). 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 Goodman to include the controller and sensor elements of Jensen to produce the predictable result of allowing the system to only apply energy to tissue if tissue is between the jaws.
Regarding claim 16, Goodman as modified does not disclose an impedance threshold to terminate the sealing signal. However, using impedance as a threshold to terminate sealing signals is common in the art as taught by Jensen ([0066]). 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 Goodman to use any commonly known method to determine a sealing endpoint, including an impedance value as taught by Jensen, that would produce the predictable result of sealing tissue in a desired manner.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Goodman and Jensen, further in view of Houser.
Regarding claim 17, Goodman as modified does not disclose a dwell interval for the sealing signal. However, dwell intervals are common in the art such as taught by Houser which notes that, optionally, a dwell interval may be employed as part a sealing stage ([0108]). 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 Goodman to include a dwell interval for the sealing stage as taught by Houser that would produce the predictable result of sealing tissue in a desired manner.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman and Jensen, further in view of Hosier.
Regarding claim 18, Goodman as modified does not disclose that the cutting signal is applied when a tissue impedance reaches a threshold that is lower than the threshold that stops the sealing signal. However, while cutting tissue after sealing tissue is common in the art, so is starting the cutting signal while the tissue is being sealed. Hosier is an example of the latter, specifically teaching that cutting can begin when a threshold is reached during the sealing signal, leading to a “quicker and thus more effective overall process” ([0028], see also [0110]-[0111]). 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 Goodman to include an impedance threshold for starting the cutting signal during the sealing signal, as taught by Hosier, that would produce the predictable result of sealing and cutting tissue. It is noted that if the start-cutting impedance threshold occurs during the sealing stage, then the start-cutting impedance threshold will be lower than the end-sealing impedance threshold by definition.
Regarding claim 19, Goodman does not disclose that the cutting signal is stopped based on an impedance threshold that is higher than the stop-sealing impedance threshold. Using impedance as a threshold to stop cutting is common in the art such as taught by Jensen ([0068]), where the fact that Jensen does not disclose what impedance threshold is in view, or what that impedance threshold is relative to the stop-sealing impedance, is simply evidence that a person of ordinary skill in the art would be able to choose an appropriate value. Further, it has been held that choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, is an obvious modification (MPEP 2141(III)) where in this case there are exactly three options for the relative impedance thresholds: the stop-sealing impedance threshold can only be less than, equal to, or greater than, the stop-cutting threshold. Further it is noted that since the claims do not recite any magnitude of difference, even functionally negligible differences are in view. 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 Goodman to employ an impedance threshold to stop the cutting signal, such as taught by Jensen, and to further use an impedance threshold that is greater than, equal to, or less than the stop-sealing threshold, however marginally, that would produce the predictable result of terminating tissue cutting in a desired manner.
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman in view of Couture.
Regarding claims 21 and 22, Goodman as modified does not disclose the use of pulses (which include intervals between the pulses by definition). However, pulsing energy is commonly known to be an effective manner of cutting tissue with RF energy, such as taught by Couture ([0083]), which also teaches that the number of pulses is based on an impedance measurement of tissue ([0083]). Therefore, before the application was filed, it would have been obvious to further modify the system of Goodman to use a pulsed cutting signal where the number of pulses are dictated by an impedance measurement of tissue, as taught by Couture, that would produce the predictable result of cutting tissue in a desired manner.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Goodman and Couture, further in view of Kellerman.
Regarding claim 23, Goodman as modified does not disclose that the time between pulses is based on impedance. However, time between pulses is commonly referred to as duty cycle and it is common in the art to change duty cycle for any number of reasons including tissue impedance as taught by Kellerman ([0040]). Therefore, before the application was filed, it would have been obvious to further modify the system of Goodman to include modification of any parameter commonly known to be relevant to treating tissue, including time between pulses based on impedance as taught by Kellerman, that would produce the predictable result of allowing a user to apply energy to tissue in a desired manner.
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 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,150,692. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Allowable Subject Matter
Claims 7 and 20 will be objected to as being dependent upon a rejected base claim, but allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, once the double patenting issues are resolved.
The following is a statement of reasons for the indication of allowable subject matter: The claims are indicated to contain allowable subject matter for substantially the same reasons as articulated in the parent case. While the prior art (which is not as extensive a collection as it might be considering the effective filing date of the pending claims) is aware of cutting and coagulation in forceps devices using various impedance thresholds, time durations and delays, there is no specific disclosure of a controller performing the steps as recited in claims 1, 2, 3, 5 and 7, and claims 11, 15, 16, 18 and 20.
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).
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
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