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 § 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 1-4, 6, 7, 9, 10, 13, 14, 19, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Highsmith (US 2021/0401483) in view of Paul (US 2012/0323237).
Regarding claims 1-4, 6, 7, 9, 10, 13 and 14, Highsmith discloses a tissue puncture system (fig. 1) for accessing a left atrium of the heart through a transseptal puncture (fig. 3A) comprising an RF generator (180), a display ([0013]), a transeptal guidewire with an active electrode (128, fig. 3A-D) and a controller (fig. 2, [0057]) configured to measure impedance during ablation using the active electrode to determine the state of the active electrode from a plurality of sates related to the position of the active electrode with respect to tissue so that the output of the generator to the active electrode can be controlled based on the impedance when the active electrode moves from the tissue contact state to the blood contact state (see discussion associated the flow chart in fig. 4). The active electrode is disposed in a dilator (150), where the state of the active electrode is also based on a position of the active electrode with respect to the dilator (compare figs. 3A-D where the dilator does not move while the active electrode does), such that the plurality of states include at least the active electrode extending from the dilator and in contact with tissue of the septum (fig. 3D) versus in contact with fluid/blood in the left atrium across the septum (fig. 3E, see also [0048] and note the discussion of fig. 4, particularly step 412). The controller includes a measurement circuit (i.e. the part of the controller that performs measuring) to obtain data from the active electrode and a return electrode (198, [0051]), the system being operated in a monopolar mode (fig. 1, [0046]). Highsmith does not disclose the use of complex impedance, or more particularly the use of phase angle of complex impedance, for determining tissue/blood contact. However, use one or more of the components of complex impedance is very common in the art and there is no evidence that using phase angle in this system produces an unexpected result (within the meaning of MPEP 716.02(a)). Paul discloses a monopolar ablation system for use in the heart and teaches several methods of determining tissue contact from impedance, including by determining the phase angle of a complex impedance ([0102]-[0108], including table 1). It has been held that the simple substitution of one known element for another, or the combination of known elements according to known methods to yield results, is an obvious modification (MPEP 2141(III)), where in this case the “known element” is the manner in which impedance is used to determine the relationship between an electrode and parts of the body. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the device of Highsmith to use any commonly known aspect(s) of impedance to determine the state of the active electrode relative to tissue and blood during ablation, including the phase angle of the complex impedance (including change thereof) as taught by Paul, that would produce the predictable result of allowing the control system and/or user to operate the device in a safe, effective and/or desired manner.
Regarding claims 19, 21 and 22, the device of Highsmith as modified performs the recited method steps during normal use, further including the visual display of a transition between states ([0056]).
Claims 5 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Highsmith and Paul, further in view of Smith (US 2014/0084949).
Regarding claim 5, Highsmith does not disclose exactly how the impedance values are correlated to states, presumably because a person of ordinary skill in the art would know how to perform that step. However, using stored values which are compared to measured values is a common mechanism for determining conditions from sensed information. Smith, for example, discloses a medical device which uses complex impedance to determine tissue contact (fig. 1, [0039]) and teaches that measured values are compared to stored reference values to determine tissue contact ([0005]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the device of Highsmith to include any commonly known steps for processing sensed information, including by comparing sensed information to stored reference information as taught by Smith, that would produce the predictable result of allowing the processor to produce information useful to a user for the safe, effective and/or desired operation of the device.
Regarding claim 23, the device of Highsmith as modified performs the recited steps during normal use.
Claims 8 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Highsmith and Paul, further in view of Stewart (US 2016/0166310).
Regarding claims 8 and 29, the device of Highsmith as discussed above (with respect to claims 1, 6 and 7) does not specifically disclose that the magnitude of the complex impedance is also monitored. However, the prior art is familiar with various parameters that can be used to determine the status of an electrode relative to tissue. Stewart, for example, discloses a cardiac ablation system and teaches no less than 20 different parameters, including both magnitude and phase angle of impedance, can be measured in any combination during an ablation procedure to determine the relationship between electrodes and tissue ([0039]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the device of Highsmith to monitor any commonly known value associated with a condition relative to the procedure being performed, including the magnitude of impedance or the other values taught by Stewart, that would produce the predictable result of allowing a user access to information relevant to the safe, effective and/or desired operation of the device. It is noted that claim 29 is simply the limitations of claims 6-8 combined with the step of measuring while the guidewire electrode is active and being advanced through the septum into the left atrium, subject matter that is discussed with respect to claim 1 as Highsmith’s “states” (language from claim 1) correspond to the guidewire as it is advanced through the septum while energy is being delivered (compare figs. 3C-E and the discussion of claim 1 above).
Claims 11, 20 and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Highsmith and Paul, further in view of Oren (US 2020/0000367).
Regarding claims 11 and 24-27, the device of Highsmith as discussed above with respect to at least claim 1 discloses all the limitations, including a visual display of the transition from the tissue contact state to the blood contact state ([0056]), but there is no specific disclosure of displaying an output corresponding to every state. However, displaying information relevant to a medical procedure is common in the art and there is no evidence that such a common step produces an unexpected result (within the meaning of MPEP 716.02(a)). Oren discloses a system with a plurality of states of an active electrode as it moves, including displaying the active electrode at each state (figs. 4A-C). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the device of Highsmith to display determined states such as taught by Oren to produce the predictable result of allowing a user access to information relevant to the safe, effective and/or desired operation of the device.
Regarding claim 20, the device of Highsmith as modified performs the recited steps during normal use.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Highsmith and Paul, further in view of Traina (US 2020/0246058).
Regarding claim 12, the device of Highsmith does not disclose the use of a memory in the puncture device capable of having information which can be accessed by the generator. However, providing device identification via read/write memory accessible by a generator is very common in the art such as taught by Traina ([0099]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the device of Highsmith to conclude a read/write memory capable of storing information relevant to a procedure for access by a generator, such as taught by Traina, to produce the predictable result of allowing a generator automatic access to operation information of the device.
Claims 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Highsmith, Paul and Stewart, further in view of Oren.
Regarding claims 15 and 18, the device of Highsmith as discussed above with respect to at least claims 1 and 8 includes all the elements except that the states include the electrode inside a delivery assembly (i.e. the dilator). However, using impedance to determine if a medical device is within a delivery assembly is common in the art and there is no evidence that this step produces an unexpected result (within the meaning of MPEP 716.02(a)). Oren, for example, discloses a medical device an electrode where impedance is used to determine if the device is inside of or outside of a delivery assembly (figs. 4A-C, [0055]-[0060]). Therefore, before the application was filed, it would have been obvious to further modify the device of Highsmith to include determining the state of the electrode being inside the delivery assembly, such as taught by Oren, that would produce the predictable result of allowing a user and/or the controller to know information relevant to the safe, effective and/or desired operation of the device.
Regarding claim 16, the device of Highsmith discloses a visual display of one of the states ([0056]), there is no specific disclosure of displaying every state. However, displaying information relevant to a medical procedure is common in the art and there is no evidence that such a common step produces an unexpected result (within the meaning of MPEP 716.02(a)). Oren discloses a system with a plurality of states of an active electrode as it moves, including displaying the active electrode at each state (figs. 4A-C). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the device of Highsmith to display determined states such as taught by Oren to produce the predictable result of allowing a user access to information relevant to the safe, effective and/or desired operation of the device.
Regarding claim 17, Highsmith does not disclose the four claimed states. However, Highsmith does disclose the tissue contact state and the blood contact state (as discussed above), where Oren further discloses the proximally/distally positioned states (figs. 4A-C). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the device of Highsmith to include allowing the user/system to know where the active electrode is when it is proximally located and distally located relative to the delivery assembly, as taught by Oren, in addition to when the active electrode is contacting blood/tissue already disclosed by Highsmith, that would produce the predictable result of allowing a user/controller to know the location/orientation of the active electrode relative to the rest of the device (i.e. the delivery assembly/dilator), the blood, so that the device can be operated in a safe, effective and/or desired manner. If it is relevant, it is noted that the claim does not require that the four states are necessarily different states (e.g. the distal position state and the blood contact state could be the same state).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Highsmith, Paul and Stewart, further in view of Kurth (US 2009/0105654).
Regarding claim 28, the system of Highsmith when modified as discussed above with respect to claims 1 and 8 discloses the controller is configured to measure complex impedance to determine the states of the electrode as the guidewire is advanced through the septum. Highsmith does not disclose that the guidewire comprises a portion configured to curve to form a shape such as a J-tip and deflect away as the guidewire is advanced, which could result in “anchoring” the guidewire in the left atrium (a purely functional limitation). However, guidewires/transseptal needles configured to curve to have various shapes, including a j-tip, are common in the art. Kurth, for example, discloses a transseptal needle/guidewire (20, fig. 2) and teaches that configuring the needle/guidewire to curve to form a J-tip after passing into the left atrium and curving away from the septum (fig. 9), has some benefits including being relatively atraumatic ([0081]). Kurth further teaches the needle/guidewire can be used to allow other, specific devices to be inserted into the left atrium ([0080], note however the explicit teaching that the needle need not function as a guidewire), which is a concern of Highsmith ([0003]). 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)). 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 Highsmith to provide the guidewire with the structural elements Kurth contemplates for the transseptal needle/guidewire to allow other, particular devices to be inserted into the left atrium over the needle so that the needle can function as a guidewire for those devices. It would also have been obvious to one of ordinary skill in the art before the application was filed to further modify the guidewire of Highsmith to include a deflecting J-tip as taught by Kurth, that would produce the predictable result of allowing the guidewire to be relatively atraumatic in the left atrium and/or because it would only produce the predictable result of allowing access into the left atrium. The guidewire of Highsmith as modified can perform the function of an “anchor.”
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Highsmith, Paul, Stewart and Oren, further in view of Kurth.
Regarding claim 30, the system of Highsmith when modified as discussed above with respect to claim 15 discloses the controller is configured to measure complex impedance to determine the states of the electrode as the guidewire is advanced through the septum. Highsmith does not disclose that the guidewire comprises a portion configured to curve to form a shape such as a J-tip and deflect away as the guidewire is advanced, which could result in “anchoring” the guidewire in the left atrium (a purely functional limitation). However, guidewires/transseptal needles configured to curve to have various shapes, including a j-tip, are common in the art. Kurth, for example, discloses a transseptal needle/guidewire (20, fig. 2) and teaches that configuring the needle/guidewire to curve to form a J-tip after passing into the left atrium and curving away from the septum (fig. 9), has some benefits including being relatively atraumatic ([0081]). Kurth further teaches the needle/guidewire can be used to allow other devices to be inserted into the left atrium ([0080], note the explicit teaching that the needle need not function as a guidewire), which is a concern of Highsmith ([0003]). 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)). 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 Highsmith to provide the guidewire with the structural elements Kurth contemplates for the transseptal needle/guidewire to allow other, particular devices to be inserted into the left atrium over the needle so that the needle can function as a guidewire for those devices. It would also have been obvious to one of ordinary skill in the art before the application was filed to further modify the guidewire of Highsmith to include a deflecting J-tip as taught by Kurth, that would produce the predictable result of allowing the guidewire to be relatively atraumatic in the left atrium and/or because it would only produce the predictable result of allowing access into the left atrium. The guidewire of Highsmith as modified can perform the function of an “anchor.”
Response to Arguments
Applicant's arguments filed 25 June 2026 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant makes two arguments. The first argument is that Highsmith does not disclose a guidewire. The term “guidewire” does require some broad features, such as being elongate and small enough to navigate into and through the body, while also requiring some broad functional limitations, such as the ability to have some hypothetical device pass over the guidewire. Highsmith discloses an element that has those features and so can reasonably be called a guidewire, as the claims are given their broadest reasonable interpretation (MPEP 2111). It is further noted that Highsmith specifically teaches a sharp tip is not necessary ([0092]), the “needle” being a reference to tissue puncturing rather than a mechanically sharp tip, where the dilator (150) does in fact pass over the tip ([0062]). Applicant’s response is to point out that the disclosed-but-not-claimed guidewire has different structural elements/features than the guidewire of Highsmith. However, it is well established that limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Further, even if elements of the specification were read into the claims the result would be profound indefiniteness issues. For example, it is not clear what structural features of Applicant’s guidewire allow it to “perform multiple functions” that are not present in a system such as Highsmith, keeping in mind that in apparatus claims the test for functional limitations (e.g. “multiple functions”) is whether the prior art is capable of performing those functions, not whether those specific functions are disclosed (MPEP 2114(II)). Further, the fact that Applicant has added two new claims which articulate the details of the guidewire undermines the argument that those features are required by the independent claims, or else these new claims would fail to further limit the independent claims as required by 35 U.S.C. 112(d).
The second argument, which is a group of arguments of the same type, is that the modification in view of Paul is not proper because Paul is a different type of system than Highsmith. These arguments are not persuasive because they are a piecemeal analysis of the references and fail to account for the level of ordinary skill in the art. Paul is cited simply and only for the general teaching that, in a related system that is concerned with ablation and tissue contact, complex impedance is recognized as a useful parameter. Applicant’s first argument in the group is that Paul is not directed to tissue crossing. This is irrelevant because Highsmith is directed to tissue crossing and the rejection is in view of both references together in the context of what a person of ordinary skill in the art would know. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant limits the level of ordinary skill in the art not only to the cited references but to Paul specifically, ignoring both the teachings and structures of Highsmith and the body of knowledge available to such a person. But the level of ordinary skill in the art of internal ablation devices is very high and it is well established that a person of ordinary skill in the art “is also a person of ordinary creativity, not an automaton” (MPEP 2141(II)(C)). It is well within the creativity and capacity of a person of ordinary skill in the art to consider how complex impedance used for determining the relationship between a device and tissue as in the system of Paul would be relevant to determining the relationship between a device and tissue as in the system of Highsmith. This is further supported by the fact that it is well established that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Second, Applicant argues that Highsmith and Paul use the change of complex impedance in different ways. Again, this is irrelevant because Highsmith is in fact doing a different kind of procedure than Paul and it would be well within the creativity and capacity of a person of ordinary skill in the art to determine how complex impedance changes in a manner that would be useful in the kind of procedure being performed by Highsmith. Further regarding both of these arguments, if obviousness rejections can only be made using references that are performing the essentially the same procedure in essentially the same way, such rejections would essentially cease to exist. On the contrary, it is frequently true that obviousness rejections do use references that are performing different procedures and disclose systems that function in different ways because a person of ordinary skill and creativity would be able to recognize how general principles apply across a field of invention. This, for example, is why the analogous art test exists (noting both “field of endeavor” not “type of medical procedure being performed” and “reasonably pertinent” not “functionally identical,” MPEP 2141.01(a)). It is reiterated that Paul is cited to show that complex impedance is known to be relevant to tissue contact, where a person of ordinary skill in the art would be able to extract that general principle and apply it in a predictable manner to the system of Highsmith. It is also noted that in the interest of compact prosecution Paul was used exactly because of the close relationship to Highsmith. There are other close references to Paul and Highsmith, to further establish the level of ordinary skill in the art, and the rejection could have just as easily been made using such a reference as Hull (US 2016/0184004) which discloses that complex impedance can be determined in addition to simple impedance to determine tissue contact ([0084]). There are countless other devices that more broadly note that impedance, or the components of impedance that comprise complex impedance, can be determined, which would also be valid references teaching that a person of ordinary skill in the art would recognize that complex impedance can be predictably substituted for “just” impedance where desired (e.g. [0034] of US 2009/0171345 to Miller and [0114] of US 2015/0133911 to Batchelor). Thus, the examiner is justified in arguing that a person of ordinary skill in the art would find complex impedance, or one or more components of complex impedance, useful and predictable in the system of Highsmith.
Regarding claims 5 and 23, the arguments are not persuasive for the same general reasons discussed above. Applicant considers the person of ordinary skill in the art to be an automation strictly limited to the knowledge provided in at least one, but not necessarily all, of the references cited. The first argument is that Smith does not have all the features claimed. This is a piecemeal analysis of the reference as discussed above. Smith does not need to disclose all the features claimed, such as intracardiac impedance measurement, because it is one of several references cited in the rejection where one or more other references that disclose that feature (as discussed in the rejections). Second, Applicant argues that Smith is performing a different function using memory and stored values. This does not account for the level of skill and creativity of a person of ordinary skill in the art who, it is maintained, would have the mental capacity to generalize the principles disclosed by Smith to the system of Highsmith which only fails to show the exact manner in which sensed data is translated into a relationship between the electrode and tissue. The fact that Applicant goes so far as to discuss the specific values that are stored in the memory of Smith, how those values are used by Smith, and why Smith’s process would not translate wholesale into the system of Highsmith (an argument of bodily incorporation as discussed above), without once engaging with the general question of what Highsmith teaches about impedance sensing and tissue contact determination or what Smith teaches about how to translate sensed impedance data into tissue contact, or even more generally how measured data is correlated to desired information, illustrates just how much of a disconnect there is between these arguments collectively and the instructions in the MPEP regarding obviousness rejections.
Regarding claim 8 (and by extension 29), the arguments are unpersuasive for the same general reasons discussed above. First, Applicant asserts that the rejection of claim 8 does not account for the context in which the monitoring limitation arises when citing Stewart. Aside from being untrue, as the rejections of claim 8 and the claims from which 8 depends discuss why the teachings of the secondary references apply to Highsmith in the context of what a person of ordinary skill in the art would know, this argument is ironic because Applicant has not accounted for the context in which the rejection is made, that is, Highsmith in view of Paul and Stewart in the context of what a person of ordinary skill in the art would know. Applicant has argued that Stewart alone does not have all the claimed features, but that is not the test for obviousness where a rejection is made in view of multiple references. Further, Applicant continues to ignore the level of skill and creativity present in the ordinary person in the art. Applicant notes that Stewart, like Paul, is performing a particular procedure as desired by those inventors, and determines that Stewart is therefore utterly irrelevant in all aspects, structures and teachings, to Highsmith. This is untenable. The level of ordinary skill of a person in the art is very high, a fact believed to be without dispute, and such a person also having ordinary creativity allows principles to be generalized and applied to other scenarios. The examiner maintains that such a person would be able to consider the use of complex impedance as in Stewart and apply those suggestions to the use of impedance in Highsmith in a predictable manner (noting again the references cited in the response to the arguments about claim 1 to further establish that the level of ordinary skill in the art is clearly familiar with impedance and the components of complex impedance).
Regarding claims 11, 20 and 24-27, the arguments are unpersuasive for the same general reasons discussed above. Applicant insists that a single reference in the obviousness rejection must show all the features of the claim, or even a specific subset of features of the claim. This is not the test for obviousness, and in fact antithetical to the very principle of obviousness because Applicant will always, by definition, be able to point out that at least one of the references does not have one or more of the claimed features. On the contrary, each of the references need not disclose specific features of the claims as long as the references together disclose all the features. Here they do, and the fact that Oren does not disclose a limitation that is in Highsmith (or another reference) is therefore irrelevant to whether the rejection is proper. Applicant insists on this distinction because of an extremely low view of the person of ordinary skill in the art that limits what such a person would know to individual references and will not allow such a person to be creative when considering how the general teachings of references might apply to the circumstances of others.
Regarding claim 12, the arguments are unpersuasive for the reasons discussed above (commensurate with the level of argument).
Regarding claims 15-18, the arguments are unpersuasive for the reasons discussed above. The arguments are largely a repetition of the type arguments presented above, including the argument that the Oren does not account for a feature in the claim that is discussed with respect to Highsmith (a piecemeal analysis of the references) and the argument that there is no grounds for modifying systems according to the structures, teachings and/or suggestions present in the prior art (a failure to account for the ordinary level of skill and creativity of a person in the art). The arguments also include attacking Paul individually again, an argument that is unpersuasive as addressed above. The obviousness rejections (including of 15-18 and all the other claims) clearly show how the references together disclose all the claimed elements, and why it would be obvious to combine those elements, and so they are maintained.
To summarize, all the arguments fail at least because they do not address the references together in the context of what a person of ordinary skill in the art, and of ordinary creativity, would know and be capable of doing as illustrated at least by the cited references. From the examiner’s point of view of the art, at least many of these modifications to Highsmith approach trivial. So common in this art is the use of complex impedance specifically that substituting complex impedance for an undefined “impedance” in any medical system, short of a teaching away or secondary considerations, would be the default position with respect to an obviousness rejection. Measuring impedance, which by definition is complex, is common in any branch of medical systems which is concerned with the interaction of a device with tissue (beyond mere contact), particular ablation devices which are a degree more dangerous than their non-destructive counterparts. This is illustrated at least in part by the several references discussing the option of using impedance or any of the components of complex impedance cited in this Action, but as another example, consider also paragraph [0058] of US 2003/0130711 to Pearson, including specifically the statement “impedance determination including complex impedance,” which clearly shows that, at the very least, the prior art recognizes that complex impedance is a known and understood subset of “just” impedance. The fact that these various references are using complex impedance in accordance with their own particular goals with respect to an electrode and tissue cannot be an argument that a person of ordinary skill in the art would not be able to modify Highsmith in accordance with other particular goals with respect to an electrode and tissue. For the record, using memory to store data for correlating to sensed data is also a common feature in the prior art (e.g. note “known in the art” as in [0038] of US 2014/0309632 to Ogata).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding the use of a deflecting transseptal guidewire with a tip curving in a “pigtail” shape, see paragraph [0034] and figure 5D of US 2012/0109079 to Asleson. It is noted that a rejection modifying a reference like Asleson (or Kurth) to include the impedance sensing to determine the relationship between the guidewire and the septum would be trivial, but is not made because this Action has already consumed significantly more time than is provided for a response to a Non-Final Rejection.
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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