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 .
Response to Arguments
I. Nonstatutory Double Patenting
Applicant’s remarks state that “The Examiner has rejected all the pending claims based on nonstatutory double patenting. Applicant is submitting a terminal disclaimer to overcome this rejection.” However, no such terminal disclaimer was filed. As such, the nonstatutory double patenting rejections are maintained.
II. Claim Rejections under 35 U.S.C. § 102
Applicant’s remarks concerning the § 102 rejections and, except for claim 79 (see next paragraph), are persuasive to the extent that the claim amendments which have amended each previous independent claim to recite additional limitations not taught by Adler alone. Those § 102 rejections are overcome and withdrawn.
Concerning claim 79, this claim has been amended into independent form. As an initial matter, it is noted that although due to a typographical error claim 79 was not listed in the previous rejections, it was nevertheless addressed clearly by the rejections of claims 78 and 80 (which previously depended from claim 79). Specifically, the rejection of claim 78 also included the additional claim language found in claim 79, i.e. the rejection of claim 78 was clearly supposed to also list claim 79. Additionally, for claim 80 to be possibly rejected under § 102 by Adler, it logically stands that claim 79 was necessarily also rejected under those same grounds. Furthermore, the teachings of Adler cited previously in the rejections of both claims 78 and/or 80 also addressed the limitations of previous claim 79, i.e. the rejections of claims 78 and/or 80 clearly conveyed how and why claim 79 was rejected as well, despite the typographical error. There appear to be no remarks specifically addressing claim 79. Since the scope of claim 79 has not changed, it is rejected under the same § 102 grounds.
III. Claim Rejections under 35 U.S.C. § 103
Applicant’s remarks concerning the § 103 rejections have been fully considered but are not persuasive. Applicant argues that Villongco requires knowing the patient’s pacing locations in advance, whereas Applicant’s claimed technology works in the opposite direction in which the location of pacing is not known in advance. This argument was made previously in parent application 17/308,400 in the response dated 10/26/2021 and was found not persuasive for the reasons explained in the “Response to Arguments” section of the Final Office Action dated 11/19/2021 (pages 2-13, and particularly pages 2-7, Section II(A) which addressed claim 1) in that application. All of those remarks are incorporated by reference herein, and the Examiner maintains and reiterates those same positions here.
To briefly summarize: the Examiner respectfully disagrees for two reasons. First, as noted in the rejection of previous claims 41 and 92 (which recited the subject matter added to the independent claims in the response), Villongco teaches in e.g. Para. 199 that applying the trained classifier to the patient cardiogram can be used “to identify the configuration parameter for the patient,” and as explained in e.g. Para. 89, the “configuration parameter” can include the site of pacing. As such, Villongco teaches that the location/site of pacing may be identified for the patient, rather than necessarily known beforehand. Second, and more importantly, these remarks fail to address how Villongco is used in the rejection in combination with Adler. Specifically, Adler already demonstrates how a current and unknown pacing location can be determined via cardiogram analysis of the patient’s own cardiogram. Villongco is used to show how the evaluation of a patient’s cardiogram to identify some type of unknown patient data-of-interest can be made more accurate by, among other things, accessing a library of cardiograms to identify and compare with a similar library cardiogram (e.g. from another patient) in which that same type of data-of-interest is already known. Taking these teachings together, it logically follows that Adler's determination of the patient pacing location from the patient cardiogram could be enhanced by identifying similar library cardiograms having a known pacing location (i.e. by incorporating Villongco's methodology). One skilled in the art would recognize that this same approach could be applied to identifying/interpreting many types of data from a cardiogram, since the comparison to similar cardiograms (having known data-of-interest) would logically make interpreting a single patient cardiogram more accurate.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 79 is rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by US 2019/0038363 A1 to Adler (hereinafter “Adler”).
Regarding Claim 79, Adler teaches a method performed by one or more computing systems for tracking location of a catheter within a heart, the catheter having an energy delivery component that receives energy from an energy source component (see e.g. “may be performed during the implantation procedure to find most optimal pacing sites” in Para. 92; also see “method … of implanting” in Para. 93; also see generally Para. 99, the abstract and FIG. 10), the method comprising:
while the catheter is within a heart repeatedly (see e.g. “may be performed during the implantation procedure to find most optimal pacing sites” in Para. 92; also see “method … of implanting” in Para. 93; also see generally Para. 99, the abstract and FIG. 10):
receiving a patient cardiogram collected during pacing of the energy delivery component while the energy delivery component is positioned at a current location within the heart (see e.g. “heart may then be paced, and the resulting ECG data may be collected” in Para. 98 and “the collected ECG data may be used to generate an updated activation map …” in Para. 99);
determining from the patient cardiogram the current location of the energy delivery component (see e.g. “In some embodiments, the ECG data may be used to identify the pacing location, which may be displayed on the activation map. Since the pacing electrode is disposed at the pacing location, the pacing location may represent the current location of the pacing electrode. Accordingly, pacing electrode locations may be displayed while navigating to a pacing location” in Para. 99; also see e.g. “when the heart is paced, the processing unit 400 may analyze the resulting ECG data to identify the corresponding pacing location 342, and thereby identify the current location of a pacing catheter, pacing electrode” in Para. 110); and
outputting an indication of the current location to track the catheter while within the heart (see e.g. “In some embodiments, the ECG data may be used to identify the pacing location, which may be displayed on the activation map. Since the pacing electrode is disposed at the pacing location, the pacing location may represent the current location of the pacing electrode. Accordingly, pacing electrode locations may be displayed while navigating to a pacing location” in Para. 99).
wherein tracking is performing during an ablation procedure and determining based on the patient cardiogram whether the current location is the source location of an arrhythmia (See e.g. Paras. 7, 9, 101, 112, 119).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 29, 31-34, 37-40, 42-53, 57-60, 62-66, 68-78, 81-85, 88-91, and 93 are rejected under 35 U.S.C. 103 as being unpatentable over Adler in view of US 2019/0332729 A1 to Villongco (hereinafter “Villongco”).
Regarding Claim 29, 42, 49, 68, and 82-84, Adler teaches a method performed by one or more computing systems for tracking location of a catheter within a heart, the catheter having an energy delivery component that receives energy from an energy source component (see e.g. “may be performed during the implantation procedure to find most optimal pacing sites” in Para. 92; also see “method … of implanting” in Para. 93; also see generally Para. 99, the abstract and FIG. 10), the method comprising:
while the catheter is within a heart repeatedly (see e.g. “may be performed during the implantation procedure to find most optimal pacing sites” in Para. 92; also see “method … of implanting” in Para. 93; also see generally Para. 99, the abstract and FIG. 10):
receiving a patient cardiogram collected during pacing of the energy delivery component while the energy delivery component is positioned at a current location within the heart (see e.g. “heart may then be paced, and the resulting ECG data may be collected” in Para. 98 and “the collected ECG data may be used to generate an updated activation map …” in Para. 99);
determining from the patient cardiogram the current location of the energy delivery component (see e.g. “In some embodiments, the ECG data may be used to identify the pacing location, which may be displayed on the activation map. Since the pacing electrode is disposed at the pacing location, the pacing location may represent the current location of the pacing electrode. Accordingly, pacing electrode locations may be displayed while navigating to a pacing location” in Para. 99; also see e.g. “when the heart is paced, the processing unit 400 may analyze the resulting ECG data to identify the corresponding pacing location 342, and thereby identify the current location of a pacing catheter, pacing electrode” in Para. 110); and
outputting an indication of the current location to track the catheter while within the heart (see e.g. “In some embodiments, the ECG data may be used to identify the pacing location, which may be displayed on the activation map. Since the pacing electrode is disposed at the pacing location, the pacing location may represent the current location of the pacing electrode. Accordingly, pacing electrode locations may be displayed while navigating to a pacing location” in Para. 99).
Adler fails to teach accessing a patient-specific library of library cardiograms and locations, each location being associated with a library cardiogram that would be collected when a heart is paced at that location, the library cardiograms not being collected from the patient; comparing the patient cardiogram to the library cardiograms to identify a library cardiogram that is similar to the patient cardiogram; furthermore, while Adler teaches determining the current location based on the patient cardiogram, as discussed above, Adler fails to teach determining the current location of the energy delivery component is the location associated with the identified library cardiogram.
Villongco teaches an analogous invention for evaluating patient cardiogram data including accessing a patient-specific library of library cardiograms and locations (see e.g. Para. 199 and e.g. “model library” in Para. 89), each location being associated with a library cardiogram that would be collected when a heart is paced at that location (see e.g. “sites of … pacing leads” in Paras. 60, 89, 172-174), the library cardiograms not being collected from the patient (see generally, e.g., Paras. 186-187 and 199); comparing the patient cardiogram to the library cardiograms to identify a library cardiogram that is similar to the patient cardiogram (see e.g. “similar” in Para. 199, and “a model cardiogram that matches a patient cardiogram collected from a patient” in Para. 187); and determining that the current location of the energy delivery component [or some other data-of-interest] that can be derived from cardiogram data] is the location [or other data-of-interest] associated with the identified library cardiogram (see e.g. Para. 199: “the method applies the trained classifier to the patient cardiogram to identify the configuration parameter for the patient” and Para. 89 [configuration parameter includes site of pacing lead]). Accordingly, it would have been obvious to one of ordinary skill in the art as of Applicant’s effective filing date to further modify Adler in view of Villongco to access a patient-specific library of library cardiograms and locations, each location being associated with a library cardiogram that would be collected when a heart is paced at that location, the library cardiograms not being collected from the patient; and compare the patient cardiogram to the library cardiograms to identify a library cardiogram that is similar to the patient cardiogram; and determine that the current location of the energy delivery component is the location associated with the identified library cardiogram., as taught by Villongco, because doing so would advantageously and predictably increase the accuracy of deriving location data from the patient cardiogram (i.e. compared to relying on the patient cardiogram by itself, as done in Adler).
Regarding Claims 31 and 50, Adler further teaches wherein the tracking of the location is for guiding implantation of the energy delivery component at a fixation location within the heart (see e.g. “may be performed during the implantation procedure to find most optimal pacing sites” in Para. 92; also see “method … of implanting” in Para. 93; also see generally Para. 99, the abstract and FIG. 10).
Regarding Claims 32 and 51, Adler further teaches analyzing a patient cardiogram to evaluate effectiveness of the fixation location for the energy delivery component (see e.g. Step 310 in FIG. 10 discussed in Paras. 99-100).
Regarding Claims 33 and 52, Adler further teaches wherein the effectiveness is based on similarity of the patient cardiogram to a target cardiogram (see e.g. “resulted in a sufficient amount of synchronicity and/or restored a desired amount of heart function” in Para. 100 – note that whatever the “desired” amount of function is, it could be represented in the form of a cardiogram, which would constitute the “target” cardiogram being compared to; also see e.g. “replicates” in Paras. 101 and 122; also see e.g. “comparison of detected ECG signals of a normal heart beat to ideal ECG normal heart beat signals” in Para. 64; also see e.g. “the pacing data may be analyzed to determine whether a pacing electrode is disposed in a suitable cardiac location for achieving a desired cardiac response. For example, the pacing data may be compared to the ECG data used to generate the activation map. In PVC, the pacing may be analyzed to determine whether the pacing data sufficiently matches the PVC ECG data recorded during presentation of the patient's PVC” in Para. 118).
Regarding Claims 34, 53 and 85, Adler further teaches wherein the outputting includes displaying a representation of a heart (“3D activation map of the heart” in Para. 93; “activation map” in Para. 99) with an indication of the current location of the energy delivery component (see e.g. “In some embodiments, the ECG data may be used to identify the pacing location, which may be displayed on the activation map. Since the pacing electrode is disposed at the pacing location, the pacing location may represent the current location of the pacing electrode. Accordingly, pacing electrode locations may be displayed while navigating to a pacing location” in Para. 99).
Regarding Claims 43, 69-72, and 93 Adler further teaches when the current location deviates from a target path from entry into the heart to the fixation location, generating an updated target path from the current location to the fixation location, information which is derived from cardiogram data (see FIG. 11C discussed in Para. 124: vector 712 represents an updated target path from current location 700 [which must lie along the total pathway starting at/before entry into the heart, since the pacing electrode originates from outside the heart and was inserted into the heart prior to the configuration shown in FIG. 11B] to target area 710 which, per the discussion in other cited portions of Adler discussed above, can represent a fixation location if the desired response occurs there; also consider the similar teaching of vector 344 in FIG. 11B; it is further noted that per Para. 127, “points may be connected by lines 708 to represent a path of the catheter during the EP process. In some embodiments, the vector 712 of FIG. 11B may also be applied to the activation map of FIG. 11C, in addition to, or in place of, the fourth point 706”).
Regarding Claims 48 and 77, Adler further teaches wherein the indication is output to a device that controls guiding of the energy delivery component (see e.g. Para. 103: “a workstation that may be use that includes the processing unit 400, the display 330, and wired or wireless connections to other hardware such as the CT/MRI device 108, the 3D camera 109, the ECG recorder 106, and/or the real-time imaging device 328. The workstation may also include an interface for controlling a surgical device, such as a catheter implantation device or other robotic surgical device”).
Regarding Claims 57 and 88, see e.g. Paras. 125-126 of Adler (“previous pacing locations”).
Regarding Claim 58, Adler’s activation map is based on measurements collected from the patient as discussed above.
Regarding Claims 78 and 81, in addition to the portions cited above, Adler further teaches that tracking is performing during an ablation procedure and determining based on the patient cardiogram whether the current location is the source location of an arrhythmia (See e.g. Paras. 7, 9, 101, 112, 119).
Regarding Claim 37, 62 and 89, Adler teaches the use of a patient cardiogram to identify the current location as discussed above, but fails to further teach wherein the determining includes applying a machine learning model to the patient cardiogram to identify the current location, the2129292.8021.US00\153158507.1Application No. 17/308,400Docket No.: 129292-8021.US00 Response to Restriction Requirement of July 14, 2021machine learning model being trained with training data that includes training cardiograms labeled with activation locations.
Another reference, Villongco, teaches a system including machine learning models (see e.g. “a machine learning based on modeled output ("MLMO")” in Para. 59) for patient cardiograms (see e.g. “The measurements can be represented via a cardiogram such as an electrocardiogram ("ECG") and a vectorcardiogram ("VCG"), an electroencephalogram ("EEG"), and so on …” in Para. 59) which were trained with training data (see e.g. “training data” in Paras. 59-60; also see e.g. “trained using training data” in Para. 188) including training cardiograms labeled with activation locations (see e.g. “a classifier could be trained using actual patient ECGs or VCGs and corresponding intracardiac basket catheter measurements of source location” in Para. 67; also see e.g. “trained using modeled cardiograms” in Para. 190; also see e.g. “pacing location” in Para. 199; see e.g. “sites of … pacing leads” in Paras. 60, 89, 172-174) which can be used for various applications including modeling the output of various implantable cardiac devices including determining the location of such a device (see e.g. “pacing leads, implantable cardioverter-defibrillator leads, cardiac resynchronization therapy leads, pacemaker pulse generator location, implantable cardioverter-defibrillator pulse generator location, subcutaneous defibrillator lead location, subcutaneous defibrillator pulse generator location, leadless pacemaker location, other implanted hardware (e.g., right or left ventricular assist devices) …” in Para. 60). Also generally see Paras. 188-201 which further describe various embodiments teaching variations of the above listed features.
Accordingly, it would have been obvious to one of ordinary skill in the art as of Applicant’s effective filing date to modify Adler to apply a machine learning model to the patient cardiogram to identify the current location, the2129292.8021.US00\153158507.1Application No. 17/308,400Docket No.: 129292-8021.US00 Response to Restriction Requirement of July 14, 2021machine learning model being trained with training data that includes training cardiograms labeled with activation locations, as taught by Villongco, because doing so would advantageously and predictably increase the accuracy of deriving location data from the patient cardiogram.
Regarding Claims 38, 63 and 90, Villongco additionally teaches that the training cardiograms can be derived from simulations of electrical activity of a heart given an activation location (see e.g. Para. 199-202). Accordingly, it would have been obvious to one of ordinary skill in the art as of Applicant’s effective filing date to further modify Adler in view of Villongco to use training cardiograms derived from simulations of electrical activity of a heart given an activation location, as taught by Villongco, because doing so would further increase the accuracy of deriving location data from the patient cardiogram.
Regarding Claims 39, 65 and 91, Villongco additionally teaches that the training cardiograms can be collected from patients (see e.g. Paras. 190-193). Accordingly, it would have been obvious to one of ordinary skill in the art as of Applicant’s effective filing date to further modify Adler in view of Villongco to use training cardiograms collected from patients, as taught by Villongco, because doing so would further increase the accuracy of deriving location data from the patient cardiogram.
Regarding Claims 40, 64 and 66, Villongco additionally teaches that the training cardiograms can be based on similarity between characteristics of the patient's heart and characteristics of a heart used in generating the training data (see e.g. Paras. 190, 199). Accordingly, it would have been obvious to one of ordinary skill in the art as of Applicant’s effective filing date to further modify Adler in view of Villongco to use training cardiograms based on similarity between characteristics of the patient's heart and characteristics of a heart used in generating the training data, as taught by Villongco, because doing so would further increase the accuracy of deriving location data from the patient cardiogram.
Regarding Claims 44 and 73, Adler further teaches when the current location deviates from a target path from entry into the heart to the fixation location, generating an updated target path from the current location to the fixation location, information which is derived from cardiogram data (see FIG. 11C discussed in Para. 124: vector 712 represents an updated target path from current location 700 [which must lie along the total pathway starting at/before entry into the heart, since the pacing electrode originates from outside the heart and was inserted into the heart prior to the configuration shown in FIG. 11B] to target area 710 which, per the discussion in other cited portions of Adler discussed above, can represent a fixation location if the desired response occurs there; also consider the similar teaching of vector 344 in FIG. 11B; it is further noted that per Para. 127, “points may be connected by lines 708 to represent a path of the catheter during the EP process. In some embodiments, the vector 712 of FIG. 11B may also be applied to the activation map of FIG. 11C, in addition to, or in place of, the fourth point 706”) Adler fails to specifically teach applying a machine learning model trained using target paths and current locations labeled with updated target paths. However, as already discussed above, Villongco teaches applying a machine learning model to cardiogram data, and it would have been obvious (for reasons explained above) to one of ordinary skill in the art as of Applicant’s effective filing date to modify Adler to apply a machine learning model to the cardiogram data to enhance the accuracy of data derived from the cardiogram data. Therefore, it logically follows that it would have been further obvious to one of ordinary skill in the art as of Applicant’s effective filing date to also similarly apply a machine learning model trained using target paths and current locations labeled with updated target paths, since these data are also derived from cardiograms (as taught by Adler) and doing so would predictably and advantageously further increase the accuracy of generating an updated target path.
Regarding Claims 45 and 74, Adler further teaches wherein the outputting indicates when the current location is the fixation location (see e.g. “Yes” leading to step 312 in FIG. 10; also see e.g. “determining whether the pacing at the first pacing location generates a desired cardiac response” in the abstract).
Regarding Claims 46 and 75, Adler further wherein the outputting provides an indication of a next location for pacing (see e.g. “No” leading back to step 302 in FIG. 10; also see e.g. “displaying guidance information related to a second pacing location on one or both of the activation map and the internal surface map” in the abstract).
Regarding Claims 47, 59-60 and 76, Villongco further teaches identifying from a cardiogram library a library cardiogram that is similar to the patient cardiogram and wherein the outputting includes displaying a representation heart-related anatomical geometry associated with the similar library cardiogram with an indication of the current location of the energy delivery component (see e.g. Paras. 194-196 and 199-200). Accordingly, it would have been obvious to one of ordinary skill in the art as of Applicant’s effective filing date to further modify Adler in view of Villongco to identify from a cardiogram library a library cardiogram that is similar to the patient cardiogram and wherein the outputting includes displaying a representation heart-related anatomical geometry associated with the similar library cardiogram with an indication of the current location of the energy delivery component, as taught by Villongco, because doing so would advantageously and predictably increase the accuracy of deriving location data from the patient cardiogram.
Claims 35-36, 54-56 and 86-87 are rejected under 35 U.S.C. 103 as being unpatentable over Adler in view of Villongco as discussed above, further in view of US 2008/0234576 A1 to Gavit-Houdant et al. (hereinafter “Gavit-Houdant”).
Regarding Claims 35-36, 54, 56, and 86-87, Adler further teaches: prior to pacing the energy delivery component for guiding implantation, receiving an indication of the fixation location (step 302 in FIG. 10; see Paras. 94-95 of Adler); Adler also teaches generating a target path to guide movement of the energy delivery component to the fixation location; and displaying the target path wherein the displayed representation further includes an indication of a target path to the fixation location (see FIG. 11C discussed in Para. 124: vector 712 represents an updated target path from current location 700 to target area 710 which, per the discussion in other cited portions of Adler discussed above, can represent a fixation location if the desired response occurs there; also consider the similar teaching of vector 344 in FIG. 11B; it is further noted that per Para. 127, “points may be connected by lines 708 to represent a path of the catheter during the EP process. In some embodiments, the vector 712 of FIG. 11B may also be applied to the activation map of FIG. 11C, in addition to, or in place of, the fourth point 706”).
Adler fails to teach that the target path is “from entry into the heart.” Furthermore, although Adler teaches in Para. 97 that the initial fixation location can be displayed along with the reference image, Adler fails to teach that the “vector” or arrow discussed above is shown at this stage (i.e. prior to pacing and prior to entry into the heart). Another reference, Gavit-Houdant, teaches an similar invention for guiding passage of a tool through the heart to an implantation location, including the display of a pathway including entry into the heart to the target/implant location (see e.g. Para. 24: “The display is generally a two-dimensional, three-dimensional or four-dimensional model or re-constructed image of the pathway from the point of entry into the subject 115 to the location of deployment at the heart”) obtained using an imaging system such as ECG similar to Adler (see Para. 24: “Examples of the type of imaging system 120 include an electrocardiogram (ECG) …”) and in which the pathway can be a target pathway (see e.g. Para. 32 and the comparison of FIGS. 3 and 4). Accordingly, it would have been obvious to one of ordinary skill in the art as of Applicant’s effective filing date to modify Adler to display the target path extending from at least entry into the heart and prior to pacing, as taught by Gavit-Houdant, because this would advantageously provide the user with a more complete visualization of the entire pathway throughout the entire procedure.
As discussed above, Adler teaches displaying both a target path as well as a current location. Thus, in the combination of Adler in view of Gavit-Houdant, it follows that both the current location as well as the target path would be displayed, and thus necessarily any deviations between the two would be plainly visible in that display (i.e. any deviation would be “indicated”). Additionally/alternatively, Gavit-Houdant also further notes that the position of the tool can be tracked and displayed along with the pathways (see e.g. Para. 39) including specifically an indication of how much the tool’s current position is deviated away from a particular pathway (see e.g. Para. 40). Accordingly, it would have been obvious to one of ordinary skill in the art as of Applicant’s effective filing date to further modify Adler to display some kind of indication of deviation of a current location from the target path, as taught in Gavit-Houdant, as doing so would advantageously help a user determine and understand how the current position relates to the target path.
Regarding Claim 55, further see e.g. Paras. 100-101 and 125 of Adler.
Claim 61 is rejected under 35 U.S.C. 103 as being unpatentable over Adler in view of Villongco as applied to claim 49 above, further in view of US 2016/0278869 A1 to Grunwald (hereinafter “Grunwald”).
Regarding Claim 61, Adler as modified fails to further teach interfacing with an ultrasound device to track the location of the energy delivery component within a vein. However, Grunwald teaches that tracking a catheter in a vein can be achieved via ultrasound imaging, and in conjunction with other tracking modalities (see e.g. the abstract). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Adler to incorporate ultrasound tracking of the delivery component within a vein, as seen in Grunwald, because it would predictably enhance the accuracy of the tracking.
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 29 and 31-40, 42-66 and 68-79 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,338,131. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite narrower versions of the pending claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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