DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 13, the claim presently sets forth the method step of “calculating a lesion durability index based on the determined amplitude of the bioelectrical signal in the frequency band, wherein the lesion durability index comprises a prediction of the efficacy of the cardiac lesion” therein.
The Examiner has reviewed the instant disclosure but is of the position that neither the instant Specification nor Drawing in this application or in the provisional US Pat. App. No. 63/267,868 would reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the at-issue claim limitations set forth above.
As a preliminary matter, the Examiner notes that claim 13 is an original claim. MPEP 2163(I)(A) discusses the need for originally filed claims to comply with the written description requirement in 35 U.S.C. 112(a). This section of the MPEP establishes that “issues of adequate written description may arise even for original claims, for example, when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the inventor had possession of the claimed invention at the time of filing. The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional or known in the art.”
The Examiner has reviewed the instant Specification and Drawings to determine if adequate written description exists for the feature of a lesion durability index, or for the step of calculating a lesion durability index based on the determined amplitude of the bioelectrical signal in the frequency band, wherein the lesion durability index comprises a prediction of the efficacy of the cardiac lesion”, but has failed to find sufficient disclosure that would describe the claimed features noted above with sufficient particularity such that one skilled in the art would recognize that the inventor had possession of the claimed invention at the time of filing.
Turning to the instant Specification, the Examiner recognizes that the terminology of “lesion durability index” appears a number of times throughout. For example, the following recitations of the terminology exist:
Paragraph [0006]: This disclosure may provide analysis techniques to develop an index, e.g., a lesion durability index, to assess lesion formation based on iEGM characteristics, for example, by selecting and analyzing iEGM components from one or more frequency bands. In some examples the index may also include other biological measurements such as temperature, impedance, and similar measurements. The specific analysis details, e.g., number of frequency bands, bandwidth of each frequency band, total frequency range of recorded signals, the timing of when to measure the iEGM and so on may differ for different types of ablation.
Paragraph [0030]: This disclosure may provide analysis techniques to develop an index to assess lesion formation based on iEGM characteristics, for example, by analyzing specific frequency spectra of measured iEGMs. In some examples the index, e.g., a lesion durability index, may also include other measurements such as temperature, monophasic action potential (MAP) waveform properties, impedance, and so on. The specific analysis details of the lesion characterization process, e.g., number of frequency bands, bandwidth of each frequency band, frequency range, the timing of when to measure the iEGM and so on may differ for different types of ablation.
Paragraph [0047] provides processing circuitry 38 is used to estimate an efficacy of the cardiac lesion and that this estimate “may be in the form of a lesion durability index, which, for example, processing circuitry 38 may cause to be displayed on user interface 52”.
Paragraph [0048]: In some examples, the estimate of the cardiac lesion may include an estimate of long-term, e.g., chronic efficacy of the lesion. The generator may display a lesion durability index based on the frequency analysis of the iEGMs and possible other physiological measurements (e.g. temperature, impedance, total iEGM signals) to the operator. In some examples, the lesion durability index may be less than a lesion durability index threshold. Then subsequent ablation energy may be delivered responsive to the estimated efficacy being less than an efficacy threshold, for example, the lesion durability index may be less than a lesion durability index threshold.
Paragraph [0052]: In some examples, ablation system 11 may collect and store bioelectrical signals, such as an iEGM, over a wide frequency range, divide the collected and stored signal into frequency bands and analyze the signals in two or more frequency bands to estimate the lesion efficacy. In other words, processing circuitry 38 of ablation system 11 may estimate the lesion efficacy, such as by calculating a lesion durability index, based on the measured bioelectrical signal in the first frequency band and in a second frequency band. In some examples, processing circuitry 38 may estimate lesion efficacy based on measurements, such as peak-to-peak voltage, in three or more frequency bands. In some examples, estimates of lesion efficacy, e.g., a lesion durability index, may also be based on signals from other sensors, such as a temperature, an impedance, a pressure, thoracic impedance, cardiac rhythm, a blood chemistry measurement, an echocardiogram and so on. In some examples, the estimated efficacy of the lesion may be based on signals in the two or more frequency bands collected at the same time or approximately the same time. In other examples, the estimated efficacy may be based on signals received at different times, such as at a second time that is a predetermined duration subsequent to receiving the first bioelectrical signals.
Paragraph [0072]: in some examples, processing circuitry of an ablation device of this disclosure may determine a threshold characteristic, e.g., a threshold amplitude based on the baseline measurement. The processing circuitry may provide an estimate of lesion efficacy based on comparing post-ablation bioelectrical signals to the threshold. For example, in the A6 frequency band, comparing signal 532 to a threshold of approximately 2 – 5 mV may provide an indication of the efficacy of the cardiac lesion. In other examples, the amplitude of the signal may increase by a different value, e.g., depending on the ablation equipment, patient, electrode location and other factors and the processing circuitry may determine a different threshold value. Similarly, comparing the decrease in amplitude found in signals 536 and 538, or other bioelectrical signals in the d3, d2 and d1 frequency bands may provide some indication of lesion efficacy. In other examples, the processing circuitry may compare the post-ablation signals to the baseline signals to estimate lesion efficacy. The processing circuity may use such comparisons to pre-ablation, post-ablation, and recovery signals or to a threshold, or any such combination of comparisons to calculate the lesion durability index.
Paragraph [0089]: “In this manner the ablation system, e.g., system 11 of FIG. 1, may estimate an efficacy of the cardiac lesion based on the measured peak-to-peak voltage of the post-ablation bioelectrical signal in the A6 frequency band. In some examples, the ablation system of this disclosure may further include analysis of other frequency bands, as well as other measurements from sensors, such as sensors 20 and sensors 46 described above in relation to FIG.1, as part of a lesion durability index to predict the chronic efficacy of a cardiac lesion formed by an ablation procedure, such as PFA.”
Paragraph [0094]: In other examples other sensors, e.g., sensor 20, including temperature, pressure or force and other types of sensors may provide a second bioelectrical signal to the processing circuitry to help evaluate the efficacy of the cardiac lesion. In some examples, the processing circuitry may use any one or more such bioelectrical to calculate a lesion durability index, as described above, which may provide a prediction of the clinical efficacy of the cardiac lesion. For example, if temperature or force increases are observed in a certain electrode, this indicates tissue contact, and can be used in conjunction with the iEGM frequency analysis to predict lesion efficacy.
Paragraph [0095]: In other example, a third and fourth bioelectrical signal may provide additional information to the processing circuity to evaluate lesion efficacy. For example, in addition an algorithm involving the change of frequency spectrum of iEGM signals, temperature, local impedance, and contact force following ablation can be integrated into an algorithm that provides predication of lesion formation. For example, a slight increase in electrode temperature, an increase in local contact force (measured via a contact force sensor), a decrease in local impedance, in conjunction with characteristic changes of frequency spectra of iEGM can provide an integrated algorithm to more accurately predict lesion efficacy. Additional bioelectrical signals may be added to such examples to make such algorithms more robust and reliable.
The Examiner has reviewed the entirety of the filed Specification including these above highlighted paragraphs that make mention to the lesion durability index and its calculation. The Examiner finds that the Specification does not sufficiently identify how the lesion durability index is calculated by the system/processor. The Examiner further finds that the Specification fails to provide for any such steps/procedures/algorithms to utilize any or all of the various parameters mentioned to have a role in the lesion durability index or for the calculation of such a lesion durability index.
To this end, much of the disclosure related to the determination, development or calculation of the lesion durability index seemingly amounts to high-level disclosure regarding possible factors and parameters that may be utilized as a portion of the lesion durability index. For example, paragraph [0006] sets forth that iEGM components from one or more frequency may be used to develop the index, and then continues in that “the index may also include other biological measurements such as temperature, impedance, and similar measurements. The specific analysis details, e.g., number of frequency bands, bandwidth of each frequency band, total frequency range of recorded signals, the timing of when to measure the iEGM and so on may differ for different types of ablation”. Paragraphs [0030], [0048], [0052] and [0089] similarly recite these high-level concepts/parameters that may be utilized as a portion of the lesion durability index. Paragraph [0072] provides additional concepts with respect to the estimation of lesion efficacy including values taken prior-to and post-ablation, but only generally notes that such estimation comparisons may be used “to calculate the lesion durability index”. Paragraph [0094] sets forth that “the processing circuitry may use any one or more such bioelectrical to calculate a lesion durability index … which may provide a predication of the clinical efficacy of the cardiac lesion”.
Paragraph [0095], while not specifically reciting a lesion durability index, provides the only disclosure of an algorithm directed to the evaluation of lesion efficacy including the use of various parameters such as a) a change of frequency spectrum of iEGM signals, b) temperature, c) local impedance, d) contact force following ablation, and e) additional bioelectrical signals. This portion of the disclosure, however, fails to convey any manner of algorithm that has specifically been developed by Applicant that integrates any one or more of the disclosure parameters so as to determine lesion efficacy, let alone an algorithm that specifically results in the calculating of a lesion durability index as contemplated in claim 13.
Said differently, while the instant Specification provides a number of recitations that make mention of a lesion durability index as well as various parameters and concepts that may be included in the calculation of the lesion durability index, the Examiner has failed to find sufficient disclosure as to how Applicant envisioned the actual calculation of the lesion durability index to be achieved at the time of filing utilizing any one or more of the parameters noted in the disclosure. The disclosure, rather, provides a broad range of parameters that may be utilized to provide for the claimed lesion durability index with no specific contemplation as to how each relate to one another or how each would factor into an overall calculation of the index. The Examiner has further reviewed the prior art during the examination of the pending claims but has failed to find that the claimed feature of a lesion durability index is a conventional, well-known feature in the prior art that would readily cure any/all of the deficiencies noted with respect to the instant disclosure. Additionally, the Examiner has reviewed the filed Drawings but such fail to provide any additional insight as to the lesion durability index.
For the sake of completeness, the Examiner notes that dependent claims 14-17 set forth additional features with respect to various processing completed by the processing circuitry. Claims 14 and 17 set forth the most relevant claim limitations to the at-issue calculation of the lesion durability index. Claim 14 sets forth the additional step of “calculating the lesion durability index based on the amplitude of the bioelectrical signal in the first frequency band and in second frequency band, wherein the lesion durability index comprises a prediction of the efficacy of the cardiac lesion” therein. While the limitations of this claim set forth that the calculation of the lesion durability index is specifically “based on the amplitude of the bioelectrical signal in the first frequency band and the second frequency band”, The Examiner is again of the position that the disclosure in this claim does nothing to remedy the above noted deficiencies in the balance of the disclosure.
Paragraph [0072] of the Specification sets forth similar disclosure with respect to the use of the amplitude of the bioelectrical signal being used to calculate the lesion durability index. In particular, [0072] provides for “comparing the decrease in amplitude found in signals 536 and 538, or other bioelectrical signals in the d3, d2 and d1 frequency bands may provide some indication of lesion efficacy. In other examples, the processing circuitry may compare the post-ablation signals to the baseline signals to estimate lesion efficacy. The processing circuity may use such comparisons to pre-ablation, post-ablation, and recovery signals or to a threshold, or any such combination of comparisons to calculate the lesion durability index.”
This additional claim language, however, further fails to provide sufficient disclosure as to how Applicant envisioned the actual calculation of the lesion durability index to be achieved at the time of filing utilizing the specific parameters set forth in claim 14, or any one or more of the parameters noted in the disclosure.
As such, it is for at least the reasoning set forth above that the above-noted limitations in claim 13 related to the calculating of the lesion durability index are considered subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 14-17 are rejected due to their respective dependency on claim 13. Appropriate correction is required.
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 1, 2, 5-11, 18 and 20-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Altmann et al. (US Pat. Pub. 2021/0401491 A1).
Regarding claim 1, Altmann provides for a method for evaluating a cardiac lesion formed by an ablation procedure, the method comprising:
receiving, by processing circuitry and following conclusion of delivery of ablation energy, a bioelectrical signal from an electrode proximate to a target location of cardiac tissue for the cardiac lesion (see [0042] providing for the acquiring of the bipolar signals via one of the pair of 50 after an IRE pulse; the processor 41 provides the processing circuitry as in at least [0043]),
determining, by the processing circuitry, an amplitude of the received bioelectrical signal in a frequency band of the received bioelectrical signal (see [0043] providing for 41 to determine the amplitude of the signal as the result of applying one of the second or third signals), and
estimating, by the processing circuitry, an efficacy of the cardiac lesion based on a comparison of the determined amplitude of the bioelectrical signal and a threshold amplitude (see [0044] providing for the comparison of the second amplitude by 41 to determine the efficacy of the IRE ablation).
Regarding claim 2, Altmann provides that the ablation energy is pulsed field ablation (PFA) (see [0036]).
Regarding claim 5, Altmann provides that subsequent ablation energy is delivered responsive to the estimated efficacy being less than an efficacy threshold (see figure 3 providing the estimation in step 106 followed by the determination against a threshold in step 108; step 104 is repeated if the target threshold is not reached).
Regarding claim 6, Altmann provides that the received bioelectrical signal is a first bioelectrical signal (see [0042] providing for the acquiring of the bipolar signals via one of the pair of 50 after an IRE pulse), the method further comprising: prior to the delivery of the ablation energy, receiving, by the processing circuitry a baseline bioelectrical signal from the electrode (see [0042] providing for acquiring the first bipolar signal prior to the delivery of IRE energy), and determining the threshold amplitude based on the baseline bioelectrical signal (see [0044] providing for the user of the first amplitude to determine efficacy and progress; see also [0061]).
Regarding claim 7, Altmann provides that estimating the efficacy of the lesion further comprises comparing the first bioelectrical signal to the baseline bioelectrical signal (see [0061] providing that the estimation is the “difference between the first and second amplitudes”).
Regarding claim 8, Altmann provides that the bioelectrical signal comprises an intracardiac electrogram (iEGM) (see [0028]).
Regarding claim 9 Altmann provides that the bioelectrical signal is a first bioelectrical signal received at a first time (see [0042] providing for the acquiring of the bipolar signals via one of the pair of 50 after an IRE pulse), the method further comprising: receiving, by the processing circuitry, a second bioelectrical signal from the electrode at a second time after the first time (see [0042] discussing the receiving of the third bipolar signal at a second time), and
determining, by the processing circuitry, an amplitude of the second bioelectrical signal (See [0043] discussing the determination of the third amplitude), wherein estimating the efficacy of the cardiac lesion further comprises estimating the efficacy of the cardiac lesion based on a comparison of the determined amplitude of the second bioelectrical signal and a second threshold amplitude (see [0056] providing for the third amplitude to be used for determining the progress/efficacy of the ablation).
Regarding claim 10, Altmann provides that determining the second threshold is based on the baseline signal (see [0056] providing for the determination to be based on the first amplitude and the third amplitude).
Regarding claim 11, Altmann provides that the second time is a predetermined duration subsequent to the first time (again, the measurement of the third amplitude is disclosed throughout as occurring subsequent to the determination of the second amplitude).
Regarding claim 18, Altmann provides that the electrode is one of a plurality of electrodes (the electrode 50 is one of a plurality of electrodes 50), wherein the received bioelectrical signal is bipolar signal, and wherein at least two electrodes of the plurality of electrodes are proximate to the cardiac tissue (50 is a bipolar pair, see at least [0049] providing for bipolar signals between 50).
Regarding claim 20, Altmann provides that the comparison comprises a ratio of the determined amplitude of the bioelectrical signal and the threshold amplitude (see [0061] providing for a ratio of the difference between amplitudes).
Regarding claim 21, Altmann provides for a medical system comprising an ablation device configured to deliver ablation energy to a target location of cardiac tissue to form a cardiac lesion (catheter 21 including the electrodes 50),
sensing circuitry comprising at least one electrode configured to be placed proximate to the target location (via the electrodes 50 functioning to acquire signals as in [0042]), and
processing circuitry (processor 41 further includes the processing circuitry as in [0043]) operatively coupled to the sensing circuitry and configured to:
receive a bioelectrical signal from the sensing circuitry following conclusion of delivery of the ablation energy (see [0041]-[0043] providing for 41 to be capable of receiving the signals from 50 after ablation energy has been delivered), determine an amplitude of the received bioelectrical signal in a frequency band of the received bioelectrical signal (see [0043] providing for 41 to determine the amplitude of the signal as the result of applying one of the second or third signals), and estimate an efficacy of the cardiac lesion based on a comparison of the determined amplitude of the bioelectrical signal and a threshold amplitude (see [0044] providing for the comparison of the second amplitude by 41 to determine the efficacy of the IRE ablation).
Regarding claim 22, Altmann provides for an ablation device comprising ablation generator circuitry configured to deliver ablation energy to a target location of cardiac tissue to form a cardiac lesion (system 20 with the generator 45),
sensing circuitry comprising at least one electrode configured to be placed proximate to the target location (via the electrodes 50 functioning to acquire signals as in [0042]), and
processing circuitry operatively coupled to the sensing circuitry (processor 41 further includes the processing circuitry as in [0043]) and configured to: receive a bioelectrical signal from the sensing circuitry following conclusion of delivery of the ablation energy (see [0041]-[0043] providing for 41 to be capable of receiving the signals from 50 after ablation energy has been delivered), determine an amplitude of the received bioelectrical signal in a frequency band of the received bioelectrical signal (see [0043] providing for 41 to determine the amplitude of the signal as the result of applying one of the second or third signals), and estimate an efficacy of the cardiac lesion based on a comparison of the determined amplitude of the bioelectrical signal and a threshold amplitude (see [0044] providing for the comparison of the second amplitude by 41 to determine the efficacy of the IRE ablation).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3, 4 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Altmann et al. (US Pat. Pub. 2021/0401491 A1) as applied to claim 1 above, and further in view of Koblish et al. (US Pat. Pub. 2020/0107877 A1).
Regarding claims 3 and 4, while Altmann provides for the determining of the amplitude of the received bioelectrical signal in a frequency band via at least the disclosure in paragraph [0043] setting for the processor 41 functioning to determine the amplitude of the signal as the result of applying one of the second or third signals at a frequency, Altmann fails to specifically provide that the frequency band is one of less than 30 Hz (per claim 3) or 0 Hz to 8 Hz (per claim 4). Koblish discloses a manner of assessing lesion formation in cardiac tissue and specifically contemplates the use of a frequency band as less than 30 Hz or 0 Hz to 8 Hz to sense cardiac activity (see [0697] providing for sensing in the 1-10Hz range). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a frequency range of 1-10Hz in view of the teaching of Koblish when sensing the amplitude of the bioelectric signal so as to assess the formation of a lesion and block within the tissue. Koblish readily provides that such bands of frequency are known in the art to readily show that development of a lesion within tissue (See at least [0742]).
Regarding claim 19, while Altmann provides that the electrode is a first electrode of a plurality of electrodes (one of 50 is a first electrode) and for a second electrode (a second electrode of 50), Altmann fails to specifically provide that the received bioelectrical signal is unipolar signal, and that the second electrode of the plurality of electrodes is separate from the first electrode. Koblish provides that it is known to utilize bipolar measurements as in Altmann or to alternative utilize unipolar voltage measurements where an electrode on a catheter and a separate reference electrode is utilized (see [0707]). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized unipolar sensing as in Koblish either in place or in addition to the bipolar sensing in Altmann to provide cardiac voltage feedback during a cardiac procedure. Koblish readily provides that either arrangement would function equally as well as one another to provide the requisite voltage feedback as required in Altmann.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Altmann et al. (US Pat. Pub. 2021/0401491 A1) as applied to claim 11 above, and further in view of Stewart et al. (US Pat. Pub. 2016/0166310 A1.
Regarding claim 12, while Altmann contemplates various times of sensing including after the delivery of ablation energy, Altmann fails to specifically provide that the second time is at least 2 minutes after delivery of ablation energy. Stewart provides for a similar methodology for determining the effectiveness of pulsed field ablation in cardiac tissue and specifically contemplates utilizing EGM measurements at least 2 minutes after the delivery of energy (see [0032] providing for “the EGM was again remeasured after approximately two minute after energy delivery”). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a second time period of at least 2 minutes for the method of Altmann in view of the teaching of Stewart to ensure that the desired treatment effect have occurred in tissue post recovery from the applied energy.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794