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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 8, 2026 has been entered.
Claim Objections
Claim 14 is objected to because of the following informalities:
In claim 14, in the 3rd to last line, --- updated --- should be inserted before “image”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With regards to claim 14, in line 9, the limitation “acquire a first X-ray image” is recited and in the fourth to last line, the limitation “acquire at least one further X-ray image” is recited. It is unclear as to whether the “first X-ray image” and the “at least one further X-ray image” are referring to the same acquired “X-ray images” set forth in line 2 or referring to different images. For examination purposes, Examiner assumes the former.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 5-11 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spahn et al. (US Pub No. 2019/0380806) in view of Davies (US Pub No. 2019/0008412).
With regards to claims 1 and 14, Spahn et al. disclose a medical X-ray system and method for automatically setting image acquisition parameters of a medical X-ray system (8) when acquiring X-ray images of a patient (14) t (Abstract; paragraphs [0026], [0062]; Figure 2), the method comprising:
acquiring, by the medical X-ray system, a first X-ray image of an object (i.e. medical instrument) arranged in a body of the patient, wherein the object has markings (i.e. a bar code) on a surface of the object with encoded information relating to a material composition of the object (paragraphs [0026], [0027], [0054], claims 10-12, referring to identifying instrument data by using an identification device that reads information medium on the instrument (e.g., a bar code and/or an RFID chip) and/or by evaluating image data (i.e. first X-ray image) of the image recording device showing the instrument, wherein the medical instrument may be detected within image data of the image recording device by segmentation algorithms, thereby also allowing the identification of properties of the medical instrument in order to adapt the operating parameters of the image recording device that are based thereon; further referring to the instrument being, for example, a catheter, which is arranged in a body of the patient; in particular, see claims 10 and 12, referring to the other input data comprising data from a part of the patient that is positioned within the field of view of the image recording device and wherein the instrument data is identified by evaluating image data (i.e. “first X-ray image”) of the image recording device [i.e. x-ray device as set forth in paragraph [0062]] showing the instrument, wherein paragraph [0027] specifically refers to the detection of the medical instrument allowing for the “identification of properties of the medical instrument…For example, at least a material of the medical instrument (e.g., platinum, plastic, iron, tantalum, iodine, etc.)…may be used as properties of the medical instruments in order to adapt the operating parameters of the image recording device that are based thereon”, and thus the encoded information relates to a “material composition” of the object; paragraphs [0053]-[0054], referring to the input data (4) which relates to medical instruments that are used on and/or in the patient during the image recording routine, wherein information about devices used may be identified by reading information media (e.g., bar codes) using a corresponding identification device, wherein the input data (4) also includes properties that have been stored with respect to the medical instruments (e.g., the material); paragraph [0062], referring to the image recording device (8) being in the form of an interventional X-ray device; Figures 1-2);
automatically determining, by an image recognition algorithm of the medical X-ray system (i.e. controller/computer of the X-ray system), the markings of the object (paragraphs [0026], [0027], referring to identifying instrument data by using an identification device that reads information medium on the instrument (e.g., a bar code and/or an RFID chip) and/or by evaluating image data of the image recording device showing the instrument, wherein the medical instrument may be detected within image data of the image recording device by segmentation algorithms (i.e. “an image recognition algorithm”); paragraphs [0053]-[0054], referring to the input data (4) which relates to medical instruments that are used on and/or in the patient during the image recording routine, wherein information about devices used may be identified by reading information media (e.g., bar codes) using a corresponding identification device; paragraphs [0041]-[0042], referring to the control device/controller and/or computer/computer program performing the method; Figures 1-2);
evaluating, by the medical X-ray system (i.e. controller/computer of the X-ray system), the markings with regard to the encoded information (i.e. properties, such as material, etc.) related to the material composition of the object (paragraphs [0027], [0054]-[0055], referring to identifying information about the devices by reading information media (e.g., bar codes) using a corresponding identification device and/or an image-based correlation of the instrument properties with the aid of segmentation algorithms, wherein the input data (4) includes properties that have been stored with respect to the medical instruments (e.g., the material/material composition of the medical instrument, such as platinum, plastic, iron, tantalum, iodine, etc. [as set forth in paragraph [0027]]), etc.; paragraphs [0041]-[0042], referring to the control device/controller and/or computer/computer program performing the method; Figure 1);
determining, by the medical X-ray system (i.e. controller/computer of the X-ray
system), updated image acquisition parameters based on the encoded information related to the material composition of the object (paragraphs [0054]-[0056], referring to physical operating parameters, which may also be referred to as image recording parameters and related to the physical image recording routine, are identified in act S1, wherein, for example, operating parameters describing the X-ray dose and the X-ray spectrum may be identified as image recording parameters by identifying compositional information relating to the radiographed region and “knowledge related to implants…The knowledge relating to implants may also influence the superimposition of collimators and/or the use of filters to optimize the X-ray spectrum…”, wherein the “knowledge related to implants” encompasses implant material/material composition [as set forth in paragraph [0027] and further in paragraph [0054] (i.e. “The input data 4 also includes properties that have been stored with respect to the medical instruments (e.g., the material)…where the properties may likewise be used during the identification of the operating parameters”)]; paragraphs [0027]-[0029], referring to the properties of the medical instruments, such as at least a material of the medical instrument and/or the geometric extension in at least one dimension, may be used as properties of the medical instruments in order to adapt the operating parameters of the image recording device that are based thereon; paragraphs [0017]-[0019], referring to use of artificial intelligence algorithm that was trained by machine learning (e.g. deep learning), wherein output data, specifically the user settings, is assigned to the identified input data in the training data, etc.; paragraphs [0041]-[0042], referring to the control device/controller and/or computer/computer program performing the method; Figure 1) and
automatically setting, by the medical X-ray system, the updated image acquisition parameters on the medical X-ray system to optimize a detectability of the object arranged in the body of the patient while minimizing an X-ray dose to the patient (paragraphs [0039]-[0040], referring to the input data including information relating to the medical instrument (i.e. material properties, as set forth in paragraph [0027]), wherein, as a result of the input data, “It is likewise extremely useful in the case of X-ray devices for workflow instructions relating to optimization of the local dose load (e.g., the skin dose) to be generated automatically at the image recording device. In this way, workflow instructions may recommend, for example, a change in recording geometries (e.g., to complementary angulations) in order to minimize the locally applied skin dose for the patient in the case of lengthy image recording routines”; paragraph [0057], referring to minimization of a skin dose, etc., being achieved by corresponding workflow instructions to the user; paragraphs [0028], [0033], referring to adapting the operating parameters with a view to improving the resolution, in addition to any optimization of operating parameters with respect to the deployment region, and further referring to the information relating to known implants may be used to optimize the X-ray spectrum and the X-ray dose, thereby optimizing a detectability of the object); paragraph [0058], referring to, in act S3, the identified operating parameters (i.e. “updated image acquisition parameters”) are then used to control the image recording device (e.g., therefore for image acquisition, etc.); and
acquiring, by the medical X-ray system, at least one further X-ray image of the patient using the updated image acquisition parameters (paragraphs [0056], [0058]-[0059], referring to the identified operating parameters being used to control the image recording device for image acquisition, wherein the image recording device is an X-ray imaging device, further referring to the described input data being updated synchronously with the imaging and the identification algorithm (6) also being performed synchronously with the image accordingly, resulting in acquiring at least one further X-ray images of the patient using updated image acquisition parameters; Figure 1, referring to the arrow 7 which indicates that the steps are repeated; Figures 1-2).
Further, with regards to claim 14, Spahn et al. disclose that the medical X-ray system comprises an X-ray machine (“interventional X-ray device”, 10, 9, 11, 12) configured to acquire X-ray images of the object (paragraph [0062]; Figure 2), and a medical X-ray system configured to acquire the first X-ray image of the object arranged in the body of the patient and perform the evaluation, assigning, setting and acquiring at least one further X-ray image steps (see above rejection of claim 1; paragraph [0063], referring to the control device (15) which is configured to perform the method; paragraphs [0041]-[0042], referring to the control device including at least one processor and/or at least one storage device) and a memory (“storage device”) with a stored list or a data link to a database, wherein the memory is configured to store the assigned image acquisition parameters for the X-ray machine (paragraphs [0041]-[0042], referring to the storage device; paragraph [0019], pg. 8, claim 4, referring to the method comprising identifying training data, the identifying of the training data comprising logging (and thus storing) a user activity that comprises at least one individual parameter adaptation (i.e. assigned image acquisition parameters for the X-ray machine) during the use of predefined measurement protocols with predefined operating parameters; paragraphs [0054], [0058], referring to the storage of data and properties (i.e. “stored list”)) and one or more processors (paragraphs [0041], [0063], referring to the control device (15) which is configured to perform the method, wherein the control device may include at least one processor and/or at least one storage device).
However, Spahn et al. do not specifically disclose that the markings on the surface of the object are specifically “X-ray visibile” markings, wherein the markings of the object that are determined are specifically “X-ray visible” markings of the first X-ray image and further, with regards to claim 14, Spahn et al. do not specifically disclose that the medical X-ray system is further configured to carry out an image recognition using an algorithm and determine the X-ray visible markings on the first X-ray image of the object.
Davies discloses a system to detect a medical device within a biological subject, wherein the detection of the medical devices can be achieved using a marker (100) to aid or infer recognition (Abstract; paragraph [0075]). Medical devices (2) may be provided with a marker (100) which can be in the form of a bar code label or insert (101) or similar other identifier designed to label or encode a medical device (2) using an image modality such as X-ray (paragraph [0075]). The identifier may offer a unique identifier for each medical device (2) and can be implemented as an X-ray-readable barcode, wherein image data (i.e. “first X-ray image”) from the marker identifies the medical device and the marker is preferably radiopaque or has one or more parts of respective radiopacity so that information can be encoded in the relative opacity of the marker to the imaging system (paragraph [0075]; Figures 1, 8). An x-ray-readable barcode or other such marker is made up from alternating bars of varying thickness of radio-opaque and non-radio-opaque portions, wherein the material of the medical device, its surface texture or some other property of the material is modulated to embody the code and that modulation is “visible” or apparent to the imaging system being used to provide the image data (paragraph [0076]). The opacity of the material of the marker, the opacity of the marker surface texture, the opacity of the marker surface contour or other property of the marker is modulated to encode information in the marker and this modulation is apparent to the imaging system being used to generate the image data derived from the biological subject and/or the modulation is apparent to the imaging system being used to generate the image data derived from the medical device (paragraphs [0077]-[0078]; Figure 9). When a body is scanned or imaged by the system, markers may be detected and the detection comprises the successful reading of information (i.e. image recognition) from a marker (100), wherein the marker is machine readable and the machine reading the marker is an X-ray imaging system (paragraph [0082]). The invention allows the correct device to be identified, recognized and importantly, verified by virtue of the practitioner being provided with real time augmenting information, for example, overlaying and pointing to and labelling up the medical devices being imaged (paragraph [0061]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to substitute the markings on the surface of the object of Spahn et al. with “X-ray visible” markings, wherein the markings of the object that are determined are specifically “X-ray visible” markings of the first X-ray image [and requires that the medical X-ray system be further configured to carry out an image recognition using an algorithm and determine the X-ray visible markings of the first X-ray image of the object], as taught by Davies, as the substitution of one known marking for another yields predictable results (i.e. provides encoded information, such as material properties, etc. related to the object/medical instrument) to one of ordinary skill in the art and further allows the correct device to be identified, recognized and importantly, verified by virtue of the practitioner being provided with real time augmenting information, for example, overlaying and pointing to and labelling up the medical devices being imaged (paragraph [0061]). One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable.
With regards to claims 2 and 15, Spahn et al. disclose that the encoded information comprises material data relating to the object (paragraphs [0027], [0054], referring to the identification of properties, such as material, of the medical instrument).
With regards to claim 3, Davies discloses that the determining of the X-ray visible markings is performed by image recognition (paragraphs [0070]-[0071], [0075]-[0077], referring to the x-ray derived imaging and x-ray-readable barcode, wherein the opacity of the material of the marker, etc. is modulated to encode information in the marker and this modulation is apparent to the imaging system).
With regards to claim 5, Spahn et al. disclose that the method further comprises repeating the determining, the evaluating, the assigning, and the automatically setting using the at least one further X-ray image (paragraph [0059], referring to the described input data being updated synchronously with the imaging and the identification algorithm (6) also being performed synchronously with the image accordingly; Figure 1, referring to the arrow 7 which indicates that the steps are repeated).
With regards to claim 6, Spahn et al. disclose that the method is repeated iteratively until a cancellation criterion is achieved (paragraph [0059], referring to “the described input data may be updated synchronously with the image (e.g., if the recording geometry and/or the position of the patient couch changes during an image sequence)”, and therefore the method is repeated iteratively until there are no recording geometry changes and/or no changes of the position of the patient couch during an image sequence [i.e. cancellation criterion]; paragraph [0036]-[0040]).
With regards to claim 7, Spahn et al. disclose that the encoded information is encoded as a one-dimensional bar code, a multi-dimensional bar code, a binary code, or a machine-readable code (paragraphs [0027], [0054], referring to the use of bar codes). Davies also discloses this limitation (paragraphs [0075]-[0076], [0129], referring to the x-ray readable bar code or other such marker made up from alternating bars of varying thickness of radio-opaque and non-radiopaque portions; Figures 1, 9).
With regards to claim 8, Spahn et al. disclose that the assigning is carried out based on a comparison with a stored list or data from database (paragraphs [0017]-[0019], [0055]-[0056], referring to the identification algorithm (6) including an artificial intelligence algorithm, wherein the algorithm is trained by machine learning (e.g., by deep learning) and training data (i.e. stored list or data) which may be identified by logging during the use of image recording devices that operate based on measurement protocols; further referring to the artificial intelligence is suitable for extracting connections between input parameters and operating parameters; note that such an artificial intelligence algorithm based on training data would ultimately and inherently be based on “a comparison” with the training data). Note that Davies also teaches this limitation (see paragraphs [0083]-[0086], referring to the databank (8) containing a record of marker signatures, etc. that are compared to the marker information derived from the medical device and the databank can operate as a lookup table so that when a match between the information derived from the medical device and the signatures in the databank is discovered, the databank (8) holds key information identifying the matched device and is operable to provide specification information for that medical device).
With regards to claim 9, Spahn et al. disclose that the image acquisition parameters comprise an X-ray current, an X-ray voltage, an X-ray dose, an exposure time, a filter setting, a collimator setting, an X-ray pulse length, or a combination thereof (paragraphs [0004], [0034], [0056], referring to information relating to known implants being used to optimize the X-ray spectrum and the X-ray dose).
With regards to claim 10, Spahn et al. disclose that additional patient information is taken into consideration when automatically setting the image acquisition parameters (paragraphs [0049], referring to supplementary information relating to the patient, such as patient-specific patient data, may be used as an input, paragraph [0051], referring to the input data (5) relating to the image recording routine or purpose being retrieved, paragraphs [0056], [0060]-[0061],referring to operating parameters being identified by identifying compositional information relating to the radiographed region based on the known part of the patient in the field of view; Figure 1).
With regards to claim 11, Spahn et al. disclose that an adaptation to a type of acquisition is additionally taken into consideration when setting the image acquisition parameters (paragraphs [0056], [0060]-[0061],referring to operating parameters being identified by identifying compositional information relating to the radiographed region based on the known part of the patient in the field of view, wherein input data 2 to 5 may specify that a coronary examination (i.e. type of acquisition) is to take place (e.g., with specific imaging requirements), etc.; paragraph [0028], referring to different image recording parameters and/or image evaluation parameters being used if the medical instrument is located in the liver region of the patient or in the heart region of the patient; Figure 1).
Response to Arguments
Applicant's arguments filed January 8, 2026 have been fully considered but they are not persuasive.
With regards to the 35 USC 112(b) rejection of claim 14, Applicant asserts that
the claims have been amended to address the Office’s comments and therefore the rejections should be withdrawn.
However, the amendments to claim 14 do not appear to address the issue concerning whether the acquired “a first X-ray image” and the “at least one further X-ray image” correspond to the acquired “X-ray images” as set forth in line 2 of claim 14, or correspond to different images. As such, the rejection is maintained.
With regards to Spahn, Applicant argues that Spahn fails to disclose or suggest the determination of updated parameters that are specifically tied to the encoded information of the object determined in a first imaging of the object, where the encoded information relates to the material composition of the object.
Examiner respectfully disagrees and points to paragraphs [0053]-[0054] of Spahn, referring to the input data (4) which relates to medical instruments that are used on and/or in the patient during the image recording routine, wherein information about devices used may be identified by reading information media (e.g., bar codes) using a corresponding identification device, wherein the input data (4) also includes properties that have been stored with respect to the medical instruments (e.g., the material), and thus the markings (i.e. bar codes) on a surface of the object has encoded information relating “the material” of the object/medical instrument, and thus the encoded information relates to a “material composition” of the object. Spahn additionally discloses in paragraph [0027] that the detection of the medical instrument allows for the “identification of properties of the medical instrument…For example, at least a material of the medical instrument (e.g., platinum, plastic, iron, tantalum, iodine, etc.)…may be used as properties of the medical instruments in order to adapt the operating parameters of the image recording device that are based thereon”, and thus the encoded information relates to a “material composition” of the object.
Applicant further argues that Spahn provides no disclosure or suggestion that the operating parameters used in the imaging process are tied to a material composition of the medical instrument, but instead the only reference to a composition within Spahn relates to the composition of the part of the patient itself in paragraph [0033] of Spahn. Applicant asserts that there is no disclosure or suggestion regarding encoded information related to a specific composition of the inserted object.
Examiner respectfully disagrees and notes that the “material composition” of the object has been interpreted as referring to the material(s) which make up the object. As such, Spahn does present disclosure regarding encoded information related to a specific composition of the inserted object and operating parameters used in the imaging process being tied to a material composition of the medical instrument as paragraphs [0054]-[0056] of Spahn refer to physical operating parameters, which may also be referred to as image recording parameters and related to the physical image recording routine, being identified in act S1, wherein, for example, operating parameters describing the X-ray dose and the X-ray spectrum may be identified as image recording parameters by identifying compositional information relating to the radiographed region and “knowledge related to implants…The knowledge relating to implants may also influence the superimposition of collimators and/or the use of filters to optimize the X-ray spectrum…”, wherein the “knowledge related to implants” encompasses implant material/material composition [as set forth in paragraph [0027] and further in paragraph [0054, referring to “The input data 4 also includes properties that have been stored with respect to the medical instruments (e.g., the material)…where the properties may likewise be used during the identification of the operating parameters”)]. Examiner emphasizes that paragraphs [0027]-[0029] of Spahn refer to the properties of the medical instruments, such as at least a material of the medical instrument and/or the geometric extension in at least one dimension, may be used as properties of the medical instruments in order to adapt the operating parameters of the image recording device that are based thereon.
Applicant further argues that Spahn does not disclose such a process of setting any updated image acquisition parameters based on such underlying information (i.e., material composition of the object), wherein such setting of parameters is specifically to optimize the detectability of the object and minimize the X-ray dose to the patient.
Examiner respectfully disagrees and points to paragraphs [0039]-[0040], referring to the input data including information relating to the medical instrument (i.e. material properties, as set forth in paragraph [0027]), wherein, as a result of the input data, “It is likewise extremely useful in the case of X-ray devices for workflow instructions relating to optimization of the local dose load (e.g., the skin dose) to be generated automatically at the image recording device. In this way, workflow instructions may recommend, for example, a change in recording geometries (e.g., to complementary angulations) in order to minimize the locally applied skin dose for the patient in the case of lengthy image recording routines” and further refers to paragraph [0057], referring to minimization of a skin dose, etc., being achieved by corresponding workflow instructions to the user. Paragraphs [0028] and [0033] of Spahn further refers to adapting the operating parameters with a view to improving the resolution, in addition to any optimization of operating parameters with respect to the deployment region, and further refers to the information relating to known implants may be used to optimize the X-ray spectrum and the X-ray dose, thereby optimizing a detectability of the object. With regards to the “updated image acquisition parameters”, Examiner notes that paragraph [0058] of Spahn refers to, in act S3, the identified operating parameters being used to control the image recording device (e.g., therefore for image acquisition, etc.), wherein such identified operating parameters correspond to updated image acquisition parameters. Further, paragraph [0059] of Spahn refers to the described input data being updated synchronously with the imaging and the identification algorithm (6) also being performed synchronously with the image accordingly. Figure 1 further depicts the arrow 7 which indicates that the steps are repeated, wherein such updating and repeating of data and steps results in “updated” image acquisition parameters.
With regards to Davies, Applicant argues that there is no discussion or suggestion within the reference regarding changing or updating image acquisition parameters for subsequent X-ray images based on identified information related to the material composition of the object within the patient. Applicant further asserts that Davies does not disclose or suggest automatically setting the updated image acquisition parameters on the medical X-ray system to optimize a detectability of the object arranged in the body of the patient while minimizing an X-ray dose to the patient.
However, Examiner notes that the claim is rejected under the combination of Spahn in view of Davies, wherein Spahn, as is set forth in the above response as well in the rejection, discloses changing/updating image acquisition parameters for subsequent X-ray images based on identified information related to the material composition of the object within the patient and further discloses automatically setting the updated image acquisition parameters on the medical X-ray system to optimize a detectability of the object arranged in the body of the patient while minimizing an X-ray dose to the patient. Davies is then relied upon to teach substituting the markers of Spahn with “X-ray visible” markings, thus resulting in the markings of the object that are determined in Spahn to be specifically “X-ray visible” markings of the first X-ray image and further requiring determining the X-ray visible markings from the first X-ray image of the object, wherein the invention of Spahn is modified in view of the above teaching of Davies to meet the limitations of claim 1, etc..
The claims therefor remain rejected under the previously applied prior art.
Conclusion
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798