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 .
Claim Status
Claims 1-19 are currently pending and under exam herein.
Claims 1-19 are rejected.
Claims 1, 4, 7, 10, 13, 16 and 19 are objected to.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. IN202121021835, filed on 05/14/2021. The effective filling date of the current application is therefore established to be 05/14/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/11/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters not mentioned in the description: 104-1, 104-2, 104-N (Figure 1). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: minor grammatical errors. Some examples include:
“Human body is a complex system” (Page 2, Line 13) – an article (e.g. “a”) is needed before “Human body”
“The ventricular myocardium in the heart is composed of three cell layer” (Page 3, Line 12) – “layer” should be plural
“the second classification in which an island of M-cells are considered to be” (Page 19, Line 20) – “are” should be is
Appropriate correction is required.
The use of the term Bluetooth®, which is a trade name, has been noted in this application. The term should be accompanied by the generic terminology (not currently present); furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Applicant is advised that should claim 16 be found allowable, claim 19 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 1, 4, 7, 10, 13, 16, and 19 are objected to because of the following informalities:
Claims 1, 7, and 13 have inconsistent use of the “-” when referring to “mid-myocardium”.
Claims 1, 7, and 13 recite the limitation - generating, via one or more hardware processors, a cell model including the M-cells present in mid-myocardium of heart. An indefinite article (“a”) is needed before “mid-myocardium of heart” and “rise and fall”.
Claim 1 recites the limitation - simulating, via the one or more hardware processor, a plurality of properties of a plurality of M-cell islands. Processor should be plural.
Claim 4, 10, 16, and 19 include the limitation - wherein different sizes of the plurality of M-cell islands is considered. Is should be changed to are.
The specification has not been exhaustively reviewed for grammar or spelling, the above are merely exemplary of grammar and spelling informalities. Applicant is encouraged to thoroughly review the specification for other grammatic and spelling issues. 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.
Claims 1-19 are rejected under 35 U.S.C. 112(b), 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.
Claims 1, 7, and 13 recite the limitation "the performance of rise and fall", “the endo-mid interface”, “the endocardium layer”, “the effect of physical characteristics”, and “the effect of short QT syndrome”. These limitations were not previously mentioned in the claims. Therefore, there is insufficient antecedent bases for these limitations in the claims. Claims 2-6, 8-12, and 14-19 are dependent on these rejected claims.
Additionally, claims 5, 11, and 17 recite the limitation "the elliptical island of the major axis”. The meaning of this limitation was unclear and the limitation was not previously mentioned in the claims. Therefore, there is insufficient antecedent bases for these limitations in the claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claims 1, 7, and 13 recite the limitation - the cell model is configured to simulate the performance of rise and fall of action potential of the cardiac cell using a differential equation. This cites a mathematical equation which is classified as an abstract idea. This limitation could also practically be done by a human mind, which makes it equivalent to a mental process and further classifies the limitation as an abstract idea. These claims also recite - the simulation includes a fivefold decrease in the GJC. This is equivalent to a mathematical equation which is classified as an abstract idea. This limitation could also practically be done by a human mind, which makes it equivalent to a mental process and further classifies the limitation as an abstract idea. These claims also recite the limitation - realizing, via the one or more hardware processors, the effect of short QT syndrome in the tissue model. Based on the specification, realizing the effect of short QT syndrome is interpreted to mean observing the effect of QT syndrome with the pseudo ECG within the model. This could practically be done by a human mind, which makes it equivalent to a mental process and is classified as an abstract idea.
Claims 3, 9, and 15 recite the limitation - the flow of current between two cardiac cells is described using Ohm's law. This cites a mathematical formula which is classified as an abstract idea. This limitation could also practically be done by a human mind, which makes it equivalent to a mental process and also classifies the limitation as an abstract idea.
These recitations are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind or mathematical relationships. Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas.
As such claims 1-19 recite an abstract idea (Step 2A, Prong 1: YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). These judicial exceptions are not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology (MPEP § 2106.04(d)(1)). Rather, the claims provide insignificant extra-solution activity (MPEP § 2106.05(g)) and provide mere instructions to apply a judicial exception (MPEP § 2106.05(f)). Specifically, the claims recite the following additional elements:
Claims 1, 7, and 13 recite a tissue model of a transmural section of one or more of a 2D ventricular tissue or a 3D ventricular tissue of the heart using the cell model, wherein the 2D ventricular tissue is made of an array of cells interconnected by gap junction conductance. Claims 1, 7, and 13 also recite a functionality of the gap junction conductance that allows passage of electric current between the M-cells. Claims 1, 7, and 13 also recite the simulation of a plurality of properties of M-cell islands. Claims 1, 7, and 13 also recite the effect of physical characteristics of the M-cells on arrhythmogenesis. Claims 1, 7, and 13 also recite a pseudo-ECG by exciting the tissues present in the tissue model.
Claims 2, 8, and 14 recite an origin of the array of cells is taken as a bottom leftmost corner.
Claims 4, 10, 16, and 19 recite the plurality of M-cell Islands is modelled as an ellipse positioned vertically with an associated center located in a mid-layer, wherein different sizes of the plurality of M-cell islands are considered.
Claims 5, 11, and 17 recites the position and shape of the plurality of M-cell islands are altered.
Claims 6, 12, and 18 recites the heart is one of an atlas heart or a personalized heart.
The above additional elements are implemented as a processor based method, a computer system, or a non-transitory machine-readable information storage medium.
There are no limitations that indicate that the claimed simulations and modeling require anything other than generic computing systems. As such, these limitations equate to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. There is no indication that these steps are affected by the judicial exception in any way and thus do not integrate the recited judicial exception into a practical application. As such, claims 1-19 are directed to an abstract idea (Step 2A, Prong 2: NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment. The instant claims recite the following additional elements:
Claims 1, 7, and 13 recite a tissue model of a transmural section of one or more of a 2D ventricular tissue or a 3D ventricular tissue of the heart using the cell model, wherein the 2D ventricular tissue is made of an array of cells interconnected by gap junction conductance. Claims 1, 7, and 13 also recite a functionality of the gap junction conductance that allows passage of electric current between the M-cells. Claims 1, 7, and 13 also recite the simulation of a plurality of properties of M-cell islands. Claims 1, 7, and 13 also recite the effect of physical characteristics of the M-cells on arrhythmogenesis. Claims 1, 7, and 13 also recite a pseudo-ECG by exciting the tissues present in the tissue model.
Claims 2, 8, and 14 recite an origin of the array of cells is taken as a bottom leftmost corner.
Claims 4, 10, 16, and 19 recite the plurality of M-cell Islands is modelled as an ellipse positioned vertically with an associated center located in a mid-layer, wherein different sizes of the plurality of M-cell islands are considered.
Claims 5, 11, and 17 recites the position and shape of the plurality of M-cell islands are altered.
Claims 6, 12, and 18 recites the heart is one of an atlas heart or a personalized heart.
The above additional elements are implemented as a processor based method, a computer system, or a non-transitory machine-readable information storage medium.
As discussed above, there are no additional limitations to indicate that the claimed simulations and modeling requires anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims. The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, claims 1-19 are not patent eligible.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed inventions absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-9, 11-15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Priya and Reddy (2017, Journal of Electrocardiology, Vol. 50, Pgs. 332-341), hereafter referred to as Priya and Reddy1, in view of Lou et al. (2016, Computing in Cardiology, Vol. 43, Pgs. 1-4), hereafter referred to as Lou et al.
Claim 1 is directed to a method drawn to the following limitations via one or more hardware processors:
i. generating a cell model including the M-cells present in mid-myocardium of heart, wherein the cell model is configured to simulate the performance of rise and fall of action potential of the cardiac cell using a differential equation
ii. generating a tissue model of a transmural section of one or more of a 2D ventricular tissue or a 3D ventricular tissue of the heart using the cell model, wherein the 2D ventricular tissue is made of an array of cells interconnected by gap junction conductance (GJC)
iii. modelling a functionality of the gap junction conductance that allows passage of electric current between the M-cells using a plurality of conductive elements
iv. simulating a plurality of properties of the M-cells, if all the cells in the mid-myocardium are considered to be M-cells, wherein the simulation includes a fivefold decrease in the GJC at an epi-mid mural junction along the whole length of the mid-myocardium, whereas there is no reduction in the GJC at the endo-mid interface
v. simulating a plurality of properties of a plurality of M-cell islands, if each M-cell island is considered to be either located completely within the mid myocardium or partially in the endocardium layer
vi. recording the effect of physical characteristics of the M-cells on arrhythmogenesis by altering a position, a shape and a size of the M-cells in a plurality of configurations using the simulated M-cells and the plurality of properties of M-cell islands
vii. synthesizing a pseudo-ECG by exciting the tissues present in the tissue model, wherein the M-cells present in the tissue model get excited and stimulate neighboring cells by creating a convex wave-front travelling from the endocardium to epicardium and from an apex to a base of the heart
viii. realizing the effect of short QT syndrome in the tissue model by changing a rectifying potassium current of M-cells to detect cardiac abnormality
Claim 7 is drawn to a computer system implementing the above limitations. Claim 13 is drawn to a non-transitory machine-readable information storage medium implementing the above limitations.
Claim 2, which is dependent on claim 1, contains an additional limitation - the origin of the array of cells is taken as a bottom leftmost corner. Claims 8 (dependent on claim 7) and 14 (dependent on claim 13) are directed to the same limitation.
Claim 3, which is dependent on claim 1, contains an additional limitation - the flow of current between two cardiac cells is described using Ohm's law. Claims 9 (dependent on claim 7) and 15 (dependent on claim 13) are directed to the same limitation.
Claim 5, which is dependent on claim 1, contains an additional limitation - the position of the plurality of M-cell islands is altered by moving the elliptical island of the major axis 75 pixels and the minor axis 10 pixels to top position and bottom position, and the shape of the plurality of M-cell islands is altered by increasing the minor axis to 15 pixels and the major axis is again varied from 25 pixels to 50, 75 and 100 pixels respectively. Claims 11 (dependent on claim 7) and 17 (dependent on claim 13) are directed to the same limitations.
Claim 6, which is dependent on claim 1, contains an additional limitation - the heart is one of an atlas heart or a personalized heart. Claims 12 (dependent on claim 7) and 18 (dependent on claim 13) are directed to the same limitation.
The claims and specification define M-cells as myocardial cells. Priya and Reddy1 teaches a cell model of ventricular transmural cells (composed of myocardial cells) which incorporates electrophysiological activity (action potentials) of the cells using a differential equation (Page 333, Column 1, Cell model) (Limitation i). Priya and Reddy1 also teach a 2D ventricular tissue model where gap junction conductance is used to connect neighboring cells within an array (Page 333, Column 2, Two dimensional Tissue) (Limitation ii). Priya and Reddy1 also teach the passage of ionic currents from one cell to another (passage of electric current between cells) (Page 333, Column 2, Two dimensional Tissue) (Limitation iii). Priya and Reddy1 also teach a fivefold decrease in gap junction conductance except at the endo-mid interface (Page 334, Column 1, Two dimensional Tissue) (Limitation iv). Priya and Reddy1 also teach a pseudo-ECG where myocardial cells are stimulated to create a wavefront between cells (Page 334, Columns 1 and 2, Two dimensional Tissue) (Limitation vii). Priya and Reddy1 also disclose that the origin of an array of cells was taken at the bottom leftmost corner (Page 333, Column 2, Two dimensional Tissue) (Claims 2, 8, and 14). Priya and Reddy1 also disclose the current between two cardiac cells is described using Ohm's law. (Page 333, Column 2, Two dimensional Tissue) (Claims 3, 9, and 15).
Priya and Reddy1 do not teach the simulation of M-cell islands and their properties (Limitation v) or how the properties of M-cells can be altered to affect arrhythmogenesis (Limitation vi). Priya and Reddy1 also do not teach how short QT is realized from changing a rectifying potassium current of M-cells in a tissue model (Limitation viii). Priya and Reddy1 also does not teach a simulation in which position and shape of an M-cell island is altered within the model (Claims 5, 11, and 17). Priya and Reddy1 also does not teach what type of heart is used in their modelling (Claims 6, 12, and 18).
Lou et al. teaches M-cell island with various configurations and sizes across the mid and endocardium tissue layers (Page 2, Column 1, Methods) (Limitation v). Lou et al. also teaches altering the shape, size, and configuration of an M-cell island to test for an effect on the excitation waves produced (Page 2, Column 2, Methods) (Limitation vi). Lou et al. also teaches how alterations to the potassium rectifier current in conjunction with the heterogeneity of M-cell island configurations in the tissue model contribute to short QT syndrome (Page 2, Column 2, Methods) (Limitation viii). Lou et al. also teaches a simulation in which position and shape of an M-cell island is altered within the model (Page 2, Column 1, Figure 1) (Claims 5, 11, and 17). Lou et al. does not explicitly mention the axes along which the changes occur. However, this is interpreted as a way of displaying the changes and not required to model the changes themselves. The specification defines an atlas heart as data and parameter derived or collected from open-source dataset or literature or unknown data poll. Lou et al. also discloses a cardiac model parameterized using data derived from the literature (Pages 1-2, Methods) (Claims 6, 12, and 18). Based on the definition provided, data derived from the literature would make it an atlas heart.
An invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some motivation in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. Lou et al. teaches the importance of M-cell islands when considering cell and tissue models used to study the electroconductivity of the heart and short QT syndrome. This would motivate Lou et al.’s combination with Priya and Reddy1 for considering novel ways to investigate the electroconductivity of the heart and the detection short QT syndrome. The two cited works also share multiple similarities that would motivate them to be combined. Priya and Reddy1 and Lou et al. share the same cell models (Ten Tusscher). The focal diseases of Priya and Reddy1 (Torsade de pointes) and Lou et al. (Short QT syndrome) are physiologically related and both cause heart arrhythmias. The mechanism for detecting the two diseases is also the same, determining the electrical activity of the heart or the generation of an ECG to assess the Q and T wave interval. Therefore, it would have been obvious to someone of ordinary skill in the art the time of filling to combine the methods from both of the references indicated above.
Furthermore, one of ordinary skill in the art would predict that the methods taught by Lou et al. could be readily added to the methods Priya and Reddy1 with a reasonable expectation of success because Lou et al. discloses using previously known methods for modeling cells and tissues of the heart. Accordingly, claims 1-3, 5-9, 11-15, and 17-18 taken as a whole would have been prima facie obvious before the effective filing date.
Claims 4, 10, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Priya and Reddy (2017, Journal of Electrocardiology, Vol. 50, Pgs. 332-341), hereafter referred to as Priya and Reddy1, in view of Lou et al. (2016, Computing in Cardiology, Vol. 43, Pgs. 1-4), hereafter referred to as Lou et al., as applied above to claims 1, 7, and 13, and in further view of Priya and Reddy (2017 IEEE 17th International Conference on Bioinformatics and Bioengineering, 2017, Pgs. 383-387), hereafter referred to as Priya and Reddy2.
Claim 4, which is dependent on claim 1, contains additional limitations - each M-cell island is modelled as an ellipse positioned vertically with an associated center located in a mid-layer, wherein different sizes of the plurality of M-cell islands are considered in which a minor axis is a constant and a major axis is varied. Claims 10 (dependent on claim 7), 16, and 19 (dependent on claim 13) are directed to the same limitations.
Priya and Reddy1, in view of Lou et al., teach claims 1, 7, and 13. However, Priya and Reddy1 and Lou et al. fail to disclose the modeling of M-cells islands in specific tissue using ellipses or changes to the size of M-cell islands through alterations along their axes.
Priya and Reddy2 disclose the modeling of simulated myocardial tissue using ellipses centered in the mid layer with size changes along the minor and major axes (Page 384, Column 2, Figure 1).
An invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some motivation in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. Priya and Reddy2 teaches a method of modeling M-cell islands when considering cell and tissues models used to study the electroconductivity of the heart. This would motivate Priya and Reddy2’s combination with Priya and Reddy1 and Lou et al. for considering novel ways to investigate the electroconductivity of the heart. The three references also share multiple similarities that would motivate them to be combined. Priya and Reddy1, Lou et al., and Priya and Reddy2 share the same cell models (Ten Tusscher). The focal diseases of Priya and Reddy1, Priya and Reddy2 (Torsade de pointes) and Lou et al. (Short QT syndrome) are physiologically related with both causing heart arrhythmias. The mechanism for detecting the two diseases is also the same, determining the electrical activity of the heart or the generation of an ECG to assess the Q and T wave interval. Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filling to combine the methods from both of the references indicated above.
Furthermore, one of ordinary skill in the art would predict that the methods taught by Priya and Reddy2 could be readily added to the methods Priya and Reddy1 and Lou et al. with a reasonable expectation of success because Priya and Reddy2 discloses using previously known methods for modeling cells and tissues of the heart. Accordingly, claims 4, 10, 16, and 19 taken as a whole would have been prima facie obvious before the effective filing date.
Conclusion
Any inquiry concerning this communication from the examiner should be directed to BLAKE ELKINS whose telephone number is (571)272-2649. The examiner can normally be reached Monday-Friday 8-4PM.
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/B.H.E./Examiner, Art Unit 1687
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687