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 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.
Claim 6 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claim 6 recites the broad recitation “a wired communication element” and “a wireless communication element”, and the claim also recites “an optical communication element” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims not explicitly rejected above are rejected due to their dependence on the above claims.
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, 3-8, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burns et. al.’972 (U.S. Patent Application 20190246972 – previously cited).
Regarding Claim 1, Burns et. al.’972 discloses an apparatus for detecting tissue damage proximate to a point of contact between a medical device and a user's skin, comprising: a first electrode and a second electrode configured to measure a level of sub-epidermal moisture (SEM) in tissue proximate to the point of contact, an electronics package individually connected to the first and second electrodes and configured to measure a capacitance between the first and second electrodes, wherein the first and second electrodes are configured to be attached to a PPE device (Paragraphs [0072-0073] and Figure 4A).
Examiner has noted that the limitation “wherein the PPE device is selected from the group consisting of: a face shield, a safety helmet, goggles, and ear muffs” recited in the last two lines of the claim has not being given patentable weight because the PPE device is not part of the claimed apparatus. Additionally, given the lack of patentable weight regarding the type of PPE device, the examiner has noted that Burns et. al.’972 discloses first and second electrodes that are capable of being attached to PPE devices such as a face shield, safety helmet, goggles, and ear muffs (Figures 5C, 6B, and 7B).
Regarding Claim 3, Burns et. al.’972 discloses wherein the first and second electrodes are shaped such that an entire surface of each electrode facing the user’s skin can contact the user's skin while the medical device is in use (Paragraph [0074] and Figure 4A).
Regarding Claim 4, Burns et. al.’972 discloses further comprising a body coupled to the first and second electrodes, the body configured to be interposed between the medical device and the user's skin when the PPE device is in use (Paragraph [0075] and Figure 4A).
Regarding Claim 5, Burns et. al.’972 discloses wherein the body is further configured to be attached to the medical device (Paragraph [0076] and Figure 4A).
Regarding Claim 6, Burns et. al.’972 discloses further comprising a communication element configured to provide real-time transfer of SEM measurements to a computing unit (Paragraph [0077] and Figure 4B), wherein the communication element is selected from a group consisting of: a wired communication element, a wireless communication element, and an optical communication element and wherein the computing unit is selected from the group consisting of: a computer, a mobile tablet, a mobile phone, and a server ([0044] - In an aspect, the electronics package 240 includes devices to communicate over link 242 to computer 252, which may be a PC, a mobile tablet, a mobile phone, a server using cloud-based data storage and analysis, or other data systems. Link 242 may include a wired or wireless communication element, optical communication elements, a network that may have one or more switches and routers, and other standard data transfer devices and protocols).
Regarding Claim 7, Burns et. al.’972 discloses an apparatus that is configured to attach to an edge of a PPE device (Paragraph [0058] - FIG. 7A depicts an example medical device 500 with controllable pressure management elements; Paragraph [0073] - where the first and second electrodes are configured to be attached to the medical device). The examiner has noted that Figure 7A represents a medical device, and given the description that “the first and second electrodes are configured to be attached to the medical device” in Paragraph [0073], it is understood that the electrodes, in a similar apparatus 250 as used in Figure 4B, could be configured to attach to any side or edge of the medical device.
Regarding Claim 8, Burns et. al.’972 discloses the apparatus 250 includes a retention device 220 with adhesive 226 (Paragraph [0041] - The system 250 includes… a layer of adhesive 226 to attach the retention device 220 to the skin of the patient 200; Figures 4A and 4B). The examiner has noted that the adhesion 226 would allow the apparatus 250 to be configured to attach to a forehead band of a face shield as claimed in the instant application.
Regarding Claim 12, Burns et. al.’972 discloses wherein the apparatus further comprises one or more pressure management elements (Paragraph [0083] and Figure 7A), and wherein each of the one or more pressure management elements is an inflatable pocket (Paragraph [0084] and Figure 7A).
For the above claim rejections, the examiner has noted the apparatus detecting tissue damage through the use of electrodes is represented as element 250 in Figure 4B in Burns et. al. (Paragraph [0041]). The term “PPE device” from the instant application falls under the umbrella term “medical device” that is used throughout the specification of the prior art of Burns et. al.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of U.S. Patent No. 9,220,455. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of the U.S. Patent is narrower in scope than the claim of the instant application, and encompasses the subject matter of the claim of the instant application. Any reference meeting the limitations set forth in Claim 1 of the U.S. Patent would also meet the limitations of Claim 1 of the instant application. It is noted that the “flexible substrate” recited in the U.S. Patent could be considered part of a “PPE device” as recited in the instant application. It would have been obvious to one of ordinary skill in the art to use at least part of a PPE device as the “flexible substrate” that is attached to a person as it would be obvious to try choosing from a finite number of identified, predictable solutions (using a material to hold sensors against a user’s skin in a medical setting), with a reasonable expectation of success. Additionally, it is noted by the examiner that the limitation “wherein the PPE device is selected from the group consisting of: a face shield, a safety helmet, goggles, and ear muffs” argues intended use which does not hold patentable weight.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of U.S. Patent No. 9,398,879. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of the U.S. Patent is narrower in scope than the claim of the instant application, and encompasses the subject matter of the claim of the instant application. Any reference meeting the limitations set forth in Claim 1 of the U.S. Patent would also meet the limitations of Claim 1 of the instant application. It is noted that the “flexible substrate” recited in the U.S. Patent could be considered part of a “PPE device” as recited in the instant application. It would have been obvious to one of ordinary skill in the art to use at least part of a PPE device as the “flexible substrate” that is attached to a person as it would be obvious to try choosing from a finite number of identified, predictable solutions (using a material to hold sensors against a user’s skin in a medical setting), with a reasonable expectation of success. Additionally, it is noted by the examiner that the limitation “wherein the PPE device is selected from the group consisting of: a face shield, a safety helmet, goggles, and ear muffs” argues intended use which does not hold patentable weight.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of U.S. Patent No. 9,980,673. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of the U.S. Patent is narrower in scope than the claim of the instant application, and encompasses the subject matter of the claim of the instant application. Any reference meeting the limitations set forth in Claim 1 of the U.S. Patent would also meet the limitations of Claim 1 of the instant application. It is noted that the “substrate” recited in the U.S. Patent could be considered part of a “PPE device” as recited in the instant application. It would have been obvious to one of ordinary skill in the art to use at least part of a PPE device as the “substrate” that is attached to a person as it would be obvious to try choosing from a finite number of identified, predictable solutions (using a material to hold sensors against a user’s skin in a medical setting), with a reasonable expectation of success. Additionally, it is noted by the examiner that the limitation “wherein the PPE device is selected from the group consisting of: a face shield, a safety helmet, goggles, and ear muffs” argues intended use which does not hold patentable weight.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of U.S. Patent No. 10,188,340. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of the U.S. Patent is narrower in scope than the claim of the instant application, and encompasses the subject matter of the claim of the instant application. Any reference meeting the limitations set forth in Claim 1 of the U.S. Patent would also meet the limitations of Claim 1 of the instant application. It is noted that the “flexible substrate” recited in the U.S. Patent could be considered part of a “PPE device” as recited in the instant application. It would have been obvious to one of ordinary skill in the art to use at least part of a PPE device as the “flexible substrate” that is attached to a person as it would be obvious to try choosing from a finite number of identified, predictable solutions (using a material to hold sensors against a user’s skin in a medical setting), with a reasonable expectation of success. Additionally, it is noted by the examiner that the limitation “wherein the PPE device is selected from the group consisting of: a face shield, a safety helmet, goggles, and ear muffs” argues intended use which does not hold patentable weight.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of U.S. Patent No. 11,253,192. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of the U.S. Patent is narrower in scope than the claim of the instant application, and encompasses the subject matter of the claim of the instant application. Any reference meeting the limitations set forth in Claim 1 of the U.S. Patent would also meet the limitations of Claim 1 of the instant application. It is noted that the “substrate” recited in the U.S. Patent could be considered part of a “PPE device” as recited in the instant application. It would have been obvious to one of ordinary skill in the art to use at least part of a PPE device as the “substrate” that is attached to a person as it would be obvious to try choosing from a finite number of identified, predictable solutions (using a material to hold sensors against a user’s skin in a medical setting), with a reasonable expectation of success. Additionally, it is noted by the examiner that the limitation “wherein the PPE device is selected from the group consisting of: a face shield, a safety helmet, goggles, and ear muffs” argues intended use which does not hold patentable weight.
Claims 1 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1 and 6 of U.S. Patent No. 11,284,810. Although the claims at issue are not identical, they are not patentably distinct from each other because Claims 1 and 6 of the U.S. Patent are narrower in scope than the claims of the instant application, and encompasses the subject matter of the claims of the instant application. While Claim 6 does not explicitly recite “real-time transfer of SEM measurements”, one of ordinary skill in the art would have found it obvious that the invention of Claim 6 of the US Patent would be best suited to convert the capacitance measurements into SEM values on a “real-time” basis. Additionally, it would have been obvious to one of ordinary skill in the art to use the processor electronically coupled to the electrodes to convert capacitance signals into SEM values in real-time as it would be obvious to try choosing from a finite number of identified, predictable solutions (the data is processed in real-time or not), with a reasonable expectation of success. Furthermore, it would have been obvious to one of ordinary skill in the art to use to transfer SEM values via a wired or wireless communication element to a computer, mobile tablet, mobile phone, or a server as it would be obvious to try choosing from a finite number of identified, predictable solutions (the data is communicated with a wired or wireless to a remote device such as a computer, server, or smart device), with a reasonable expectation of success. It is noted that the “substrate” recited in the U.S. Patent could be considered part of a “PPE device” as recited in the instant application. It would have been obvious to one of ordinary skill in the art to use at least part of a PPE device as the “substrate” that is attached to a person as it would be obvious to try choosing from a finite number of identified, predictable solutions (using a material to hold sensors against a user’s skin in a medical setting), with a reasonable expectation of success. Additionally, it is noted by the examiner that the limitation “wherein the PPE device is selected from the group consisting of: a face shield, a safety helmet, goggles, and ear muffs” argues intended use which does not hold patentable weight.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 19 of U.S. Patent No. 11,471,094. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 19 of the U.S. Patent is narrower in scope than the claims of the instant application, and encompasses the subject matter of the claims of the instant application. Any reference meeting the limitations set forth in Claim 19 of the U.S. Patent would also meet the limitations of Claim 12 of the instant application. Additionally, it would have been obvious to one of ordinary skill in the art to use “inflatable pockets” as “pressure management elements” as it would be obvious to try choosing from a finite number of identified, predictable solutions (making a device tighter via inflatable pockets provides is a form of pressure management for a device), with a reasonable expectation of success. It is noted that the “inflatable pockets” as a form of a “pressure management element” was recited in the U.S. Patent in Claim 18. Additionally, it is noted by the examiner that the limitation “wherein the PPE device is selected from the group consisting of: a face shield, a safety helmet, goggles, and ear muffs” argues intended use which does not hold patentable weight.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of U.S. Patent No. 11,779,265. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of the U.S. Patent is narrower in scope than the claim of the instant application, and encompasses the subject matter of the claim of the instant application. Any reference meeting the limitations set forth in Claim 1 of the U.S. Patent would also meet the limitations of Claim 1 of the instant application. It is noted that the “flexible substrate” recited in the U.S. Patent could be considered part of a “PPE device” as recited in the instant application. It would have been obvious to one of ordinary skill in the art to use at least part of a PPE device as the “flexible substrate” that is attached to a person as it would be obvious to try choosing from a finite number of identified, predictable solutions (using PPE as a medical device to hold sensors against a user’s skin in a medical setting), with a reasonable expectation of success. Additionally, it is noted by the examiner that the limitation “wherein the PPE device is selected from the group consisting of: a face shield, a safety helmet, goggles, and ear muffs” argues intended use which does not hold patentable weight.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 2 of U.S. Patent No. 11,980,475. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 2 of the U.S. Patent is narrower in scope than the claims of the instant application, and encompasses the subject matter of the claims of the instant application. Any reference meeting the limitations set forth in Claim 2 of the U.S. Patent would also meet the limitations of Claim 1 of the instant application. It is noted that the “medical device” recited in the U.S. Patent could be considered part of a “PPE device” as recited in the instant application. It would have been obvious to one of ordinary skill in the art to use at least part of a PPE device as the “medical device” that is attached to a person as it would be obvious to try choosing from a finite number of identified, predictable solutions (using PPE as a medical device), with a reasonable expectation of success. Additionally, it is noted by the examiner that the limitation “wherein the PPE device is selected from the group consisting of: a face shield, a safety helmet, goggles, and ear muffs” argues intended use which does not hold patentable weight.
This following are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claim 1 rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 23 of co-pending U.S. Application No. 18,064,446. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 23 of the co-pending U.S. Application is narrower in scope than the claim of the instant application, and encompasses the subject matter of the claim of the instant application. While Claim 23 does not explicitly recite “an electronics package individually connected to each of the electrodes”, one of ordinary skill in the art would have found it obvious that the invention of Claim 23 of the co-pending U.S. Application would require an electronics package (a processing unit) to convert the capacitance measurements into SEM values. Furthermore, it would have been obvious to one of ordinary skill in the art to individually connect each electrode to the electronics package as it would be obvious to try choosing from a finite number of identified, predictable solutions (the electrodes are either individually connected to the electronics package or not), with a reasonable expectation of success. It is noted that the “first surface of an apparatus” recited in the co-pending U.S. Application could be considered part of a “PPE device” as recited in the instant application. It would have been obvious to one of ordinary skill in the art to use at least part of a PPE device as the “first surface of an apparatus” that is attached to a person as it would be obvious to try choosing from a finite number of identified, predictable solutions (using PPE as a medical device to hold sensors against a user’s skin in a medical setting), with a reasonable expectation of success. Additionally, the limitation “wherein the PPE device is selected from the group consisting of: a face shield, a safety helmet, goggles, and ear muffs” argues intended use which does not hold patentable weight.
Response to Arguments
Applicant's arguments filed 14 August 2025 have been fully considered and they are not entirely persuasive. Applicant’s amendments have overcome any prior Drawing issues. Applicant’s amendments have overcome any prior Claim Objections. Applicant’s amendments have overcome any prior 112(f) Interpretations. Applicant’s amendments have overcome any prior 112b Rejections, but the amendments have also created additional 112b Rejections that are addressed in Paragraph 3 above. Applicant’s amendments have overcome any prior 101 Rejections. Regarding the rejections under 35 U.S.C. 102, the examiner has noted that the applicant is arguing intended use by including types of PPE devices recited in the independent claim. As the PPE device is not positively recited as part of the claimed apparatus, the language regarding the type of PPE device is not being given patentable weight, and the cited prior art need not teach the particular type of PPE device recited in claim 1. Any apparatus comprising first and second electrodes capable of being attached to a PPE device would read on the claims as currently written. The apparatus shown in any of Figures 4A, 4B, 5C, 6A, 6B, and 7B of Burns comprises first and second electrodes and an electronic package as recited in Claim 1, wherein the first and second electrodes are capable of being attached to any of a face shield, a safety helmet, goggles, and ear muffs. Therefore, the cited reference remains to anticipate the instant application’s system, as discussed in Paragraph 4 above. It is noted by the Examiner that in order for the details of the PPE device to be given patentable weight, the PPE device must be recited as part of the system rather than just “configured to be attached” to the claimed apparatus. Regarding Double Patenting, the amendments to the claims have overcome some of the prior rejections, but some of the rejections still stand as addressed in Paragraphs 5 and 6 above. The examiner has noted that “intended use” does not change the structure of the apparatus and therefore, a majority of the double rejections have not been overcome.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Awiszus et. al.’427 (U.S. Patent Application 20210052427) and Hall et. al.’989 (U.S. Patent Application 20210290989) are applications that utilize sensors within PPE such as face shields, helmets/hats, and earmuffs/earbuds.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791