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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to PCT/IB2021/057721 filed August 23, 2021 and to Foreign App. No. PLP.435072 filed August 24, 2020.
Status of Claims
This Office Action is responsive to the preliminary amendment filed on February 24, 2023. As directed by the amendment: claims 1-2, 6, 18-22, 24-30, 32, 35, 39-40, 42, and 43 have been amended; and claims 3-5, 7-17, 23, 31, 33-34, 36-38, and 41 have been cancelled. Thus, claims 1-2, 6, 18-22, 24-30, 32, 35, 39-40, 42, and 43 are presently pending in this application.
Claim Objections
Claim 21 is objected to because of the following informalities:
Claim 21 recites “verifying, by the position sensor, the inhaler position”, ln 16 should read --verifying, by a position sensor, the inhaler position--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 18-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 18, the claim recites mesh sizes with relatively large openings of width between 0.94 and 1 cm and height between 0.97 and 1.03 cm and spacing between of 0.47 and 0.53 cm. The specification does recite these particular values (Paragraphs 0029-0031), however also recites these same values but at a different order of magnitude (Paragraphs 0051-0053). Thus, the different descriptions of the mesh appear to be contrary or point towards wholly different values/ranges and is thus not described sufficiently so as to reasonably convey that the inventor had possession of the particular dimensions of the mesh.
Similar arguments can be made for claims 19 and 20.
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 6, 21, and 32, and claims 22, 24-30, 32, 35, 39-40, 42, and 43 by dependency, 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.
Claim 6 recites “wherein the electronic board comprises at least one of an audio indicator, a switch that, via the coupler, is coupled with the base, and an antenna, a connector, an on/off switch, a resetting element, and a real time clock, that are coupled with a microprocessor, and wherein a battery is arranged in a frame”, ln 2-7 it is unclear what the electronic board comprises. For the purpose of this Office Action the electronic board has been interpreted as comprising at least one of an audio indicator, a switch, an antenna, a connector, an on/off switch, a resetting element, a real time clock, and a battery; wherein the switch that, via the coupler, is coupled with the base, wherein the antenna, the connector, the on/off switch, the resetting element, and the real time clock are coupled with a microprocessor; and wherein the battery is arranged in a frame.
Claim 21 contains the trademark/trade name Bluetooth. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe wireless communication that uses the Bluetooth specification and, accordingly, the identification/description is indefinite.
Claim 21 recites “ending the inhalation process”, ln 20 there is insufficient antecedent basis for this limitation in the claim. The limitation “inhalation process” has not previously been introduced, as such has been interpreted as --ending the inhalation process--.
Further, it is unclear from Applicant’s specification (¶ 0050 and Fig. 17) how the method is intended to end the inhalation process of a user. Specifically, it is unclear how the method forces the user to end inhalation. Therefore, Examiner is not making a judgment on the subject matter of claim 21 because the Examiner is unable to provide cogent and reasonable interpretation for claim 21 that would resolve the issues listed above.
Claim 32 recites “The method according claim 1,” ln 1, however claim 1 is directed to the device of a capsule inhaler. Examiner believes this is a typographical error. For the purpose of this Office Action claim 32 has been interpreted as depending from the independent method claim 21.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 21, and claims 22, 24-30, 32, 35, 39-40, 42, and 43 by dependency, rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 21 recites “ending the inhalation process”, ln 20 which positively recites ending the inhalation of a user. Therefore, the method of independent claim 21 explicitly requires a human organism be achieved.
Claims 21-22, 24-30, 32, 35, 39-40, 42, and 43 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claims recite an apparatus, a method, and a system satisfying two of the statutory categories; therefore, the claims pass step 1 of the eligibility analysis. For step 2A, the claim(s) are directed to a breath detection apparatus for monitoring individual breaths of a patient. The claims recite an abstract idea in the form of determining a state of the relative humidity during the breath and displaying a predetermined visual alert in response to the state of the relative humidity during the breath. This represents a mental processes because it can equivalently be done by a person simply observing the output of a signal of the parameter of the humidity of the breath and determining the state of humidity during the breath and determine a visual alert depending on the state of the humidity of the breath. These are actions that a person could do purely in the mind. If a claim recites a limitation, which under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas.
Using Claim 21, also applicable to Claims 42 and 43, as a representative example that is applicable to claims 22, 24-30, 32, 35, and 39-40, the abstract idea is defined by the elements of:
Claim 21:
A method for monitoring intake of a substance using a capsule inhaler, the method comprising the following steps executed by a processing unit:
periodically activating the processing unit;
verifying whether Bluetooth is active;
verifying the status of the process in an inhaler memory;
verifying opening of a base of a mouthpiece by monitoring a coupling element;
activating and reading out of sensors;
verifying closing of the base of the mouthpiece by monitoring the coupling element;
verifying pressing of press buttons, by checking whether the signal from magnetic field sensors exceeds a predetermined threshold value;
verifying, by a position sensor, the inhaler position;
verifying the status of a pressure sensor that monitors breath-in,
verifying the value of the breath-in force and breath-in duration time;
verifying the value of the breath-in force and breath-in duration;
ending the inhalation process; and
verifying ending of the inhalation process.
The above bolded limitations recite a method for monitoring intake of a substance using a capsule inhaler, activates the processing unit and verifies the various signals and conditions, that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. The process of verifying: the conditions of Bluetooth activeness, status of the process in memory, condition of open/close of the base of the mouthpiece, measuring an electrical signal of sensors (i.e. magnetic field sensor, position sensor, pressure sensor), condition of the press buttons, condition of the inhaler position can be carried out in a person’s mind. This is further defining the abstract idea.
Furthermore, this is a process known to be capable of being performed by people mentally, and not limited to be carried out via computer for automation. People (patients or doctor or caregivers) are capable of measuring through observations an electrical signal representing magnetic field, position, pressure, breath-in force, and breath-in duration. Further, people (patients or doctor or caregivers) are capable of determining through observations the condition of the base, mouthpiece, coupling element, press button, and inhaler position. This is further defining mental process in the form of observations, evaluations, judgments, and opinions.
Looking at signal of pressing of press buttons and determining if it exceeds a predetermined threshold valve can be carried out manually. This is considered longstanding practice that is the focus of the (patent ineligible) claimed invention and is further defining the abstract idea. The mere nominal recitation of “processing unit”, “base,” “mouthpiece”, “ coupling element”, “press buttons”, “magnetic field sensors”, “position sensor”, and “pressure sensor” does not take the claim out of the group of mental processes.
This judicial exception is not integrated into a practical application (2nd prong of eligibility test for step 2A) because the additional elements of the claim amount to the use of “processing unit”, “magnetic field sensors”, “position sensor”, and “pressure sensor” which is used for extra solution data gathering and high-level of generality as stated in Fato (U.S Pub. No. 2022/0305220 A1) (¶¶ 0060-0070, 0079-0081). Additionally, the use of “base,” “mouthpiece”, “ coupling element”, “press buttons”, are field of use and/or extra solution activity these are merely being used as a tool to execute the abstract idea, see MPEP 2106.05(f). For example, “base,” “mouthpiece”, “ coupling element”, and “press buttons”, of high-level of generality shown in Fato (U.S Pub. No. 2022/0305220 A1) (¶¶ 0060-0070, 0079-0081). Also, “pressure sensor” shown that they are conventional and well-known in the art by Cannan (WO 2018/160073 A1) (¶ 0072). In addition, the use of “processing unit” has limitations that are not indicative of integration into a practical application because they are being recited at a high-level of generality as shown in Cameron (U.S. Pub. No. 2017/0182267 A1) (¶ 0148) (i.e., as a generic processor performing a generic computer function of communicating data between users) or Brodkin (U.S. Pub. No. 20120118291 A1) (¶¶ 0040, 0059) such that they amount no more than mere instructions to apply the exception using a generic computer component. This is indicative of the fact that the claim has not integrated the abstract idea into a practical application and therefore the claim is found to be directed to the abstract idea identified by the examiner.
A “magnetic field sensors”, “position sensor”, and “pressure sensor”, which is used for extra solution data gathering; “processing unit” and “inhaler memory” are general purpose computers; and “pressing of press buttons”, “base”, “mouthpiece”, “coupling element”, and “press buttons” are field of use or extra solution activity that are also recited in Claim 21, are all considered nothing more than a general link to a technological environment and generic computing devices to perform generic communicating functions such as storing data and instructions, transmitting and receiving data between computers. The “processing unit” is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of communicating data between users) such that they amount no more than mere instructions to apply the exception using a generic computer component; for example, the additional elements are directed to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Thus, the claim is directed to an abstract idea identified by the examiner.
For step 2B, the independent claim(s) Claim 22 and 42-43 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not amount to more than simply instructing one to practice the abstract idea by using a computer to carry out the steps that define the abstract idea. This does not render the claims as being eligible. See MPEP 2106.05(f). The additional elements did not add significantly more to the abstract idea because they were simply applying the abstract idea on a computer without any recitation of details of how to carry out the abstract idea. The rationale set forth for the 2nd prong of the eligibility test above is also applicable to the entirety of the claims. The processor and control computer are generic computer systems and the ventilation system and breathing apparatus are drawn to a field of use.
Likewise, the rationale set forth for the 2nd prong of the eligibility test above for claim 1 is also applicable to 22, 24-30, 32, 35, and 39-40.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of copending Application No. 18/042,807 (hereinafter: “App’807”) in view of Cannan (WO 2018/160073 A1).
Regarding Claim 1, App’807 discloses a capsule inhaler (Claim 8), but is silent regarding the electronic board comprising at least one pressure sensor.
Cannan teaches a capsule inhaler comprising at least one pressure sensor (¶ 0072) for the purpose of determining the differences between the presence or absence of the capsule (¶ 0072).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the electronic board of App’807 to include the at least one pressure sensor as taught by Cannan for the purpose of determining the differences between the presence or absence of the capsule (See Cannan: ¶ 0072).
This is a provisional nonstatutory double patenting rejection.
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, 2, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Fato (U.S Pub. No. 2022/0305220 A1) in view of Cannan (WO 2018/160073 A1).
Regarding Claim 1, Fato discloses a capsule inhaler for administering a single dose of dry powder from a capsule (¶ 0001), said inhaler comprising a body (10; Fig. 1, 2), a mouthpiece (20; Fig. 1-2, 5-9) having a sieve (A, Fig. A annotated below), a base (B, Fig. A annotated below), and a cover (50; Fig. 3) comprising an opening (¶ 0102; Fig. 3-5; Examiner notes: Fato discloses a cap 50 which protects the mouthpiece and can be opened/has an opening to remove the cap.), the mouthpiece being coupled with the body (Fig. 1-2, 4-8), a capsule receiver (12, 13; Fig. 1-3), at least one press button (32; Fig. 1-3) with a capsule piercing mechanism (30; Fig. 1-3) comprising at least one piercing element (31; Fig. 1, 2), at least one electronic board (40, 46, 48; Fig. 1-2), the electronic board comprising a microprocessor (¶¶ 0062-0070; Fig. 1; Examiner notes: Fato discloses monitoring system 40 includes a printed circuit board 48 with electronic processing unit 46 soldered onto the board to receive and process signals.), at least one position sensor (42; Fig. 1; ¶ 0054), at least one magnetic field sensor (¶¶ 0060, 0061, 0086; Examiner notes: Fato discloses the monitoring system 40 is adapted to detect magnetic fields or features, which may be a dedicated magnetic sensor.), and at least one light indicator (¶ 0097, Examiner notes: Fato discloses the inhaler can include a visual lighting system to be signaled by the electronic processing unit), positioned in the proximity of the at least one press button (Fig. 1, 2; ¶¶ 0060-0062; Examiner notes: Fato discloses monitoring system 40 in proximity of the at least one electronic board. Further, it is noted that applicant has not defined the bounds of ‘proximity’ and thus the position sensor, magnetic sensor, pressure sensor, and light being anywhere in/on the body 10 may be considered ‘in proximity’.), a coupler (49a; Fig. 1) coupling the electronic board with the base of the mouthpiece )Fig. 1; ¶¶ 0079-0081).
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Figure A, Adapted from Figure 9 of Fato.
Fato does not explicitly disclose the capsule inhaler comprising at least one magnet, nor specifically disclose the capsule inhaler comprising at least one pressure sensor.
However, Fato teaches that the capsule piercing mechanism can be adapted to generate magnetic fields on actuation (¶¶ 0060, 0086) and wherein the magnetic field is generated in proximity to the piercing element and in proximity to the magnetic field sensor (¶¶ 0060, 0086, the sensing unit 44 may include a magnetic switch which detects actuation of the capsule piercing mechanism based on the generated magnetic fields generated by the capsule piercing mechanism).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Fato to have included a magnet in the capsule piercing mechanism and in proximity to the piercing element and magnetic field sensor, such as that taught by Fato, in order to detect actuation of the button (¶¶ 0060, 0086).
The modified device of Fato does not specifically disclose the capsule inhaler comprising at least one pressure sensor.
Cannan teaches a capsule inhaler comprising at least one pressure sensor (¶ 0072) for the purpose of determining the differences between the presence or absence of the capsule (¶ 0072).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Fato to include the at least one pressure sensor as taught by Cannan for the purpose of determining the differences between the presence or absence of the capsule (See Cannan: ¶ 0072).
Regarding Claim 2, the modified device of Fato disclose the capsule inhaler wherein the capsule piercing mechanism further comprises at least one spring (A, Fig. B annotated below).
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Figure B, Adapted from Figure 1 of Fato.
Regarding Claim 6, the modified device of Fato disclose the capsule inhaler wherein the electronic board comprises an antenna (See Fato: ¶ 0062) coupled with a microprocessor [46; Fig. 1; ¶ 0062; Examiner notes: Fato discloses a transmitter-receiver unit that acts as or comprises the antenna, not shown in the attached figures, coupled with the electronic processing unit and configured to implement at least one radio communication with external electronic apparatus, for example a smartphone or a remote server. Such radio communication uses a standard from the short range related protocols communicating over a WPAN (including BLE, Bluetooth 5 and, IEEE 802.15.4, and all their variants) and a WLAN (including IEEE 802.11 and all their variants). The transmitter-receiver unit may be configured to wirelessly exchange data.], and a battery (See Fato: ¶ 0077) arranged in a frame (See Fato: “special electrical contact elements”; ¶ 0077) in proximity to the electronic board (See Fato: ¶ 0077).
Allowable Subject Matter
Claims 18-20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The closest prior art is Roszczyk (WO 2019043639 A1) and Schmidt (U.S 6,293,279 B1) and Kafer (U.S 6,367,473 B1) and Hoekman (U.S 2014/0083424 A1) and Von Hollen (U.S 2011/0232636 A1) and Walz (U.S 2010/0189780 A1) and Hannon (U.S 2018/0369513 A1) and Beyleveld (U.S 2021/0085564 A1).
Regarding claim 23, none of the prior art teaches or suggest the sieve having the specific dimensions of rectangular openings with width between 0.94 and 1 cm and a height between 0.97 and 1.03 cm and spacings between the openings of 0.47 to 0.53 cm. It is noted that the prior art has drastically smaller mesh sizes and a plurality of openings that are typically an order of magnitude smaller. While the prior art does include some baffles or outlets which have only a small number of openings, it would not have been obvious to arbitrarily make said openings rectangular and with the particularly large dimensions. Furthermore, the previously cited prior art Roszczyk reference which has similar structure and mesh structure nested in the mouthpiece has openings on a scale of 1mm and not an order of magnitude larger to 1cm. Thus, it would not have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the limitations of claim 23 unless through impermissible hindsight reasoning or through arbitrary reconstruction of the mesh to scale it to such a larger size than is taught by the prior art.
Similar arguments can be made for claims 24 and 25.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIOT S RUDDIE whose telephone number is (571)272-7634. The examiner can normally be reached M-F usually 9-7 EST.
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785