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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/09/2024 have been considered by the examiner and been placed of record in the file.
Priority
This application repeats a substantial portion of prior Application No. 17/167,830, filed 02/04/2021, and adds disclosure not presented in the prior application. Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Limitations related to the disclosures of a caliper and image have priority date of 11/17/2023 which is the filing date the instant application.
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 23-33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims mainly describe a printed material, which discloses a descriptive non-functional item.
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 16-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
As to Independent claim 16:
Step 1 Analysis: Is the claim to a process, machine, manufacture or composition of matter? See MPEP § 2106.03.
Yes, the claim is a process.
Step 2A Prong One Analysis: Do the claims recite an abstract idea, law of nature, or natural phenomenon? See MPEP § 2106.04(II)(A)(1).
Yes, the limitation “displaying a data portion 170 with one or more data zones on a device display 520 of the smart device; receiving, via a caliper, lesion data of the clinical lesion; determining, from the lesion data, a size of the clinical lesion; and applying size indicia 550, indicia to one or more of data zones 175 indicative of an evaluation of the clinical lesion” recited in independent claims 16 is the abstract idea of a mental process. See MPEP § 2106.04(a)(2)(III)(A).
Step 2A Prong Two Analysis: Does the claim recite additional elements that integrate the judicial exception into a practical application? See MPEP § 2106.04(d).
No, the limitations “determining, from the lesion data, a size of the clinical lesion; and applying size indicia 550, indicia to one or more of data zones 175 indicative of an evaluation of the clinical lesion” recited in claim 16 are an additional elements that amounts to a person examining the measurements and evaluating the data. The claimed invention does not disclose that the device is configured to perform the cited limitations. See MPEP § 2106.04(a)(2)(III) (B) “If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea.”.
Step 2B Analysis: Does the claim recite additional elements that amount to significantly more than the judicial exception? See MPEP § 2106.05.
No, the limitations “determining, from the lesion data, a size of the clinical lesion; and applying size indicia 550, indicia to one or more of data zones 175 indicative of an evaluation of the clinical lesion” recited in claim 16 are an additional elements that amounts to a person examining the measurements and evaluating the data. The claimed invention does not disclose that the device is configured to perform the cited limitations. See MPEP § 2106.04(a)(2)(III) (B) “If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea.”.
Dependent claims 17-22:
As to claim 17:
Step 1 Analysis: Are the claim to a process, machine, manufacture or composition of matter? See MPEP § 2106.03.
Yes, the claim is a process.
Step 2A Prong One Analysis: Do the claims recite an abstract idea, law of nature, or natural phenomenon? See MPEP § 2106.04(II)(A)(1).
Yes, the limitation “layering a schematic representation 555 of the clinical lesion over one or more of: one of first zone arcs 210 correspond to the size of the clinical lesion; and one of third zone circles 350 corresponding to the size of the clinical lesion that is smaller than first zone arcs 210” See MPEP § 2106.04(a)(2)(III) (B) “If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea.”.
Step 2A Prong Two Analysis: Do the claims recite additional elements that integrate the judicial exception into a practical application? See MPEP § 2106.04(d).
No, all elements are part of the abstract idea as shown above.
Step 2B Analysis: Do the claims recite additional elements that amount to significantly more than the judicial exception? See MPEP § 2106.05.
No, all elements are part of the abstract idea as shown above.
As to claim 18:
Step 1 Analysis: Is the claim to a process, machine, manufacture or composition of matter? See MPEP § 2106.03.
Yes, the claim is a process.
Step 2A Prong One Analysis: Does the claim recite an abstract idea, law of nature, or natural phenomenon? See MPEP § 2106.04(II)(A)(1).
Yes, the limitation “evaluating the clinical lesion from the size of the clinical lesion by: comparing the size of the clinical lesion against a lookup chart 580 accessible by the smart device, via on-board memory or over a wireless connection.” See MPEP § 2106.04(a)(2)(III) (B) “If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea.”.
Step 2A Prong Two Analysis: Does the claim recite additional elements that integrate the judicial exception into a practical application? See MPEP § 2106.04(d).
No, all elements are part of the abstract idea as shown above.
Step 2B Analysis: Does the claim recite additional elements that amount to significantly more than the judicial exception? See MPEP § 2106.05.
No, all elements are part of the abstract idea as shown above.
As to claim 19:
Step 1 Analysis: Is the claim to a process, machine, manufacture or composition of matter? See MPEP § 2106.03.
Yes, the claim is a process.
Step 2A Prong One Analysis: Does the claim recite an abstract idea, law of nature, or natural phenomenon? See MPEP § 2106.04(II)(A)(1).
Yes, the limitation “evaluating the clinical lesion from the size of the clinical lesion by: comparing the size of the clinical lesion against a lookup chart 580 accessible by the smart device, via on-board memory or over a wireless connection.” See MPEP § 2106.04(a)(2)(III) (B) “If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea.”.
Step 2A Prong Two Analysis: Does the claim recite additional elements that integrate the judicial exception into a practical application? See MPEP § 2106.04(d).
No, all elements are part of the abstract idea as shown above.
Step 2B Analysis: Does the claim recite additional elements that amount to significantly more than the judicial exception? See MPEP § 2106.05.
No, all elements are part of the abstract idea as shown above.
As to claim 20:
Step 1 Analysis: Is the claim to a process, machine, manufacture or composition of matter? See MPEP § 2106.03.
Yes, the claim is a process.
Step 2A Prong One Analysis: Does the claim recite an abstract idea, law of nature, or natural phenomenon? See MPEP § 2106.04(II)(A)(1).
Yes, the limitation “inquiring via a display whether a single or multiple lesions are being considered for the evaluation; and successively determining the size for each lesion and determining a total size for the multiple lesions, and thereafter evaluating the multiple lesions as the clinical lesion.” See MPEP § 2106.04(a)(2)(III) (B) “If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea.”.
Step 2A Prong Two Analysis: Does the claim recite additional elements that integrate the judicial exception into a practical application? See MPEP § 2106.04(d).
No, all elements are part of the abstract idea as shown above.
Step 2B Analysis: Does the claim recite additional elements that amount to significantly more than the judicial exception? See MPEP § 2106.05.
No, all elements are part of the abstract idea as shown above.
As to claim 21:
Step 1 Analysis: Is the claim to a process, machine, manufacture or composition of matter? See MPEP § 2106.03.
Yes, the claim is a process.
Step 2A Prong One Analysis: Does the claim recite an abstract idea, law of nature, or natural phenomenon? See MPEP § 2106.04(II)(A)(1).
Yes, the limitation “determining that the clinical lesion is elliptically shaped; determining a length (L) and width (W), and a L/W ratio of the clinical lesion; and determining the size of the clinical lesion with reference to the determined length and width, and the L/W ratio, and further reference to SDN correlation information, which is a function of at least a lesion length and a lesion L/W ratio.” See MPEP § 2106.04(a)(2)(III) (B) “If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea.”.
Step 2A Prong Two Analysis: Does the claim recite additional elements that integrate the judicial exception into a practical application? See MPEP § 2106.04(d).
No, all elements are part of the abstract idea as shown above.
Step 2B Analysis: Does the claim recite additional elements that amount to significantly more than the judicial exception? See MPEP § 2106.05.
No, all elements are part of the abstract idea as shown above.
As to claim 22:
Step 1 Analysis: Is the claim to a process, machine, manufacture or composition of matter? See MPEP § 2106.03.
Yes, the claim is a process.
Step 2A Prong One Analysis: Does the claim recite an abstract idea, law of nature, or natural phenomenon? See MPEP § 2106.04(II)(A)(1).
Yes, the limitation “determining a SDN of the clinical lesion includes: determining that the clinical lesion is elliptically shaped; determining a length (L) and width (W) of the clinical lesion; and receiving input representing a lesion depth (D) of the clinical lesion; and determining the SDN of the clinical lesion from a calculated volume of the clinical lesion, wherein the calculated volume is based on L, W and D.” See MPEP § 2106.04(a)(2)(III) (B) “If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea.”.
Step 2A Prong Two Analysis: Does the claim recite additional elements that integrate the judicial exception into a practical application? See MPEP § 2106.04(d).
No, all elements are part of the abstract idea as shown above.
Step 2B Analysis: Does the claim recite additional elements that amount to significantly more than the judicial exception? See MPEP § 2106.05.
No, all elements are part of the abstract idea as shown above.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-33 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 4-8 and 24-32 of U.S. Patent Application No. 17/167830. Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims scopes are identical.
Instant application
Application 17/167830
Claim 1.
A system for identifying a size doubling number (SDN) of a clinical lesion relative to a predetermined size of the clinical lesion, the system 100 comprising:
a ruler having:
a planar surface 110 including a first planar surface end 120, the planar surface 130 extending longitudinally aft from the first planar surface end 120 to a second planar surface end 140;
the planar surface 130 defining a data portion first end 160 that is adjacent the first planar surface end 120, and a data portion 170 extending longitudinally aft from the data portion first end 160 to a data portion second end 174, wherein the data portion 170 includes data zones 175, including:
a first zone 180 defining a first zone first end 190 that is adjacent the data portion first end 160, the first zone 180 extending longitudinally aft from the first zone first end 190 to a first zone second end 205, wherein:
the first zone 180 defines first zone arcs 210, the first zone arcs 210 being distributed in a concentric configuration, the first zone arcs 210 defining first mutually unique radiuses R1, ranging from a first minimum radius R1min of a first zone first arc 220 to a first maximum radius R1max of a first zone last circle 230, and wherein a concentric center 240 of the first zone arcs 210 is adjacent the first zone first end 190;
the first zone arcs 210 are successively larger from each other by a predetermined multiplication factor;
the first zone 180 includes first zone size markers 245, respectively positioned adjacent ones of the first zone arcs 210, and the first zone size markers 245 respectively identify the size doubling number (SDN) of the clinical lesion having a size that corresponds to a respective one of the first zone arcs 210;
a slider 400 configured to slide longitudinally along the planar surface 110, the slider 400 defining a laterally extending marker 410;
a caliper 1220 configured with a stationary arm disposed at one edge of the ruler and a movable arm that moves with the slider as the slider 400 moves longitudinally along the ruler and the marker 410 moves longitudinally away from the concentric center 240 of the first zone arcs 210; and
a smart device configured to communicate over a network with the caliper 1220 to receive lesion data indicative of the size of the clinical lesion, whereby the system is configured to determine and display on the display of the smart device one or more of the size doubling number (SDN) of a lesion and a stability status of the lesion.
Claim 1.
A device for identifying size doubling numbers (SDNs) of a clinical lesion relative to a predetermined size of the clinical lesion, the device 100 comprising:
a planar surface including a first planar surface end, the planar surface extending longitudinally aft from the first planar surface end to a second planar surface end;
the planar surface defining a data portion first end that is adjacent the first planar surface end, and a data portion extending longitudinally aft from the data portion first end to a data portion second end, wherein the data portion includes data zones, including:
a first zone defining a first zone first end that is adjacent the data portion first end, the first zone extending longitudinally aft from the first zone first end to a first zone second end, wherein:
the first zone defines first zone arcs, the first zone arcs being distributed in a concentric configuration, the first zone arcs defining first mutually unique radiuses RI, ranging from a first minimum radius Rlmin of a first zone first arc to a first maximum radius Rlmax of a first zone last circle, and wherein a concentric center of the first zone arcs is adjacent the first zone first end;
the first zone arcs are successively larger from each other by a predetermined multiplication factor;
the first zone includes first zone size markers, respectively positioned adjacent ones of the first zone arcs, and the first zone size markers respectively identify the size doubling numbers (SDNs) of the clinical lesion having a size that corresponds to a respective one of the first zone arcs, the first zone arcs are laterally aligned and longitudinally spaced apart from each other within the first zone, between the concentric center and the first zone second end; and
the first zone first arc represents 2^nl volume doublings relative to a single tumor cell of the clinical lesion, and the first zone last arc represents 2^ml volume doublings relative to the single tumor cell, where ml = nl + cl, wherein c is the number of circles in the first zone arcs, and wherein nl = 30, and cl = 10 or greater; and
the data zones include:
a second zone that is laterally adjacent the first zone, the second zone defining a second zone first end that is longitudinally aligned with the first zone, the second zone extending longitudinally aft from the second zone first end to a second zone second end, wherein:
the second zone defines a graduated line gauge and defines second zone size markers, wherein the second zone size markers identify one or more of radius R, area A, volume V, and the SDN of the clinical lesion.
The similarities between the two independent claims are shown in bold face
The new material that is included in the instant application is related to adding a caliper to the existing device to further measure the size of a lesion. In the related field of endeavor Knight et al. (US 2021/0191889 A1) discloses the idea of using electronic calipers to measure the size of tumors. Motivation, to combine, is related to obtaining more accurate measurements.
Dependent claims:
Claim 2, all limitations can be obtained from claim 1 of application17/167830.
Claim 3, all limitations can be obtained from claim 1 of application17/167830.
Claim 4, all limitations can be obtained from claim 4 of application17/167830.
Claim 5, all limitations can be obtained from claim 5 of application17/167830.
Claim 6, all limitations can be obtained from claim 6 of application17/167830.
Claim 7, all limitations can be obtained from claim 7 of application17/167830.
Claim 8, all limitations can be obtained from claim 7 of application17/167830.
Claim 10, all limitations can be obtained from claim 7 of application17/167830, in view of Knight et al. (US 2021/0191889 A1).
Claim 11, all limitations can be obtained from claim 1 of application17/167830, in view of Knight et al. (US 2021/0191889 A1).
Claim 12, all limitations can be obtained from claim 1 of application17/167830, in view of Knight et al. (US 2021/0191889 A1).
Claim 13, all limitations can be obtained from claim 1 of application17/167830, in view of Knight et al. (US 2021/0191889 A1).
Claim 14, all limitations can be obtained from claim 1 of application17/167830, in view of Knight et al. (US 2021/0191889 A1).
Claim 15, all limitations can be obtained from claim 4 of application17/167830, in view of Knight et al. (US 2021/0191889 A1).
Claim 16.
A method of evaluating a clinical lesion with a smart device, comprising: displaying a data portion 170 with one or more data zones on a device display 520 of the smart device;
receiving, via a caliper, lesion data of the clinical lesion;
determining, from the lesion data, a size of the clinical lesion; and
applying size indicia 550, indicia to one or more of data zones 175 indicative of an evaluation of the clinical lesion.
Independent claim 16 is a method claim which does not have a corresponding claim in the parent case. However, the steps namely describe the use of the disclosed tool of claim 1. Consequently, all limitations of claims 16 can be obtained from claim 1 of the parent case in view of Knight et al. (US 2021/0191889 A1). Motivation, to combine, is related to obtaining more accurate measurements.
Dependent claims:
Claims 17-22: all limitations can be obtained from independent Claim 1 and the associated independent claims in view of Knight et al. (US 2021/0191889 A1). The claim language pertains to a method however the limitations are related.
Claim 23.
A printed radiographic image of a lesion, comprising:
an image of a ruler that includes:
a planar surface 110 including a first planar surface end 120, the planar surface 130 extending longitudinally aft from the first planar surface end 120 to a second planar surface end 140; the planar surface 130 defining a data portion first end 160 that is adjacent the first planar surface end 120, and a data portion 170 extending longitudinally aft from the data portion first end 160 to a data portion second end 174, wherein the data portion 170 includes data zones 175, including: a first zone 180 defining a first zone first end 190 that is adjacent the data portion first end 160, the first zone 180 extending longitudinally aft from the first zone first end 190 to a first zone second end 205, wherein:
the first zone 180 defines first zone arcs 210, the first zone arcs 210 being distributed in a concentric configuration, the first zone arcs 210 defining first mutually unique radiuses R1, ranging from a first minimum radius R1min of a first zone first arc 220 to a first maximum radius R1max of a first zone last circle 230, and wherein a concentric center 240 of the first zone arcs 210 is adjacent the first zone first end 190;
the first zone arcs 210 are successively larger from each other by a predetermined multiplication factor;
the first zone 180 includes first zone size markers 245, respectively positioned adjacent ones of the first zone arcs 210, and the first zone size markers 245 respectively identify the size doubling number (SDN) of a clinical lesion having a size that corresponds to a respective one of the first zone arcs 210, wherein the image of the lesion 1510 is located on the image of the ruler for determining a doubling number of the lesion, and wherein the image is printed on a digital display or on x-ray film.
Claim 1.
A device for identifying size doubling numbers (SDNs) of a clinical lesion relative to a predetermined size of the clinical lesion, the device 100 comprising:
a planar surface including a first planar surface end, the planar surface extending longitudinally aft from the first planar surface end to a second planar surface end;
the planar surface defining a data portion first end that is adjacent the first planar surface end, and a data portion extending longitudinally aft from the data portion first end to a data portion second end, wherein the data portion includes data zones, including:
a first zone defining a first zone first end that is adjacent the data portion first end, the first zone extending longitudinally aft from the first zone first end to a first zone second end, wherein:
the first zone defines first zone arcs, the first zone arcs being distributed in a concentric configuration, the first zone arcs defining first mutually unique radiuses RI, ranging from a first minimum radius Rlmin of a first zone first arc to a first maximum radius Rlmax of a first zone last circle, and wherein a concentric center of the first zone arcs is adjacent the first zone first end;
the first zone arcs are successively larger from each other by a predetermined multiplication factor;
the first zone includes first zone size markers, respectively positioned adjacent ones of the first zone arcs, and the first zone size markers respectively identify the size doubling numbers (SDNs) of the clinical lesion having a size that corresponds to a respective one of the first zone arcs, the first zone arcs are laterally aligned and longitudinally spaced apart from each other within the first zone, between the concentric center and the first zone second end; and
the first zone first arc represents 2^nl volume doublings relative to a single tumor cell of the clinical lesion, and the first zone last arc represents 2^ml volume doublings relative to the single tumor cell, where ml = nl + cl, wherein c is the number of circles in the first zone arcs, and wherein nl = 30, and cl = 10 or greater; and
the data zones include:
a second zone that is laterally adjacent the first zone, the second zone defining a second zone first end that is longitudinally aligned with the first zone, the second zone extending longitudinally aft from the second zone first end to a second zone second end, wherein:
the second zone defines a graduated line gauge and defines second zone size markers, wherein the second zone size markers identify one or more of radius R, area A, volume V, and the SDN of the clinical lesion.
The similarities between the two independent claims are shown in bold face.
The new material that is included in the instant application is related to measuring the size of a lesion from an x-ray image. In the related field of endeavor Kim et al. (US 2024/0029258 A1) discloses the idea of using x-rays to measure the size of lesions.
Motivation to combine is related to obtaining more accurate measurements.
Dependent claims:
All limitations of the dependent claims: 24-33 can be obtained from claim 1 of application 17/167830 in view of Kim et al. (US 2024/0029258 A1).
It would have been obvious to a person of ordinary skill in the art, at the time the invention was filed to use claims of US Patent Application No. 17/167830 to provide all the functions of the current application 18/513016 in view of Knight et al. (US 2021/0191889 A1) with respect to claims 1-22 and in view of Kim et al. (US 2024/0029258 A1) with respect to claims 23-33.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Refer to PTO-892.
Prior art included in PTO-892, Spears (US 4131998 A), Luis (EP 1652472 A1) and Lee et al. (US 4279259 A), disclose similar ideas as in the instant application. However the prior art on record does not disclose the details as shown in the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED RACHEDINE whose telephone number is (571)272-9249. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeanette J. Parker can be reached at (571)270-3647. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MOHAMMED . RACHEDINE
Examiner
Art Unit 2649
/MOHAMMED RACHEDINE/Primary Examiner, Art Unit 2646
Prosecution Insights