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 .
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.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11158416. Although the claims at issue are not identical, they are not patentably distinct from each other because independent claims 1, 9, and 15 of pending applications broadens their scope from patented claim 1 by reciting limitations in their dependent claims such as claims 1, 6, 8, 16, 20.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “caregiver electronic computing device” in claim 8, “electronic computing device” and “feeding management system” in claim 9, and “computing device” in claim 15.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception(s) without significantly more.
[STEP 1] The claim recites at least one step or structure. Thus, the claim is to a process or product, which is one of the statutory categories of invention (Step 1: YES).
[STEP2A PRONG I] The claim(s) recite(s):
A method for treating one or more feeding behaviors in a subject, comprising the steps of: [claim 1];
A system for treating one or more feeding behaviors in a subject, comprising: an electronic computing device; and a feeding management system configured to: [claim 9];
A non-transitory computer-readable medium that, when executed by at least one computing device, causes the at least one computing device to: [claim 15];
screening a subject for one or more feeding behaviors;
assessing the subject to determine a particular intervention by comparing the one or more feeding behaviors observed during screening with one or more predefined rules;
conducting the particular intervention, wherein the particular intervention comprises at least one meal session during which a feeder presents food to the subject and records intervention data; and
discharging the subject from care, if additional intervention is deemed not appropriate, wherein additional intervention is deemed not appropriate if the intervention data does not meet one or more predefined guidelines.
The non-highlighted aforementioned limitation, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation between people but for the recitation of generic computer components. That is, other than reciting “electronic computing device” and “feeding management system” [claim 9], “non-transitory computer-readable medium” and “computing device” [claim 15], and arguably “conducting the particular intervention,” nothing in the claim element precludes the step from practically being performed between people. For example, but for the recited language, the step in the context of this claim encompasses medical practitioner screening, assessing, intervening, and discharging patients with feeding disorder.
If a claim limitation, under its broadest reasonable interpretation, covers managing interactions between people, then it falls within the “Organization of Human Activity” grouping of abstract ideas.
Alternatively, the non-highlighted aforementioned, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting the aforementioned additional elements, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the recited language, the step in the context of this claim encompasses medical practitioner screening, assessing, and determining a discharge of patients with feeding disorder.
Accordingly, the claim recites a judicial exception, and the analysis must therefore proceed to Step 2A Prong Two.
[STEP2A PRONG II] This judicial exception is not integrated into a practical application. In particular, the claim only recites the additional element(s) – “electronic computing device” and “feeding management system”, “non-transitory computer-readable medium” and “computing device”, and arguably “conducting the particular intervention”.
The “electronic computing device,” “feeding management system”, “non-transitory computer-readable medium,” and “computing device” in the aforementioned steps is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function) such that it amounts no more than mere instructions to apply the exception using a generic computer component.
Also, claims recite limitation ““conducting the particular intervention.” The examiner determines that the limitation recites certain organization of human activities because feeding a baby is what human has been done from the beginning of mankind. Alternatively and arguably, if this is considered additional element, the additional element step is recited at a high level of generality, and amounts to mere data gathering, which is a form of insignificant extra-solution activity. Each of the additional limitations is no more than mere instructions to apply the exception using a generic computer component.
Accordingly, the additional element(s) do(es) not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea and the claim is therefore directed to the judicial exception. (Step 2A: YES).
[STEP2B] The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform the aforementioned steps amounts to no more than mere instructions to apply the exception using a generic computer component, which cannot provide an inventive concept.
As noted previously, the claim as a whole merely describes how to generally “apply” the aforementioned concept in a computer environment. Thus, even when viewed as a whole, nothing in the claim adds significantly more (i.e., an inventive concept) to the abstract idea.
As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform the aforementioned step(s) amounts to no more than adding insignificant extra-solution activity to the judicial exception, which cannot provide an inventive concept.
Under the 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be reevaluated in Step 2B. Here, the aforementioned step(s) was/were considered to be extra-solution activity in Step 2A, and thus it is reevaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The background of the specification does not provide any indication that the additional element(s) is/are anything other than a generic, off-the-shelf computer component, and the Symantec, TLI, and OIP Techs. court decisions cited in MPEP 2106.05(d)(II) indicate that mere collection or receipt of data over a network is a well-understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here). Accordingly, a conclusion that the aforementioned step(s) is/are well-understood, routine, conventional activity is supported under Berkheimer Option 2.
As noted previously, the claim as a whole merely describes how to generally adding insignificant extra-solution activity to the judicial exception. Thus, even when viewed as a whole, nothing in the claim adds significantly more (i.e., an inventive concept) to the abstract idea.
The claim is not patent eligible. (Step 2B: NO).
Claim(s) 2-8, 10-14, and 16-20 is/are dependent on supra claim(s) and includes all the limitations of the claim(s). Therefore, the dependent claim(s) recite(s) the same abstract idea. The claim recites the additional limitations of “transmitting/receiving [data] to/from a caregiver electronic computing device” [claim 8], which are no more than mere instructions to apply the exception using a generic computer component, generally linking the use of the judicial exception to a particular technological environment or field of use, insignificant extra-solution activity, or that are well understood, routine and conventional activities previously known to the industry. Accordingly, the additional element(s) do(es) not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea and the claim is therefore directed to the judicial exception. The additional element of using “caregiver electronic computing device” to perform the aforementioned steps amounts to no more than mere instructions to apply the exception using a generic computer component, which cannot provide an inventive concept. Under the 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity or well-known, routine, and conventional activity in Step 2A should be reevaluated in Step 2B. Here, the aforementioned step(s) “transmitting/receiving [data]” was/were considered to be extra-solution activity in Step 2A, and thus it is reevaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The background of the specification does not provide any indication that the additional element(s) is/are anything other than a generic, off-the-shelf computer component, and the Symantec, TLI, and OIP Techs. court decisions cited in MPEP 2106.05(d)(II) indicate that mere collection or receipt of data over a network is a well-understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here), and the Electric Power Group, LLC v. Alstom S.A., and Ameranth, court decisions cited in MPEP 2106.05(g) indicate that displaying data is a well-understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here). Further, the examiner takes OFFICIAL NOTICE that the aforementioned additional elements are well-known, routine and conventional activity. Accordingly, a conclusion that the aforementioned step(s) is/are well-understood, routine, conventional activity is supported under Berkheimer Option 2. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Thus, even when viewed as a whole, nothing in the claim adds significantly more (i.e., an inventive concept) to the abstract idea.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Babbitt et al., Behavioral assessment and treatment of pediatric feeding disorders. Developmental and Behavioral Pediatrics, 15, 278–291 (1994), hereafter Babbitt.
Regarding claims 1, 9, and 15, Babbitt discloses a method/system/medium for treating one or more feeding behaviors in a subject (Abstract), comprising the steps of:
screening a subject for one or more feeding behaviors (p. 280, col. 1: “The Feeding and Swallowing Program at KKI serves as a screening mechanism for potential inpatients.”);
assessing the subject to determine a particular intervention by comparing the one or more feeding behaviors observed during screening with one or more predefined rules (Assessment in pp. 280-283; p. 280: “At Kennedy Krieger Institute (KKI) our assessment process involves consideration of the child's feeding history as well as direct observations of the child and caregiver under multiple baseline conditions.”; p. 282: “the standard feeding baseline condition minimizes control by extraneous variables and provides a standard for comparison of data later collected during treatment to assess treatment efficacy”);
conducting the particular intervention, wherein the particular intervention comprises at least one meal session during which a feeder presents food to the subject and records intervention data (Treatment in p. 283: “Treatment usually begins with the least intrusive intervention available with additional treatment components introduced as necessary”; FIG. 2 illustrates recorded intervention; see also p. 281: “Consumption data are recorded as frequency counts of bites/drinks taken of each food/drink per minute, as these are typically discrete events with readily observable starting and ending points. Data for inappropriate behaviors, such as dawdling or negative vocalizations, are usually recorded using an interval sampling procedure, as their starting and ending points are often less clear. In this procedure, just the occurrence or nonoccurrence of each behavior is recorded during each minute.”); and
discharging the subject from care, if additional intervention is deemed not appropriate, wherein additional intervention is deemed not appropriate if the intervention data does not meet one or more predefined guidelines (p. 288: “A recent evaluation of our inpatient program yielded a number of findings. Of 40 children treated in the last 2 years, 15% were discharged home on a basic positive reinforcement protocol.”; p. 289: “Eighty-six percent of those children who were tube dependent at admission took all nutrition and hydration orally by time of discharge. One child had to be discharged prematurely due to medical complications.”).
Regarding claim 2, Babbitt further discloses that discharging the subject comprises the steps of: providing instructions related to the subject; conducting a generalized intervention based on the instructions; and determining a discharge plan based on the generalized intervention (see Programming Generalization in pp. 286-287; see also p. 282: “This interaction analysis is conducted both inside and outside of meals to assess the caregiver's skills using a specific treatment protocol, as well as general behavior management skills.”; see also p. 282: “After baseline data are collected, the next step is to plan and methodically carry out a treatment, while maintaining systematic measurement, such that functional relationships between treatment procedures and the child's behavior are demonstrated.”).
Regarding claim 3, Babbitt further discloses that assessing the subject comprises the steps of: determining an appropriate assessment type based on the screening; and conducting an observation based on the appropriate assessment type (pp. 280-281: “The KKI assessment protocol includes an initial medical assessment followed by behavioral assessment including a semistructured caregiver interview, standardized observations of behavior under baseline conditions, as well as functional consequence and food preference assessments.”).
Regarding claim 4, Babbitt further discloses determining if an additional assessment is appropriate based on the observation; and upon determining that the additional assessment is appropriate, conducting the additional assessment (p. 282: “This procedure is conducted for a number of pairs of foods within a food group. Foods not initially chosen are re-paired and the procedure is repeated. In the end, the therapist compiles a list of highly preferred foods (chosen on the first round), moderately preferred foods (chosen after being re-paired), and nonpreferred foods (not chosen). This procedure is then repeated for other food groups.”).
Regarding claim 5, Babbitt further discloses that the observation is completed by one or more practitioners (p. 280: “For the inpatient treatment the child receives services from an interdisciplinary team, consisting of Gastroenterology, Developmental Pediatrics, Behavioral Psychology, Nutrition, Social Work, and Occupational Therapy. Other disciplines such as Physical Therapy, Psychiatry, or Special Education participate as needed.”).
Regarding claim 6, Babbitt further discloses that the observation comprises a feeding session completed by a caregiver of the subject (p. 281: “These conditions include a home condition (in which the caregiver is instructed to feed as she or he would at home), and a prespecified, standard baseline procedure.”).
Regarding claim 7, Babbitt further discloses that the appropriate assessment type is based at least in part on a severity associated with the one or more feeding behaviors (Medical Assessment in p. 281: “The initial intention of a medical assessment is to determine if any underlying condition can be identified that might be amenable to therapeutic intervention.”; see also p. 281: “The standard baseline assessment is individually tailored for each child, depending primarily on whether the child is a self- or nonself-feeder.”).
Regarding claim 8, Babbitt further discloses that the screening comprises the steps of: transmitting an evaluation to a caregiver electronic computing device; receiving evaluation data from the caregiver electronic computing device, wherein the evaluation data is based on the evaluation; and determining that the one or more feeding behaviors are present in the subject (p. 281: “Finally, pre- and postmeal weights of foods and drinks (as well as bibs, napkins, and sometimes clothing) are taken. From all of this information, the number of grams of each food or drink consumed are calculated. The percentage of each portion consumed, the percentage of intervals for which each inappropriate behavior occurred. and the percentage of bites or drinks taken independently or with prompting can also be determined.”).
Regarding claim 10, Babbitt further discloses that conducting the particular intervention further comprises: performing a comparison of the intervention data to the one or more predefined rules; and modifying the one or more predefined rules based on the comparison (p. 283: “Positive reinforcement is usually first delivered immediately after every occurrence of the target behavior. Once a high, stable rate of behavior is achieved, the frequency of reinforcement may then be systematically decreased, such that high rates of behavior are maintained with little effort on the part of the person feeding the child (i.e., the feeder).”).
Regarding claim 11, Babbitt further discloses that the at least one meal session comprises an oral-motor session (p. 280: “treatment options consisted typically of medical or surgical management, or occupational therapy, which focused primarily on oral stimulation, fine motor skill development, and the use of adaptive equipment.”).
Regarding claim 12, Babbitt further discloses that the particular intervention comprises an inpatient intervention or an outpatient intervention (p. 279: “the basic assessment and treatment procedures used by a specialized pediatric inpatient program,”).
Regarding claim 13, Babbitt further discloses that the one or more feeding behaviors comprises food refusal or food selectivity (p. 278, Abstract, “food refusal”).
Regarding claim 14, Babbitt further discloses that the one or more feeding behaviors comprises choking, gagging, vomiting, difficulty swallowing, oral-motor deficiencies, or tantrums (p. 279: “Food avoidance in these cases may take various forms-fighting, crying, gagging, and/or vomiting.”).
Regarding claim 16, Babbitt further discloses that the intervention data comprises an acceptance response or a disruption response by the subject (p. 283: “Positive reinforcement for oral acceptance and consumption of food has been demonstrated as an effective treatment for food refusal in some children.”).
Regarding claim 17, Babbitt further discloses that acceptance response comprises at least half of a feeding utensil entering the subject’s mouth (p. 281: “For example, accepting a bite of food (accept) may be operationally defined as ''child's mouth open such that food enters within 5 seconds of presentation." The physical characteristics of the behavior described here are topography (mouth open), extensity (open sufficiently such that food may enter), and latency (within 5 seconds of presentation).”; p. 284 further suggests that using the utensil is also considered: “if a child refuses food by throwing[] his utensils”).
Regarding claim 18, Babbitt further discloses that the disruption response comprises the subject turning its head away, the subject pushing away a feeding utensil, or the subject pushing away the feeder’s hand (p. 284: ““if a child refuses food by throwing[] his utensils””).
Regarding claim 19, Babbitt further discloses that the food comprises a plurality of food items with a plurality of textures (p. 279: “food selectivity by type or texture”).
Regarding claim 20, Babbitt further discloses that the intervention data comprises an amount of the food consumed by the subject (p. 283: “amounts consumed roughly doubled in preference assessment sessions”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS J HONG whose telephone number is (571)272-0993. The examiner can normally be reached 9AM-5PM.
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, Peter Vasat can be reached at (571) 270-7625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THOMAS J. HONG
Primary Examiner
Art Unit 3715
/THOMAS J HONG/ Primary Examiner, Art Unit 3715