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 .
Response to Amendment
The amendments made to claims 1 and 6-9 in the response filed on 9/23/2025 are acknowledged. Claims 1-16 are still pending in the application and are examined below.
Response to Arguments
Applicant's arguments, see page 8, filed 9/23/2025, with respect to the objections of claims 5 1 and 7-8 have been fully considered and are persuasive. Therefore, the objections have been withdrawn.
Applicant’s arguments, see pages 8-9, filed on 9/23/2025, with respect to the rejection of claims 1-5 under 35 U.S.C 101 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Applicant’s arguments, see pages 9-10, filed on 9/23/2025, with respect to the rejection of claim 1, 3-8, and 12-16 under 35 U.S.C 103 have been fully considered and are persuasive. However, upon further consideration, a new ground of rejection was made in view of Francis (US 20110065360 A1) in view of Quintero (US 20190298616 A1) to meet the newly added limitations of claim 1. Please see below of how Quintero still applies to the rejection.
Although Quintero does not suggest a nipple shield but rather teaches a baby bottle, the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem). Both the instant application and the nipple of the baby bottle of Quintero have a common goal of infant nourishment and care. Therefore, Quintero can still be used as a teaching for the 35 U.S.C 103 rejection.
Applicant’s arguments, see pages 10, filed on 9/23/2025, with respect to the rejection of claims 2 and 10-11 under 35 U.S.C 103 have been fully considered but are moot due to the new ground of rejection in independent claims 1 and 6.
Applicant’s arguments, see pages 11, filed on 9/23/2025, with respect to the rejection of claim 9 under 35 U.S.C 103 have been fully considered but are moot due to the new ground of rejection in independent claim 6.
Claim Objections
Claim 15 objected to because of the following informalities: “The nipple shield of any claim 6” should be “The nipple shield of claim 6” in line 1. Appropriate correction is required.
Claim 16 objected to because of the following informalities: “The nipple shield of any claim 6” should be “The nipple shield of claim 6” in line 1. Appropriate correction is required.
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.
Claims 1, 4, 6, and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Francis (US 20110065360 A1) in view of Quintero (US 20190298616 A1).
Regarding claim 1, Francis discloses a nipple shield (100 – figure 1, a nipple shield: paragraph 0022) for covering a nipple and surrounding area of a breast during breastfeeding (the nipple shield [100] shields a nipple and portion of a breast during breastfeeding: paragraph 0022), the nipple shield (100) comprising: a flexible, thin, single-layer barrier having a shape (110/120 – figure 1, the nipple shield [100] comprises a base portion [110] and nipple portion [120]; the nipple shield [100] is made of a thin, pliant material such as silicone rubber: paragraph 0022-0023) configured to conform with the nipple and surrounding area of a person breastfeeding (figure 8, the nipple shield [100] conforms with the nipple and surround area of a person breastfeeding: paragraph 0033), the barrier (110/120) comprising: a cone portion (120 – figure 1, the nipple portion: paragraph 0028) having a first end region (170 – figure 1, a flat end wall: paragraph 0028) and a second end region (150 – figure 1, first transition portion: paragraph 0028) opposite the first end region (170) (figure 1, the second end region [150] is opposite of the first end region [170]), the first end region of the cone portion (170) comprising multiple extraction holes (180 – figure 1, a plurality of openings that allows milk to flow through: paragraph 0028) extending through the first end region of the cone portion (170) to allow an infant to extract milk during breastfeeding (the multiple extraction holes [180] allows milk to pass through and to enter the baby’s mouth: paragraph 0028); and a base portion (110 – figure 1, a generally dome-shaped to cup to receive the mother’s breast: paragraph 0025) extending radially outwardly from the second end region (150) and surrounding the cone portion (120) (figure 1, the base portion [110] extends radially outwardly from the second end region [150] and surrounds the cone portion [120]).
However, Francis fails to disclose wherein at least a portion of the barrier comprises a thermochromic material configured to change visibility of the barrier at a threshold temperature such that— the thermochromic material is transparent when a temperature of the barrier is at or above a threshold temperature, wherein the threshold temperature is above 20°C and below 36.7°C to allow visibility to the nipple through the cone portion while breastfeeding; and the thermochromic material is at least partially opaque and has a visible color when the temperature of the barrier is below the threshold temperature to allow locating the nipple shield when not used for breastfeeding.
Quintero teaches wherein at least a portion of an analogous barrier (103/105/106/107 – figure 1, a nipple shaped as a natural-shaped nipple [103] comprising of a nipple tip [105], nipple neck [106], and nipple base [107]: paragraph 0068) comprises a thermochromic material (the barrier [103/105/106/107] comprise a thermochromic material: paragraph 0038/0070) configured to change visibility of the barrier at a threshold temperature such that— the thermochromic material is transparent when a temperature of the analogous barrier (103/105/106/107) is at or above a threshold temperature, wherein the threshold temperature is above 20°C and below 36.7°C to allow visibility to the nipple through an analogous cone portion (105 – figure 1, nipple tip: paragraph 0068) while breastfeeding (the thermochromic material can become transparent when heating to 80°F, which is capable of allowing visibility to the nipple through the cone portion [105] while breastfeeding: paragraph 0034-0038); and the thermochromic material is at least partially opaque and has a visible color when the temperature of the barrier is below the threshold temperature to allow locating the nipple shield when not used for breastfeeding (the thermochromic material can change to an opaque visible color state below the threshold temperature [for example, temperature of ambient air, before the barrier {103/105/106/107} entering the infant’s mouth, or before user heating the thermochromic material to 80°F], which allows the capability of locating the nipple shield when not used for breastfeeding: paragraph 0034-0038).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the barrier of Francis with a thermochromic material as taught by Quintero in order to provide a nipple shield that has an improved barrier to provide a visual indication of a change in one or more temperature conditions to the user (paragraph 0034-0038, Quintero).
Regarding claim 4, Francis in view of Quintero discloses invention as discussed in claim 1. Francis further discloses wherein the base portion (110) comprises an irregular peripheral edge (130 – figure 1, a semicircular cutout: paragraph 0026) (figure 1, the base portion [110] comprises an irregular peripheral edge [130]; the term “irregular” is defined as “lacking perfect symmetry or evenness” by https://www.merriam-webster.com/dictionary/irregular; the peripheral edge of the base portion [25] is not even).
Regarding claim 6, Francis discloses a nipple shield (100 – figure 1, a nipple shield: paragraph 0022) for covering a nipple and surrounding of a breast area during breastfeeding (the nipple shield [100] shields a nipple and portion of a breast during breastfeeding: paragraph 0022), the nipple shield (100) comprising: a flexible, thin, single-layer barrier (110/120 – figure 1, the nipple shield [100] comprises a base portion [110] and nipple portion [120]; the nipple shield [100] is made of a thin, pliant material such as silicone rubber: paragraph 0022-0023) comprising: a cone portion (120 – figure 1, the nipple portion: paragraph 0028) having a first end region (170 – figure 1, a flat end wall: paragraph 0028) and a second end region (150 – figure 1, first transition portion: paragraph 0028) spaced apart from the first end region (170) (figure 1, the second end region [150] is opposite of the first end region [170]), the first end region of the cone portion (170) having plurality of extraction holes (180 – figure 1, a plurality of openings that allows milk to flow through: paragraph 0028) extending therethrough (the multiple extraction holes [180] allows milk to pass through and to enter the baby’s mouth: paragraph 0028); and a base portion (110 – figure 1, a generally dome-shaped to cup to receive the mother’s breast: paragraph 0025) surrounding the cone portion (120) and extending radially outwardly from the second end region of the cone portion (150) (figure 1, the base portion [110] extends radially outwardly from the second end region [150] and surrounds the cone portion [120]).
However, Francis fails to disclose wherein the cone portion and the base portion comprise a thermochromic material, and wherein— the thermochromic material has a visible color when a temperature of the nipple shield is below a threshold temperature, and the thermochromic material is transparent when the temperature of the nipple shield is at or above the threshold temperature.
Quintero teaches wherein an analogous cone portion (105 – figure 1, nipple tip: paragraph 0068) and an analogous base portion (106/107 – figure 1, a nipple neck [106] and nipple base [107]: paragraph 0068) comprise a thermochromic material (the cone portion [105] and base portion [106/107] comprises a thermochromic material: paragraph 0038/0070), and wherein— the thermochromic material has a visible color when a temperature of an analogous nipple shield is below a threshold temperature (the thermochromic material can change to an opaque visible color state of the nipple shield [comprising the cone {105} and base portion {106/107}] below the threshold temperature [for example, temperature of ambient air, before the cone {105} and base portion {106/107} entering the infant’s mouth, or before user heating the thermochromic material to 80°F]: paragraph 0034-0038), and the thermochromic material is transparent when the temperature of an analogous nipple shield is at or above the threshold temperature (the thermochromic material of the nipple shield [comprising the cone {105} and base portion {106/107}] can become transparent when heating to 80°F [26.667°C]: paragraph 0034-0038).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the barrier of Francis with a thermochromic material as taught by Quintero in order to provide a nipple shield that has an improved barrier to provide a visual indication of a change in one or more temperature conditions to the user (paragraph 0034-0038, Quintero).
Regarding claim 12, Francis in view of Quintero discloses invention as discussed in claim 6. Quintero further teaches wherein, when the thermochromic material is below the threshold temperature, the visible color of the thermochromic material is at least partially opaque (the thermochromic material can change to an opaque visible color state below the threshold temperature [for example, temperature of ambient air, before the cone {105} and base portion {106/107} entering the infant’s mouth, or before user heating the thermochromic material to 80°F]: paragraph 0034-0038).
Regarding claim 13, Francis in view of Quintero discloses invention as discussed in claim 6. Francis further discloses wherein the nipple shield (100) comprises a silicone material (the nipple shield is made from a silicone material: paragraph 0023). Quintero further teaches the thermochromic material comprises a thermochromic dye embedded throughout the silicone material (the thermochromic material [which can be thermochromic leuco dues] can be disposed within the nipple shield [105/106/107] that is made of silicone material: paragraph 0016/0041/0069/0072).
Regarding claim 14, Francis in view of Quintero discloses the invention as discussed in claim 6.
However, Francis in view of Quintero fails to explicitly disclose wherein the threshold temperature is 35 °C or above.
Quintero teaches wherein the threshold temperature is 80°F [26.667°C].
It would have been prima facie obvious to one of ordinary skills in the art before the filing date to have modified the threshold temperature from 80°F [26.667°C] to 35 °C or above to offer precise color changes for a bigger range of temperatures (paragraph 0047-0048, Quintero) even though the claimed ranges or amounts do not overlap with the prior art (please see MPEP 2144.05 I., “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)”). Further, applicant places no criticality on the range claimed, indicating simply that the threshold temperature “in some embodiments” can be within the claimed ranges (written specification: paragraph 0028).
Regarding claim 15, Francis in view of Quintero discloses the invention as discussed in claim 6. Quintero further teaches wherein the threshold temperature is at or above 26°C (the thermochromic material of the nipple shield [comprising the cone {105} and base portion {106/107}] becomes transparent when heating to 80°F [26.667°C]: paragraph 0034-0038).
Regarding claim 16, Francis in view of Quintero discloses the invention as discussed in claim 6. Quintero further teaches wherein the visible color of the analogous nipple shield (comprising the cone {105} and base portion {106/107}), which is visible when the temperature of the analogous nipple shield (105/106/107) is below the threshold temperature, is indicative of a predefined size of the analogous nipple shield (105/106/107) (the thermochromic material can change to an opaque visible color state below the threshold temperature [for example, temperature of ambient air, before the cone {105} and base portion {106/107} entering the infant’s mouth, or before user heating the thermochromic material to 80°F], which allows the capability of locating a predefined size of the nipple shield: paragraph 0034-0038).
Claims 2 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Francis (US 20110065360 A1) in view of Quintero (US 20190298616 A1) and in further view of Rohrig (US 20060157065 A1).
Regarding claim 2, Francis in view of Quintero discloses the invention as discussed in claim 1. Francis further discloses wherein the barrier (110) has an outer surface (A – see annotated figure 1, outer surface) configured to face away from the breast (see annotated figure 1/figure 8, the outer surface [A] faces away from the breast: paragraph 0033).
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Annotated figure 1: nipple shield of Francis et al.
However, Francis in view of Quintero fails to disclose and wherein the outer surface has a texture that replicates human skin.
Rohrig teaches wherein an analogous outer surface (B – see annotated figure 2, an outer surface) has a texture (8 – figure 2, protruding knobs: paragraph 0024) that replicates human skin (the texture [8] is formed with a texture similar to a mother’s natural nipple; additionally, the outer surface [B] roughness is different: paragraph 0010-0012).
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Annotated figure 2: shield of Rohrig
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided outer surface of Francis in view of Quintero with a texture that replicates human skin as taught by Rohrig in order to provide a nipple shield that has an improved outer surface to provide a pleasant feeling for the infant when the texture comes into contact with an infant’s lips or cheeks (paragraph 0010-0012, Rohrig).
Regarding claim 10, Francis in view of Quintero discloses the invention as discussed in claim 6. Francis further discloses wherein the nipple shield (100) has: a first surface (D – see annotated figure 3, first surface) configured to be at least partially in contact with the nipple and the surrounding area during breastfeeding (see annotated figure 3/figure 8, the first surface [D] contacts the nipple and the surround area during breastfeeding: paragraph 0033); and a second surface (E – see annotated figure 3, a second surface) opposite to the first surface (D) (see annotated figure 3, the second surface [E] is opposite to the first surface [D]) and configured to face away from the breast during breastfeeding (see annotated figure 3/figure 8, the first surfaces faces away from the breast: paragraph 0033).
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Annotated figure 3: cross section view of the nipple shield of Francis
However, Francis in view of Quintero fails to disclose wherein the second surface has a first texture configured to replicate human skin.
Rohrig teaches wherein an analogous second surface (F – see annotated figure 4, an outer surface) has a first texture (8 – figure 2, protruding knobs: paragraph 0024) configured to replicate human skin (the texture [8] is formed with a texture similar to a mother’s natural nipple; additionally, the second surface’s [H] roughness is different: paragraph 0010-0012).
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Annotated figure 4: first and second surface of Rohrig
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the second surface of Francis in view of Quintero with a first texture configured to replicate human skin as taught by Rohrig in order to provide a nipple shield that has an improved second surface to provide a pleasant feeling for the infant when the texture comes into contact with an infant’s lips or cheeks (paragraph 0010-0012, Rohrig).
Regarding claim 11, Francis in view of Quintero and in further view of Rohrig discloses the invention as discussed in claim 10. Rohrig further teaches wherein an analogous first surface (G – see annotated figure 4, a first surface) has a second texture that is different from the first texture (8) (the first surface [G] does not have the first texture [protruding knobs]: paragraph 0012).
Claims 3, 5, and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Francis (US 20110065360 A1) in view of Quintero (US 20190298616 A1) and in further view of Yu et al. (CN 203089469 U).
Regarding claim 3, Francis in view of Quintero discloses invention as discussed in claim 1.
However, Francis in view of Quintero fails to disclose wherein the base portion comprises a plurality of ventilation openings extending completely through the barrier.
Yu et al. teaches wherein an analogous base portion (1 – figure 1, a nipple patch: detailed description) comprises a plurality of ventilation openings (3 – figure 1, air holes: detailed description) extending completely through an analogous barrier (figure 1, nipple patch and shield) (figure 3, the plurality of ventilation openings [3] extends completely through the base portion [1] of the barrier [figure 1]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the base portion of Francis in view of Quintero with a plurality of ventilation openings as taught by Yu et al. in order to provide a nipple shield that has an improved base portion to ensure air permeability (breathability) while using the device and promote comfort for the patient (detailed description, Yu et al.).
Regarding claim 5, Francis in view of Quintero discloses invention as discussed in claim 1.
However, Francis in view of Quintero fails to disclose wherein the base portion comprises a plurality of ventilation openings radiating outwardly from the second end region, wherein the plurality of ventilation openings extend circumferentially around the cone portion.
Yu teaches wherein an analogous base portion (1 – figure 1, a nipple patch: detailed description) comprises a plurality of ventilation openings (3 – figure 1, air holes: detailed description) radiating outwardly from an analogous second end region (C – see annotated figure 5, second end region of the cone portion) (see annotated figure 5/figure 3, the plurality of ventilations openings [3] are radiating outwardly from the second end region [A]), wherein the plurality of ventilation openings (3) extend circumferentially around an analogous cone portion (2 – figure 1/ figure 2, a cylindrical shield: detailed description) (figure 1/figure 3, the plurality of ventilation openings [3] extend circumferentially around the cone portion [2]).
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Annotated figure 5: nipple shield of Yu et al.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the base portion of Francis in view of Quintero with a plurality of ventilation openings that radiates outwardly from the second region and extend circumferentially around the cone portion as taught by Yu et al. in order to provide a nipple shield that has an improved base portion to ensure air permeability (breathability) while using the device and promote comfort for the patient (detailed description, Yu et al.).
Regarding claim 7, Francis in view of Quintero discloses invention as discussed in claim 6.
However, Francis in view of Quintero fails to disclose wherein the base portion defines multiple ventilation openings extending completely therethrough, the multiple ventilation openings positioned to surround the cone portion from all sides of the cone portion.
Yu teaches wherein an analogous base portion (1 – figure 1, a nipple patch: detailed description) defines multiple ventilation openings (3 – figure 1, air holes: detailed description) extending completely therethrough (figure 3, the plurality of ventilation openings [3] extends completely through the base portion [1]), the multiple ventilation openings (3) positioned to surround an analogous cone portion (2 – figure 1/figure 2, a cylindrical shield: detailed description) from all sides of the analogous cone portion (2) (figure 1/figure 3, the plurality of ventilation openings [3] surrounds the cone portion [2] from all sides).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the base portion of Francis in view of Quintero with multiple ventilation openings that surrounds the cone portion from all sides as taught by Yu et al. in order to provide a nipple shield that has an improved base portion to ensure air permeability (breathability) while using the device and promote comfort for the patient (detailed description, Yu et al.).
Regarding claim 8, Francis in view of Quintero and in further view of Yu et al. discloses invention as discussed in claim 7.
However, Francis in view of Quintero and in further view of Yu et al. fails to explicitly disclose wherein the multiple ventilation openings have a petal or oval shape; and the multiple ventilation openings are arranged in a circular configuration around the cone portion.
Yu et al. teaches wherein the multiple ventilation openings (3) have a circular shape (the multiple ventilation openings [3] have a circular shape: detailed description).
It would have been an obvious matter of design choice to make the ventilation openings of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Further, applicant places no criticality on shape claimed, indicating simply that the shape “in some embodiments” and “in these and other embodiments” can be circular, oval, polygonal, freeform shapes, petals, and/or combinations thereof (written specification: paragraph 0023/0044).
However, Francis in view of Quintero and in further view of Yu et al. fails to explicitly disclose the multiple ventilation openings are arranged in a circular configuration around the cone portion.
Yu teaches the multiple ventilation openings (3) are arranged in a configuration around the analogous cone portion (2) (figure 3, the multiple ventilation openings [3] are arranged in a configuration around the cone portion [2]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention was made to arrange the multiple ventilation openings in a circular configuration around the cone portion to promote breathability and comfort for the user (detailed description, Yu et al.), since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Further, applicant places no criticality on the circular configuration, indicating simply that the ventilation openings can be arranged in a circular configuration, symmetrical manner, or asymmetrically positioned with respect to the cone portion (written specification: paragraph 0023/0044).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Francis (US 20110065360 A1) in view of Quintero (US 20190298616 A1) and in further view of Rigert et al. (US 20180028733 A1).
Regarding claim 9, Francis in view of Quintero discloses the invention as discussed in claim 6.
However, Francis in view of Quintero fails to explicitly disclose wherein the base portion comprises a peripheral edge with a wave-shaped pattern.
Rigert et al. teaches wherein an analogous base portion (11 – figure 11/figure 12, a funnel: paragraph 0057) comprises a peripheral edge (12 – figure 11/figure 12, a lay-on edge: paragraph 0058/0060) with a wave-shaped pattern (figure 11/figure 12, the peripheral edge [12] is a wave-shaped pattern: paragraph 0060).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the base portion of Francis in view of Quintero with a peripheral edge that has a wave-shaped pattern as taught by Rigert et al. in order to provide a nipple shield that has an improved base portion to allow the base portion to comfortably abut flatly against the mother’s breast and provide optimal sealing: paragraph 0026/0061).
Conclusion
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 ANDREW JUN-WAI MOK whose telephone number is (703)756-4605. The examiner can normally be reached 8am-4pm.
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/ANDREW JUN-WAI MOK/Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786