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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
130 as recited in paragraph [0098].
116 as recited in paragraph [0101].
203 as recited in paragraph [0102].
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
CSV in Figs. 3C, 3D, 3E, 3F, and 3H.
111 in Fig. 5C.
112 in Fig. 5C.
114 in Fig. 5D.
115 in Fig. 5D.
220 in Figs. 9A – 9B.
221 in Fig. 9A – 9B.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because of the following:
Within Fig. 4I the label for SCV labels what appears to be the superior vena cava but the reference indicia “SCV” refers to the subcutaneous void and/or passage.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
[0077] should be amended to recite “in some other embodiments, at least one portion there [[if]] is designed and configured for flexing”.
[0101] should be amended to recite “Port 100 may be configured such that distal portion 113 is uncovered by outer member [[20]] 110 which may extend distally and transversely therefrom”.
[0103] should be amended to recite “by moving first and second arms 208 and 209 along a first and second of routes 205, respectively.”
Appropriate correction is required.
Claim Objections
Claims 26 – 34 are objected to because of the following informalities:
Claims 26 – 34 each recite “A method according to.” The Examiner suggests amending this to recite “[[A]] The method according to” to provide proper antecedent basis for the preamble of each claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 33 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 33 recites the limitation "the vein." There is insufficient antecedent basis for this limitation in the claim.
Information Disclosure Statement
The information disclosure statement filed 3 October 2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the following information referred to therein has not been considered.
No copy of Non-Patent Literature Documents Final Office Action mailed on 7 May, 2024 in JP 2023-501349 (Attorney Ref.: PORTAL.005JP) and Non-Patent Literature Document Notice of Allowance mailed on 27 January, 2025 in JP 2023-501349 (Attorney Ref.: Portal. 005JP) have been provided.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
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 –
Claim(s) 25, 27, 29, 31, and 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Woo et al. (WO 2020/028847 A1) hereinafter referred to as “Woo”.
Woo is cited in the Information Disclosure Statement dated 6 January 2023.
With regards to claim 25, Woo discloses a method (see Fig. 6 and [0091] “In an exemplary method of use…”) comprising:
forming a surgical opening across skin layers in a subject (see [0091] “The clinician can then urge the placement tool subcutaneously, by using the blade 640 to form an incision”);
creating a subcutaneous void and/or passage beneath the skin layers via the surgical opening (see [0090] “In an embodiment each of the blades 640A, 640B can slide over each other in a scissor-like action as the finger loops are moved toward and apart from each other by the clinician” and [0091] “The clinician continues to urge the placement tool 600 subcutaneously to dissect the tissue and form a tissue pocket”);
clamping a port gripping portion (see [0089] “The port holder 610 is configured to receive a side portion of a port 30”) of a subcutaneous port (30) with a medical clamp (600) (see [0091] “A user can close the port holder 610 about the port 30 by moving the finger loops 618 toward each other until the latch 620 engages and locks the placement tool in a closed position.”) (Claim 25 is being examined under the broadest reasonable interpretation of the claim language where the forming, creating, and clamping steps are not recited in a specific order of performance of the steps of the method claim. This interpretation is supported by the claim language of Claim 26 which recites “creating or enlarging the subcutaneous void and/or passage with the medical clamp prior to the clamping” where the claim language of “prior” further limits the order of the forming, creating, and clamping steps of Claim 25 thereby suggesting that Claim 25 does not recite a particular order until Claim 26 introduces the order);
pushing the subcutaneous port with the medical clamp through the surgical opening and the subcutaneous void and/or passage to a target implantation site (see [0091] “The clinician can the urge the placement tool subcutaneously, by using the blade 640 to form an incision”);
releasing the medical clamp from the port gripping portion (see [0091] “When the port 30 is placed, the clinician can unlock the latch 620 and move the finger loops 618 apart to release the port 30.”); and
removing the medical clamp from the subcutaneous void and/or passage (see [0091] “The placement tool 600 can then be withdrawn.”).
With regards to claim 27, Woo discloses the method of claim 25, and Woo further discloses (see [0091] and Fig. 6) wherein the port gripping portion comprises a wall comprising opposing first and second outer wall surfaces (see [0089] “A distal end of the first and second arms 612, 614 each include a port holder 610, e.g. first and second port holder 610A, 610B. The port holder 610 is configured to receive a side portion of a port 30. In an embodiment, the port holder includes a curved loop shaped to receive a lobe of the port body although it will be appreciated that the shape of the port holder 610 can vary to fit different shaped ports.” Here, the first and second outer wall surfaces are the portions of the port 30 which the first and second port holder 610A, 610B engage with), wherein the clamping comprises interlocking manually operable arms (612, 614) of the medical clamp (600) so as to apply continuous grip against the first and second wall surfaces of the port gripping portion (see [0088] – [0090]).
With regards to claim 29, Woo discloses the method of claim 25, and Woo further discloses (see Fig. 2B) comprising inserting a first end of a catheter (50) (see Fig. 2B and left end of the catheter 50) to vasculature of the subject via the surgical opening (see [0060] “The catheter 50 can then engage the stem 230 to provide fluid communication between the reservoir 222 and the vasculature of the patient.”) and coupling a second end of the catheter (see Fig. 2B and the right end of the catheter 50) to the subcutaneous port (30) (see [0079] “It will be appreciated that port 30 can include any of the port embodiments 110, 210, 310 disclosed herein as well as other generic access ports” and see [0090] “It will be appreciated that port placement can be performed with or without a catheter 50 coupled to the port 30.”) to form fluid communication between a lumen of the catheter (see at 230 in Fig. 2B) and a cavity of the subcutaneous port (222) (see [0058]).
With regards to claim 31, Woo discloses the method of claim 29, and Woo further discloses (see Fig. 2B) wherein any access to the vasculature and/or across the skin layers of the subject after the forming is made directly through the surgical opening (see [0060] “The catheter 50 can then engage the stem 230 to provide fluid communication between the reservoir 222 and the vasculature of the patient,” [0079] “It will be appreciated that port 30 can include any of the port embodiments 110, 210, 310 disclosed herein as well as other generic access ports,” and [0090] “It will be appreciated that port placement can be performed with or without a catheter 50 coupled to the port 30.” Within the disclosure of Woo the only access to the vasculature and across the skin layers of the subject is recited to be made directly through the surgical opening).
With regards to claim 34, Woo discloses the method of claim 25, and Woo further discloses (see Fig. 6 and [0090]) wherein the medical clamp (600) (see [0088]) is configured as medical forceps (see [0088]) and/or selected from Kelly forceps, a surgical needle holder, and locking forceps (see [0088]).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 28, 30, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woo in view of Pardo et al. (NPL Central Venous Port Placement: A Comparison of Axillary Versus Anterior Chest Wall Placement) hereinafter referred to as NPL Pardo.
With regards to claim 28, Woo discloses the claimed invention of claim 25, however, Woo is silent with regards to forming the surgical opening at an axilla of the subject.
Nonetheless NPL Pardo, which is within the analogous art of central venous port placement (see title), teaches forming the surgical opening at an axilla of the subject (see Fig. 1 and the Results and Conclusions sections on page 468).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the forming step of the method of Woo in view of a teaching of NPL Pardo such that forming the surgical opening at an axilla of the subject. One of ordinary skill in the art would have been motivated to make this modification because NPL Pardo teaches that forming the surgical opening at an axilla of the subject spares the patient the negative cosmetic outcomes of chest wall ports (see the Conclusion section on page 468).
With regards to claim 30, Woo discloses the claimed invention of claim 29, however, Woo is silent with regards to wherein the first end of the catheter is inserted to the vasculature via axillary vein or jugular vein of the subject.
Nonetheless NPL Pardo, which is within the analogous art of central venous port placement (see title), teaches the first end of the catheter is inserted to the vasculature via axillary vein or jugular vein of the subject (see Results section on page 468 and middle paragraph on the second column of page 468).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the first end of the catheter of the method of Woo in view of a teaching of NPL Pardo such that the first end of the catheter is inserted to the vasculature via axillary vein or jugular vein of the subject. One of ordinary skill in the art would have been motivated to make this modification because NPL Pardo teaches that forming the surgical opening at an axilla of the subject spares the patient the negative cosmetic outcomes of chest wall ports while allowing for catheters to be placed in the jugular vein for administration of chemotherapy medications (see the Methods, Results, and Conclusion sections on page 468).
With regards to claim 33, Woo discloses the claimed invention of claim 25, however, Woo is silent with regards to wherein the vein is an axillary vein or a jugular vein.
Nonetheless NPL Pardo, which is within the analogous art of central venous port placement (see title), teaches wherein the vein is an axillary vein or a jugular vein (see Results section on page 468 and middle paragraph on the second column of page 468).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the vein in which the catheter is inserted into of the method of Woo in view of a teaching of NPL Pardo such that the vein is an axillary vein or a jugular vein. One of ordinary skill in the art would have been motivated to make this modification because NPL Pardo teaches that forming the surgical opening at an axilla of the subject spares the patient the negative cosmetic outcomes of chest wall ports while allowing for catheters to be placed in the jugular vein for administration of chemotherapy medications (see the Methods, Results, and Conclusion sections on page 468).
Claim(s) 25 – 27, 29, 32, and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Withoon Ungkitphaiboon (NPL Screen Captures from YouTube video entitled "Port A Cath Implantation,” Uploaded on 25 February 2014, Retrieved from Internet: <https://www.youtube.com/watch?v=FqYJC1J6qks>).
Withoon Ungkitphaiboon will hereinafter be referred to as “Withoon.”
Harders et al. will hereinafter be referred to as “Withoon.”
With regards to claim 25, Withoon discloses a method (see screenshot #1 of YouTube video below) comprising:
forming a surgical opening across skin layers in a subject (see screenshot #2 of the YouTube video below);
creating a subcutaneous void and/or passage beneath the skin layers via the surgical opening (see screenshot #2 of the YouTube video below);
pushing the subcutaneous port with the medical clamp through the surgical opening and the subcutaneous void and/or passage to a target implantation site (see screenshot #4 of the YouTube video below).
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However, the method of the Withoon is silent with regards to clamping a port gripping portion of a subcutaneous port with a medical clamp,
releasing the medical clamp from the port gripping portion; and
removing the medical clamp from the subcutaneous void and/or passage.
Nonetheless Harders, which is within the analogous art of implantable injection ports (see abstract and title), teaches clamping a port gripping portion of a subcutaneous port with a medical clamp (see [0037] “For example, a doctor's thumb and/or fingers may be utilized to implant the injection port. Standard forceps or hemostats may also be used” and [0049] “outside of the base 130 and/or the shell 133 may be textured to provide a better gripping surface for the physician”),
releasing the medical clamp from the port gripping portion (see [0049] – [0051] where a person of ordinary skill in the art would recognize that the medical clamp/forceps is released once the port 110 is placed); and
removing the medical clamp from the subcutaneous void and/or passage (see [0049] – [0052] wherein a person of ordinary skill in the art would recognize that the medical clamp/forceps is removed from the subcutaneous void/and or passage until the forcep is reinserted to remove the port 110) .
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Withoon in view of a teaching of Harders such that the port is not inserted using the clamping by the hands of the clinician but rather using a forceps as taught by Harders. One of ordinary skill in the art would have been motivated to make this modification because Harders teaches that it is well known to use forceps or hemostats to implant an injection port (see [0037] of Harders). A person of ordinary skill in the art would also have been motivated to make this modification because forceps or hemostats reduce or prevent the port from slipping from the clinician’s fingers such as when the clinician’s fingers have blood or other fluids on them.
The method of Withoon modified in view of Harders will hereinafter be referred to as the method of Withoon and Harders.
Young et al. will hereinafter be referred to as “Young.”
With regards to claim 26, the method of Withoon and Harders teaches the claimed invention of claim 25, and the method of Withoon and Harders further teaches creating or enlarging the subcutaneous void and/or passage with the medical clamp prior to the clamping (see Screenshot #3 above of the Withoon YouTube video) (Here, Withoon teaches the creating or enlarging of the subcutaneous void and/or passage with forceps prior to clamping the port with the hands of the clinician. Withoon modified in view of Harders teaches using forceps to insert the port rather than the clinician’s hands. Therefore, the method of Withoon and Harders teaches creating or enlarging the subcutaneous void and/or passage with the medical clamp prior to the clamping of the medical port.).
With regards to claim 27, the method of Withoon and Harders teaches the claimed invention of claim 25, and Withoon is silent with regards to wherein the port gripping portion comprises a wall comprising opposing first and second outer wall surfaces, wherein the clamping comprises interlocking manually operable arms of the medical clamp so as to apply continuous grip against the first and second wall surfaces of the port gripping portion.
Nonetheless Harders, which is within the analogous art of implantable injection ports (see abstract and title), teaches the port gripping portion comprises a wall comprising opposing first and second outer wall surfaces (see [0049] “In various embodiments, the outside of the base 130 and/or the shell 133 may be textured to provide a better gripping surface for the physician.”), wherein the clamping comprises interlocking manually operable arms of the medical clamp so as to apply continuous grip against the first and second wall surfaces of the port gripping portion (see [0037] and [0049]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the port of the method of Withoon and Harders in view of a further teaching of Harders such that the port gripping portion comprises a wall comprising opposing first and second outer wall surfaces, wherein the clamping comprises interlocking manually operable arms of the medical clamp so as to apply continuous grip against the first and second wall surfaces of the port gripping portion. One of ordinary skill in the art would have been motivated to make this modification because Harders teaches that it is well known to use forceps or hemostats to implant an injection port (see [0037] of Harders). A person of ordinary skill in the art would also have been motivated to make this modification because forceps or hemostats reduce or prevent the port from slipping from the clinician’s fingers such as when the clinician’s fingers have blood or other fluids on them.
With regards to claim 29, the method of Withoon and Harders teaches the claimed invention of claim 25, and Withoon further teaches the method further comprising inserting a first end of a catheter to vasculature of the subject via the surgical opening (see screenshot #9 of the YouTube video below) and coupling a second end of the catheter to the subcutaneous port to form fluid communication between a lumen of the catheter and a cavity of the subcutaneous port (see screenshot #10 of the YouTube video below).
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With regards to claim 32, the method of Withoon and Harders teaches the claimed invention of claim 25, and Withoon further teaches the method further comprising at least one of: accessing into a vein of the subject with an access needle, inserting a wire into the vein through the access needle (see Screenshot #5 of the YouTube video below and at timestamp 0:10 which states “Puncture Rt. Internal jugular vein and insert Guidewire”), removing the access needle from the vein (see at timestamp 0:14 where the access needle is removed), inserting a peel apart sheath (see at screenshot #7) and/or a dilator into the vein over the wire (see at screenshot #6 of the YouTube video below), removing the wire and/or the dilator from the vein (see at timestamp 8:14), inserting a first end of a catheter into the vein through the peel apart sheath (see at timestamp 9:05), and removing the peel apart sheath from the vein (see at Screenshot #8 below).
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With regards to claim 34, the method of Withoon and Harders teaches the claimed invention of claim 25, however, Withoon is silent with regards to the medical clamp is configured as medical forceps and/or selected from Kelly forceps, a surgical needle holder, and locking forceps.
Nonetheless Harders, which is within the analogous art of implantable injection ports (see abstract and title), teaches the medical clamp is configured as medical forceps and/or selected from Kelly forceps, a surgical needle holder, and locking forceps (see [0037] “Standard forceps or hemostats”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the medical clamp of the method of Withoon and Harders in view of a further teaching of Harders such that the medical clamp is configured as medical forceps and/or selected from Kelly forceps, a surgical needle holder, and locking forceps. One of ordinary skill in the art would have been motivated to make this modification because Harders teaches that it is well known to use forceps or hemostats to implant an injection port (see [0037] of Harders). A person of ordinary skill in the art would also have been motivated to make this modification because forceps or hemostats reduce or prevent the port from slipping from the clinician’s fingers such as when the clinician’s fingers have blood or other fluids on them.
Claim(s) 28, 30, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Withoon and Harders as applied to claim 25 above, and in further view of NPL Pardo.
With regards to claim 28, the method of Withoon and Harders teaches the claimed invention of claim 25, however, Withoon is silent with regards to forming the surgical opening at an axilla of the subject.
Nonetheless NPL Pardo, which is within the analogous art of central venous port placement (see title), teaches forming the surgical opening at an axilla of the subject (see Fig. 1 and the Results and Conclusions sections on page 468).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the forming step of the method of Withoon and Harders in view of a teaching of NPL Pardo such that forming the surgical opening at an axilla of the subject. One of ordinary skill in the art would have been motivated to make this modification because NPL Pardo teaches that forming the surgical opening at an axilla of the subject spares the patient the negative cosmetic outcomes of chest wall ports (see the Conclusion section on page 468).
With regards to claim 30, the method of Withoon and Harders teaches the claimed invention of claim 29, however, Withoon is silent with regards to wherein the first end of the catheter is inserted to the vasculature via axillary vein or jugular vein of the subject.
Nonetheless NPL Pardo, which is within the analogous art of central venous port placement (see title), teaches the first end of the catheter is inserted to the vasculature via axillary vein or jugular vein of the subject (see Results section on page 468 and middle paragraph on the second column of page 468).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the first end of the catheter of the method of Woo and Harders in view of a teaching of NPL Pardo such that the first end of the catheter is inserted to the vasculature via axillary vein or jugular vein of the subject. One of ordinary skill in the art would have been motivated to make this modification because NPL Pardo teaches that forming the surgical opening at an axilla of the subject spares the patient the negative cosmetic outcomes of chest wall ports while allowing for catheters to be placed in the jugular vein for administration of chemotherapy medications (see the Methods, Results, and Conclusion sections on page 468).
With regards to claim 33, the method of Withoon and Harders teaches the claimed invention of claim 25, however, Withoon is silent with regards to wherein the vein is an axillary vein or a jugular vein.
Nonetheless NPL Pardo, which is within the analogous art of central venous port placement (see title), teaches wherein the vein is an axillary vein or a jugular vein (see Results section on page 468 and middle paragraph on the second column of page 468).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the vein in which the catheter is inserted into of the method of Woo and Harders in view of a teaching of NPL Pardo such that the vein is an axillary vein or a jugular vein. One of ordinary skill in the art would have been motivated to make this modification because NPL Pardo teaches that forming the surgical opening at an axilla of the subject spares the patient the negative cosmetic outcomes of chest wall ports while allowing for catheters to be placed in the jugular vein for administration of chemotherapy medications (see the Methods, Results, and Conclusion sections on page 468).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
11/03/2025