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
This Office Action is in response to the Applicant’s amendment filed 5 May 2026 wherein Claims 25 – 34 are amended, no claims are newly added, and no claims are cancelled. Therefore Claims 25 – 34 are pending.
The Applicant’s amendments to the Drawings and Specification dated 5 May 2026 have been fully considered. These amendments have overcome each Drawing and Specification Objection set forth in the Non-Final Rejection dated 5 November 2025 (hereinafter referred to as the “Non-Final Rejection”). Therefore, each Drawing and Specification Objection set forth in the Non-Final Rejection is withdrawn.
The Applicant’s amendments to the Claims dated 5 May 2026 has been fully considered. These amendments have overcome each Claim Objection and Claim Rejection under 35 U.S.C. § 112(b) set forth in the Non-Final Rejection. Therefore, each Claim Objection and Claim Rejection under 35 U.S.C. § 112(b) set forth in the Non-Final Rejection is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 9 – 10, filed 5 May 2026, with respect to the rejection(s) of independent claim(s) 25 under 35 U.S.C. §§ 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 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) in view of Woo et al. (WO 2020/028847 A1) and Harders et al. (US 2011/0196394 A1).
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.
Claims 25 – 34 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 25 recites the limitation " the medical clamp." There is insufficient antecedent basis for this limitation in the claim.
Claims 26 – 34 are rejected under 35 U.S.C. § 112(b) based on their dependency on Claim 24.
Claim 27 recites the limitation "the first and second wall surfaces of the port gripping portion.” There is insufficient antecedent basis for this limitation in the claim.
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) 25, 26, 29, 31, 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) (hereinafter referred to as “Withoon”) in view of Woo et al. (WO 2020/028847 A1) (hereinafter referred to as “Woo”) and Harders et al. (US 2011/0196394 A1) (hereinafter referred to as “Harders”).
Withoon, Woo, and Harders are each cited in the Notice of References Cited form dated 5 November 2025.
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 #3 of the YouTube video below).
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However Withoon is silent with regards to the following steps of the method:
clamping a wall comprising first and second substantially flat and parallel outer wall surfaces located adjacent to a catheter connector on a proximal portion of a subcutaneous port between substantially straight parallel distal tips of medical forceps;
pushing the subcutaneous port with the medical clamp through the surgical opening and the subcutaneous void and/or passage to a target implantation site;
releasing the distal tips of the medical forceps from the wall; and
removing the medical forceps from the subcutaneous void and/or passage.
Nonetheless Woo, which is within the analogous art of implantable port placement systems (see abstract and title), teaches clamping a wall (154) (see [0057]) comprising first and second substantially flat and parallel outer wall surfaces (see Fig. 1A where the first and second substantially flat and parallel outer wall surfaces are either side of the protrusion 154) located adjacent to a catheter connector (130) (see [0057]) on a proximal portion (see at 110 in Fig. 1C) of a subcutaneous port (110) (see [0048]) by a placement tool (700) (see [0092], [0093], and [0094]);
pushing the subcutaneous port with the placement tool through the surgical opening and the subcutaneous void and/or passage to a target implantation site (see [0013], [0014], and [0094]);
releasing the placement tool (see [0013], [0014], and [0094]); and
removing the placement tool from the subcutaneous void and/or passage (see [0013], [0014], and [0094]).
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 Woo such that the method further comprises clamping a wall comprising first and second substantially flat and parallel outer wall surfaces located adjacent to a catheter connector on a proximal portion of a subcutaneous port by a placement tool; pushing the subcutaneous port with the placement tool through the surgical opening and the subcutaneous void and/or passage to a target implantation site; releasing the distal tips of the placement tool from the wall; and removing the placement tool from the subcutaneous void and/or passage. One of ordinary skill in the art would have been motivated to make this modification because using a placement tool to clamp, push, and release the wall of the subcutaneous port increases the surgeon’s grip on the subcutaneous port. The increase in grip reduces the likelihood of the surgeon’s fingers from slipping during the insertion of the subcutaneous port. A person of ordinary skill in the art would recognize that the structure of the subcutaneous port and placement tool taught by Woo is beneficial because it would reduce the chances that the surgeon would incorrectly place the subcutaneous port.
The method of Withoon modified in view of a teaching of Woo will hereinafter be referred to as the method of Withoon and Woo.
However, the method of Withoon and Woo is silent with regards to using medical forceps for the clamping, pushing, releasing, and removing steps of the method.
Nonetheless Harders, which is within the analogous art of implantable injection ports (see abstract and title), teaches that using medical forceps to clamp, push, and release the subcutaneous port within a patient is well known (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] – [0052]).
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 and Woo in view of a teaching of Harders such that the clamping, pushing, releasing, and removing steps are completed using medical forceps taught by Harders rather than the placement tool taught by Woo. One of ordinary skill in the art would have been motivated to make this modification because using standard medical forceps of Harders over the specialized placement tool of Woo is beneficial because standard forceps are widely available, cost-effective, and adaptable to unexpected situations in contrast to specialized medical placement tools. Medical forceps are widely available in surgical settings. In resource limited settings, it would be beneficial to be able to insert the subcutaneous port using standard medical forceps rather than relying upon specialized placement tools. Medical forceps are also typically less expensive to purchase and maintain in comparison to specialized placement tools. Furthermore medical forceps can be used for multiple purposes during and after insertion of the subcutaneous port thereby reducing the need for further instruments. In view of the aforementioned rationale, a person having ordinary skill in the art would utilize the medical forceps taught by Harders to perform the clamping, pushing, releasing, and removing steps of the method.
The method of Withoon and Woo modified in view of a teaching of Harders will hereinafter be referred to as the method of Withoon, Woo, and Harders.
With regards to claim 26, the method of Withoon, Woo, and Harders teaches the claimed invention of claim 25, and Withoon further teaches creating or enlarging the subcutaneous void and/or passage with the medical forceps 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 medical forceps prior to clamping the port. The method of Withoon, Woo, and Harders teaches that the creation or enlargement of the subcutaneous void and/or passage with the medical forceps occurs prior to clamping the port with the medical forceps).
With regards to claim 29, the method of Withoon, Woo, and Harders teaches the claimed invention of claim 25, and Withoon further teaches 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 31, the method of Withoon, Woo, and Harders teaches the claimed invention of claim 29, however, Withoon is silent with regards to 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.
Nonetheless Woo, which is within the analogous art of implantable port placement systems (see abstract and title) teaches 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).
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, Woo, and Harders in view of a further teaching of Woo such that any access to the vasculature and/or across the skin layers of the subject after the forming is made directly through the surgical opening. One of ordinary skill in the art would have been motivated to make this modification because doing so would prevent further trauma to the patient’s body. Furthermore, placing the port with the catheter already coupled reduces the chance of an incomplete coupling of the catheter with the subcutaneous port because the surgeon has better visibility of the components than when the catheter is being coupled to the subcutaneous port within the patient as shown in the YouTube video.
With regards to claim 32, the method of Withoon, Woo, 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, removing the access needle from the vein, 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, Woo, and Harders teaches the claimed invention of claim 25, however Withoon is silent with regards to wherein the medical forceps are 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 forceps are selected from Kelly forceps (see [0037] “Standard forceps or hemostats”), 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 forcep of the method of Withoon, Woo, and Harders in view of a further teaching of Harders such that the medical forceps are 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) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Withoon, Woo, and Harders as applied to claim 25, and further in view of Propp et al. (US 2003/0181944 A1) (hereinafter referred to as “Propp”).
With regards to claim 27, the method of Withoon, Woo, and Harders teaches the claimed invention of claim 25, however, Withoon is silent with regards to wherein the clamping comprises interlocking manually operable arms of the medical forceps so as to apply continuous grip against the first and second wall surfaces of the port gripping portion.
Nonetheless Propp, which is within the analogous art of surgical instrument (see abstract and title), teaches the clamping comprises interlocking manually operable arms (12, 14) (see [0023] and [0026]) of the medical forceps (10) (see [0023]) so as to apply continuous grip against the first and second wall surfaces of the port gripping portion (see [0026]).
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 forceps of the method of Withoon, Woo, and Harders in view of a teaching of Propp such that the clamping comprises interlocking manually operable arms of the medical forceps 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 Propp teaches that this structure effectively locks the interlocking manually operable arms of the medical forceps into an urged engagement that enhances the grip of the working tips when the medical forceps is in the operative position (see [0026] and Figures 4 – 5 of Propp).
Claim(s) 28, 30, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Withoon, Woo, and Harders as applied to claims 25, 29, and 32 above, and further in view of Pardo et al. (NPL Central Venous Port Placement: A Comparison of Axillary Versus Anterior Chest Wall Placement) (hereinafter referred to as “Pardo”).
Pardo is cited in the Notice of References Cited form dated 5 November 2025.
With regards to claim 28, the method of Withoon, Woo, and Harders teaches the claimed invention of claim 25, however, Withoon is silent with regards to the method further comprising 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, Woo, 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, Woo, 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 Withoon, 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, Woo, and Harders teaches the claimed invention of claim 32, 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 Withoon, 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
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571)270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
07/08/2026
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