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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8 October 2025 has been entered.
Response to Amendment
This Office Action is in response to the Applicant’s amendment dated 8 October 2025 wherein Claims 1, 4, 9, 21 – 24, 26 – 28, and 30 are amended, Claims 6, 11 – 20, and 29 are or previously were cancelled, no claims are newly added. Therefore, Claims 1 – 5, 7 – 10, 21 – 28, and 30 are currently pending within the application.
The Applicant’s amendment to the Claims dated 8 October 2025 has overcome each Drawing Objection set forth in the Final Rejection dated 9 October 2024 (hereinafter referred to as the “Final Rejection”). Therefore, the Drawing Objection set forth in the Final Rejection is withdrawn.
The Applicant’s amendment to the Claims dated 8 October 2025 has overcome each Claim Objection set forth in the Final Rejection. Therefore, each of the Claim Objection set forth in the Final Rejection is withdrawn.
The Applicant’s amendment to the Claims has overcome each Claim Rejection set forth under 35 U.S.C. §§ 112(a) and 112(b) within the Final Rejection. Therefore, each Claim Rejection set forth under 35 U.S.C. §§ 112(a) and 112(b) within the Final Rejection is withdrawn.
Response to Arguments
Applicant’s arguments, see page 2, filed 8 October 2025, with respect to the rejection(s) of independent claim(s) 1 and its respective dependent claims 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 Therefore, the rejection has been withdrawn.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 the following:
Woo et al. (US 2020/02847 A1) modified in view of Harders et al. (US 2011/0196394 A1); and
Teitelbaum (US 2002/0010442 A1) modified in view of Harders et al. (US 2011/0196394 A1).
Information Disclosure Statement
The information disclosure statement filed 20 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. No copy of GB 2011173820, JPH 3168159A or the Notice of Allowance mailed on 27 January, 2025 in JP 2023-501349 have been provided. All references are considered within the IDS dated 20 October 2025 barring the aforementioned two foreign patent documents and non-patent literature publication which have not been provided.
Claim Objections
Claim(s) 2 – 5, 7 – 10, 21 – 28, and 30 are objected to because of the following informalities:
Claims 2 – 5, 7 – 10, 21 – 28, and 30 each recite “The subcutaneous port according to claim…”. This is the incorrect preamble for these dependent claims as Claim 1 recites “An apparatus, comprising:…”. The Examiner suggests amending the preamble of Claims 2 – 5, 7 – 10, 21 – 28, and 30 to correct 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(s) 1 – 5, 7 – 10, 21 – 28, and 30 are 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 1 recites “medical forceps comprising distal tips…wherein the distal tips of the medical forceps are releasably affixed to the port gripping portion to receive manual forces and/or torques from the medical forceps in at least one axis.” It is unclear if the Applicant intends for the Claims to positively recite that the forceps are in a state of being affixed to the port gripping portion or if this claim language is functional claim language. Therefore Claim 1 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
If this claim language is intended to positively recite the releasable affixing then the prior art must disclose, teach, or suggest the releasable affixing of the medical forceps to the port gripping portion thereby substantially limiting the apparatus to require both the port body and the medical forceps wherein the port body and medical forceps can be releasably affixed together. On the other hand, if this claim limitation is functional language then the claimed apparatus needs to only be capable of used in such a manner. MPEP 2144.04. The Examiner requests further clarity regarding the claim language and if the limitations regarding the medical forceps are functional or positively recited.
The 35 U.S.C. § 103 rejections below reject Claim 1 and its dependents under both interpretations of the claim language (i.e., positive recitation or functional recitation of the medical forceps and its uses).
Claims 2 – 5, 7 – 10, 21 – 28, and 30 are dependent upon Claim 1 and are therefore rejected for the same rationale.
Claim 3 recites “subcutaneous port” twice. Each of these limitations lacks antecedent basis within the claim language. Therefore Claim 3 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
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) 1 – 5, 7 – 10, 21 – 23, and 25 – 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over 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”).
Woo is cited within the IDS dated 7 January 2022.
With regards to claim 1, Woo discloses (see Figs. 1A – 1D and 7) an apparatus (110, 700; see [0048] and [0057]), comprising:
medical forceps (700) comprising distal tips (see [0057] “a distal end of a placement tool, for example insertion tool 700 shown in FIG. 7”);
a port body (112, 114) (see [0048]) enclosing a cavity (122) (see [0048]), wherein the cavity comprises a first opening (see at 122 in Fig. 1C) covered by a septum (116) (see [0048]) configured for repeated needle penetrations therethrough (see [0048]) and a second opening (see at 132 in Fig. 1C) configured for facilitating fluid communication between the cavity and a catheter (50) (see [0049]);
wherein the port body comprises a rigid port gripping portion (150) (see [0057] “a stem cover 150…The cover 150 can further include one or more protrusions 154, detents 156, or combinations thereof that are configured to engage a distal end of a placement tool”) configured to be gripped between the distal tips of the medical forceps (the claim language of “a rigid port gripping portion configured to be gripped between distal tips of medical forceps” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim and is to be limited by structural limitations. The Office submits that the apparatus of Woo meets the structural requirements of the claim, and the rigid port gripping portion is capable of being gripped between distal tips of medical forceps based on paragraph [0057] of Woo), and wherein the port body is configured to be pushed into a subcutaneous target implantation site using the medical forceps when the distal tips of the medical forceps are engaged with the port gripping portion (the claim language of “wherein the port body is configured to be pushed into a subcutaneous target implantation site using the medical forceps when the distal tips of the medical forceps are engaged with the port gripping portion” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the apparatus of Woo meets the structural limitations of the claim, and is capable of being pushed into a subcutaneous target implantation site using the medical forceps when the distal tips of the medical forceps are engaged with the port gripping portion based on the disclosures of paragraphs [0050], [0053], [0054], [0056] and [0057] of Woo);
wherein the distal tips of the medical forceps are releasably affixed to the port gripping portion to receive manual forces and/or torques from the medical forceps in at least one axis (the claim language of “wherein the distal tips of the medical forceps are releasably affixed to the port gripping portion to receive manual forces and/or torques from the medical forceps in at least one axis” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the apparatus of Woo meets the structural limitations of the claim, and is capable of having the distal tips of the medical forceps being releasably affixed to the port gripping portion to receive manual forces and/or torques from the medical forceps in at least one axis based on the disclosure of paragraphs [0050], [0053], [0054], [0056] and [0057] of Woo).
However if it is determined that the aforementioned claim limitations are not functional claim language but positive recitations of the medical forceps and its usage then Woo is silent with regards to the apparatus comprising:
medical forceps comprising distal tips;
wherein the rigid port gripping portion is configured to be gripped between the distal tips of the medical forceps, and wherein the port body is configured to be pushed into a subcutaneous target implantation site using the medical forceps when the distal tips of the medical forceps are engaged with the port gripping portion;
wherein the distal tips of the medical forceps are releasably affixed to the port gripping portion to receive manual forces and/or torques from the medical forceps in at least one axis.
Nonetheless Harders, which is within the analogous art of implantable injection ports (see abstract and title), teaches using standard forceps or hemostats to implant the injection port (see [0037] “ The injection ports may be implanted without using specialized implantation equipment, except for laproscopic tools. 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.”).
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 specialized placement tool used with the apparatus of Woo in view of a teaching of Harders such that the apparatus comprises medical forceps comprising distal tips; wherein the rigid port gripping portion is configured to be gripped between the distal tips of the medical forceps, and wherein the port body is configured to be pushed into a subcutaneous target implantation site using the medical forceps when the distal tips of the medical forceps are engaged with the port gripping portion; wherein the distal tips of the medical forceps are releasably affixed to the port gripping portion to receive manual forces and/or torques from the medical forceps in at least one axis.
One of ordinary skill in the art would have been motivated to make this modification because forceps help a surgeon grasp, hold, and manipulate the port body during implantation and removal. Forceps are better than gloved hands during surgery because they provide precision, stability, control of pressure, and reduce the likelihood of the surgeon losing their grip on the port because of exposure to blood or other fluids. Additionally, forceps are extremely well-known and a fundamental surgical instrument that is widely available to surgeons or medical staff. It would be beneficial to use forceps to implant and remove the port with forceps rather than a specialized tool because of their wide availability to surgeons or medical staff. Requiring a specialized tool can be detrimental especially if this tool becomes unsterile or breaks during implantation or removal (see [0037] of Harders). Furthermore, a person having ordinary skill in the art would recognize that gripping the rigid port gripping portion with the distal tips of the forceps is beneficial because the rigid port gripping portion provides for a frictional surface that is easier for the distal tips to grasp. For all of the aforementioned reasons a person having ordinary skill in the art would have been motivated to use medical forceps to perform the aforementioned implantation and manipulation of the port body.
The apparatus of Woo modified in view of a teaching of Harders will hereinafter be referred to as the apparatus of Woo and Harders.
With regards to claim 2, the apparatus of Woo and Harders teaches the claimed invention of claim 1, and Woo further teaches (Figs. 1A – 1D) wherein the port body (112, 114; see [0048]) includes a rigid port body member (114; see [0048]) surrounding the cavity (122) and/or defining the first opening (see at 122 in Fig. 1C), the rigid port body member comprising a front portion (see at 166 in Fig. 1B), a rear portion (see at 150 in Fig. 1B), and lateral portions (see at 114 and the opposing side in Fig. 1B) extending from opposing sides thereof between the front portion and the rear portion, wherein the rear portion comprises the port gripping portion (150; see [0057] “a stem cover 150”).
With regards to claim 3, the apparatus of Woo and Harders teaches the claimed invention of claim 1, and Woo further teaches (Figs. 1A – 1D) wherein the manual forces and/or torques received at the port gripping portion (150; see [0057] “a stem cover 150”) are sufficient to form or enlarge a subcutaneous void and/or passage in a body of a subject using the subcutaneous port (110; see [0048] “implantable access port (‘port’) 110”) and/or to maneuver the subcutaneous port along the subcutaneous void and/or passage, without slipping from, or releasing grip of, the port gripping portion (the claim language of “wherein the manual forces and/or torques received at the port gripping portion are sufficient to form or enlarge a subcutaneous void and/or passage in a body of a subject using the subcutaneous port and/or to maneuver the subcutaneous port along the subcutaneous void and/or passage, without slipping from, or releasing grip of, the port gripping portion” constitute functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the apparatus of Woo and Harders meets the structural limitations of the claim, and is capable of receiving the manual forces and/or torques received at the port gripping portion to form or enlarge a subcutaneous void and/or passage in a body of a subject using the subcutaneous port and/or maneuver the subcutaneous port along the subcutaneous void and/or passage, without slipping from, or releasing grip of, the port gripping portion based on the disclosures of paragraphs [0050], [0053], [0054], [0056] and [0057] of Woo and [0037] of Harders).
With regards to claim 4, the apparatus of Woo and Harders teaches the claimed invention of claim 1, and Woo further teaches (Figs. 1A – 1D) wherein the port gripping portion (150; see [0057] “a stem cover 150”) comprises a wall (154; see [0057] “one or more protrusions 154, detents 156, or combinations thereof that are configured to engage a distal end of a placement tool”), wherein the wall comprises opposing first and second outer wall surfaces (see the opposing sides of the one or more protrusions 154 in Fig. 1A) to which the distal tips of the medical forceps are releasably affixed (see [0057] “The cover 150 can further include one or more protrusions 154, detents 156, or combinations thereof that are configured to engage a distal end of a placement tool”) (additionally, see the rejection of Claim 1 above wherein the placement tool taught by Woo is replaced with the medical forceps taught by Harders).
With regards to claim 5, the apparatus of Woo and Harders teaches the claimed invention of claim 4, and Woo further teaches (Figs. 1A – 1D) wherein the port gripping portion (150; see [0057] “a stem cover 150”) is configured such that the manual forces are equal to or smaller than 10 kgf and/or the manual torques are equal to or smaller than about 0.25 N*m, when the distal tips of the medical forceps are oriented and spaced apart with each other to substantially match a shape and a thickness of the wall (the claim language of “wherein the port gripping portion is configured such that the manual forces are equal to or smaller than 10 kgf and/or the manual torques are equal to or smaller than about 0.25 N*m, when the distal tips of the medical forceps are oriented and spaced apart with each other to substantially match a shape and a thickness of the wall wherein the port gripping portion is configured such that the manual forces are equal to or smaller than 10 kgf and/or the manual torques are equal to or smaller than about 0.25 N*m, when the distal tips of the medical forceps are oriented and spaced apart with each other to substantially match a shape and a thickness of the wall” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the apparatus of Woo and Harders meets the structural limitations of the claim, and is capable of receiving the manual forces equal to or smaller than 10 kgf and/or the manual torques are equal or smaller than about 0.25 N*m, when the distal tips of the medical forceps are oriented and spaced apart with each other to substantially match a shape and thickness of the wall based on the disclosures of paragraphs [0050], [0053], [0054], [0056] and [0057] of Woo and [0037] of Harders).
With regards to claim 7, the apparatus of Woo and Harders teaches the claimed invention of claim 4, and Woo further teaches (Figs. 1A – 1D) wherein each of the first and second outer wall surfaces (see at 154 in Fig. 1A) extend vertically between (see Fig. 1B) lateral portions (see at 114 and the opposing side in Fig. 1B) of the port body (112, 114; see [0048]).
With regards to claim 8, the apparatus of Woo and Harders teaches the claimed invention of claim 4, and Woo further teaches (Figs. 1A – 1D) wherein each of the first and second outer wall surfaces (see at 154 in Fig. 1A) extend horizontally between a bottom portion (see at 128 in Fig. 1C) and a top portion (see near 126 in Fig. 1C) of the port body (112, 114; see [0048]).
With regards to claim 9, the apparatus of Woo and Harders teaches the claimed invention of claim 4, and Woo further teaches (Figs. 1A – 1D) that the wall has a thickness (see the thickness of the wall 154 in Fig. 1A).
However, Woo does not explicitly disclose that an average or maximal thickness of the wall is between about 1 mm and about 4 mm.
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 thickness of the wall of the port gripping portion of the port body of the apparatus of Woo and Harders such that an average or maximal thickness of the wall is between about 1 mm and about 4 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984); MPEP 2144.04(IV)(A). Here, the thickness of the wall being the thickness disclosed by Woo or thickness being modified to be between 1 mm and about 4 mm as claimed would not cause the wall to perform differently because either thickness of the wall would be engageable with a distal end of a placement tool for inserting the port into the patient (see [0057] of Woo).
With regards to claim 10, the apparatus of Woo and Harders teaches the claimed invention of claim 1, and Woo further teaches (Figs. 1A – 1D) wherein the second opening (see at 132 in Fig. 1C) is in juxtaposition with, and/or located inferiorly to (see Fig. 1C), the port gripping portion (150; see [0057] “a stem cover 150”).
With regards to claim 21, the apparatus of Woo and Harders teaches the claimed invention of claim 1, and Woo further teaches (Figs. 1A – 1D) wherein the port gripping portion (150; see [0057] “a stem cover 150”) comprises one or more recessed portions in the port body (156; see [0057] “The cover 150 can further include one or more protrusions 154, detents 156, or combinations thereof that are configured to engage a distal end of a placement tool.”), and wherein the distal tips of the medical forceps are positioned in the one or more recessed portions of the port body (the language “wherein the distal tips of the medical forceps are positioned in the one or more recessed portions of the port body” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the apparatus of Woo and Harders meets the structural limitations of the claim, and is capable of accepting positioning the distal tips of the medical forceps in the one or more recessed portions of the port body based on the disclosure of paragraph [0057] of Woo and [0037] of Harders).
With regards to claim 22, the apparatus of Woo and Harders teaches the claimed invention of claim 21, and Woo further teaches (Figs. 1A – 1D) wherein the port gripping portion (150; see [0057] “a stem cover 150”) comprises a wall (154; see [0057] “one or more protrusions 154”), wherein the wall comprises opposing first and second outer wall surfaces (see at either side of 154 in Fig. 1A) to which the distal tips of the medical forceps are releasably affixed (see [0057] “The cover 150 can further include one or more protrusions 154, detents 156, or combinations thereof that are configured to engage a distal end of a placement tool”) (additionally, see the rejection of Claim 1 above wherein the placement tool taught by Woo is replaced with the medical forceps taught by Harders).
With regards to claim 23, the apparatus of Woo and Harders teaches the claimed invention of claim 22, and Woo further teaches (Figs. 1A – 1D) wherein the wall (154; see [0057] “one or more protrusions 154”) is positioned between the one or more recessed portions in the port body (see Fig. 1D which shows the wall 154 positioned between the recessed portions 156 in the port body 112, 114).
With regards to claim 25, the apparatus of Woo and Harders teaches the claimed invention of claim 4, and Woo further teaches (Figs. 1A – 1D) wherein the wall (see Fig. 1A which shows the wall 154 oriented vertically and horizontally and having a thickness and a width).
However, Woo does not explicitly recite wherein the wall being 0.5 to 3 mm thick and is 2 to 5 mm wide.
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 thickness and width of the wall of the port gripping portion of the port body of the apparatus of Woo and Harders such that the wall is 0.5 to 3 mm thick and is 2 to 5 mm wide, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984); MPEP 2144.04(IV)(A). Here, the thickness of the wall being the thickness disclosed by Woo or thickness being modified to be 0.5 to 3 mm as claimed would not cause the wall to perform differently because either thickness of the wall would be engageable with a distal end of a placement tool for inserting the port into the patient (see [0057] of Woo). Similarly, the width of the wall being the width disclosed by Woo or width being modified to be 2 to 5 mm as claimed would not cause the wall to perform differently because either width of the wall would be engageable with a distal end of a placement tool for inserting the port into the patient (see [0057] of Woo).
With regards to claim 26, the apparatus of Woo and Harders teaches the claimed invention of claim 25, and Woo further teaches (Figs. 1A – 1D) wherein the port gripping portion (150; see [0057] “a stem cover 150”) comprises one or more recessed portions (156; see [0057] “The cover 150 can further include one or more protrusions 154, detents 156”) in the port body (112, 114; see [0048] “The port 110 includes a port housing (‘housing’) 112, a port body (‘body’) 114”), wherein the wall is positioned adjacent to the one or more recessed portions in the port body (see Figs. 1A and 1D which shows the wall 154 being positioned adjacent to the one or more recessed portions 156 in the port body 112, 114), and wherein one or more of the distal tips of the medical forceps are contained within the one or more recessed portions (the language “wherein one or more of the distal tips of the medical forceps are contained within the one or more recessed portions” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the apparatus of Woo and Harders meets the structural limitations of the claim, and is capable of containing one or more of the distal tips of medical forceps are contained within the one or more recessed portions based on the disclosure of paragraphs [0047], [0057], and [0058] of Woo and [0037] of Harders).
Claim(s) 1 – 5, 7 – 10, 21 – 28, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teitelbaum (US 2002/0010442 A1) modified in view of Harders.
With regards to claim 1, Teitelbaum discloses (see Figs. 2, 11, and 13) an apparatus (see Fig. 2), comprising:
a port body (218; see [0045] “a housing 118 and 218”) enclosing a cavity (230; see [0049] “injection conduit 130 and 230”), wherein the cavity comprises a first opening (see at 232 in Fig. 13) covered by a septum (232; see [0049] “constricting means 132 and 232 for constricting the proximal end of the aspiration and injection conduit 130 and 230 so as to create a water-tight seal between the port 128 and 228”) configured for repeated needle penetrations therethrough (see [0050] “The constricting means 132 and 232 is used by inserting an access needle, such as a 14 or 15 gauge needle, into the port 128 and 228”) and a second opening (see at 208 in Fig. 13) configured for facilitating fluid communication between the cavity and a catheter (208; see [0034] “two delivery lumens 208”);
wherein the port body comprises a rigid port gripping portion (see at the wall formed between the two injection ports 228 in Fig. 2 and Fig. 13) configured to be gripped between the distal tips of the medical forceps, and wherein the port body is configured to be pushed into a subcutaneous target implantation site using the medical forceps when the distal tips of the medical forceps are engaged with the port gripping portion (the language of “configured to be gripped between distal tips of medical forceps, and wherein the port body is configured to be pushed into a subcutaneous target implantation site using the medical forceps when the distal tips of the medical forceps are engaged with the port gripping portion” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the apparatus of Teitelbaum meets the structural limitations of the claim, and is capable of being gripped between distal tips of medical forceps; and wherein the port body is configured to be pushed into a subcutaneous target implantation site using the medical forceps when the distal tips of the medical forceps are engaged with the port gripping portion. The Examiner bases this capability and functionality based on paragraphs [0047], [0057], and [0058]);
wherein the distal tips of the medical forceps are releasably affixed to the port gripping portion to receive manual forces and/or torques from the medical forceps in at least one axis (the language of “wherein the distal tips of the medical forceps are releasably affixed to the port gripping portion to receive manual forces and/or torques from the medical forceps in at least one axis” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the apparatus of Teitelbaum meets the structural limitations of the claim, and wherein the port gripping portion is capable of receiving manual forces and/or torques from the medical forceps in at least one axis when the distal tips of the medical forceps are releasably affixed to the port gripping portion. The Examiner bases this capability and functionality based on paragraphs [0047], [0057], and [0058]).
However if it is determined that the aforementioned claim limitations are not functional claim language but positive recitations of the medical forceps and its usage then Teitelbaum is silent with regards to the apparatus comprising:
medical forceps comprising distal tips;
wherein the rigid port gripping portion is configured to be gripped between the distal tips of the medical forceps, and wherein the port body is configured to be pushed into a subcutaneous target implantation site using the medical forceps when the distal tips of the medical forceps are engaged with the port gripping portion;
wherein the distal tips of the medical forceps are releasably affixed to the port gripping portion to receive manual forces and/or torques from the medical forceps in at least one axis.
Nonetheless Harders, which is within the analogous art of implantable injection ports (see abstract and title), teaches using standard forceps or hemostats to implant the injection port (see [0037] “ The injection ports may be implanted without using specialized implantation equipment, except for laproscopic tools. 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.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify manner of implanting and removing the apparatus of Teitelbaum in view of a teaching of Harders such that the apparatus comprises medical forceps comprising distal tips; wherein the rigid port gripping portion is configured to be gripped between the distal tips of the medical forceps, and wherein the port body is configured to be pushed into a subcutaneous target implantation site using the medical forceps when the distal tips of the medical forceps are engaged with the port gripping portion; wherein the distal tips of the medical forceps are releasably affixed to the port gripping portion to receive manual forces and/or torques from the medical forceps in at least one axis.
One of ordinary skill in the art would have been motivated to make this modification because forceps help a surgeon grasp, hold, and manipulate the port body during implantation and removal. Forceps are better than gloved hands during surgery because they provide precision, stability, control of pressure, and reduce the likelihood of the surgeon losing their grip on the port because of exposure to blood or other fluids. Additionally, forceps are extremely well-known and a fundamental surgical instrument that is widely available to surgeons or medical staff. It would be beneficial to use forceps to implant and remove the port with forceps rather than a specialized tool because of their wide availability to surgeons or medical staff. Requiring a specialized tool can be detrimental especially if this tool becomes unsterile or breaks during implantation or removal (see [0037] of Harders). Furthermore, a person having ordinary skill in the art would recognize that gripping the rigid port gripping portion with the distal tips of the forceps is beneficial because the rigid port gripping portion provides for a frictional surface that is easier for the distal tips to grasp. For all of the aforementioned reasons a person having ordinary skill in the art would have been motivated to use medical forceps to perform the aforementioned implantation and manipulation of the port body.
The apparatus of Teitelbaum modified in view of a teaching of Harders will hereinafter be referred to as the apparatus of Teitelbaum and Harders.
With regards to claim 2, the apparatus of Teitelbaum and Harders teaches the claimed invention of claim 1, and Teitelbaum further teaches (Figs. 2, 11, and 13) wherein the port body (218; see [0045] “a housing 118 and 218”) includes a rigid port body member (see at 218 in Fig. 2 and Fig. 13) surrounding the cavity (230; see [0049] “injection conduit 130 and 230” and Fig. 13) and/or defining the first opening (see at 232 in Fig. 13), the rigid port body member comprising a front portion (see right-side of 218 in Fig. 13), a rear portion (see left-side of 218 in Fig. 13), and lateral portions extending from opposing sides thereof between the front portion and the rear portion (see top and bottom sides of 218 in Fig. 13), wherein the rear portion comprises the port gripping portion (see at 228 in Fig. 13).
With regards to claim 3, the apparatus of Teitelbaum and Harders teaches the claimed invention of claim 1, and Teitelbaum further teaches wherein the manual forces and/or torques received at the port gripping portion (see the wall formed between the injection ports 228 in Fig. 2 and Fig. 13) are sufficient to form or enlarge a subcutaneous void and/or passage in a body of a subject using the subcutaneous port and/or to maneuver the subcutaneous port along the subcutaneous void and/or passage, without slipping from, or releasing grip of, the port gripping portion (the claim language of “the manual forces and/or torques received at the port gripping portion are sufficient to form or enlarge a subcutaneous void and/or passage in a body of a subject using the subcutaneous port and/or to maneuver the subcutaneous port along the subcutaneous void and/or passage, without slipping from, or releasing grip of, the port gripping portion” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the apparatus of Teitelbaum and Harders meets the structural limitations of the claim, and is capable of receiving the manual forces and/or torques received at the port gripping portion are sufficient to form or enlarge a subcutaneous void and/or passage in a body of a subject using the subcutaneous port and/or to maneuver the subcutaneous port along the subcutaneous void and/or passage, without slipping from, or releasing grip of, the port gripping portion. The Examiner bases this capability and functionality based on paragraphs [0047], [0057], and [0058]).
With regards to claim 4, the apparatus of Teitelbaum and Harders teaches the claimed invention of claim 1, and Teitelbaum further teaches (Figs. 2, 11, and 13) wherein the port gripping portion comprises a wall (see the wall formed between the injection ports 228 in Fig. 2 and Fig. 13), wherein the wall comprises opposing first and second outer wall surfaces (see Examiner’s annotated Fig. 2 and Fig. 13 below; hereinafter referred to as Fig. A) to which the distal tips of the medical forceps are releasably affixed (the claim language of “sized to accommodate the distal tips of the medical forceps” constitutes functional claim language indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the apparatus of Teitelbaum and Harders meets the structural limitations of the claim, and is capable of accommodating the distal tips of the medical forceps. The Examiner bases this capability and functionality based on paragraphs [0047], [0057], and [0058] and [0037] of Harders).
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With regards to claim 5, the apparatus of Teitelbaum and Harders teaches the claimed invention of claim 4, and Teitelbaum further teaches (Figs. 2, 11, and 13) wherein the port gripping portion (see at the wall formed between the two injection ports 228 in Fig. 2 and Fig. 13) is configured such that the manual forces are equal to or smaller than 10 kgf and/or the manual torques are equal to or smaller than about 0.25 N*m, when the distal tips of the medical forceps are oriented and spaced apart with each other to substantially match a shape and a thickness of the wall (the claim language of “wherein the port gripping portion is configured such that the manual forces are equal to or smaller than 10 kgf and/or the manual torques are equal to or smaller than about 0.25 N*m, when the distal tips of the medical forceps are oriented and spaced apart with each other to substantially match a shape and a thickness of the wall wherein the port gripping portion is configured such that the manual forces are equal to or smaller than 10 kgf and/or the manual torques are equal to or smaller than about 0.25 N*m, when the distal tips of the medical forceps are oriented and spaced apart with each other to substantially match a shape and a thickness of the wall” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the apparatus of Teitelbaum and Harders meets the structural limitations of the claim, and is capable of receiving the manual forces equal to or smaller than 10 kgf and/or the manual torques are equal or smaller than about 0.25 N*m, when the distal tips of the medical forceps are oriented and spaced apart with each other to substantially match a shape and thickness of the wall based on the disclosures of paragraphs [0047], [0057], and [0058] and [0037] of Harders).
With regards to claim 7, the apparatus of Teitelbaum and Harders teaches the claimed invention of claim 4, and Teitelbaum further teaches (Figs. 2, 11, and 13) wherein each of the first and second outer wall surfaces (see Fig. A reiterated below) extend vertically between lateral portions (see top and bottom sides of 218 in Fig. 13) of the port body (218; see [0045] “a housing 118 and 218”).
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With regards to claim 8, the apparatus of Teitelbaum and Harders teaches the claimed invention of claim 4, and Teitelbaum further teaches (Figs. 2, 11, and 13) wherein each of the first and second outer wall surfaces (see Fig. A reiterated above) extend horizontally between a bottom portion (see at 218 in Fig. 2) and a top portion (see at 248 in Fig. 2) of the port body (218; see [0048]).
With regards to claim 9, the apparatus of Teitelbaum and Harders teaches the claimed invention of claim 4, and Teitelbaum further teaches (Figs. 2, 11, and 13) the wall has a thickness (see Fig. A above at the annotated wall).
However Teitelbaum is silent with regards to wherein an average or maximal thickness of the wall is between about 1 mm and about 4 mm.
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 thickness of the wall of the port gripping portion of the port body of the apparatus of Teitelbaum and Harders such that an average or maximal thickness of the wall is between about 1 mm and about 4 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984); MPEP 2144.04(IV)(A). Here, the thickness of the wall being the thickness disclosed by Teitelbaum or thickness being modified to be between 1 mm and about 4 mm as claimed would not cause the wall to perform differently because either thickness of the wall would be engageable with a distal end of a placement tool for inserting the port into the patient. Additionally, either thickness dimensions would allow for an access needle to enter the port 228 (see [0050] of Teitelbaum).
With regards to claim 10, the apparatus of Teitelbaum and Harders teaches the claimed invention of claim 1, and Teitelbaum further teaches (Figs. 2, 11, and 13) wherein the second opening (see at 208 in Fig. 13) is in juxtaposition with, and/or located inferiorly to, the port gripping portion (see at the wall formed between the two injection ports 228 in Fig. 2 and Fig. 13) (see Fig. 13 which shows the second opening at the opposite side of the port gripping portion or in other words juxtaposed or located inferiorly to the port gripping portion).
With regards to claim 21, the apparatus of Teitelbaum and Harders teaches the claimed invention of claim 1, and Teitelbaum further teaches (Figs. 2, 11, and 13) wherein the port gripping portion (see at the wall formed between the two injection ports 228 in Fig. 2 and Fig. 13) comprises one or more recessed portions in the port body (see at 228 in Fig. 2 and [0048] “each port 128 and 228 is configured to be concave toward the distal end of the housing 118 and 218” wherein this concavity is the one or more recessed portions), and wherein the distal tips of the medical forceps are positioned in the one or more recessed portions of the port body (the language “wherein the distal tips of the medical forceps are positioned in the one or more recessed portions of the port body” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the apparatus of Teitelbaum meets the structural limitations of the claim, and is capable of positioning the distal tips of the medical forceps in the one or more recessed portions of the port body based on the disclosure of paragraphs [0047], [0057], and [0058]).
With regards to claim 22, the apparatus of Teitelbaum and Harders teaches the claimed invention of claim 21, and Teitelbaum further teaches (Figs. 2, 11, and 13) wherein the port gripping portion (see at the wall formed between the two injection ports 228 in Fig. 2 and Fig. 13) comprises a wall (see Fig. A reiterated below), wherein the wall comprises opposing first and second outer wall surfaces (see Fig. A reiterated below) to which the distal tips of the medical forceps are releasably affixed (see the rejection of Claim 1 above and [0037] of Harders).
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With regards to claim 23, the apparatus of Teitelbaum and Harders teaches the claimed invention of claim 22, and Teitelbaum further teaches (Figs. 2, 11, and 13) wherein the wall (see Fig. A reiterated above) is positioned between the one or more recessed portions (see at 228 in Fig. 2 and [0048] “each port 128 and 228 is configured to be concave toward the distal end of the housing 118 and 218” wherein this concavity is the recessed portions) in the port body (218) (Fig. A shows the wall between the recessed portions).
With regards to claim 24, the apparatus of Teitelbaum and Harders teaches the claimed invention of claim 22, and Teitelbaum further teaches (Figs. 2, 11, and 13) wherein the one or more recessed portions comprise two laterally bound cavities (see at 228 in Fig. 2 and directly adjacent to 228 in Fig. 2 and [0048] “each port 128 and 228 is configured to be concave toward the distal end of the housing 118 and 218” wherein this concavity is the recessed portions), and wherein the wall is configured as a septum (see Fig. A above) dividing the two laterally bound cavities (see at 230 and near 232 in Fig. 13) in the port body (218).
With regards to claim 25, the apparatus of Teitelbaum and Harders teaches the claimed invention of claim 4, and Teitelbaum further teaches (Figs. 2, 11, and 13) wherein the wall (see Fig. A reiterated above) is oriented vertically or horizontally (see Fig. A which shows the wall oriented vertically and horizontally and having a thickness and a width).
However, Teitelbaum does not explicitly recite wherein the wall being 0.5 to 3 mm thick and is 2 to 5 mm wide.
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 thickness and width of the wall of the port gripping portion of the port body of the apparatus of Teitelbaum and Harders such that the wall is 0.5 to 3 mm thick and is 2 to 5 mm wide, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984); MPEP 2144.04(IV)(A). Here, the thickness of the wall being the thickness disclosed by Teitelbaum or thickness being modified to be 0.5 to 3 mm as claimed would not cause the wall to perform differently because either thickness of the wall would be engageable with a distal end of a placement tool for inserting the port into the patient. Similarly, the width of the wall being the width disclosed by Teitelbaum or width being modified to be 2 to 5 mm as claimed would not cause the wall to perform differently because either width of the wall would be engageable with a distal end of a placement tool for inserting the port into the patient. Additionally, either thickness or width dimensions would allow for an access needle to enter the port 228 (see [0050] of Teitelbaum).
With regards to claim 26, the apparatus of Teitelbaum and Harders teaches the claimed invention of claim 25, and Teitelbaum further teaches (Figs. 2, 11, and 13) wherein the port gripping portion (see at the wall formed between the two injection ports 228 in Fig. 2 and Fig. 13) comprises one or more recessed portions (see at 228 in Fig. 2 and directly adjacent to 228 in Fig. 2 and [0048] “each port 128 and 228 is configured to be concave toward the distal end of the housing 118 and 218” wherein this concavity is the one or more recessed portions)in the port body (218), wherein the wall is positioned adjacent to the one or more recessed portions in the port body (see Fig. A reiterated above wherein the wall is positioned adjacent to the one or more recessed portions in the port body 218), and wherein one or more of the distal tips of the medical forceps are contained within the one or more recessed portions (the language “wherein one or more of the distal tips of the medical forceps are contained within the one or more recessed portions” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the apparatus of Teitelbaum and Harders meets the structural limitations of the claim, and is capable of containing the one or more of the distal tips of the medical forceps within the one or more recessed portions based on the disclosure of paragraphs [0047], [0057], and [0058]).
With regards to claim 27, the apparatus of Teitelbaum and Harders teaches the claimed invention of claim 26, and Teitelbaum further teaches (Figs. 2, 11, and 13) wherein the one or more recessed portions comprise two recessed portions (see at 228 in Fig. 2 and directly adjacent to 228 in Fig. 2and [0048] “each port 128 and 228 is configured to be concave toward the distal end of the housing 118 and 218” wherein these concavities are the two recessed portions), and wherein the wall is formed as a septum (see Fig. A reiterated below) between the two recessed portions of the port body (218).
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With regards to claim 28, the apparatus of Teitelbaum and Harders teaches the claimed invention of claim 26, and Teitelbaum further teaches (Figs. 2, 11, and 13) wherein the two recessed portions comprise two laterally bound cavities (see at 228 in Fig. 2 and directly adjacent to 228 in Fig. 2and [0048] “each port 128 and 228 is configured to be concave toward the distal end of the housing 118 and 218” wherein these concavities are the two recessed portions), and wherein the wall is formed as a septum (see Fig. A reiterated below) between the two laterally bound cavities of the port body (218).
With regards to claim 30, the apparatus of Teitelbaum and Harders teaches the claimed invention of claim 27, and Teitelbaum further teaches (Figs. 2, 11, and 13) wherein the wall (see Fig. A reiterated above) is oriented vertically or horizontally (see Fig. A which shows the wall oriented vertically and horizontally and having a thickness and a width).
However Teitelbaum is silent with regards to the wall being 0.5 to 3 mm thick and 2 to 5 mm wide.
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 thickness and width of the wall of the port gripping portion of the port body of the apparatus of Teitelbaum such that the wall is 0.5 to 3 mm thick and is 2 to 5 mm wide, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984); MPEP 2144.04(IV)(A). Here, the thickness of the wall being the thickness disclosed by Teitelbaum or thickness being modified to be 0.5 to 3 mm as claimed would not cause the wall to perform differently because either thickness of the wall would be engageable with a distal end of a placement tool for inserting the port into the patient. Similarly, the width of the wall being the width disclosed by Teitelbaum or width being modified to be 2 to 5 mm as claimed would not cause the wall to perform differently because either width of the wall would be engageable with a distal end of a placement tool for inserting the port into the patient. Additionally, either thickness or width dimensions would allow for an access needle to enter the port 228 (see [0050] of Teitelbaum).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Harders et al. (US 2015/0133877 A1) see [0038].
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 01/22/2026