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 27 July 2026 wherein Claims 1, 3, 5, 7, 8, 21 – 28, and 30 are amended, Claims 31 – 34 are newly added, and Claims 2, 4, 6, 9 – 20, and 29 are or previously were cancelled. Therefore Claims 1, 3, 5, 7, 8, 21 – 28, and 30 – 34 are currently pending.
The Applicant’s amendments to the Claims dated 27 July 2026 has overcome each Claim Objection set forth in the Non-Final Rejection dated 27 July 2026 (hereinafter referred to as the “Non-Final Rejection”). Therefore, each of the Claim Objections set forth in the Non-Final Rejection is withdrawn.
The Applicant’s amendments to the Claims dated 27 July 2026 and Remarks dated 27 July 2026 has overcome each 35 U.S.C. § 112(b) rejection set forth in the Non-Final Rejection. Therefore each 35 U.S.C. § 112(b) rejection set forth in the Non-Final Rejection is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 7 – 8, filed 27 July 2026 (hereinafter referred to as the “Remarks”), with respect to the 35 U.S.C. 103 rejection in view of Teitelbaum (US 2002/0010442 A1) modified in view of Harders et al. (US 2011/0196394 A1) have been fully considered and are persuasive. The 35 U.S.C. § 103 rejection in view of Teitelbaum modified in view of Harders has been withdrawn.
Nonetheless, the Applicant’s arguments within the Remarks regarding the 35 U.S.C. § 103 rejection of Woo (WO 2020/028847 A1) modified in view of Harders have been fully considered but they are not persuasive. Additionally, upon further consideration, a new ground(s) of rejection is made in view of (1) Tallarida (US 5,906,596 A); and (2) Daly et al. (US 8,267,915 B2).
In response to Applicant’s argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The protrusion 154 of Woo (WO 2020/028847 A1) would not need to be modified or optimized to be suitable for solid gripping by the distal tips of the medical forceps as alleged by the Applicant. See page 7 of the Remarks. Woo discloses that the protrusion 154 and detents 156 of the cover 150 are configured to engage a distal end of a placement tool, for example insertion tool 700 shown in Figure 7. See [0057] of Woo. An obvious example of a placement tool would be the medical forceps taught by Harders. No modification or optimization would be necessary to use the medical forceps of Harders to releasably affix the port body of Woo via the protrusion 154 and/or detents 156. There is no hindsight reasoning because the conclusion of obviousness took into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge only gleaned from the Applicant’s disclosure.
The Examiner finds the Applicant’s argument that applying Harders to Woo would result in using forceps to grasp the entire port body to be unpersuasive. See page 8 of the Remarks. Woo discloses that the protrusion 154 and detents 156 of the cover 150 are configured to engage a distal end of a placement tool, for example insertion tool 700 shown in Figure 7. See [0057] of Woo. An obvious example of a placement tool would be the medical forceps taught by Harders. A person having ordinary skill in the art would recognize that the medical forceps taught by Harders would be used to grip the protrusion 154, detents 156, and/or both the protrusion 154 and detents 156 simultaneously while maneuvering the port body within the patient.
In response to the Applicant’s argument regarding new claim 31, the protrusion 154 of Woo would not need to be made horizontal. See page 8 of the Remarks. The protrusion 154 comprises a horizontal dimension and therefore can be considered a horizontally extending wall comprising two opposing surfaces shown at either side of 154 to the right and left in Figure 1A of Woo. Therefore, the Applicant’s argument that Woo does not disclose a horizontally extending wall and that making the protrusion 154 horizontal would interfere with coupling the tool to the protrusion is unpersuasive. Additionally, a new ground(s) of rejection is made in view of (1) Tallarida (US 5,906,596 A); and (2) Daly et al. (US 8,267,915 B2).
Claim Objections
Claims 1 and 31 are objected to because of the following informalities:
Claim 1 recites “the port gripping portion” twice. The Examiner suggests amending these to recite “the rigid port gripping portion” as each of the other recitations of this structure within Claim 1 uses this nomenclature.
Claim 31 recites “a rigid port gripping portion configured to be gripped between the distal tips of the medical forceps.” The Examiner suggests amending this to recite “a rigid port gripping portion configured to be gripped between [[the]] distal tips of [[the]] a medical forceps” as this is the first recitation of this structure within Claim 31.
Claim 31 recites “the port gripping portion.” The Examiner suggests amending this phrase to recite “the rigid port gripping portion” as each of the other recitations of this structure within Claim 31 uses this nomenclature.
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) 7, 8, 22 – 24, 30, 32, and 34 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 7 recites “each of the first and second outer wall surfaces.” This claim limitation lacks antecedent basis. Therefore Claim 7 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 join inventor regards as the invention.
Claim 7 recites “between lateral portions of the port body.” This claim limitation lacks antecedent basis. It is unclear if the recited “lateral portions of the port body” recited within Claim 7 refer to the lateral portions of the port body recited in Claim 1 or separate lateral portions of the port body. Therefore Claim 7 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 join inventor regards as the invention.
Claim 8 recites “each of the first and second outer wall surfaces.” This claim limitation lacks antecedent basis. Therefore Claim 8 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 join inventor regards as the invention.
Claim 22 recites “wherein the port gripping portion comprises a wall, wherein the wall comprises opposing first and second outer wall surfaces to which the distal tips of the medical forceps are releasably affixed. Claim 22 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 because it cannot be determined if the recited “wall” is referring to the wall previously recited in Claim 1 or if the port gripping portion comprises a second wall.
Claims 23 and 24 are rejected under 35 U.S.C. § 112(b) based on their dependency on Claim 22.
Claim 30 recites “wherein the wall is oriented vertically or horizontally.” Claim 30 is dependent upon Claim 27 which is dependent upon Claim 26 which is dependent upon Claim 25. Claim 25 recites “wherein the wall is oriented vertically or horizontally.” Claim 30 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 because the recited claim limitation of Claim 30 recites the same subject matter as Claim 27.
Claim 32 recites “wherein the wall is positioned adjacent to the one or more recessed portions in the port body configured to contain one or more of the distal tips of the medical forceps when the distal tips of the medical forceps are gripped between the distal tips of the medical forceps. Claim 32 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 because this recited language of Claim 34 cannot be understood. Currently, as recited the distal tips of the medical forceps are gripped between the distal tips of the medical forceps. How can the distal tips of the medical forceps be gripping themselves?
Claim 34 are rejected under 35 U.S.C. § 112(b) based on their dependency on Claim 32.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 30 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 30 recites “wherein the wall is oriented vertically or horizontally.” Claim 30 is dependent upon Claim 27 which is dependent upon Claim 26 which is dependent upon Claim 25. Claim 25 recites “wherein the wall is oriented vertically or horizontally.” Claim 30 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends because the recited claim limitation of Claim 30 recites the same subject matter as Claim 27.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tallarida (US 5,906,596 A).
With regard to claim 31, Tallarida discloses a subcutaneous port (10), comprising:
a port body (12) comprising a front portion, a rear portion, and lateral portions extending from opposing sides thereof between the front portion and the rear portion (see Examiner annotated Fig. 2 below; hereinafter referred to as “Fig. A”), wherein the port body encloses a cavity (see the cavity of the port section in Figure 1), wherein the cavity comprises a first opening (see at 15 in Figure 1) covered by a septum (15) configured for repeated needle penetrations therethrough (see Col. 3, lines 35 – 45) and a second opening (see at 18 in Figure 1) in the rear portion of the port body configured for facilitating fluid communication between the cavity and a catheter (22);
wherein the port body comprises a rigid port gripping portion (24) (see Col. 3, line 52 – Col. 4, line 28) configured to be gripped between the distal tips of the medical forceps (the claim language “a rigid port gripping portion configured to be gripped between the distal tips of the medical forceps” constitutes functional claim language, indicating that the claim needs only to be capable of being used in such a manner. MPEP 2173.05(g). The claim is an apparatus claim and is to be limited by structural claim limitations. MPEP 2114. The Office submits that the rigid port gripping portion of Tallarida is capable of being 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 claim language “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 claim needs only to be capable of being used in such a manner. MPEP 2173.05(g). The claim is an apparatus claim and is to be limited by structural claim limitations. MPEP 2114. The Office submits that the port body 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 because Tallarida describes the device being subcutaneously located. See Col. 3, line 52 – Col. 4, line 28);
wherein the rigid port gripping portion is positioned in the rear portion of the port body adjacent to the second opening of the cavity (see Figures 1 – 2 which shows the biocompatible mesh material being positioned in the rear portion of the port body adjacent to the second opening of the cavity because the biocompatible mesh material extends completely around the port device; therefore at least a portion of the rigid port gripping portion is positioned in the rear portion of the port body adjacent to the second opening of the cavity);
wherein the rigid port gripping portion is formed as a horizontally extending wall (see at 24 in Figure 1) comprising two opposing surfaces (see Examiner annotated Figure 1 below; hereinafter referred to as “Fig. B”) sized and shaped for effective clamping by the distal tips of the medical forceps (see Figures 1 – 2 wherein size and shape of the of the biocompatible mesh 24 is effective for clamping by the distal tips of medical forceps).
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Claim(s) 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by (WO 2020/028847 A1) (hereinafter referred to as “Woo”).
Woo is cited in the IDS dated 7 January 2022.
With regard to claim 31, Woo discloses (see Figs. 1A – 1D and 7) a subcutaneous port (110) (see [0048] and [0057]) , comprising:
a port body (112, 114) (see [0048]) comprising a front portion (see at 166 in Fig. 1A), a rear portion (see at 152 in Fig. 1A), and lateral portions (see at 114 and the opposing side to 114 in Fig. A1) extending from opposing sides thereof between the front portion and the rear portion, wherein the port body encloses 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) in the rear portion of the port body 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 rigid port gripping portion is positioned in the rear portion of the port body adjacent to the second opening of the cavity (see Figure 1A where the rigid port gripping portion 150 is located in the rear portion of the port body adjacent to the second opening);
wherein the rigid port gripping portion is formed as a horizontally extending wall (154) (see Fig. 1A and [0057] which shows and discloses that the rigid port gripping portion is formed as a horizontally extending wall) comprising two opposing surfaces (see either side of the protrusion 154 in Fig. 1A) sized and shaped for effective clamping by the distal tips of the medical forceps (the claim language of “sized and shaped for effective clamping by 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 Woo meets the structural limitations of the claim, and is capable of being effectively clamped by the distal tips of the medical forceps based on its current size and shape according to at least paragraph [0057] and Figures 1A of Woo).
Claim(s) 31 and 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Daly et al. (US 8,267,915 B2) (hereinafter referred to as “Daly”).
With regard to claim 31, Daly discloses a subcutaneous port (see Fig. 1), comprising:
a port body (100) comprising a front portion (see at 114 in Fig. 2), a rear portion (see at 116 in Fig. 2), and lateral portions (see at either side of port 100 in between 112, 114) extending from opposing sides thereof between the front portion and the rear portion, wherein the port body encloses a cavity (104), wherein the cavity comprises a first opening (see at 106 in Fig. 1) covered by a septum (106) configured for repeated needle penetrations therethrough (see Col. 3, line 64 – Col. 4, line 26) and a second opening (see Examiner annotated 1 below; hereinafter referred to as “Fig. C”) in the rear portion of the port body configured for facilitating fluid communication between the cavity and a catheter (see Col. 4, lines 45 – 67 “For example, the distance X between the centers of the channels 108 and 110 may be selected to match a distance between lumens of a dual lumen catheter which is to be connected thereto. This catheter may then be connected directly to the channels 108, 110.”);
wherein the port body comprises a rigid port gripping portion (120) 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 the 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 Daly meets the structural requirements of the claim, and the rigid port gripping portion 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 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 Daly meets the structural requirements of the claim 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 based on Col. 2, line 66 – Col. 3, line 19 of Daly);
wherein the rigid port gripping portion is positioned in the rear portion of the port body adjacent to the second opening of the cavity (see Figures 1 and 2 of Daly and Fig. C below);
wherein the rigid port gripping portion is formed as a horizontally extending wall (see 120 in Figure 1) comprising two opposing surfaces (see along 108 and 110 in Fig. 1 near 120) sized and shaped for effective clamping by the distal tips of the medical forceps (the claim language of “sized and shaped for effective clamping by 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 Daly meets the structural requirements of the claim wherein the two opposing surfaces are sized and shaped for effective clamping by the distal tips of the medical forceps).
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With regard to claim 32, Daly discloses the claimed invention of Claim 31, and Daly further discloses wherein the port gripping portion (120) comprises one or more recessed portions (108, 110) in the port body (100), wherein the wall (see at 120 in Figure 1) is positioned adjacent to the one or more recessed portions in the port body (see Figure 1) configured to contain one or more of the distal tips of the medical forceps when the distal tips of the medical forceps are gripped between the distal tips of the medical forceps (the claim language of “configured to contain one or more of the distal tips of the medical forceps when the distal tips of the medical forceps are gripped between 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 Daly meets the structural requirements of the claim wherein the one or more recessed portions in the port body are configured to contain one or more of the distal tips of the medical forceps when the distal tips of the medical forceps are gripped between the distal tips of the medical forceps).
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, 3, 5, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tallarida and Harders et al. (US 2011/0196394 A1) (hereinafter referred to as “Harders”).
Harders is cited in the Notice of References Cited form dated 27 January 2026.
With regard to claim 1, Tallarida discloses an apparatus (10), comprising:
a port body (12) comprising a front portion, a rear portion, and lateral portions extending from opposing sides thereof between the front portion and the rear portion (see Fig. A reiterated below), wherein the port body encloses a cavity (see the cavity of the port section 14 in Figure 1), wherein the cavity comprises a first opening (see at 15 in Figure 1) covered by a septum (15) configured for repeated needle penetrations therethrough (see Col. 3, lines 35 – 45) and a second opening (see at 18 in Figure 1) in the rear portion of the port body configured for facilitating fluid communication between the cavity and a catheter (22);
wherein the port body comprises a rigid port gripping portion (24) (see Col.3, line 52 – Col. 4, line 28) configured to be gripped between the distal tips of the medical forceps (the claim language “a rigid port gripping portion configured to be gripped between the distal tips of the medical forceps” constitutes functional claim language, indicating that the claim needs only to be capable of being used in such a manner. MPEP 2173.05(g). The claim is an apparatus claim and is to be limited by structural claim limitations. MPEP 2114. The Office submits that the rigid port gripping portion of Tallarida is capable of being 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 claim language “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 claim needs only to be capable of being used in such a manner. MPEP 2173.05(g). The claim is an apparatus claim and is to be limited by structural claim limitations. MPEP 2114. The Office submits that the port body 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 because Tallarida describes the device being subcutaneously located. See Col. 3, line 52 – Col. 4, line 28);
wherein the rigid port gripping portion is positioned in the rear portion of the port body adjacent to the second opening of the cavity (see Figures 1 – 2 which shows the biocompatible mesh material being positioned in the rear portion of the port body adjacent to the second opening of the cavity because the biocompatible mesh material extends completely around the port device; therefore at least a portion of the rigid port gripping portion is positioned in the rear portion of the port body adjacent to the second opening of the cavity);
wherein the rigid port gripping portion is formed as a wall (see at 24 in Figure 1) comprising two opposing surfaces (see Fig. B reiterated below) sized and shaped for effective clamping by the distal tips of the medical forceps (see Figures 1 – 2 wherein the size and shape of the of the biocompatible mesh 24 is effective for clamping by the distal tips of medical forceps), wherein an average thickness of the wall is between 1 mm and 4 mm (see Col. 4, lines 8 – 28 “ the mesh material 24 projects outwardly for a distance of 0.1 to 4.0 inches, and is disk shaped, with a thickness in the range of about 0.001 to 0.060 inches”) (here 0.001 to 0.060 inches equates to 0.0254 mm – 1.524 mm), and wherein an angle formed between the opposing surfaces of the wall is equal to or smaller than 20 degrees (the angle formed between the opposing surfaces of the wall is equal to 0 degrees which is smaller than 20 degrees).
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However, Tallarida is silent with regards to:
medical forceps comprising distal tips; and
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 a port (see [0037] “The injection ports may be implanted without using specialized implantation equipment, except for laparoscopic 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.” Standard forceps or hemostats comprise distal tips.).
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 apparatus of Tallarida in view of a teaching of Harders such that the apparatus further comprises medical forceps comprising distal tips; and 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. Furthermore, a person who has 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 Tallarida modified in view of a teaching of Harders will hereinafter be referred to as the apparatus of Tallarida and Harders.
With regard to claim 3, the apparatus of Tallarida and Harders teaches the claimed invention of claim 1, and the apparatus of Tallarida and Harders further teaches wherein the manual forces and/or torques received at the port gripping portion (24) (see Col.3, line 52 – Col. 4, line 28) are sufficient to form or enlarge a subcutaneous void and/or passage in a body of a subject using the port body (12) and/or to maneuver the port body 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 Tallarida 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 Col. 3, line 52 - Col. 4, line 28 of Tallarida and [0037] of Harders).
With regard to claim 5, the apparatus of Tallarida and Harders teaches the claimed invention of claim 1, and the apparatus of Tallarida and Harders further teaches wherein the port gripping portion (24 of Tallarida) (see Col.3, line 52 – Col. 4, line 28 of Tallarida) 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, and wherein the distal tips of the medical forceps (see the rejection of Claim 1 above where the medical forceps comprising distal tips are incorporated into the apparatus) are oriented and spaced apart with each other to substantially match the shape and 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 Tallarida 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 Col. 3, line 52 - Col. 4, line 28 of Tallarida and [0037] of Harders).
With regard to claim 25, the apparatus of Tallarida and Harders teaches the claimed invention of claim 1, and the apparatus of Tallarida and Harders further teaches wherein the wall (see at 24 in Figure 1) is oriented vertically or horizontally (see Figure 1 which shows the wall being oriented vertically and horizontally).
Claim(s) 1, 3, 5, 7, 8, 21 – 23, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woo and Harders.
With regard to claim 1, Woo discloses (see Figs. 1A – 1D and 7) an apparatus (110; see [0048] and [0057]), comprising:
a port body (112, 114) (see [0048]) comprising a front portion (see at 166 in Fig. 1A), a rear portion (see at 152 in Figure 1A), and lateral portions (see at 114 and the opposing side to 114 in Figure 1A) extending from opposing sides thereof between the front portion and the rear portion, wherein the port body(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) in the rear portion of the port body 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 rigid port gripping portion is positioned in the rear portion of the port body adjacent to the second opening of the cavity (see Figure 1A where the rigid port gripping portion 150 is located in the rear portion of the port body adjacent to the second opening);
wherein the rigid port gripping portion is formed as a wall (154) comprising two opposing surfaces (see either side of 150 in Figure 1A) sized and shaped for effective clamping by the distal tips of the medical forceps (the claim language of “sized and shaped for effective clamping by 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 Woo meets the structural limitations of the claim, and is capable of being effectively clamped by the distal tips of the medical forceps based on its current size and shape according to at least paragraph [0057] and Figures 1A of Woo);
wherein an angle formed between the opposing surfaces of the wall is equal to or smaller than 20 degrees (see the opposing surfaces of the wall 154 in Figure 1A wherein the angle between these opposing surfaces is zero because the opposing surfaces are perpendicular to each other).
However, Woo is silent with regards to:
medical forceps comprising distal tips;
wherein an average thickness of the wall is between 1 mm and 4 mm; and
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.
However, neither Woo or Harders explicitly teaches:
wherein an average thickness of the wall is between 1 mm and 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 of the wall is between 1 mm and 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 regard 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…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”) are sufficient to form or enlarge a subcutaneous void and/or passage in a body of a subject using the port body (112, 114) (see [0048]) and/or to maneuver the port body 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 port body and/or to maneuver the port body 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 port body and/or maneuver the port body 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 regard to claim 5, 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…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”) 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, and wherein the distal tips of the medical forceps are oriented and spaced apart with each other to substantially match the shape and 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, and wherein 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, and wherein 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 regard to claim 7, the apparatus of Woo and Harders teaches the claimed invention of claim 1, and Woo further teaches (Figs. 1A – 1D) wherein each of the first and second outer wall surfaces (see at 154 in Figure 1A) extend vertically between lateral portions (see at 114 and the opposing side in Fig. 1B) of the port body (112, 114)(see [0048]).
With regard to claim 8, the apparatus of Woo and Harders teaches the claimed invention of claim 1, and Woo further teaches (Figs. 1A – 1D) wherein each of the first and second outer wall surfaces (see at 154 in Figure 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 regard 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]) comprises one or more recessed portions (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.”) in the port body (112, 114) (see [0048]), 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 regard 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 regard 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 regard to claim 25, the apparatus of Woo and Harders teaches the claimed invention of claim 1, and Woo further teaches (Figs. 1A – 1D) wherein the wall (154) is oriented vertically or horizontally (see Figure 1A which shows the wall being oriented vertically and horizontally).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woo.
With regard to claim 33, Woo discloses the claimed invention of claim 31, and Woo further discloses wherein an angle formed between the opposing surfaces of the wall is equal to or smaller than 20 degrees (the angle formed between the opposing surfaces of the wall is equal to 0 degrees which is smaller than 20 degrees).
However, Woo does not explicitly recite:
wherein the wall is 2 to 5 mm wide, an average thickness of the wall is between 1 mm and 4 mm.
Nonetheless 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 subcutaneous port of Woo such that the wall is 2 to 5 mm wide, and an average of the wall is between 1 mm and 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 2 to 5 mm wide, with an average thickness of the wall being 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.
Claim(s) 1, 3, 5, 7, 8, 21 – 28, and 30 is/are rejected under 35 U.S.C. 103 as being obvious over Daly modified in view of Harders.
With regard to Claim 1, Daly discloses an apparatus (see Figure 1), comprising:
a port body (100) comprising a front portion (see at 114 in Fig. 2), a rear portion (see at 116 in Fig. 2), and lateral portions (see at either side of port 100 in between 112, 114 in Fig. 2) extending from opposing sides thereof between the front portion and the rear portion, wherein the port body enclosing encloses a cavity (104), wherein the cavity comprises a first opening (see at 106 in Fig. 1) covered by a septum (106) configured for repeated needle penetrations therethrough (see Col. 3, line 64 – Col. 4, line 26) and a second opening (see Fig. C reiterated below) in the rear portion of the port body configured for facilitating fluid communication between the cavity and a catheter (see Col. 4, lines 45 – 67 “For example, the distance X between the centers of the channels 108 and 110 may be selected to match a distance between lumens of a dual lumen catheter which is to be connected thereto. This catheter may then be connected directly to the channels 108, 110.”);
wherein the port body comprises a rigid port gripping portion (120) 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 Daly meets the structural requirements of the claim, and the rigid port gripping portion 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 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 Daly meets the structural requirements of the claim 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 based on Col. 2, line 66 – Col. 3, line 19 of Daly);
wherein the rigid port gripping portion is positioned in the rear portion of the port body adjacent to the second opening of the cavity (see Figures 1 and 2 of Daly and Fig. C below);
wherein the rigid port gripping portion is formed as a wall (see at 120 in Fig. 1) comprising two opposing surfaces (see along 108 and 110 in Fig. 1 near 120) sized and shaped for effective clamping by the distal tips of the medical forceps (the claim language of “sized and shaped for effective clamping by 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 Daly meets the structural requirements of the claim wherein the two opposing surfaces are sized and shaped for effective clamping by the distal tips of the medical forceps); and wherein an angle formed between the opposing surfaces of the wall is equal to or smaller than 20 degrees (the angle formed between the opposing surfaces of the wall is equal to 0 degrees because the opposing surfaces are shown to be parallel with each other in Figure 1).
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Daly is silent with regards to the apparatus comprising:
medical forceps comprising distal tips;
wherein an average thickness of the wall is between 1 mm and 4 mm, and
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 an injection port (see [0037] “ The injection ports may be implanted without using specialized implantation equipment, except for laparoscopic 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 apparatus of Daly 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. Furthermore, a person who has 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 Daly modified in view of a teaching of Harders will hereinafter be referred to as the apparatus of Daly and Harders.
However, neither Daly or Harders explicitly teaches:
wherein an average thickness of the wall is between 1 mm and 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 Daly and Harders such that an average of the wall is between 1 mm and 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 Daly 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.
With regard to Claim 3, the apparatus of Daly and Harders teaches the claimed invention of Claim 1, and the apparatus of Daly and Harders further teaches wherein the manual forces and/or torques received at the port gripping portion (120) are sufficient to form or enlarge a subcutaneous void and/or passage in a body of a subject using the port body (100) and/or to maneuver the port body 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 port body and/or to maneuver the port body 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 Daly 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 port body and/or maneuver the port body along the subcutaneous void and/or passage, without slipping from, or releasing grip of, the port gripping portion based on [0037] of Harders).
With regard to Claim 5, the apparatus of Daly and Harders teaches the claimed invention of Claim 1, and the apparatus of Daly and Harders further teaches wherein the port gripping portion (120) 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, and wherein the distal tips of the medical forceps are oriented and spaced apart with each other to substantially match the shape and 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, and wherein the distal tips of the medical forceps are oriented and spaced apart with each other to substantially match the shape and 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 Daly 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 [0037] of Harders).
With regard to Claim 7, the apparatus of Daly and Harders teaches the claimed invention of Claim 1, and Daly further teaches wherein each of the first and second outer wall surfaces (see along 108 and 110 in Fig. 1 near 120) extend vertically (see Fig. 1 which shows the vertical extension of the wall surfaces) between lateral portions (see at either side of port 100 in between 112, 114 in Fig. 2) of the port body (100).
With regard to Claim 8, the apparatus of Daly and Harders teaches the claimed invention of Claim 1, and Daly further teaches wherein each of the first and second outer wall surfaces (see along 108 and 110 in Fig. 1 near 120) extend horizontally (see Fig. 1 which shows the horizontal extension of the wall surfaces) between a bottom portion (see near 108 in Fig. 1) and a top portion (see near 114 in Fig. 1) of the port body (100).
With regard to Claim 21, the apparatus of Daly and Harders teaches the claimed invention of Claim 1, and Daly further teaches wherein the port gripping portion (120) comprises one or more recessed portions (108, 110) in the port body (100), 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 Daly 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 [0037] of Harders).
With regard to Claim 22, the apparatus of Daly and Harders teaches the claimed invention of Claim 21, and Daly further teaches wherein the port gripping portion (120) comprises a wall (see at 120 in Fig. 1), wherein the wall comprises opposing first and second outer wall surfaces (see along 108 and 110 in Fig. 1 near 120) to which the distal tips of the medical forceps are releasably affixed (see the rejection of Claim 1 above where the medical forceps taught by Harders is incorporated into the apparatus of Daly).
With regard to Claim 23, the apparatus of Daly and Harders teaches the claimed invention of Claim 22, and Daly further teaches wherein the wall (see at 120 in Fig. 1) is positioned between the one or more recessed portions (108, 110) in the port body (100) (see Figure 1).
With regard to Claim 24, the apparatus of Daly and Harders teaches the claimed invention of Claim 22, and Daly further teaches wherein the one or more recessed portions (108, 110) comprise two laterally bound cavities (see at 108 and 110 in Figure 1), and wherein the wall (see at 120 in Fig. 1) is configured as a septum dividing the two laterally bound cavities in the port body (100) (see Figure 1).
With regard to Claim 25, the apparatus of Daly and Harders teaches the claimed invention of Claim 1, and Daly further teaches wherein the wall (see at 120 in Figure 1) is oriented vertically or horizontally (see Figure 1 which shows the wall being oriented vertically and horizontally).
With regard to Claim 26, the apparatus of Daly and Harders teaches the claimed invention of Claim 25, and Daly further teaches wherein the port gripping portion (120) comprises one or more recessed portions (108, 110) in the port body (100), wherein the wall (see at 120 in Figure 1) is positioned adjacent to the one or more recessed portions in the port body (see Figure 1), 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 Daly and Harders meets the structural limitations of the claim and is capable of containing one or more of the distal tips of the medical forceps in the one or more recessed portions of the port body based on the disclosure of [0037] of Harders).
With regard to Claim 27, the apparatus of Daly and Harders teaches the claimed invention of Claim 26, and Daly further teaches wherein the one or more recessed portions (108, 110) comprise two recessed portions (see Figure 1), and wherein the wall (see at 120 in Figure 1) is formed as a septum between the two recessed portions of the port body (100) (see Figure 1).
With regard to Claim 28, the apparatus of Daly and Harders teaches the claimed invention of Claim 26, and Daly further teaches wherein the two recessed portions (108, 110) comprise two laterally bound cavities (see at 108 and 110 in Figure 1), and wherein the wall (see at 120 in Figure 1) is formed as a septum between the two laterally bound cavities of the port body (100) (see Figure 1).
With regard to claim 30, the apparatus of Daly and Harders teaches the claimed invention of Claim 27, and Daly further teaches wherein the wall (see at 120 in Figure 1) is oriented vertically or horizontally (see Figure 1 which shows the wall being oriented vertically and horizontally).
Claim(s) 33 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daly.
With regard to claim 33, Daly discloses the claimed invention of claim 31, and Daly further discloses wherein an angle formed between the opposing surfaces of the wall is equal to or smaller than 20 degrees (the angle formed between the opposing surfaces of the wall 120 is equal to 0 degrees because the opposing surfaces are shown to be parallel with each other in Figure 1).
However, Daly is silent with regards to wherein the wall is 2 to 5 mm wide, an average thickness of the wall is between 1 mm and 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 subcutaneous port of Daly such that an average of the wall is between 1 mm and 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 Daly 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.
With regard to claim 34, Daly discloses the claimed invention of claim 32, and Daly further discloses wherein an angle formed between the opposing surfaces of the wall is equal to or smaller than 20 degrees (the angle formed between the opposing surfaces of the wall 120 is equal to 0 degrees because the opposing surfaces are shown to be parallel with each other in Figure 1).
However, Daly is silent with regards to wherein the wall is 2 to 5 mm wide, an average thickness of the wall is between 1 mm and 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 subcutaneous port of Daly such that an average of the wall is between 1 mm and 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 Daly 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.
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.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
09/24/2026
