DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The claim objections have been withdrawn in light of amendments.
The 35 USC § 112(b) rejections have been withdrawn in light of amendments.
Response to Arguments
Applicant's arguments filed on August 4th, 2026, have been fully considered.
With regards to applicant’s argument under “Rejections Under 35 U.S.C. § 103” on pages 6-9 of Remarks, “Tal fails to teach or suggest a single port body member that both defines a reservoir and transitions between expanded and collapsed configurations.” for claim 1, have been fully considered but they are not persuasive. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., single port body) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With regards to applicant’s argument under “Rejections Under 35 U.S.C. § 103” on pages 6-9 of Remarks, “The Tal port body extension 65 contributes nothing to the asserted reservoir, cavity 63.” and “does not disclose that the structure defining the reservoir transitions between expanded and collapsed configurations” for claim 1, have been fully considered but they are not persuasive. Tal expressly describes the port body being interlockable with the port body extension to form a unified structure having a final shape and size (Para [0085]). Thus, the port body and the extensions of Tal collectively constitute the port body structure disclosed by claim 1. Even though the reservoir may be primarily defined by a portion of the unified port body structure, it does not negate the port body structure, including the extensions, transitions between the expanded and collapsed configuration.
Applicant’s arguments, see Remarks, page 10, filed 08/04/2026, with respect to the rejection(s) of claim(s) 1-20 under 35 U.S.C. § 103, regarding the remark, “which teaches the expanded configuration of FIG. 3C has a lower surface-area-to-volume ratio, appears to contradict rather than support the assertions of the Office Action that "the collapsed configuration defining a smaller overall profile."” 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 different interpretation of the previously applied reference.
With regards to applicant’s argument under “Rejections Under 35 U.S.C. § 103” on page 11 of Remarks, “Olsen's diaphragm 105 is an internal membrane within a rigid housing, not a body that transitions to a smaller overall profile” for claim 1, have been fully considered but they are not persuasive. Olsen is relied upon for teaching the use of a shape memory material in a structure, not for teaching the entirety of the claimed port body. The rejection relies on the combination of Tal and Olsen, wherein the port body of Tal is modified to include the shape memory material taught by Olsen.
With regards to applicant’s argument under “Rejections Under 35 U.S.C. § 103” on page 11 of Remarks, “A superelastic, recoverably deformable port body 61 would be unable to deform port body extension 65 as Tal requires, rendering Tal unsatisfactory for its intended purpose.” for claim 1, have been fully considered but they are not persuasive. As discussed above, the port body and the port body extensions of Tal are described as being combined to form a unified structure. Accordingly, the claimed “body” is reasonably mapped to the unified port body structure including the port body and the port body extensions. The shape memory material taught by Olsen may therefore be provided in a portion of that unified structure, including the port body extensions, without requiring the entire unified body to be formed of the shape memory material. Further, applicant has not identified any claim limitation that the entirety of the port body is of a shape memory material, rather “a body including a shape memory material”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1, 5-8 and 19-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tal (WO 2021007287 A1) in view of Olsen et al. (US Pub No. 20070043335 A1, Herein, Olsen), for ease of discussion, the examiner will be referencing the foreign reference document (Tal), submitted by the applicant on 05/24/2024.
Regarding claim 1, Tal discloses a subcutaneous access system, comprising:
a catheter (15 – Fig.1A) defining a lumen (16 – Fig.1A); and
a port (60 – Fig.3A, Para [0140]) comprising:
a port stem (25 – Fig.2A) configured to engage the catheter and provide fluid communication therewith (“configured for providing fluid communication between the cavity and a lumen” – Para [0140]);
a body (61, 65 – Fig.3A) and defining a reservoir (63 – Fig.3A) in fluid communication with the port stem (“an outlet (fluidly connected to the inlet) in a lower (inferior) portion thereof in proximity to rear (proximal) end of port body which is optionally opened to a connector” – Para [0140]), the body transitionable between an expanded configuration (Fig.3C) and a collapsed configuration (Fig.3B, Para [0141]), the collapsed configuration defining a smaller overall profile (Fig.3B, Fig.3C, the examiner interprets “a smaller overall profile” as a reduction in an overall dimension of the body, such as the width, this interpretation is consistent with Figs.3B and 3C, the body in Fig.3C is in an expanded configuration, wherein the portions of the body extend outwardly and thereby define a larger overall profile, while the body in Fig.3B is in the collapsed configuration, wherein portions of the body are retracted/inwardly positioned, thereby defining a smaller overall profile); and
a needle penetrable septum (62 – Fig.3A) disposed over the reservoir and configured to provide percutaneous access thereto (“needle access opening or septum, which is sized and shaped for repeatedly receiving a needle tip” – Para [0120]).
However, Tal does not expressly disclose wherein the body includes a shape memory material.
Olsen teaches a body (101 – Fig.2) including a shape memory material (105 – Fig.2, “shape memory alloy metal such as NITINOL ” – Para [0038]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the port body of Tal to include a shape memory material, Nitinol, as taught by Olsen since Olsen teaches that shape memory material, Nitinol, is superelastic and capable of undergoing large elastic deformation or strain when compared to typical metals, allowing for the port body to undergo a recoverable deformation between a collapsed configuration and an expanded configuration, thereby improving deployability while maintain structural integrity (Olsen, Para [0038]).
Regarding claim 5, Tal discloses the subcutaneous access system, as modified above, wherein the shape memory material includes a metal, composite, or an alloy and includes one of nickel, titanium, zinc, copper, gold, iron, aluminum, a copper-aluminum-nickel alloy, a nickel-titanium alloy, or Nitinol (Olsen, “shape memory alloy metal such as NITINOL” – Para [0038]).
Regarding claim 6, Tal discloses the subcutaneous access system, as modified above, wherein the body in the expanded configuration defines one of a first port height, a first port width, or a first port length (Fig.3C), and wherein the body in the collapsed configuration defines one of a second port height, a second port width, or a second port length (Fig.3B, “unified structure being greater in length, width and/or height than the port body alone in the delivery configuration.” – Para [0130]).
Regarding claim 7, Tal discloses the subcutaneous access system, as modified above, wherein one of the second port height is less than the first port height, the second port width is less than the first port width, or the second port length is less than the first port length (“unified structure being greater in length, width and/or height than the port body alone in the delivery configuration.” – Para [0130]).
Regarding claim 8, Tal discloses the subcutaneous access system, as modified above, wherein the body in the expanded configuration defines a first port volume, and the body in the collapsed configuration defines a second port volume, the second port volume being less than the first port volume (“expand or increase in cross section or volume” – Para [0130]).
Regarding claim 19, Tal discloses the subcutaneous access system, as modified above, but Tal does not explicitly disclose wherein the body includes one of a frame, a shell, a honeycomb or an exoskeleton morphology formed of the shape memory material.
Olsen teaches wherein a body (101 – Fig.2) includes one of a frame, a shell, a honeycomb or an exoskeleton morphology formed of the shape memory material (105 – Fig.2, “The diaphragm is made from a shape memory alloy metal such as NITINOL” – Para [0038]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the port body of Tal, as modified, to include a frame as taught by Olsen since the superelastic metal materials allow for the frame to be displaced many cycles while encountering large strain and not fracture allowing the body to undergo a recoverable deformation between a collapsed configuration and an expanded configuration, thereby improving deployability while maintain structural integrity (Olsen, Para [0038]).
Regarding claim 20, Tal discloses the subcutaneous access system, as modified above, further including a second material different from the shape memory material and disposed thereon to form a continuous outer profile (“ silicon septum” – Para [0193]).
Claims 2, 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Tal in view of Olsen as applied to claim 1 above, and further in view of Eckert (US Pub No. 20160213399 A1).
Regarding claim 2, Tal discloses the subcutaneous access system, as modified above, but Tal does not disclose wherein the port stem includes the shape memory material and is configured to transition between an expanded configuration and a collapsed configuration.
Eckert teaches a lumen (10 – Fig.5A) including a shape memory material (32 – Fig.5A, “a shape memory material, such as nitinol ” – Para [0043]) and is configured to transition between an expanded configuration (Fig.5B) and a collapsed configuration (Fig.5A).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the port stem of Tal to include shape memory material and configure it to transition between an expanded configuration and a collapsed configuration as taught by Eckert Since Eckert teaches that shape memory material is a well-known material to be used in a lumen and the lumen may be transitioned to an expanded state which would permit an increased fluid flow rate through the lumen, which would allow for faster fluid delivery to the patient (Eckert, Para [0035]).
Regarding claim 3, Tal discloses the subcutaneous access system, as modified above, but does not disclose wherein the port stem in the collapsed configuration defines a first outer stem diameter, and the port stem in the expanded configuration defines a second outer stem diameter, the second outer stem diameter being larger than the first outer stem diameter.
Eckert teaches a lumen (10 – Fig.5A) in a collapsed configuration (Fig.5A) defining a first outer lumen diameter, and the lumen in the expanded configuration (Fig.5B) defines a second outer lumen diameter, the second outer stem diameter being larger than the first outer lumen diameter (“the contracted state to the expanded state causes the cross sectional area of the needle and the inner diameter of the needle to increase” – Para [0035]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the port stem of Tal, as modified, wherein the port stem in the collapsed configuration defines a first outer stem diameter, and the port stem in the expanded configuration defines a second outer stem diameter, the second outer stem diameter being larger than the first outer stem diameter as taught by Eckert since Eckert teaches that the lumen may be transitioned to an expanded state to permit an increased fluid flow rate through the lumen, which would allow for faster delivery of fluids to the patient (Para [0035]).
Regarding claim 4, Tal discloses the subcutaneous access system, as modified above, wherein Tal discloses the port stem as capable of transitioning between an expanded configuration and a collapsed configuration but Tal does not expressly disclose wherein the first outer stem diameter is less than an inner lumen diameter of the catheter in a relaxed state and the second outer stem diameter is greater than the inner lumen diameter of the catheter in the relaxed state.
However, It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to dimension the stem such that, in a relaxed state, the first outer stem diameter is less than the inner lumen diameter of the catheter to permit insertion and advancement within the lumen of the catheter, and such that, in an expanded configuration, the second outer stem diameter is greater than the inner lumen diameter to provide engagement, sealing, or retention within the catheter. A person of the ordinary skill would have been motivated to select these dimensions to ensure ease of insertion through the catheter’s lumen and secure position or sealing upon expansion, which are well-known and predictable considerations in catheter-based systems.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Tal in view of Olsen as applied to claim 1 above, and further in view of Bansal (GB 2489518 A), for ease of discussion, the examiner will be referencing the foreign reference document (Bansal), submitted by the applicant on 05/24/2024.
Regarding claim 9, Tal discloses the subcutaneous access system, as modified above, but Tal does not expressly disclose wherein the reservoir in the expanded configuration defines one of a first reservoir height, a first reservoir width, or a first reservoir length, and wherein the reservoir in the collapsed configuration defines one of a second reservoir height, a second reservoir width, or a second reservoir length.
Bansal teaches a port (12 – Fig.6) with a reservoir (32 – Fig.6) in an expanded configuration defining one of a first reservoir height, a first reservoir width, or a first reservoir length (Fig.7B), and wherein the reservoir in an collapsed configuration defines one of a second reservoir height, a second reservoir width, or a second reservoir length (Fig.7A).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the reservoir of Tal wherein in the expanded configuration defines one of a first reservoir height, a first reservoir width, or a first reservoir length, and wherein the reservoir in the collapsed configuration defines one of a second reservoir height, a second reservoir width, or a second reservoir length as taught by Bansal since Bansal teaches a port that is switchable between a compressed state for insertion through the skin and an uncompressed state minimizes tissue damage during implantation (Bansal, Page.3, lines 10-13).
Regarding claim 10, Tal discloses the subcutaneous access system, as modified above, wherein one of the second reservoir height is less than the first reservoir height, the second reservoir width is less than the first reservoir width, or the second reservoir length is less than the first reservoir length (Bansal, Fig.7A, Fig.7B).
Regarding claim 11, Tal discloses the subcutaneous access system, as modified above, but Tal does not expressly disclose wherein the reservoir in the expanded configuration defines a first reservoir volume, and the reservoir in the collapsed configuration defines a second reservoir volume, the second reservoir volume being less than the first reservoir volume.
Bansal teaches a port (12 – Fig.6) wherein a reservoir (32 – Fig.6) in an expanded configuration defines a first reservoir volume, and the reservoir in an collapsed configuration defines a second reservoir volume, the second reservoir volume being less than the first reservoir volume (Fig.7A, Fig.7B, Page. 14, lines 1-10).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the reservoir of Tal wherein in the expanded configuration defines a first reservoir volume, and the reservoir in the collapsed configuration defines a second reservoir volume, the second reservoir volume being less than the first reservoir volume as taught by Bansal since Bansal teaches a port that is switchable between a compressed state for insertion through the skin and an uncompressed state minimizes tissue damage during implantation (Bansal, Page.3, lines 10-13).
Claims 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Tal in view of Olsen as applied to claim 1 above, and further in view of Hong et al. (US Pub No. 20130237929 A1, herein, Hong).
Regarding claim 12, Tal discloses the subcutaneous access system, as modified above, wherein the port’s body may be used between a martensitic or an austenite phase (Olsen, Para [0038]) but Tal does not disclose wherein the body at a first temperature can transition from the collapsed configuration to the expanded configuration, and the body at a second temperature can transition from the expanded configuration to the collapsed configuration.
Hong teaches a port (330 – Fig.13A) comprising a body (332a, 332b – Fig.13A), wherein the body at a first temperature (“martensitic at or below ambient temperature, e.g., below twenty degrees Celsius (20º C.)” – Para [0103]) can transition from the collapsed configuration to the expanded configuration (Para [0103]), and the body at a second temperature (“at thirty seven degrees Celsius (37º C.) or higher, the bands 350 may be substantially austenitic” – Para [0103]) can transition from the expanded configuration to the collapsed configuration (Para [0103]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the body of Tal, as modified, to comprise the first and second temperatures taught by Hong wherein the body at the first temperature can transition from the collapsed configuration to the expanded configuration, and the body at the second temperature can transition from the expanded configuration to the collapsed configuration as taught by Hong since this allows the body of the port to be relatively soft and/or plastically deformable, which may facilitate manipulation, introduction, or implantation of the port and to recover any desired shape programmed into the material and to provide elastic or superelastic properties to the port once the port is implanted within a patient's body, thereby improving deliverability while maintaining structural integrity of the port once implanted (Hong, Para [0103]).
Regarding claim 13, Tal discloses the subcutaneous access system, as modified above, wherein the first temperature is equal to or greater than 98.6° F. (37° C.) (Hong, “at thirty seven degrees Celsius (37º C.) or higher “ – Para [0103]) and the second temperature is less than 98.6° F. (37° C.) (Hong, “ below twenty degrees Celsius (20º C.)” – Para [0103]).
Regarding claim 14, Tal discloses the subcutaneous access system, as modified above, wherein the first temperature is greater than 98.6° F. (37° C.)(Hong, “at thirty seven degrees Celsius (37º C.) or higher “ – Para [0103]) and the second temperature is equal to or less than 98.6° F. (37° C.)(Hong, “ below twenty degrees Celsius (20º C.)” – Para [0103]).
Regarding claim 15, Tal discloses the subcutaneous access system, as modified above, wherein the body at the second temperature is configured to be plastically deformable (Hong, “may be relatively soft and/or plastically deformable” – Para [0103]).
Regarding claim 16, Tal discloses the subcutaneous access system, as modified above, wherein the body at the first temperature is in an austenite phase (Hong, “At around body temperature… may be substantially austenitic” – Para [0103]), and the body at the second temperature is in a martensite phase (Hong, “substantially martensitic at or below ambient temperature” – Para [0103]).
Allowable Subject Matter
Claims 17-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/MARISSA TAYLOR/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
