DETAILED ACTION
Response to Amendment
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/14/2025 has been entered.
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) 30-40 and 42-29 are rejected under 35 U.S.C. 103 as being unpatentable over Bootman et al. (US 4,543,088; hereafter Bootman) in view of Bourne et al. (US 9,168,365; hereafter Bourne).
In regard to claim 30, Bootman discloses an access port device (10) for intrathecal drug delivery in a patient in need thereof (see col. 6, lines 44-53), the access port device comprising a housing (16) and at least one biocompatible flange or skirt (28) extending radially from a lateral wall of the housing (see Fig. 1; see col. 3, lines 23-28 for biocompatible construction), wherein the at least one biocompatible flange or skirt (28) provides a greater surface area for suturing the access port device to a subcutaneous tissue of the patient during surgical implantation of the access port device (see col. 6, lines 13-33), and wherein the access port device is used for intrathecal drug delivery (see col. 6, lines 44-53).
Bootman fails to expressly disclose wherein the suturing can be done at any location in the at least one biocompatible flange or skirt as is recited in claim 30.
In a similar art, Bourne discloses an implantable port (10) comprising a flange or skirt (30) defining a perimeter region (35), wherein, in a particular embodiment, the perimeter region, in its entirety, can be made of a needle-penetrable material that is penetrable by a suture needle to define a large suture location. (see at least the Abstract, col. 6, lines 37-54, especially 47-53). This configuration allows the entire perimeter to serve as a suture location when the device is to be sutured into place subcutaneously. Bourne further teaches an advantage is to provide physician flexibility during insertion in that the suture locations do not have to be pre-planned before surgery (see col. 6, line 54- col. 7, line 6). A needle-penetrable skirt is one where suturing can be done at any location as is recited.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bootman with the needle- penetrable region as disclosed by Bourne in order to provide an art-recognized means for securing an implanted device in place and for providing the surgeon with flexibility before and during the surgery because the skirt can be sutured at any location.
In regard to claim 31, the combination teaches wherein the at least one biocompatible flange or skirt (28) extends along the entire circumference of the access port housing (see col. 6, lines 17-19 and Fig. 4 of Bootman and/or see Bourne, col. 6, lines 49-53).
In regard to claim 32, Bootman discloses wherein the at least one biocompatible flange or skirt (28) is composed of a stretchable, elastic biocompatible material (see col. 3, lines 23-28; silicone is stretchable and elastic biocompatible material). Bourne also discloses similar materials.
In regard to claim 33, Bootman discloses, wherein the stretchable, elastic biocompatible material is selected from the group consisting of: rubber, latex, silicone, and elastomer (see col. 3, lines 23-28; silicone is stretchable and elastic biocompatible material). Bourne also discloses similar materials.
In regard to claim 34, Bootman discloses wherein the at least one biocompatible flange or skirt (28) is an extension of the access port device (10) (28 extends from the outer wall and therefore can be considered an extension).
In regard to claim 35, Bootman discloses, wherein the at least one biocompatible flange or skirt (28) is secured to the access port device with a stretchable biocompatible material in a shape of a sleeve or sock (28 can be considered the sleeve or sock in this interpretation; see Figure 1; the shape of 28 is sleeve-like or sock-like and fits over the rest of the housing).
In regard to claim 36, Bootman discloses wherein the at least one biocompatible flange or skirt (28) extends along the entire circumference of the access port housing (see col. 6, lines 17-19 and Fig. 4 of Bootman and/or see Bourne, col. 6, lines 49-53).
In regard to claim 37, Bootman discloses wherein the at least one biocompatible flange or skirt (28) extends along a portion of the circumference of the access port housing (see col. 6, lines 17-21 and Fig. 4 of Bootman; Bootman discloses extending along portion or entirety of the periphery and/or see Bourne, col. 6, lines 49-53).
In regard to claim 38, Bootman discloses wherein the at least one biocompatible flange or skirt (28) consists of one biocompatible flange or skirt (see Figure 1).
In regard to claims 39-40, Bootman fails to disclose wherein the flange or skirt consists of two biocompatible flanges or skirts as is recited in claim 39, or three flanges or skirts as is recited in claim 40. In a similar art, Bourne discloses implantable ports with different numbers of flanges or skirts (72). See Figures 7-9 and 12. The number of flanges depends on the use of the device. Bourne discloses that any unused flanges or skirts can be cut. See Figure 21. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bootman with the ability to add or subtract flanges based on the need of the patient and/or procedure as taught by Bourne in order to provide a device with the desired number of suture locations. The examiner contends that 2 or 3 flanges are within a range of desired suture locations based on the disclosed embodiments of Bourne.
In regard to claim 42, please see the rejection of claim 30 as the examiner believes all of the limitations are addressed. The method is interpreted as providing the recited structure.
In regard to claim 43, the combination teaches wherein the at least one biocompatible flange or skirt (28) extends along the entire circumference of the access port housing (see col. 6, lines 17-19 and Fig. 4 of Bootman and/or see Bourne, col. 6, lines 49-53).
In regard to claim 44, please see the rejection of claim 32.
In regard to claim 45, please see the rejection of claim 33.
In regard to claim 46, please see the rejection of claim 34.
In regard to claim 47, please see the rejection of claim 35.
In regard to claim 48, please see the rejection of claim 36.
In regard to claim 49, please see the rejection of claim 37.
Response to Arguments
Applicant's arguments filed 11/14/2025 have been fully considered but they are not persuasive.
Applicant’s arguments are almost entirely moot because the base reference has been changed to Bootman which expressly discloses that the physical properties of the device can be chosen to meet the demands for intrathecal placement (see col. 6, lines 44-53).
The applicant’s arguments rely on the Declaration by one of the co-inventors, Dr. Pericles Calias, submitted on 11/14/2025 and entered with the RCE filed on 11/14/2025. The examiner thanks applicant for the submission of the declaration but the declaration is not found to be persuasive.
The main issue with the Arguments/Declaration is that the applicant is trying to tie the importance of the recited biocompatible flange/skirt to the feature of intrathecal delivery. See ¶5 of the Declaration and page 7 of the Remarks filed on 11/14/2025. However, the application, as filed, never links the biocompatible flange/skirt to improvement of intrathecal delivery. The applicant’s attention is drawn to par. [0054], [0057], and [0061] of the instant pg-publication US 2024/0335647. These paragraphs detail the importance of the disclosed/recited flange for providing greater surface area to generic subcutaneous tissue. There is no disclosure that the flange specifically improves intrathecal delivery.
In ¶6 of the Declaration, the applicant does point to disclosure (par. [0004]-[0005] of the Subject Application) that details issues with access port failure for intrathecal delivery but the examiner notes that these paragraphs assign the failure to the lack of ability to adjust the catheter length thereby causing downstream issues like dislodgement of catheters, migration of catheters, port separation with extravasation, suture disruption, and mechanical failure of the access port system. There is no disclosure the disclosed flange alleviates the issues with intrathecal access ports specifically. Applicant discloses other features that provide catheter length adjustment.
¶7-¶10 detail various issues with intrathecal delivery but are moot in view of the disclosure of Bootman. Bootman shows it is already known in the art to modify the size of the access device (10) to be configured for use in intrathecal delivery (see col. 6, lines 44-53). The flange (28) of Bootman is configured to extend around the entire periphery of the device (see col. 6, lines 17-19 and see Figure 4) and is equipped with multiple suture locations (30). Bourne is simply used to modify the flange to be suturable at all locations of the flange. It is inconsequential that Bourne fails to mention intrathecal delivery because Bootman already discloses intrathecal delivery.
For these reasons, the arguments and declaration are not considered to be persuasive. It is further noted that the arguments/declaration are moot in light of the new rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783