DETAILED ACTION
Response to Amendment
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 511. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 31, 36, 43, and 48 are objected to because of the following informalities:
Claims 31 and 36 are duplicate claims.
Claims 43 and 48 are duplicate claims.
Appropriate correction is required.
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 Flaherty et al. (US 5,695,490; hereafter Flaherty) in view of Bourne et al. (US 9,168,365; hereafter Bourne).
In regard to claim 30, Flaherty discloses an access port device (1) for intrathecal drug delivery in a patient in need thereof (see col. 2, lines 28-31, col. 3, lines 36-41), the access port device comprising a housing (cone-shaped portion of 2) and at least one biocompatible flange or skirt (7) extending radially from a lateral wall of the housing (see Fig. 1-8 and 10; see at least col. 4, line 36 for biocompatible construction), wherein the at least one biocompatible flange or skirt (7) 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 (via apertures 8; see col. 4, lines 35-39), and wherein the access port device is used for intrathecal drug delivery (see col. 2, lines 28-31, col. 3, lines 36-41).
Flaherty 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 Flaherty 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 (7) extends along the entire circumference of the access port housing (see Figs. 1 and 3 of Flaherty and/or see Bourne, col. 6, lines 49-53).
In regard to claim 32, Bourne teaches wherein the at least one biocompatible flange or skirt (30) is composed of a stretchable, elastic biocompatible material (see col. 8, line 63- col. 9, line 9).
In regard to claim 33, Bourne teaches, wherein the stretchable, elastic biocompatible material is selected from the group consisting of: rubber, latex, silicone, and elastomer (see col. 8, line 63- col. 9, line 9).
In regard to claim 34, Flaherty discloses wherein the at least one biocompatible flange or skirt (7) is an extension of the access port device (7 extends from the outer wall of the cone-shaped portion of 2 and therefore can be considered an extension).
In regard to claim 36, Flaherty discloses wherein the at least one biocompatible flange or skirt (7) extends along the entire circumference of the access port housing (see Figs. 1 and 3 of Flaherty and/or see Bourne, col. 6, lines 49-53).
In regard to claim 37, Flaherty discloses wherein the at least one biocompatible flange or skirt (7) extends along a portion of the circumference of the access port housing (see Figs. 1 and 3 of Flaherty; Bootman discloses extending along portion or entirety of the periphery and/or see Bourne, col. 6, lines 49-53).
In regard to claim 38, Flaherty discloses wherein the at least one biocompatible flange or skirt (7) consists of one biocompatible flange or skirt (see Figure 1).
In regard to claims 39-40, Flaherty 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 Flaherty 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 (7) extends along the entire circumference of the access port housing (see Figs. 1 and 3 of Flaherty 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 48, please see the rejection of claim 36.
In regard to claim 49, please see the rejection of claim 37.
Allowable Subject Matter
Claims 35 and 47 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.
Response to Arguments
The applicant’s remarks regarding claims 35 and 47 are considered persuasive. The new reference Flaherty ‘490 also fails to disclose the recited structure of claims 35 and 47 and therefore these claims are indicated as allowable above.
The new reference Flaherty ‘490 more explicitly discloses intrathecal drug delivery and the associated structure for intrathecal delivery.
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See 892.
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
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