DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/30/26 has been entered.
Response to Amendment
The amendment filed 01/30/26 has been entered. Claim 13 has been amended. Claims 14-17 are in the original/ previously presented form. Claims 1-6 are cancelled. Claims 7-12 and 18-26 remain withdrawn. Thus, claims 13-17 are under examination in the application. Applicant’s amendments to the Claims have overcome each and every objection and 112(b) rejection previously set forth in the Final Office Action mailed 10/30/25.
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.
Claims 13-17 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.
Regarding claim 13, line 2-6 include a claim amendment and recite “a catheter tube, wherein the catheter tube comprises a proximal end and a distal end; a catheter tip; an anchoring device, wherein the anchoring device is configured for anchoring the distal end into deep dorsal fascia or musculature and wherein the catheter tip is configured for coupling to the catheter tube after anchoring of the distal end”. Applicant points to [0039] and [0042] for support for the claim amendment (see page 9 of Applicant Remarks filed 01/30/26). [0039] of the current Application discloses that the distal end of a distal catheter is anchored at the distal end. [0042] of the current Application discloses that this distal catheter is then coupled (at the distal catheter proximal end) to a separate catheter tube. Thus, Applicant discloses that the distal catheter with catheter tip is the anchored portion of the device.
Thus, in view of Applicant disclosure, the claim language “wherein the catheter tip is configured for coupling to the catheter tube after anchoring of the distal end” is unclear because the language implies that the distal end of the catheter tube is anchored (instead of the distal end of the distal catheter comprising the catheter tip being anchored).
Therefore, for purposes of examination and to ensure the claim language is supported by and aligns with Applicant disclosure, the examiner interprets claim 13 to read:
“A pumpless, implantable nerve blocking device comprising:
a catheter tube, wherein the catheter tube comprises a proximal end and a distal end;
a distal catheter comprising a catheter tip;
an anchoring device, wherein the anchoring device is configured for anchoring the distal [[end]] catheter into deep dorsal fascia or musculature and wherein the catheter tip is configured for coupling to the catheter tube after anchoring of the distal [[end]] catheter; and
a percutaneous access port, wherein the percutaneous access port comprises a septum, wherein the implantable nerve blocking device is configured for fluid injection through the septum into and through the catheter tube, wherein the septum is in fluid communication with the catheter tube via the proximal end such that fluid injected through the septum flows into and through the catheter tube from the proximal end to the distal end without a force provided by an implanted, subcutaneous pumping component, and wherein the catheter tip is configured to direct the injected fluid to contact nerves post coupling to the catheter tube.”
Due to claim dependency, claims 14-17 are subsequently rejected under 112b unless further explained below.
Regarding claim 15, lines 1-2 recite “wherein the anchoring device is configured to anchor the distal end in a prevertebral location.” Similar to claim 13, this language implies that the distal end of the proximally located/ separate catheter tube is the tube anchored at the distal end (instead of the catheter tip of the distal catheter being anchored as in at least Applicant disclosure of [0039] and [0042]). Therefore, for purposes of examination and to ensure the claim language is supported by and aligns with Applicant disclosure, the examiner interprets claim 15 lines 1-2 to read “wherein the anchoring device is configured to anchor the distal [[end]] catheter in a prevertebral location”.
Regarding claim 16, lines 1-2 recite “wherein the anchoring device is configured to anchor the distal end in a paravertebral location.” Similar to claim 13, this language implies that the distal end of the proximally located/ separate catheter tube is the tube anchored at the distal end (instead of the catheter tip of the distal catheter being anchored as in at least Applicant disclosure of [0039] and [0042]). Therefore, for purposes of examination and to ensure the claim language is supported by and aligns with Applicant disclosure, the examiner interprets claim 15 lines 1-2 to read “wherein the anchoring device is configured to anchor the distal [[end]] catheter in a paravertebral location”.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13 and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cassada (U.S. PGPUB No. 2009/0149838).
Regarding claim 13, Cassada discloses a pumpless, implantable nerve blocking device (see FIG. 5 and [0020]: FIG. 5 shows a method using a device embodiment in a patient body, such as the device embodiment shown in FIG. 2) comprising:
a catheter tube (26, see FIG. 2 and [0032-0033]), wherein the catheter tube (26) comprises a proximal end (28, see [0032] and ‘Modified FIG. 2’ below) and a distal end (30, see [0033] and ‘Modified Fig. 2’ below);
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a distal catheter (40, see ‘Modified FIG. 2’ above and [0034-0035]) comprising a catheter tip (44, see [0035]);
an anchoring device (a suture, see [0045]: portion of tube comprising the tip is anchored by suture), wherein the anchoring device (a suture) is configured for anchoring the distal [[end]] catheter (40 with tip 44) into deep dorsal fascia or musculature (a suture is placed by physician by choice and is therefore “configured for” anchoring into deep dorsal fascia or musculature) and wherein the catheter tip (44) is configured for coupling to (see [0033-0034]: coupling member 34 as seen in FIG. 2 couples catheter tube 26 to distal catheter 40 comprising the catheter tip 44 to establish fluid flow from reservoir. Therefore the catheter tip of the catheter distal end is “configured for coupling” to the catheter tube by way of the proximal end 42 of the distal catheter 40 that connects to the coupling member 34) the catheter tube (26) after anchoring (coupling member 34 located at the opposite end of the tip and therefore is “configured to” couple “after” anchoring because the manipulation of the opposite end to couple the distal catheter would not disturb the previously set anchoring device) of the distal [[end]] catheter (40); and
a percutaneous access port (12), wherein the percutaneous access port (12) comprises a septum (22, see [0030]: septum 22 repeatedly accessible by cannula for refilling reservoir), wherein the implantable nerve blocking device (as seen in FIG. 5) is configured for fluid injection through the septum (22) into and through (see [0046-0048]: cannula 68 introduces medicine by penetrating septum and fluid pressure drives medicine through catheter tube to contact nerve tissue 62 at the distal catheter tip) the catheter tube (26, see [0033-0034]), wherein the septum (22) is in fluid communication with the catheter tube (26) via the proximal end (28, see FIG. 2 and [0032]) such that fluid injected through the septum (22) flows into and through (see [0032-0035]) the catheter tube (26) from the proximal end (28) to the distal end (30) without a force provided by an implanted, subcutaneous pumping component (see [0047]: force to drive fluid provided by fluid pressure via, see [0048]: in an example, a syringe), and wherein the catheter tip (44) is configured to direct the injected fluid to contact nerves (see [0047]: medicine flows through apertures 46, seen in FIG. 2, of catheter tip to contact nerves) post coupling to (see [0032-0035]: coupling to member 34 must be established before fluid flow can be provided to catheter tip) the catheter tube (26).
Regarding claim 15, Cassada discloses the pumpless, implantable nerve blocking device of claim 13, and Cassada further discloses wherein the anchoring device (a suture, see [0045]: portion of tube comprising the tip is anchored by suture) is configured to anchor the distal [[end]] catheter (tube 40 comprises tip 44 in FIG.2)in a prevertebral location (see [0050]: tube can be implanted above any muscle or bone tissue under the skin and [0045]: suture is optionally provided anywhere along the tube comprising the tip. Therefore, the device is “configured to” anchor the distal end of the tube in a prevertebral location because the distal end of the tube may be optionally anchored above any muscle or bone tissue.).
Regarding claim 16, Cassada discloses the pumpless, implantable nerve blocking device of claim 13, and Cassada further discloses wherein the anchoring device (a suture, see [0045]: portion of tube comprising the tip is anchored by suture) is configured to anchor the distal [[end]] catheter (tube 40 comprises tip 44 in FIG.2) in a paravertebral location (see [0050]: tube can be implanted above any muscle or bone tissue under the skin and [0045]: suture is optionally provided anywhere along the tube comprising the tip. Therefore, the device is “configured to” anchor the distal end of the tube in a paravertebral location because the distal end of the tube may be optionally anchored above any muscle or bone tissue.).
Regarding claim 17, Cassada discloses the pumpless, implantable nerve blocking device of claim 13, and Cassada further discloses wherein the catheter tube (26, see FIG. 2) is in fluid communication with (see [0046-0048]: fluid introduced to tube through port 12 and therefore the tube and port MUST be in fluid communication in order to enable delivery of fluid to nerves as disclosed. See further description of fluid communication in [0032-0035] for specific device of FIG. 2) the percutaneous access port (12).
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Cassada as applied to claim 13 above, and further in view of Huntoon (U.S. PGPUB No. 2012/0323219).
Regarding claim 14, Cassada discloses the pumpless, implantable nerve blocking device of claim 13, but Cassada is silent to “wherein the anchoring device comprises a non-crimping anchor”
However, Huntoon discloses an implantable nerve blocking device (104, see FIG.1 and [0042]: drug eluting implant 104 delivers drugs to sites such as, see [0039]: nerves) comprising an anchoring device (108), wherein the anchoring device (108) comprises a non-crimping anchor (see [0042] & [0049]: an anchoring screw).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the suturing anchoring device disclosed in Cassada with the non-crimping anchor taught by Huntoon for the purpose of ensuring that the implant can remain implanted at a treatment site for a certain amount of time before removal (see [0049]), thus achieving “wherein the anchoring device comprises a non-crimping anchor”.
Response to Arguments
Applicant's arguments filed 01/30/26 have been fully considered but they are not persuasive.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections. Although Applicant states that Cassada fails to disclose the coupling between the catheter tube and catheter tip (see at least page of Applicant remarks), this statement is not further explained.
Thus, the examiner maintains that Cassada teaches the coupling (see evidence as cited in the rejection of claim 13 above).
However, to further expedite prosecution, the examiner has provided another reference (see conclusion section below, Rajendran) that would also meet the coupling limitation as argued and claimed. Applicant is encouraged to further amend the claims to recite structural components that distinguish the current invention from the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Rajendran et al. (U.S. PGPUB No. 2014/0316327) teaches an implantable nerve blocking device (see FIG. 1 and [0165]) with a distal catheter (102) and proximal catheter tube (112) coupled together (see coupling hub 104 and [0166]) to supply medication to nerves (106) using a pump (110, see [0166]). It would be obvious to substitute the pump of Rajendran with a refillable implantable device pump, such as that taught in Cassada, to enhance patient mobility and/or refill the medicament at predetermined periods instead of continuously.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783