DETAILED ACTION
This is in response to the Patent Application filed 9/28/2023 wherein claims 1-29 are presented for examination.
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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “drug reservoir comprises a drug refill port fluidly connected to the drug reservoir, the drug refill port configured to receive a drug from an external source and to provide a fluidic path to the drug reservoir” (Claim 20, lines 1-3), the “drug reservoir is an implantable drug reservoir” (Claim 21, lines 1-2), the “pump communicably coupled to the drug reservoir and configured to move a drug from the drug reservoir to the implant via the tube” (Claim 22, lines 1-3), the ”pump comprises an additional drug refill port through which the drug reservoir can be filled” (Claim 23, lines 1-2), the “pump is an implantable pump” (Claim 24, lines 1-2), and the “drug reservoir is implanted in the head, the neck, or the abdominal wall of the subject” (Claim 27, lines 3-4) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 1-4, 6-8, 11-15, 18-19, 22, 26, and 27 are objected to because of the following informalities:
“the apertures” (Claim 1, line 4; Claim 11, line 2; Claim 12, line 2; and Claim 13, line 2) is believed to be in error for - - the one or more apertures - -;
“the body” (Claim 1, line 5; Claim 1, line 6; Claim 14, line 2; and Claim 15, line 2) is believed to be in error for - - the distal body - -;
“the support members” (Claim 1, line 6; Claim 2, line 1; Claim 3, lines 1-2; Claim 4, lines 2-3; Claim 6, line 2; Claim 7, line 2; Claim 8, line 2; Claim 11, line 2; Claim 12, line 3; and Claim 13, line 3) is believed to be in error for - - the pair of support members - -;
“the distal portion” (Claim 18, line 2; and Claim 18, line 3) is believed to be in error for - - the distal body - -;
“the implant” (Claim 19, line 4; Claim 22, line 3; and Claim 27, line 2) is believed to be in error for - - the implantable device - -;
“a target location” (Claim 26, line 2) is believed to be in error for - - the target location - -;
“the head” (Claim 27, line 3) is believed to be in error for - - a head - -;
“the neck” (Claim 27, line 3) is believed to be in error for - - a neck - -;
“the abdominal wall” (Claim 27, lines 3-4) is believed to be in error for - - an abdominal wall - -.
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.
Claims 1-29 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 1 recites the limitation "the apertures" in line 4. It is unclear how many apertures are required by the claim, since line 3 of claim 1 recites “one or more” apertures, and line 4 requires a plurality of “apertures”.
Claim 1 recites the limitation "the body" in line 5 and line 6. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-29 are rejected for the same reasons discussed above based on their dependency to claim 1.
Claim 18 recites the limitation "the distal portion" in line 2 and line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the implant" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claims 20-24 are rejected for the same reasons discussed above based on their dependency to claim 19.
Claim 26 recites the limitation "a target location" in kune 2. It is unclear if this “target location” is the same “target location” that is recited in line 5 of claim 25 or a different target location.
Claim 27 recites the limitation "the implant" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 28 is rejected for the same reasons above based on its dependency to claim 20.
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.
Claims 1-8, 11-14, 18, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cichocki, JR. et al. (US 2021/0077781).
Regarding Independent Claim 1, Cichocki teaches (Figures 1-28C) an implantable device (100) for drug delivery (see title), the implantable device (100) comprising:
a distal body (102) having a wall (116) extending from a proximal end (104) to a distal end (106), and a lumen (122; see abstract, Paragraph 0136, and Figures 2D and 3) extending therethrough in a longitudinal direction (see Figures 2A-3), the distal body (102) comprising one or more apertures (110) located along the wall (116), the apertures (110) being in fluid communication with (see Figure 3 and Paragraph 0135) the lumen (122); and
a pair of support members (108) protruding from the body (102) in a transverse direction (see Figures 2A-2E) and extending along the body (102) in the longitudinal direction (see Figures 2A-2E), wherein the support members (108) are separated by a gap distance (the distance between adjacent barbs 108) that extends along in the longitudinal direction (see Figures 2C-2E).
Regarding Claim 2, Cichocki teaches the invention as claimed and as discussed above. Cichocki further teaches (Figures 1-28C) wherein the support members (108) are substantially parallel to one another in the transverse direction (see Figures 2C-2E).
Regarding Claim 3, Cichocki teaches the invention as claimed and as discussed above. Cichocki further teaches (Figures 1-28C) wherein the support members (108) extends in the same direction along a transverse plane (a direction outward from 116; see Figures 2C-2E).
Regarding Claim 4, Cichocki teaches the invention as claimed and as discussed above. Cichocki further teaches (Figures 1-28C) wherein the distal body (102) has a circular cross-section along a transverse plane (see Figure 2D), and wherein the support members (adjacent 108 extending from the lower portion of 102) are disposed on a minor arc portion of the circular cross-section (see Figures 2C-2D).
Regarding Claim 5, Cichocki teaches the invention as claimed and as discussed above. Cichocki further teaches (Figures 1-28C) wherein the minor arc portion of the circular cross-section (the portion of the cross section where adjacent support members 108 extend from 102) is less than 25% of a circumference of the circular cross-section (see Figures 2C-2D).
Regarding Claim 6, Cichocki teaches the invention as claimed and as discussed above. Cichocki further teaches (Figures 1-28C) wherein the support members (108) have a rectangular shape along the transverse plane (see Figure 2D).
Regarding Claim 7, Cichocki teaches the invention as claimed and as discussed above. Cichocki further teaches (Figures 1-28C) wherein the support members (108) have a rectangular shape along the longitudinal plane (see Figure 2E).
Regarding Claim 8, Cichocki teaches the invention as claimed and as discussed above. Cichocki further teaches (Figures 1-28C) wherein the support members (108) is an elongate fin (see Figures 2C-2E).
Regarding Claim 11, Cichocki teaches the invention as claimed and as discussed above. Cichocki further teaches (Figures 1-28C) wherein the apertures (110) are located along the wall (116) at about 90 degrees from (see Figure 2D) the support members (108).
Regarding Claim 12, Cichocki teaches the invention as claimed and as discussed above. Cichocki further teaches (Figures 1-28C) wherein the apertures (110) are located along the wall (116) from about 90 degrees to about 180 degrees (see Figure 2D) from the support members (108).
Regarding Claim 13, Cichocki teaches the invention as claimed and as discussed above. Cichocki further teaches (Figures 1-28C) wherein the apertures (110) are located along the wall (118) from about 10 degrees to no more than 90 degrees (see Figures 2A-2D) from the support members (108).
Regarding Claim 14, Cichocki teaches the invention as claimed and as discussed above. Cichocki further teaches (Figures 1-28C) wherein the body (102) has a length of about 30mm to about 60 mm (the barbed microcatheter has a length of about 2 inches, about 50 mm; see Paragraph 0135).
Regarding Claim 18, Cichocki teaches the invention as claimed and as discussed above. Cichocki further teaches (Figures 1-28C) further comprising a collar (112) coupled at the proximal end (104) of the distal portion (102), wherein the collar (112) has a wall thickness that is greater than (see Figure 1) a wall thickness of the distal portion (104).
Regarding Claim 19, Cichocki teaches (Figures 1-28C) a system for drug delivery (see title, abstract, and Figures 27A-27C), the system comprising:
the implantable device of claim 1 (100, discussed above);
a drug reservoir (599); and
a tube (see Figure 27C) fluidly connecting the implant (500) to the drug reservoir (599).
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.
Claims 1, 4, 9, 15, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Muni et al. (US 2006/0106361).
Regarding Independent Claim 1, Muni teaches (Figures 1-11C) an implantable device for drug delivery (100; see abstract and Paragraph 0095), the implantable device (100) comprising:
a distal body (240) having a wall (242) extending from a proximal end (the lower portion of Figure 4L) to a distal end (the upper portion of Figure 4L), and a lumen (104) extending therethrough in a longitudinal direction (see Figure 4L), the distal body (240) comprising one or more apertures (248) located along the wall (242), the apertures (248) being in fluid communication (via 244) with the lumen (104).
Muni’s Figure 4L embodiment does not teach a pair of support members protruding from the body in a transverse direction and extending along the body in the longitudinal direction, wherein the support members are separated by a gap distance that extends along in the longitudinal direction.
The embodiment of Figure 6E of Muni teaches a pair of support members (an adjacent two of 354; see Figure 6E) protruding from the body (at 106) in a transverse direction (see Figure 6E) and extending along the body in the longitudinal direction (see Figure 6E), wherein the support members (an adjacent two of 354) are separated by a gap distance (separated by 90 degree intervals) that extends along in the longitudinal direction (see Figure 6E).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Figure 4L embodiment of Muni to have a pair of support members protruding from the body in a transverse direction and extending along the body in the longitudinal direction, wherein the support members are separated by a gap distance that extends along in the longitudinal direction, as taught by the Figure 6E embodiment of Muni, in order to prevent slipping of the substance delivery device out of an anatomical opening (Paragraph 0148 of Muni).
Regarding Claim 4, Muni teaches the invention as claimed and as discussed above. Muni further teaches (Figures 1-11C) wherein the distal body (at 106) has a circular cross-section along a transverse plane (see Figure 6E), and wherein the support members (an adjacent two of 354) are disposed on a minor arc portion of the circular cross-section (at a 90 degree interval; see Figure 6E).
Regarding Claim 9, Muni teaches the invention as claimed and as discussed above. Muni further teaches (Figures 1-11C) wherein the gap distance (the space between adjacent arms 354 of 106) is configured to engage tissue during implantation (the tissue surrounding the sinus; see Figures 4B-4E and 6E).
Regarding Claim 15, Muni teaches the invention as claimed and as discussed above. Muni further teaches (Figures 1-11C) wherein the body has an outer diameter of about 1mm to about 3mm (the device may be sized to maintain a desired diameter of a surgically enlarged or dilated opening of about 2 mm; see Paragraph 0164 of Muni).
Regarding Claim 17, Muni teaches the invention as claimed and as discussed above. Muni further teaches (Figures 1-11C) wherein the gap distance between the pair of support members is about 1 mm to about 3 mm (since the devices is sized to maintain a desired diameter of about 2mm or a 6.28 mm circumference, leading to a gap distance of about 1.57 mm when the support members are distributed at 90 degree intervals; see Figure 6E and Paragraph 0164).
Regarding Claim 19, Muni teaches (Figures 1-11C) a system for drug delivery (see Figure 4D), the system comprising:
the implantable device (100) of claim 1 (discussed above);
a drug reservoir (at 208; see Figure 4D); and
a tube (at 102) fluidly connecting (see Figure 4D) the implant (100) to the drug reservoir (208).
Claims 10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Muni et al. (US 2006/0106361) in view of Wong (US 2012/0239004).
Regarding Claim 10, Muni teaches the invention as claimed and as discussed above. Muni does not teach, as discussed so far, wherein each support member has a height to length ratio of about 0.1 to 1.0.
Wong teaches (Figures 1-12) a pair of support members (an adjacent pair of projections 22; see Figure 12) protruding from a body (2) in a transverse direction (see Figure 12) and extending along the body (2) in the longitudinal direction (see Figure 12), wherein the support members (an adjacent pair of projections 22; see Figure 12) are separated by a gap distance that extends along in the longitudinal direction (the distance between adjacent projections 22; see Figure 12). Wong also schematically shows that each support member (an adjacent pair of projections 22) has a height to length ratio of between about 0.1 to 1.0 (see Figure 12). Wong also teaches that “projections 22 extend outwardly a distance less than two times the tube member outer diameter 5 . . . the projections 22 can longitudinally extending [sic] along the tube member 2 any desired length” (see Paragraphs 0087-0088).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Muni to have each support member have a height to length ratio of about 0.1 to 1.0, as taught by Wong, in order to minimize the resistance to insertion and removal of the catheter (Paragraph 0088 of Wong).
It is further noted, in cases like the present, where patentability is said to be based upon particular chosen dimensions or upon another variable recited within the claims, applicant must show that the chosen dimensions are critical. As such, the claimed dimensions appear to be an obvious matter of engineering design choice and thus, while being a difference, does not serve in any way to patentably distinguish the claimed invention from the applied prior art. In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990); In re Kuhle, 526 F2d. 553, 555, 188 USPQ 7, 9 (CCPA 1975).
Regarding Claim 16, Muni teaches the invention as claimed and as discussed above. Muni does not teach, as discussed so far, wherein each of the support members has a length of about 1mm to about 10 mm.
Wong teaches that “projections 22 can longitudinally extending [sic] along the tube member 2 any desired length” (see Paragraphs 0087-0088).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Muni to have a desired length of about 1mm to about 10mm, as taught by Wong, in order to minimize the resistance to insertion and removal of the catheter (Paragraph 0088 of Wong) and 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 SPQ 232 (1984).
It is further noted, in cases like the present, where patentability is said to be based upon particular chosen dimensions or upon another variable recited within the claims, applicant must show that the chosen dimensions are critical. As such, the claimed dimensions appear to be an obvious matter of engineering design choice and thus, while being a difference, does not serve in any way to patentably distinguish the claimed invention from the applied prior art. In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990); In re Kuhle, 526 F2d. 553, 555, 188 USPQ 7, 9 (CCPA 1975).
Claims 20-22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Muni et al. (US 2006/0106361) in view of Haase et al. (US 2011/0166522).
Regarding Claim 20, Muni teaches the invention as claimed and as discussed above. Muni does not teach, as discussed so far, wherein the drug reservoir comprises a drug refill port fluidly connected to the drug reservoir; the drug refill port configured to receive a drug from an external source and to provide a fluidic path to the drug reservoir.
Haase teaches (Figures 1-6B) a drug reservoir (34) that comprises a drug refill port (36) fluidly connected to (see Figure 2) the drug reservoir (34), the drug refill port (36) configured to receive a drug from an external source (Paragraph 0043) and to provide a fluidic path to the drug reservoir (34).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Muni to have the drug reservoir comprises a drug refill port fluidly connected to the drug reservoir; the drug refill port configured to receive a drug from an external source and to provide a fluidic path to the drug reservoir, as taught by Haase, in order to provide a mechanism for percutaneous access to the device and provide access to the reservoir to aspirate the implantable medical device and refill the device with therapeutic fluid delivered to the patient (Paragraph 0043 of Haase).
Regarding Claim 21, Muni teaches the invention as claimed and as discussed above. Muni does not teach, as discussed so far, wherein the drug reservoir is an implantable drug reservoir.
Haase teaches (Figures 1-6B) a drug reservoir (34) that is an implantable drug reservoir (within 12; see Figure 2 and Paragraph 0020).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Muni to have the drug reservoir be an implantable drug reservoir, as taught by Haase, in order to have the ability for chronic or temporary therapy delivery (Paragraph 0017 of Haase).
Regarding Claim 22, Muni teaches the invention as claimed and as discussed above. Muni does not teach, as discussed so far, further comprising a pump communicably coupled to the drug reservoir and configured to move a drug from the drug reservoir to the implant via the tube.
Haase teaches (Figures 1-6B) a pump (32) communicably coupled to a drug reservoir (34) and configured to move a drug (see Figure 2) from the drug reservoir (34) to the implant (18b) via a tube (38).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Muni to have a pump communicably coupled to the drug reservoir and configured to move a drug from the drug reservoir to the implant via the tube, as taught by Haase, in order to draw fluid from the reservoir and pump the fluid through the tubing to the patient to effect a treatment (see Paragraph 0043 of Haasse).
Regarding Claim 24, Muni in view of Haase teaches the invention as claimed and as discussed above. Muni in view of Haase does not teach, as discussed so far, wherein the pump is an implantable pump.
Haase teaches (Figures 1-6B) wherein the pump (32) is an implantable pump (Paragraph 0017).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Muni in view of Haase to have the pump be an implantable pump, as taught by Haase, in order to have the ability for chronic or temporary therapy delivery (Paragraph 0017 of Haase).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Muni et al. (US 2006/0106361) in view of Haase et al. (US 2011/0166522) and Haase (US 2007/0255233).
Regarding Claim 23, Muni in view of Haase ‘522 teaches the invention as claimed and as discussed above. Muni in view of Haase ‘522 does not teach, as discussed so far, wherein the pump comprises an additional drug refill port through which the drug reservoir can be filled.
Haase ‘233 teaches (Figures 1-6C) a pump (22) that comprises an additional drug refill port (34) through which the drug reservoir (32) can be filled (see Figure 2B).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Muni in view of Haase ‘522 to have the pump comprises an additional drug refill port through which the drug reservoir can be filled, as taught by Haase ‘233, in order to facilitate filling the reservoir from a point exterior to the housing (Paragraph 0020 of Haase ‘233).
Claims 25 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (US 2010/0174308) in view of Muni et al. (US 2006/0106361).
Regarding Claim 25, Chang teaches (Figures 1-14E) a method of implanting an implantable device (302) in a nasal region (within the nose of the patient; see Paragraph 0023), the method comprising:
making an incision in skin of a subject (initial puncture by the puncturing device 300; see Figure 3A);
delivering the implantable device (302) from the incision to a target location in the nasal region (the maxillary sinus; see Figure 3A); and
placing at least a portion of the implantable device within the target location (see Figures 3B-3C).
Chang does not teach that the implantable device comprises a distal body having a wall extending from a proximal end to a distal end, and a lumen extending therethrough in a longitudinal direction, the distal body comprising one or more apertures located along the wall, the apertures being in fluid communication with the lumen, and a pair of support members protruding from the body in a transverse direction and extending along the body in the longitudinal direction, wherein the support members are separated by a gap distance that extends along in the longitudinal direction.
Muni teaches (Figures 1-11C) an implantable device for drug delivery (100; see abstract and Paragraph 0095), the implantable device (100) comprising: a distal body (240) having a wall (242) extending from a proximal end (the lower portion of Figure 4L) to a distal end (the upper portion of Figure 4L), and a lumen (104) extending therethrough in a longitudinal direction (see Figure 4L), the distal body (240) comprising one or more apertures (248) located along the wall (242), the apertures (248) being in fluid communication (via 244) with the lumen (104).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Chang to have the implantable device comprise a distal body having a wall extending from a proximal end to a distal end, and a lumen extending therethrough in a longitudinal direction, the distal body comprising one or more apertures located along the wall, the apertures being in fluid communication with the lumen, as taught by Muni, in order to deliver drugs and other therapeutic or diagnostic substances to desired locations within a subject (see abstract of Muni).
Muni’s Figure 4L embodiment does not teach a pair of support members protruding from the body in a transverse direction and extending along the body in the longitudinal direction, wherein the support members are separated by a gap distance that extends along in the longitudinal direction.
The embodiment of Figure 6E of Muni teaches a pair of support members (an adjacent two of 354; see Figure 6E) protruding from the body (at 106) in a transverse direction (see Figure 6E) and extending along the body in the longitudinal direction (see Figure 6E), wherein the support members (an adjacent two of 354) are separated by a gap distance (separated by 90 degree intervals) that extends along in the longitudinal direction (see Figure 6E).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Chang in view of Muni to have a pair of support members protruding from the body in a transverse direction and extending along the body in the longitudinal direction, wherein the support members are separated by a gap distance that extends along in the longitudinal direction, as taught by the Figure 6E embodiment of Muni, in order to prevent slipping of the substance delivery device out of an anatomical opening (Paragraph 0148 of Muni).
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Bays (US 2001/0018584) in view of Muni et al. (US 2006/0106361).
Regarding Claim 25, Bays teaches (Figures 1-12) a method of implanting an implantable device (12) in a nasal region (at 100), the method comprising:
making an incision in skin (114) of a subject (see Figure 7 and Paragraph 0032);
delivering the implantable device (12) from the incision to a target location (at 100) in the nasal region (see Figures 6-8); and
placing at least a portion of the implantable device (12) within the target location (at 100).
Bays does not teach that the implantable device comprises a distal body having a wall extending from a proximal end to a distal end, and a lumen extending therethrough in a longitudinal direction, the distal body comprising one or more apertures located along the wall, the apertures being in fluid communication with the lumen, and a pair of support members protruding from the body in a transverse direction and extending along the body in the longitudinal direction, wherein the support members are separated by a gap distance that extends along in the longitudinal direction.
Muni teaches (Figures 1-11C) an implantable device for drug delivery (100; see abstract and Paragraph 0095), the implantable device (100) comprising: a distal body (240) having a wall (242) extending from a proximal end (the lower portion of Figure 4L) to a distal end (the upper portion of Figure 4L), and a lumen (104) extending therethrough in a longitudinal direction (see Figure 4L), the distal body (240) comprising one or more apertures (248) located along the wall (242), the apertures (248) being in fluid communication (via 244) with the lumen (104).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Bays to have the implantable device comprise a distal body having a wall extending from a proximal end to a distal end, and a lumen extending therethrough in a longitudinal direction, the distal body comprising one or more apertures located along the wall, the apertures being in fluid communication with the lumen, as taught by Muni, in order to deliver drugs and other therapeutic or diagnostic substances to desired locations within a subject (see abstract of Muni).
Muni’s Figure 4L embodiment does not teach a pair of support members protruding from the body in a transverse direction and extending along the body in the longitudinal direction, wherein the support members are separated by a gap distance that extends along in the longitudinal direction.
The embodiment of Figure 6E of Muni teaches a pair of support members (an adjacent two of 354; see Figure 6E) protruding from the body (at 106) in a transverse direction (see Figure 6E) and extending along the body in the longitudinal direction (see Figure 6E), wherein the support members (an adjacent two of 354) are separated by a gap distance (separated by 90 degree intervals) that extends along in the longitudinal direction (see Figure 6E).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Bays in view of Muni to have a pair of support members protruding from the body in a transverse direction and extending along the body in the longitudinal direction, wherein the support members are separated by a gap distance that extends along in the longitudinal direction, as taught by the Figure 6E embodiment of Muni, in order to prevent slipping of the substance delivery device out of an anatomical opening (Paragraph 0148 of Muni).
Regarding Claim 26, Bays in view of Muni teaches the invention as claimed and as discussed above. Bays further teaches (Figures 1-12) forming a tunnel (at 102) extending from the incision (on 114; see Figures 6-8) to a target location (at 100) in the nasal region of the subject (see Figures 6-8), wherein the forming the tunnel (at 102) includes drilling a hole that extends perpendicularly through a nasion of the subject (see Paragraph 0032 and Figures 6-8).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (US 2010/0174308) in view of Muni et al. (US 2006/0106361) and Haase et al. (US 6,293,922).
Regarding Claim 27, Chang in view of Muni teaches the invention as claimed and as discussed above. Chang in view of Muni does not teach, as discussed so far, further comprising fluidly connecting the implant to a drug reservoir via a tube and implanting the drug reservoir and the tube in the subject, wherein the drug reservoir is implanted in the head, the neck, or the abdominal wall of the subject.
Haase teaches (Figures 1-6) fluidly connecting an implant (22A) to a drug reservoir (12) via a tube (22) and implanting the drug reservoir (12) and the tube (22) in the subject (see Figures 1-2), wherein the drug reservoir (12) is implanted in the head, the neck, or the abdominal wall of the subject (see Figure 2 and Column 3, lines 7-11 of Haase).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Chang in view of Muni to fluidly connect the implant to a drug reservoir via a tube and implant the drug reservoir and the tube in the subject, wherein the drug reservoir is implanted in the head, the neck, or the abdominal wall of the subject, as taught by Haase, in order to deliver drugs or other liquid medications over long periods of time to selected locations in the human body (Column 1, lines 32-48 of Haase).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (US 2010/0174308) in view of Muni et al. (US 2006/0106361), Haase et al. (US 6,293,922), and Hwang et al. (US 2015/0011951).
Regarding Claim 28, Chang in view of Muni and Haase teaches the invention as claimed and as discussed above. Although Haase teaches (Figures 1-6) delivering drugs (via 10) from a drug reservoir (12) to the implantable device (22A), Chang in view of Muni and Haase does not teach, as discussed so far, continuously delivering the drugs.
Hwang teaches (Figures 1-3) an implantable device (10) that is used to continuously deliver drugs (see abstract, Paragraph 0001, and Paragraph 0008).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Chang in view of Muni and Haase to have a continuous delivering of drugs, as taught by Hwang, in order to minimize various inconveniences and side effects (see abstract, Paragraph 0001, and Paragraph 0008 of Hwang).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (US 2010/0174308) in view of Muni et al. (US 2006/0106361) and Bleier (US 2021/0023295).
Regarding Claim 29, Chang in view of Muni teaches the invention as claimed and as discussed above. Chang in view of Muni does not teach, as discussed so far, the target location includes a submucosal space of an olfactory mucosa of the subject.
Bleier teaches (Figures 1-12) a target location of drug delivery is the submucosal space of the olfactory mucosa (see Paragraph 0005).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Chang in view of Muni to have the target location include a submucosal space of an olfactory mucosa of the subject, as taught by Bleier, since dosing the submucosal space leads to minimizing the barriers to diffusion to the olfactory nerves relative to transepithelial delivery and the drugs are thereby protected from multiple degradative enzymes present in nasal mucus (Paragraph 0005 of Bleier).
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS P BURKE whose telephone number is (571)270-5407. The examiner can normally be reached M-F 8:30-5:00 PM.
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, Phutthiwat Wongwian can be reached at (571) 270-5426. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format.
For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THOMAS P BURKE/Primary Examiner, Art Unit 3741