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 .
Status of Claims
This office action is responsive to the application filed 8 September 2023.
Claims 1-10 are presently pending in this application.
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 following must be shown or the features canceled from the claims:
Drip hole – claim 6
Scale – claim 6
Rigid wire – claim 6
Limited structure – claim 9
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 2-10 are objected to because of the following informalities:
Claims appear to be written in the style of an international/foreign document. Claims should be written to conform with US practice.
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 1-10 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 following limitations lacking antecedent basis:
“the other end” – line 5
Interpreted as –another end—
All claims with this limitation are interpreted the same way
“the output end” – line 5
Interpreted as –an output end--
Claim 6 recites the following limitations lacking antecedent basis:
"the side wall" - line 3
Interpreted as --a side wall--
“the outer wall” – line 5
Interpreted as –an outer wall--
“the end” – line 6
Interpreted as –an end--
“the drip fitting” – line 6
Interpreted as --a drip fitting—
“the end” – line 7 and 8
Interpreted as –an end—
Claim 7 recites the following limitations lacking antecedent basis:
“the locking joint” – line 2
“the drip fitting” – line 2
“the hollow body” – line 3
“the end” – line 3
Interpreted as –an end—
“the through hole” – line 7
Interpreted as –a through hole—
Claim 7 is interpreted as being dependent on claim 2.
Claim 8 recites the following limitations lacking antecedent basis:
“the drip connector” – line 5 and 6
Interpreted as –a drip connector—
“the top end” – line 8
Interpreted as –a top end—
Claim 10 recites the limitations lacking antecedent basis:
“the through hole” – line 3
Interpreted as –a through hole—
“the drip fitting” – line 3
“the hollow body” – line 3
“the locking joint” – line 3 and 4
Claim 10 is interpreted as being dependent from claim 2.
There is insufficient antecedent basis for these limitation in the claim. For the purposes of examination, examiner interprets each of the limitations as described above.
All other claims are rejected as they depend from independent claim 1.
The use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). When claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008).
The claimed features of claim 5 are recited functionally and do not convey the structure of the claimed apparatus. Therefore, claim 5 is indefinite as the scope of the claim is unclear.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Hoekman et al. (US Patent Publication No. 20150100042 A1), hereinafter Hoekman, in view of Xu et al. (US Patent Publication No. 20230321362 A1), hereinafter Xu.
Regarding claim 1, Hoekman discloses a nasal drug delivery device (Hoekman: Fig. 1, device 1) with adjustable position, characterized in that the nasal drug delivery device (1) comprises: an intranasal locking connector (Fig. 1, comprising nasal guide 10 and base 40), a nasal dropper (Fig. 1, tube 20), and a syringe (Fig. 1, pump 30), wherein one end of the nasal dropper (20) is movably set through the intranasal locking connector (tube 20 can slide within guide 10; para. 0035) and the nasal dropper (20) is fixed by the intranasal locking connector (10 and 20), and the other end of the nasal dropper (20) is connected to the output end of the syringe (Fig. 1, tube 20 is shown to be connected to output of pump 30).
Hoekman does not expressly disclose a syringe pump, wherein the syringe is connected to the syringe pump.
Xu teaches a syringe pump (Xu: Fig. 2, syringe pump 20), wherein a syringe (Fig. 2, syringe 22) is connected to the syringe pump (Fig. 2, syringe pump 20 is connected to push-pull device 23).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Hoekman such that it included a syringe pump, wherein the syringe is connected to the syringe pump as taught by Xu in order to allow for automatic control of the syringe discharging (Xu: para. 0006).
Claims 2-4, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Hoekman in view of Xu, in further view of Wu et al. (Foreign Patent Publication No. CN 109793975 A), hereinafter Wu.
Regarding claim 2, Hoekman in view of Xu does not expressly disclose the intranasal locking connector comprises a drip fitting, a locking joint, and a hollow body, wherein the drip fitting, the locking joint and the hollow body are provided with concentric through-holes in the middle of each other, wherein the hollow body is provided in the drip fitting, the hollow body has a material with elastic deformation, and the nasal dropper passes through the hollow body before locking and fits with or against an inner wall of the hollow body through holes, the drip fitting and the locking joint are detachably connected.
Wu teaches a locking connector comprises a drip fitting (Wu: Fig. 1, locking cap 110), a locking joint (Fig. 1, locking base 120), and a hollow body (Fig. 1, locking ring 130), wherein the drip fitting (110), the locking joint (120), and the hollow body (130) are provided with concentric through-holes in the middle of each other (Fig. 1, cap 110, base 120, and ring 130 are all shown with concentric through-holes in the middle of each), wherein the hollow body (130) is provided in the drip fitting (Fig. 1, when assembled, ring 130 would be provided within the cap 110; Example 1), the hollow body (130) has a material with elastic deformation (locking ring 130 is elastic; Example 1), and a conduit (Fig. 1, hollow conduit 200) passes through the hollow body (130) before locking (locking ring 130 contracts around conduit 200, fixing the base 120 to conduit 200; Example 1) and fits with an inner wall of the hollow body (130) through holes, the drip fitting (110) and the locking joint (120) are detachably connected (Fig. 1, cap 110 and base 120 are shown to be detachably connected; Example 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Hoekman in view of Xu such that the intranasal locking connector comprises a drip fitting, a locking joint, and a hollow body, wherein the drip fitting, the locking joint and the hollow body are provided with concentric through-holes in the middle of each other, wherein the hollow body is provided in the drip fitting, the hollow body has a material with elastic deformation, and the nasal dropper passes through the hollow body before locking and fits with or against an inner wall of the hollow body through holes, the drip fitting and the locking joint are detachably connected as taught by Wu in order to prevent the nasal dropper from collapsing, allowing for fast and convenient locking (Wu: Summary of the Invention and Example 1).
Regarding claim 3, Hoekman in view of Xu and Wu discloses the device above.
Hoekman in view of Xu does not expressly disclose the connection of the locking joint to the drip fitting comprises a threaded connection or a press-fit connection.
Wu teaches a connection of a locking joint (Wu: 120) to a drip fitting (110) comprises a threaded connection (Fig. 1, cap 110 is threaded onto base 120 via threading; Example 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Hoekman in view of Xu such that the connection of the locking joint to the drip fitting comprises a threaded connection or a press-fit connection as taught by Wu in order to prevent the nasal dropper from collapsing, allowing for fast and convenient locking (Wu: Summary of the Invention and Example 1).
Regarding claim 4, Hoekman in view of Xu and Wu discloses the device above.
Hoekman in view of Xu does not expressly disclose the drip fitting and the locking joint switch between a pre-locked state and a post-locked state by the threaded connection, wherein before locking, the hollow body rotates with the locking joint during a circumferential rotation of the locking joint when the nasal dropper fits the inner wall of the hollow body through the holes with clearance, wherein the nasal dropper rotates relative to the hollow body, or the nasal dropper and the hollow body remain relatively stationary and jointly rotate relative to the locking joint so that the nasal dropper does not rotate with the locking joint in a circumferential direction.
Wu teaches a drip fitting (Wu: 110) and a locking joint (120) switch between a pre-locked state (Fig. 1) and a post-locked state by a threaded connection (cap 110 is threaded onto base 120 via threading; Example 1), wherein before locking, a hollow body (130) rotates with the locking joint (120) during a circumferential rotation of the locking joint (120) when a conduit (200) fits the inner wall of the hollow body (130) through the holes with clearance (Fig. 1, ring 130 is shown is sleeved with clearance around conduit 200), wherein the conduit (200) and the hollow body (130) remain relatively stationary and jointly rotate relative to the locking joint (Example 1) so that the conduit (200) does not rotate with the locking joint (120) in a circumferential direction (rotation of the locking cap 110 allows for the locking procedure to occur; Example 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Hoekman in view of Xu such that the drip fitting and the locking joint switch between a pre-locked state and a post-locked state by the threaded connection, wherein before locking, the hollow body rotates with the locking joint during a circumferential rotation of the locking joint when the nasal dropper fits the inner wall of the hollow body through the holes with clearance, wherein the nasal dropper rotates relative to the hollow body, or the nasal dropper and the hollow body remain relatively stationary and jointly rotate relative to the locking joint so that the nasal dropper does not rotate with the locking joint in a circumferential direction as taught by Wu in order to prevent the nasal dropper from collapsing, allowing for fast and convenient locking (Wu: Summary of the Invention and Example 1).
Regarding claim 7, Hoekman in view of Xu and Wu discloses the device above.
Hoekman in view of Xu and Wu does not expressly disclose that the locking joint is provided with a groove near the drip fitting, and the hollow body is provided in the groove, a passage tube is provided at the end of the locking joint near the drip fitting, wherein when the drip fitting and the locking joint are connected, the passage tube is tightened against one end of the hollow body to achieve a coaxial relationship with the hollow body, and an aperture diameter in the middle of the passage tube is larger than that of the through hole of the hollow body.
Wu teaches a locking joint (Wu: 120) is provided with a groove (Fig. 1, first step 124) near a drip fitting (Fig. 1, when assembled, step 124 would be near cap 110), and a hollow body (130) is provided in the groove (Fig. 1, when assembled, ring 130 would be inside step 124), a passage tube (Fig. 2, cavity 123) is provided at an end of the locking joint (120) near the drip fitting (Fig. 1, when assembled, cap 110 would be near cavity 123), wherein when the drip fitting (110) and the locking joint (120) are connected, the passage tube (123) is tightened against one end of the hollow body (Fig. 1, when assembled, ring 130 is pressed against step 124; Example 1) to achieve a coaxial relationship with the hollow body (Example 1), and an aperture diameter in the middle of the passage tube (123) is larger than that of the through hole of the hollow body (Fig. 1, the diameter of cavity 123 is shown to be larger than the diameter of the through hole of ring 130).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Hoekman in view of Xu such that the locking joint is provided with a groove near the drip fitting, and the hollow body is provided in the groove, a passage tube is provided at the end of the locking joint near the drip fitting, wherein when the drip fitting and the locking joint are connected, the passage tube is tightened against one end of the hollow body to achieve a coaxial relationship with the hollow body, and an aperture diameter in the middle of the passage tube is larger than that of the through hole of the hollow body as taught by Wu in order to fix the locking ring in place and increase the static friction between the conduit and fix the conduit in place (Wu: Example 1).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hoekman in view of Xu, and Wu, in further view of Atkinson et al. (US Patent Publication No. 20130174849 A1), hereinafter Atkinson.
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Regarding claim 6, Hoekman in view of Xu and Wu discloses the device above, wherein one end of the nasal dropper (Hoekman: 20) is provided with a nasal dropper connector (Fig. 1 above, nasal device connector A), wherein the nasal dropper connector (A) is connected to the output end of the syringe (Fig. 1 above, connector A is shown connected to the output end of pump 30).
Hoekman in view of Xu and Wu does not expressly disclose one end of the nasal dropper is sealed and a drip hole is provided on the side wall; an outer wall of the nasal dropper is provided with a scale, wherein the scale of the nasal dropper is provided at an end close to the drip fitting; and a rigid wire is detachably provided inside the nasal dropper, which is loaded and removed from the end of the nasal dropper near the syringe.
Atkinson teaches one end of a nasal dropper (Atkinson: Fig. 5C, catheter 50C) is sealed and a drip hole (Fig. 5A, side ports 58) is provided on a side wall; an outer wall of the nasal dropper (50C) is provided with a scale (Fig. 5C, incremental graduated markers are shown; para. 0043), wherein the scale (markers; para. 0043) of the nasal dropper (50C) is provided at an end (Fig. 5C, markers are provided along entire length of catheter 50C); a rigid wire (Fig. 5C, free wire 55) is detachably provided inside a nasal dropper (Fig. 5C, free wire 55 is releasably inserted through catheter 50C), which is loaded and removed from an end of the nasal dropper (Fig. 5C, free wire 55 is inserted from back end of catheter 50C; para. 0047).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Hoekman in view of Xu and Wu such that one end of the nasal dropper is sealed and a drip hole is provided on the side wall; an outer wall of the nasal dropper is provided with a scale, wherein the scale of the nasal dropper is provided at an end close to the drip fitting; and a rigid wire is detachably provided inside the nasal dropper, which is loaded and removed from the end of the nasal dropper near the syringe as taught by Atkinson in order to clean or flush a patient’s nasal cavity in a predetermined direction (Atkinson para. 0042 and 0044), determine insertion distance (Atkinson para. 0043), and provide graduated flexibility, atraumatic insertion, curvature, and tactile sensation of the correct insertion distance (Atkinson para. 0047).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hoekman in view of Xu and Wu, in further view of Bassett et al. (US Patent Publication No. 20220142653 A1), hereinafter Bassett and Xia et al. (US Patent Publication No. 20130158475 A1), hereinafter Xia.
Regarding claim 8, Hoekman in view of Xu and Wu discloses the device above.
Hoekman in view of Xu and Wu does not expressly disclose the nasal drug delivery device further comprises an intranasal connector, the intranasal connector is a four-way connector having a lower hole and three branches, wherein the lower hole is connected to a drip fitting and the intranasal connector extends into the nasal cavity for drug delivery instead of the drip connector, wherein the three branches are an upper branch, a left branch and a right branch, wherein the upper branch is an intranasal branch.
Bassett teaches a drug delivery device (Bassett: Fig. 2, system 100) comprises a connector (Fig. 2, comprising T-branch fitting 122 and Y-connector 112), the connector (122 and 112) is a four-way connector (Fig. 2, fitting 112 and Y-connector 112 are shown to have a total of four different tubing paths) having a lower hole (Fig. 2, tubing segment 113) and three branches (Fig. 2, tubing to syringe 124, and Y-connector 112), wherein the lower hole (113) is connected to a drip fitting (Fig. 2, fitting 111) and the connector (122 and 112) extends into a cavity (catheter 108, which is part of system 100, extends into a cavity; para. 0093) for drug delivery (delivery of fluids; para. 0092), wherein the three branches (124 and 112) are an upper branch (Fig. 2, tubing to syringe 124), a left branch (Fig. 2, tubing of connector 112 to syringe 117) and a right branch (Fig. 2, tubing of connector 112 to syringe 115).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Hoekman in view of Xu and Wu such that the nasal drug delivery device further comprises an intranasal connector, the intranasal connector is a four-way connector having a lower hole and three branches, wherein the lower hole is connected to a drip fitting and the intranasal connector extends into the nasal cavity for drug delivery instead of the drip connector, wherein the three branches are an upper branch, a left branch and a right branch as taught by Bassett in order to provide a plurality of therapeutic fluids and flush fluids (Bassett: para. 0097).
Hoekman in view of Xu, Wu, and Bassett does not expressly disclose the intranasal branch is provided with a guide spacer near the top end to guide the nasal dropper towards a nasal flank side.
Xia teaches an intranasal tube (Xia: Fig. 7, device 54) is provided with a guide spacer (Fig. 6, curved introducer 62) near a top end (Fig. 6, introducer 62 is near top end of device 54) to guide a nasal dropper (Fig. 7, injector 56) towards a nasal flank side (Fig. 7, passageway 64).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Hoekman in view of Xu, Wu, and Bassett such that the intranasal branch is provided with a guide spacer near the top end to guide the nasal dropper towards a nasal flank side as taught by Xia in order to guide the dropper towards a specific side of the nostril of a patient (Xia: para. 0059).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Hoekman in view of Xu and Wu, in further view of Baid et al. (US Patent No. 12599753 B2), hereinafter Baid.
Regarding claim 9, Hoekman in view of Xu and Wu discloses the device above.
Hoekman in view of Xu and Wu does not expressly disclose the nasal dropper is provided with a limiting structure that is detachably connected to the nasal dropper by gluing, threading or clamping.
Baid teaches a dropper (Baid: Fig. 7A and B, needle 420) is provided with a limiting structure (Fig. 7A and B, needle guard 426) that is detachably connected to the dropper (420) by clamping (col 18, ln 10-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Hoekman in view of Xu and Wu such that the nasal dropper is provided with a limiting structure that is detachably connected to the nasal dropper by gluing, threading or clamping as taught by Baid in order to limit axial movement of the dropper (Baid: col 18, ln 10-25) and prevent premature axial release (col 17, ln 9-24).
Regarding claim 10, Hoekman in view of Xu and Wu discloses the device above.
Hoekman in view of Xu and Wu does not expressly disclose the diameter length of the limiting structure being greater than the diameter length of the through hole formed by the drip fitting, the hollow body and the locking joint.
Baid teaches a diameter length of a limiting structure (Baid: 426) being greater than a diameter length of a through hole formed by a drip fitting (Fig. 7B, hub 412) and a hollow body (Fig. 7B, stopping element 438).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Hoekman in view of Xu and Wu such that the diameter length of the limiting structure being greater than the diameter length of the through hole formed by the drip fitting , the hollow body and the locking joint as taught by Baid in order to limit axial movement of the dropper (Baid: col 18, ln 10-25) and prevent premature axial release (col 17, ln 9-24).
Conclusion
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
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