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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “retracting linkage assembly 6”. 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. 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 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 7-8 & 10-11 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.
Claims 7 & 10 recites the limitation "a push needle". It’s unclear whether the push needle in claims 7 & 10 are the same as the push needle in claim 1. It is interpreted to be the same.
The remaining claim(s) is/are rejected due to dependency upon a rejected claim.
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.
Claim(s) 1-5, 7-8, and 17 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Badawi et al. (US 11504270 B1).
Regarding Claim 1, Badawi discloses an ocular implant delivery device ("systems and methods for ab interno fluid delivery to Schlemm's canal and for trabeculotomy" col. 3 ln. 57-58), comprising:
a housing ("housing (206)" col. 8 ln. 34; FIG. 2A), a rotating wheel ("wheel (210)" col. 8 ln. 39), a push needle linkage assembly ("linkage (230)" col. 21 ln. 42), a retracting linkage assembly ("drive assembly" col. 8 ln. 37), a sleeve ("distal end of the housing" col. 21 ln. 22), and a puncture needle ("cannula (208)" col. 21 ln. 21),
wherein the housing is provided with a through hole at a distal end of the housing, and the sleeve extends from an inside of the housing to an outside of the housing through the through hole, and is fixedly connected to the housing (see FIG. 2B);
wherein the puncture needle runs through the sleeve ("cannula (208) is coupled to and extends from the housing's distal end" col. 8 ln. 35-36), a proximal end of the puncture needle is fixedly connected to the retracting linkage assembly (see FIG. 2B), and a push needle ("slidable elongate member (250)") of the push needle linkage assembly runs through an inner hole of the puncture needle ("distal end of the elongate member (250) may be slidably and coaxially disposed within the lumen of the cannula (208)" col. 8 ln. 35-36);
wherein the rotating wheel is connected to an inside of the housing via rotating shafts (see FIG. 2C), an opening corresponding to the rotating wheel is provided on the housing ("At least a portion of the wheel on a side of the linear gear may extend outside of the housing for a user to manipulate" col. 16 ln. 11-12; FIG. 2C), and the rotating wheel is drivingly connected to the push needle linkage assembly and the retracting linkage assembly via a rack and pinion mechanism ("drive assembly may comprise a linear gear (e.g., a rack) (216), a pair of pinion gears (218) attached to the wheels (210)" col. 16 ln. 45-47), so that the push needle linkage assembly is driven to move toward the distal end of the housing or the retracting linkage assembly is driven to move away from the distal end of the housing by rotating wheel rotating ("distal rotation of the portion of the wheel (210) extending out of the housing (206) moves the linear gear (216) distally (and, as described in more detail herein, moves the elongate member toward an extended position), and proximal rotation of the portion of the wheel extending out of the housing moves the linear gear proximally (and, as described in more detail herein, moves the elongate member toward a retracted position)" col. 16-17 ln. 66-6).
Regarding Claim 2, Badawi discloses the rotating shafts disposed on two sides of the rotating wheel each are provided with a sector gear ("pair of pinion gears (218) attached to the wheels (210), and a pair of idler gears (224)" col. 16 ln. 46-48; FIG. 2F); and the push needle linkage assembly and the retracting linkage assembly each are provided with a rack at a proximal end ("linear gear (216)" col. 21 ln. 26; FIG. 2H), the racks on the push needle linkage assembly and on the retracting linkage assembly extending to the two sides of the rotating wheel respectively (see FIG. 2C), and each of the racks being configure to intermesh with the sector gear on the rotating shaft on the corresponding side of the rotating wheel ("teeth (236) may be located on a surface perpendicular to the sides having teeth (220, 222) configured to interface with the pinion gears (218). The surface having teeth (236) may also face inward toward track (240)" col. 22 ln. 2-6).
Regarding Claim 3, Badawi discloses the sector gears on the rotating shafts on the two sides of the rotating wheel are disposed on the same side of the rotating shafts along a radial direction of the rotating shaft, and the racks disposed on the push needle linkage assembly and on the retracting linkage assembly are arranged at intervals along a radial direction of the rotating wheel, and each of the racks is configured to intermesh with the sector gear on the rotating shaft on the corresponding side (col. 21 ln. 51 - col. 22 ln. 6; FIG. 2F).
Regarding Claim 4, Badawi discloses the first rack on the push needle linkage assembly is disposed above the rotating shafts of the rotating wheel, and the second rack on the retracting linkage assembly is disposed below the rotating shafts of the rotating wheel (see FIG. 2C); and the sector gear on the rotating shaft of the rotating wheel corresponding to the first rack on the push needle linkage assembly intermeshes with the first rack on the push needle linkage assembly in an initial state, and the sector gear on the rotating shaft of the rotating wheel corresponding to the second rack on the retracting linkage assembly is located on the upper part of the rotating shaft in the initial state (col. 22 ln. 6-50).
Regarding Claim 5, Badawi discloses the first rack on the push needle linkage assembly is disposed below the rotating shafts of the rotating wheel, the second rack on the retracting linkage assembly is disposed above the rotating shafts of the rotating wheel (see FIG. 2C); and the sector gear on the rotating shaft of the rotating wheel corresponding to the first rack on the push needle linkage assembly intermeshes with the first rack on the push needle linkage assembly in an initial state, and the sector gear on the rotating shaft of the rotating wheel corresponding to the second rack on the retracting linkage assembly is located on the lower part of the rotating shaft in the initial state (col. 22 ln. 6-50).
Regarding Claim 7, Badawi discloses the push needle linkage assembly comprises a push needle, a push needle link, and a first rack; and a proximal end of the push needle is fixedly connected to a distal end of the push needle link, a proximal end of the push needle link is fixedly connected to the first rack horizontally arranged, and teeth on the first rack are disposed toward the rotating shaft (col. 25 ln. 23-40; FIG. 2F).
Regarding Claim 8, Badawi discloses the push needle linkage assembly further comprises a folded corner portion, the folded corner portion being disposed at an end of the push needle link close to the first rack and fixedly connected to the first rack; and the folded corner portion has an extending direction that deviates from an extending direction of the first rack, and extends from the first rack in a direction toward the retracting linkage assembly (see FIG. 2F).
Regarding Claim 17, Badawi discloses the housing comprises an upper housing and a lower housing fixedly connected to the upper housing, the upper housing and the lower housing each comprise a cylinder portion, a gripping portion, and a conical portion that are fixedly connected together; a rotating wheel mount is disposed on an inner wall surface of the cylinder portion of the housing, and the rotating wheel is fitted on the rotating wheel mount via the rotating shafts; and a stop block is provided on an inner wall surface of at least one of the cylinder portion, the gripping portion, and the conical portion, and the stop block is configured to limit the push needle linkage assembly and the retracting linkage assembly in a radial direction (col. 7 ln. 54 - col. 8 ln 43; FIG. 2B).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Badawi.
Regarding Claim 6, Badawi fails to specify a central angle of the sector gear is in a range of 30° to 180°. However, it would be obvious to one of ordinary skill to optimize the sector gear to have a central angle of 30° to 180° to suitably control the “advancement distance of the elongate member” (col. 28 ln. 24-48), since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 13 & 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Badawi in view of Horvath et al. (CN 105899170 A).
Regarding Claims 13 & 15-16, Badawi fails to specify a stop seat configured to define a distance between the push needle linkage assembly and the retracting linkage assembly; a proximal end of the sleeve is fixedly connected to a sleeve seat which is disposed in the housing at a position close to the through hole, and the sleeve extends through the through hole on the housing to the outside of the housing; the puncture needle is provided with a puncture needle seat at a proximal end, the puncture needle being fixedly connected to the puncture needle seat and running through the sleeve, and the puncture needle seat being fixedly connected to a distal end of the retracting linkage assembly. However, Horvath teaches “An inserter for treating glaucoma” (Abstract) comprising a stop seat configured to define a distance between the push needle linkage assembly and the retracting linkage assembly (FIG. 21); a proximal end of the sleeve is fixedly connected to a sleeve seat which is disposed in the housing at a position close to the through hole, and the sleeve extends through the through hole on the housing to the outside of the housing ([0170]; FIG. 14A); the puncture needle is provided with a puncture needle seat at a proximal end, the puncture needle being fixedly connected to the puncture needle seat and running through the sleeve, and the puncture needle seat being fixedly connected to a distal end of the retracting linkage assembly ([0170]; FIG. 14A). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Badawi to incorporate the teachings of Horvath to securely hold the needle in the assembly while allowing for sliding movement.
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Badawi in view of Kahook et al. (CN 112638332 A).
Regarding Claims 18-19, Badawi discloses the rotating wheel is provided with teeth on an outer circumferential surface (see FIG. 2A), but fails to specify the housing is provided with an operating-sliding sleeve at a position corresponding to the opening, the operating-sliding sleeve being slidably fitted with the housing; and the operating-sliding sleeve is provided with a rack portion on an inner wall, the rack portion intermeshing with the teeth on the rotating wheel; the housing is provided with a spring sheet on an outer wall, the spring sheet extending to the outside of the housing and cooperating with the rack portion on an inner wall of the operating-sliding sleeve. However, Kahook teaches “an inserter device for intraocular implantation process” (Abstract) wherein the housing is provided with an operating-sliding sleeve ("actuator 252a") at a position corresponding to the opening, the operating-sliding sleeve being slidably fitted with the housing (FIG. 30B); and the operating-sliding sleeve is provided with a rack portion on an inner wall, the rack portion intermeshing with the teeth on the rotating wheel (see FIG. 30B); the housing is provided with a spring sheet on an outer wall ("spring 259b may be disposed in the handle 254b"), the spring sheet extending to the outside of the housing and cooperating with the rack portion on an inner wall of the operating-sliding sleeve ("biasing material is configured to bias the handle actuator 252b away from the handle 254b"). Therefore, it would have been obvious to modify Badawi to arrive at the claimed device to suitably “prevent the needle 253 from retracting during insertion of the needle 253 into the eye 101”.
Allowable Subject Matter
Claims 9-12 & 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The specific structures claimed are not found in any of the cited references. It would not have been obvious to modify the cited references to arrive at the claimed invention since the addition of the claimed structures would increase complexity of the device and increase the cost of manufacturing. Furthermore, the cited reference lack the motivations for modification.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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, Rebecca E. Eisenberg can be reached at (571) 270-5879. 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.
/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
Prosecution Insights