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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). A certified copy of Parent Application 10-2024-0003771, filed in The Republic Of Korea on 09 January 2024 has been received.
Claim Objections
The claims contain minor informalities.
Claim 1 recites the phrase “implant for an eye disease” four times. Examiner suggests to shorten this phrase for brevity to “implant” after first introducing this feature.
Throughout the claims, the phrase “… implant [[for an eye disease]]…” should be shortened for brevity.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 1 calls for “… a handle part connected to the cannula and configured to be held by an operator…” which should be revised to remove the operator from the claim scope.
Applicant is recommended to use inferential language (e.g. configured to, adapted to or whereby) to avoid positively claiming the human body.
Claims 2-9 are rejected for depending on a rejected parent 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 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) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless—
(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; or
(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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olson; Jeffrey (US 20150025540 A1).
Regarding claim 1, Olson discloses an injector for an implant for an eye disease (¶ [0003], [0006], [0019], [0020], FIG. 1, an injectable securement device 100; ¶ [0023], FIG. 2, a system 200);
comprising: a cannula comprising an inner space (¶ [0023], FIG. 2, a system 200 … an elongate element 114; ¶ [0024] Elongate element 114 as described herein is generally any longitudinally extending structure configured to have a lumen extending therethrough … Thus, elongate elements include but are not limited to cannulas, trocars, needles, ports, introducer sheaths, introducers, sheaths, tubes with lumens (e.g., catheters), hollow wires (e.g., guidewires), hollow stylets, metal tubes (e.g., hypotubes), and polymer tubes);
in which at least a part of the implant for an eye disease comprising a ripcord (¶ [0020], FIG. 1, an injectable securement device 100 … comprises one or more sutures 102 and a bolster 104. Suture 102 is generally an elongate, flexible element configured to form one or more of a loop 106 and be tied into a securement 108);
is to be accommodated; and an implant opening into which the implant for an eye disease is to be inserted (¶ [0024] Elongate element 114 as described herein is generally any longitudinally extending structure configured to have a lumen extending therethrough, through which injectable securement device 100 as described above, and one or more fastening element can be passed);
a handle part connected to the cannula and to be held by an operator (Fig. 2, system 200 comprises a tapered cylindrical element connected to the cannula); and
a holder configured to be coupled to the handle part and comprising a receiving part in which the ripcord of the implant for an eye disease is to be accommodated (Fig. 2, system 200 comprises a cylindrical element connected to the handle, and which also accommodates the elongate element 114).
PNG
media_image1.png
619
1018
media_image1.png
Greyscale
Regarding the claimed handle part, Olson shows that the cannula (elongate element 114) connects to a tapered cylindrical part (Fig. 2)
Regarding the claimed holder and receiving part that accommodates the ripcord, Olson further depicts a narrower cylindrical section of the handle (Fig. 2). Although the ripcord (sutures 102) do not directly pass through the holder, the holder surrounds both the cannula and ripcord. In other words, Olson’s cannula accommodates the ripcord, and the holder accommodates the cannula. Therefore, the holder also accommodates the ripcord.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Olson; Jeffrey (US 20150025540 A1) in view of Hagemeier, Charles (US 20030135153 A1).
Regarding claim 2, Olson discloses an injector, wherein the cannula comprises: a first portion comprising one end of the cannula; a second portion connected to the first portion; and a third portion connected to the second portion (Fig. 2, elongate element 114).
Regarding the first, second and third portions, this claim distinguishes the portions only by their relative arrangement, and not by any other physical features or functions. Olson’s elongate element 114 extends as a cylindrical tube from one end of a handle, as shown in Fig. 2.
Olson teaches the invention substantially as claimed by Applicant except for an implant opening formed on a side surface. Hagemeier discloses an injector for an ocular implant (¶ [0001], [0013], [0015], [0030], needle 10);
comprising a cannula that includes an implant opening formed on a side surface (¶ [0033] More particularly, needle 10 is seen to include a lateral opening 14 therein adjacent distal end 10a thereof. Opening 14 serves to releasably hold drug implant 12 therein until the distal end 10a of needle 10 reaches the implant site in the organism, at which time drug implant 12 is released from opening 14).
Hagemeier prevents coring eye tissue by configuring the cannula with a closed distal end (¶ [0030], a distal end of a needle 10 having a pointed, distal end 10a). One would be motivated to modify Olson with Hagemeier’s side opening since Olson suggests to alter the cannula’s shape including its distal or piercing end (¶ [0024], Elongate elements can be any material and can have any cross-sectional shape … Elongate element 114 can be further configured at its distal end to pierce or puncture tissue, for example, by having an angled or sharpened end). Therefore, it would have been obvious to modify Olson with Hagemeier’s lateral side opening in order to minimize damage to surrounding tissues when deploying an implant.
Regarding claim 3, Olson further discloses that a body of the implant for an eye disease has a tube shape; one end of the ripcord is inserted through the tube-shaped body (¶ [0021] Bolster 104 is generally a structure configured to prevent unraveling of loop 106 and/or slipping of securement 108; ¶ [0022], suture 102 is threaded through bolster 104); and
the other end of the ripcord is inserted into the receiving part of the holder; and at least a portion of the implant for an eye disease is located inside the second portion (¶ [0034] For example, and with reference to FIG. 4B-1, pressure in the form of a gas, fluid, or viscoelastic material can be used to advance injectable securement device 100 out the distal end of elongate element 114; ¶ [0035] With reference to FIG. 4B-2, as noted above, a rod or plunger 416 can be used to advance injectable securement device 100 out the distal end of elongate element 114).
Regarding the ripcord being inserted into the receiving part of the holder; and the implant being located inside the second portion, Olson shows that both the ripcord (suture 102) and implant (bolster 104) extend through the cannula and holder (Figs. 4B-1, 4B-2).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Olson and Hagemeier in view of Silvestrini; Tom et al. (US 20090182421 A1).
Regarding claim 4, Olson and Hagemeier lack a wing portion. Silvestrini discloses an implant for an eye disease comprising a wing portion protruding in a direction different from a longitudinal direction of the implant (¶ [0108] The implant 105 can also include structural features that aid in anchoring or retaining the implanted implant 105 in the eye. For example, as shown in FIG. 4, the implant 105 can include one or more retaining or retention structures 410, such as protrusions, wings, tines, or prongs, that lodge into anatomy to retain the implant in place).
Silvestrini retains an implant more securely by altering its outer profile. One would be motivated to modify Olson and Hagemeier with Silvestrini’s wing portion since Olson generally seeks to immobilize the implant relative to eye tissue (¶ [0023], A fastening element as described herein is generally configured to be coupled with an end of suture 102 as described above, puncture tissue, and/or secure suture 102 with respect to the tissue, for example, on a tissue inner surface, a tissue outer surface, and/or through the tissue as with suturing techniques known in the art). Therefore, it would have been obvious to modify Olson and Hagemeier with Silvestrini’s wing portion in order to more securely fasten the implant.
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Olson; Jeffrey (US 20150025540 A1) in view of Weber; David A. et al. (US 20060241650 A1).
Regarding claims 5-8, Olson does not explicitly disclose a cannula assembly. Weber discloses methods and apparatus for introducing ocular implants (¶ [0002], [0008], [0037], FIGS. 1-9. As shown, implant delivery apparatus 10);
comprising an implant (¶ [0038] As used herein, "implants" refers to ocular implants or drug delivery devices which can be implanted into any number of locations in the eye; ¶ [0042] As seen in FIG. 5 … implant 1);
a cannula comprising an inner space (¶ [0037], FIGS. 1-9 … Cannula 40; ¶ [0042] As seen in FIG. 5 … cannula 40);
a holder (¶ [0042], nose cone 30);
configured to be coupled to a handle part (¶ [0037], external housing 20);
further comprising a cannula assembly coupled to the cannula and configured to be inserted into the holder (¶ [0042] As seen in FIG. 5 … cannula assembly 42 which consists of cannula 40 and cannula hub 44);
wherein the holder comprises a body having an inner space into which the cannula assembly is to be inserted and through which the cannula coupled to the cannula assembly is to be exposed to outside of the holder (¶ [0042] As seen in FIG. 5, nose cone 30 receives cannula assembly 42);
wherein the handle part comprises a protrusion formed at one end of the handle part and at least partially inserted into the holder to couple the handle part to the holder (¶ [0041] As shown more clearly in FIG. 4 … Specifically, collar 24 extends from the housing as shown; ¶ [0043] Referring to FIG. 6, it can be seen that housing 20 is formed of two half sections 21 and 22. These sections are preferably configured to snap-fit together … Nose cone 30 can be secured to collar 24 of housing 20 by similar means);
wherein the protrusion comprises: a first protrusion inserted into the cannula assembly to couple the handle part to the cannula assembly; and a second protrusion connected to the first protrusion, having a larger diameter than the first protrusion, and configured to be inserted into the holder (Fig. 4, collar 24 of housing 20 has a tapered shape comprising a narrow tip and wider base);
wherein the holder comprises a projection formed on an inner surface of the holder; wherein the protrusion comprises a third protrusion connected to the second protrusion, having a larger diameter than the second protrusion, and comprising a coupling protrusion to be engaged with the projection of the holder (¶ [0043] Referring to FIG. 6, it can be seen that housing 20 is formed of two half sections 21 and 22. These sections are preferably configured to snap-fit together … Nose cone 30 can be secured to collar 24 of housing 20 by similar means).
PNG
media_image2.png
710
791
media_image2.png
Greyscale
Regarding the first, second and third protrusions, Weber’s collar 24 comprises a tapered shape that can be divided into any number of diameters. In order for the nose cone 30 and collar 24 to connect via a snap fit, the wider end of collar 24 must include a projection or ridge that engages a complimentary shape inside nose cone 30.
Weber provides an ergonomically configured handle that a user can manipulate intuitively (¶ [0040] The apparatus is ergonomically configured for easy gripping and manipulation, and has a general overall shape similar to a conventional pen or other writing instrument. The apparatus will typically be grasped by the user between the thumb and the middle finger). One would be motivated to modify Olson with Weber’s cannula assembly and associated projections so that a user can maneuver an implant more easily. Therefore, it would have been obvious to modify Olson with Weber’s cannula assembly and projections in order to manipulate the injector more easily.
Allowable Subject Matter
Claims 8 and 9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kurihashi; Katsuaki US 20060106352 A1
Utkhede; Deepank et al. US 20090104243 A1
Rapacki; Alan R. et al. US 20090104248 A1
Burns; Thomas W. et al. US 20130090534 A1
Haffner; David et al. US 20130289467 A1
Novakovic; Zoran et al. US 20150238687 A1
Meyer; Thomas E. et al. US 20170258988 A1
Erickson; Signe et al. US 20180243131 A1
Pinchuk; Leonard et al. US 20210045772 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Tel 571-272-2590
Fax 571-273-2590
Email Adam.Marcetich@uspto.gov
The Examiner can be reached 8am-4pm Mon-Fri.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application is assigned is 571-273-8300.
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.
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
