DETAILED ACTION
Note: 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
1. Claims 1-7, 10-20, 30 and 45 are pending and currently under consideration for patentability.
Priority
2. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted September 5, 2024 and January 8, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
4. Claims 10, 18 and 30 are objected to because of the following informalities: Each of the claims recites “formed at a distal of a cannula”; however, this is grammatically incorrect. It is suggested that each limitation be amended to --- formed at a distal end of a cannula---. 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.
5. Claim 13-15 is 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 13-15 recites the limitation "the insertion tip" in line 2. There is insufficient antecedent basis for this limitation in the claim. While antecedent basis for this limitation is provided in claim 10, claims 13-15 depend from claim 1.
Claim 15 recites the limitation "the tangential angle" in line 2. There is insufficient antecedent basis for this limitation in the claim. While antecedent basis for this limitation is provided in claim 10, claims 15 depends from claim 1.
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.
6. Claim(s) 1-7, 13-17, 30 and 45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prausnitz et al. (US PGPUB 2015/0209180 A1).
7. With regard to claim 1, Prausnitz discloses a method of treating an eye of a subject (abstract; Figs. 17-18; [0133-0138]), comprising: tangentially administering a therapeutic agent (drug formulation) to the eye to infuse the therapeutic agent to a suprachoroidal space (SCS) of the eye ([0134-0137]; shows to be administered tangentially along the eye, as shown by arrows CC within the suprachoroidal space, 36).
8. With regard to claims 2-4, Prausnitz discloses that the therapeutic agent is administered to the eye at an entry of the eye that is at least 30 degrees from a perpendicular center line of the eye (Figs. 17-18; [0134-0137]; agent shown to be administered from an entry point of the eye being the point at the tip of the needle 1010 and the center line being the horizontal line extending through the center of the eye, similar to applicant’s horizontal line shown in instant Fig. 8, wherein Fig, 17 of Prausnitz shows the angle between the entry and the perpendicular center line to be about 70 degrees).
9. With regard to claim 5, Prausnitz discloses that the eye (10) is penetrated and the therapeutic agent is administered (arrows BB) through a penetration site (arrows CC; Fig. 18; [0133-0138]).
10. With regard to claims 6-7, Prausnitz discloses that the tangential administration of a composition comprising the therapeutic agent in a given time period results in pressure within the SCS (36) that is reduced, at least 5 percent less, compared to the pressure within the SCS (36) that results by perpendicular administration of a same volume of the therapeutic agent composition within a same time period (Figs. 17, 18; [0063-0064]; [0138]; [0141]).
11. With regard to claims 13 and 14, Prausnitz discloses that the insertion tip (1017) is a needle (1010) that penetrates the SCS (36) of the eye (Figs. 17-18; [0133-0138]).
11. With regard to claim 15, Prausnitz discloses that the tangential angle of the insertion tip (1017) is about 0-15 degrees (0.1 degree to 12 degree angle THETA_1; best seen in Figs. 8-10, insertion tip, 417; [0109]; [0134-0137]).
12. With regard to claims 16 and 17, Prausnitz discloses that the therapeutic agent is administered via an insertion tip (1017; Fig. 18) that is asymmetric and veers toward the sclera upon insertion to a subject's eye (best seen in Figs. 8-10, insertion tip, 417; [0063-0064]; [0109]; [0134-0137]).
13. With regard to claim 30, Prausnitz discloses a method of delivering one or more therapeutic agents into an eye (10; abstract; Figs. 17-18; [0133-0138]), comprising: penetrating the eye (10) at a tangential angle with an insertion tip (distal edge, 1017) formed at a distal of a cannula through which the one or more therapeutic agents are delivered into the eye (10) via a continuous and controlled infusion (Figs. 17, 18; [0084]; [0133]; [0217-0220]); and delivering the one or more therapeutic agents to the eye ([0134-0137]; shows to be administered tangentially along the eye, as shown by arrows CC within the suprachoroidal space, 36).
14. With regard to claim 45, Prausnitz discloses a surgical instrument (medicament delivery device, 1000) for delivery of therapeutic agents into an eye (10; Figs. 17, 18; [0133-0138]), comprising: a cannula (1010) connected to a handle (cartridge housing, 1030) of the surgical instrument (1000) and through which therapeutic agents are delivered into the eye (10) via a continuous and controlled infusion (Figs. 17, 18; [0084]; [0133]; [0217-0220]); and an insertion tip (1017) formed at a distal end of the cannula (1010) to penetrate tissue of the eye at a tangential angle ([0134-0137]; shows to be administered tangentially along the eye, as shown by arrows CC within the suprachoroidal space, 36).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
15. Claim(s) 10, 11, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz.
16. With regard to claims 10 and 18, Prausnitz discloses penetrating the eye (10) at a tangential angle with an insertion tip (distal edge, 1017) formed at a distal of a cannula (microneedle, 1010) through which the therapeutic agent is delivered into the SCS of the eye via a continuous and controlled infusion (Figs. 17, 18; [0084]; [0133]; [0217-0220]); and delivering the therapeutic agent to the SCS (36) of the eye (10; Fig. 18).
While Prausnitz fails to explicitly disclose releasing the cannula into the eye; and connecting infusion tubing to the cannula to deliver the therapeutic agent therethrough, Prausnitz expressly teaches that any of the cannulas (1010) described can be flexible ([0274]) and that a proximal end portion of the cannula (1010) may be coupled to a medical device or cartridge via sterile flexible tubing ([0096]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the cannula and method disclosed by Prausnitz to include a release of the cannula into the eye and connection of infusion tubing, similar to the flexible tubing connections and flexible cannulas suggested by Prausnitz, in order to provide an intervening structure which allows for delivery of the drug formulation at specific target tissue locations, as suggested by Prausnitz in paragraph [0096], with a reasonable expectation of success.
17. With regard to claims 11 and 19, Prausnitz discloses deploying a sheath (needle cap; [0051]; [0064]) having a diameter greater than a diameter of the cannula (1010) and in which the cannula (1010) is housed (best seen in Fig. 6 as cap, 250; [0093]).
18. Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz in view of Hee et al. (US PGPUB 2010/0173866 A1).
19. With regard to claim 12, while Prausnitz expressly teaches that any of the cannulas (1010) described can be flexible ([0274]) and that a proximal end portion of the cannula (1010) may be coupled to a medical device or cartridge via sterile flexible tubing ([0096]), Prausnitz fails to explicitly disclose that the cannula is bent at a particular angle to position the cannula on the eye.
Within the same field of SCS drug delivery, Hee discloses an apparatus and method for ocular treatment (abstract; Figs. 1-5), wherein a cannula (microcannulae, 1) is provided for delivery of therapeutic agents to the eye, and the cannula is bent at a particular angle to position the cannula on the eye ([0009-0010]; [0013]; [0031-0032]; [0034]; [0042]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the cannula disclosed by Prausnitz to be bent at a particular angle, similar to that disclosed by Hee, in order to approximate the curvature of the eye and safely reach the posterior region of the suprachoroidal space from an anterior access point with a reasonable expectation of success, as suggested by Hee in paragraph [0032].
20. Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz, as applied to claim 18 above, and further in view of Abt et al. (US PGPUB 2022/0233768 A1).
21. With regard to claim 20, while Prausnitz expressly teaches that any of the cannulas (1010) described can be flexible ([0274]); that a proximal end portion of the cannula (1010) may be coupled to a medical device or cartridge via sterile flexible tubing ([0096]); and that therapeutic agent is delivered into the SCS of the eye via a continuous and controlled infusion (Figs. 17, 18; [0084]; [0133]; [0217-0220]), Prausnitz fails to explicitly disclose that the infusion tubing is connected to a controlled flow system to provide controlled flow rates of the therapeutic agent.
Within the same field of subocular injections, Abt discloses a method and apparatus for subretinal injection (abstract; Figs. 1A, 2C, 8A, 9A), wherein a proximal end of a cannula (110) is connected to an infusion tubing (120) which is connected to a controlled flow system (fluid control unit, 140) to provide controlled flow rates of the therapeutic agent ([0038-0039]; [0041]; [0044]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the infusion tubing disclosed by Prausnitz to be connected to a controlled flow system, similar to that disclosed by Abt, in order to control operation of fluid pumping, while also regulating the fluid flow rates from the flow system, as suggested by Aby in paragraph [0044].
Conclusion
22. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tsai et al. (US PGPUB 2019/0183674) discloses a therapeutic agent delivery device.
PAques et al. (US PGPUB 2010/0010452) discloses an apparatus for intra-ocular injection.
23. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/ Primary Examiner, Art Unit 3781
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