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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on March 5, 2026. As directed by the amendment: claim 16 has been amended. Thus, claims 1, 2, 4-6, and 10-18 are presently pending in this application with claims 11-16 and 18 presently withdrawn.
Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed November 5, 2025.
Response to Arguments
Applicant's arguments filed March 5, 2025 have been fully considered but they are not persuasive.
Applicant argues on pg. 6 of the Remarks that “Hammack apparently does not disclose the creation of a passage in the suprachoroidal space. Instead, Hammack discloses a guard mechanism designed to limit penetration depth and prevent tissue damage during injection”. The examiner respectfully notes that even though Hammack discloses an intended use of the guard mechanism is to prevent the distal tip from penetrating the choroid (paragraph 33), Hammack explicitly discloses that an inherent result of this function is the displacement of tissue upon guard activation so that Hammack discloses the step of creating a passage in the suprachoroidal space since the passage is created upon tissue displacement when the guard is deployed.
Applicant argues on pg. 6 of the Remarks that “Hammack apparently does not disclose this sequence. In Hammack: the needle penetrates tissue, the guard limits penetration depth, the drug is injected through the needle. There is no apparent disclosure that a passage is formed first and then subsequently used as the target of the injection”. The examiner respectfully disagrees and notes that in another embodiment of the guard, Hammack discloses that a fluidic guard can be used which is used to “sufficiently displace the tissues without overinflating the eye but allowing enough space to safely perform an injection” (paragraph 38). Although this disclosure is relative to a fluidic guard embodiment, the examiner maintains that PHOSITA would recognize that displacement of the tissue would occur first which forms a passage and is subsequently followed by injection into that passage since Hammack teaches that the displacement is useful in providing enough space to perform an injection. Additionally, Hammack discloses that fluid can be delivered to the space while the guard is deployed so that the tissues would be displaced during injection (paragraph 36).
Applicant argues on pg. 7 of the Remarks that “temporary displacement of tissue by a safety guard does not constitute formation of a passage within the suprachoroidal space. The reference apparently contains no disclosure that a channel, separation, or passage is created within the suprachoroidal space prior to injection”. The examiner respectfully notes that it appears that the guard of Hammack creates a similar passage as created by Applicant’s invention so that the examiner’s interpretation of the term “passage” appears aligned with Applicant’s. Paragraph 40 of the published application discloses that the separator creates some detachment between the choroid and the sclera so that fluid can be introduced into the suprachoroidal space; as best understood by the examiner, this “detachment” is the created passage. The examiner notes that while paragraph 40 discloses that the separator is advanced into the choroid, this passage would be a passage in the choroid and not the suprachoroidal space. The suprachoroidal space is itself a space bounded by the sclera and the choroid; however, the suprachoroidal space itself is devoid of any structure. It would appear that a passage created within the suprachoroidal space, as required by the claim, would necessarily require displacement of surrounding tissue in order to widen the suprachoroidal space. It appears that Applicant believes that a passage requires a narrow channel and that Hammack does not teach such narrow channel. However, such a narrow channel cannot be made in a “space”, the channel would require structure to form the channel. As such, the examiner maintains that the interpretation relied upon in the rejection appears within the scope of the disclosed invention.
Applicant argues on pg. 7 of the Remarks that “Hammack instead apparently discloses injecting fluid through the lumen of the needle. The fluid is delivered through the needle tip rather than into a previously created passage in the suprachoroidal space”. As noted above, Hammack teaches that the displacement of tissues is also useful in ensuring there is enough space for injection (paragraph 38) so that PHOSITA would recognize that fluid is injected into the passage created by the guard member.
Applicant argues on pg. 7 of the Remarks that “the guard apparently does not create a passage used for injection. Rather, the guard merely protects tissue while the needle delivers the substance.” The examiner respectfully disagrees and notes that while the guard ensure that needle does not inadvertently penetrate the choroid, an inherent result of the guard is that tissue displacement occurs which is disclosed as also being useful in providing enough space for injection (paragraph 38).
Applicant argues on pg. 8 of the Remarks that “The Examiner's rejection appears to rely on an inference that displacement of tissue by a guard element inherently creates a passage corresponding to the claimed passage… Nothing in Hammack apparently teaches or suggests intentionally creating a passage within the suprachoroidal space prior to injection”. The examiner respectfully disagrees and notes that regardless if the act of tissue displacement is an intention method step of Hammack, Hammack explicitly discloses that deployment of the guard inherently results in tissue displacement which creates the claimed passage (paragraph 36) so that Hammack discloses creating the claimed passage.
Applicant argues on pg. 8 of the Remarks that “The claimed method intentionally forms a passage in the suprachoroidal space…Hammack, by contrast, apparently performs direct injection through a needle, with the guard serving only as a protective mechanism to control penetration depth”. As discussed previously, the examiner notes that Hammack discloses the step of creating a passage since the passage is inherently created upon deployment of the guard member. The present claim language does not require an intentionally formed passage.
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, 2, 4-6, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hammack (US 20120271272).
Regarding claim 1, Hammack discloses a method for delivering a substance to a suprachoroidal space of an eye, comprising:
creating an entrance to a suprachoroidal space of an eye without penetrating into a choroid of the eye with a sharp instrument (paragraph 35 discloses creating a tract in a sclera using main shaft 12 which comprises a sharpened tip 13 in fig. 3);
introducing a blunt instrument (guard 18 in fig. 3), which is blunter than said sharp instrument (fig. 3 and paragraph 36 discloses that comprises a blunt tip 17 which is blunter than the tip of shaft 12), distally through said entrance to create a passage in the suprachoroidal space (paragraph 36 discloses that once the shaft 12 penetrates into the suprachoroidal space, the guard extends distally to push the choroid away from the tip of the shaft which would create a passage in the suprachoroidal space; paragraph 57); and
injecting said substance into said passage (paragraph 36 discloses attaching a syringe to luer 14 in fig. 3 and delivering a fluid via the syringe, which would encompass injecting a fluid into the passage created by guard 18), wherein said substance comprises a gene therapy agent (paragraph 47).
Regarding claim 2, Hammack discloses said blunt instrument passes through a lumen of said relatively sharp instrument (fig. 3).
Regarding claim 4, Hammack discloses at least partially withdrawing said blunt instrument prior to injection of said substance into said passage (paragraph 36 discloses removing the guard assembly before connecting the syringe).
Regarding claim 5, Hammack discloses said passage has a length of at least 1mm (paragraph 50 discloses that the main shaft length is no more than the thickness of the combined tissue and the amount of tissue displacement due to the guard, which this amount of tissue displacement being equated to the claimed “length”; paragraph 50 discloses that the max length of the main shaft is 2.75 mm and the thickness of the combined tissue proximal to the suprachoroidal space is 0.38 mm which equates to a displacement amount of 2.37 mm).
Regarding claim 6, Hammack discloses said passage has a length of at least 2 mm (paragraph 50 discloses that the main shaft length is no more than the thickness of the combined tissue and the amount of tissue displacement due to the guard, which this amount of tissue displacement being equated to the claimed “length”; paragraph 50 discloses that the max length of the main shaft is 2.75 mm and the thickness of the combined tissue proximal to the suprachoroidal space is 0.38 mm which equates to a displacement amount of 2.37 mm).
Regarding claim 16, Hammack discloses injecting said substance to treat at least one of macular degeneration (paragraph 2).
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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hammack, as applied to claim 1 above, and further in view of Heitzmann (US 20160354309).
Regarding claim 10, Hammack discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose said substance also comprises an active pharmaceutical ingredient selected from the claimed group.
Heitzmann is directed towards a method of delivering a substance to the suprachoroidal space (paragraph 360) in which the substance comprises a gene therapy agent (paragraph 375) and that the substance can comprise multiple active therapeutic ingredients (paragraph 367 discloses “one or more drugs”) and that an example of another active therapeutic ingredient which can be delivered is anti-inflammatory agents (paragraph 374). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the substance of Hammack to include both a gene therapy agent and an anti-inflammatory agent, as taught by Heitzmann, to decrease inflammation in the ocular tissue.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hammack.
Regarding claim 17, Hammack discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not explicitly teach or disclose said blunt instrument has a thickness equal to or greater than a thickness of the choroid of the eye.
However, Hammack teaches that an example thickness of the blunt instrument is 0.18 mm (paragraph 52 discloses a diameter of a spring loaded guard element). Additionally, Applicant’s specification discloses that the thickness of the choroid can be between 0.1-0.2 mm (paragraph 3). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of Hammack to be used on a choroid which comprises a thickness of 0.1-0.18 mm so that the blunt instrument has a thickness equal to or greater than a thickness of the choroid of the eye. This range of thickness is within the normal range for thickness of the choroid and it appears that the method of Hammack would be equally effective on an eye with the claimed thicknesses of the choroid.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BHISMA MEHTA can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783