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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 8/3/2026 is acknowledged.
Claims 20-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/3/2026.
Claim Objections
Claim 17 is objected to because of the following informalities: the limitation “the cells” should be “the plurality of cells”. 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 10, 13 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.
Regarding claim 10, the limitation “a plurality of cells” renders the claim indefinite because its unclear whether this is the same as that previously claimed or not.
Regarding claim 13, the limitation “a distal end thereof” renders the claim indefinite because its unclear whether this is the distal end of the hub or of the cannula or something else. Additionally, its unclear how the cannula tip can extend from the distal end of the cannula shaft when the cannula tip is a part of the cannula shaft.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3-4, 11-12, 14, 19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 3-4, 11-12, 14, 19 all depend on claim 0 which does not exist and thus do not include all the limitations of a claim on which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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)(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(s) 1-2, 8-10, 13, 15-17 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Stojanov US 2024/0423835.
Regarding claim 1, Stojanov discloses a method of cell transplantation using an injection attachment having a hub 2870 containing a plurality of cells, see para. [0068] stating that therapeutic substances or stem cells may be injected into a subretinal space of an eye, and a cannula 2890 extending from a distal end 2851 of the hub, the method comprising: orienting the injection attachment such that the cannula points downwardly until the plurality of cells settle together proximate the distal end, referring to fig. 32A, the mechanism keeps the cannula and the hub such that the distal end is pointed downwardly and would allow for some of the stem cells to settle at the bottom; inserting the cannula into a tissue of a subject, the insertion of the cannula into the eye tissue of the subject is shown in fig. 16b; and injecting the plurality of cells into the tissue of the subject using the injection attachment, the injection of the cells is shown in fig. 16D, element 1634.
Regarding claim 2, Stojanov discloses the hub includes a funnel shaped inner surface 2897 extending between the distal end 2851 and a proximal end 2874.
Regarding claim 8, Stojanov discloses at least 99% of the plurality of cells within the hub are injected into the tissue. The embodiments of Stojanov discloses injecting all of the injection fluids into the tissue, which would be all of the plurality of cells in the hub. See para. [0300].
Regarding claim 9, Stojanov discloses the injection attachment is held at an angle greater than 45 degrees relative to the ground surface while injecting the plurality of cells into the tissue of the subject. See fig. 32a, the hub is held at a steep angle during injection into the eye near 90 degrees where the angle is greater than 45 degrees.
Regarding claim 10, Stojanov discloses providing a plurality of cells to the injection attachment such that the hub is prefilled. See para. [0089] stating that the injection fluid may be prefilled in the deliver device 500.
Regarding claim 13, Stojanov discloses the cannula comprises a cannula shaft 2880 and a cannula tip 2855 extending from a distal end thereof from both the hub distal end and the distal end of the cannula.
Regarding claim 15, Stojanov discloses the cannula tip is blunt ended, see fig. 28A tip 2855 is blunt ended.
Regarding claim 16, Stojanov discloses the tissue is retinal tissue. See para. [0273] the injection occurs in the subretinal space.
Regarding claim 17, Stojanov discloses the cells are stem cells or stem cell derived cells.
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.
Claim(s) 5-7, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stojanov in view of Perking Elmer In Vivo Reagents STANDARD OPERATING PROCEDURE.
Regarding claims 5-7 and 18, Stojanov discloses all elements including a method of cell transplantation in an eye using an injection attachment having a hub containing a plurality of cells and a cannula extending from a distal end of the hub, the method comprising: orienting the injection attachment such that the cannula points downwardly until the plurality of cells settle together proximate the distal end, inserting the cannula into retinal tissue of a subject; and injecting the plurality of cells into the retinal tissue of the subject using the injection attachment as discussed in claims 1 and 16 above. Stojanov additionally discloses the hub includes an engagement end 2874 and a delivery end 2851 and an inner surface 2897 extending form the engagement end and the delivery end, wherein the inner surface tapers inward between the engagement end to the delivery end, s3ee for example fig. 28A. Stojanov does not specifically state pointing the annual downwardly for at least 30 seconds, 2 minutes, or 5 minutes as required in claims 5-7, 18.
Perkin Elmer teaches a standard operating procedure for injecting cells into a mice where prior to injecting the syringe is inverted to ensure the cells are in suspension. Perkin Elmer does not specifically state that the inversion occurs for a particular length of time; however, Perkin Elmer does state that the inversion ensures the cells are suspended. “[W]here 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). In order to properly support a rejection on the basis that an invention is the result of “routine optimization”, the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). See also In re Van Os, 844 F.3d 1359,1361,121 USPQ2d 1209, 1211 (Fed. Cir. 2017). Here, the inversion ensures suspension where an ordinary skilled worker would understand the optimal duration of the suspension would ensure the proper suspension. Thus, the claimed 30 sec, 2 minute, 5 minute inversion would be considered obvious to ensure adequate suspension.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GERALD LUTHER SUNG whose telephone number is (571)270-3765. The examiner can normally be reached 9-5 PST.
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, Devon Kramer can be reached at (571)272-7118. 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.
/GERALD L SUNG/Primary Examiner, Art Unit 3741
Prosecution Insights