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 .
This office action is in response to applicant’s communication of 6/17/2024. Currently claims 1-15, 19, 21, 26-30
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/02/2025, 08/28/2025, 08/21/2024, 04/04/2024 is being considered by the examiner.
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.
Claim 15 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.
Claim 15 contains the trademark/trade name VeroClear, Med610, Med615, and Med620. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe Stratasys LTD transparent material and, accordingly, the identification/description is indefinite.
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) 1-11, 13-15, 19, 21, 26-27, and 30 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kapec et al. (US 2019/0274809).
Kapec discloses a cell transplant carrier (figures 1-6; para ([0012]-[0044]) comprising: a carrier plate (20) comprising a body (20) and one or more chambers (48, figure 3-4) defined in the body, wherein each of the one or more chambers is configured to receive a cell transplant therein (figures 3-4; para [0028]); and a carrier housing comprising a carrier plate opening (opening of 56 receiving 12) leading to an inner compartment configured to removably receive the carrier plate (compartment of 56 figures 5-6).
Concerning claim 2 and the carrier plate is rectangular in shape (see figure 3 and 20).
Concerning claim 3 and each of the one or more chambers (48) includes a slot (side portions of 48) portion defining an overhang of the body (each side of 20) of the carrier plate, the slot portion configured to retain the cell transplant from migrating therefrom.
Concerning claim 4 and each of the one or more chambers extends into a side edge of the carrier plate (note chamber 48 extends to side of plate 20).
Concerning claim 5 and each of the one or more chambers includes a recessed portion (see re3cess depth of 52) defined on the side edge of the carrier plate, the cell transplant including a tab portion (22) configured to overhang the recessed portion when the cell transplant is received within the one or more chambers.(note the transplant is not a positively claimed structure and further the “overhang” orientation is not specified).
Concerning claim 6 and the one or more chambers are symmetrically distributed along the dimensions of the drawer (see figures 3).
Concerning claim 7 and the carrier housing includes a plurality of openings extending from an outer surface to the inner compartment to provide a plurality of passageways for a preservation fluid to pass therethrough (note plurality of openings in figure 5 of housing 56).
Concerning claim 8 and the carrier housing comprises four sidewalls, the plurality of passageways defined on at least two of the sidewalls (note sidewalls which make up housing 56 as in figure 5).
Concerning claim 9 and in an assembled state, the carrier plate is positioned within the inner compartment of the carrier housing (as in figure 5) and the tab portion of the cell transplant opposes one of the sidewalls of the carrier housing without the plurality of passageways defined therein (see figure 5 and also note the transplant is not a positively claimed structure and further the “overhang” orientation is not specified).
Concerning claim 10 and the carrier housing and the carrier plate, when positioned within the inner compartment of the carrier housing, are sized to fit within a tube of predetermined size for storage and/or transport (again see figures 5-6 and housing 56).
Concerning claim 11 and each of the one or more chambers comprises two symmetrical flat tabs configured to hold the cell transplant in place in a correct orientation within each chamber (note chamber 48 comprises tabbed portions left and right surfaces of 48 as in figure 3 which hold the transplant 22 in place).
Concerning claim 13 and the carrier housing has a cuboid shape (note 56 and note shape figures 5-6).
Concerning claim 14 and at least one of the carrier housing and/or and carrier plate is 3D printed (see para [0022] and this appears to be a method of making or way of forming a structure).
Concerning claim 15 and one of the carrier housing and/or and the carrier plate is manufactured from at least one of VeroClear, Med610, Med615, and Med620 (see para [0014] and transparent material which would include VeroClear, Med610, Med615, and Med620 as these are well known transparent materials to form medical devices from.).
Concerning claim 19 and each of the one or more chambers is shaped to cause the cell transplant to be at least partially exposed or accessible in order to permit removal of the cell transplant therefrom (see figure 3 and note 48 chamber permits removal of 22).
Concerning claim 21 and a carrier device comprising: a cell transplant carrier according to claim 1 (note disclosure of prior art for claim 1 above); one or more cell transplants (see 22) housed within the cell transplant carrier; and a chamber (48) configured to receive the cell transplant carrier therein (see figure 1 and 5-6 for examples).
Concerning clam 26 and a method of preserving viability of cells or a cellular implant or cellular tissue, comprising: placing the cells or a cellular implant or cellular tissue into a cell transplant carrier according claim 1 (note disclosure of prior art for claim 1 above); transferring the cell transplant carrier into a chamber configured to receive the cell transplant carrier to form a carrier device; and filling the carrier device with a stabilizing medium and preserving the viability of the cells or cellular implant or cellular tissue (see para [0022]) and use of fluid ethanol to preserve the implant 22).
Concerning claim 27 and comprising removing the cells or the cellular implant or cellular tissue from the cell transplant carrier using a surgical device (see para 0029 and use of surgical instrument to remove the 22 implant).
Concerning claim 30 and a surgical kit comprising: a cell transplant carrier of claim 1 (note disclosure of prior art for claim 1 above); one or more cell transplants housed within the cell transport carrier; and instructions for use (see para [0041] and note of inclusion of instructions and tissue graft cellular implant 22).
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.
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) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kapec et al. (US 2019/0274809).
Concerning claim 12 and at least one of the one or more chambers has a length of about 2 mm to about 20 mm, a width of at least 1 mm and not more than 3 mm, and a height of at least 0.25 mm and not more than 0.75 mm
Kapec discloses the claimed invention except for explicitly stating the size of the device only saying that it could be any size. It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the Kapex device with a size of at least one of the one or more chambers has a length of about 2 mm to about 20 mm, a width of at least 1 mm and not more than 3 mm, and a height of at least 0.25 mm and not more than 0.75 mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). This is a common size known in the medical arts to house and store a tissue implant or medical specimen. It is examiners position that a PHOSITA would know to make the device with the size of at least one of the one or more chambers has a length of about 2 mm to about 20 mm, a width of at least 1 mm and not more than 3 mm, and a height of at least 0.25 mm and not more than 0.75 mm in order to be large enough to hold a cellular implant but not so large as to waste material or contain excess space for contamination.
Claim(s) 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kapec et al. (US 2019/0274809) in view of Waterhouse et al. (US 2020/0179105 A1).
Concerning claim 28 and 29 and the method comprising implanting the cells or the cellular implant or cellular tissue into an eye of a subject using the surgical device and treating an eye condition in the subject and of the retina.
Kapec discloses the claimed invention except for the implanting the cells or the cellular implant or cellular tissue into an eye of a subject using the surgical device and treating an eye condition in the subject and of the retina. Waterhouse teaches that it is known to use implanting the cells or the cellular implant or cellular tissue into an eye of a subject using the surgical device and treating an eye condition in the subject and of the retina as set forth in figures 2a-2e and para [0035]-[0044)] to provide a replacement lens procedure in order to treat a patient suffering from an ocular disease. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Kapec with implanting the cells or the cellular implant or cellular tissue into an eye of a subject using the surgical device and treating an eye condition in the subject and of the retina as taught by Waterhouse, since such a modification would provide the method with implanting the cells or the cellular implant or cellular tissue into an eye of a subject using the surgical device and treating an eye condition in the subject and of the retina for providing a replacement lens procedure in order to treat a patient suffering from an ocular disease.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be reached M-F 9-5 EST (FLEX).
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, Michael Tsai can be reached at (571)270-5246. 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.
PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
Prosecution Insights