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 action is in response to the papers filed June 27, 2024.
Claims 1-10 are pending in the application and examined on the merits.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on December 26, 2022.
Receipt is acknowledged of certified untranslated copies of the application CN2022116735591 as required by 37 CFR 1.55 filed on 8/5/2024.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus, the earliest possible priority for the instant application is December 26, 2022.
Claim Rejections - 35 USC § 112(b)
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 1-10 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.
Claims 1 and 2 recites the limitation "the material" in steps 4 and 5 respectively. There is insufficient antecedent basis for this limitation in the claim as only “biomaterial” is mentioned. It is unclear what material is removed and to what extent said material is removed.
Claims 1 and 2 are indefinite in their recitation of term “the cell/material mixture” in line 4. There is not proper antecedent bases for “material mixture’ in the claims. Step (2) of claim 1 and 2 refer to “aqueous biomaterial solution”. As such the metes and bounds of the claims are indefinite.
Claims 1 and 2 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: an active transport step between steps 3 and 4 in claim 1 and 4 and 5 in claim 2. The previous step states that the composition is being prepared for transport and the following step recites “after transport.” However, there is no transport step.
Claims 3, 4, 5, 7, 8, 9 and 10 are indefinite in their recitation of “in various methods,” as it is unclear whether the phases refer to the different steps of claim 1 or 2, the independent methods of claims and 2 and others. As such the metes and bounds of the claims are indefinite.
Claim 3 is in improper Markush form; a Markush group should be in the form “ a biomaterial selected from the group consisting of A, B, and C”. Currently, it is not clear which species are included in the Markush group and which are not. The claim language is indefinite as it is unclear what the metes and bounds of the claim are and if the options are all inclusive, or in the alternative. For example, “at least” would indicate all alternative biomaterials being in the composition at once as an option, one biomaterial such as “poloxamer” or two biomaterials with “chitosan and its derivative.”
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.
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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Li (2018, PLoS ONE13(1): e0190364) in view of Connon (US20140072601).
Regarding claim 1 step (1), Li teaches embedding cells in a mixture of PNIPAAM-PEG solution (i.e. biomaterial) (Figure 1B). The temperature is 4°C when the cells are mixed with the hydrogel solution (Figure 1B). The sucking up and mixing uniformly limitations are interpreted as being met as the cells are seeded into the biomaterial (Figure 1B, p. 6, last paragraph). Regarding step (2), Li teaches that the hydrogel mixture forms a solid hydrogel at 37°C which encapsulates the cells (Figure 1B). Regarding step (3), Li teaches placing the hydrogels in culture medium (Figure 1B; p.3, 1st paragraph). Regarding step (4), Li teaches that cells can be removed from hydrogels through adding PBS and dissolving the hydrogel before centrifuging the cells (p. 4, 1st paragraph). Although this is disclosed in Li for subsequent passaging, one of ordinary skill in the art would have a reasonable expectation of success of removing the cells from the hydrogel for a different purpose other than passaging.
However, Li does not teach the transportation of cells in between the culture and the removal.
Connon teaches a method of transporting cells comprising isolating limbal cells and culturing them in basal media before encapsulating them in calcium alginate gels (i.e. biomaterial solution, alginate) via mixing them with the gel mixture (Claim 1, para. 0168).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to utilize the hydrogel of Li for transportation of cells to a different location before removing the material, and isolating the cells by centrifugation
Regarding claim 2, Li and Connon make obvious the method of transportation of cells recited in claim 1. The steps (1) and (2) of claim 1 read on steps (1) and (2) of claim 2, and claim 1 steps (3) and (4) read on Claim 2 step (4) and (5). Moreover, regarding claim 2 step (3), Li teaches performing a 3D cell culture in a cell incubator at 37°C (p. 3-4, bridging paragraph; Figure 1B).
Regarding claim 3, Li and Connon make obvious the method of transportation of cells recited in claim 1. Moreover, Li teaches that the biomaterial comprises poly (N-isopropyl acrylamide) (Figure 1).
Regarding claim 4, Li and Connon make obvious the method of transportation of cells recited in claim 1 and claim 3. Moreover, Li teaches that the PNIPAAm-PEG solution is 10% of the biomaterial (p. 3, last paragraph). Therefore, the concentration of claim 4 in wt% is met.
Regarding claim 5, Li and Connon make obvious the method of transportation of cells recited in claim 1. Moreover, Li teaches utilizing cell densities such as 1 x 106 cells/mL (p. 4, last paragraph).
Regarding claim 6, Li and Connon make obvious the method of transportation of cells recited in claim 1. Moreover, Li teaches culturing cells up to 8 days (Figure 3C-E).
Regarding claim 7, Li and Connon make obvious the method of transportation of cells recited in claim 1. Moreover, Connon teaches storage of hydrogels during transport at cell culture conditions such as 37°C, chilled conditions such as 4-6°C or ambient conditions such as 10-25°C (para. 0079).
Regarding claim 8, Li and Connon make obvious the method of transportation of cells recited in claim 2. Moreover, Li teaches that the biomaterial comprises poly (N-isopropyl acrylamide) (Figure 1).
Regarding claim 9, Li and Connon make obvious the method of transportation of cells recited in claim 2. Moreover, Li teaches utilizing cell densities such as 1 x 106 cells/mL (p. 4, last paragraph).
Regarding claim 10, Li and Connon make obvious the method of transportation of cells recited in claim 2. Moreover, Connon teaches storage of hydrogels during transport at cell culture conditions such as 37°C, chilled conditions such as 4-6°C or ambient conditions such as 10-25°C (para. 0079).
Therefore, the invention as a whole would have been prima facie obvious at the time of the effective filing date.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA CONNORS whose telephone number is (571)272-7010. The examiner can normally be reached Monday - Friday (9AM-5PM).
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/ALEXANDRA F CONNORS/ Examiner, Art Unit 1634
/MARIA G LEAVITT/ Supervisory Patent Examiner, Art Unit 1634
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