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 .
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.
Claim Status
Claims 22-42 are currently pending and examined on the merits.
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 27, 34, 39 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.
Claim 27 contains the limitation “wherein the culture or maintenance medium is diluted between 1:0.05 and 1:200”. This claim does not indicate with what the media is diluted. Therefore, it is unclear what this limitation is intending to convey.
Claim 34 recites the limitations "the environment” and the cells". There is insufficient antecedent basis for this limitation in the claim.
Claim 39 contains the limitation wherein the biological material is selected from the group consisting of: an autologous source, an allogeneic, a xenogeneic source”. Claim 22 from which claim 39 depends directed to preparing an immunoisolation device. Neither claim 1 nor 22 contain any administration steps. In order for a source material to be considered autologous, allogeneic, or xenogeneic, there must be an administration of that material. Therefore, it is unclear what this limitation encompasses.
Claim Rejections - 35 USC § 102
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) 22, 34-42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson et al., US Publication No. 2012/0213708 (cited on IDS dated 9/8/23, hereinafter Anderson).
Regarding claims 22, 36, 42 Anderson discloses compositions containing hydrogels encapsulating mammalian cells and therapeutics, and methods of making thereof (Abstract). In a preferred embodiment, the composition is formulated with a hydrogel core containing mammalian cells, and an envelope hydrogel containing therapeutics ([0055]-[0056]). Any suitable biocompatible hydrogel for encapsulation may be used such as polyethylene glycol (PEG) (para 22, 58). The core and the envelope may be the same or different hydrogels ([0058], [0064], [0073]-[0075], [0090]-[0093]).
Regarding claim 34, Anderson discloses that the composition allows for sufficient diffusion of oxygen and nutrients to the encapsulated cells, and also allows for the outward diffusion of therapeutics ([0014], [0041], [0101]-[0102])
Regarding claim 35, Anderson explains that microencapsulating cells is a strategy for providing cells to subjects in need thereof while preventing rejection of the implant and without the need for systemic anti-rejection drugs (i.e., the material is immunoisolated) ([0003], [0013]).
Regarding claims 37-38, 40-41, Anderson discloses that cells suitable for encapsulation are generally secretory or metabolic cells, such as islets, hepatocytes ([0025], [0101]-[0102]). Anderson explains that secretory cells, like islets, secret a therapeutic factor, such as insulin ([0025], [0053], [0101]-[0102]).
Regarding claim 39, Anderson discloses that the cells may be allogeneic, xenogeneic, or autologous ([0100]).
Therefore, every limitation of claims 22, and 34-42 is present in Anderson and the subject matter is anticipated.
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.
Claim(s) 23-24, 26-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson as applied to claims 22, and 34-42 above, and further in view of Anderson et al., (2011) The performance of human mesenchymal stem cells encapsulated in cell-degradable polymer-peptide hydrogels. Biomaterials, 32(14): 3564-3574 (hereinafter Anderson 2011).
Regarding claim 23, Anderson does not disclose that the inner core comprises mixing a hydrogel solution with a protease degradable linker peptide, cross-linking the hydrogel, and implanting biological material into the degradable hydrogel. Regarding claim 24, Anderson does not disclose placing the inner core in hydrogel solution comprising a non-degradable hydrogel precursor solution and a photoinitiator, and crosslinking.
Regarding claims 23-24, Anderson 2011 discloses methods of encapsulating human mesenchymal stem cells (MSCs) in degradable polymer-peptide hydrogels (Abstract). The MSCs are suspended in a PEG-norbornene solution with various combinations of MMP-degradable peptide and PEG-dithiol (2.3). The cell and hydrogel combination is then exposed to UV light to cross-link the hydrogel (2.3). Anderson 2011 explains that the percentage of cell-degradation of the hydrogel may be varied by altering the ratio of MMP-degradable peptide to the non-degradable PEG-dithiol linker (i.e., in some embodiments the hydrogel is cell-degradable, and in others the hydrogel is at least partially non-degradable) (3.1, Fig. 1).
Regarding claims 26-33, Anderson does not explicitly disclose that the biological material is maintained in a culture or maintenance media under certain conditions prior to encapsulation.
Regarding claims 26-30, Anderson 2011 discloses culturing MSCs in a growth media comprising DMEM supplemented 10% FBS, bFGF, antibiotic, and antimycotic (i.e., the media is diluted with supplements) at 37°C (2.3).
Regarding claims 32-33 Anderson does not explicitly disclose that the inner encapsulation is configured to expand and contract, or that the inner encapsulation is configured to allow the cells to grow.
Regarding claims 32, Anderson 2011 discloses that the hydrogel demonstrates volume expansion over a 14 day culture period (3.1, Fig. 2).
Regarding claims 33, Anderson 2011 discloses that the encapsulated MSCs demonstrate cell proliferation within the hydrogel (3.1, Fig. 2).
As both Anderson and Anderson 2011 are directed to methods of cell encapsulation utilizing hydrogels, it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would be motivated to utilize the hydrogels of Anderson in 2011 as Anderson explains that any suitable biocompatible hydrogel may be used, including PEG ([0022], [0058]). A skilled artisan would understand that the known hydrogels of Anderson 2011 could be used the methods of Anderson as a simple substitution of one known hydrogel type for another, with a reasonable expectation of successfully encapsulating cells.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson as in view of Anderson 2011, as applied to claims 23-24, 26-33 above, as evidenced by Life in the Lab Staff. Consider humidity in your CO2 incubator for excellent cell growth. ThermoFisher Scientific, July 2024 [retrieved 2026-01-07]. Retrieved from the Internet: https://www.thermofisher.com/blog/life-in-the-lab/consider-humidity-for-excellent-cell-growth/ (hereinafter ThermoFisher).
Regarding claim 31, the combination does not explicitly disclose that the biological material is maintained at a humidity of between 40% and 100% humidity. However, well-known, industry standard tissue culture practice calls for maintaining humidity at 85-95% as evidenced by ThermoFisher. Therefore, it would be obvious to one of ordinary skill in the art to use well-known, industry standard tissue culture practices for the culture of the cells utilized in the combination.
Allowable Subject Matter
Claim 25 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 22-24, 26-42 are rejected. Claim 25 is objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632