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
Claims 12-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventive group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/22/2026.
Applicant's election with traverse of Inventive Group I in the reply filed on 09/02/2026 is acknowledged. The traversal is on the ground(s) that there is no additional search burden on the Examiner. This is not found persuasive because the inventions have acquired a separate status in the art due to their recognized divergent subject matter and the inventions require a different field of search. Inventive group II requires use of the alginate coated hydrogels to promote osteogenesis in a subject, introducing the additional search burden of osteogenesis trials. Inventive group III requires the incorporation of multiple aqueous phases in the creation of the product of inventive group I, introducing the additional search burden of multiple steps of creation. Inventive group IV requires the generation of a microfluidic device, introducing the additional search burden of a microfluidic device.
The requirement is still deemed proper and is therefore made FINAL.
Claim Interpretation
Claim 2 is worded in a way that is confusing regarding the requirements of claim 1, of which claim 2 depends. Claim 1 states a product which is alginate-coated cells which requires the alginate to be conjugated to a cell surface receptor ligand, whereas claim 2 is worded as follows: “The alginate-coated cells of claim 1, wherein the alginate-coated cells are elongated relative to alginate-coated cells in which the cell surface receptor ligand is evenly distributed over the surface of the alginate-coated cells”. The wording implies that there is a population of non-conjugated hydrogel encapsulated cells, which goes directly against the requirements of claim 1. Examiner will proceed under the assumption that there is a single population of encapsulated cells which are required to be conjugated to a cell surface receptor ligand.
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 2 is 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 2 recites the limitation "wherein the alginate-coated cells are elongated relative to the alginate-coated cells in which the cell surface receptor ligand is evenly distributed…:" in the second to fourth lines of claim 2. There is insufficient antecedent basis for this limitation in the claim. Claim 2 is dependent on claim 1, and claim 1 only makes reference to a population of cells which have been encapsulated with a crosslinked alginate hydrogel layer which has a cell surface receptor ligand distributed throughout. Therefore, there is no antecedent basis for any other type of cell population such as the alginate-coated cells without a cell surface receptor ligand as stated in claim 2.
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.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shin et al.
Regarding claims 1 and 6: Shin discloses alginate-coated cells composed of a cross-linked alginate hydrogel layer encapsulating single mesenchymal stem cells which are conjugated to one or more adhesive ligands. (0004) As claim 1 requires either random or predefined distribution of the cell surface receptor ligand, it is inherent that in the coating process said ligands would either be randomly distributed or predestined in their distribution, as this encompasses all possible patterns of distribution.
Per the Specification submitted by the Applicant, polarization is defined as being caused by an asymmetric presentation of ligand receptors which force the cell to undergo polarization due to membrane tension caused by the distribution of ligand receptors across the membrane. (0021) As claim 6 depends from claim 1 and therefore inherits all the limitations of said claim, as claim 1 states that the cell surface ligand receptor may be unevenly distributed across the surface of the hydrogel, said uneven distribution would result in the polarization of the cells of claim 1.
Regarding claim 2: As mesenchymal stem cells are known to have an elongated shape, it is inherent that the alginate-coated MSCs are elongated in shape.
Regarding claim 3: Shin discloses that the hydrogel layer has a thickness of about 0.5-5 microns, a softness of about .01-10 kPa, and a molecular weight of about 250-500 kDa. (0004)Though the entire claimed range of the thickness of the hydrogel is not encompassed, per MPEP 2144.05.I, “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range)”
Regarding claim 4: Shin discloses that cell adhesive ligands are often polysaccharides or short peptide sequences. (0028)
Regarding claim 5: Shin discloses that ideally the cation cross-linked with the alginate hydrogel is a divalent cation such as Ca2+, Sr2+, or Ba2+. (0034)
Regarding claims 7 and 8: In Example 1 of the claimed invention, Shin uses mesenchymal stem cells encapsulated in alginate microcapsule hydrogels in order to promote osteogenesis. (0050)
Regarding claim 9: Shin discloses that an embodiment of the invention comprises growth factors. (0030)
Regarding claim 10: Shin discloses that the alginate-coated cells may be prepared into a composition with a pharmaceutically acceptable carrier. (0038)
Regarding claim 11: Shin discloses in claim 13 of the invention that the composition comprising said alginate microcapsules further comprises one or more ion channel modulators and/or one or more cell contractility modulators. (Pg 79, Claim 13)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA M THUESON whose telephone number is (571) 272-3680. The examiner can normally be reached M-F 7:30-5 EST. 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, Tracy Vivlemore, can be reached on (571) 272-2914. 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.
/HANNA MARIE THUESON/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
