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 .
Applicants’ election with traverse of Group I, claims 1-11 in the reply filed on 5/21/2026 is acknowledged. The traversal is on the ground(s) that the elected group of claims is director a product and the nonelected claims are method claims and claim 1 is generic to method claims. This is not found persuasive because Applicant has not pointed out any defect in the restriction requirement mailed on 3/27/2026.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 5/21/2026.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11807870. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed cellular microcompartment comprises the same structural features as the cellular microcompartment as claimed in ‘870. Further, instant dependent claims 2-11 encompass the same structural features as set forth in claims 2-15 of ‘870.
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 3, 8 and 9 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.
The term “several” in claims 3 and 9 is a relative term which renders the claim indefinite. The term “several” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claims 8 and 9, the phrase "preferentially" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claim(s) 1-4 and 6-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (2014, Analyst, Vol. 139, pgs. 2449-2458) in view of Taniguchi et al. (2015, Stem Cell Reports, Vol. 5, pgs. 954-962) and further evidenced by the teachings of Hashemi et al. (2026, bioRxiv preprint, pgs. 1-50).
Regarding claims 1, 2, 4 and 7, Wang et al. teaches an enclosed spherical cellular microcompartment for carcinoma cells comprising alginate and Matrigel and comprising a hydrogel outer layer between 5 to 40 μm (see Abstract, pg. 2451 col. 2 parag. 3 and Fig. 4C).
Regarding claims 3, 9 and 10, while Wang does not explicitly disclose their cell density of encapsulated cells of the thickness of the extracellular matrix layer, it is interpreted that the number of cells encapsulated is between 1 and several thousand and that the extracellular matrix layer represents 5 to 80% of the radius of the microcompartment in view of the images taught in Figs. 5A/B.
Regarding claim 6, while Wang does not teach the weight of their alginate, the teachings of Hashemi are relied upon in teaching that alginate has a molecular mass between 100 to 400 KDa, depending on usage.
Regarding claim 8, Wang teaches the diameter of some hydrogel beads is greater than 230 μm and less than 290 μm (figure 4f, for example).
Regarding claim 11, Wang teaches that the extracellular matrix layer is attached to the inner side of the hydrogel shell (pg. 2451 col. 2 parags. 2-3 bridge pg. 2451 and Fig. 4A).
Wang does not teach:
Polarized human pluripotent cells.
Regarding polarized human pluripotent cells, Taniguchi et al. teach that human
embryonic stem cells intrinsically form polarized lumens in 3D culture (see Abstract and pg. 954 col. 1 parag. 1 and pg. 955, col. 1 parag. 1).
Taniguchi continues to teach that “the malleable nature of the lumenal shape, coupled
with the pluripotent characteristics of the cells, will facilitate a wide variety of biological and biomechanical investigations in the context of tube formation and function.” (pg. 961 col. 1 last line bridge col. 2 lines 1-3).
Thus at the time of filing it would have been prima facie obvious to combine the teachings of Wang regarding a cellular microcompartment comprising an extracellular matrix and alginate with the teachings of Taniguchi regarding the nature of pluripotent cells to form lumen structures to arrive at the claimed invention.
One of ordinary skill would have been motivated to culture the human pluripotent cells of Taniguchi in the microcompartment of Wang in view of the teachings of Taniguchi that a detailed under-standing of the lumen-forming process and the mechanisms underlying it is critical for the proper engineering of transplantable tissues.
One of ordinary skill would have had a reasonable expectation of success in culturing the human pluripotent stem cells of Taniguchi in the cellular microcompartment of Wan in view of the teachings of Wang that the viability of cells encapsulated in the mixed hydrogel beds was more than 90%.
Thus the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (2014, Analyst, Vol. 139, pgs. 2449-2458) in view of Taniguchi et al. (2015, Stem Cell Reports, Vol. 5, pgs. 954-962) as applied to claims 1-4 and 6-11 above, and further in view of Schmidt et al. (WO 2014/093489 A2).
The teachings of Wang and Taniguchi are relied upon above in teachings a cellular microcompartment comprising polarized human pluripotent cells.
Wang and Taniguchi do not teach:
An alginate comprising more than 80% α-L-guluronate.
Regarding an alginate comprising more than 80% α-L-guluronate, Schmidt et al.
teach alginate hydrogels that comprise 80% or more α-L-guluronate and less than 20% β-D-mannuronate.
Specifically, Schmidt teaches that “the alginate component may be a copolymer of
mannuronate (M) units and guluronate (G) chemical units. The alginate backbone may consist of these two units arranged in repeating blocks and alternating blocks (e.g., MMMMMM, GGGGGG, and MGMGMG patterns). The proportion of Mand G units in a particular alginate is dependent on, for example, the plant source from which the alginate is harvested in some embodiments. Alginates may be characterized by the proportion of M and G units. The alginate component in an embodiment may be any type of alginate including alginates with a high proportion of M units (i.e., high-M alginate), alginates with a high proportion of G units (i.e., high-G alginate) and blends of high-M and high-G alginates. In an embodiment a "high proportion" of a unit constitutes more than 50% but in other embodiments the value may be 60%, 70%, 80%, 90%, or higher. (parag. 10).
Thus at the time of filing it would have been prima facie obvious to combine the teachings of Wang and Taniguchi regarding a cellular microcompartment comprising an extracellular matrix and alginate with the teachings of Schmidt regarding the varying percentages of α-L-guluronate to arrive at the claimed invention.
One of ordinary skill would have been motivated to vary the percentage of α-L-guluronate above 80% in an alginate gel since Schmidt teaches that this can be a design choice for making an alginate hydrogel.
There would have been a reasonable expectation of success that the α-L-guluronate in the alginate gel of Wang could be more than 80% since Schmidt teaches that α-L-guluronate can be more than 90%.
Thus the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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/DAVID A MONTANARI/Examiner, Art Unit 1632
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