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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/19/2026 has been entered.
Priority
This application is a DIV of 15/579,776 (filed 12/05/2017) PAT 10900021 which is a 371 of PCT/US2016/036464 (filed 06/08/2016) which claims benefit of 62/172,449 (filed 06/08/2015). Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Status of the Claims
Applicant’s amendment filed on 02/19/2026 is acknowledged.
Claims 14 and 35 are amended. Claims 37-39 are new. Claims 21 and 31 are cancelled.
Claims 14, 19, 20, 29, 30 and 32-39 are pending (claim set as filed on 02/19/2026) and are examined on the merits herein.
Withdrawal of Rejections
The response and amendment filed on 02/19/2026 are acknowledged. All of the amendment and arguments have been thoroughly reviewed and considered.
For the purposes of clarity of the record, the reasons for the Examiner's withdrawal and/or maintaining if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner's response to arguments section.
New Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 37-39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 37 recites: “deionized water”. The limitation “deionized water” is not described in the specification and thus not supported by the specification. The specification describes rehydration with water (Tables I, II, III paragraphs 0052, 0080, 0086) but not with deionized water. Thus, since the support for claim 1 is not provided, claim 1 contains new matter. One of ordinary skill in the art would not conclude that the applicant would have been in possession of the subject matter of claim 1 at the time of filing application.
Claim 38 recites that upon rehydration the beads exhibit no visible cracks. In Example 6 the specification describes beads exhibiting no visible cracks only for one condition when beads were soaked in 125 mM NaCl and 1 ml of DMSO prior to drying (Table III, treatment #15). Claim 38 depends on claim 14 which recites infiltration of beads with 1-5 wt% of the saccharide selected from sucrose, glucose or their combination and 10-125 mM monovalent cation selected from sodium potassium, ammonium or their combination. Claim 14 does not require infiltration of DMSO. The specification shows in Example 6 that when DMSO is not present beads have cracks (treatment #13, Table III). Thus, the specification does not support to rehydration of beads of claim 14 treated with saccharide and monovalent cation exhibiting no visible cracks. Therefore, since the support for claim 38 is not provided, claim 38 contains new matter. One of ordinary skill in the art would not conclude that the applicant would have been in possession of the subject matter of claim 38 at the time of filing application.
Claim 39 recites that upon rehydration the beads recover at least 90% of their pre-drying diameter. In Example 5 the specification describes diameter of rehydrated beads after pre-hydration treatment. Table II shows that two treatments provide at least 90% of pre-drying diameter, i.e. treatment #10 with 125 mM NaCl and DMSO – 256 µm diameter compared to 258 µm diameter before drying and treatment #9 with 500 mM NaCl and DMSO – 307 µm diameter, larger that before drying. Claim 39 depends on claim 14 which recites infiltration of beads with 1-5 wt% of the saccharide selected from sucrose, glucose or their combination and 10-125 mM monovalent cation selected from sodium potassium, ammonium or their combination. Claim 14 does not require infiltration of DMSO. Thus, the specification does not support to rehydration of beads of claim 14 treated with saccharide and monovalent cation resulting in recovery of at least 90% of their pre-drying diameter. Therefore, since the support for claim 39 is not provided, claim 38 contains new matter. One of ordinary skill in the art would not conclude that the applicant would have been in possession of the subject matter of claim 39 at the time of filing application.
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 37 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 37 has wherein clause reciting: “the beads are completely rehydrated using deionized water”. Thus, limitations in wherein clauses of claim 37 appears to be directed to rehydrated beads. Claims 37 is dependent on claim 1 directed to a cell culture article comprising sterilized beads and therefore it is that are dehydrated and the wherein clause of rehydrating is future intended use. Thus, the dependent claims are unclear if Applicant is attempting to claim the rehydrated product in claim 37. Claim 38 and 39 recite “upon” and thus are clearly still directed to the intended use recitation of the base claim. However, claim 37 recites the beads which causes confusion as to what product is being claimed; the dehydrated beads or the rehydrated beads.
For examination purposes the wherein clauses in claims 37-39 are interpreted as intended use.
Maintained/Modified Rejections
The following rejections are maintained and/or modified taking into consideration amendment to claims filed on 02/19/2026.
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.
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 14, 20, 30, 32-39 are rejected under 35 U.S.C. 103 as being unpatentable over Boyan (US 20140370111 A1) in view of Voo (Voo et al. J. Biosc. Bioengen., 2011, 111, 294-299) in further view of Fike (US 20150064785 A1) and optionally in view of Frondoza (WO 03083044 A2) as evidenced by Santagapita (Santagapita et al. Biomacromolecules, 2011, 12, 3147-3155).
Regarding claim 14, Boyan teaches microbead carriers for delivery of cells or biologically active substances to diseased or damaged tissues (Abstract). The microbeads are: “… biodegradable polymeric hydrogel microbeads …” (paragraph 0022). Boyan describes alginate as encapsulation matrix (paragraph 0066) cross-linked with CaCl2 as polymerizing agent (paragraph 0069). Boyan mentions that alginate interacts with calcium chloride in saline (paragraphs 0069, 0073). Saline is 0.9% NaCl solution. 0.9% NaCl corresponds to 155 mM concentration. Boyan teaches addition of glucose as nutrient osmolyte: “Glucose is a suitable nutrient osmolyte that maybe used in the polymerization solution. The amount of glucose can be from about 50 to about 200 mM, typically about 150 mM.” (paragraph 0071). 50 mM-200 mM glucose corresponds to 0.9-3.6% that reads on instant glucose concentration limitation. Boyan teaches saccharide, glucose, and saline in the encapsulating matrix and hence glucose and NaCl are infiltrated into the microcarrier. Boyan describes that encapsulating matrix can be formed in any shape by lyophilization or air drying (paragraph 0077) and hence will be free of water. Boyan demonstrated viability of encapsulated in microbeads chondrocytes in Example 3 (paragraph 0194).
Boyan does not teach the claimed concentration of NaCl. Boyan describes sterilization by UV light of alginate during beads preparation (paragraph 0190), however, does not teach sterilization of cell culture article. Boyan does not teach culturing cells on the bead surface.
Voo teaches comparative study on the stability and potential of alginate and pectin based beads to encapsulate cells for production of poultry probiotics (Abstract). Voo describes preparation of alginate, pectinate and alginate/pectinate beads by extrusion-dripping technique. Voo discloses formation of beads by stirring the gelling solution of alginate, 50 mM calcium chloride in the presence of 100 mM NaCl and 1g/l of Tween 80 (p. 295, left column, 3rd paragraph). Voo provides characterization of beads chemical and mechanical stability (p. 295, right column, 1st and 2nd paragraphs).
Fike teaches a method of preparation of cell culture media, feed or supplement composition comprising encapsulated micro or nanosuspensions (paragraph 0016). Fike describes preparation of microcapsules by crosslinking alginate with divalent cation such as calcium chloride (paragraph 0067). After formation, the bead is dried (paragraph 0018) and irradiated with gamma-irradiation (paragraph 0020). The described microcapsules can be used for different purposes: “Alginate microcapsules have been used for many purposes, including drug delivery and the immobilization of cells growing in cell culture to enhance cell growth and viability.” (paragraph 0063).
Frondoza teaches culturing cells on the microcarrier to achieve an expansion in the number of cells (Abstract). Frondoza describes that microcarrier may be made of different inorganic and organic materials including calcium alginate (p. 21, 3rd paragraph). Frondoza mentions that the surface of the microcarrier can be coated with bioactive peptides to improve cell adhesion and expansion (p. 21, last paragraph and p. 22, 1st paragraph). Frondoza provides example of attachment and proliferation of chondrocytes on the surface of microcarrier beads and describes that chondrocytes exhibit 95% viability (Example 1 , p. 26).
First, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Boyan and Voo teachings and use the instant amount of 100 mM NaCl of Voo teaching during preparation of microcarrier beads. One would have been motivated to do so with reasonably expected success since Boyan and Voo teach preparation of microcarrier beads for the same purpose of cells’ encapsulation, made from the same components, i.e. alginate and calcium chloride, and containing NaCl to provide bead stability.
Second, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add sterilization of alginate beads by gamma-irradiation from Fike teaching to preparation of microcarrier beads based on Boyan and Voo teachings. One would have been motivated to do so since Fike teaches that the sterilized by gamma-irradiation alginate beads can be used for cell culture to enhance cell growth and viability or for drug delivery and sterilization of a product rather than its components ensures complete sterilization necessary for culturing of cells or delivery of drugs. A skilled artisan would have reasonably expected success in this modification because Boyan, Voo and Fike describe preparation of alginate-CaCl2 beads for encapsulation of biological material.
Regarding the recitation of infiltrating the beads limitation, this is a product-by-process limitation. See MPEP 2113: “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)” Thus, in instant case, addition of glucose as taught by Boyan and NaCl as taught by Voo during preparation of Ca-alginate microcarrier beads will result in the presence of glucose and NaCl in the beads and hence infiltration of glucose and NaCl in the beads prior to drying and sterilization step. Therefore the combination of prior art of Boyan and Voo will provide the product as claimed prior to drying unless shown on the contrary.
Last, regarding the intended use recitation “for culturing cells on the surface”, it is the examiner’s position that the prior art teaches a substantially similar bead and thus it would be capable of the intended use. However, for compact prosecution, the examiner points to Frondoza. Frondoza teaches that the microcarrier beads such as Ca-alginate beads can be used for cell adhesion and expansion and provides example of proliferation of chondrocytes on the surface of microcarrier beads. Thus, one would have expected the beads would be capable of the intended use especially since Boyan, Voo, Fike and Frondoza describe preparation of alginate-CaCl2 beads for encapsulation of biological material or cell propagation.
Thus, Boyan, Voo, Fike and Frondoza teach the claimed cell culture article which can be used for culturing cell on the surface of the beads and comprising alginate cross-linked with CaCl2 beads comprising 0.9-3.6% glucose and 100 mM NaCl wherein the beads are dried and sterilized. The limitation of complete rehydration of the cell culture article with water is interpreted as a recitation of intended use. The intended use is given weight to the extent that it imparts a structural limitation and the prior art needs to be capable of performing the intended use. See MPEP 2111.02, section II. Since there is no indication that the recitation can impart the structural difference between the claimed invention and the prior art, the prior art is capable of performing the intended use. In instant case, the prior art renders the instantly claimed structure obvious and therefore the cell culture article described in prior art is capable of complete rehydration with water.
Therefore, Boyan, Voo, Fike and optionally Frondoza teachings make claim 14 obvious.
Regarding claim 20, Boyan teaches calcium ions in the microbead composition (paragraph 0069) and hence Boyan teaching in combination with Voo, Fike and Frondoza teachings renders claim 20 obvious.
Regarding claim 30, Boyan teaches saccharide to be glucose at 50 mM-200 mM corresponding to 0.9-3.6% (paragraph 0071). Boyan teaches alginate and CaCl2 solutions in saline which is 0.9% NaCl (paragraph 0069) and Voo teaches preparation of Ca-alginate beads at 100 mM NaCl (p. 295, left column, 3rd paragraph). Thus, Boyan, Voo, Fike and optionally Frondoza teachings render claim 30 obvious.
Regarding claims 32 and 37-39, the limitation of complete rehydration of the cell culture article is interpreted as intended use the claimed structure as described above. The limitation of complete rehydration within 15 min, complete rehydration in deionized water, no visible cracks in beads after rehydration and recovering of at least 90% of the pre-drying volume after rehydration are further limitations of the same intended use. Since there is no indication that the recitations can impart the structural difference between the claimed invention and the prior art, the prior art is capable of performing the intended use. In instant case, the prior art renders the instantly claimed structure obvious and therefore the cell culture article described in prior art is capable of being rehydrated within 15 min, completely rehydrate in deionized water, do not exhibit visible cracks in beads after rehydration and recover of at least 90% of the pre-drying volume of beads. Thus, Boyan, Voo, Fike and optionally Frondoza teachings render claims 32 and 37-39 obvious.
Regarding claim 33, Voo teaches comparative study on the stability and potential of alginate and pectin based beads for production of poultry probiotics (Abstract). Pectin is a polygalacturonic polymer as evidenced by Santagapita: “Pectin is a polygalacturonic polymer partially methoxylated and shares some characteristics with alginate: it is nontoxic, biodegradable, and biocompatible. It is also used as encapsulating agent because the low methoxyl pectins can form gels with divalent cations by ionotropic gelation.” (p. 3147, right column, 1st paragraph). Voo is using low methoxyl pectin (p. 295, left column, 2nd paragraph) and describes that pectin forms hydrogels upon addition of divalent cations, such as Ca2+ (p. 297, right column, 2nd paragraph). Voo discloses that pectin beads were found to be more stable than alginate beads (p. 299, left column, last paragraph) and concludes: “In conclusion, pectin was found to be a potential encapsulation material for probiotic cell production owing to its stability and favorable microenvironment for cell growth” (p. 299, right column, 1st paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace alginate in Boyan teaching with polygalacturonic acid compound (pectin) from Voo teaching for preparation of cell culture article comprising beads. One would have been motivated to do so since Voo teaches increased stability of pectin-based beads. A skilled artisan would have reasonably expected success in this modification because Boyan, Fike, optionally Frondoza and Voo describe preparation of microcarriers for cell culture. Thus, Voo teaching in combination with Boyan, Fike and optionally Frondoza teachings as evidenced by Santagapita renders claim 33 obvious.
Regarding claim 34 and 35, Boyan teaches saccharide to be glucose at 50 mM-200 mM corresponding to 0.9-3.6% (paragraph 0071). Boyan teaches alginate and CaCl2 solutions in saline which is 0.9% NaCl (paragraph 0069) and Voo teaches preparation of Ca-alginate beads at 100 mM NaCl (p. 295, left column, 3rd paragraph). Thus, Boyan, Voo, Fike and optionally Frondoza teachings as evidenced by Santagapita renders claims 34 and 35 obvious.
Regarding claim 36, the limitation of complete rehydration of the cell culture article is interpreted as the intended use of the claimed structure as described above. The limitation of complete rehydration within 15 min is a further limitation of the same intended use. Since there is no indication that the recitations can impart the structural difference between the claimed invention and the prior art, the prior art is capable of performing the intended use. In instant case, the prior art renders the instantly claimed structure obvious and therefore the cell culture article described in prior art is capable of being rehydrated within 15 min. Thus, Boyan, Voo, Fike and optionally Frondoza teachings as evidenced by Santagapita render claim 36 obvious.
Claims 19 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Boyan (US 20140370111 A1) in view of Voo (Voo et al. J. Biosc. Bioengen., 2011, 111, 294-299) in further view of Fike (US 20150064785 A1) and optionally in view of Frondoza (WO 03083044 A2) as applied to claim 14 above, and further in view of Hirai (Hirai et al. Plant Cell Reports, 1999, 19, 150-155).
The teachings of Boyan, Voo, Fike and optionally Frondoza have been set forth above.
Boyan, Voo, Fike and optionally Frondoza do not teach drying formulation to comprise low molecular weight polyethylene glycol or DMSO at amount of about 0.1 ml to about 2.0 ml per 100 ml of the beads.
Regarding claim 19, Hirai teaches encapsulation of meristems in alginate cross-linked with CaCl2 in the presence of 0.4 M sucrose (p. 151, left column, 2nd paragraph). Hirai discloses dehydration of the meristem beads in PVS2 solution comprising 15% (w/v) DMSO and applied at 1-2 ml per bead: “PVS2 solution was used at 1-2 ml per bead. PVS2 solution contains 30% (w/v) glycerol, 15% (w/v) ethylene glycol, and 15% (w/v) DMSO in MS medium supplemented with 0.4 M sucrose (pH 5.8).” (p. 151, left column, 3rd paragraph). Hirai described that dehydrated encapsulated meristems were cryopreserved and developed shoots at 90% rate after plating (Abstract).
Regarding claim 29, Hirai teaches dehydration of the meristem beads in PVS2 solution comprising 15% (w/v) DMSO and applied at 1-2 ml per bead (p. 151, left column, 3rd paragraph). The instant limitation is 0.1 ml-2.0 ml of DMSO per 100 ml of beads where number of beads in 100 ml and the concentration of DMSO are not specified. The claim limitation is interpreted as 0.1 ml-2.0 ml of 100% DMSO per 100 ml of bead solution containing any number of beads. Therefore, Hirai taught DMSO concentration can read on instant limitation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow guidance of Hirai and add DMSO in drying formulation at 1-2 ml per bead from 15% DMSO for dehydrating microcarriers based on Boya, Voon, Fike and optionally Frondoza teachings. One would have been motivated to use DMSO during drying of microcarriers since Hirai teaches effective preservation of meristem shoots following dehydration with DMSO at the described concentration. A skilled artisan would have reasonably expected success in this modification because Boyan and Fike describe preparation of alginate-based microcarriers that can be dried and Hirai suggests DMSO in drying formulation for dehydration of alginate-CaCl2 beads. Thus, Hirai teaching in combination with Boyan, Voo, Fike and optionally Frondoza teachings renders claims 19 and 29 obvious.
Response to Arguments
Applicant's arguments filed 02/19/2026 have been fully considered but they are not persuasive.
Applicant argues (addressing p. 6-7 of the Remarks) that “the claimed beads are defined by how they are made, and specifically by infiltration of formed beads with a drying formulation having narrowly defined component types and concentration ranges. Neither Boyan nor Fike teaches or suggests infiltrating formed beads with a drying formulation comprising 1-5 wt.% saccharide and 10-125 mM monovalent cation prior to drying and sterilization. These arguments are not persuasive because:
Claim 14 is interpreted as product-by-process claim as described in the rejection above. Claim 14 is directed to a product obtained by the recited process steps. A claimed product is dried and sterilized beads comprising (a) a polygalacturonic acid compound or an alginic acid compound cross-linked with divalent ions, (b) a saccharide at 1-5 wt% selected from sucrose, glucose or their combination and (c) monovalent cation at 10-125 mM selected from sodium, potassium, ammonium or their combination. Boyan, Voo and Fike teach alginic acid cross-linked with calcium chloride, Boyan teaches presence of 0.9-3.6% of glucose (paragraph 0071) and Voo - presence of 100 mM NaCl (p. 295, left column, 3rd paragraph) during preparation of microcarrier beads and prior to drying and hence glucose and NaCl will infiltrate the Ca-alginate beads and provide the claimed structure unless shown on the contrary.
Applicant argues (addressing p. 6-7 of the Remarks), that Boyan and Fike describe beads for cell encapsulation and not for culturing on a surface of beads. These arguments are not persuasive because:
Although Boyan and Fike teach cells for encapsulation and not for culturing on the surface of beads, “culturing cells on the bead surface” is interpreted as intended use. The optional prior art of Frondoza teaches that similar Ca-alginate beads can be used for culturing of cells on the surface of beads when beads are modified by coating with bioactive peptide to promote adhesion of cells as described in the rejection above (p. 21, last paragraph and p. 22, 1st paragraph). The transitional phrase of claim 14: “comprising” allows to include additional components and/or treatment. It is also noted that the specification describes culturing cell on the surface of beads coated with Synthemax (paragraphs 0057, 0063, 0071). Therefore beads of Boyan and Fike teachings are capable of the intended use, i.e. culturing cells on the bead surface.
Applicant argues (addressing p. 7-8 of the Remarks) that NaCl concentration in Boyan cannot be
a result-effective variable for rehydration, because rehydration is not even a result addressed or recognized by the cited art. These arguments are not persuasive because:
Current rejection does not interpret NaCl of Boyan teaching as a result-effective variable and relies on concentration of 100 mM NaCl of Voo teaching used during preparation of Ca-alginate beads (p. 295, left column, 3rd paragraph). Boyan and Voo teach preparation of microcarrier beads for the same purpose of cells’ encapsulation, made from the same components, i.e. alginate and calcium chloride, and containing NaCl and Voo provides characterization of beads stability providing motivation to substitute saline (155 mM NaCl) in Boyan teaching with 100 mM NaCl of Voo teaching during preparation of microcarrier beads.
Applicant further argues (addressing p. 8-9 of the Remarks) that Boyan does not teach the claimed NaCl concentration, the infiltration with the claimed drying formulation, the sterilization of beads and hence does not disclose the resulting bead structure. These arguments are not persuasive because:
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Current rejection is based on combination of prior art of Boyan, Voo and Fike as described above. Boyan provides microcarrier beads formed by alginate cross-linked with calcium in the presence of glucose at claimed concentration, Voo describes preparation of similar beads with claimed NaCl concentration; glucose and NaCl can infiltrate the beads during preparation as addressed above; Fike teaches sterilization of Ca-alginate beads and optional reference of Frondoza describes that Ca-alginate beads are capable of culturing cells on the surface of beads.
Thus, the 35 U.S.C. 103 rejection is maintained and modified necessitated by amendment of claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIOUBOV G KOROTCHKINA whose telephone number is (571)270-0911. The examiner can normally be reached Monday-Friday: 8:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila G Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G.K./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
Prosecution Insights