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 .
Notes
All the objections and rejections in the previous Office Action not reiterated herein have been withdrawn.
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 1-4, 9-16 and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Ling (already of record, US 2021/0317396) in view of Roeder et al (US 10,945,854; hereinafter “Roeder”).
Regarding claim 1, Ling discloses a three-dimensional (3D) bioreactor for growth of cells comprising: a biocompatible polymer material ([0060]) having a plurality of voids and a surface for cell expansion having a diameter (D) in the range of 0.4 mm to 100.0 mm (see, e.g., FIGS. 1c-d: bioreactor fixed-bed (10) having voids (14); [0011], [0057]); a plurality of pore channels with openings between said voids having a diameter (d) in the range of 0.2 mm to 10.0 mm ([0011]); wherein (a) 90.0% or more of said voids have a selected volume V that does not vary
by more than+/- 10.0% ([0011]); and (b) 90.0% or more of said pore channel openings between said voids have a value of d that does not vary by more than +/- 10.0% ([0011]).
Ling does not explicitly disclose a plurality of internal structures positioned within said voids having an internal structure volume (VIS). Roeder discloses a three-dimensional (3D) bioreactor comprising a biocompatible polymer material (col. 2, ll. 52-55) having a plurality of voids and a surface for cell expansion (FIGS. 1A-1B: synthetic porous composite material (100) having voids (106); col. 6, ll. 53-60), and a plurality of internal structures positioned within said voids having an internal structure volume (voids includes carrier material; col. 3, ll. 58-63; col. 7, ll. 43-49). In view of Roeder, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the plurality of internal structures of Roeder within said voids of Ling to arrive at the claimed invention. One of ordinary skill in the art would have made said modification for the purpose of enhancing the process of cell culture as disclosed by Roeder (col. 3, ll. 58-63; col. 7, ll. 43-49). Modified Ling does not explicitly disclose wherein (c) 90.0 % or more of said internal structures have an internal structure volume (VIS) that does not vary by more than +/-10.0%. However, Ling is concerned with uniformity of the structure of the 3D bioreactor (see Ling at [0008], [0011], [0073], [0075], [0094]). It would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have designed the structure of the three-dimensional (3D) bioreactor of modified Ling to have uniform internal structure volume (VIS) such that it does not vary by more than +/- 10.0%, in order to ensure uniform cel culture environment in each void.
Regarding claim 2, modified Ling further discloses wherein said internal structures have an outer surface, said voids have a surface, wherein there is a radial separation (Rsep) between said outer surface of said internal structures and said surface of said voids (outer surface of the carrier materials within the spherical voids would necessarily be radially separated from the surface of the voids).
Regarding claim 3, modified Ling does not explicitly disclose wherein said radial separation (Rsep) has a value that does not vary by more than+/- 10.0%. However, Ling is concerned with uniformity of the structure of the 3D bioreactor (see Ling at [0008], [0011], [0073], [0075], [0094]). It would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have designed the structure of the three-dimensional (3D) bioreactor of modified Ling to have uniform radial separation such that it does not vary by more than +/- 10.0%, in order to ensure uniform cel culture environment in each void.
Regarding claim 4, modified Ling discloses the claimed radial separation but does not explicitly disclose wherein said radial separation (Rsep) has a value in the range of 0.25 mm to 1.00 mm. However, since the instant specification is silent to unexpected results, it would have been prima facie obvious to one of ordinary skill in the art to have modified the radial separation of modified Ling to have the claimed value in the range of 0.25 mm to 1.00 mm, since such a modification would have involved a mere change in the size (or dimension) of a component. A change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. Furthermore, it’s noted that the courts have held where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777). See MPEP 2144.04 IV. A.
Regarding claim 9, modified Ling further discloses wherein said voids have a shape selected from the group consisting of spheres, cubes, cuboids, or cylinder (Ling at [0057]).
Regarding claim 10, modified Ling further discloses wherein said voids have an internal concave surface (Ling at [0057]).
Regarding claim 11, modified Ling discloses wherein the said pore channels have a length between said voids (see Ling at FIGS. 1, 1c-D) but does not explicitly disclose wherein said length is 0.1 mm to 1.0 mm. However, since the instant specification is silent to unexpected results, it would have been prima facie obvious to one of ordinary skill in the art to have modified the pore channels length of modified Ling to have the claimed value in the range of 0.1 mm to 1.0 mm, since such a modification would have involved a mere change in the size (or dimension) of a component. A change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. Furthermore, it’s noted that the courts have held where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777). See MPEP 2144.04 IV. A.
Regarding claim 12, modified Ling discloses wherein the said pore channels have a length between said voids (see Ling at FIGS. 1, 1c-D) but does not explicitly disclose wherein 90% or more of the pore channel lengths have a value that does not vary by more than+/- 10.0%. However, Ling is concerned with uniformity of the structure of the 3D bioreactor (see Ling at [0008], [0011], [0073], [0075], [0094]). It would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have designed the structure of the three-dimensional (3D) bioreactor of modified Ling to have uniform pore channel lengths such that they do not vary by more than +/- 10.0%, in order to ensure uniform cel culture environment in the three-dimensional (3D) bioreactor of Ling. Further, one of ordinary skill in the art would have made said modification for the purpose of achieving desired fluid flow profile between said voids.
Regarding claim 13, Ling discloses a method for expansion of cells comprising: supplying a three-dimensional (3D) bioreactor comprising a plurality of voids having a
surface area for cellular expansion (Ling at [0008]; claim 1); said plurality of voids having a diameter (D) including a plurality of pore channels with openings between said voids having a diameter (d), such that D>d (Ling at FIGS. 1, 1c-D; [0008]; claim 1) and wherein: (a) 90% or more of said voids have a void volume (V) that does not vary by more than +/- 10.0% (Ling at ([0011]); (b) 90% or more of said pore openings between said voids have a value of d that does not vary by more than+/- 10.0% (Ling at ([0011]); seeding said three-dimensional (3D) bioreactor with cells ([0009]; claim 1) and flowing a perfusion media through said three-dimensional (3D) bioreactor and promoting cellular expansion ([0010]; claim 1). Ling does not explicitly disclose and a plurality of internal structures within said plurality of voids also having a surface area for cell expansion. Roeder discloses a three-dimensional (3D) bioreactor comprising a biocompatible polymer material (col. 2, ll. 52-55) having a plurality of voids and a surface for cell expansion (FIGS. 1A-1B: synthetic porous composite material (100) having voids (106); col. 6, ll. 53-60), and a plurality of internal structures positioned within said voids having an internal structure volume (voids includes carrier material; col. 3, ll. 58-63; col. 7, ll. 43-49). In view of Roeder, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the plurality of internal structures of Roeder within said voids of Ling to arrive at the claimed invention. One of ordinary skill in the art would have made said modification for the purpose of enhancing the process of cell culture as disclosed by Roeder (col. 3, ll. 58-63; col. 7, ll. 43-49).
Modified Ling does not explicitly disclose wherein (c) 90% of more of said internal structures within said voids have a volume (VIS) that does not vary by more than +/- 10.0%. However, Ling is concerned with uniformity of the structure of the 3D bioreactor (see Ling at [0008], [0011], [0073], [0075], [0094]). It would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have designed the structure of the three-dimensional (3D) bioreactor of modified Ling to have uniform internal structure volume (VIS) such that it does not vary by more than +/- 10.0%, in order to ensure uniform cel culture environment in each void.
Regarding claim 14, modified Ling further discloses wherein said internal structures have an outer surface, said voids have a surface, wherein there is a radial separation (Rsep) between said outer surface of said internal structures and said surface of said voids (outer surface of the carrier materials within the spherical voids would necessarily be radially separated from the surface of the voids).
Regarding claim 15, modified Ling does not explicitly disclose wherein said radial separation (Rsep) has a value that does not vary by more than+/- 10.0%. However, Ling is concerned with uniformity of the structure of the 3D bioreactor (see Ling at [0008], [0011], [0073], [0075], [0094]). It would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have designed the structure of the three-dimensional (3D) bioreactor of modified Ling to have uniform radial separation such that it does not vary by more than +/- 10.0%, in order to ensure uniform cel culture environment in each void.
Regarding claim 16, modified Ling discloses the claimed radial separation but does not explicitly disclose wherein said radial separation (Rsep) has a value in the range of 0.25 mm to 1.00 mm. However, since the instant specification is silent to unexpected results, it would have been prima facie obvious to one of ordinary skill in the art to have modified the radial separation of modified Ling to have the claimed value in the range of 0.25 mm to 1.00 mm, since such a modification would have involved a mere change in the size (or dimension) of a component. A change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. Furthermore, it’s noted that the courts have held where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777). See MPEP 2144.04 IV. A.
Regarding claim 20, modified Ling further discloses wherein said voids have a shape selected from the group consisting of spheres, cubes, cuboids, or cylinder (Ling at [0057]).
Regarding claim 21, modified Ling further discloses wherein said voids have an internal concave surface (Ling at [0057]).
Regarding claim 22, modified Ling further discloses wherein seeding said three-dimensional (3D) bioreactor with viral vector producing cells and flowing a perfusion medium through said three-dimensional (3D) bioreactor and promoting viral vector cell expansion ([0007]-[0010]; claim 1).
Regarding claim 23, modified Ling further discloses wherein delivery of a transfection reagent to said viral vector producing cells in said three-dimensional (3D) bioreactor and producing a viral vector (Claim 2).
Regarding claim 24, modified Ling further discloses wherein said viral vector cells comprise HEK 293T cells and said viral vector comprises a lentiviral vector (Claim 3).
Allowable Subject Matter
Claims 5-8 and 17-19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed on August 7, 2026 have been fully considered but they are not persuasive.
Applicant argues that the combination does not teach the feature “a plurality of internal structures positioned within said voids having an internal structure volume (Vis) wherein 90.0 % or more of said internal structures have said internal structure volume (Vis) that does not vary by more than+/- 10.0%.” See pages 7 to 8 of the Remarks.
Examiner respectfully disagrees. As discussed in the rejection, Roeder, in the same filed of endeavor, discloses a three-dimension bioreactor comprising a biocompatible polymer material that has a plurality of voids. The voids include a plurality of internal structures positioned within the voids. The internal structures facilitate the delivery of materials into the cells within the voids and thereby enhance the cell culturing process (see Roeder at col. 3, ll. 58-63; col. 7, ll. 43-49). Therefore, one of ordinary skill in the art would be motivated to include the internal structures of Roeder that are capable of delivering desired materials to the cells within the voids of Ling for the benefit of enhancing the cell culturing process. In response to the Applicant’s argument regarding the feature “wherein 90.0 % or more of said internal structures have said internal structure volume (Vis) that does not vary by more than +/- 10.0%,” Applicant’s argument is not persuasive. Ling repeatedly identifies surface area maximization as the goal of the invention. The bioreactor is designed to provide “a continuous interconnected 3D surface area” for cell adherence and growth ([0057]). Paragraph [0073] states that the purpose of uniform void volume exists “to achieve the most efficient 3D space packing and offer the largest corresponding continuous surface area.” Therefore, one of ordinary skill in the art would have designed the added internal structures into the voids of Ling to the same +/- 10.0% tolerance to remain consistent with the very design principle of Ling.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799
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