DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, 17834652, US 20220389380, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group II, Claims 22-34, in the reply filed on 10/24/2025 is acknowledged.
Priority
The filing receipt, mailed 6/24/2022, states that this application, filed 6/7/2022, claims benefit of domestic priority benefit of 63197971, filed 6/7/2021.
It is noted that priority document 63197971, filed 6/7/2021, does not appear to use the present claim term “bifunctional” in the provisional specification. The instant specification does not use the term “bispecific,” and does not provide a limiting definition of “bifunctional.” The words specific and function may not have the same scope, (see e.g., Kraingkum at pp. 32-33, bridging paragraph, stating that a “bispecific antibody is distinct from bifunctional antibody both in terms of structure and function”). Thus, it appears that the benefit provisional application 63197971, filed 6/7/2021, does not provide support for the examined claims 22-34. Therefore, the priority date for examined claims 22-34 is considered to be the application filing date, 6/7/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 9/14/2022, 12/30/2022, and 1/18/2024, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
1. Claim(s) 22-34, is/are rejected under 35 U.S.C. 103 as being unpatentable over Fiering 1, PG Publication US 20180313816, published 11/1/2018, (of Serial No. 15965368, now US 10,914,723, issued 2/9/2021), Fiering 2, PG Publication US 20190290829, published 9/26/2019, (of Serial No. 16302429), and Essakali, (2018) BMC Biotechnology, vol. 8, number 6, pages 1 to 5.
Fiering 1, PG Publication US 20180313816, (‘816 PGP), published 11/1/2018, (of Serial No. 15965368, now US 10,914,723, issued 2/9/2021), throughout the pre-grant publication and abstract and at claims 30-62 and para [12]-[13], [94]-[121] teach systems for separation of particles in biofluids comprising the use of acoustic transduces to apply a standing acoustic wave transverse to a microfluidic separation channel. Claim 30 of reference the Fiering 1 PG-Pub recites:
30. A system for microfluidic particle separation configured to separate target particles from non-target particles in a biofluid, the system comprising: at least one microfluidic separation channel comprising at least one inlet, a first outlet, and a second outlet; a source of the biofluid in fluid communication with the at least one inlet of the at least one microfluidic separation channel; a source of an additive in fluid communication with the source of the biofluid, configured to introduce at least one additive into the biofluid, the additive capable of altering at least one of size of the target particles, size of the non-target particles, compressibility of the biofluid, compressibility of the target particles, compressibility of the non-target particles, aggregation potential of the target particles, and aggregation potential of the non-target particles; and at least one acoustic transducer coupled to a wall of the at least one microfluidic separation channel.
Fiering 1 (‘816 PGP) at claim 30.
Fiering 1 at para [142]-[143] teaches that the additive may provide efficient separation of target particles from other non-target particles through pretreatment of the biofluid with an additive capable of altering, for example, the aggregation of non-target particles, because particle migration generally depends on particle size, density, and compressibility relative to the density and compressibility of the suspending biofluid. Fiering 1 at para [73] teaches the additive may comprise biochemical moieties, such as antibodies, that bind target particles or non-target particles. The cell aggregator may comprise a solution comprising antibodies that bind and aggregate target particles or non-target particles, which reads on the instant claim term “cluster”.
Fiering 1, at ‘816 PGP claims 54-61, and para [0122]-[0125], recite and disclose kits for microfluidic particle separation, including microfluidic separation channels, a source of additive fluidly connectable with the microfluidic separation channels, and instructions for use.
Fiering 1 does not teach or fairly suggest bifunctional antibodies that form non-target cell clusters.
Fiering 2, PG Publication US 20190290829, (‘829 PGP), published 9/26/2019, (of Serial No. 16302429), throughout the ‘829 publication, abstract, and claims. Independent reference Claim 30 recites a system for microfluidic cell separation configured to separate target cells from non-target cells in a biofluid by applying acoustic energy to the microfluidic separation channel, (see para [70]. Claim 54 recites a kit therefor. Claim 8 recites antibodies that bind and aggregate non-target cells. Fiering 2, at [0131], describe using a cell aggregator that is Ficoll PM300 cell media comprising a long-chain polysaccharide, that provided superior non-target cell removal but inferior target cell recovery, compared to treatment with a density gradient medium.
Essakali, (2018) BMC Biotechnology, vol. 8, number 6, pages 1 to 5, throughout the publication and abstract, teach cell sample enrichment suing a “bifunctional rosette-based antibody cocktail.” Essakali, at p. 2 of 5, para 3, state: We used a bifunctional antibody cocktail for B-cell enrichment (RosetteSepTM (RS))that binds erythrocytes (via glycophorin)on one side and white cell populations other than B-cells (via the CD2, CD3, CD16, CD36, CD56 and/ or CD66b antigens) on the other side thus forming dense rosettes of erythrocytes surrounding the unwanted white blood cells when added to whole blood.”
It would have been prima facie obvious before the filing date of the instant application for one of ordinary skill in the art to have combined bifunctional antibodies that form non-target cell clusters, as taught by Essakali, with the systems for separation of particles in biofluids comprising the use of acoustic transduces to apply a standing acoustic wave transverse to a microfluidic separation channel, and kits thereof, as taught by Fiering 1 and Fiering 2.
One of ordinary skill in the art would have motivated to have combined bifunctional antibodies that form non-target cell clusters, as taught by Essakali with the systems for separation of particles in biofluids comprising the use of acoustic transduces to apply a standing acoustic wave transverse to a microfluidic separation channel, and kits thereof, as taught by Fiering 1 and Fiering 2, in order to affect particle migration in acoustic bioprocessing separation.
2. Claim(s) 22-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fiering 3, PG Publication US 20190307946, published 10/10/2019, (of 16452191, now US 11,291,756, issued 04/05/2022), Fiering 2, PG Publication US 20190290829, published 9/26/2019, (of Serial No. 16302429) and Essakali, (2018) BMC Biotechnology, vol. 8, number 6, pages 1 to 5.
Fiering 3, PG Publication US 20190307946, throughout the pre-grant publication and abstract and at claims 10-20 recite a system for microfluidic cell separation configured to separate target cells from non-target cells comprising at least one microfluidic separation channel with an inlet and a first and second outlet, further comprising an acoustic transducer coupled to a wall of the microfluidic channel. Claims 6 and 13 teaches antibodies as T cell activators. Fiering 3 at claims 54-62 and para [0116]- [0117], claim and disclose kits for the claimed invention.
Fiering 3 does not teach or fairly suggest bifunctional antibodies that form non-target cell clusters.
Fiering 2, PG Publication US 20190290829, (‘829 PGP), published 9/26/2019, (of Serial No. 16302429), throughout the ‘829 publication, abstract, and claims. Independent reference Claim 30 recites a system for microfluidic cell separation configured to separate target cells from non-target cells in a biofluid by applying acoustic energy to the microfluidic separation channel, (see para [70]. Claim 54 recites a kit therefor. Claim 8 recites antibodies that bind and aggregate non-target cells. Fiering 2, at [0131], describe using a cell aggregator that is Ficoll PM300 cell media comprising a long-chain polysaccharide, that provided superior non-target cell removal but inferior target cell recovery, compared to treatment with a density gradient medium.
Essakali, (2018) BMC Biotechnology, vol. 8, number 6, pages 1 to 5, throughout the publication and abstract, teach cell sample enrichment suing a “bifunctional rosette-based antibody cocktail.” Essakali, at p. 2 of 5, para 3, state: We used a bifunctional antibody cocktail for B-cell enrichment (RosetteSepTM (RS))that binds erythrocytes (via glycophorin)on one side and white cell populations other than B-cells (via the CD2, CD3, CD16, CD36, CD56 and/ or CD66b antigens) on the other side thus forming dense rosettes of erythrocytes surrounding the unwanted white blood cells when added to whole blood.”
It would have been prima facie obvious before the filing date of the instant application for one of ordinary skill in the art to have combined bifunctional antibodies that form non-target cell clusters, as taught by Essakali, with the systems for separation of particles in biofluids comprising the use of acoustic transduces to apply a standing acoustic wave transverse to a microfluidic separation channel, and kits thereof, as taught by Fiering 3 and Fiering 2.
One of ordinary skill in the art would have motivated to have combined bifunctional antibodies that form non-target cell clusters, as taught by Essakali with the systems for separation of particles in biofluids comprising the use of acoustic transduces to apply a standing acoustic wave transverse to a microfluidic separation channel, and kits thereof, as taught by Fiering 3 and Fiering 2, in order to affect particle migration in acoustic bioprocessing separation.
3. Claim(s) 22-34, is/are rejected under 35 U.S.C. 103 as being unpatentable over Fiering 2, PG Publication US 20190290829, published 9/26/2019, (of Serial No. 16302429), and in view of Fiering 1, PG Publication US 20180313816, published 11/1/2018, (of Serial No. 15965368, now US 10,914,723, issued 2/9/2021), and Essakali, (2018) BMC Biotechnology, vol. 8, number 6, pages 1 to 5.
Fiering 2, PG Publication US 20190290829, (‘829 PGP), published 9/26/2019, (of Serial No. 16302429), throughout the ‘829 publication, abstract, and claims. Independent reference Claim 30 recites a system for microfluidic cell separation configured to separate target cells from non-target cells in a biofluid by applying acoustic energy to the microfluidic separation channel, (see para [70]. Claim 54 recites kits therefor. Claim 8 recites antibodies that bind and aggregate non-target cells. Fiering 2, at [0131], describe using a cell aggregator that is Ficoll PM300 cell media comprising a long-chain polysaccharide, that provided superior non-target cell removal but inferior target cell recovery, compared to treatment with a density gradient medium.
Fiering 2 does not teach or fairly suggest bifunctional antibodies that form non-target cell clusters.
Fiering 1, PG Publication US 20180313816, (‘816 PGP), published 11/1/2018, (of Serial No. 15965368, now US 10,914,723, issued 2/9/2021), throughout the pre-grant publication and abstract and at claims 30-62 and para [12]-[13], [94]-[121] teach systems for separation of particles in biofluids comprising the use of acoustic transduces to apply a standing acoustic wave transverse to a microfluidic separation channel. Claim 30 of reference the Fiering 1 PG-Pub recites:
30. A system for microfluidic particle separation configured to separate target particles from non-target particles in a biofluid, the system comprising: at least one microfluidic separation channel comprising at least one inlet, a first outlet, and a second outlet; a source of the biofluid in fluid communication with the at least one inlet of the at least one microfluidic separation channel; a source of an additive in fluid communication with the source of the biofluid, configured to introduce at least one additive into the biofluid, the additive capable of altering at least one of size of the target particles, size of the non-target particles, compressibility of the biofluid, compressibility of the target particles, compressibility of the non-target particles, aggregation potential of the target particles, and aggregation potential of the non-target particles; and at least one acoustic transducer coupled to a wall of the at least one microfluidic separation channel.
Fiering 1 (‘816 PGP) at claim 30.
Fiering 1 at para [142]-[143] teaches that the additive may provide efficient separation of target particles from other non-target particles through pretreatment of the biofluid with an additive capable of altering, for example, the aggregation of non-target particles, because particle migration generally depends on particle size, density, and compressibility relative to the density and compressibility of the suspending biofluid. Fiering 1 at para [73] teaches the additive may comprise biochemical moieties, such as antibodies, that bind target particles or non-target particles. The cell aggregator may comprise a solution comprising antibodies that bind and aggregate target particles or non-target particles, which reads on the instant claim term “cluster”.
Fiering 1, at ‘816 PGP claims 54-61, and para [0122]-[0125], recite and disclose kits for microfluidic particle separation, including microfluidic separation channels, a source of additive fluidly connectable with the microfluidic separation channels, and instructions for use.
Essakali, (2018) BMC Biotechnology, vol. 8, number 6, pages 1 to 5, throughout the publication and abstract, teach cell sample enrichment suing a “bifunctional rosette-based antibody cocktail.” Essakali, at p. 2 of 5, para 3, state: We used a bifunctional antibody cocktail for B-cell enrichment (RosetteSepTM (RS))that binds erythrocytes (via glycophorin)on one side and white cell populations other than B-cells (via the CD2, CD3, CD16, CD36, CD56 and/ or CD66b antigens) on the other side thus forming dense rosettes of erythrocytes surrounding the unwanted white blood cells when added to whole blood.”
It would have been prima facie obvious before the filing date of the instant application for one of ordinary skill in the art to have combined bifunctional antibodies that form non-target cell clusters, as taught by Essakali, with the systems for separation of particles in biofluids comprising the use of acoustic transduces to apply a standing acoustic wave transverse to a microfluidic separation channel, and kits thereof, as taught by Fiering 1 and claimed by Fiering 2.
One of ordinary skill in the art would have motivated to have combined bifunctional antibodies that form non-target cell clusters, as taught by Essakali with the systems for separation of particles in biofluids comprising the use of acoustic transduces to apply a standing acoustic wave transverse to a microfluidic separation channel, and kits thereof, as taught by Fiering 1 and claimed by Fiering 2, in order to affect particle migration in acoustic bioprocessing separation.
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.
1. Claim(s) 22-34, is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of Fiering 1, US 10,914,723, in view of Fiering 2, PG Publication US 20190290829, published 9/26/2019, (of Serial No. 16302429), and Essakali, (2018) BMC Biotechnology, vol. 8, number 6, pages 1 to 5.
Fiering 1, PG Publication US 20180313816, (‘816 PGP), published 11/1/2018, (of Serial No. 15965368, now US 10,914,723, issued 2/9/2021), throughout the pre-grant publication and abstract and at claims 30-62 claim systems for separation of particles in biofluids comprising the use of acoustic transduces to apply a standing acoustic wave transverse to a microfluidic separation channel. Claim 30 of reference the Fiering 1 PG-Pub recites:
30. A system for microfluidic particle separation configured to separate target particles from non-target particles in a biofluid, the system comprising: at least one microfluidic separation channel comprising at least one inlet, a first outlet, and a second outlet; a source of the biofluid in fluid communication with the at least one inlet of the at least one microfluidic separation channel; a source of an additive in fluid communication with the source of the biofluid, configured to introduce at least one additive into the biofluid, the additive capable of altering at least one of size of the target particles, size of the non-target particles, compressibility of the biofluid, compressibility of the target particles, compressibility of the non-target particles, aggregation potential of the target particles, and aggregation potential of the non-target particles; and at least one acoustic transducer coupled to a wall of the at least one microfluidic separation channel.
Fiering 1 (‘816 PGP) at claim 30.
Fiering 1, at ‘816 PGP claims 54-61, claim kits for microfluidic particle separation, including microfluidic separation channels, a source of additive fluidly connectable with the microfluidic separation channels, and instructions for use.
Fiering 1 does not teach or fairly suggest bifunctional antibodies that form non-target cell clusters.
Fiering 2, PG Publication US 20190290829, (‘829 PGP), published 9/26/2019, (of Serial No. 16302429), throughout the ‘829 publication, abstract, and claims. Independent reference Claim 30 recites a system for microfluidic cell separation configured to separate target cells from non-target cells in a biofluid by applying acoustic energy to the microfluidic separation channel, (see para [70]. Claim 54 recites a kit therefor. Claim 8 recites antibodies that bind and aggregate non-target cells. Fiering 2, at [0131], describe using a cell aggregator that is Ficoll PM300 cell media comprising a long-chain polysaccharide, that provided superior non-target cell removal but inferior target cell recovery, compared to treatment with a density gradient medium. Fiering 2, at claims 54-62, teach and claim a kit.
Essakali, (2018) BMC Biotechnology, vol. 8, number 6, pages 1 to 5, throughout the publication and abstract, teach cell sample enrichment suing a “bifunctional rosette-based antibody cocktail.” Essakali, at p. 2 of 5, para 3, state: We used a bifunctional antibody cocktail for B-cell enrichment (RosetteSepTM (RS))that binds erythrocytes (via glycophorin)on one side and white cell populations other than B-cells (via the CD2, CD3, CD16, CD36, CD56 and/ or CD66b antigens) on the other side thus forming dense rosettes of erythrocytes surrounding the unwanted white blood cells when added to whole blood.”
It would have been prima facie obvious before the filing date of the instant application for one of ordinary skill in the art to have combined bifunctional antibodies that form non-target cell clusters, as taught by Essakaki, with the systems for separation of particles in biofluids comprising the use of acoustic transduces to apply a standing acoustic wave transverse to a microfluidic separation channel, and kits thereof, as taught by Fiering 1 and Fiering 2.
One of ordinary skill in the art would have motivated to have combined bifunctional antibodies that form non-target cell clusters, as taught by Essakali with the systems for separation of particles in biofluids comprising the use of acoustic transduces to apply a standing acoustic wave transverse to a microfluidic separation channel, and kits thereof, as taught by Fiering 1 and Fiering 2, in order to affect particle migration in acoustic bioprocessing separation.
2. Claim(s) 22-34 is/are on the ground of nonstatutory double patenting as being unpatentable over claims 9-19 of U.S. Patent No. Fiering 3, US 11,291,756, (issued 04/05/2022), in view of Fiering 2, PG Publication US 20190290829, published 9/26/2019, (of Serial No. 16302429) and Essakali, (2018) BMC Biotechnology, vol. 8, number 6, pages 1 to 5.
Fiering 3, PG Publication US 20190307946, throughout the pre-grant publication and abstract and at claims 10-20 recite a system for microfluidic cell separation configured to separate target cells from non-target cells comprising at least one microfluidic separation channel with an inlet and a first and second outlet, further comprising an acoustic transducer coupled to a wall of the microfluidic channel. Claims 6 and 13 teaches antibodies as T cell activators.
Fiering 3 does not claim bifunctional antibodies that form non-target cell clusters and does not claim kits of the claimed invention.
Fiering 2, PG Publication US 20190290829, (‘829 PGP), published 9/26/2019, (of Serial No. 16302429), throughout the ‘829 publication, abstract, and at Claim 30, recites a system for microfluidic cell separation configured to separate target cells from non-target cells in a biofluid by applying acoustic energy to the microfluidic separation channel, (see para [70]. Claim 54 recites a kit therefor. Claim 8 recites antibodies that bind and aggregate non-target cells. Fiering 2, at [0131], describe using a cell aggregator that is Ficoll PM300 cell media comprising a long-chain polysaccharide, that provided superior non-target cell removal but inferior target cell recovery, compared to treatment with a density gradient medium. Fiering 2 at claims 54-61 claim kits for the microfluidic cell separation using acoustic energy.
Essakali, (2018) BMC Biotechnology, vol. 8, number 6, pages 1 to 5, throughout the publication and abstract, teach cell sample enrichment suing a “bifunctional rosette-based antibody cocktail.” Essakali, at p. 2 of 5, para 3, state: We used a bifunctional antibody cocktail for B-cell enrichment (RosetteSepTM (RS))that binds erythrocytes (via glycophorin)on one side and white cell populations other than B-cells (via the CD2, CD3, CD16, CD36, CD56 and/ or CD66b antigens) on the other side thus forming dense rosettes of erythrocytes surrounding the unwanted white blood cells when added to whole blood.”
It would have been prima facie obvious before the filing date of the instant application for one of ordinary skill in the art to have combined bifunctional antibodies that form non-target cell clusters, as taught by Essakali, with the systems for separation of particles in biofluids comprising the use of acoustic transduces to apply a standing acoustic wave transverse to a microfluidic separation channel, and kits thereof, as claimed by Fiering 3 and taught by Fiering 2.
One of ordinary skill in the art would have motivated to have combined bifunctional antibodies that form non-target cell clusters, as taught by Essakali with the systems for separation of particles in biofluids comprising the use of acoustic transduces to apply a standing acoustic wave transverse to a microfluidic separation channel, and kits thereof, as taught by Fiering 3 and Fiering 2, in order to affect particle migration in acoustic bioprocessing separation. One of ordinary skill in the art would have been motivated to make and use kits for the separation channel invention for convenience and ease of use.
3. Claim(s) 22-34, is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30-62 of Fiering 2, copending Application Serial No. 16302429, and in view of Fiering 1, PG Publication US 20180313816, published 11/1/2018, (of Serial No. 15965368, now US 10,914,723, issued 2/9/2021), and Essakali, (2018) BMC Biotechnology, vol. 8, number 6, pages 1 to 5.
Fiering 2, Serial No. 16302429, at Claim 30 recites a system for microfluidic cell separation configured to separate target cells from non-target cells in a biofluid by applying acoustic energy to the microfluidic separation channel. Claim 54 recites kits therefor. Claim 8 recites antibodies that bind and aggregate non-target cells.
Fiering 2 does not claim bifunctional antibodies that form non-target cell clusters.
Fiering 1, PG Publication US 20180313816, (‘816 PGP), published 11/1/2018, (of Serial No. 15965368, now US 10,914,723, issued 2/9/2021), throughout the pre-grant publication and abstract and at claims 30-62 and para [12]-[13], [94]-[121] teach systems for separation of particles in biofluids comprising the use of acoustic transduces to apply a standing acoustic wave transverse to a microfluidic separation channel. Claim 30 of reference the Fiering 1 PG-Pub recites:
30. A system for microfluidic particle separation configured to separate target particles from non-target particles in a biofluid, the system comprising: at least one microfluidic separation channel comprising at least one inlet, a first outlet, and a second outlet; a source of the biofluid in fluid communication with the at least one inlet of the at least one microfluidic separation channel; a source of an additive in fluid communication with the source of the biofluid, configured to introduce at least one additive into the biofluid, the additive capable of altering at least one of size of the target particles, size of the non-target particles, compressibility of the biofluid, compressibility of the target particles, compressibility of the non-target particles, aggregation potential of the target particles, and aggregation potential of the non-target particles; and at least one acoustic transducer coupled to a wall of the at least one microfluidic separation channel.
Fiering 1 (‘816 PGP) at claim 30.
Fiering 1 at para [142]-[143] teaches that the additive may provide efficient separation of target particles from other non-target particles through pretreatment of the biofluid with an additive capable of altering, for example, the aggregation of non-target particles, because particle migration generally depends on particle size, density, and compressibility relative to the density and compressibility of the suspending biofluid. Fiering 1 at para [73] teaches the additive may comprise biochemical moieties, such as antibodies, that bind target particles or non-target particles. The cell aggregator may comprise a solution comprising antibodies that bind and aggregate target particles or non-target particles, which reads on the instant claim term “cluster”.
Fiering 1, at ‘816 PGP claims 54-61, and para [0122]-[0125], recite and disclose kits for microfluidic particle separation, including microfluidic separation channels, a source of additive fluidly connectable with the microfluidic separation channels, and instructions for use.
Essakali, (2018) BMC Biotechnology, vol. 8, number 6, pages 1 to 5, throughout the publication and abstract, teach cell sample enrichment suing a “bifunctional rosette-based antibody cocktail.” Essakali, at p. 2 of 5, para 3, state: We used a bifunctional antibody cocktail for B-cell enrichment (RosetteSepTM (RS))that binds erythrocytes (via glycophorin)on one side and white cell populations other than B-cells (via the CD2, CD3, CD16, CD36, CD56 and/ or CD66b antigens) on the other side thus forming dense rosettes of erythrocytes surrounding the unwanted white blood cells when added to whole blood.”
It would have been prima facie obvious before the filing date of the instant application for one of ordinary skill in the art to have combined bifunctional antibodies that form non-target cell clusters, as taught by Essakali, with the systems for separation of particles in biofluids comprising the use of acoustic transduces to apply a standing acoustic wave transverse to a microfluidic separation channel, and kits thereof, as taught by Fiering 1 and claimed by Fiering 2.
One of ordinary skill in the art would have motivated to have combined bifunctional antibodies that form non-target cell clusters, as taught by Essakali with the systems for separation of particles in biofluids comprising the use of acoustic transduces to apply a standing acoustic wave transverse to a microfluidic separation channel, and kits thereof, as taught by Fiering 1 and claimed by Fiering 2, in order to affect particle migration in acoustic bioprocessing separation.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark L Shibuya whose telephone number is (571)272-0806. The examiner can normally be reached M-F, 9AM-4:30PM.
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, James (Doug) Schultz, can be reached at (571) 272-0763. 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.
MARK L. SHIBUYA
Primary Patent Examiner
Art Unit 1631
/MARK L SHIBUYA/Primary Patent Examiner, Art Unit 1631