Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 17, 2025 has been entered.
Detailed Action
This office action is a response to applicant’s communication submitted November 17, 2025 wherein claims 2 and 11 are amended and claims 3 and 12 are canceled. This application is a continuation of US application 16/890752, now US patent 11254927, filed June 2, 2020, which is a continuation of US application 16/818458, now US patent 11060082, filed March 13, 2020, which is a continuation of US application 16/158752, now US patent 10590410, filed October 12, 2018, which is a continuation of US application 14/976746, now US patent 10100302, filed December 21, 2015, which is a continuation of US application 14/262525, now US patent 9217143, filed April 25, 2014, which is a continuation of US application 13/692980, now US patent 8710211, field December 3, 2012, which is a continuation of US application 12/172214, now US patent 8324372, filed July 11, 2008, which claims benefit of provisional application 60/959437, filed July 13, 2007.
Claims 2, 4-11, 13-15, and 17-21 are pending in this application.
Claims 2, 4-11, 13-15, and 17-21 as amended are examined on the merits herein.
Withdrawn Rejections
Applicant’s amendment, submitted November 17, 2025, with respect to the rejection of claims 2-10 under 35 USC 112(a) for containing new matter, has been fully considered and found to be persuasive to remove the rejection as the claims have been amended so as to refer to an amide bond rather than a carbodiimide. Therefore the rejection is withdrawn. Additionally, the claims are amended are all seen to find support in the aforementioned priority documents and therefore have an effective filing date of July 13, 2007.
The following rejections of record in the previous action are maintained:
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 4-11, 14-15 and 17-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Farchaus et al. (PCT international publication WO2008/118566, Reference of record in previous action) in view of Yoza et al. (“Fully Automated DNA extraction from Blood Using Magnetic Particles Modified with a Hyperbranched Polyamidoamine Dendrimer,” Journal of Bioscience and Bioengineering vol. 95 no. 1 pp. 21-26, Reference 1691 cited in PTO-1449 submitted April 11, 2022) in view of Tyvoll et al (US pre-grant publication 2004/0086870, cited in PTO-1449 submitted April 30, 2024)
Independent claim 2 is directed to a kit which is composed of a process tube containing beds which are amide-bonded to polycationic polyamine dendrimers, and a lytic enzyme, and further composed of a release solution capable of eluting nucleic acids from the beads, a pipette tip configured to dispense the release solution into the process tube, and a separate microfluidic cartridge configured to receive polynucleotides released form the beads. The beads are further described as carboxyl-modified beads to which polyamine dendrimers are linked via one or more carbodiimide bonds. As discussed under 35 USC 112(a), the limitation requiring the dendrimer to be linked via one or more carbodiimide bonds is new matter not supported by the original disclosure, and appears to be intended to refer to amide bonds produced using carbodiimide coupling agents. Therefore this limitation is interpreted as requiring that somewhere within the structure of the dendrimer-bead conjugate there be an amide bond attaching a dendrimer portion to the bead. While claim 2 has been amended to describe an intended use wherein the magnetic beads are suspended in the solution, this limitation is reasonably considered to merely require that the magnetic beads are in a form that could be suspended in a solution, whether or not they are specifically suspended in a solution in actual practice.
Dependent claims 4-7 and 10 further specify structural limitations of the dendrimers. Dependent claims 8 and 9 further define the contents of the container. Claims 11, 13-15 and 17--21 are directed to a kit essentially comprising the same elements.
Farchaus et al. discloses a biological sample preparation system comprising a dried reagent on top of a separation column. (p. 4 lines 10-15) In a particular embodiment the dried reagent is intended to process a biological sample when reconstituted in aqueous solution and the separation column is intended to separate components of interest form the biological sample. (p. 4 line 16-23) In one embodiment the reagent system is intended to isolate label, detect, amplify, modify, or sequence nucleic acids. (p. 9 lines 8-15) In a particular embodiment the dried reagent is a lysis reagent such as proteinase K. (p. 5 lines 2-3) Various different separation devices can be used in these sample preparation systems, including a column containing a matrix. (p. 5 lines 6-11, p. 10 lines 17-24) These columns are used in methods of preparing a biological sample by adding an aqueous solution and a biological sample to the dried reagent solution, incubating the combination to process the sample, and separating the components of the sample. (p. 6 lines 13-22) Therefore these columns are reasonably considered to fall within the scope of “process tubes” recited in present claims 2 and 11.
Regarding the presence of a release solution and a pipette tip in the kit, Farchaus et al. describes the use of pipette tips and elution steps in their working examples. (p. 17 line 15 – p. 18 line 12) It would therefore have been obvious to one of ordinary skill in the art to package the columns described by Farchaus et al. along with appropriate reagents such as an elution buffer and other elements such as pipette tips, as doing so is directly suggested by the fact that Farchaus et al. describes these elements as being necessary to use the disclosed columns.
Regarding the limitation requiring that the kit contain an additional microfluidic cartridge external to the container that is configured to receive polynucleotides released from the beads, Farchaus et al. does not specifically disclose a kit having an additional microfluidic cartridge as described in this limitation. However, Farchaus et al. does disclose that the purified nucleic acids released from the device can be used for analytical techniques such as amplification, as discussed above. Tyvoll et al. further discloses a microfluidic device for enriching and amplifying a particular nucleic acid target sequence form a sample. (p. 1 paragraph 4, also figures 10-12, for example) This device is reasonably considered to fall within the scope of a cartridge as recited in present claims 2 and 11. This device enriches the nucleic acid by specifically binding the target nucleic acid preferentially from other nucleic acids. (p. 3 paragraphs 39-43) This is a different method of purification and solves a different problem than the removal of non-nucleic-acid inhibitory compounds described in the disclosure of Farchaus et al. The assay performed by the device can include polymerase chain reaction. (p. 8 paragraph 83)
It would therefore have been obvious to one of ordinary skill in the art to include in a kit for nucleic acid analysis both one or more spin columns according to Farchaus et al. and one or more cartridges according to Tyvoll et al. One of ordinary skill in the art would have considered these two cartridges to be useful together for the purpose of analyzing a biological sample, first by purifying nucleic acids from a biological sample and then by selecting and amplifying a particular target nucleic acid to be analyzed.
Farchaus et al. additionally does not disclose a kit or system wherein the matrix for purifying the nucleic acid is a dendrimer attached to magnetic particles as recited in the present claims.
Yoza et al. discloses a DNA extraction method based on dendrimer-modified magnetic particles bearing a polyamidoamine (PAMPM) dendrimer. (p. 21 left column third paragraph) These dendrimers are based on 3-[2-(2-aminoethyl)ethylamino]propyltrimethoxysilane (AEEA) further reacted with sequential cycles of methyl acrylate and ethylenediamine. (p. 21 right column, “modification of bacterial and artificial magnetic particles with a hyperbranched polyamidoamine dendrimer”) These dendrimers were constructed from between 1-6 generations. (p. 23 table 1) These particles were found to bind and release DNA. (p. 24 right column third paragraph, also table 3)
It would have been obvious to one of ordinary skill in the art at the time of the invention to use a cationic PAMAM dendrimer as described by Yoza et al. as the matrix in the system described by Farchaus et al., and to assemble a kit or system containing lyophilized dendrimer modified particles, a lytic enzyme, and release solution as described in the present claims. One of ordinary skill in the art would have seen the disclosure of Farchaus et al. as generally describing a matrix for binding DNA as being useful in such a system, and therefore would have realized that the dendrimers described by Yoza et al. are useful for this purpose.
With respect to the particular structural elements described in claims 4-7, 10, 12-15, 17, and 21, the dendrimers described by Yoza et al. would have the following structure:
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With the exact molecular weight, and number of branches and amino groups, depending on the generation to which it is constructed. Because Yoza et al. discloses that the generation can be anywhere between 1 and 6, one of ordinary skill in the art would have found it to be obvious to use any of these different generations of dendrimers as the matrix in the methods of Farchaus et al., rendering obvious larger dendrimers having the number of amine groups recited in claims 4, 6, and 7, or smaller dendrimers having a low molecular weight as recited in claim 5, for example.
With respect to the requirement that the dendrimer is connected via amide bonds as recited in present claims 2 and 16, the claims do not describe a specific structural formula localizing the amide bond to a particular position. Therefore the broadest reasonable interpretation of “amide bonded” as it is used in the claims merely requires that somewhere in the dendrimer structure there exists an amide bond with a dendron structure on one side and a linker structure connecting to the particle on the other side. Since the PAMAM dendrimers described by Yoza et al. contain amide bonds fulfilling these criteria, they infringe this limitation. Similarly, with respect to the “initial monomer core of ethylene diamine,” as recited in present claims 10 and 21, the present claims are not directed to a synthetic process where there is a clearly defined initial starting material, nor are they directed to a specific chemical structure having an ethylenediamine moiety in a particular position. Rather, the broadest reasonable interpretation of this limitation is merely that there exists an ethylenediamine substructure somewhere within the larger structure of the dendrimer. Because this is clearly the case for the PAMAM dendrimer described by Yoza et al., these claims are infringed by this structure as well. Further regarding the reference to a carbodiimide in present claim 2, as discussed under 35 USC 112(a), for the sake of this action this limitation is interpreted as a product-by-process limitation requiring that the amide bond be one which could have been formed using a carbodiimde coupling agent. Looking to the PAMAM structure above, the amide bonds in said structure could in fact have been formed using a carbodiimide coupling agent.
For these reasons the invention taken as a whole is prima facie obvious.
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 2, 4-11, 13-15 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11254927. (of record in previous action, herein referred to as ‘927) in view of Farchaus et al. (PCT international publication WO2008/118566, Reference included with PTO-892)
Specifically, claims 1 and 15 of ‘927 claim a system or kit comprising dendrimer-coated magnetic beads, a lytic enzyme, and a release solution as recited in present claims 2 and 11. With respect to the newly added limitation requiring that the kit also contain a microfluidic cartridge external to the container configured to receive polynucleotides released from the beads, claim 1 of ‘927 further describes the kit as including a microfluidic cartridge configured to receive polynucleotides from the polynucleotide-retained beads. Since this cartridge is separate from the beads, it would necessarily be external to whatever the chamber contained the beads, meeting this limitation. Dependent claims 2-8, 14, 16-19, and 22 further define the structure of the dendrimers in the same manner as present claims 2-7, 10-18, and 21. Dependent claims 9-13 and 20-21 define additional features of the kit as recited in present claims 8, 9, 19, and 20. While the claims of ‘927 do not specifically describe the container as a process tube, as discussed under 35 USC 103(a), Farchaus et al. describes a device which is a spin column reasonably considered to fall within the scope of “process tube” which further contains a matrix and a lytic enzyme, and is configured to receive a biological sample and separate nucleic acids from the sample. Therefore in view of this disclosure one of ordinary skill in the art would have found it to be obvious that the “container” containing the lytic reagent and the magnetic beads described in the claims of ‘927 could be arranged as a centrifuge tube, as described by Farchaus. Furthermore as described under 35 USC 103(a) Farchaus et al. suggests methods of using these devices that involve pipette tips, rendering obvious the inclusion of a pipette tip in the kit.
Claims 2, 4-11, 11-15 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-7 of U.S. Patent No. 10494663 (of record in previous action, herein referred to as ‘663) in view of Farchaus et al. (PCT international publication WO2008/118566, Reference included with PTO-892) in view of Yoza et al. (“Fully Automated DNA extraction from Blood Using Magnetic Particles Modified with a Hyperbranched Polyamidoamine Dendrimer,” Journal of Bioscience and Bioengineering vol. 95 no. 1 pp. 21-26, Reference 1691 cited in PTO-1449 submitted April 11, 2022)
Independent claim 1 of ‘663 is directed to a method comprising lysing a biological sample with a lysing reagent, retaining a polynucleotide from the biological sample on binding particles comprising a polycationic molecule, and later releasing the polynucleotides using a release solution, and receiving the released polynucleotides into a second region for processing the sample, which could reasonably be considered to be an additional cartridge as required by the newly introduced limitations in claims 2 and 11. Dependent claims 4-5 of ‘663 further specify that the polycationic substance is connected to the binding particles by carboxylic groups. Claims 6 and 7 of ‘663 further recite that the binding particles are preloaded with a lysing reagent that can be proteinase K. While the claims of ‘663 do not claim a DNA-binding kit or system having the additional components recited in present claims 2 and 11, comprising a PAMAM dendrimer, as discussed previously under 35 USC 103, Yoza et al. discloses that PAMAM dendrimer coated beads can bind DNA, and Farchaus et al. discloses a system comprising dried lytic reagent and a nucleic acid binding matrix that meets all of the other claim limitations. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use polycationic coated beads claimed by ‘663 in a polynucleotide purification system as described by Farchaus et al., as one of ordinary skill in the art would have expected that they were useful for binding and purifying DNA. It would also have been obvious to one of ordinary skill in the art to use one of the PAMAM dendrimers described by Yoza as the polycationic binding moiety, in view of the fact that Yoza et al. describes these moieties as being useful for the same purpose of binding polynucleotides. Furthermore as described under 35 USC 103(a) Farchaus et al. suggests methods of using these devices that involve pipette tips, rendering obvious the inclusion of a pipette tip in the kit.
Claims 2, 4-11, 13-15 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11060082 (of record in previous action, herein referred to as ‘062) in view of Farchaus et al. (PCT international publication WO2008/118566, Reference included with PTO-892) in view of Yoza et al. (“Fully Automated DNA extraction from Blood Using Magnetic Particles Modified with a Hyperbranched Polyamidoamine Dendrimer,” Journal of Bioscience and Bioengineering vol. 95 no. 1 pp. 21-26, Reference 1691 cited in PTO-1449 submitted April 11, 2022) in view of Tyvoll et al (US pre-grant publication 2004/0086870, cited in PTO-1449 submitted April 30, 2024)
Independent claim 1 of ‘082 is directed to a composition of carboxyl-modified magnetic beads bound via amide bonds to polycationic polyamine dendrimers. Dependent claims 2-18 of ‘082 further specify that the dendrimer is a PAMAM dendrimer having a structure falling within the limitations recited in present claims 2-7, 10-18, and 21. While the claims of ‘082 do not specifically claim the beads as part of a DNA-binding kit or system having the additional components recited in present claims 2 and 11, as discussed previously under 35 USC 103, Yoza et al. discloses that PAMAM dendrimer coated beads can bind DNA, Farchaus et al. discloses a system comprising dried lytic reagent and a nucleic acid binding matrix that meets all of the other claim limitations, and Tyvoll et al. discloses a different cartridge for selectively amplifying a target nucleic acid from a mixture that one of ordinary skill in the art would have recognized as useful for further processing nucleic acids released from Farchaus’s purification columns. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the PAMAM coated beads claimed by ‘082 in such a system, as one of ordinary skill in the art would have expected that they were useful for binding and purifying DNA.
Claims 2, 4-11, 13-15 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-13, 14, 16, 19, and 20 of U.S. Patent No. 10590410 (of record in previous action, herein referred to as ‘410) in view of Farchaus et al. (PCT international publication WO2008/118566, Reference included with PTO-892) in view of Tyvoll et al (US pre-grant publication 2004/0086870, cited in PTO-1449 submitted April 30, 2024)
Independent claim 8 of ‘410 is directed to a method of nucleic acid isolation comprising contacting a biological sample with binding particles amide-bonded to a polycationic dendrimer. Dependent claims 9-12 further define the dendrimer as a PAMAM having the same structure recited in present claims 2-7, 10-18, and 21. Claim 14 of ‘410 describes the binding particles as magnetic. Claim 16 of ’410 further describes using a lysis solution to lyse the biological sample.
While the claims of ‘410 do not specifically claim the beads as part of a DNA-binding kit or system having the additional components recited in present claims 2 and 11, as discussed previously under 35 USC 103, Farchaus et al. discloses a system comprising dried lytic reagent and a nucleic acid binding matrix that meets all of the other claim limitations, and Tyvoll et al. discloses a different cartridge for selectively amplifying a target nucleic acid from a mixture that one of ordinary skill in the art would have recognized as useful for further processing nucleic acids released from Farchaus’s purification column. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the PAMAM coated beads claimed by ‘410 in such a system, as one of ordinary skill in the art would have expected that they were useful for binding and purifying DNA as required by the systems disclosed by Farchaus et al. and Tyvoll et al.
Claims 2, 4-11, 13-15 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10100302 (Cited in PTO-1449 submitted 4/11/2022, herein referred to as ‘302) in view of Farchaus et al. (PCT international publication WO2008/118566, Reference included with PTO-892) in view of Yoza et al. (“Fully Automated DNA extraction from Blood Using Magnetic Particles Modified with a Hyperbranched Polyamidoamine Dendrimer,” Journal of Bioscience and Bioengineering vol. 95 no. 1 pp. 21-26, Reference 1691 cited in PTO-1449 submitted April 11, 2022) in view of Tyvoll et al (US pre-grant publication 2004/0086870, cited in PTO-1449 submitted April 30, 2024)
Independent claim 1 of ‘082 is directed to a kit comprising a lysis buffer, binding particles having PAMAM generation zero covalently bound, a wash solution, and a release solution. Dependent claims 2, 3, 5-6, and 14 of ‘302 further specify that the PAMAM dendrimer has a structure falling within the limitations recited in present claims 2-7, 10-18, and 21. While the claims of ‘302 do not specifically claim the lysis buffer, binding particles, and release solution as parts of a system or kit having a container recited in present claims 2 and 11, as discussed previously under 35 USC 103, Yoza et al. discloses that PAMAM dendrimer coated beads can bind DNA, Farchaus et al. discloses a system comprising dried lytic reagent and a nucleic acid binding matrix that meets all of the other claim limitations, and Tyvoll et al. discloses a different cartridge for selectively amplifying a target nucleic acid from a mixture that one of ordinary skill in the art would have recognized as useful for further processing nucleic acids released from Farchaus’s purification column. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the PAMAM coated beads and other components claimed by ‘302 in such a system, as one of ordinary skill in the art would have expected that they were useful for binding and purifying DNA.
Claims 2, 4-11, 13-15 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, and 7 of U.S. Patent No. 8710211 (of record in previous action, herein referred to as ‘211) in view of Farchaus et al. (PCT international publication WO2008/118566, Reference included with PTO-892) in view of Tyvoll et al (US pre-grant publication 2004/0086870, cited in PTO-1449 submitted April 30, 2024)
Independent claim 1 of ‘211 is directed to a method of nucleic acid isolation comprising contacting a biological sample with a lysis solution, and then with magnetic binding particles amide-bonded to a polycationic PAMAM dendrimer, before further washing the particles and then contacting them with a release solution. Dependent claim 2 further defines the dendrimer as a PAMAM generation zero dendrimer which according to the figure on p. 19 of the specification as originally filed has a structure falling within the dendrimer structure recited in present claims 2-7, 10-18, and 21.
While the claims of ‘211 do not specifically claim the beads as part of a DNA-binding kit or system configured as recited in present claims 2 and 11, as discussed previously under 35 USC 103, Farchaus et al. discloses a system using a DNA binding column that meets all of the other claim limitations, and Tyvoll et al. discloses a different cartridge for selectively amplifying a target nucleic acid from a mixture that one of ordinary skill in the art would have recognized as useful for further processing nucleic acids released from Farchaus’s purification column. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the PAMAM generation zero coated beads and other reagents claimed by ‘211 in such a system, as one of ordinary skill in the art would have expected that they were useful for binding and purifying DNA as required by the system disclosed by Farchaus et al.
Claims 2, 4-11, 13-15 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6, and 9 of U.S. Patent No. 8324372 (of record in previous action, herein referred to as ‘372) in view of Farchaus et al. (PCT international publication WO2008/118566, Reference included with PTO-892) in view of Tyvoll et al (US pre-grant publication 2004/0086870, cited in PTO-1449 submitted April 30, 2024)
Independent claim 1 of ‘372 is directed to a method of nucleic acid isolation comprising contacting a biological sample with a lysis solution, and then with magnetic binding particles amide-bonded to a polycationic PAMAM generation zero dendrimer, before further washing the particles and then contacting them with a release solution. According to the figure on p. 19 of the specification as originally filed, the PAMAM generation zero dendrimer has a structure falling within the dendrimer structure recited in present claims 2-7, 10-18, and 21. Claims 5 and 6 of ‘372 further specify that the dendrimer is covalently linked to carboxyl groups of the polymeric material, and claim 9 specifies that at least some of the particles are magnetic.
While the claims of ‘372 do not specifically claim the beads as part of a DNA-binding kit or system configured as recited in present claims 2 and 11, as discussed previously under 35 USC 103, Farchaus et al. discloses a system using a DNA binding column that meets all of the other claim limitations, and Tyvoll et al. discloses a different cartridge for selectively amplifying a target nucleic acid from a mixture that one of ordinary skill in the art would have recognized as useful for further processing nucleic acids released from Farchaus’s purification column. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the PAMAM generation zero coated beads and other reagents claimed by ‘372 in such a system, as one of ordinary skill in the art would have expected that they were useful for binding and purifying DNA as required by the system disclosed by Farchaus et al.
Claims 2, 4-11, 13-15 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15-25 of U.S. Patent No. 9217143 (of record in previous action, herein referred to as ‘143) in view of Farchaus et al. (PCT international publication WO2008/118566, Reference included with PTO-892) in view of Tyvoll et al (US pre-grant publication 2004/0086870, cited in PTO-1449 submitted April 30, 2024)
Independent claim 1 of ‘143 is directed to a method of nucleic acid isolation comprising contacting a biological sample with a lysis solution, and then with magnetic binding particles amide-bonded to a polycationic PAMAM generation zero dendrimer, before further washing the particles and then contacting them with a release solution. According to the figure on p. 19 of the specification as originally filed, the PAMAM generation zero dendrimer has a structure falling within the dendrimer structure recited in present claims 2-7, 10-18, and 21. Claims 15-25 of ‘143 further specify particular structural features of the dendrimer recited in the present claims.
While the claims of ‘143 do not specifically claim the beads as part of a DNA-binding kit or system configured as recited in present claims 2 and 11, as discussed previously under 35 USC 103, Farchaus et al. discloses a system using a DNA binding column that meets all of the other claim limitations, and Tyvoll et al. discloses a different cartridge for selectively amplifying a target nucleic acid from a mixture that one of ordinary skill in the art would have recognized as useful for further processing nucleic acids released from Farchaus’s purification column. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the PAMAM generation zero coated beads and other reagents claimed by ‘143 in such a system, as one of ordinary skill in the art would have expected that they were useful for binding and purifying DNA as required by the system disclosed by Farchaus et al.
Claims 2, 4-11, 13-15 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 10364456 (of record in previous action, herein referred to as ‘456) in view of Farchaus et al. (PCT international publication WO2008/118566, Reference included with PTO-892) in view of Yoza et al. (“Fully Automated DNA extraction from Blood Using Magnetic Particles Modified with a Hyperbranched Polyamidoamine Dendrimer,” Journal of Bioscience and Bioengineering vol. 95 no. 1 pp. 21-26, Reference 1691 cited in PTO-1449 submitted April 11, 2022) in view of Tyvoll et al (US pre-grant publication 2004/0086870, cited in PTO-1449 submitted April 30, 2024)
Independent claim 1 of ‘456 is directed to a method comprising retaining a polynucleotide on binding particles comprising a polycationic substance, and then releasing the polynucleotides using a release solution. Dependent claim 4 of ‘456 further specifies that the polycationic substance is connected to the binding particles by carboxylic groups. While the claims of ‘456 do not claim a DNA-binding kit or system having the additional components recited in present claims 2 and 11, comprising a PAMAM dendrimer, as discussed previously under 35 USC 103, Yoza et al. discloses that PAMAM dendrimer coated beads can bind DNA, Farchaus et al. discloses a system using a DNA binding column that meets all of the other claim limitations, and Tyvoll et al. discloses a different cartridge for selectively amplifying a target nucleic acid from a mixture that one of ordinary skill in the art would have recognized as useful for further processing nucleic acids released from Farchaus’s purification cartridge. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use polycationic coated beads claimed by ‘456 in a polynucleotide purification system as described by Farchaus et al., as one of ordinary skill in the art would have expected that they were useful for binding and purifying DNA. It would also have been obvious to one of ordinary skill in the art to use one of the PAMAM dendrimers described by Yoza as the polycationic binding moiety, in view of the fact that Yoza et al. describes these moieties as being useful for the same purpose of binding polynucleotides.
Claims 2, 4-11, 13-15 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 10443088 (of record in previous action, herein referred to as ‘088) in view of Farchaus et al. (PCT international publication WO2008/118566, Reference included with PTO-892) in view of Yoza et al. (“Fully Automated DNA extraction from Blood Using Magnetic Particles Modified with a Hyperbranched Polyamidoamine Dendrimer,” Journal of Bioscience and Bioengineering vol. 95 no. 1 pp. 21-26, Reference 1691 cited in PTO-1449 submitted April 11, 2022) in view of Tyvoll et al (US pre-grant publication 2004/0086870, cited in PTO-1449 submitted April 30, 2024)
Independent claim 1 of ‘088 is directed to a method comprising retaining a polynucleotide on binding particles comprising a polycationic substance, and then releasing the polynucleotides using a release solution. Dependent claim 4 of ‘088 further specifies that the polycationic substance is connected to the binding particles by carboxylic groups. While the claims of ‘088 do not claim a DNA-binding kit or system having the additional components recited in present claims 2 and 11, comprising a PAMAM dendrimer, as discussed previously under 35 USC 103, Yoza et al. discloses that PAMAM dendrimer coated beads can bind DNA, Farchaus et al. discloses a system using a DNA binding column that meets all of the other claim limitations, and Tyvoll et al. discloses a different cartridge for selectively amplifying a target nucleic acid from a mixture that one of ordinary skill in the art would have recognized as useful for further processing nucleic acids released from Farchaus’s purification column. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use polycationic coated beads claimed by ‘088 in a polynucleotide purification system as described by Farchaus et al., as one of ordinary skill in the art would have expected that they were useful for binding and purifying DNA. It would also have been obvious to one of ordinary skill in the art to use one of the PAMAM dendrimers described by Yoza as the polycationic binding moiety, in view of the fact that Yoza et al. describes these moieties as being useful for the same purpose of binding polynucleotides.
Claims 2, 4-11, 13-15 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 9382532 (of record in previous action, herein referred to as ‘532) in view of Farchaus et al. (PCT international publication WO2008/118566, Reference included with PTO-892) in view of Yoza et al. (“Fully Automated DNA extraction from Blood Using Magnetic Particles Modified with a Hyperbranched Polyamidoamine Dendrimer,” Journal of Bioscience and Bioengineering vol. 95 no. 1 pp. 21-26, Reference 1691 cited in PTO-1449 submitted April 11, 2022) in view of Tyvoll et al (US pre-grant publication 2004/0086870, cited in PTO-1449 submitted April 30, 2024)
Independent claim 1 of ‘532 is directed to a method comprising binding a polynucleotide from a biological sample to binding particles comprising a polycationic dendrimer molecule, and later releasing the polynucleotides using a release solution. Dependent claim 2 of ‘532 specifies that the microparticles are magnetic microparticles, and that they are bonded to the cationic dendrimer by an amine-reactive ester. While the claims of ‘532 do not claim a DNA-binding kit or system having the additional components recited in present claims 2 and 11, comprising a PAMAM dendrimer, as discussed previously under 35 USC 103, Yoza et al. discloses that PAMAM dendrimer coated beads can bind DNA, Farchaus et al. discloses a system using a DNA binding column that meets all of the other claim limitations, and Tyvoll et al. discloses a different cartridge for selectively amplifying a target nucleic acid from a mixture that one of ordinary skill in the art would have recognized as useful for further processing nucleic acids released from Farchaus’s purification column. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use polycationic coated beads claimed by ‘532 in a polynucleotide purification system as described by Farchaus et al., as one of ordinary skill in the art would have expected that they were useful for binding and purifying DNA. It would also have been obvious to one of ordinary skill in the art to use one of the PAMAM dendrimers described by Yoza as the polycationic binding moiety, in view of the fact that Yoza et al. describes these moieties as being useful for the same purpose of binding polynucleotides.
Claims 2, 4-11, 13-15 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 9540636 (of record in previous action, herein referred to as ‘636) in view of Farchaus et al. (PCT international publication WO2008/118566, Reference included with PTO-892) in view of Yoza et al. (“Fully Automated DNA extraction from Blood Using Magnetic Particles Modified with a Hyperbranched Polyamidoamine Dendrimer,” Journal of Bioscience and Bioengineering vol. 95 no. 1 pp. 21-26, Reference 1691 cited in PTO-1449 submitted April 11, 2022) in view of Tyvoll et al (US pre-grant publication 2004/0086870, cited in PTO-1449 submitted April 30, 2024)
Independent claim 1 of ‘636 is directed to a method comprising binding a polynucleotide from a biological sample to binding particles comprising a polycationic dendrimer molecule, and later releasing the polynucleotides using a release solution. Dependent claim 2 of ‘636 specifies that the microparticles are magnetic microparticles, and that they are bonded to the cationic dendrimer by an amine-reactive ester. While the claims of ‘636 do not claim a DNA-binding kit or system having the additional components recited in present claims 2 and 11, comprising a PAMAM dendrimer, as discussed previously under 35 USC 103, Yoza et al. discloses that PAMAM dendrimer coated beads can bind DNA, Farchaus et al. discloses a system using a DNA binding column that meets all of the other claim limitations, and Tyvoll et al. discloses a different cartridge for selectively amplifying a target nucleic acid from a mixture that one of ordinary skill in the art would have recognized as useful for further processing nucleic acids released from Farchaus’s purification column. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use polycationic coated beads claimed by ‘532 in a polynucleotide purification system as described by Farchaus et al., as one of ordinary skill in the art would have expected that they were useful for binding and purifying DNA. It would also have been obvious to one of ordinary skill in the art to use one of the PAMAM dendrimers described by Yoza as the polycationic binding moiety, in view of the fact that Yoza et al. describes these moieties as being useful for the same purpose of binding polynucleotides.
Claims 2, 4-11, 13-15 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8852862 (of record in previous action, herein referred to as ‘862) in view of Farchaus et al. (PCT international publication WO2008/118566, Reference included with PTO-892) in view of Yoza et al. (“Fully Automated DNA extraction from Blood Using Magnetic Particles Modified with a Hyperbranched Polyamidoamine Dendrimer,” Journal of Bioscience and Bioengineering vol. 95 no. 1 pp. 21-26, Reference 1691 cited in PTO-1449 submitted April 11, 2022) in view of Tyvoll et al (US pre-grant publication 2004/0086870, cited in PTO-1449 submitted April 30, 2024)
Independent claim 1 of ‘862 is directed to a method comprising retaining a polynucleotide on binding particles comprising a polycationic substance, and then releasing the polynucleotides using a release solution. While the claims of ‘862 do not claim a DNA-binding kit or system having the additional components recited in present claims 2 and 11, comprising a PAMAM dendrimer, as discussed previously under 35 USC 103, Yoza et al. discloses that PAMAM dendrimer coated beads can bind DNA, Farchaus et al. discloses a system using a DNA binding column that meets all of the other claim limitations, and Tyvoll et al. discloses a different cartridge for selectively amplifying a target nucleic acid from a mixture that one of ordinary skill in the art would have recognized as useful for further processing nucleic acids released from Farchaus’s purification column. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use polycationic coated beads claimed by ‘862 in a polynucleotide purification system as described by Farchaus et al., as one of ordinary skill in the art would have expected that they were useful for binding and purifying DNA. It would also have been obvious to one of ordinary skill in the art to use one of the PAMAM dendrimers described by Yoza as the polycationic binding moiety, in view of the fact that Yoza et al. describes these moieties as being useful for the same purpose of binding polynucleotides.
Claims 2, 4-11, 13-15 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 6 of U.S. Patent No. 10604788 (of record in previous action, herein referred to as ‘788) in view of Farchaus et al. (PCT international publication WO2008/118566, Reference included with PTO-892) in view of Yoza et al. (“Fully Automated DNA extraction from Blood Using Magnetic Particles Modified with a Hyperbranched Polyamidoamine Dendrimer,” Journal of Bioscience and Bioengineering vol. 95 no. 1 pp. 21-26, Reference 1691 cited in PTO-1449 submitted April 11, 2022) in view of Tyvoll et al (US pre-grant publication 2004/0086870, cited in PTO-1449 submitted April 30, 2024)
Independent claim 1 of ‘788 is directed to a system for isolating polynucleotides form a biological sample comprising a lysing container comprising magnetic binding particles comprising a polycationic substance, and a release solution. Dependent claim 5 and 6 of ‘788 further specify that proteinase K is included in the lysing chamber as a lysing reagent. While the claims of ‘788 do not claim a DNA-binding kit or system having the additional components recited in present claims 2 and 11, comprising a PAMAM dendrimer, as discussed previously under 35 USC 103, Yoza et al. discloses that PAMAM dendrimer coated beads can bind DNA, Farchaus et al. discloses a system using a DNA binding column that meets all of the other claim limitations, and Tyvoll et al. discloses a different cartridge for selectively amplifying a target nucleic acid from a mixture that one of ordinary skill in the art would have recognized as useful for further processing nucleic acids released from Farchaus’s purification column. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use polycationic coated beads claimed by ‘788 in a polynucleotide purification system as described by Farchaus et al., as one of ordinary skill in the art would have expected that they were useful for binding and purifying DNA. It would also have been obvious to one of ordinary skill in the art to use one of the PAMAM dendrimers described by Yoza as the polycationic binding moiety, in view of the fact that Yoza et al. describes these moieties as being useful for the same purpose of binding polynucleotides.
Claims 2, 4-11, 13-15 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 21, 25, and 28 of U.S. Patent No. 8570586 (of record in previous action, herein referred to as ‘586) in view of Farchaus et al. (PCT international publication WO2008/118566, Reference included with PTO-892) in view of Yoza et al. (“Fully Automated DNA extraction from Blood Using Magnetic Particles Modified with a Hyperbranched Polyamidoamine Dendrimer,” Journal of Bioscience and Bioengineering vol. 95 no. 1 pp. 21-26, Reference 1691 cited in PTO-1449 submitted April 11, 2022) in view of Tyvoll et al (US pre-grant publication 2004/0086870, cited in PTO-1449 submitted April 30, 2024)
Independent claim 1 of ‘586 is directed to a device for isolating polynucleotides form a biological sample comprising a lysing container comprising magnetic binding particles comprising a polycationic substance. Dependent claim 21 of ‘788 further specify that a lysing reagent is included in the lysing chamber. Dependent claim 25 specifies that the polycationic substance is attached to a carboxyl group of the particles by an amide bond. Claim 28 of ‘586 recites that at least some of the particles are magnetic. While the claims of ‘586 do not claim a DNA-binding kit or system having the additional components recited in present claims 2 and 11, comprising a PAMAM dendrimer, as discussed previously under 35 USC 103, Yoza et al. discloses that PAMAM dendrimer coated beads can bind DNA, Farchaus et al. discloses a system using a DNA binding column that meets all of the other claim limitations, and Tyvoll et al. discloses a different cartridge for selectively amplifying a target nucleic acid from a mixture that one of ordinary skill in the art would have recognized as useful for further processing nucleic acids released from Farchaus’s purification column. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use polycationic coated beads claimed by ‘586 in a polynucleotide purification system as described by Farchaus et al., as one of ordinary skill in the art would have expected that they were useful for binding and purifying DNA. It would also have been obvious to one of ordinary skill in the art to use one of the PAMAM dendrimers described by Yoza as the polycationic binding moiety, in view of the fact that Yoza et al. describes these moieties as being useful for the same purpose of binding polynucleotides.
Response to Arguments
Applicant’s arguments, submitted November 17, 2025, with respect to the above grounds of rejection, have been fully considered and not found to be persuasive to remove the rejections.
Applicant points out that the devices described by Farchaus et al. contain a stationary medium such as a glass fiber column which is present with the lytic reagent and used to purify the nucleic acid. This statement is not directly relevant to the obviousness of the present claims. Rather the question is whether it would have been obvious to one of ordinary skill in the art at the time of the invention to replace the stationary glass fibre column exemplified by Farchaus with a different solid phase binding material, namely dendrimer-coated magnetic beads as described by Yoza. With respect to this consideration, Applicant quotes MPEP 2143.01, stating that a proposed modification cannot render the prior art invention unsatisfactory for its claimed purpose or change the principle of operation of the prior art invention being modified.
In the present case, there is no particular reason that the proposed modification of the prior art device would render it unsatisfactory for its claimed purpose. The purpose of the device described by Farchaus is to allow for lysis and purification of biological samples in a streamlined, simple manner. Since both the stationary columns described by Farchaus and the magnetic particles described by Yoza are solid phases that bind nucleic acids and can be easily separated from a liquid phase. Furthermore on p. 22 figure 1B of Yoza, the reference illustrates carrying out cell lysis in a suspension containing the magnetic particles wherein the released DNA binds to the magnetic particles. Given that the binding can take place in the lysis buffer, one of ordinary skill in the art would reasonably conclude that the magnetic particles described by Yoza would function as intended if used as the separation phase in the device described by Farchaus.
Regarding whether this modification would change the principle of operation of the device described by Farchaus, the principle of operation of the prior art device is described on p. 4 lines 16-24 of Farchaus:
In a first embodiment, the invention provides a sample preparation system for a biological sample, comprising: a dried reagent mixture for processing the biological sample; and means for separating components of the biological sample. The dried reagent mixture, when rehydrated, is used to process the biological sample, and the separation means is capable of separating components of interest from the biological sample. Usually, the dried reagent mixture includes at least one reagent that is temperature sensitive in an aqueous solution and is ambient temperature stable in the dried mixture.
In its broadest disclosure, Farchaus simply requires that the separation means be capable of separating components of interest, such as nucleic acids, from the sample after it has contacting the dried lysis reagent mixture. P. 7 lines 21-24 again describes the desired specifications for the device, namely that it reduces sample processing steps and minimizes human contact with the sample. Using magnetic particles rather than a column as the solid phase does not essentially change the principle of operation of this device, beyond substituting one material for a different material usable for the same purpose and fulfilling the same role. As quoted in p. 10 lines 10-13, “There are many separation devices to choose from. It is desirable to choose a device that is effective in separating the macromolecules of interest which could also withstand the lyophilization process. Such a device enables lyophilization of a reagent mixture within the device.” Being a stationary column or filter is not a necessary part of the broadest disclosed specification for the separation device and not necessary for its operation. Therefore using magnetic particles rather than a glass fiber column and a magnet rather than a centrifuge would not change the basic principle by which the invention operates.
Regarding the dependent claims, Applicant does not address these claims separately. Therefore the rejection of these claims is seen to be proper for the same reasons given above.
Regarding the rejections made on the grounds of nonstatutory double patenting, Applicant does not provide any specific arguments addressing the merits of these rejections. Therefore they are deemed proper and maintained.
Conclusion
No claims are allowed in this action.
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/ERIC OLSON/ Primary Examiner, Art Unit 1693 11/21/2025
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