DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Preliminary Remark
The Examiner of record has been changed from the examiner of the parent applications. All future correspondence should be directed to Young J. Kim of Group Art Unit 1681.
Information Disclosure Statement
The IDS received on September 11, 2023 is proper and is being considered by the Examiner.
Drawings
The drawings received on June 16, 2023 and the replacement drawing received on September 11, 2023 are acceptable.
Claim Interpretation
The term, “kinship analysis” has been interpreted according to the description found on section [0084] of the specification:
“Kinship analysis involves comparing the genetic profiles (e.g., STR profiles) of two or more persons and estimating the likelihood of a familial relationship between the people, for example, whether the two people are parent and a child, siblings, cousins, second cousins, grandparent and grandchild, uncle/aunt and niece/nephew, etc.”
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.
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Claims 1 and 3-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 8,894,946 in view of Liu et al. (Analytical Chemistry, 2007, vol. 79, pages 1881-1889) and Liu et al. (Forensic Science International: Genetics 2, 2008, pages 301-309, herein, “Liu-2”).
With regard to instant claim 1, claims of the ‘946 patent also claims a system for analyzing a sample comprising:
a cartridge comprising a sample receptacle configured to receive an article configured to deliver a sample to the sample receptacle (see claim 25, “comprising a sample receptacle comprising a sample chamber adapted to receive a sample”, also claim 26, “said sample chamber is adapted to hold a cotton swab”, cotton swab is the article that delivers the sample), wherein the cartridge comprises a plurality of chambers separated from each other by at least one seal (see claim 1(b)(i), “cartridge comprising … container comprising a plurality of closed and fluidically isolated chambers, wherein each of the plurality of chambers comprises a first and second opening, each opening closed by a friable seal”);
a cartridge module comprising:
a cartridge receptacle configured to receive the cartridge (see claim 1(a), “a cartridge module comprising a receptacle for receiving a cartridge”); and
a puncturing element configured to puncture the at least one seal, wherein a punctured state of the at least one seal, the plurality of chambers are in a fluidic communication (see claim 1(b)(ii), “a plurality of puncturing elements, wherein each fluidic channel communicates with a first port and a second port in a fluidic device, and wherein said puncturing elements each include one of said ports communicating with one of said fluidic channels”, also claim 1(c), “said puncturing elements puncture the friable seal … putting each opening in a communication with one of the ports, thereby (1) creating a flow path…”); and
an analysis module comprising:
an electrophoresis assembly (see claim 6, “system … further comprising … a separation and detection module configured to separate and detect the amplification products”,
a detection assembly (see immediately above); and
an analysis assembly (see claim 6, “an analysis module”).
With regard to claim instant claim 13, the ‘946 patent claims a system which comprises the above discussed structure which is recited in claim 13, and the article is not actively required by the claim. This is because the system comprises a cartridge having a sample receptacle configured to receive an article.
In view of this, the system of the ‘946 further comprises:
a cartridge comprising a sample receptacle that receives sample (“further comprising a sample receptacle”, see claim 25); and
a cartridge module comprising a cartridge receptacle (“cartridge module comprising a receptacle for receiving a cartridge”, see claim 1(a)).
Claims of the ‘946 patent, while explicitly teaching that the system is configured to perform an amplification reaction, separation of the amplified products, and detection of the amplified products (see above), with explicit processing step of “identif[ing] an allele of one amplified nucleotide sequence, or alleles of at least one or all of the plurality of amplified nucleotide sequences” (see claim 6, step (e)), do not explicitly state that the separation of the amplified product is an electrophoretic step (claim 1, in-part)
Consequently, claims of the ‘946 patent do not explicitly claim that the system comprises a detection assembly that is configured to detect emission signals transmitted from the separation of products in the electrophoretic separation, or an analysis assembly that analyzes the detected separation of the products and outputs the data (claim 1, in-part and claim 13, in-part), said resulting data being compared against a national index database (claims 3 and 14), for the purpose of identifying kinship (claims 4 and 15), wherein the comparison is made based on a local database or a remote database (claims 5 and 16), wherein the amplified products are dye labeled STR alleles (claims 6, 7, and 17-19).
As well, the claims of the ‘946 patent do not explicitly claim a well-known means of generating an electrophoretic separation, such as the utilization of an anode/cathode assembly and a power supply for generating a current therebetween (claims 8 and 20), via use of fluid (claim 9), or that the assembly further comprises one or more denature assembly (denaturation during electrophoresis, claim 10), in a separation matrix in buffer (claim 11).
Claims of the ‘946 patent explicitly claim that the cartridge receptacle of the system is configured as a slot (see claim 10), wherein said cartridge receptacle is a plurality of cartridge receptacles configured to receive and hold a plurality of cartridges (see claim 11), and therefore, the one face of the cartridge would be facing a first side of the receptacle and the other face would be facing an opposite side of said receptacle (claim 12).
Liu et al. teach a well-known means of performing well-known analytical assays therein, wherein the artisans explicitly teach an embodiment directed to performing electrophoretic separation of amplified nucleic acids, wherein the amplification products are short tandem repeats (STRs):
“Since the inception of mTAS in 1990, much progress has been made to miniaturize and integrate DNA analysis steps into microchip format, including DNA extraction, PCR amplification, and CE separation. These technologies are now beginning to be translated into forensic applications” (page 1881, 2nd column, bottom paragraph)
“high-throughput and integrated instruments are needed to improve the data productivity … rapid and portable DNA typing devices that can provide on-site forensic analysis could be valuable in crime scene investigation and for law enforcement and security applications” (page 1881, 2nd column)
“Short tandem repeat (STR) assays have become an indispensable and routine technique in modern forensic casework since their first application in 1991. Polymerase chain reaction (PCR)-based amplification of multiple STR loci followed by capillary electrophoretic (CE) separation provides STR assays with high sensitivity and high discrimination power. In addition to forensic identification, STR assays have found application in paternity testing missing person investigation, human identification in mass disasters, evolution, and clinical diagnosis” (page 1881)
Liu et al. teach that PCR amplified products are separated via CE, so as to provide a separation pattern of STR loci, wherein the detection of the separated STR markers made via their transmitted emission signals.
“we present the design and operation of a new PCR-CE microfluidic device for forensic STR analysis … which contain all the electronics and optics for temperature control, microfluidic manipulation, CE separation, and four-color detection” (page 1882, 2nd column, 1st paragraph)
The detection signals of the STR allelic markers are shown by separation based on their migration time (see Fig. 4, also “PCR amplifications were conducted from 9948 male and 9947A female genomic DNA … All DNA templates were also amplified … to obtain the sizes of the allele fragments and validate corresponding on-chip results”, page 1885, 2nd column, bottom paragraph to page 1886, 1st column, 1st paragraph) and the STR markers are fluorescently labeled (FAM-FAM, FAM-R6G, FAM-TMR, see Figure 4 legend).
The capillary electrophoresis is performed by the injection of the amplified products into CE which is filled with a separation medium (containing urea as a denaturant) and heated and voltage applied between a cathode and an anode end in buffer (“the CE separation channel was heated to 70oC using the channel heater … the amplified sample was electrophoretically injected into the CE system … by applying an electric field of ~100 V/cm while floating the anode and cathode. A separation field of 250 V/cm was then applied between the cathode and anode”, page 1886, 1st column, 2nd paragraph; also “separation matrix, 5% (w/v) linear polyacrylamide with 6M urea in 1x Tris TAPS EDTA (TTE) buffer”, page 1885, 2nd column).
Liu-2 teaches a well-known means of comparing a STR profile generated from a sample against a database comprising a collection of STR profiles:
“9-plex autosomal STR typing system is constructed with amelogenin, a sex-typing marker, and eight combined DNA index system (CODIS) core STR loci … STR analysis on the PCR-CE microdevice, and a DNA profile search against a mock CODIS database with a ‘convicted offender’ sample are successfully conducted within 6 h of crime scene arrival” (page 302, 1st column, bottom paragraph)
“The PCR reaction was complete in 2 h, and the electrophoretic trace was obtained … male suspect profile was reviewed and submitted … to be searched against the mock CODIS convicted offender database …” (page 307, 2nd column, 1st paragraph)
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the claims of the ‘946 patent with the teachings of Liu et al. and Liu-2, thereby arriving at the invention as claimed for the following reasons.
As discussed above, claims of the ‘946 patent claims a system which is configured to receive a cartridge into a receptable, wherein upon integration, is structurally configured perform various reactions and assays. And as discussed above, claims of the ‘946 patent explicitly claim that the system is configured to amplify nucleic acids, followed by their separation and detection.
While the claims did not explicitly state that the separation was an electrophoretic separation, wherein the separation was for STR markers, one of ordinary skill in the art would have been motivated to combine the teachings of Liu et al. and Liu-2 with the claimed system of the ‘946 patent because the amplification of markers and their separation in molecular diagnostics, such as diagnostics based on STR profiles had been well-established. Given that the system of the ‘946 patent already provided the framework of the cartridge that is capable of performing amplification, separation (of amplification products), and detection steps, incorporating the capillary electrophoresis separation and detection means of Liu et al. into the separation means of the ‘946 patent would have resulted in a system which is capable of performing an STR analysis.
And combining a well-known practice of comparing the STR profile produced from the sample to those profile of a reference database, be it local or remote, would have been an obvious application as demonstrated by Liu-2, for the benefit of determining the identity of a crime suspect (as taught by Liu-2) or determining paternity1 (i.e., kinship determination).
Combination of elements which result in no more than such a predictable outcome observed in the art has been deemed obvious as discussed by the Supreme Court (in KSR, citation omitted):
“[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 415-16, 82 USPQ2d at 1395.
The Supreme Court stated that there are “[t]hree cases decided after Graham [that] illustrate this doctrine.” Id. at 416, 82 USPQ2d at 1395. (1) “In United States v. Adams, . . . [t]he Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”
Therefore, for these reasons, the invention as claimed is deemed prima facie obvious over the claims of the ‘946 patent in view of Liu et al. and Liu-2.
Conclusion
No claims are allowed.
Claims are free of prior art. The prior art does not teach or suggest the system comprising the configuration cartridge presently claimed, with a puncturing element that punctures at least one seal, and its puncturing results in the plurality of chambers in the device being in fluid communication.
Inquiries
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Young J. Kim whose telephone number is (571) 272-0785. The Examiner can best be reached from 7:30 a.m. to 4:00 p.m (M-F). The Examiner can also be reached via e-mail to Young.Kim@uspto.gov. However, the office cannot guarantee security through the e-mail system nor should official papers be transmitted through this route.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Gary Benzion, can be reached at (571) 272-0782.
Papers related to this application may be submitted to Art Unit 1681 by facsimile transmission. The faxing of such papers must conform with the notice published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 CFR 1.6(d)). NOTE: If applicant does submit a paper by FAX, the original copy should be retained by applicant or applicant’s representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED, so as to avoid the processing of duplicate papers in the Office. All official documents must be sent to the Official Tech Center Fax number: (571) 273-8300. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-1600.
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/YOUNG J KIM/Primary Examiner
Art Unit 1637 January 2, 2026
/YJK/
1 “[i]n addition to forensic identification, STR assays have found application in paternity testing missing person investigation, human identification in mass disasters, evolution, and clinical diagnosis”, see page 1881, Liu et al.