DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,541,393. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘993 Patent recite: A system for detecting at least one protein and at least one genetic component associated with at least one pathogen of a biological specimen, comprising: a disposable cartridge frame comprising: a sample inlet port configured to receive the biological specimen; a first reservoir containing a protein buffer for preparing a sample of the biological specimen for detection of a target protein associated with the at least one pathogen in the biological specimen; a second reservoir containing a genetic buffer for preparing the sample of the biological specimen for detection of a target genetic component associated with the at least one pathogen in the biological specimen, wherein at least one reagent of one of the protein and the genetic buffer is absent from the other buffer, a first sensor configured to detect the target protein associated with the at least one pathogen in the sample; a second sensor configured to detect the target genetic component associated with the at least one pathogen in the sample; and at least one release mechanism coupled to the first and the second reservoirs for releasing at least a portion of a liquid in the first reservoir for transfer to the first sensor and for releasing at least a portion of a liquid in the second reservoir for transfer to the second sensor. In addition, claims 9 and 29 recite additional wells which store processing reagents that may be considered to be a third reservoir as recited in the claim. Also, the dependent claims of the ‘393 Patent recite all of the features of the rejected dependent claims. Therefore claims 1-30 of the ‘393 Patent fully encompass the scope of claims 10-12.
Claims 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,541,393 in view of Khattak et al. (US 2015/0064693). Claims 1-30 of the ‘393 Patent recite every element of claims 13-15 except for the swab port, saline solution and filter. Khattak teaches a cartridge and system for analyzing a collected sample. The portions of the device most relevant to the instant claims are shown in Figures 7A-12B and 18A-18B and described in Paragraphs 0093-0117. As shown in Figures 7A-12B and 18A-18B, Khattak teaches a cartridge (700) comprising an inlet for receiving a sample, a first reservoir (824) for storing at least a first processing reagent, a second reservoir (828) for storing a second processing reagent, a third reservoir (826) for storing a third processing reagent, at least a first sensor (758a) configured for detection of at least one protein in the sample, at least a second sensor (758b) configured for detection of at least one genetic component in the sample, at least a third sensor (758c) configured for detection of a small molecule biomarker in the sample, wherein said first, second and third processing reagent are suitable for preparing the sample for delivery to said first, second and third sensor, respectively. Khattak further teaches channels (825, 827, and 835) for connecting with analysis channel (832) in Figures 10A-10B and Paragraphs 0122-0124. Khattak teaches a frangible membrane (823) in Figure 10A and Paragraph 0101; and a saline solution as one of the sample preparation reagents in Paragraph 0081. Khattak discloses use a filter in a channel coupled to the inlet in Paragraphs 0163-0165. Khattak teaches a swab port (410) for receiving a sample swab (400) in Figures 12A-12B.
Regarding claims 13 and 14 – The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to add the swab port with membrane and saline solution from Khattak to the system recited in claims 1-30 of the ‘393 Patent. One of ordinary skill in the art at the time would add the swab port and swab to the system recited in the ‘393 Patent in order to collect samples by swab and directly insert them into the cartridge as taught by Khattak. One of ordinary skill in the art at the time would add the saline solution to the system recited in the ‘393 Patent in order to provide a sample preparation reagent as taught by Khattak.
Regarding claim 15 – The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to add the filter element from Khattak to the system recited in claims 1-30 of the ‘393 Patent. One of ordinary skill in the art at the time would add the filter to the system recited in the ‘393 Patent in order to filter samples in the channels of the cartridge as taught by Khattak.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) both a law of nature and an abstract idea. These judicial exceptions are not integrated into a practical application because the claims do not recite an additional element that utilize the judicial exceptions in a manner that imposes meaningful limit on the exceptions. Claim 1 recites
a method for preparation of a biological sample indicative of the presence of an emergent variant of a known pathogen in the biological sample, the method comprising: preparing a first portion of the biological sample in a first reservoir and analyzing the portion of the biological sample to detect a structural protein, if any, that exhibits a homology of at least about 80% among different known variants of the pathogen; and preparing a second portion of the biological sample in a first reservoir and analyzing the second portion in a second reservoir to detect any one of a plurality of genetic components, if any, in the sample, where each of said plurality of genetic components is unique to one of the known variants of the pathogen; wherein a detection of said structural protein and a lack of detection of any of said plurality of genetic components is indicative of a presence of an emergent variant of the pathogen in the sample.
The Examiner submits that the method steps directed to comparing protein homology and gene sequences to determine the existence of alterations is the recitation of a mental process. The Examiner directs Applicant to MPEP 2106.04(a)(2), Section III, A which states: claims to "comparing BRCA sequences and determining the existence of alterations," where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 763, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional steps directed to the types of assays recite determining the presence of the protein variant to be recognized as a routine and conventional technique. Additionally, the MPEP states that collecting information, analyzing the information, and determining results is an abstract idea when the analysis steps are recited at a high level of generality such that they could be performed in the human mind (MPEP 2106.04(a)(2), Section III A). The Examiner further submits that the comparing of a sample of a pathogen to its known variants, establishing thresholds for homology and determining a difference to determine an emerging variant is a natural correlation between the expected proteins and the known variant which falls under the concept of laws of nature of natural phenomena. See examples in MPEP 2106.04(b) , Section I. As such, the additional elements recited in the claims do not recite eligible subject matter.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 10-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khattak et al. (US 2015/0064693). Khattak teaches a cartridge and system for analyzing a collected sample. The portions of the device most relevant to the instant claims are shown in Figures 7A-12B and 18A-18B and described in Paragraphs 0093-0117.
Regarding claims 10, 11, 12 and 13 – As shown in Figures 7A-12B and 18A-18B, Khattak teaches a cartridge (700) comprising an inlet for receiving a sample, a first reservoir (824) for storing at least a first processing reagent, a second reservoir (828) for storing a second processing reagent, a third reservoir (826) for storing a third processing reagent, at least a first sensor (758a) configured for detection of at least one protein in the sample, at least a second sensor (758b) configured for detection of at least one genetic component in the sample, at least a third sensor (758c) configured for detection of a small molecule biomarker in the sample, wherein said first, second and third processing reagent are suitable for preparing the sample for delivery to said first, second and third sensor, respectively. Khattak further teaches channels (825, 827, and 835) for connecting with analysis channel (832) in Figures 10A-10B and Paragraphs 0122-0124. Khattak teaches a swab port (410) for receiving a sample swab (400) in Figures 12A-12B.
Regarding claim 14 – Khattak teaches a frangible membrane (823) in Figure 10A and Paragraph 0101; and a saline solution as one of the sample preparation reagents in Paragraph 0081.
Regarding claim 15 – Khattak discloses use a filter in a channel coupled to the inlet in Paragraphs 0163-0165.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAYNE K HANDY whose telephone number is (571)272-1259. The examiner can normally be reached M-F 10AM-7PM.
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/DWAYNE K HANDY/Examiner, Art Unit 1798 September 26, 2025
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798