DETAILED CORRESPONDENCE
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 .
This action is in response to the papers filed June 2, 2026. Currently, claims 1, 3-9, 11, 13-15, 19-20, 23, 27-28, 41-43 are pending. Claims 8-9, 11, 13-15, 27-28, 42 have been withdrawn as drawn to non-elected subject matter.
Election/Restrictions
Applicant's election without traverse of Group I, Claims 1, 3-7, 19-20, 23, 25, 41, 43 in the paper filed June 2, 2026 is acknowledged.
Despite electing without traverse, the response argues that Group III should be included, searched and examined along with Group I because these would not be a serious search burden. As noted in the original restriction requirement, Group I and III are related as combination/subcombination. In the event that the elected subcombination were to become allowable, the combination would be considered for rejoinder.
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application claims priority to
PNG
media_image1.png
72
532
media_image1.png
Greyscale
Drawings
The drawings are acceptable.
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, 3-7, 19-20, 23, 41, 43 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, the rejected claim(s) do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
Briefly, Claims 1, 3-7, 19-20, 23, 41, 43 are rejected because these claims are drawn to a set of primers and optionally probes for 13 different viral and bacterial respiratory pathogens.
Claims 1, 3-7, 19-20, 23, 41, 43 are directed to nucleic acid fragments from the influenza A, influenza B, RSV, parainfluenza, Bordetella, mycoplasma, chlamydia pneumoniae, adenovirus, SARS-CoV-2, alpha/beta coronavirus genomes, i.e. known naturally occurring nucleic acids. Such isolated nucleic acid molecules, that are identical to fragments of naturally occurring nucleic acid molecules are not patent eligible subject matter, i.e. they are judicial exceptions to patentable subject matter.
MPEP 2106.04(b)(II) discusses products of nature. The MPEP specifically discusses DNA, primers and probes. The isolated DNA of Myriad and the primers of Ambry Genetics were described as products of nature by the courts. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116-17, 106 USPQ2d 1972, 1979 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). The MPEP further states the “product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See, e.g., Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 ("Contrary to Myriad's argument, it makes no difference that the identified gene sequences are synthetically replicated. As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible.").” The Federal Circuit in Ambry Genetics reviewed “[t]he Supreme Court held ineligible claims directed to segments as short as 15 nucleotides, the same length as the primer claims at issue here, suggesting that even short strands identical to those found in nature are not patent eligible. Compare ’492 patent col. 170 ll. 32–38, with ’282 patent col. 153 ll. 66–67.”
In the instant case, the claims, embrace probes and primers that are identical to naturally occurring gene fragments and clearly read on nature-based products that themselves do not exhibit markedly different characteristics from the naturally occurring gene. See e.g. Myriad in which one claim at issue was drawn to “[a]n isolated DNA having at least 15 nucleotides [an isolated DNA coding for a BRCA1 polypeptide having the amino acid sequence of SEQ ID NO: 2] (Myriad at 2113). The Court recognized that this claim, if valid, would have given Myriad exclusive right to isolate any strand of 15 or more nucleotides of an individual’s BRCA1 gene (paragraph bridging 2113 and 2114). This is directly analogous to the instant situation wherein Applicant’s claims cover probe and primer molecules that are fragments of a naturally occurring viral and bacterial genome sequences. The Court held that “[a] naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated”, and that “Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together” (page 2118). The Court found that while Myriad had located and sequenced an important gene, Myriad had not created anything, and that “separating that gene from its surrounding genetic material is not an act of invention” (page 2118). Consistent with the findings of the Court in Myriad, the Office finds that the primers and probe molecules embraced by the instant clams are not patent eligible compositions of matter regardless of whether or not they are isolated from the genome. The Guidelines indicate that a change in biological function or activity maybe a characteristic of an isolated product that can provide a marked difference sufficient to distinguish over a naturally occurring product. However, in this case, as in the Ambry case, the function of the nucleic acids is the same function as the relevant portion of the naturally occurring sequence. Just as in nature, primers and probes utilize the innate ability of DNA to bind to itself.
Having established that the claims include a naturally occurring product that is a judicial exception, it must now be determined whether or not the claims recite an element or combination of elements that amount to significantly more than that exception, and whether those additional elements also amount to significantly more for the other claimed exception(s), which ensures that the claim does not have a preemptive effect with respect to any of the recited exceptions. To determine whether a claim that includes a nature-based product limitation recites a “product of nature” exception, an analysis is performed in which it is first determined if a claim includes a nature-based product that has markedly different characteristics from the corresponding naturally occurring product, and if it does not, then it is determined whether or not other elements of the claim are sufficient to ensure that the claim as a whole amounts to significantly more than the exception itself (see the Interim Guidance on Patent Subject Matter Eligibility published 12/16/2014 in the Federal Register at pages 74618-74633). In order to be markedly different the claimed product must possess at least one characteristic that is different from that of the counterpart.
In the instant case, the claims require a cartridge comprising a cartridge body, reaction vessel and a filter. None of these limitations provides any significant addition to the judicial exceptions already claimed that would prevent the claims from having a pre-emptive effect on the use of the judicial exception. The presence of a “box" in a composition comprising a nucleic acid is entirely conventional and does not represent a modification that amounts to something significantly more than the judicial exception. The Guidelines indicate that a change in biological function or activity may be a characteristic of an isolated product that can provide a marked difference sufficient to distinguish over a naturally occurring product However, in this case, as in the Ambry case, the function of the nucleic acids is the same function as the relevant portion of the naturally occurring sequence. Primers and probes utilize the innate ability of DNA to bind to itself.
The fact that these natural products are organized into a cartridge with an intended use adds nothing to the judicial exceptions that would distinguish them from the naturally occurring material. The kit must be considered in the context of whether or not the combination can provide some way of ensuring it does not limit the public’s access to the naturally occurring material. That does not occur in this case because the naturally occurring material exists as a distinct entity within the kit, and is not integrated in terms of form or function with any other element of the kit. Similarly, a claim to a kit in which one of the kit elements is naturally-occurring product that is separate and distinct from the other kit elements would forestall the use of that naturally occurring product.
Therefore, the claims are properly rejected under 35 USC 101 as being drawn to patent-ineligible subject matter.
Claim Objections
Claims 41 are objected to because the claim contains more than one period (see 609.01(m)). Periods may not be used elsewhere in the claims except for abbreviations. For example, a. b. i. ii. Iii. contains a period and the end of the claim contains a period. This objection may be overcome by amending a. to read a) (see MPEP 608.01(m)).
Claim Rejections - 35 USC § 112- Second Paragraph
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 3, 6-7, 23, 25, 41 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 3, 6-7 recite the reaction vessel comprises up to four reaction chambers. The “up to four” appears to put an upper limit on the number of reaction vessels however, the claim recites comprising that encompasses additional elements. Thus, it is unclear whether the reaction vessel comprises 1, 2, and 3 reaction chambers or whether the reaction vessel may encompass more. Further, “up to 4” is unclear whether 4 is included or excluded. It is unclear whether the claims encompass up to and including 4 or just up to 4. Clarification is required.
Claims 5, 23, 41 are indefinite because it claims both product and method steps for using the products. The claim defines a step “wherein detection and identification of the plurality of amplification products is via real-time PCR and melt curve analysis”. As the limitations of the claim are drawn to a method step, and not to a further product limitation of the kit, there is confusion as to when direct infringement occurs. See MPEP 2173.05(p). Claim 23 is further indefinite because the term “employs” is unclear whether this is a method step or whether this is a limitation the cartridge comprises an exogenous control. Claim 41 is further directed to “are combined” which is a method step. Clarification is required.
Claim 23 is indefinite over the recitation “kit” or “the method further employs” because “the kit” and “the method” lacks proper antecedent basis. It is unclear what kti and method are being referred to. Claim 23 depends on Claim 1 which is a cartridge, i.e. a product, not a method. Correction is required.
Claim 25 is dependent on a canceled claim (i.e. claim 2) and is therefore “incomplete.” See MPEP § 608.01(n)(V). The claim 25 limitation ( “The cartridge” and “the one or more lysis reagents …” ) lacks antecedent basis from canceled base claim 2. See MPEP § 2173.05(e).
Claim Rejections - 35 USC § 102
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.
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 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.
Claim(s) 1, 3-7, 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cassidy et al. (Frontiers in Microbiology, Vol. 13, Article 854209, March 2022) as evidenced by Leber et al. (J. of Clinical Microbiology, Vol. 58, No. 5, e00155-20, May 4, 2020) and FDA QIAstat-Dx Respiratory Panel Plus Regulatory Information.
Cassidy teaches QIAstat-Dx RP 2.20 for the rapid detection of respiratory pathogens including SARS-CoV-2. Cassidy teaches point-of-care syndromic panels allow the simultaneous and rapid detection of respiratory pathogens from nasopharyngeal swabs. Th QIAstat-Dx RP2.0 analyzes 21 targets and SARS-CoV-2. The following pathogens are tested: adenovirus; coronaviruses 229E (alpha coronavirus); coronavirus HKU1 (beta coronavirus), human metapneumovirus; influenza A, influenza B, parainfluenza, rhinovirus/enterovirus, RSV, Bordetella pertussis, Chlamydia pneumonia and Mycoplasma and SARS-CoV-2 (page 6).
Cassidy does not particularly teach the QIAstat-DX RP inherently has up to 4 analytical modules.
Leber teaches a cartridge, namely the QIAstat-Dx Respiratory panel cartridges for detection of viruses and bacteria in nasopharyngeal swab specimens. Figure 1 illustrates the cartridge that comprises a cartridge body with chambers and reaction vessel, filter and primers (page 2). The QIAstat-Dx RP is a multiplexed real-time PCR test intended for use with the QIAstat-Dx system for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) (page 2)(limitations of Claim 5-6). Leber teaches up to four analytical modules can be connected with one operational module (Figure 1)(limitations of Claim 3). The QIAstat-Dx cartridges rely upon melt-curves and is a graphical output from the multiplex real-time PCR (RT-PCR) process that shows how the fluorescence signal changes as the temperature increases during the “melt” phase of the assay.
The FDA Regulatory Information provides the gene targets in the QIAstat-Dx RP2.0 are the same genes claimed in Claim 19. The FDA information also provides the cartridge has controls.
PNG
media_image2.png
492
712
media_image2.png
Greyscale
Conclusion
No claims allowable.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chu et al. (US 2022/0017979, January 20, 2022) teaches methods of detecting SARS-COV-2, influenza and RSV. While this is Applicant’s own work, Chu does not teach all of the claimed respiratory tract infections.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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, Wu-Cheng Winston Shen can be reached on (571)272-3157. 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.
/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
July 5, 2026
Prosecution Insights