DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .2. This action is in response to the amendment filed on 22 September 2025. Applicant's arguments and amendments to the claims have been fully considered but do not place the application in condition for allowance. All rejections not reiterated herein are hereby withdrawn.
3. Claims 1, 3-5, and 7-11 are pending and have been examined herein.
Priority
4. The present application filed 14 March 2022 is a CIP of U.S. Application 17/246,920, filed 03 May 2021, which is a CON of U.S. Application 15/938,890, filed 28 March 2018, which claims the benefit of EP Application EP17000524.3, filed 20 March 2017.
Claims 1, 3-5, and 7-11 are entitled to the filing date of the present application of 14 March 2022.
Note that a claim as a whole is assigned an effective filing date rather than the subject matter within a claim being assigned individual effective filing dates. U.S. Application 15/938,890, U.S. Application 17/246,920 and the EP17000524.3 application do not provide support for each of the embodiments recited in the present claims.
The response of 22 September 2025 states “Claim 1 is supported by the priority application 15/938890 (in the form of U.S. Patent I1,028,452), col. 2, lines 32-56; col. 8, line 43 et seq.: and claim 2: and by EP 17000524.3.” It is also stated that “Claims 4 and II are supported by the '890 priority application (in the form of U S. Patent I 1,028,452). col. 2. lines 32-56; col. 8, line 43 et seq. and claims 1, 2 and 17: and by EP 17000524.3.”
However, regarding claims 1, 4, 5, 7, 8, 10 and 11, the priority applications (including the portions cited by Applicant) provide support only for a carrier that is a silane coated microarray plate made of a material selected from the group consisting of a glass material, a plastic material, or a silicon material or a carrier that is a bead. The priority applications do not provide support for any carrier that is made from a glass material, a plastic material or a silicon material.
Regarding claims 8-10 and the recitation of a “modified nucleic acid comprising a linker,” the ’920, ‘890 and EP17000524.3 applications disclose only nucleic acid probes comprising a 5’ C6-amino-linker. In particular, the ‘890 and ‘920 applications disclose: 5′ C6-Amino-linker-GATCCTTGGCGTACGGATGCATA 3 (SEQ ID NO: 14) at para [0071]; 5′ C6-Amino-linker-GATGTAGGCCCAAAATCATTGCCTACAC 3 (SEQ ID NO: 24) and 5′ C6-Amino-linker-CTGCCCCAACTTTTGGCAACTG 3′ (SEQ ID NO: 25) at para [0080] and [0094]; 5’ C6-Amino-linker-TAGGCAATGATTTTGGGCCTA (SEQ ID NO: 26) and 5’ C6-Amino-linker-CATCGGCGAGGACCATCGGA 3 (SEQ ID NO: 27) at para [0087] and [0101]; and 5′ C6-Amino-linker-GCAATGGTTCTGGGCCTACATC 3 (SEQ ID NO: 28) at para [0101] (note that paragraph numbering is with respect to the published ‘890 application). The ‘920, ‘890 and EP17000524.3 applications do not disclose the broader concept of nucleic acid probes attached to any linker, as encompassed by the claims. The disclosure of the single species of a 5’ C6-amino-linker does not provide basis for the broader concept of the genus of any linker attached (at the 5’ or 3’ end) to the nucleic acid (probe).
Further regarding claims 8-10, the ‘920, ‘890 and/or EP17000524.3 applications do not disclose that “the linker and the nucleic acid are coupled via poly A / poly T interaction, thiol-epoxy crosslinking, carbodiimide crosslinking, Streptavidin / Biotin interaction or a hydrazide reaction.”
Regarding claims 3 and 9, the ‘920, ‘890 and/or EP17000524.3 applications do not disclose that the nucleic acids are attached to a carrier that is a bead.
If Applicant asserts that the present claims are entitled to priority to the provisional applications, Applicant should point to specific teachings (e.g., by page and line number) in the priority applications to establish priority for each of the recitations set forth in the claims.
See MPEP 2163 II at “(b) New Claims, Amended Claims, or Claims Asserting Entitlement to the Benefit of an Earlier Priority Date or Filing Date under 35 U.S.C. 119, 120, 365, or 386” states “To comply with the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, or to be entitled to an earlier priority date or filing date under 35 U.S.C. 119, 120, 365, or 386, each claim limitation must be expressly, implicitly, or inherently supported in the originally filed disclosure.”
New Claim Rejections - 35 USC § 101
5. 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, 3-5, and 7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a natural phenomenon / naturally occurring product without significantly more. The judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons that follow.
Applicant’s attention is directed to the USPTO January 7, 2019 Revised Patent Subject Matter Eligibility Guidance (i.e., “PEG”) available at URL:
<https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf>.
Regarding Step 1 of the PEG, the claims are directed to the statutory category of a product.
Regarding Step 2A, prong one, the claims recite the judicial exception of a natural phenomenon – i.e., a naturally occurring product.
Pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. (June 2013), a naturally-occurring nucleic acid or fragment thereof, whether isolated or not, is not patent-eligible subject matter. Specifically, the Supreme Court held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.”
In the present situation, the claims recite naturally occurring nucleic acids. Although SEQ ID NO: 1 is a consensus sequence, the presence of an “N” at the variable positions encompasses the individual, naturally occurring, nucleic acids from the different Trichophyton species. Thus, the claimed nucleic acids contain the same genetic information as the naturally occurring Trichophyton genome. Further while the claims recite that the nucleic acid is “modified,” the term “modified” has not been defined in the specification or the claims and there is no requirement in the claims that the modified nucleic acid is distinct from the naturally occurring Trichophyton nucleic acids.
Claims 1, 3, and 11 also recite that the nucleic acid is attached to a carrier. However, the claims do not set forth how the nucleic acid is attached to the carrier. Nucleic acids may be attached to carriers comprising glass, plastic and silicon materials, by ionic / affinity interactions. Such attachment does not chemically or otherwise materially modify the nucleic acid itself (as opposed to, e.g., nucleic acids covalently attached to a carrier). Thus, the limitation of a “carrier” comprising the nucleic acids is not sufficient to distinguish the claimed oligonucleotides from naturally occurring DNA molecules, following the analysis set forth in the Supreme Court decision. The nucleic acid segments encompassed by the claims do not have markedly different characteristics from their naturally occurring counterparts because the nucleic acid segments convey the same genetic information.
It is noted that claims 4, 7 and 10 have been amended so that they no longer require that the primer is labeled with a fluorescent label, a radioactive label, a colloidal gold label or an enzymatic label. The label is now optional and thereby the claims include the embodiment in which the primers do not include the recited labels.
Regarding the recitations of probes and primers, Applicant’s attention is further directed to MPEP 2106.04(c)IIC which states:
“In Ambry Genetics, the court identified claimed DNA fragments known as "primers" as products of nature, because they lacked markedly different characteristics. University of Utah Research Foundation v. Ambry Genetics Corp., 774 F.3d 755, 113 USPQ2d 1241 (Fed. Cir. 2014). The claimed primers were single-stranded pieces of DNA, each of which corresponded to a naturally occurring double-stranded DNA sequence in or near the BRCA genes. The patentee argued that these primers had markedly different structural characteristics from the natural DNA, because the primers were synthetically created and because "single-stranded DNA cannot be found in the human body". The court disagreed, concluding that the primers’ structural characteristics were not markedly different than the corresponding strands of DNA in nature, because the primers and their counterparts had the same genetic structure and nucleotide sequence.”
In response to the patentee’s position that the primers “have a fundamentally different function than when they are part of the DNA strand,” the Court rejected this position on the basis that the natural DNA performed a similar function to bind to complementary nucleotide sequences – i.e., “just as in nature, primers utilize the innate ability of DNA to bind to itself.” Thereby, the Court held that the primers did not have a different structure as compared to their full length naturally occurring nucleic acid counterparts and were therefore patent ineligible.
Further, regarding kits per se, MPEP 2106.04(c)IA states “Where the claim is to a nature-based product in combination with non-nature based elements (e.g., a claim to "a yogurt starter kit comprising Lactobacillus in a container with instructions for culturing Lactobacillus with milk to produce yogurt"), the markedly different characteristics analysis should be applied only to the nature-based product limitation.” Thereby, the markedly different characteristics analysis is applied herein to the nature-based product limitations.
Regarding Step 2A, prong two, having determined that the claims recite a judicial exception, it is then determined whether the claims recite additional elements that integrate the judicial exception into a practical application.
Herein, the claims do not recite additional steps or elements that integrate the recited judicial exceptions into a practical application of the exception(s).
Regarding Step 2B, the next question is whether the remaining elements/steps – i.e., the non-patent-ineligible elements/steps - either in isolation or combination, amount to significantly more than the judicial exception.
Regarding attaching nucleic acids to carriers and including carriers in kits, including silicon covered glass, plastic and silicon material microarray plates were well-known, routine and conventional in the prior art
This fact is evidenced by the teachings in the specification - see, e.g., para [0070] of the published application, which states “Suitable microarrays, ways how to prepare and how to use them are described in the state of the art, for example in Muller, H. J & Roder, T. (2004) Der Experimentator-Microarrays, Elsevier/Spektrum, Chapters 3 and 4.”. Accordingly, the presence of the carrier does not add something ‘significantly more’ to the recited judicial exception.
Regarding carriers, the attachment of nucleic acids to carriers / supports was well-known, routine and conventional in the prior art, as were the supports of plates, microarray plates, microbeads, capture surfaces and test strips. For example, Drmanac et al (U.S. 20110033854) states “[0413] Nucleic acids are generally immobilized to the discrete regions by a variety of methods known in the art and described in further detail below. In specific embodiments, nucleic acids are immobilized to discrete regions on an array through non-covalent electrostatic interactions.” Drmanac teaches that “Suitable solid support materials include materials such as glass, polyacrylamide-coated glass, ceramics, silica, silicon, quartz, various plastics, and the like” (para [0425])Green, L. (U.S. 2004/0166494) which states “[0007]… Most microarrays are produced using covalent, electrostatic or hydrophobic binding to attach capture probes to the surface of a solid matrix.” Sampas (U.S. 2006/0110744) teaches “[0074]… Where the arrays are arrays of nucleic acids, the nucleic acids may be adsorbed, physisorbed, chemisorbed, or covalently attached to the arrays at any point or points along the nucleic acid chain.” Sampas (para [0071]) also states “The phrase “surface-bound polynucleotide” refers to a polynucleotide that is immobilized on a surface of a solid substrate, where the substrate can have a variety of configurations, e.g., a sheet, bead, or other structure. In certain embodiments, the collections of oligonucleotide probe elements employed herein are present on a surface of the same planar support, e.g., in the form of an array.”
Regarding claims 4, 7 and 11, the term “kit” has not been clearly defined in the specification or the claims. The recitation of kit reads on component parts capable of being assembled. Accordingly, the word “kit” does not impart any additional special structural or functional features which render the claimed polynucleotides patent-eligible. Also, to the extent that the claims may include kits that also comprise instructions or a carrier, the presence of other components in a kit, including instructions or a carrier, does not alter the structure or functional attributes of the nucleic acids present in the composition. Moreover, the inclusion of instructions per se and/or a carrier in a kit was well-known, routine and conventional in the prior art.
Additionally regarding instructions, it is first noted that the written material in the instructions is not considered to be within the statutory classes (see MPEP 706.03(a)). The presence of instructions per se do not materially alter the characteristics of the naturally occurring products in the kit. Again, the components of the kit, including the instructions, may exist side-by-side and do not interact with one another in a meaningful way. Further, the inclusion of instructions in kits was well-known, routine and conventional in the prior art. See, e.g., Ahern, H. (The Scientist. July 1995. 9(15): 20-25) which teaches including instructions in kits to provide the benefits of cost-effectiveness and time efficiency (e.g., p. 22). Promega (PCR Optimization Kit. Instructions for Use of Product. October 2016. 8 pages, available via URL <promega.com/-/media/files/resources/protocols/technical-manuals/101/tm497-pcr-optimization-kit-usage-information.pdf?rev=4e9939af1daf44f282c00c78a88082bb&sc_lang=enf>) provides the instructions included in their kit for optimizing PCR.
For the reasons set forth above, the claims are not considered to recite something significantly different than a judicial exception and thereby are not directed to patent eligible subject matter.Response to Remarks:
In responding to the prior rejection of the claims under 35 U.S.C. 102, Applicant included remarks asserting that the amended claims meet the requirements of 35 U.S.C. 101. Applicant states that claim 1 “satisfies 35 U.S C. §101 as it features a carrier, wherein the carrier is made from a material selected from a glass material, a plastic material, or a silicon material.”
This argument is not persuasive because while the carriers are not naturally occurring products, their presence in a kit or the attachment of the nucleic acid to the carrier does not alter the characteristics of the nucleic acids so that the nucleic acids are distinct over their naturally occurring counterparts. As discussed in the rejection, the claims do not specify how the nucleic acids are attached to the carrier. Nucleic acids may be attached to carriers comprising glass, plastic and silicon materials or to beads by ionic / affinity interactions. Such attachment does not chemically or otherwise materially modify the nucleic acid itself (as opposed to, e.g., nucleic acids covalently attached to a carrier). Thus, the limitation of a carrier comprising the nucleic acids is not sufficient to distinguish the claimed oligonucleotides from naturally occurring DNA molecules. Further, the inclusion of carriers in kits and the attachment of nucleic acids to carriers was well-known, routine and conventional in the prior art. Thereby, the recitations of carriers and beads in the claims does not amount to significantly more than the judicial exception.
Regarding claim 4, it is argued that the claim satisfies “35 U.S.C. §101 as they feature one or both of (i) a carrier that is made of a material selected from the group consisting of a glass material, a plastic material, or a silicon material: and (ii) wherein at least one of the forward primer and the reverse primer are labeled with a label and form the primer pair, wherein the label is selected from the group consisting of a fluorescently label, a radioactive label, a colloidal gold label. and an enzymatically active label.” It is also stated that “The combination of a set of primers, wherein one primer comprises a label. and a probe does not exist in nature, and is configured for a specific diagnostic application, as demonstrated by the present invention.”
These arguments have been fully considered but are not persuasive. The arguments pertaining to a carrier are addressed above. Regarding the label, this argument does not pertain to the claims as amended. Applicant specifically amended claim 4 so that the label is optional. Thus, the label need not be present and cannot be relied upon to establish that the naturally occurring product has markedly different characteristics from the product found in nature.
Claim Rejections - 35 USC § 112(b) - Indefiniteness
6. 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 9 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 is indefinite over the recitation of “the probe comprises the modified nucleic acid comprising a linker” because it is unclear as to what is meant by this phrase. Claim 3 from which claim 9 depends recites: “A carrier comprising a nucleic acid probe, wherein said nucleic acid probe comprises a modified nucleic acid.” It appears that claim 9 should recite “the probe comprising the modified nucleic acid.” Further, the recitation of “the modified nucleic acid comprising a linker” lacks proper antecedent basis since the claim does not previously refer to a modified nucleic acid comprising a linker. It appears that claim 9 should recite that the “nucleic acid comprises a linker.”
Maintained / Modified Double Patenting
7. 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 1, 4, 5, 7 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11028452 (cited in the IDS of 02/17/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims and the claims of ‘452 of both inclusive of a nucleic acid probe comprising: a modified nucleic acid, wherein the modified nucleic acid is capable of hybridizing specifically to a nucleic acid sequence from a single species of a human pathogenic dermatophyte that causes at least one of a skin, hair, and nail infection, the human pathogenic dermatophyte belonging to a Trichophyton genus, wherein the nucleic acid sequence from the human pathogenic dermatophyte comprises at least one of the sequence that is at least 98% identical to the full-length of SEQ ID NO: 1, a strand complementary to SEQ ID NO: 1, or SEQ ID NO: 1 in a vector or cell, wherein the modified nucleic acid is at least 95% identical to at least one of the full-length of SEQ ID NO: 1, the strand complementary to SEQ ID NO: 1, or SEQ ID NO: 1 in the vector or cell, over a length of at least 15 consecutive nucleotides, and wherein the length of the nucleic acid probe is no more than 200 nucleotides. The claims of ‘452 and particularly claim 5 recites that the modified nucleic acid is attached via a 5′ C6-amino-linker and claim 5 of ‘452 to a carrier that is a silane microarray plate made from a glass material, a plastic material, or a silicon material.
Regarding present claims 4 and 11, claim 9 of ‘452 recites kits comprising the same instructions, primer pair and modified nucleic acid probe that is at least 95% identical to the full length of SEQ ID NO: 1 and recites that the modified nucleic acid probe comprises the particular linker of a 5’ C6-amino-linker, as well as a carrier for immobilizing the nucleic acid probe, wherein the carrier is a silane coated microarray plate made of a glass material, a plastic material, or a silicon material.
Regarding present claims 5 and 7, claims 11, 12 and 14 of ‘452 recite nucleic acid probes, carriers and kits wherein the Trichophyton is selected from the group consisting of T. tonsurans, T. equinum, T. interdigitale, T. benhamiae (african), T. benhamiae (yellow), T. concentricum, and T. erinacei.
Further regarding present claim 11, claim 1 of ‘452 recites “wherein each of the forward primer and the reverse primer are labeled with a label and form the primer pair, wherein the label is selected from the group consisting of a fluorescent label, a radioactive label, a colloidal gold label, and an enzymatically active label.”New Grounds of Rejection:8. Claims 3 and 8-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11028452 (cited in the IDS of 02/17/2023) in view of Nguyen (US20140274756).
The claims of ‘452 are discussed above.
Claims 4 and 5 of ‘452 recite that the nucleic acid is attached to a carrier and that the carrier is a silane coated microarray plate made from a material selected from the group consisting of a glass material, a plastic material, or a silicon material.
The claims of ‘452 do not recite that the nucleic acid is attached to a bead (present claims 3 and 9) or that the nucleic acid and linker are coupled via a Streptavidin / biotin interaction (present claims 8-10).
However, Nguyen teaches compositions and methods for detecting nucleic acids (e.g., para [0009], [0082] and [0091]), including microbial nucleic acids (para [0071]) using nucleic acid probes wherein the nucleic acid probes are immobilized onto a solid support, and particularly the solid support of a bead, via a linker, such as a streptavidin-biotin interaction (para [0035] and [0082]). Specifically Nguyen (para [0035]) states:
“a capture probe can specifically hybridize to a capture extender (and/or can include a sequence complementary to a nucleic acid of interest, e.g., to directly and specifically capture the nucleic acid of interest) and that is tightly bound (e.g., covalently or non-covalently, directly or through a linker, e.g., streptavidin-biotin or the like) to a solid support, a spatially addressable solid support, a slide, a particle, a microsphere, a bead, or the like.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the nucleic acid probes of ‘452 so as to have attached the nucleic acid probes to a bead via the linker of a streptavidin-biotin interaction, as taught by Nguyen. One would have been motivated to have done so for the advantage taught by Nguyen that the nucleic acid probe immobilized on the bead via the linker of a streptavidin/biotin interaction could be used as a capture probe to specifically isolate and detect target nucleic acids in a sample.
Response to Remarks:
The response states “the rejection of Claims 1-10 under the doctrine of nonstatutory obviousness-type double patenting over U.S. 11,028,452 is believed to be unsustainable as not all claims of the present invention are not obvious over the reference claims.”
This argument is not persuasive. Applicant does not point to any specific features of claims 1, 4, 5, and 11 which are not claimed in the ‘452 patent. The amendments to claims 3 and 8-10 are addressed above.
Modified Claim Rejections - 35 USC § 102
9. 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.
Claim(s) 1, 4, 5, 7 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harder et al (U.S. 20180291472, published 10/11/2018; cited in the IDS of 02/17/2023).
Regarding claim 1, Harder discloses a nucleic acid probe comprising a 5’-C6- amino-linker and a nucleic acid sequence that is at least 95% identical to at least 15 contiguous nucleotides of SEQ ID NO: 1 or the complement thereof, wherein the probe is not more than 200 nucleotides in length (see, e.g., para [0045-0047], [0071], [0080], [0087], and [0101]). Harder teaches that the nucleic acid is attached to a carrier and that the carrier is a silane coated glass, plastic or silicon material microarray plate (para [0017-0018] and [0058]).
Regarding claims 4 and 11, Harder teaches kits (e.g., para [0058]) comprising: instructions how to use the kit to diagnose at least one of a skin, hair, and nail infection (e.g., para [0058], primer pair comprising a forward primer having a length of 14 to 30 nucleotides, being at least 90 percent identical to Trichophyton sequence over the full-length of the forward primer, and having a final base of the forward primer no more than 200 bp away from a first base of SEQ ID NO: 1 in a 5' to 3' orientation, and a reverse primer having a length of 14 to 30 nucleotides, being at least 90 percent identical to Trichophyton sequence over the full-length of the reverse primer, and having a final base of the reverse primer is no more than 200 bp away from a final base of SEQ ID NO: 1 in the 5' to 3' orientation (e.g., para [0036] and [0041-0044]), wherein each primer is labeled with one or more of a fluorescent label, a radioactive label, a colloidal gold label, and an enzymatically active label (e.g., [0015], [0043] and [0054]); a probe comprising a modified nucleic acid, wherein the a modified nucleic acid probe is at least 95% identical to the full length of SEQ ID NO: 1 and is no more than 200 nucleotides in length (para [0044-0046]), and a carrier for immobilizing the nucleic acid probe, wherein the carrier is a silane coated microarray plate made of a glass material, a plastic material, or a silicon material (e.g., para [0058]).
Regarding claims 5 and 7, Harder teaches that the Trichophyton is selected from the group consisting of T. tonsurans, T. equinum, T. interdigitale, T. benhamiae (african), T. benhamiae (yellow), T. concentricum, and T. erinaceid (e.g., para [0029]).
Response to Remarks:
The response argues that the claims have priority to the 15/938,890 and EP1700524.3 applications and thereby Harder is not prior art to the claimed invention.
This argument is not persuasive because, for the reasons discussed in detail in paragraph 4 above, the claims do not have priority to the 15/938,890 or EP1700524.3 application.
New Claim Rejections - 35 USC § 103
10. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harder et al (U.S. 20180291472, published 10/11/2018; cited in the IDS of 02/17/2023) in view of Nguyen (U.S. 20140274756).
The teachings of Harder are presented above.
Harder teaches that the nucleic acid probes comprise a 6-amino-linker at their 5’ end (e.g., para [0071], [0080], [0087], and [0101]) and are attached to a carrier that is a is a silane coated glass, plastic or silicon material microarray plate (para [0018] and [0058]).
With respect to claims 3 and 9, Harder does not teach that the nucleic acid probe is attached to a bead. With respect to claims 8-10, Harder does not teach that a linker is attached to the nucleic acid probe via a Streptavidin / biotin interaction.
However, Nguyen teaches compositions and methods for detecting nucleic acids (e.g., para [0009], [0082] and [0091]), including microbial nucleic acids (para [0071]) using nucleic acid probes wherein the nucleic acid probes are immobilized onto a solid support, and particularly the solid support of a bead, via a linker, such as a streptavidin-biotin interaction (para [0035] and [0082]). Specifically Nguyen (para [0035]) states:
“a capture probe can specifically hybridize to a capture extender (and/or can include a sequence complementary to a nucleic acid of interest, e.g., to directly and specifically capture the nucleic acid of interest) and that is tightly bound (e.g., covalently or non-covalently, directly or through a linker, e.g., streptavidin-biotin or the like) to a solid support, a spatially addressable solid support, a slide, a particle, a microsphere, a bead, or the like.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the nucleic acid probes of Harder so as to have attached the nucleic acid probes to a bead via the linker of a streptavidin-biotin interaction, as taught by Nguyen. One would have been motivated to have done so for the advantage taught by Nguyen that the nucleic acid probe immobilized on the bead via the linker of a streptavidin/biotin interaction could be used as a capture probe to specifically isolate and detect target nucleic acids in a sample.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CARLA J MYERS/Primary Examiner, Art Unit 1682