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 .
Election/Restrictions
Claims 4 and 27are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on February 4, 2026.
Applicant's election with traverse of the species of “shellfish” and the corresponding primer sequences (SEQ ID: 1-4) in the reply filed on February 4, 2026 is acknowledged. The traversal is on the ground(s) that examination of all species would not be a burden to the Examiner. This is not found persuasive because each species represents mutually exclusive organisms which are genetically and taxonomically distant and are associated with different biological markers and testing protocols. As a result, the search would require investigation into each organism individually, thereby imposing a serious search burden.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
The following claims are objected to because of the following informalities:
Claim 1, sections (c) and (d): “a sample” should instead be “the sample”.
Claim 1, section (d), third line: “where each” should be “wherein each”
Claim 8, section (c): “rhPCR primer” should be “rhPCR primers”
Claim 8, section (d): an “and” should be between “RNase H2 enzyme” and “RNase H2 enzyme buffer”
Claim 10: “master mix has an inhibitor resistant properties” should be either “…has [[an]] inhibitor resistant properties” or “…has an inhibitor resistant property”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language (i.e. creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 11(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
In addition, this application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Claim limitations that use the word “means” (or “step”), or a generic placeholder, coupled with functional language are indicated below:
Claim 1(e): “means of detection…provides a present/not present result.”
This language invokes treatment under 35 U.S.C. 112(f) because there is a lack of sufficient structure to perform the recited function as presented and, therefore, is are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Claim 11 provides the corresponding structure, stating that the “detection means comprises a lateral flow assay or qPCR machine.” Therefore, the limitation of Claim 1(e) shall be read as “a lateral flow assay or qPCR machine wherein a present/not present result is provided.”
Claim 17: (a) “container for amplification”, (b) “instrument for sample collection”, (c) “reagents for amplification”, (d) “instrument for rapid amplification”, (e) “means of detecting whether the specific food product is present or not.”
The language of 17(e), the limitation shall be interpreted as described above for claim 1(e).
Regarding the language of 17(a) and 17(c), MPEP 2181.I.A states: " Note that there is no fixed list of generic placeholders that always result in 35 U.S.C. 112(f) interpretation, and likewise there is no fixed list of words that always avoid 35 U.S.C. 112(f) interpretation. Every case will turn on its own unique set of facts. The standard is whether the words of the claim are understood by persons of ordinary skill in the art to have a sufficiently definite meaning as the name for structure." Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1349, 115 USPQ2d 1105, 1111 (Fed. Cir. 2015). A skilled artisan would recognize that “container for” and “reagents for,” in the context of Claim 17, provide sufficiently definite meanings. Therefore, interpretation of these limitations under 35 U.S.C. 112(f) is not required.
Regarding the language of 17(b), treatment under 35 U.S.C. 112(f) is invoked because there is a lack of sufficient structure to perform the recited function as presented. On page 12 of the specification of the instant application, applicant states: “The sample can be obtained from a variety of means. Typically, either a whole fish or shellfish can be sampled, or a piece of meat or other tissue sample can be used. A toothpick, tweezers, a swab, or other small device for gathering a DNA sample can be used. The device can be passed along the surface of the sample, or can be plunged into the sample.” As such, this limitation will be broadly interpreted to include any method of sample collection.
Regarding the language of 17(d), treatment under 35 U.S.C. 112(f) is invoked because there is a lack of sufficient structure to perform the recited function as presented. Claim 21 provides corresponding structure, stating that the “instrument for rapid amplification is a small footprint PCR machine.” Therefore, the limitation of Claim 17(d) shall be read as “a small footprint PCR machine.”
Claim 18: “centrifugation means”
This language invokes treatment under 35 U.S.C. 112(f) because there is a lack of sufficient structure to perform the recited function as presented. Claim 19 provides corresponding structure for this limitation, stating that the “centrifugation means is a small footprint microcentrifuge.” Therefore, the limitation of Claim 18 shall be read as “a small footprint microcentrifuge.”
If applicant does not intend to have these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claims 11, 19 and 21 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitations recite sufficient structure, materials, or acts to entirely perform the recited function. Because these claim limitations are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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.
Claim 28 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (including a product of nature) without significantly more.
The claim recites “a nucleic acid sequence with 90% or more identity to any of SEQ ID NOs: 1-4”. When these sequences are searched, they each show 100% concordance with naturally occurring sequences (see comparison table below). This judicial exception is not integrated into a practical application because there are no additional limitations in the claim which would do so. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements. Therefore, claim 28 does not contain eligible subject matter.
SEQ ID NO: 1 compared to Accession #MT072717
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56
261
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SEQ ID NO: 2 compared to Accession #MT072717
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56
251
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SEQ ID NO: 3 compared to Accession #MH300639
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54
257
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SEQ ID NO: 4 compared to Accession #MH300629
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52
248
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Greyscale
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b) and (d):
(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.
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second and fourth paragraphs:
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.
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 1-3, 6-11,15-19,21, 25, 26, and 28 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “small” in claims 1, 17-19, and 21 is a relative term which renders the claim indefinite. The term “small” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the size of the claimed amplification and centrifugation device is indefinite. In regards to the amplification device, exemplary dimensions for acceptable devices is provided on page 12 of the specification. Therefore, any amplification device fitting this description shall be considered to read on the instant claims.
The term “rapid” in claims 17 and 21 is a relative term which renders the claim indefinite. The term “rapid” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the speed at which a device is capable of performing PCR is indefinite.
Claim 6 contains the trademark/trade name “Watson PCR machine”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a thermocycler and, accordingly, the identification/description is indefinite. As such, any thermocycler meeting the exemplary dimensions provided on page 12 of the specification will be interpreted as reading on this claim.
The term “activated” in claim 16 renders the term indefinite as it is unclear in which way the reagents are being activated. A skilled artisan could reasonably interpret this claim to mean that the reagents are activated by cleavage of the blocker on the rhPCR primers by RNase H2, or activated via reconstitution with water of lyophilized reagents.
Claims 2, 3, 7-11, 15, 25, and 26 ultimately depend from either claim 1 or 17 and inherit the indefiniteness issues of the parent. Therefore, these claims are rejected.
Claims 11, 19, and 21 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
As discussed in the claim interpretation section of this office action, claims 11, 19, and 21 provide the structure for limitations within their respective parent claims which invoke interpretation under 35 U.S.C. 112(f). Therefore, as these claims provide no additional limitations other than the aforementioned structure, they do not further limit the claims upon which they depend.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 6, 7, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taboada (Taboada L et. al. Food Chemistry. 2017 Oct 15; 233:182-9) as evidenced by Cytiva (Cytiva. Illustra puReTaq Ready-To-Go PCR Beads Product Booklet. 2021 (27955701PL AI): 1-18.) and American Laboratory Trading (American Laboratory Trading. Applied Biosystems 2720 Thermal Cycler. Accessed: March 3, 2026).
Taboada discloses a method for the molecular identification of seafood products. This method analyzed the mitochondrial cytochrome b gene via PCR amplification followed by detection using a lateral flow dipstick (Taboada, p183). First, a sample from a fish product was digested in a microcentrifuge tube and the DNA isolated using the Wizard DNA Clean-Up System kit from Promega (Taboada, Supplementary Data 3). To perform PCR amplification, Taboada used the PureTaq™ Ready-To-Go™ PCR bead system. These beads contain all the reagents necessary to perform PCR (with the exception of template and primer) and are provided predispensed in either PCR tubes or in the wells of a PCR plate (aka a container) (Cytiva, p4). To each well or tube, Taboada added primers (forward and reverse), template DNA, and sterile water to a final volume of 25uL (Taboada, p184). This reaction mix was then thermocycled using an Applied Biosystems 2720 Thermal Cycler (Taboada, p184). This instrument has a footprint of 8.3in x 14.2in and weighs 13.5lbs (according to American Laboratory Trading), thus meeting the requirements of a “small footprint amplification device” as previously discussed in the 112b rejection. Finally, the amplified product was detected via lateral flow dipstick, allowing for the visual detection of a positive or negative result within 5 minutes. This positive or negative result was used to determine if the food product had been accurately labeled (Taboada, p184).
Claim 28 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Korzik (Korzik et al. PLoS ONE. 12 Mar 2020; 15(3): e0229512 and associated data).
Korzik discloses a sequence (Accession #MT072717) from the mitochondrion of P. setiferus (white shrimp) which shows 100% similarity to both SEQ ID NOs: 1 and 2. Therefore, the sequence of Korzik anticipates both claimed sequences.
Claim Rejections - 35 USC § 103
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.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Taboada in view of Korzik.
The limitations of claim 1 (from which claims 2 and 3 ultimately depend) have been previously discussed. However, Taboada does not teach applying their method of identifying commercial fish products to the identification of shellfish (specifically L. setiferus).
Korzik teaches that 21% of seafood in the United States is mislabeled which can have consequences such as exacerbating over-fishing, negative human health impacts, and perpetuating human rights abuses in international fisheries (Korzik p2). Korzik specifically focused on the impact of seafood mislabeling in the context of shrimp. In pursuit of this goal, Korzik applied standard DNA barcoding techniques to consider three different shrimp species (F. aztecus, L. setiferus, and F. duorarum), finding that 34% of shrimp sold by vendors in North Carolina were mislabeled (Korzik, abstract, p2). Taboada teaches that these DNA barcoding techniques is complex as it requires skilled personnel, high analysis time, and the use of expensive equipment (Taboada p183).
Therefore, one of ordinary skill in the art prior to the effective filing date of the claimed invention looking to address the issue of improperly labeled seafood products, would be motivated to use the method of Taboada to analyze shellfish products for the presence or absence of L. setiferus DNA as this method represents a more widely-adaptable form of analysis.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Taboada in view of Dobosy (Dobosy JR et al. BMC Biotechnology. 2011 Aug 10. 11(80): 1-18).
The limitations of claim 1 (from which claim 8 depends) have been previously discussed. Taboada does not teach that the amplification reagents used in their method include rhPCR primers, RNase H2 enzyme, or RNase H2 enzyme buffer.
However, Dobosy teaches an enzyme coupled PCR assay used to increase primer specificity, termed rhPCR, which is particularly useful in the detection of single nucleotide polymorphisms (SNPs). In this method, primers are modified to contain a single RNA reside at the 3`-end, which prevents extension by DNA polymerase. When the primer hybridizes to its target, RNase H2 enzyme cleaves the RNA from the primer, thus activating it and initializing PCR (Dobosy, p2). The cleavage reaction takes place by incubating the substrate in “Mg Cleavage Buffer” (aka RNase H2 enzyme buffer) for 20 minutes at 70oC (Dobosy, p3). Dobosy further teaches that this enzyme/primer system is compatible with any thermostable DNA polymerase and little to no modification of the reaction set up (cycling times, temperatures, etc.) is required (Dobosy, p2).
Taboada’s method relies on the identification of SNPs in small segments of the cytochrome b mitochondrial DNA sequence of the target species (Taboada, p184). Therefore, one of ordinary skill in the art prior to the effective filing date of the claimed invention would have been motivated to adapt the method of Taboada by using rhPCR chemistry in order to improve primer specificity and resulting in a method better able to distinguish between closely related fish species. Additionally, as rhPCR is adaptable for use with any existing PCR system, a skilled artisan would recognize that the addition of rhPCR primers and RNase H2 enzyme to the PCR beads used by Taboada is a viable way to easily improve Taboada’s method. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Taboada in view of Dobosy and Korzik.
The limitations of claims 1 and 8, from which claim 9 depends, have been previously discussed. Neither Taboada nor Dobosy teach the use of the claimed primers.
However, the targets of the claimed primers (SEQ ID NOs: 1-2) are known in the art (see 101 and 102 rejections). Additionally, Taboada states that cytochrome b is suitable for use in the kind of species differentiation analysis performed by Taboada and the instant application as the existence of SNPs in segments of this sequence are known (Taboada p185). Therefore, the use of cytochrome b as a target for analysis represents an obvious choice.
As the sequence of cytochrome b is well characterized, standard primer design principles (i.e. primer length, melting temperature, GC content) would provide clear and predictable guidance for generating suitable primers. Accordingly, developing primers for this known genomic regions would have been akin to choosing from a finite number of predictable primer candidates and, therefore, obvious to try.
The Supreme Court decided that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. Therefore, choosing from a finite number of identified, predictable solutions, with a reasonable expectation for success, is likely to be obvious to a person if ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, E.).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Taboada in view of Dobosy as evidenced by Cytiva and Kreader (Kreader C. Applied and Environmental Microbiology. 1996 Mar; 62(3): 1102-1106.)
The limitations of claims 1 and 8, from which claim 10 depends, have been previously discussed. When performing PCR amplification of a sample, Taboada used the PureTaq™ Ready-To-Go™ PCR bead system which provides predispensed amplification reagents. Each of these beads contains stabilizers, BSA, dNTPs, polymerase, and reaction buffer (Cytiva, p4). The inclusion of BSA in a reaction mixture provides relief from the effects of inhibition (Kreader, abstract); therefore, its inclusion in the PCR bead system would impart inhibitor resistant properties.
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Taboada in view of Dobosy as evidenced by Cytiva.
The limitations of claims 1 and 8, from which claims 15 and 16 depend, have been previously discussed.
Regarding claim 15, the PCR beads used by Taboada provide amplification reagents in a predispensed (aka premixed) form (Cytiva, p4).
Regarding claim 16, the PCR beads are reconstituted via the addition of primers, template and water to a final volume of 25uL (Cytiva, p9). Additionally, if a skilled artisan were modifying this method to perform rhPCR, as discussed earlier, the addition of the RNase H2 enzyme to the mix would cleave the RNA residue attached to the primers, thereby activating the reaction.
Claims 17 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Taboada in view of Yin (Yin et al. Food Chemistry. 2020 Mar 1; 318: 126541) and Polansky (US 2004/0023207) as evidenced by American Laboratory Trading.
As previously discussed, Taboada teaches a method for authenticating the identity of a food product. In the course of performing this method, Taboada uses the PureTaq™ Ready-To-Go™ PCR beads (container and reagents for amplification) to set up an amplification reaction which is thermocycled on the Applied Biosystems 2720 Thermal Cycler. The amplification products are then detected via lateral flow dipstick, allowing for the visual detection of a positive or negative result within 5 minutes, which corresponds to whether the specific food product is present or not (Taboada, p183-184).
While Taboada does not specifically discuss the method used to gather their samples for testing, they do indicate that DNA was extracted from 0.3g of thawed muscle and tissue samples. As discussed in the claim interpretation section of this office action, the limitation of “an instrument for sample collection” is being broadly interpreted as including any method for sample collection. Yin discloses that one method to obtain a tissue sample is by mincing a portion of meat and then transferring it directly into a microcentrifuge tube (Yin, p2). A skilled artisan would recognize the mincing method of Yin as easy to perform and capable of collecting a large amount of sample for testing, thus increasing the likelihood of testing success, and thus be motivated to apply it to the method of Taboada.
Furthermore, while Taboada does not provide the materials for their method in kit form, Polansky teaches that “well known advantages of commercial kits include convenience and reproducibility due to manufacturing standardization, quality control and validation procedures (Polansky, ¶0919).” A skilled artisan aiming to provide a fast, reliable, and easy-to-perform method of authenticating food products would therefore be motivated to supply all the necessary components of Taboada’s method in a singular kit, particularly for those wishing to make the product amenable to in-the-field testing where laboratory supplies/instruments may not be readily available.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Taboada in view of Yin and Polansky as evidenced by Promega (Promega. Wizard DNA Clean-Up System. Part #9FBD21. 2009 Mar; 1-2.).
The limitations of claim 17 (from which claims 18 and 19 ultimately depend) have been previously addressed in this office action. Taboada discloses the use of the Wizard DNA Clean-Up System kit from Promega during the DNA isolation step of their method (Taboada, Supplementary Data 3). According to the manual, the method of this kit includes multiple centrifugation steps and thus requires the use of a centrifuge (Promega, p1-2).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Taboada in view of Yin, Polansky, and Korzik.
The limitations of claim 17, from which claim 25 depends, have been previously addressed. Taboada, Yin, Polansky, and Korzik do not teach the use of the primers of the instant application. However, as discussed in the rejection of claim 9, designing primers for a known and well-characterized region of the genome for which there is motivation to assess, would be common practice. As SEQ ID NOs: 1-2 represent primers targeting areas of the shrimp genome that are well-characterized and often used for the same purpose as taught by the instant application, the creation of primers for those regions is obvious.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Taboada in view of Yin, Polansky, and Spielmann (Spielmann et al. European Food Research and Technology. 23 Nov 2018; 245: 987-995).
The limitations of claim 17, from which claim 26 depends, have been previously addressed. Taboada, Yin, and Polansky do not teach the use of the primers of the instant application. However, as discussed in the rejection of claim 9, designing primers for a known and well-characterized region of the genome for which there is motivation to assess, would be common practice.
Spielmann compared three DNA marker regions to determine their suitability for use in identifying food relevant decapods and in doing so disclosed sequences from the mitochondrion of X. kroyeri (sea bob shrimp, Accession #MH300629) and P. Jordani (pink shrimp, Accession #MH300639) which show 100% similarity to claimed SEQ ID NOs: 4 and 3, respectively (Spielmann, abstract, p990). These sequences represent the 16S ribosomal RNA genes of these shrimp species, show that they are conserved across multiple species which would make them suitable for use as a positive control in the testing of shrimp food-products.
Therefore, SEQ ID NOs: 3-4 represent well-characterized regions of the shrimp mitochondrial genome for which a skilled artisan would be motivated to develop primers.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kara N Kovach whose telephone number is (571)272-8134. The examiner can normally be reached Monday - Friday, 9am - 3pm.
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/K.N.K./Examiner, Art Unit 1681
/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681