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
Applicant’s election without traverse of Group I (claims 1-3, 6-7, 11-12, 14, 17, and 20) in the reply filed on 5/21/2026 is acknowledged.
Claim Status
Claims 1-3, 6-7, 11-12, 14, 17, 20-23, 26-27, and 37-41 are pending.
Claims 21-23, 26-27, and 37-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/21/2026.
Claims 1-3, 6-7, 11-12, 14, 17, and 20 are being examined on the merits.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “100, 200” has been used to designate both “a tag nucleic acid molecule” (e.g., pg 32, ln 24) and “tags” (pg 33, ln 5, 26). Reference character “100” has been used to designate both a tag nucleic acid molecule (100, 200; pg 32, ln 24) and “DNA sequence” (pg 34, ln 6). Reference character “304” has been used to designate both “a non-human animal” (e.g., pg 26, ln 16) and “an animal” (e.g., pg 27, ln 24, 27, 29, 35), “individual animals” (pg 32, ln 16), “groups of animals” (pg 32, ln 16), and “farmed animals” (pg 32, ln 25). Reference character “307” has been used to designate both an “injector” (pg 23, ln 29) and “mixing chamber” (pg 21, ln 34). Reference character “411” has been used to designate both “pharmaceutical package” (pg 25, ln 32) and “vaccine-tag product” (pg 26, ln 26). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it is more than 150 words and contains legal phraseology such as “said”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Specification
The use of the term “AF488” (referring to an Alexa Fluor, pg 30, ln 7), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112b - Indefiniteness
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.
Claims 3, 11, 14, 17, and 20 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.
Claims 3, 11, and 17: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation “a non-mammalian aquatic animal”, and the claim also recites “a fish” which is the narrower statement of the range/limitation. Additionally, claim 3 recites the broad recitation “a fish” and the claim also recites “salmon, tuna, cod, or sea trout”. Claim 11 recites the broad recitation “a circular configuration”, and the claim also recites “a plasmid or plasmid-like structure” which is the narrower statement of the range/limitation. Claim 17 recites the broad recitation “the non-human animal”, and the claim also recites “a fish” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 14 recites the limitations "the PCR primers", “the PCR product”, “the probe binding site” and “the product”. There is insufficient antecedent basis for these limitations in the claim.
Claim 20 recites the limitation "the sample" in line 1-2. There is insufficient antecedent basis for this limitation in the claim. There are two types of sample in claim 1, from which claim 20 depends. Claim 1 is defines “a body tissue or fluid sample”. It is unclear what “the sample” is referring to, especially given that the listed alternatives are a mixture of both types of sample. Clarification is required.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-3, 6-7, 11-12, 14, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dollinger (Dollinger et al., WO 90/14441) in view of Zografos (Zografos et al., US 2015/0322426 A1; cited on IDS of 3/1/2024).
Claim 1: Dollinger teaches a method for tagging and tracing materials using nucleic acids for their identification (Abstract). Dollinger teaches “taggants” which are nucleic acid molecules with specific identifying nucleotide sequences (reads on ID sequence which is unique to the tag) and which is non-functional in a living cell (reads on non-coding and/or cannot be transcribed; pg 3, ln 20-28).
Dollinger teaches that the taggant can be applied to food stuffs (pg 12, ln 13-18) and teaches that there is a societal need for tracking the manufacture and distribution of animals (pg 1, ln 8-19) but does not specifically teach applying the taggants (tag nucleic acid molecules) to a non-human animal wherein the tag is detectable on the animal or in a body tissue of the animal. However, application of tag nucleic acid molecules to non-human animals is known in the art, as taught by Zografos.
Zografos teaches a method which is directed to labeleing food products with at least one DNA bar code (paragraph [0008]). Zografos teaches that this technology can be used to trace food, such as from “raised land animals or sea creatures” from their source (the grower; paragraph [0026]). Zografos teaches that the DNA barcode can be sprayed directly on the object to be tracked, which includes meats, poultry and seafood (reads on a body tissue…from said animal; paragraphs [0024-0026 and 0046]).
It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of Dollinger to include application of the tag nucleic acid molecule technology to non-human animals such as “raised animals or sea creatures” as taught by Zografos. One would be motivated to do so given the assertion by Zografos that this technology applied to non-human animals “offers an opportunity to trace food along multiple steps in the supply chain and ultimately to the consumer by applying the product identification directly on many food products, at a cost significantly lower than any other method” (paragraph [0025]). One would have a reasonable expectation of success given that Dollinger and Zografos are both teaching similar types of labeling technologies (barcoded nucleic acids) to be applied to surfaces of items (or animals) to be traced.
Claim 3: Zografos teaches that the animal is a “raised land animal” which reads on a farmed animal (paragraph [0026]).
Claim 6: Zografos teaches that the animal can receive an identification sequence that is specific to the date of processing (or slaughter; paragraph [0027]). This reads on the same tag nucleic acid molecule is administered to a cohort…of animals, the cohort being the animals that were processed on the same date who would receive the same identification sequence.
Claim 7: Dollinger teaches that the tag nucleic acid molecule is DNA (pg 4, ln 15-16).
Claim 11: Dollinger teaches that synthetic oligonucleotides can be used to reduced degradation by nuclease activity, and one example of this is phosphorothioate deoxyribonucleotides (pg 4, ln 19-21, 29).
Claim 12: Dollinger teaches that when the method of detection is PCR (“the preferred means for amplification”) the tag nucleic acid molecule is long enough to permit “the hybridization of two primers” which reads on the tag nucleic acid molecule comprises primer bindings sites for amplification of the ID sequence (pg 8, ln 4-9).
Claim 14: Dollinger teaches that the tag nucleic acid molecule is detected by a PCR reaction (pg 7, ln 10-22).
Claim 17: Zografos teaches that the DNA tag molecule can be provided within a carrier that is then attached to the item to be tagged (which includes non-human animals; claims 14-15 and paragraph [0042]).
Claim 20: Zografos teaches application of the DNA taggant to meat, while Dollinger teaches application of spray to food stuffs (pg 12, ln 13-18). Dollinger teaches that when food stuff have a spray administered, the food stuff can be washed and the was can be subjected to a standard PCR (pg 12, ln 13-18). This reads on the sample is a sample of…wash taken from a body site of the animal).
Claim 2: Dollinger teaches a method for tagging and tracing materials using nucleic acids for their identification (Abstract). Dollinger teaches “taggants” which are nucleic acid molecules with specific identifying nucleotide sequences (reads on ID sequence which is unique to the tag) and which is non-functional in a living cell (reads on non-coding and/or cannot be transcribed; pg 3, ln 20-28). Dollinger teaches detecting in or on the item the presence and identity of the tag nucleic acid molecule or “taggant” (pg 2, ln 2-5).
Dollinger teaches that the taggant can be applied to food stuffs (pg 12, ln 13-18) and teaches that there is a societal need for tracking the manufacture and distribution of animals (pg 1, ln 8-19) but does not specifically teach applying the taggants (tag nucleic acid molecules) to a non-human animal wherein the tag is detectable on the animal or in a body tissue of the animal. However, application of tag nucleic acid molecules to non-human animals is known in the art, as taught by Zografos.
Zografos teaches a method which is directed to labeling food products with at least one DNA bar code (paragraph [0008]). Zografos teaches that this technology can be used to trace food, such as from “raised land animals or sea creatures” from their source (the grower; paragraph [0026]). Zografos teaches that the DNA barcode can be sprayed directly on the object to be tracked, which includes meats, poultry and seafood (reads on a body tissue…from said animal; paragraphs [0024-0026 and 0046]).
It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of Dollinger to include application of the tag nucleic acid molecule technology to non-human animals such as “raised animals or sea creatures” as taught by Zografos. One would be motivated to do so given the assertion by Zografos that this technology applied to non-human animals “offers an opportunity to trace food along multiple steps in the supply chain and ultimately to the consumer by applying the product identification directly on many food products, at a cost significantly lower than any other method” (paragraph [0025]). One would have a reasonable expectation of success given that Dollinger and Zografos are both teaching similar types of labeling technologies (barcoded nucleic acids) to be applied to surfaces of items (or animals) to be traced.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAILEY E CASH whose telephone number is (571)272-0971. The examiner can normally be reached Monday-Friday 8:30am-6pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571)272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAILEY ELIZABETH CASH/Examiner, Art Unit 1683
/STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683
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