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 .
DETAILED ACTION
1. Claims 12-20 are under consideration.
Priority
2. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Since a certified English translation of has not been provided for Korean application 10-2021-0159907, until foreign priority is perfected, the effective filing date for the purposes of applying prior art is 6/14/2022.
Information Disclosure Statement
3. The information disclosure statement (IDS) was submitted on 5/30/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
4. The drawings were received on 5/17/2024. The drawings are objected to because the labels should read “FIG.” instead of “FIGURE” (See MPEP 1825).
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Specification
5. The disclosure is objected to because of the following informalities:.
The use of trademarked terms, which is a trade name or a mark used in commerce, has been noted in this application on pages 16, 20, 28. 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.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
6. Claims 12-20 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.
See claims 12-20 as submitted 5/17/2024.
As to claims 12, 14, 15, the claim recites “represented by … represented by”. It is not clear what the metes and bounds of the term “represented by”, if that reads on the entire sequence or not.
As to claim 13, it is no clear what ‘a recombined by genes” means.
As to claims 15-20, it is not clear what “improving infectious diseases” means.
As to claim 20, it is not clear what “a porcine” is, or if that is intended to mean a pig or if language is missing.
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.
7. Claims 12-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
See claims 12-14 as submitted 5/17/2024.
See also the 35 U.S.C. 112(b) rejection above.
In view of the 2019 PEG (“The 2019 Revised Patent Subject Matter Eligibility Guidance” (2019 PEG) found at https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf ), based upon an analysis with respect to the claims as a whole, claims 12-14 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
The claims are directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more (these claims are interpreted in light of the most recent Guidelines (See “Subject Matter Eligibility” found at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility ; as well as Subject Matter Eligibility Examples: Life Sciences at https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf )
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. In view of the Subject Matter Eligibility Test for Products and Processes and the Steps cited below (See flowchart at pages 10-11 at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf ), the claims are directed to an ineligible product as further detailed below.
In this case, claims 12-14 recite, read on, or are directed to a composition of matter (Step 1) and recite natural phenomenon(s) (in this case, a PCV2 nucleic acid sequence and protein) that is directed to a judicial exception (in this case, a natural phenomenon)(Step 2A).
Claim 12 recites a nucleic acid encoding a recombinant porcine circovirus type 2 (PCV2) protein represented by a nucleotide sequence represented by SEQ ID NO: 1.
Claim 13 recites the nucleic acid of claim 12, wherein the nucleic acid is a recombined by genes of porcine circovirus types 2b and 2d. Such a recitation is interpreted as a product by process interpreted as reading on a nucleic acid resulting from recombination of genes of PCV 2b and 2d (See MPEP 2113: I. PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted)).
Claim 14 recites a recombinant porcine circovirus type 2 protein encoded by a nucleotide
sequence represented by SEQ ID NO: 1.
Such products are considered to read upon naturally occurring PCV2 nucleic acid and protein (See Ho et al. cited below teaching gene and protein from PCV2 QIA244; wherein QIA244 is a PCV2d isolate (See [0088] of Ho et al.)).
Thus, the claimed product of nucleic acid and protein is not markedly different from its naturally occurring counterpart (See Nature-Based Products, Example 4 (“Purified Proteins”) at https://www.uspto.gov/sites/default/files/documents/mdc_examples_nature-based_products.pdf ; see also Subject Matter Eligibility Examples: Life Sciences, 28. Vaccines, Claim 3). Claims 12-14 read on naturally occurring nucleic acid and protein and does not show a difference in characteristics between the claimed nucleic acid and protein and naturally occurring nucleic acids and proteins. Thus the claims also read upon naturally occurring nucleic acids and proteins, or a composition of matter as recited in Step 1 and a natural phenomenon as recited in Step 2A.
Thus the claimed product of nucleic acids and proteins is not markedly different from its naturally occurring counterpart (see Part I. A.3 of the Interim Eligibility Guidance, Example 2, p. 29). Thus the claims also read upon naturally occurring nucleic acids and proteins, or a composition of matter as recited in Step 1 and a natural phenomenon as recited in Step 2A.
The claims thus recite a nature-based product limitation that does not exhibit markedly different characteristics from its naturally occurring counterpart, or is directed to a “product of nature” exception.
Further as to Step 2A in view of the 2019 PEG, in view of Prong 1 of Revised Step 2A, the claims recite a natural phenomenon.
As to Prong 2 of Step 2A, the instant claims do not recite additional elements that integrate the judicial exception (natural phenomenon according to MPEP 2106.04(b)) into a practical application. “Integration into a practical application” requires an additional element(s) or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception (See for example, Slide 18 of 2019 PEG training at http://ptoweb.uspto.gov/patents/exTrain/101.html )
Further, in view of Step 2B and the “No” pathway, the claims do not recite additional elements that amount to significantly more than the judicial exception.
Therefore, claims 12-14 do not recite eligible subject matter under 35 U.S.C.101 in view of the Subject Matter Eligibility Test for Products and Processes, and the claimed invention is directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
8. Claims 12-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ho et al. (KR102168646)(See PTO-892: Notice of References Cited) (See also the WIPO English translation of KR102168646)(See PTO-892: Notice of References Cited).
See claims 12-20 as submitted 5/17/2024.
See also the 35 U.S.C. 112(b) rejection above.
Ho et al. teaches: nucleotide sequences according to ORF2 of PCV2a, PCV2b, and PCV2d to increase yield of recombinant protein and completed vaccine composition effective against PCV2a, PCV2b, PCV2c, PCV2d [0005 of translation](as recited in claim 16); including SEQ ID NO: 4 (PCV2d ORF2 DNA (QIA244), which has 93.9% identity with instant SEQ ID NO: 1 (See Result 45 of STIC Sequence Search Result 20260616_132618_us-18-711-502-1.rng in Supplemental Content Tab)(which reads on “a” nucleic acid encoding “a” recombinant PCV2 protein “represented by a nucleotide sequence represented by SEQ ID NO: 1”)(as recited in claims 12, 16 and 13 (See MPEP 2113: I. PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted)); as well as protein which has 95.8% identity with protein encoded by SEQ ID NO: 1 (See duplicate of Result 8 of STIC Sequence Search Result 20260616_132709_us-18-711-502-1.rag in Supplemental Content Tab))(which reads on “a” recombinant PCV2 protein “represented by a nucleotide sequence represented by SEQ ID NO: 1”)(as recited in claims 14, 15)); preventing infectious disease of PCV, comprising administering vaccine composition [0052](as recited in claims 15, 19); wherein disease include PRRS [0043](as recited in claim 17); intravenously [0053](as recited in claim 18); to a pig [0054](as recited in claim 20).
Thus, Ho et al. anticipates the instant claims.
Conclusion
9. Full length SEQ ID NO: 1 is free of the prior art of record.
10. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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