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 .
Claims 1-2 are pending.
An action on the merits is set forth below.
Claim Objection
Claim 2 is objected to because of the following informalities: the term “oligos” should be spelled out for clarity. 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.
Claims 1-2 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.
Claim 1-2 are indefinite over Golden Gate cloning. The claims contain the trademark/trade name Golden Gate cloning. 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 cloning and, accordingly, the identification/description is indefinite.
Claims 1-2 are indefinite over “regardless of internal restriction sites” in claim 1. In particular it is not clear if the phrase is intending to limit the cloning to not having internal restriction sites, to work even if there are internal restriction sites, or how the internal restriction sites limit the cloning.
Claims 1-2 are unclear “using modified nucleotides during PCR of a DNA”. It is not clear if the modified nucleotides are used in PCR or if the DNA is intended to be modified nucleotides.
Regarding claims 1-2, the phrase "such that" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 2 is not clear over “or the like as described herein” as this appears to fail to point out what is included or excluded by the claim language. This claim is an omnibus type of claim. Further it is not clear what structures are intending to be encompassed by the terms “compositions” and “components” as these terms do not appear to limit the structure of the kit in such a way one would know which structures would be sufficient for carrying out using modified nucleotides.
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 therefore, subject to the conditions and requirements of this title.
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to compositions, components, enzymes, primers, oligos or the like without significantly more. The claim(s) recite(s) broad claim language that is interpreted as the same structure as a product of nature. This judicial exception is not integrated into a practical application because the claims do not require a particular structure other than structures that can be found in nature.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, the claims read on the nucleotides and components, compositions and enzymes found in nature. The native nucleotide sequence, enzymes, components or compositions are products of nature and is not patentable.
Question 1
The claimed invention is directed to a naturally occurring product.
Question 2A – Prong 1
The claims are directed towards a naturally occurring product of a structure of nucleic acids (primers, oligos), compositions, components, enzymes.
MPEP 2106.04(b)(II) discusses products of nature. The MPEP specifically discusses DNA, primers and probes. The isolated DNA of Myriad and the primers of Ambry Genetics were described as products of nature by the courts. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"). The Federal Circuit in Ambry reviewed “[t]he Supreme Court held ineligible claims directed to segments as short as 15 nucleotides, suggesting that even short strands identical to those found in nature are not patent eligible.”
In the instant case, the claims include naturally occurring genes, compositions and components, and enzymes. The court in Myriad held that “[a] naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated”. The court found that while Myriad had located and sequenced an important gene, Myriad had not created anything, and that “separating that gene from its surrounding genetic material is not an act of invention” (page 2118).
Accordingly, the claims are directed to judicial exceptions.
Question 2A – Prong 2
The judicial exceptions are not integrated into practical application because the claims do not recite additional elements that integrate the judicial exceptions into practical application of the exceptions.
Accordingly, claims are directed towards judicial exceptions.
Question 2B
The claims are directed to judicial exceptions with no additional limitations.
Thus, the claims do not recite additional elements that amount to significantly more than the judicial exceptions.
For those reasons, the claims are rejected under section 101 as being 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.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a) as being anticipated by Kuhn et al. (US Patent Application Publication 20220195417 June 23, 2022).
With regard to Claim 1, Kuhn et al. teaches one pot golden gate cloning (para 363-364). Kuhn et al. teaches using modified nucleotides of DNA from PCR methodology (para 326-334). Kuhn et al. teaches that internal restriction sites can be blocked and flanking unblocked (para 169, 293). As such Kuhn et al teaches the required step of the method.
With regard to claim 2, Kuhn et al. teaches performing a PCR and therefore would encompass oligonucleotides, primers, enzymes, compositions and components (para 326-334).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Cheng (Winston) Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE D SALMON/ Primary Examiner, Art Unit 1682
Prosecution Insights