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 and SEQ ID No. 1 and 2 (iATPSnFR2) in the reply filed on 7/24/2026 is acknowledged.
Claims 1-21 are pending. CLiams 7-9, 14-17 are withdrawn as being drawn to an unelected invention or species.
An action on the merits for claims 1-6, 10-13 and 18-21 is set forth below.
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 1-6, 10-13 and 18-21 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 1-6, 10-13 and 18-21 are indefinite over the phrase “having at least …identity to an amino acid sequences selected from”. The phrase is not completely clear as it is not clear if the claims require the whole sequence of SEQ ID No. 1 or if the claim can be interpreted as requiring a fragment that is 95% identical.
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.
Claims 10-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nucleic acid 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 which are products of nature and is not patentable. It is noted that unlike claim 1, claims 10-13 do not require a fluorophore.
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.
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.
Conclusion
It is noted that the claims appear free of the art.
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.
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/KATHERINE D SALMON/ Primary Examiner, Art Unit 1682
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