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 .
The examiner attempted to call attorney Matthias Scholl (of record) on 8/13/25 but the telephone number associated with the customer number was not in service. Updating the contact information will facilitate future communication.
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 1, 2, 3, and 4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) nucleic acid molecules which are fragments of naturally occurring nucleic acid molecules. The claims set forth a primer pair having nucleic acid sequences represented by SEQ ID NO: 3 and SEQ ID NO: 4. These molecules fragments of naturally occurring gene in American shad (Alosa sapidissima) (specification para 33 and following teach identifying the sequences as part of a marker in American caudal fin samples). Thus, the claims set forth product of nature limitations. The claimed primers encompassing nucleic acids may have a different structural characteristic than the naturally occurring genes because the chemical bonds at each end are severed to produce shorter “primer” molecules, but the claims encompass molecules with the same nucleotide sequence as the naturally occurring genes. The claimed nucleic acids have no different functional characteristics from the naturally occurring counterparts. Under the holding of Myriad, isolated but otherwise unchanged nucleic acids are not different enough from what exists in nature. In other words, the claimed probes and primers may be different from, but are not markedly different from the naturally gene they are a fragment of. Claim 2 is a process claim that is drafted in such a way that there is no difference in substance from the product claim as it focuses on the product rather than the process steps (MPEP 21-6.04(c)(I)(C)). Under the broadest reasonable interpretation, the method of claim 2 is focused on the primers themselves, which are nature-based products. Claim 4 requires an additional element which can also be a naturally occurring product (polymerase or nucleic acid fragments of known length). The claims do not require any non-nature-based product limitation. The inclusion of the probes in the kit does not change their characteristics. Thus, the primers are not mixed together, and in the kit the primers do not have markedly different characteristics from their natural counterparts in their natural state and are “product of nature” exceptions. Accordingly, the claims are directed to a judicial exception. This judicial exception is not integrated into a practical application because there are no additional elements in the claims. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements in the claims.
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 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 claims describe the sequences using the phrase “having a sequence represent by” followed by a SEQ ID NO. This language is unclear because it does not have a well-established meaning and it is not defined in the specification. It is unclear if a sequence represented by a SEQ ID NO must comprise or consist of that sequence, and it is unclear if “represented by” allows for changes within the sequence. Amending the claims to recite, for example, the primer pair comprising SEQ ID NO: 3 and SEQ ID NO: 4 would overcome this rejection.
Claim 2 is indefinite because it sets forth that it is a “method for preparing a kit” yet the body of the claim doesn’t make any mention of a kit or preparing a kit. The single process step in the claim, “applying the primer pair” is vague as it is not clear what it means to “apply” a primer pair or how this relates to preparing a kit.
Claim 6 requires a “2xTaq reaction mixture II (2xTaq Plus Master Mix II (Dye Plus)).” It is unclear if the parentheticals are exemplary or further limitation. Furthermore, the metes and bounds of the reaction mixture are unclear because its contents are not disclosed in the specification and there is no well-established meaning of the phrase used in the prior art.
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 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NEB catalog (1996/1997), pp. 111.
The claims are directed to a kit comprising two primers. The claims contain additional language that set for the intended use of the kit. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
The NEB catalog offered for sale a random primer mix of 24mer nucleotide primers. As the calculation below shows, about 9 molecules of every single 24 mer are present in each tube of the 24 nucleotide mixtures.
e. Molecular weight of 24-mer:
24 x 325 daltons/nucleotide = 7,800 daltons = 7,800 g/mol
f. Total number of possible 24-mers:
424 = 2.8 x 1014 molecules
g. How many molecules of 24-mer in a vial sold by NEB:
1 A260 unit = 33 mg = 3.3 x 10-5 g
3.3 x 10-5 g / 7,800 g/mol = 4.2 x 10-9 mol
(4.2 x 10-9 mol) x (6.02 x 1023 molecules/mol) = 2.5 x 1015 molecules
h. How many molecules of each 24-mer in a single vial:
2.5 x1015 molecules / 2.8 x 1014 molecules = 9 molecules/vial
The claims encompass a large genus of possible nucleic acid primers considering that the meaning of “represented by” is unknown. Even if the claims require a primer comprising SEQ ID NO: 2 and a primer comprising SEQ ID NO: 3, these molecules are 24mers and would be present in each vial of 24mer nucleic acids. The NEB catalog kits inherently and necessarily contained 24 nucleotide primers encompassed by the claimed recitation.
Regarding claim 2, the disclosure of the kit in the catalog is evidence that the method of preparing the kit was being practiced, where “applying” is met by packaging the kits.
Thus, the prior art inherently teaches each and every structural limitation of the instant claims.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over NEB catalog (1996/1997), pp. 111.
The teachings of NEB as they relate to claim 3, from which claim 4 depends are given previously in this Office action and are fully incorporated here.
NEB teaches that the primers are used for universal detection and visualization of DNA fragments.
NEB does not teach that the kit includes a DNA extraction reagent. However, the examiner takes Official notice that at the time the invention was made, DNA extraction was a common step prior to detection and visualization of DNA.
Therefore, it would have been obvious to have modified the NEB kit and included a DNA extraction reagent. One would have been motivated to do so in order to provide a kit that has reagents useful for detection and visualization of DNA fragments.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Silva teaches identifying sex-specific DNA fragments for the freshwater fish Brycon amazonicus, which is in a similar field of endavour as the instant claims (Fish Physiol Biochem (2012) 38:1487–1496). However, no reference teaches sex-specific DNA fragments for American shad, and in particular no reference teaches a composition consisting of primer pair consisting of SEQ ID NO: 1 and 2, or methods which employ this primer pair for determining the sex of an American shad.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Juliet Switzer whose telephone number is (571)272-0753. The examiner can normally be reached Monday to Thursday, 8:00 AM-3:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Winston Shen can be reached at (571)-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Juliet Switzer
Primary Examiner
Art Unit 1682
/JULIET C SWITZER/Primary Examiner, Art Unit 1682