DETAILED ACTION
Status of Application
The response filed 12 February 2026 are acknowledged and have been considered in their entireties. Claims 1-4, 6-8 and 11-20 remain pending and subject to examination on the merits.
The instant Office action is a Non-final Office action due to the introduction of additional rejections below.
Terminal Disclaimer
As a reiteration, the terminal disclaimer filed on 26 June 2024 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patents 10633697 and 11519025 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawal of Previous Rejection
The rejection of claim(s) 1-4, 6-8 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gelfand et al. (US 5561058 – cited previously) is withdrawn upon further consideration. However, said reference is utilized in a new rejection below.
New Rejection
Claim Rejections - 35 USC § 112(b)
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.
Claims 12-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The claims recite various concentrations of magnesium divalent cation or EGTA. However, it is unclear if the concentrations are to mean the concentrations of these two items that are actually in the kit, or if the concentrations are intended to be the concentrations of these components in the process utilizing an amplification reaction mixture at a later point in time. That is, the amplification reaction mixture is not a component of the kit.
Claim Interpretation
The claims are drawn to “A kit, comprising: (i) a DNA polymerase suitable for nucleic acid amplification, (ii) a buffer suitable for the nucleic acid amplification, comprising: (a) Tris, (b) magnesium divalent cation, and (c) EGTA, wherein when in an amplification reaction mixture, the magnesium divalent cation is at a concentration between 0.01 and 20 mM, and EGTA is at a concentration between 1.5 and 8 mM, and (iii) a reverse transcriptase, wherein the nucleic acid amplification is not an isothermal nucleic acid amplification.”
The wherein clause merely informs the intended use of the kit (e.g. nucleic acid amplification) and that at some point later in time what the concentrations of magnesium divalent cations and EGTA are supposed to be. The claims, however, do not stipulate what the actual concentrations of magnesium divalent cations and EGTA are in the kit and thus, it can be ascertained they are in a concentration that eventually these concentrations can eventually be achieved at a point later in time.
Modified-New Rejection(s)
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6-8 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gelfand et al. (US 5561058 – cited previously).
Gelfand et al. teach:
Regarding claims 1-4, 6-8 a “kit” for Reverse Transcription/PCR comprising a Thermus thermophilus DNA polymerase suitable of nucleic acid amplification (See Example 1(V)(C, D, E)), Moloney murine leukemia MMLV/MoMuLV reverse transcriptase (See Example 1(V)(A), 10x PCR Buffer comprising 100 mM Tris (pH8.3)), 18.75 mM MgCl2 and 7.5 mM EGTA (See Example 1(IV)(G)).
Regarding the concentrations of for EGTA and magnesium divalent cations as in claims 1 and 12-20, as noted, above in the claim interpretation section, given there is no required concentration for EGTA and magnesium divalent cations when actually in the kit itself, it is interpreted any concentration which is capable of achieving the future concentrations of magnesium divalent cation at a concentration between 0.01 and 20 mM, and EGTA is at a concentration between 1.5 and 8 mM meets the limitations of the claims.
In addition, it is further noted, the claiming of a new or different use, new or different function or unknown property which is inherently present in the prior art does not impart novelty to the claimed product – In re Best 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). M.P.E.P. § 2112(I). As such, the intended uses of the components of the kits can be different as long as the components of the kit itself are the same.
Regarding claim 11, dNTP’s at 2mM are utilized as stock components – See Example I, part III (col. 31).
In addition, in Example IX, kits are taught comprising:
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There is nothing in the claims which require the DNA polymerase and reverse transcriptase to be different enzymes in the kit. Here, rTth DNA polymerase has both DNA polymerase activity and reverse transcriptase activity – See Col. 17, lines 46-56.
Applicant’s Remarks and Examiner’s Rebuttal:
Applicant’s traverse the previous rejection of claims 1-4, 6-8 and 11 under 35 U.S.C. 103 as being obvious over Gelfand et al. (US 5561058 – cited previously). Applicant’s remarks have been considered in their entireties.
The previous rejection under 35 U.S.C. 103 has been withdrawn. The same reference is not utilized as a 35 U.S.C. 102 anticipatory reference.
Applicant’s argue the concentrations of EGTA and magnesium, not when it is in a kit, but at a later point in time when the components are utilized in a PCR method. As noted in the rejection above, there are two items relevant to this. First, there is no claimed concentration for the magnesium divalent cations and EGTA which is found in the kit per se, only concentrations that for these two items, determined at a later point in time when the magnesium divalent cations and EGTA are placed in an amplification reaction mixture. Thus, the concentration of the magnesium divalent cations and EGTA in the kit must only then be capable of achieving these concentrations at a later point in time. The teachings of Gefland et al. do teach such concentrations, for example, 25 mM MgCl2 or 7.5 mM EGTA, where these concentrations can be adjusted (or not) at a later point in time to achieve the ranges of 0.01 to 20mM magnesium divalent cations and 1.5 to 8 mM EGTA. Second, the kits of Gefland et al. in meeting the claimed limitations, except at times for the intended use of the kit, still gives rise to an anticipatory reference given the new use for an old prior art product does not make the old product patentably new upon discovery of a new use for it – See In re Best 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977) and M.P.E.P. § 2112(I).
Conclusion
This action is Non-final. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached on M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 21 May 2026
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