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 .
Applicant’s arguments and amendments submitted 12/11/2025 have been thoroughly reviewed and considered. Applicant has cancelled claims 2, 4, and 6. Claims 1, 3, 5, 7-14, and 16-21 are pending and are examined on the merits herein.
Response to Applicant’s Amendments
35 USC 112(b) Rejections
Claims 2-5 and 8-12 were rejected due to indefiniteness issues associated with claim 2. Claims 2 and 4 have been canceled, and so these rejections have been rendered moot. Claims 3, 5, and 8-12 have been amended to depend from claim 1, and so these rejections have been withdrawn. However, see also new grounds of rejection below.
35 USC 112(a) Rejections
Claims 2-5 and 8-12 were rejected due to new matter issues associated with claim 2. Claims 2 and 4 have been canceled, and so these rejections have been rendered moot. Claims 3, 5, and 8-12 have been amended to depend from claim 1, and so these rejections have been withdrawn. However, see also new grounds of rejection below.
35 USC 112(d) Rejections
Claims 2-5 and 8-12 were rejected due to claims 2, 8, and 9 not further limiting the claims upon which they depend. Claims 2 and 4 have been canceled, and so these rejections have been rendered moot. Claims 3, 5, and 8-12 have been amended to depend from claim 1, and so these rejections have been withdrawn. However, see also new grounds of rejection below.
35 USC 103 Rejections
Claims 1-3, 8-14, 16-18, and 20-21 were rejected under 35 U.S.C. 103 as being unpatentable over Ankenbauer (US 2008/0248535 A1) in view of Bray et al. (Human Mutation, 2001).
Claims 4-7 and 19 were rejected under 35 U.S.C. 103 as being unpatentable over Ankenbauer (US 2008/0248535 A1), in view of Bray et al. (Human Mutation, 2001), and further in view of Wittwer et al. (WO 2017/079636 A1; cited in a previous Office Action).
Applicant’s arguments and amendments have been thoroughly reviewed and considered. Claims 2, 4, and 6 have been canceled, and so these rejections have been rendered moot. The rejections for claims 1, 3, 5, 7-14, 16-21 have been withdrawn, but see new grounds of rejection below. See also “Response to Applicant’s Arguments” below.
Response to Applicant’s Arguments
Applicant has provided arguments regarding the 35 USC 103 Rejections presented in the Non-Final Rejection mailed 10/8/2025. Specifically, Applicant argues that Ankenbauer in view of Bray does not teach the newly amended portions of claim 1 (which are taken from previous claims 4 and 6, now canceled). The Examiner agrees with this assessment, and stated as such in the Non-Final Rejection (see para. 37 for example). Applicant then states that Wittwer, which was used to reject previous claims 4 and 6, does not teach or suggest the same method as the claimed invention, and so the ordinary artisan would not have been motivated to combine the references in the manner cited by the Examiner to arrive at the claimed invention (Remarks, pages 5-6).
In the statement of rejection for combining these references, it is not asserted by the Examiner that the rapid RT PCR methods of Wittwer be utilized in the methods of Ankenbauer in view of Bray. In fact, in para. 39 of the Non-Final Rejection, it is stated, “Though the methods generally described by Wittwer are not the exact same as those described by Ankenbauer in view of Bray, Wittwer does teach methods for rapid RT-PCR reactions. The methods and conditions described by Wittwer above relate to the amplification portion of the RT-PCR reactions, and so can provide the ordinary artisan with useful information about how to optimize the amplification reactions of Ankenbauer in view of Bray.” MPEP 2141.03 I states, “"A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396… The "hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art." Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988).” Thus, Wittwer performs a RT PCR method related to that of Ankenbauer in view of Bray, and so these references are in the same field of endeavor and would be known the ordinary artisan. Subsequently, the ordinary artisan would be capable, through ordinary capability and creativity, of using the reaction conditions described by Wittwer to aid in optimizing the reaction conditions in Ankenbauer in view of Bray.
The rationale used to combine these references and arrive at previous claims 4 and 6 did not rely on teachings or motivations regarding the RT-PCR methods of Wittwer, and instead focused on obviousness related to similar/overlapping ranges and differences in concentrations. Applicant does not appear to address these rationale in their response, and so these arguments are not considered persuasive.
New grounds of rejection are required below due to Applicant’s claim amendments, and the relevant portions of previous rejections have been reiterated below.
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.
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 8-12 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 8 recites the limitation "the cofactor" in line 1. There is insufficient antecedent basis for this limitation in the claim, as “a cofactor” is not recited earlier in the claim, or in claim 1, from which this claim depends.
Additionally, claim 8 is indefinite because it describes the cofactor as magnesium salt or a manganese salt. However, claim 1 already recites the use of a manganese salt, but does not state that this salt is a cofactor. Thus, it is overall unclear if the cofactor in claim 8 is the same as the manganese salt in claim 1, or if there is both the salt and the cofactor. Additionally, when magnesium salt is used as a cofactor, it is unknown if this is replacing the manganese salt of claim 1 or being used with the manganese salt.
Claims 9-10 are rejected due to their dependence on rejected claim 8.
Claim 9 is also rejected for reasons similar to those for claim 8, because it specifically recites that the cofactor of claim 8 is a manganese salt. It is thus overall unclear if the cofactor in claim 9 is the same as the manganese salt in claim 1.
Claim 10 is also rejected because it recites “the manganese salt,” in line 1, and it is unclear if this is referring to the cofactor of claims 8-9 or the manganese salt of claim 1, particularly when taken in light of the indefiniteness issues described above.
Claim 11 recites the limitation "the cofactor" in line 1. There is insufficient antecedent basis for this limitation in the claim, as “a cofactor” is not recited earlier in the claim, or in claim 1, from which this claim depends. It will be interpreted as though the cofactor is referring to the manganese salt in claim 1.
Claim 12 is also rejected due to its dependence on rejected claim 11.
Claim Rejections - 35 USC § 112(a) – New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In the 35 USC 112(b) Rejections above, it is noted that it is unclear if the cofactor of claim 8 is replacing the manganese salt in or adding to the amplification reagents listed in claim 1. In the case where the cofactor would be adding to the reagents of claim 1, then there would potentially be both a magnesium salt cofactor and manganese salt present. The instant specification and the claims as originally filed do not teach that multiple cofactors may be used in a single embodiment, and so claim 8 is considered to present new matter.
Claims 9-10 are rejected due to their dependence on rejected claim 8.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8-10 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8 is rejected for failing to further limit the claim upon which it depends, claim 1. In the 35 USC 112(b) Rejections above, it is noted that it is unclear if the cofactor of claim 8 is replacing or adding to the manganese salt listed in claim 1. In the case where the cofactor would be replacing the salt of claim 1, claim 8 does not further limit claim 1.
Claims 9-10 are rejected due to their dependence on rejected claim 2.
Claim 9 depends on claim 8 and specifically requires that the cofactor be a manganese salt. As noted above in the 35 USC 112(b) Rejection, the manganese salt of claim 1 can already be considered the cofactor in claims 8-9. Thus, this claim does not further limit the subject matter upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 3, 5, 7-14, and 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Ankenbauer (US 2008/0248535 A1), in view of Bray et al. (Human Mutation, 2001), and in view of Wittwer et al. (WO 2017/079636 A1).
Ankenbauer teaches performing rapid one-step RT-PCR (Abstract). This method involves providing a sample, providing reagents necessary to perform reverse transcription and amplification, performing a reverse transcription incubation for a time interval of 0 seconds to 40 seconds, and performing amplification with denaturing and annealing steps (paras. 32-39, 42, and 45; instant claims 13-14 and 16-17). The enzyme used is a polymerase with DNA-dependent and RNA-dependent activity (para. 46). The reagents used specifically include buffers, primers, and dNTPs (para. 37)
As for specific polymerases for use in the method of Ankenbauer, para. 46 notes that DNA polymerase of Thermus thermophilus is preferred. Para. 7 of Ankenbauer specifically notes that such a polymerase, referred to as Tth polymerase, shows reverse transcriptase activity only in the presence of manganese ions.
Bray teaches that Tth polymerase is “an RNA polymerase that acts as a DNA polymerase in the presence of manganese chloride,” (page 298, column 2, para. 1)
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious for one of ordinary skill in the art to combine the teachings of Ankenbauer and Bray to arrive at the general inventive method of instant claims 1 and 8-10. Ankenbauer teaches that in the one-step RT-PCR, elements can be added that are generally needed for reverse transcription and amplification (paras. 32-37). The reference also teaches that a Tth polymerase would be preferable to use. Bray teaches that such an enzyme acts in a DNA-dependent and RNA-dependent fashion when in the presence of manganese chloride, and so it would be prima facie obvious for the ordinary artisan to add this reagent into the method of Ankenbauer to ensure that the polymerase works as intended. There would be a reasonable expectation of success as Ankenbauer generally teaches the addition of manganese compounds into their RT-PCR -methods (see para. 69).
However, neither of these references discuss the primer concentrations of claim 1 and 5, the polymerase concentrations of claims 1 and 7, or the amplification conditions of claim 19, though Ankenbauer does note that, “an optimization of concentrations used in the context of the present invention can be obtained through routine experiments,” (para. 37).
Wittwer teaches methods, kits, and mixtures for performing rapid RT-PCR (Abstract). This involves rapid reverse transcription, lasting as little as 1 second (Figures 27 and 28, paras. 74 and 75). In this 1 second embodiment, an RSV primer pair and KlenTaq were used along with PCR master solution (para. 210). KlenTaq is a DNA polymerase (para. 132). 2 μM of KlenTaq was used, corresponding to over 0.8 U/μL of polymerase (paras. 210 and 117). Wittwer also teaches PCR methods where the polymerase concentration is 1 μM (i.e. 0.8 U/μL, as taught in para. 117, paras. 135 and 140; instant claim 7). In additional embodiments, Wittwer teaches RT-PCR methods where primer concentration is 6 μM each (para. 196), reverse transcription occurred for 20 seconds, forward and reverse primers were used, and amplification involved denaturation (para. 196, which also references Example 13 which discusses their PCR parameters in para. 186). The reference notes that in extreme PCR, primer concentrations of 1.5-20 μM each are used “to obtain excellent annealing efficiency despite annealing times of 0.05 - 0.3 seconds,” and that these concentrations are needed when polymerase concentrations of “0.4 - 12 U/μl of any standard polymerase (0.5-16 μM of KlenTaq),“ are used (paras. 111 and 117; instant claim 5). Finally, Wittwer also teaches various PCR parameters in Table 2, including one embodiment for the NQO1 gene where denaturation occurs at 90°C and annealing/extension occurs at 72°C. The annealing/extension occurs in 1 second, and with a 1.93 second total cycle time, leaving 0.93 seconds for denaturation (Table 2). This table also shows denaturation temperatures up to 92°C, annealing/extension temperatures of 60°C and 65 °C, as well as annealing/extension times of up to 5 seconds. Wittwer also discloses embodiments involving momentary (i.e. “0” second) denaturation at 95°C (paras. 178 and 8; instant claim 19).
Though the methods generally described by Wittwer are not the exact same as those described by Ankenbauer in view of Bray, Wittwer does teach methods for rapid RT-PCR reactions. The methods and conditions described by Wittwer above relate to the amplification portion of the RT-PCR reactions, and so can provide the ordinary artisan with useful information about how to optimize the amplification reactions of Ankenbauer in view of Bray.
MPEP 2144.05 I states, “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)… Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).” Because Wittwer discloses concentration, temperature, and time ranges that encompass those recited in claims 1, 5, 7, and 19, and also recites a specific embodiment where the recited temperatures and times are close to those in claim 19, it would be obvious to use these claimed concentration, temperature, and time ranges in the method of Ankenbauer in view of Bray. Though some of the embodiments in Table 2 of Wittwer do not encompass RT-PCR, it would still be obvious to use these parameters in a RT-PCR method, as once the target sequence has been reverse transcribed, the protocol for amplifying the resulting cDNA is the same as for other DNA samples, and the resulting product is the same – namely amplified DNA of interest.
Additionally, MPEP 2144.05 II (A) states, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Applicant has not provided evidence that the concentrations, temperatures, and times recited in claims 1, 5, 7, and 19 are critical. Though in Applicant’s working example of their invention (i.e., Example 1), the parameters encompassed by these claims are used, the discussion of this example does not explain that any of these parameters are vital to the success of the method (instant specification pages 11-12). Applicant does state that “Surprisingly, a 0 second RT paired with Fast PCR cycling conditions yielded a product,” (page 12), but only discusses cycling conditions generally, and does not discuss denaturing or annealing steps. Therefore, the concentrations, temperatures, and times recited in claims 1, 5, 7, and 19 are considered routine optimization, and the specific claimed parameters are not viewed as inventive.
Thus, claims 1, 5, 7-10, 13-14, 16-17, and 19 are prima facie obvious over Ankenbauer, in view of Bray, and in view of Wittwer.
Regarding claim 3, Ankenbauer teaches that the primers associated with the PCR portion of their one-step RT-PCR are forward and reverse primers (para. 55), and also shows forward and reverse primers in Example 1 (para. 64).
Regarding claims 11-12, Ankenbauer teaches an example in which manganese acetate is provided at a concentration of 3.25 mM for the PCR reaction (para. 69). As manganese chloride is used in the rejection of claim 1 described above, it would be prima facie obvious to use the same or a similar concentration for this cofactor in the method of Ankenbauer, in view of Bray, and in view of Wittwer. MPEP 2144.05 I states, “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)… Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).” Additionally, MPEP 2144.05 II (A) states, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Applicant has not provided evidence that the concentrations recited in claims 11-12 are critical. Though in Applicant’s working example of their invention (i.e., Example 1), the cofactor concentration taught in claim 12 is used (4 mM McCl2), the discussion of this example does not explain that this concentration is vital to the success of the method (instant specification pages 11-12). Applicant mainly compares the use of manganese versus magnesium (page 12), but does not discuss if concentration is important in said comparison. Therefore, the concentrations recited in claims 11-12 are considered routine optimization, and the specific claimed parameters are not viewed as inventive.
Regarding claim 18, Ankenbauer teaches that the reverse transcription can occur anywhere from 20°C to 65°C (para. 32). MPEP 2144.05 I states, “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)… Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).” Additionally, MPEP 2144.05 II (A) states, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Applicant has not provided evidence that the temperature recited in claim 18 is critical. Though in Applicant’s working example of their invention (i.e., Example 1), the temperature taught in claim 18 is used, the discussion of this example does not explain that these temperatures are vital to the success of the method (instant specification pages 11-12). Applicant does state that “Surprisingly, a 0 second RT paired with Fast PCR cycling conditions yielded a product,” (page 12), but this is focused on the length of reverse transcription, and not the temperature of said reaction. Therefore, the temperature recited in claim 18 is considered routine optimization, and the specific claimed parameters are not viewed as inventive.
Regarding claims 20-21, Ankenbauer teaches the use of “multiple cycles” for the amplification reaction (see paras. 12 and 32) with specific examples having 45 cycles (pars. 72). It is noted that claim 20 requires the thermal cycling to comprise at least 30 amplification cycles and claim 21 requires that it comprise 40 amplification cycles. The use of the word “comprises” indicates that this language is open ended, and so additional components (such as additional cycles) may be included. Thus, these teachings of Ankenbauer read on these claims.
Conclusion
No claims are currently allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/F.F.G./Examiner, Art Unit 1681
/ANGELA M. BERTAGNA/Primary Examiner, Art Unit 1681