DETAILED ACTION
Status of the Claims
Claims 1-2, 5-7, 10, 14, 17, 21, 26, 31, 34-36, 45-46, 56, and 60 are currently pending.
Claims 1-2, 5-7, 10, 14, 17, 21, 26, 31, 34-36, 45-46, and 56 are amended.
Claims 3-4, 8-9, 11-13, 15-16, 18-20, 22-25, 27-30, 32-33, 37-44, 47-50, 51-54, 55, and 57-59 have been canceled by Applicant.
Claim 60 is new.
Claims 1-2, 5-7, 10, 14, 17, 21, 26, 31, 34-36, 45-46, 56, and 60 are the subject of this Office Action.
The following Office Action is in response to Applicant’s communication dated 05/15/2026. Rejection(s) and/or objection(s) not reiterated from previous office actions are hereby withdrawn. The following rejection(s) and/or objection(s) are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Withdrawn Claim Objection(s)/Rejection(s)
The objection to claim 5 because of minor informalities is withdrawn in light of amendments made by Applicant to the claim.
All rejections of claims 51-52 are withdrawn in light of Applicant cancelling these claims.
The rejection of claims 1-2, 5, 10, 17, and 56 under 35 U.S.C. 102(a)(1) as being anticipated by Leal et al. (ACS Synth. Biol., 2015, 4:407−413, of record) is withdrawn in light of amendments made by Applicant to claims 1 and 5 limiting the identities of the RNA comprising unnatural ribonucleotides that are reverse transcribed into DNA comprising the claimed unnatural nucleobases.
The rejection of claims 1, 2, 5, 10, 31, and 56 under 35 U.S.C. 102(a)(1) as being anticipated by Eggert et al., claims 1, 2, 5, 10, 17, 31, and 56 under 35 U.S.C. 103 as being unpatentable over Eggert et al., and claims 1, 2, 5, 10, 17, 31, 34-36, 45-46, 51-52, 54, and 56 under 35 U.S.C. 103 as being unpatentable over Spetzler et al. in view of Eggert et al. are withdrawn in light of amendments made by Applicant to the claims requiring measuring the incorporation of the claimed unnatural nucleotides into DNA during reverse transcription, which is not fairly taught or suggest by Eggert et al. or Spetzler et al.
Modified/New Claim Rejections - 35 USC § 112(a) – Written Description
Necessitated by Amendments
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-2, 5-7, 10, 14, 17, 21, 26, 31, 34-36, 45-46, 56, and 60 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 claims contain 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As per MPEP 2163.03(V), while there is a presumption that an adequate written description of the claimed invention is present in the specification as filed, In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976), a question as to whether a specification provides an adequate written description may arise in the context of an original claim. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
As per MPEP 2163.02, the courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it").
Finally, MPEP 2163.04 describes the burden on the examiner with regard to the Written Description requirement, stating that in rejecting a claim, the examiner must set forth express findings of fact which support the lack of written description conclusion. These findings should:
(A) Identify the claim limitation(s) at issue; and
(B) Establish a prima facie case by providing reasons why a person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed.
In the present case, the disclosure as originally filed lacks sufficient written description support required to show that Applicant was in possession of the full breadth of claimed unnatural nucleotides and reverse transcriptase enzymes.
All claims recite reverse transcription of an RNA moiety with at least one unnatural nucleotide to produce a cDNA moiety with complimentary unnatural nucleotide(s). The specification at multiple locations recites that unnatural nucleotides contain some type of difference in the nucleobase, sugar, and/or phosphate moieties as compared to naturally occurring nucleotides (e.g., as per para [0088], [0104], [0113]-[0114], etc.). However, the disclosure as originally filed only shows an actual reduction to practice for the reverse transcription of RNA moieties with natural nucleotides plus NaM and TPT3 nucleotides to produce cDNA moieties with natural nucleotides plus dNaM, dTPT3, dMMO2bio, and d5SICS nucleotides, with only naturally occurring (deoxy)ribose sugars and phosphodiester backbones present. Such reduction to practice is clearly shown in the Examples and Figures of the disclosure. Similarly, the claims recite more reverse transcriptases than the three that were reduced to practice in the application, which were SuperScript® III, SuperScript® IV, and AMV reverse transcriptase.
However, as per MPEP 2163, a showing of an actual reduction to practice is not the only way to show possession. Possession may also be shown by disclosing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See MPEP 2163.02. An adequate written description could include any sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention, or by showing that the inventor constructed an embodiment or performed a process that met all the limitations of the claim and determined that the invention would work for its intended purpose. For some arts, there is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement and information which is well known in the art need not be described in detail in the specification. See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986) as cited in MPEP 2163.
In the present case, the disclosure acknowledges the lack of knowledge in the art at the time, for example, stating in para [0004] that “while it is clear that different DNA polymerases, T7 RNA polymerase, and E. coli ribosomes are able to productively recognize the [unnatural base pair], the ability of reverse transcriptases, which mediate the only other common DNA/RNA transaction, has not been thoroughly explored, and the only available data suggests that they might not productively recognize the [unnatural base pair]”. This section then recites Eggert et al. (ChemBioChem, 2019, 20:1642-1645, cited in IDS of 08/22/2023), which states “the application of [unnatural base pairs] in reverse transcription (rtc), which is a key step for RNA-based SELEX, has not been reported so far.” Note that Eggert only discloses testing commercial reverse transcriptases with the TPT3 and NaM nucleotides.
Therefore, it is reasonable that the specificity of disclosure necessary to satisfy the written description requirement here is much higher than would be needed for other arts for which there is more known and/or are more mature fields of endeavor. In the present case, there is little or nothing present in the disclosure beyond the reduction to practice of reverse transcription with TPT3 and NaM using SuperScript® III, SuperScript® IV, and AMV reverse transcriptase. In conclusion, the application lacks sufficient written description support for the full breadth of the claimed invention and therefore the claims are properly rejected.
Furthermore, it is noted that all of claims 1-2, 5-7, 10, 17, 21, 26, 31, 34-36, 45-46, 56, and 60 recite the limitation of measuring the incorporation of an unnatural nucleotide into the DNA during reverse transcription, however, the only method disclosed in the specification utilizes a biotin gel shift assay (e.g., as per para 00137-00141 and the Examples as per para 00172). The generic recitation of “measuring” in the claims reasonably includes any method of measuring incorporation, such as by mass spectrometry, NMR spectroscopy, immunoassays with appropriate antibodies, biotin gel shift assays, etc. MPEP § 2163 discusses that Applicant may show a “representative number of species” in the disclosure as originally filed to prove possession of the full scope of a claimed genus. A "representative number of species" means that the species which are adequately described are representative of the entire genus. MPEP § 2163 further instructs:
The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 "merely by clearly describing one embodiment of the thing claimed." LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand inventor to have invented, and been in possession of, the invention as broadly claimed. In LizardTech, claims to a generic method of making a seamless discrete wavelet transformation (DWT) were held invalid under 35 U.S.C. 112, first paragraph, because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method. Id.; see also Tronzo v. Biomet, 156 F.3d at 1159, 47 USPQ2d at 1833 (Fed. Cir. 1998) (holding that the disclosure of a species in a parent application did not provide adequate written description support for claims to a genus in a child application where the specification taught against other species).
In the present case, the specification discloses but a single method of measuring unnatural nucleotide incorporation, as discussed above, such that a person skilled in the art would not understand that Applicant was in possession the invention as broadly claimed. Note that only claim 14 is limited to performing a biotin shift assay as a means of measuring unnatural nucleotide incorporation during reverse transcription, which appears to be fully supported in the specification.
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Response to Arguments
The 05/15/2026 remarks argue: claims have sufficient written description support.
Applicant's arguments have been fully considered but they are not persuasive for at least the following reasons.
Specifically, the remarks at pages 15-16 assert that amendments to independent claims 1, 5, and 34 render the Examiner’s allegations moot. This is not persuasive at least because the scope of the claims is still more broad than what is supported by the disclosure as originally filed.
In particular, the rejection above describes what scope find proper written description support in the specification. In contrast, the claims are broader, for example by including nucleotides beyond NaM/dNaM and TPT3/dT3TP (and dMMO2bio & d5SICS). For example, newly amended claim 1 recites nucleotides with nucleobases of the formula:
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wherein X is carbon, R2 is hydrogen, C1-C6 alkyl or halogen, Y is sulfur or oxygen, and E is sulfur or oxygen. While this encompasses TPT3/dTPT3, it also includes other nucleotides for which the specification does not reasonably provide sufficient support.
Further, at least some claims recite a MMLV reverse transcriptase, which reasonably includes wild-type MMLV reverse transcriptase, whereas the specification only reduces to practice the use of SuperScript® III, SuperScript® IV, and AMV reverse transcriptase (e.g., in the Examples).
Note that while claim 31 recites limits the claims to ribonucleotides NaM and TPT3, it is rejected herein as encompassing unsupported reverse transcriptases.
For at least these reasons, the rejection is proper.
Modified Claim Rejections - 35 USC § 112(a) – Enablement
Necessitated by Amendments
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 1-2, 5-7, 10, 14, 17, 21, 26, 31, 34-36, 45-46, 56, and 60 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for reverse transcription reactions with TPT3 and NaM using SuperScript® III, SuperScript® IV, and AMV reverse transcriptase, does not reasonably provide enablement for the full breadth of any unnatural nucleotides and any reverse transcriptase (or even for all the claimed reverse transcriptases and unnatural nucleotides comprising the nucleobases depicted in the claims). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Minerals Separation Ltd. v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term "undue experimentation," it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988). See also United States v. Telectronics, Inc., 857 F.2d 778, 785, 8 USPQ2d 1217, 1223 (Fed. Cir. 1988) ("The test of enablement is whether one reasonably skilled in the art could make or use the invention from the disclosures in the patent coupled with information known in the art without undue experimentation.").
Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) and MPEP 2164.01(A)) as follows: 1) quantity of experimentation necessary, 2) the amount of direction or guidance presented, 3) the presence and absence of working examples, 4) the nature of the invention, 5) the state of prior art, 6) the relative skill of those in the art, 7) the predictability or unpredictability of the art, and 8) the breath of the claims. While all the above factors have been fully considered and have led the Examiner to conclude that the specification fails to teach how to make and/or use the claimed invention without undue experimentation, only the most relevant factors are addressed in detail below.
As per MPEP 2164.08, the Federal Circuit has repeatedly held that "the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’", citing In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). Further, the propriety of a rejection based upon the scope of a claim relative to the scope of the enablement concerns (1) how broad the claim is with respect to the disclosure and (2) whether one skilled in the art could make and use the entire scope of the claimed invention without undue experimentation.
The breath of the claims. All pending claims recite reverse transcription of an RNA moiety with at least one “unnatural nucleotide” to produce a cDNA moiety with complimentary unnatural nucleotide(s). The specification at multiple locations defines unnatural nucleotides as containing some type of difference in the nucleobase, sugar, and/or phosphate moieties as compared to naturally occurring nucleotides (e.g., as per para [0088], [0104], [0113]-[0114], etc.). Therefore, the all claims encompass embodiments wherein the (deoxy)ribose and phosphate moieties are naturally occurring, as well as embodiments wherein they are not naturally occurring. Examples (from the specification) would include methylphosphonate, phosphorothioate, phosphoroamidate and phosphorodithioate internucleotide linkages, as per para [0125], as well as unnatural sugars, such as pentose, deoxypentose, hexose, deoxyhexose, glucose, arabinose, xylose, lyxose, or a sugar "analog" cyclopentyl group, etc., as per para [00118]. Note that even claims 51-52, and 54, which recite the allowed nucleobases, can reasonably encompass unnatural backbone and/or sugar components. Similarly, several claims encompass any reverse transcriptase. Note that while most claims limit them to Avian Myeloblastosis Virus (AMV) reverse transcriptase, Moloney Murine Leukemia Virus (MMLV) reverse transcriptase, SuperScript® III (SS III) reverse transcriptase, and/or SuperScript® IV (SS IV) reverse transcriptase; the specific reverse transcriptase is presented in the alternative (e.g., the reverse transcriptase is either one of the listed, or the reverse transcription reaction takes place in vitro).
The amount of direction or guidance presented and the existence of working examples. The disclosure as originally filed only shows an actual reduction to practice for the reverse transcription of RNA moieties with natural nucleotides plus NaM and TPT3 nucleotides to produce cDNA moieties with natural nucleotides plus dNaM and dTPT3 nucleotides, with only naturally occurring (deoxy)ribose sugars and phosphodiester backbones present, and only with SuperScript® III, SuperScript® IV, and AMV reverse transcriptases.
The state of prior art, the relative skill of those in the art, and the predictability or unpredictability of the art. As of the effective filing date, the specification states that nucleosides of dNaM, dTPT3, NAM, TPT3, d5SICS and dMMO2bio could be synthesized and triphosphorylated commercially, as per para [0167], although it is noted that only dNaM, dTPT3, NAM, and TPT3 were revealed by the disclosure to be used in RT reactions. Eggert et al. (ChemBioChem, 2019, 20:1642-1645, cited in IDS of 08/22/2023), similarly only discloses testing commercially available reverse transcriptases (e.g., AMV, MMLV, SS II, SS IV, and V2G) with the TPT3 and NaM (deoxy)ribonucleotides. Certainly, several other commercially available RTs were known at the time, as well as perhaps a number of cloned RTs that were within reach for the skilled artisan. Additionally, many, many unnatural nucleotides were available for order and/or synthesis, although reasonably only a subset of them could readily be made as triphosphates or phosphoramidites as needed to be incorporated into oligonucleotides as needed to be substrates for RTs.
The level of skill would be high, most likely at the Ph.D. level or equivalent number of years of experience. Persons of ordinary skill in the art are likely able to set up reverse transcription (RT) assays at least with commercially available RTs and commercially available oligos and nucleotides. However, such persons of ordinary skill in this art, given its unpredictability, would have to engage in undue (non-routine) trial and error experimentation to carry out the invention as claimed.
Perhaps the biggest source of unpredictability relevant for the scope of the claims arises from the difficulty or inability to predict which unnatural nucleotides could be used in reverse transcription reactions to successfully make complementary DNAs. As noted herein, by Applicant’s own admission, as stated in para [0004] of the specification as filed, “while it is clear that different DNA polymerases, T7 RNA polymerase, and E. coli ribosomes are able to productively recognize the [unnatural base pair], the ability of reverse transcriptases, which mediate the only other common DNA/RNA transaction, has not been thoroughly explored, and the only available data suggests that they might not productively recognize the [unnatural base pair]”. This section then recites Eggert et al. (ChemBioChem, 2019, 20:1642-1645, cited in IDS of 08/22/2023), which states “the application of [unnatural base pairs] in reverse transcription (rtc), which is a key step for RNA-based SELEX, has not been reported so far.” Note that Eggert only discloses testing commercial reverse transcriptases with the TPT3 and NaM nucleotides.
Therefore, it can be concluded that the level of unpredictability in the art for RT reactions using unnatural nucleotides would be extremely high.
The quantity of experimentation required to practice the claimed invention based on the teachings of the specification.
Based on the sheer breadth of the claims, especially regarding the RTs and unnatural nucleotides, it is deemed that vast research of an unpredictable nature would be necessary to make or use the invention as claimed. Thus, due to the inadequacies of the instant disclosure, undue experimentation would be required of one of skill in the art to practice the full scope of the claimed invention.
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Response to Arguments
The 05/15/2026 remarks argue: the claims are enabled.
Applicant's arguments have been fully considered but they are not persuasive for at least the following reasons.
Specifically, the remarks at pages 16-17 assert that amendments to independent claims 1, 5, and 34 render the Examiner’s allegations moot. This is not persuasive at least because the scope of the claims is still more broad than what is enabled by the disclosure as originally filed.
In particular, the rejection above describes what scope finds proper enablement support in the specification. In contrast, the claims are broader, for example by including nucleotides beyond NaM/dNaM and TPT3/dT3TP (and dMMO2bio & d5SICS). For example, newly amended claim 1 recites nucleotides with nucleobases of the formula:
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wherein X is carbon, R2 is hydrogen, C1-C6 alkyl or halogen, Y is sulfur or oxygen, and E is sulfur or oxygen. While this encompasses TPT3/dTPT3, it also includes other nucleotides for which the specification does not reasonably enable.
Further, at least some claims recite a MMLV reverse transcriptase, which reasonably includes wild-type MMLV reverse transcriptase, whereas the specification only reduces to practice the use of SuperScript® III, SuperScript® IV, and AMV reverse transcriptase (e.g., in the Examples).
Note that while claim 31 recites limits the claims to ribonucleotides NaM and TPT3, it is rejected herein as encompassing non-enabled reverse transcriptases.
For at least these reasons, the rejection is proper.
Maintained 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.
Claim 56 is 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 pre-AIA the applicant regards as the invention.
Claim 56 contains the trademark/trade names SuperScript®. 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 names are used to identify/describe commercially available reverse transcriptase enzymes and, accordingly, the identification/description is indefinite.
Given that a trademark or trade name is used to identify a source of goods, and not the goods themselves, it is suggested that Applicant amend the claims to properly define the reverse transcriptase enzymes (e.g. using generic descriptions).
As per MPEP 2173: It is of utmost importance that patents issue with definite claims that clearly and precisely inform persons skilled in the art of the boundaries of protected subject matter. Therefore, claims that do not meet this standard must be rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph as indefinite. Further, as per MPEP 2173.02: If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. As currently written, the metes and bounds of the rejected claims are unascertainable for the reasons set forth above, thus the above claim(s) and all dependent claims are rejected under 35 USC 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
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Response to Arguments
The 05/15/2026 remarks argue: claim is not indefinite.
Applicant's arguments have been fully considered but they are not persuasive for at least the following reasons.
Specifically, the remarks at page 18 argue that “[o]ne of ordinary skill in the art would understand the meaning of ‘SuperScript® III (SS III) reverse transcriptase’ and ‘SuperScript® IV (SS IV) reverse transcriptase’ as they are well known in the art and described in the specification.”
This is not persuasive, at least because whether or not such enzymes were well known in the art and/or have a ThermoFisher Scientific catalog number is irrelevant to the determination of compliance with 35 U.S.C. 112(b) here. As clearly stated in MPEP § 2173.05(u), “[i]f the 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 the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph”, citing Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982).
Accordingly, the rejection is proper.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEREMY FLINDERS whose telephone number is (571)270-1022. The examiner can normally be reached M-F 10-6:00 EST.
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/JEREMY C FLINDERS/Primary Examiner, Art Unit 1684
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