DETAILED ACTION
CONTINUED EXAMINATION UNDER 37 CFR 1.114 AFTER FINAL REJECTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission of RCE and amendment filed on November 3, 2025 have been entered. The claims pending in this application are claims 1-18 and 20 wherein claims 1-8 and 14-17 have been withdrawn due to the restriction requirement mailed on August 16, 2024. The objection and rejections not reiterated from the previous office action are hereby withdrawn in view of applicant’s amendment filed on November 3, 2025. Claims 9-13, 18, and 20 will be examined.
Claim Objections
Claim 18 or 20 is objected to because of the following informalities: (1) “primer subset (a)” should be “the primer subset (a)”; and (2) “primer subset (b)” should be “the primer subset (b)”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Scope of Enablement
This rejection is different from the rejection under 35 U.S.C. 112(a) mailed on August 7, 2025.
Claims 9-13, 18, and 20 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 forming a composition comprising a universal loop mediated isothermal amplification (LAMP) template, an incomplete set of LAMP primers used for the universal LAMP template, and a set of primers for generating
a single stranded DNA (ssDNA) oligonucleotide when a target nucleic acid is present in a sample, does not reasonably provide enablement for forming a complete set of LAMP primers configured to interact with the universal LAMP template to promote a LAMP reaction indicative of the target nucleic acid by combining only the incomplete set of LAMP primers and the single stranded DNA (ssDNA) oligonucleotide as recited in claims 9-13, 18, and 20. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404,
“Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
The Nature of The Invention
The claims are drawn to a composition. The invention is a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology.” Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The Breadth of The Claims
Claims 9-13, 18, and 20 encompass a composition comprising: a universal loop-mediated isothermal amplification (LAMP) template; an incomplete set of LAMP primers corresponding to the universal LAMP template; and a set of primers configured to associate with a target nucleic acid, wherein the set of primers is configured to enable a transduction reaction that generates a single stranded DNA (ssDNA) oligonucleotide when the target nucleic acid is present in a sample; wherein the ssDNA oligonucleotide functions as a LAMP primer that combines with the incomplete set of LAMP primers to form a complete set of LAMP primers configured to interact with the universal LAMP template to promote a LAMP reaction indicative of the target nucleic acid.
Working Examples
The specification provides no working example for forming a complete set of LAMP primers configured to interact with the universal LAMP template to promote a LAMP reaction indicative of the target nucleic acid by combining only the incomplete set of LAMP primers and the single stranded DNA (ssDNA) oligonucleotide as recited in claims 9-13, 18, and 20.
The Amount of Direction or Guidance Provided and The State of The Prior Art
The specification provides no working example for forming a complete set of LAMP primers configured to interact with the universal LAMP template to promote a LAMP reaction indicative of the target nucleic acid by combining only the incomplete set of LAMP primers and the single stranded DNA (ssDNA) oligonucleotide as recited in claims 9-13, 18, and 20. Furthermore, there is no experimental condition and/or experimental data in the specification to support the claimed invention. During the process of the prior art search, the examiner has not found any prior art which is related to form a complete set of LAMP primers configured to interact with the universal LAMP template to promote a LAMP reaction indicative of the target nucleic acid by combining only the incomplete set of LAMP primers and the single stranded DNA (ssDNA) oligonucleotide as recited in claims 9-13, 18, and 20.
Level of Skill in The Art, The Unpredictability of The Art, and The Quantity of Experimentation Necessary
While the relative skill in the art is very high (the Ph.D. degree with laboratory experience), there is no predictability whether a complete set of LAMP primers configured to interact with the universal LAMP template to promote a LAMP reaction indicative of the target nucleic acid can be formed by combining only the incomplete set of LAMP primers and the single stranded DNA (ssDNA) oligonucleotide as recited in claims 9-13, 18, and 20.
Since the specification shows that “[D]isclosed are compositions and methods that enable loop-mediated isothermal amplification (LAMP) of one or more nucleic acid targets without the need for conventional LAMP primer design customized to each target. A transduction reaction is performed upstream from the LAMP reaction. The transduction reaction generates a single stranded DNA (ssDNA) oligonucleotide when the target nucleic acid is present in the sample. The ssDNA generated in the transduction reaction functions as a required LAMP primer for a universal LAMP template. The ssDNA thus promotes the LAMP reaction. Analysis of the LAMP products can determine the presence of the one or more nucleic acid targets”, “[I]n FIG. 4, the present invention's universal LAMP reaction is illustrated. The purpose of the universal LAMP reaction is to sense the release of the ssDNA ‘U’ from the transduction reaction to rapidly initialize a pre-designed and highly optimized LAMP reaction, the result of which can, for example, be easily interpreted by simple and rapid visual inspection of a pH-based colorimetric readout”, and “[S]tep (a) illustrates the hybridization reaction between the universal template and the FIP primer via the primer binding site F2c on the universal template; step (b) illustrates the polymerization reaction initialized from the 3′ end of F2 of the nucleic acid complex produced from step (a); step (c) illustrates the hybridization reaction between the ssDNA ‘U’ released from the transduction reaction and the nucleic acid complex produced from step (b) via the primer binding site U on the universal template; step (d) illustrates the strand-displacing polymerization reaction initialized from the 3’ end of Ū of the nucleic acid complex produced from step (c), where the displaced ssDNA forms a nucleic acid complex with a loop structure at its 5’ end; step (e) illustrates the hybridizations of the BIP primer and the B3 primer with the nucleic acid complex produced from step (d) via the primer binding site B2c and B3c on the complex, respectively; step (f) illustrates the strand-displacing polymerization reaction initialized from the 3’ end of B2 of the nucleic acid complex produced from step (e) and the strand-displacing polymerization reaction initialized from the 3’ end of B3 of the nucleic acid complex produced from step (e), where the displaced ssDNA forms a nucleic acid complex with the loop structure at both ends; step (g) illustrates the hybridizations of the FIP primer, the BIP primer, the LoopF primer, and the LoopB primer with the nucleic acid complex produced from step (f) via the primer binding site F2c, B2c, FLP, and BLP on the complex, respectively; step (h) indicates the LAMP’s self-primed auto-cycling amplification facilitated by the strand-displacing polymerization reactions initialized from the 3’ end of FIP, the 3’ end of Loop B, the 3’ end of BIP, and the 3’ end of Loop F of the nucleic acid complex produced from step (g), respectively” (see abstract, paragraphs [0039] and [0040], and Figure 4 of US 2022/0372569 A1, which is US publication of this instant case), the specification clearly indicates that the universal LAMP template comprises, from its 3’ to its 5’, an Ū region, a F2c region, a F1c region, B1 region, B2 region, and B3 region, the single stranded DNA (ssDNA) oligonucleotide generated from a set of primers when a target nucleic acid is present in a sample is complementary to the Ū region, the incomplete set of LAMP primers comprises a FIP primer and a BIP primer wherein the FIP primer, from its 5’ to its 3’, comprises a region F1c and a region F2 that is complementary to the region F2c and BIP primer, wherein the BIP primer, from its 5’ to its 3’, comprises a region B1c that is complementary to the region B1 and a region B2, and a complete set of LAMP primers comprises the single stranded DNA (ssDNA) oligonucleotide generated from a set of primers when a target nucleic acid is present in a sample, the FIP primer, the BIP primer, LoopF primer, and LoopB primer. However, the scope of claim 9 is much broader than the teaching of the specification. Since claim 9 does not provide structures of the universal LAMP template and the set of incomplete set of LAMP primers, does not indicate where the universal LAMP template is complementary to the single stranded DNA (ssDNA) oligonucleotide generated from a set of primers, and does not require that the universal LAMP template comprises, from its 3’ to its 5’, an Ū region, a F2c region, a F1c region, B1 region, B2 region, and B3 region, the single stranded DNA (ssDNA) oligonucleotide generated from a set of primers when a target nucleic acid is present in a sample is complementary to the Ū region, the incomplete set of LAMP primers comprises a FIP primer and a BIP primer wherein the FIP primer, from its 5’ to its 3’, comprises a region F1c and a region F2 that is complementary to the region F2c and BIP primer, wherein the BIP primer, from its 5’ to its 3’, comprises a region B1c that is complementary to the region B1 and a region B2, and a complete set of LAMP primers comprises the single stranded DNA (ssDNA) oligonucleotide generated from a set of primers when a target nucleic acid is present in a sample, the FIP primer, the BIP primer, LoopF primer, and LoopB primer, it is unpredictable how a complete set of LAMP primers configured to interact with the universal LAMP template to promote a LAMP reaction indicative of the target nucleic acid can be formed by combining only the incomplete set of LAMP primers and the single stranded DNA (ssDNA) oligonucleotide as recited in claims 9-13, 18, and 20.
Case law has established that “(t)o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright 990 F.2d 1557, 1561. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) it was determined that “[T]he scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art”. The amount of guidance needed to enable the invention is related to the amount of knowledge in the art as well as the predictability in the art. Furthermore, the Court in Genentech Inc. v Novo Nordisk 42 USPQ2d 1001 held that “[I]t is the specification, not the knowledge of one skilled in the art that must supply the novel aspects of the invention in order to constitute adequate enablement”.
In view of above discussions, the skilled artisan will have no way to predict the experimental results. Accordingly, it is concluded that undue experimentation is required to make the invention as it is claimed. These undue experimentation at least includes to test whether a complete set of LAMP primers configured to interact with the universal LAMP template to promote a LAMP reaction indicative of the target nucleic acid can be formed by combining only the incomplete set of LAMP primers and the single stranded DNA (ssDNA) oligonucleotide as recited in claims 9-13, 18, and 20.
Conclusion
In the instant case, as discussed above, the level of unpredictability in the art is high, the specification provides one with no guidance that leads one to claimed methods. One of skill in the art cannot readily anticipate the effect of a change within the subject matter to which the claimed invention pertains. Thus given the broad claims in an art whose nature is identified as unpredictable, the unpredictability of that art, the large quantity of research required to define these unpredictable variables, the lack of guidance provided in the specification, the absence of any working example related to claimed invention and the no teaching in the prior art balanced only against the high skill level in the art, it is the position of the examiner that it would require undue experimentation for one of skill in the art to perform the method of the claim as broadly written.
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 18 and 20 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 18 is rejected as vague and indefinite. Since claim 9 only requires a set of primers configured to associate with a target nucleic acid and claim 13 requires that set of primers comprises a primer subset (a) and a primer subset (b) while claim 18 requires that primers from primer subset (a) are configured to generate an identical LAMP primer (A) in the presence of their respective nucleic acid targets and primers from primer subset (b) are configured to generate an identical LAMP primer (B) in the presence of their respective nucleic acid targets, it is unclear what is the relationship between a target nucleic acid in claim 9 and their respective nucleic acid targets in claim 18. Please clarify.
Response to Arguments
Applicant’s arguments with respect to claims 9-13, 18, and 20 have been considered but are moot because the new ground of rejection does not rely on any teaching or matter specifically challenged in the argument.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Frank Lu, Ph. D., whose telephone number is (571)272-0746. The examiner can normally be reached Monday to Friday, 9 AM to 5 PM.
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/FRANK W LU/
Primary Examiner, Art Unit 1683
March 7, 2026