DETAILED ACTION
Response to Amendment
Applicant’s response to the office action filed on June 3, 2026 has 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 The claims pending in this application are claims 1-18 and 20 wherein claims 1-8 and 14-17 have been withdrawn due to the restriction requirement mailed on August 16, 2024. The objection and rejection not reiterated from the previous office action are hereby withdrawn in view of applicant’s amendment filed on June 3, 2026. Claims 9-13, 18, and 20 will be examined.
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 modified from the rejection under 35 U.S.C. 112(a) mailed on March 11, 2026.
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 for performing a LAMP 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, and wherein the universal LAMP template comprises primer binding sites for each LAMP primer of the complete set of LAMP primers, including a primer binding site complementary to the ssDNA oligonucleotide.
Working Examples
The specification provides no working example for forming a complete set of LAMP primers for performing LAMP 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 for performing LAMP 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 for performing LAMP 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 for performing LAMP 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.
It is known in the art that 6 primers are required for performing a loop-mediated isothermal amplification (LAMP) and these 6 primers are an internal FIP primer, an internal BIP primer, an external primer F3, an external primer B3, a Loop primer FL, and a Loop primer BL (see page 1 of “Loop-mediated isothermal amplification” from Wikipedia). 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 an internal FIP primer, an internal BIP primer, an external primer B3, a LoopF primer, and a LoopB primer wherein the internal FIP primer, from its 5’ to its 3’, comprises a region F1c and a region F2 that is complementary to the region F2c and wherein the internal BIP primer, from its 5’ to its 3’, comprises a region B1c and a region B2 that is complementary to the region B2C, 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 internal FIP primer, the internal BIP primer, the external primer B3, the LoopF primer, and the 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 does not require that the set of incomplete set of LAMP primers comprises an internal FIP primer, an internal BIP primer, an external primer B3, a LoopF primer, and a LoopB primer, and a single stranded DNA (ssDNA) oligonucleotide generated from a set of primers when a target nucleic acid is present in a sample, 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 and is used as an external primer F3 in a LAMP, 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 the BIP primer, from its 5’ to its 3’, comprises a region B1c and a region B2 that is complementary to the region B2C, it is unpredictable how a complete set of LAMP primers for performing LAMP 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 for performing LAMP 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.
Response to Arguments
In page 7, fourth paragraph bridging to page 10, second paragraph of applicant’s remarks, applicant argues that “[F]irst, the Examiner's own analysis confirms that the specification discloses how to form a complete primer set. Across pp. 6-7 of the Office Action, the Examiner provides a detailed and accurate recitation of the specification's teachings, specifically reciting that the universal LAMP template comprises, from its 3’ to 5’, a Ū region, a F2c region, a F1c region, a B1 region, a B2 region, and a B3 region; that the ssDNA oligonucleotide is complementary to the First, the Examiner's own analysis confirms that the specification discloses how to form a complete primer set. Across pp. 6-7 of the Office Action, the Examiner provides a detailed and accurate recitation of the specification's teachings, specifically reciting that the universal LAMP template comprises, from its 3’ to 5’, a Ū region, a F2c region, a F1c region, a B1 region, a B2 region, and a B3 region; that the ssDNA oligonucleotide is complementary to the U region; that the incomplete set of LAMP primers comprises a FIP primer and a BIP primer each with defined structural compositions; and that a complete set of LAMP primers comprises the ssDNA, FIP, BIP, LoopF, and LoopB primers. This recitation is a precise description of the enabling disclosure in FIG. 3 and the accompanying description of the originally filed specification (e.g., paragraph [0037]). In other words, the Examiner’s own analysis demonstrates that the specification teaches, in explicit structural detail, how to form a complete set of LAMP primers. The Examiner then fails to reconcile this disclosure with the conclusion that the specification does not enable the claimed composition, which Applicant respectfully asserts is an internal inconsistency that is fatal to the rejection. Second, LAMP is a well-established technology and the specification provides extensive, detailed guidance. LAMP technology was well known in the art at the time of filing of the present application. See, e.g., paragraphs [0002]-[0006] of the originally filed specification (citing numerous foundational LAMP references). The specification provides detailed, step-by- step working examples across FIGS. 1-7 and paragraphs [0030]-[0056], including a complete description of the transduction mechanism, the universal LAMP template architecture, the primer design principles, and the reaction steps required to practice the invention. A person of ordinary skill in the art, whom the Examiner characterizes as having ‘the Ph.D. degree with laboratory experience’ (Office Action, p. 5), would readily understand from this guidance how to design and assemble the compositions recited in the claims and use them to detect a target nucleic acid, without undue experimentation” and “[T]hird, Applicant respectfully asserts that the Examiner has not satisfied the requisite analysis under the In re Wands framework. The Federal Circuit set forth eight factors for evaluating whether undue experimentation is required. In re Wands, 858 F.2d 731, 737, 8USPQ2d 1400, 1404 (Fed. Cir. 1988). These factors include the quantity of experimentation necessary, the amount of direction or guidance provided, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claims. Id. The Office Action does not provide a substantive analysis of the quantity of experimentation required or articulate why any such experimentation would rise to the level of being "undue." Instead, the rejection rests primarily on the absence of working examples directed to the specific combination step and an unsupported assertion of unpredictability. The absence of a working example is not, standing alone, sufficient to establish non-enablement. MPEP § 2164.02. Moreover, two of the Wands factors weigh strongly in Applicant's favor: factor 6 (skill level in the art, which the Examiner concedes is very high) and factor 5 (state of the prior art, discussed below). Fourth, the Examiner's inability to identify prior art showing that the claimed configuration could not be made or used does not itself establish non-enablement. Applicant acknowledges that the state of the prior art and predictability of the art are Wands considerations. However, the relevant question is whether the disclosure, in view of the knowledge and skill in the art, teaches the claimed composition without undue experimentation. Here, the specification supplies the structural and reaction-level details for the universal template, target-triggered ssDNA primer, incomplete primer set, and resulting complete primer set. The Office Action therefore has not identified the specific missing technical information or technical reason why a person of ordinary skill in the art could not implement the claimed composition without undue experimentation. Notwithstanding the foregoing, and solely to advance prosecution toward allowance without acquiescence to this rejection or its underlying rationale, Applicant has amended independent claim 9 to add the following clause: ‘…wherein the universal LAMP template comprises primer binding sites for each LAMP primer of the complete set of LAMP primers, including a primer binding site complementary to the ssDNA oligonucleotide.’ This amendment expressly requires that the universal LAMP template be structurally configured to interact with each member of the complete primer set, including the ssDNA oligonucleotide generated by the transduction reaction. This structural requirement directly addresses the Examiner's concern by grounding the claim in the enabling disclosure of the specification, which teaches that the universal LAMP template comprises primer binding sites, including a binding site for the ssDNA, as part of the complete primer set interaction required to promote the LAMP reaction. See, e.g., FIG. 3 and the accompanying description of the universal LAMP reaction components in the originally filed specification (e.g., paragraph [0037]). Critically, this amendment does not narrow claim 9 to the specific Ū/F2c/F1c/B1/B2/B3 architecture described in the specification; it preserves the meaningful breadth of the claim while making explicit the structural relationship between the template and the complete primer set that the specification clearly enables”.
The above arguments have been fully considered but they are not persuasive toward the withdrawal of the rejection.
First, although applicant argues that “[T]he Examiner then fails to reconcile this disclosure with the conclusion that the specification does not enable the claimed composition, which Applicant respectfully asserts is an internal inconsistency that is fatal to the rejection”, “[L]AMP is a well-established technology and the specification provides extensive, detailed guidance. LAMP technology was well known in the art at the time of filing of the present application. See, e.g., paragraphs [0002]-[0006] of the originally filed specification (citing numerous foundational LAMP references). The specification provides detailed, step-by- step working examples across FIGS. 1-7 and paragraphs [0030]-[0056], including a complete description of the transduction mechanism, the universal LAMP template architecture, the primer design principles, and the reaction steps required to practice the invention”, and “[A]pplicant respectfully asserts that the Examiner has not satisfied the requisite analysis under the In re Wands framework” because “[T]he Office Action does not provide a substantive analysis of the quantity of experimentation required or articulate why any such experimentation would rise to the level of being "undue." Instead, the rejection rests primarily on the absence of working examples directed to the specific combination step and an unsupported assertion of unpredictability. The absence of a working example is not, standing alone, sufficient to establish non-enablement”, since claim 9 does not provide structures of the universal LAMP template and does not require that the set of incomplete set of LAMP primers comprises an internal FIP primer, an internal BIP primer, an external primer B3, a LoopF primer, and a LoopB primer, and a single stranded DNA (ssDNA) oligonucleotide generated from a set of primers when a target nucleic acid is present in a sample, 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 and is used as an external primer F3 in a LAMP, 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 the BIP primer, from its 5’ to its 3’, comprises a region B1c and a region B2 that is complementary to the region B2C, it is unpredictable how a complete set of LAMP primers for performing LAMP 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. Furthermore, the rejection is not based on the absence of working example in the specification as argued by applicant.
Second, although applicant argues that “the Examiner's inability to identify prior art showing that the claimed configuration could not be made or used does not itself establish non-enablement”, nowhere in MPEP states that an enablement rejection on a claim must be made based on identifying a prior art showing that the claim cannot be made or used.
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 wherein the LAMP reaction proceeds only when both LAMP primer (A) is generated in the presence of a nucleic acid target associated with the primer subset (a) and LAMP primer (B) is generated in the presence of a nucleic acid target associated with the primer subset (b), it is unclear what is the relationship between a target nucleic acid in claim 9 and a nucleic acid target associated with the primer subset (a) or a nucleic acid target associated with the primer subset (b)
in claim 18. Please clarify.
Response to Arguments
In page 6, fourth paragraph bridging to page 7, third paragraph of applicant’s remarks, applicant argues that “Applicant has amended the final clause of claim 18. Specifically, the phrase ‘both LAMP primer (A) and LAMP primer (B) are generated’ has been replaced with ‘LAMP primer (A) is generated in the presence of a nucleic acid target associated with the primer subset (a) and LAMP primer (B) is generated in the presence associated with a nucleic acid target of the primer subset (b).’ This amendment expressly identifies the relationship between each primer subset and its respective nucleic acid target, thereby addressing the Examiner's concern and further clarifying the scope of the claim. Support for this amendment can be found, for example, in paragraphs [0054] and [0055] of the originally filed specification.
Because the § 112(b) rejection of claim 20 was premised solely on the alleged indefiniteness of claim 18, Applicant respectfully submits that the amendment to claim 18 also resolves the rejection of claim 20”.
The above arguments have been fully considered but they are not persuasive toward the withdrawal of the rejection because claim 18 does not indicate what is the relationship between a target nucleic acid in claim 9 and a nucleic acid target associated with the primer subset (a) or a nucleic acid target associated with the primer subset (b) in claim 18.
Conclusion
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow, Ph.D., can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FRANK W LU/
Primary Examiner, Art Unit 1683
July 23, 2026
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