DETAILED ACTION
Election/Restrictions
Applicant’s response in the reply filed on December 23, 2025 is acknowledged. In view of the preliminary amendment filed on September 22, 2025 and the applicant’s response the examiner agreed to withdrawn the restriction requirement mailed on October 23, 2025 (for detailed reasons, see attached interview summary date on December 8, 2025). Claims 3 and 4 will be examined.
Priority
Acknowledgment is made of applicant’s claim for foreign priority based on an application, Chinese Patent Application No. 202211491947.8, filed in China on November 26, 2022. It is noted, however, that applicant has not filed a certified copy of this application as required by 37 CFR 1.55.
Claim Objections
Claim 3 is objected to because of the following informalities: (1) “DNA of rice” in line 3 should be “DNA from rice”; and (2) “HZ” in line 7 is an abbreviation. It can be used only after the whole phrase representing this abbreviation appears once.
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
Claims 3 and 4 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 extracting a DNA from rice, obtaining amplification products using primer pairs of molecular markers for PCR amplification of the DNA, and carrying out electrophoresis detection on the amplification products, does not reasonably provide enablement for selecting and breeding rice varieties resistant to whitebacked planthopper using the methods recited in claims 3 and 4. 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 method for a selection and a breeding of rice varieties resistant to whitebacked planthopper. 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 3 and 4 encompass a method for a selection and a breeding of rice varieties resistant to whitebacked planthopper, comprising: extracting a DNA of rice, using primer pairs of molecular markers for PCR amplification of the DNA to obtain amplification products, carrying out electrophoresis detection on the amplification products, and analyzing the resistance of the rice to the whitebacked planthopper by the first band patterns, wherein if a band tends to a parent HZ, it indicates that the resistance of a strain rice to whitebacked planthopper is better, and if the band tends to Nekken 2, it indicates that the resistance is poor; the molecular markers comprise Indel Wbph-1 and Indel Wbph-2; primer pairs for the Indel Wbph-1 are: upstream primer: 5’-AGGAGACCGCCGTTTTTGAT-3’, SEQ ID NO: 1; downstream primer: 5’-AAGC
GTTTCGTTTCGGTTGG-3’, SEQ ID NO: 2; primer pairs for the Indel Wbph-2 are: upstream primer: 5’-CTATGGCTACCGCGACGTAC-3’ SEQ ID NO: 3; downstream primer: 5’-GCTGC
TCACGTCGACGAC-3’, SEQ ID NO: 4.
Working Examples
The specification provides no working example for selecting and breeding rice varieties resistant to whitebacked planthopper using the methods recited in claims 3 and 4.
The Amount of Direction or Guidance Provided and The State of The Prior Art
The specification provides no working example for selecting and breeding rice varieties resistant to whitebacked planthopper using the methods recited in claims 3 and 4. 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 select and breed rice varieties resistant to whitebacked planthopper using the methods recited in claims 3 and 4.
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 rice varieties resistant to whitebacked planthopper can be selected and bred using the methods recited in claims 3 and 4.
It is known that “[S]ix major genes conferring WBPH resistance in rice have been identified, including Wbph1 (Sidhu and Khush 1979), Wbph2 (Angeles et al. 1981, Ravinder et al. 1982), Wbph3 (Hernandez and Khush 1981), wbph4 (Hernandez and Khush 1981), Wbph5 (Wu and Khush 1985), and Wbph6 (Min et al. 1991)” (see page 153, left column from Chen et al., Breeding Science, 60, 153-159, 2010). Although the specification shows that “[M]olecular markers Indel Wbph-1 and Indel Wbph-2 were set at the upstream and downstream of QTL locus qWBPH1.1, and primers were designed”, “the primer pairs for the molecular marker Indel Wbph-1 were: upstream primer: SEQ ID NO: 5’-AGGAGACCGCCGTTTTTGAT-3’; downstream primer: SEQ ID NO: 5’-AAGCGTTTCGTTTCGGTTGG-3’”, “the primer pairs for the molecular marker Indel Wbph-2 were: upstream primer: SEQ ID NO: 5’-CTATGGCTACCG
CGACGTAC-3’; downstream primer: SEQ ID NO: 5’-GCTGCTCACGTCGACGAC-3’”, “[G]enomic DNA was extracted from the leaves of the parents Nekken 2, HZ and their F1 generations and RIL populations, and PCR amplification was performed on their genomic DNA using the above molecular markers”, “PCR reaction system: 1 μL of upstream primer (10 μmol), 1 μL of downstream primer (10 μmol), 2 μL of DNA template (>100 ng/μL), 6 μL of mix enzyme (TsingkeBiotechnologyCo., Ltd., 2×Taq Master Mix), 1 μL of ddH2O”, “reaction procedure: pre-denaturation at 94° C for 3 min; denaturation at 94° C for 30 s, annealing at 57° C for 30 s, extension at 72° C for 30 s, amplification for 38 cycles; and finally final extension at 72° C for 10 min”, “PCR amplification products were detected by 4% agarose gel electrophoresis, and some results are shown in FIG. 4 and FIG. 5”, and “[T]he electrophoretic detection band patterns were analyzed. Among them, if the band tends to the parent HZ, it indicates that the resistance of this strain rice to whitebacked planthopper is better, and if the band tends to Nekken 2, it indicates that the resistance is poor” (see paragraphs [0023], [0024], [0040] to [0046], and Figures 4 and 5 of US 2024/0175097 A1, which is US publication of this instant case), the specification only teaches that amplification products amplified from DNAs isolated from recombinant inbred rice lines using a upstream primer and a downstream primer specific for Wbph-1 gene (SEQ ID Nos: 1 and 2) and an amplification product amplified from DNAs isolated from HuaZhan rice using the upstream primer and the downstream primer specific for Wbph-1 gene (SEQ ID Nos: 1 and 2) have the same or similar size based on the result of a gel electrophoresis and amplification products amplified from DNAs isolated from recombinant inbred rice lines using a upstream primer and a downstream primer specific for Wbph-2 gene (SEQ ID Nos: 3 and 4) and an amplification product amplified from DNAs isolated from HuaZhan rice using the upstream primer and the downstream primer specific for Wbph-2 gene (SEQ ID Nos: 3 and 4) have the same or similar size based on the result of a gel electrophoresis wherein the recombinant inbred rice lines are hybrid rice lines produced from HuaZhan rice and Nekken 2 rice. Since it is known that genes from a hybrid rice may contain one or more single-nucleotide polymorphisms (see page 1747, left column, third paragraph from Gu et al., Nature Genetics, 55, 1745-1756, 2023) and claim 3 does not require to compare the DNA sequences of Wbph-1 gene and Wbph-2 gene of HuaZhan rice and the DNA sequences of Wbph-1 gene and Wbph-2 gene of the recombinant inbred rice lines produced from HuaZhan rice and Nekken 2 rice and test functions of Wbph-1 gene and Wbph-2 gene in the recombinant inbred rice lines produced from HuaZhan rice and Nekken 2 rice, and indicates what is the relationship among rice in line 3, parent HZ, and Nekken 2, even though the amplification products amplified from DNAs isolated from the recombinant inbred rice lines using the upstream primer and the downstream primer specific for Wbph-1 gene (SEQ ID Nos: 1 and 2) and the amplification product amplified from DNAs isolated from the HuaZhan rice using the upstream primer and the downstream primer specific for Wbph-1 gene (SEQ ID Nos: 1 and 2) have the same or similar size based on the results of the gel electrophoresis and the amplification products amplified from DNAs isolated from the recombinant inbred rice lines using the upstream primer and the downstream primer specific for Wbph-2 gene (SEQ ID Nos: 3 and 4) and the amplification product amplified from DNAs isolated from the HuaZhan rice using the upstream primer and the downstream primer specific for Wbph-2 gene (SEQ ID Nos: 3 and 4) have the same or similar size based on the results of the gel electrophoresis wherein the recombinant inbred rice lines are hybrid rice lines produced from the HuaZhan rice and the Nekken 2 rice, if Wbph-1 gene and/or Wbph-2 gene of the recombinant inbred rice lines produced from HuaZhan rice and Nekken 2 rice contain one or more substitution polymorphisms which cause Wbph-1 gene and/or Wbph-2 gene to lose its/their functions, the recombinant inbred rice lines produced from HuaZhan rice and Nekken 2 rice resistant to whitebacked planthopper may become poor. Thus, it is unpredictable how a skilled artisan knows that, if a band on a gel after an electrophoresis tends to a parent HZ, it can indicate that the resistance of a strain rice to whitebacked planthopper is better, and if the band on a gel after an electrophoresis tends to Nekken 2, it can indicate that the resistance is poor such that rice varieties resistant to whitebacked planthopper cannot be selected and bred using the methods recited in claims 3 and 4. Furthermore, since claim 3 does not require to plant the recombinant inbred rice lines produced from HuaZhan rice and Nekken 2 rice in a testing ground for rice production, without planting the recombinant inbred rice lines produced from HuaZhan rice and Nekken 2 rice in a testing ground for rice production, it is unpredictable how a skilled artisan knows that the recombinant inbred rice lines produced from HuaZhan rice and Nekken 2 rice resistant to whitebacked planthopper become better only based on that a band on a gel after an electrophoresis tends to a parent HZ and the recombinant inbred rice lines produced from HuaZhan rice and Nekken 2 rice resistant to whitebacked planthopper become poor only based on that the band on a gel after an electrophoresis tends to Nekken 2 such that rice varieties resistant to whitebacked planthopper cannot be selected and bred using the methods recited in claims 3 and 4. In addition, since claim 4 does not require that a mix of enzyme contains a DNA polymerase, if the mix of enzyme recited in claim 4 does not have a DNA polymerase, it is unpredictable how the PCR amplification can be performed.
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 rice varieties resistant to whitebacked planthopper can be selected and bred using the methods recited in claims 3 and 4.
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 3 and 4 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 3 recites the limitation “the whitebacked planthopper” in the preamble of the claim. There is insufficient antecedent basis for this limitation in the claim because there is no phrase “whitebacked planthopper” before “the whitebacked planthopper”. Please clarify.
Claim 3 is rejected as vague and indefinite in view of the preamble of the claim. Although the claim is directed to a method for a selection and a breeding of rice varieties resistant to whitebacked planthopper, since there is no method step for selecting and breeding rice varieties resistant to whitebacked planthopper in the content of the claim, the goal of the claim (see the preamble) cannot be reached. Please clarify.
Claim 3 is rejected as vague and indefinite because it is unclear what is the relationship among rice in line 3, parent HZ, and Nekken 2. Furthermore, although the molecular markers in the claim comprise Indel Wbph-1 and Indel Wbph-2, since the molecular markers in the claim are not limited to the Indel Wbph-1 and the Indel Wbph-2, it is unclear what is the relationship among primer pairs of molecular markers for PCR amplification of the DNA, primer pairs for the Indel Wbph-1, and the primer pairs for the Indel Wbph-2. Please clarify.
Claim 4 is rejected as vague and indefinite because it is unclear that the upstream primer means the upstream primer for Indel Wbph-1 or the upstream primer for Indel Wbph-2 and the downstream primer means the downstream primer for Indel Wbph-1 or the downstream primer for Indel Wbph-2. Furthermore, since claim 3 does not contain a phrase “a DNA template”, it is unclear which DNA in claim 3 can be considered as a DNA template in claim 4. Please clarify.
Conclusion
No claim is allowed.
Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center. The faxing of such papers must conform with the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993)(See 37 CAR § 1.6(d)). The CM Fax Center number is (571)273-8300.
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 on Monday-Friday from 9 A.M. to 5 P.M.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Dr. Anne Gussow, Ph.D., can be reached on (571)272-6047.
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/FRANK W LU/Primary Examiner, Art Unit 1683 January 26, 2026