DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant claims herein are examined utilizing the accepted effective filing date of 4/27/2023 for the basis of any prior art rejections as the application claims no priority to an earlier filed application.
Claim Objections
Claim 1 and 6 are objected to because of the following informalities:
Claim 1 recites “bos grunniensLnc4047” which is missing a space between “grunniens” and “Lnc4047”.
Claim 6 recites “whereinan” which is missing a space between “wherein” and “an.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7 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 1 recites the limitation "wherein the nucleotide sequence of the bos grunniens Lnc4047 is shown in SEQ ID No. 1." It is unclear if SEQ ID NO: 1 is required for the claimed invention or if the SEQ ID NO: 1 is merely exemplary. Thus, the claim is indefinite.
Attempts to claim a process without setting forth any steps involved in the process generally raise an issue of indefiniteness under 35 U.S.C. 112(b). For example, a claim which read: “[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon” was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). In this regard, claim 2 recites a “An application of the bos grunniens Lnc4047 according to claim 1 in regulating myoblast proliferation of bos grunniens.” However, said claim fails to set forth any active, positive steps delimiting how the neural precursor cells are actually used. Thus, the claim is indefinite. Please note that claims 3-4 are included in this rejection for being dependent on indefinite claim 2.
Attempts to claim a process without setting forth any steps involved in the process generally raise an issue of indefiniteness under 35 U.S.C. 112(b). For example, a claim which read: “[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon” was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). In this regard, claim 5 recites a “An application of the bos grunniens Lnc4047 according to claim 1 in regulating myoblast differentiation of bos grunniens.” However, said claim fails to set forth any active, positive steps delimiting how the neural precursor cells are actually used. Thus, the claim is indefinite. Please note that claims 6-7 are included in this rejection for being dependent on indefinite claim 5.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 recites “application of the bos grunniens Lnc4047 . . in regulating myoblast differentiation”, while claim 7 recites “wherein a silent bos grunniens Lnc4047 promotes myoblast proliferation.” Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Product of Nature
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (natural product) without significantly more. This judicial exception is not integrated into a practical application and does not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below:
Claim interpretation: Under the broadest reasonable interpretation (BRI), the terms of the claims are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art (see MPEP 2111). The specification indicates on page 6-8 that Lnc4047 was isolated from newborn calf skeletal muscle cells (myoblasts). As such, under BRI, the claims encompass bos grunniens Lnc4047 found in naturally occurring bos grunniens myoblasts.
Step 1 (Statutory Category): This part of the eligibility analysis evaluates whether the claim falls within any statutory category. Here, the claims recite “A bos grunniens Lnc4047, wherein the nucleotide sequence of the bos grunniens Lnc4047 is shown in SEQ ID NO: 1.” This is a composition of matter; therefore, the claims fall within a statutory category. [Step 1: YES]
Step 2A (Judicial Exceptions), Prong 1: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. A claim “recites” a judicial exception when the exception is “set forth” or “described” in the claim (see MPEP 2106.04(II)). Because the claims recite nature-based product limitations, the markedly different characteristics analysis is used to determine if the nature-based product limitations are a product of nature exception (see MPEP 2106.04(c)(I)). This analysis is performed by comparing the nature-based product limitations in the claims to its naturally occurring counterparts to determine if it has markedly different characteristics (see MPEP 2106.04(c)(II).
The appropriate natural counterpart to the claimed bos grunniens Lnc4047 is bos grunniens Lnc4047 as found in its natural state. The second step in the analysis requires identifying appropriate characteristics to compare. When the claimed bos grunniens Lnc4047 is compared to this counterpart, the comparison indicates that there is no differences in structure, function, or other characteristics. Therefore, the claimed bos grunniens Lnc4047 is a product of nature.
Thus, the claims recite a judicial exception, a natural product. [Step 2A, Prong 1: YES]
Therefore, the analysis proceeds to Step 2A Prong 2.
Step 2A (Judicial Exceptions), Prong 2: This part of the eligibility analysis evaluates whether the claims as a whole integrate the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claims beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claims as a whole integrate the exception into a practical application. The bos grunniens Lnc4047 is a product of nature, and there are no additional elements that impose a practical use or application of the claimed natural products. In this regard, the claims fail to recite additional elements that integrate the judicial exception natural products into a practical application. [Step 2A, Prong 2: NO]
Step 2B (Significantly More): This part of the eligibility analysis evaluates whether the claims as a whole amount to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (MPEP 2106.05).
As stated in Step 2A Prong 2, the claim does not recite any additional elements. As such, none of these limitations impose a practical use or application of the claimed natural products as stated in Step 2A2, and thus do not add significantly more to the exception. [Step 2B: NO]
The claims fail to recite additional elements that are sufficient to amount to significantly more than the judicial exception. Therefore, the claims do not qualify as eligible subject matter under 35 USC 101.
Non-Statutory Subject Matter
Claim 2-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because “use” claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 129 USPQ227, 228 (CCPA 1961) (“one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. 101”). In this case, claim 2 recites “An application of the bos grunniens Lnc4047 according to claim 1 in regulating myoblast proliferation of bos grunniens.” Claim 5 recites “An application of the bos grunniens Lnc4047 according to claim 1 in regulating myoblast differentiation of bos grunniens” (i.e., use claims). However, said claims fails to recite at least one of the four categories of patent eligible subject matter.
Examiner’s Note
SEQ ID NO: 1, which is required for the invention of instant claim 1, is free of the prior art.
Conclusion
No claim is allowed.
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/G.R./Examiner, Art Unit 1632
/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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