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 .
Claim Objections
Claims 1 and 4 are objected to because of the following informalities:
In claim 1, the Sequence Identifier should be formatted as “SEQ ID NO: 1.” Further, “having a 16S rDNA sequence comprising SEQ ID NO: 1” is more effective terminology for indicating that the whole sequence of SEQ ID NO: 1 is required.
Claim 4, lines 4-5, recites “activating the strain H12 frozen and preserved at -80[Symbol font/0xB0]C for two successive generations” is understood as meaning “activating the strain H12 for two successive generations to produce an activated strain H12 wherein the strain H12 has been frozen and preserved at -80[Symbol font/0xB0]C prior to activating” as the only reasonable meaning of the claim and the claim should be amended to reflect the same. The degree of experimental detail in claim 4 may be desired to be reviewed.
Appropriate correction is required.
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.
Claims 2 and 3 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 for the following reasons.
MPEP 2173.05(q) states:
"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, 709, 129 USPQ 227, 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 Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction."
An ”Application” as recited in claims 2 and 3 is considered to be synonymous with a “use” wherein none of a process, machine, manufacture, or composition of matter is claimed. Claim 2 recites the verb “producing” and claim 3 recites the verb “converting.” However, “producing” and “converting” is recited as a desired outcome of the recited “applications” and are not presented in the form of an active step of a method.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite(s) a naturally-occurring microorganism. This judicial exception is not integrated into a practical application because the claim do not recite any features that can be considered to be a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not recite any additional elements.
MPEP 2106(III) directs that claims drawn to 1) a composition of matter (step 1), 2) a law of nature or a natural phenomenon or a product of nature (step 2A) and 3) lacking recitation of additional elements that make the claims directed to significantly more than a judicial exception (step 2B) are ineligible for patenting under 35 U.S.C. 101. See MPEP 2106(III), flow chart. Step 2A into two prongs.
“If the claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim is directed to a ‘product of nature’ exception (Step 2A: YES), and requires further analysis in Step 2B [and prong 1 of Step 2B] to determine whether any additional elements in the claim add significantly more to the exception.” MPEP 2106.04(c). “It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart.” MPEP 2106.04(b)(II). “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception. Examiners should keep in mind that if the nature-based product limitation is naturally occurring, there is no need to perform the markedly different characteristics analysis because the limitation is by definition directed to a naturally occurring product and thus falls under the product of nature exception.” MPEP 2106.04(c)(II).
The specification provides:
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That is, the H12 strain deposited as CGMCC No. 27186 is understood as having been isolated from root tissue of a plant (Panax being the genus of ginseng) as to be a naturally-occurring microorganism and a nature-based product. Since the H12 strain is naturally-occurring, “there is no need to perform the markedly different characteristics analysis because the limitation is by definition directed to a naturally occurring product and thus falls under the product of nature exception” such that step 2A, prong one, is resolved in favor of a judicial exception.
Regarding, step 2A, prong 2, “Prong Two asks does the claim recite additional elements that integrate the judicial exception into a practical application? In Prong Two, examiners evaluate whether the claim as a whole integrates the exception into a practical application of that exception.” MPEP 2106(II)(A)(2). “Examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application, using one or more of the considerations introduced in subsection I supra, and discussed in more detail in MPEP §§ 2106.04(d)(1), 2106.04(d)(2), 2106.05(a) through (c) and 2106.05(e) through (h).” MPEP 2106.04(d). Here, the claim does not recite any additional elements other than the strain H12 such that step 2A, prong 2, indicates that the claim is a judicial exception.
Regarding Step 2B, Step 2B asks: Does the claim recite additional elements that amount to significantly more than the judicial exception”? MPEP 2106.05(II). The claim does not recite any additional elements other than the strain H12 such that step 2B is answered in the negative and claim 1 is directed towards a judicial exception.
Claim Rejections - 35 USC § 112
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 2-4 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.
MPEP 2173.05(b)(IV) provides: When a subjective term is used in the claim, the examiner should determine whether the specification supplies some objective standard for measuring the scope of the term. Some objective standard must be provided in order to allow the public to determine the scope of the claim. A claim term that requires the exercise of subjective judgment without restriction may render the claim indefinite.
Claims 3-4 recite “low-molecular weight pullulan” and claim 3 recites “high-molecular weight pullulan.” The molecular weight that separates low-molecular weight pullulan from high-molecular weight pullulan is not defined in the specification and does not have a well-understood meaning in the art. As such, what constitutes “low-molecular weight pullulan” and “high-molecular weight pullulan.” As such, whether a “low-molecular weight pullulan” is produced as to meet the features of claims 3-5 requires exercise of subject judgment in the absence of any objective standard without restriction such that the claims are indefinite in view of the guidance of MPEP 2173.05(b)(IV). The claims may be amended to recite a “lower” molecular weight pullulan relative to an initial pullulan or similar.
MPEP 2173.05(q) provides: It is appropriate to reject a claim that recites a use but fails to recite steps under 35 U.S.C. 101 and 35 U.S.C. 112(b) if the facts support both rejections.
The rejections of claims 2 and 3 under 35 U.S.C. 101 set forth above are incorporated herein by reference. As discussed above, claims 2 and 3 do not set forth steps of a method and it is unclear how claims 2 and 3 are or are not infringed such that the facts support a further rejection under 112(b).
Further regarding claim 4, the claim in lines 8-9, recites “adding commercial pullulan.” As such, claim 4 is understood as reciting that adding “commercial pullulan” will infringe the claim but adding a non-commercial pullulan, for example pullulan isolated from a microbial source outside of any commercial transaction, will not infringe the claim. That is, “commercial” has to be give some meaning that narrows the scope of the claim term such that the terms “commercial pullulan” has a smaller scope of infringement compared to if the claim recited “pullulan” instead of “commercial pullulan.”
While claim 4 recites a method, “commercial pullulan” is a product that is not required to be made by any specific process including necessarily having to have been obtained through a commercial transaction. As such, it is not clear how a “commercial pullulan” is structurally different from “pullulan” such that an ordinarily skilled artisan is unable to determine how to avoid infringement. By analogy, MPEP 2173.05(b) provides that: “The addition of the word "type" to an otherwise definite expression (e.g., Friedel-Crafts catalyst) extends the scope of the expression so as to render it indefinite.” MPEP 2173.05(b)(III)(E). Here, the use of adjective “commercial” limits or narrows the scope of the otherwise definite claim term “pullulan” in an analogous manner that renders the term “commercial pullulan” as to what pullulan structure will or will not infringe the claim.
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 1-4 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
An “analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.” MPEP 2164.01. “A conclusion of lack of enablement means that . . . the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention [i.e. commensurate scope] without undue experimentation.” In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); MPEP 2164.01.
In In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988), several factors implicated in determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” are identified. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). No single factor is independently determinative of enablement; rather “[i]t is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others.” MPEP 2164.01. Likewise, all factors may not be relevant to the enablement analysis of any individual claim.
“According to In re Bowen, 492 F.2d 859, 862-63, 181 USPQ 48, 51 (CCPA 1974), the minimal requirement is for the examiner to give reasons explaining the uncertainty of the enablement. This standard is applicable even when there is no evidence in the record of operability without undue experimentation beyond the disclosed embodiments.” See also In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995); MPEP 2164.04.
Claims 1-4 recites a strain Bacillus mojavensis H12 specifically deposited as CGMCC No. 27186.
“Biological material need not be deposited unless access to such material is necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112. If a deposit is necessary, it shall be acceptable if made in accordance with these regulations.” 37 CF 1.802(b). Here, it is not possible to practice the invention of claims 1-4 (i.e. claims are not enabled as required by 35 U.S.C. 112(a)) without a repeatable means for obtaining the H12 strain.
More specifically, for Wands factors (A)-(C), a very specific strain is required to practice the invention such that the only way to obtain strain H12 is to have a repeatable means for obtaining the strain H12. Strain H12 appears not be described in the prior art nor available from a commercial or open source.
For Wands factors (D)-(H), even in view of the guidance of the specification, it is not predictable to obtain the identical strain H12 from a randomly selected sample of Panax plants to see if the exact same strain H12 as recited can be re-obtained such that no quantity of experimentation can be considered to be sufficient to re-isolate the strain H12 by repeating the process of isolation described in the specification as excerpted above under the rejection under 35 U.S.C. 101. As such, the Wands factors listed above are not deemed to be satisfied in favor of enablement of the recited strain H12 or any method employing the same. As such, the recited strain H12 should have been deposited as set forth in 37 CFR 1.801-1.809 for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112; however, there is no indication on the present record that such a deposit has been made in full satisfaction of these requirements.
It is noted that applicants have deposited the organism but there is no indication in the specification as to public availability. If the deposit was made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that the strain will be available to the public under the conditions specified in 37 CFR 1.808, would satisfy the deposit requirement made herein.
Further, 37 CFR 1.809(d) provides:
(d) For each deposit made pursuant to these regulations, the specification shall contain:
(1) The accession number for the deposit;
(2) The date of the deposit;
(3) A description of the deposited biological material sufficient to specifically identify it and to permit examination; and
(4) The name and address of the depository.
In particular, the specification should be amended to include the address of the depository if not already present. A receipt of deposit under the Budapest Treaty can be provided as part of any response.
If the deposit has not been made under the Budapest treaty, the criteria set forth in 37 CFR 1.801-1.809 must be complied with including the requirements for an acceptable depository set forth in 37 CFR 1.803.
Statement regarding prior art
An rDNA sequence identical to recited SEQ ID NO: 1 is described for several microorganisms in the prior art including for Bacillus species other that B. mojavensis. For example, GenBank, Accession No. JN029538.1, 2012, www.ncbi.nlm.nih.gov, describes an identical 16S ribosomal RNA from Bacillus subtilis. However, it cannot be asserted based upon the evidence of record that the same B. subtilis strain is the same as the deposited strain H12 nor that any other Bacillus strain prior described in the art is identical to the deposited strain H12.
The best understanding of, for example, claim 4 is tat the strain H12 secretes a pullulanase that then serves to hydrolyze pullulan to a lower molecular weight. The use of a pullulanase produced by B. mojavensis to hydrolyze pullulan is known in the prior art. For example, Jin et al. (U.S. 2019/0270976 A1), abstract, para. [0010] and Table 4, describes a pullulanase from Bacillus mojavensis that may or may not be the same pullulanase enzyme produced by strain H12. Regardless, as discussed, the prior art cannot be considered to teach the same H12 strain recited in the claims.
Since no foreign priority claim is filed in this application, a careful search was performed regarding any foreign applications that may qualify as prior art due to prior publication. CN 117511788 A appearing to be substantially identical to the current application was identified. However, CN’788 has the same nine inventors and is published on 02/06/2024 less than one year prior to the filing date of the current application (01/15/2025) as to fall under the exception of 35 USC 102(b)(1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD M EPSTEIN whose telephone number is (571)272-5141. The examiner can normally be reached Mon-Fri 9:00a-5:30p.
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/TODD M EPSTEIN/Primary Examiner, Art Unit 1652
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