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 .
DETAILED ACTION
Status of the Claims
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement filed on May 24th 2024 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
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 5 and 7 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because they are directed to “application of the guaianolide oligomers…” and “application of the pharmaceutical composition…” The claims are not directed towards a “process, machine, manufacture, or composition,” but merely the “application of” a composition (i.e. the use of a composition). The “application of” a composition implies a process, but no methodological steps are recited. See MPEP § 2173.05(q):
“Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. 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).”
“"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." In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101: "The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid."
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, 3-5, and 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 is indefinite for the phrase “new guaianolide oligomers 1-4 as represented by Formula I,” because it is unclear whether the claim requires all four of the recited oligomers, any one of them, or some combination thereof.
Formula I is presented as encompassing four discrete compounds:
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It is unclear to one of ordinary skill in the art whether:
The claim is directed to each of the four compounds.
The claim requires all four compounds together.
The claim is directed towards a mixture containing some/all of the compounds.
When a claim refers to multiple specific compounds under a single formula designation without clarifying language (e.g. “a compound selected from the group consisting of…”; “any one of compounds 1-4…” etc.), the scope of the claim is ambiguous. See MPEP § 2173.05(h).
Claim 3 recites:
“A method for preparing the guaianolide oligomers according to claim 1, which comprises a preparation of guaianolide diene via epoxy isomerization from arglabin-DMA, and a Diels-Alder reaction between the guaianolide diene and dienophiles/ deprotection of NMe2 to obtain the guaianolide oligomers, wherein dienophiles include guaianolides such as ludartin, micheliolide, guaianolide dimers and trimers containing α, β-unsaturated y-lactone fragments…”
The phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase (ludartin, micheliolide, guaianolide dimers and trimers containing α, β-unsaturated y-lactone fragments) are part of the claimed invention. See MPEP § 2173.05(d).
One of ordinary skill in the art could not reasonably determine the metes and bounds of the claimed “dienophiles.” It is unclear whether the term is limited to the specifically recited compounds/structures or whether it encompasses other guaianolides (or non-guaianolide compounds). See MPEP § 2173.05(b)(II):
“A claim may be rendered indefinite when a limitation of the claim is defined by reference to an object and the relationship between the limitation and the object is not sufficiently defined. That is, where the elements of a claim have two or more plausible constructions such that the examiner cannot readily ascertain positional relationship of the elements, the claim may be rendered indefinite. See, e.g., Ex parte Miyazaki, 89 USPQ2d 1207 (Bd. Pat. App. & Inter. 2008) (precedential) and Ex parte Brummer, 12 USPQ2d 1653 (Bd. Pat. App. & Inter. 1989).”
Claim 4 is indefinite for the phrase “wherein the method mainly includes the following two key reaction steps,” because one of ordinary skill in the art could not reasonably determine from the term, “mainly includes,” whether or not the method of claim 4 is open or closed in scope. The term, “mainly includes,” is not a standard transitional phrase. The standard transitional phrases recognized in patent practice are “comprising,” (open scope), “consisting of,” (closed scope), and “consisting essentially of,” (partially closed scope).
While other transitional phrases are sometimes used in claim construction, their interpretation is determined within the context of the specification. However, the term “mainly includes,” is not defined in the specification other than its use in language identical to that found in the claims (see specification, paragraphs [0007] – [0009]). Thus, it is unclear whether or not the claimed method is intended to be open or closed in nature. See MPEP § 2111.03(IV):
Transitional phrases such as "having" must be interpreted in light of the specification to determine whether open or closed claim language is intended. See, e.g., Lampi Corp. v. American Power Products Inc., 228 F.3d 1365, 1376, 56 USPQ2d 1445, 1453 (Fed. Cir. 2000) (interpreting the term "having" as open terminology, allowing the inclusion of other components in addition to those recited); Crystal Semiconductor Corp. v. TriTech Microelectronics Int’l Inc., 246 F.3d 1336, 1348, 57 USPQ2d 1953, 1959 (Fed. Cir. 2001) (term "having" in transitional phrase "does not create a presumption that the body of the claim is open"); Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1573, 43 USPQ2d 1398, 1410 (Fed. Cir. 1997) (in the context of a cDNA having a sequence coding for human PI, the term "having" still permitted inclusion of other moieties). The transitional phrase "composed of" has been interpreted in the same manner as either "consisting of" or "consisting essentially of," depending on the facts of the particular case. See AFG Industries, Inc. v. Cardinal IG Company, 239 F.3d 1239, 1245, 57 USPQ2d 1776, 1780-81 (Fed. Cir. 2001) (based on specification and other evidence, "composed of" interpreted in same manner as "consisting essentially of"); In re Bertsch, 132 F.2d 1014, 1019-20, 56 USPQ 379, 384 (CCPA 1942) ("Composed of" interpreted in same manner as "consisting of"; however, the court further remarked that "the words ‘composed of’ may under certain circumstances be given, in patent law, a broader meaning than ‘consisting of.’").
Claim 4 is further indefinite for the term, “preferably,” because it is unclear whether the limitations following the phrase are part of the invention or mere exemplary language.
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One of ordinary skill in the art therefore could not reasonably determine the metes and bounds of the claimed ‘isomerizing agent.’ See MPEP § 2173.05(d).
Claims 5 and 7 are indefinite for reciting the “application of the guaianolide oligomers…” and the “application of the pharmaceutical composition…” because it is unclear how the claims further limit the guaianolide oligomers of claim 1 and the pharmaceutical composition of claim 6, respectively. Specifically, the “use of” a compound is not patently distinct from the compound itself, and does not belong to any of the four patentable statutory categories, a ‘process, machine, article of manufacture, or composition of matter.’
Allowable Subject Matter
Claims 1-7 are free of the art.
Applicant has developed oligomers of guaianolide,
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a terpenoid compound found in various plants of the Artemisia genus, and known to have anticancer properties. Applicant’s compounds have the following structures:
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While guaianolide oligomers are known throughout the art (Zhamilya et al., Monomeric and dimeric sesquiterpene lactones from Artemisia heptapotamica. Chin J Nat Med. 2019 Oct;17(10):785-791) (Ding et al., Cytotoxic Guaianolide Sesquiterpenoids from Ainsliaea fragrans. J. Nat. Prod. 24 September 2021; 84 (9): 2568–2574) (U.S. Patent No. 9,670,226), applicant’s particular connectivity pattern between the guaianolide monomers is not. As such variance in connectivity between the fused ring structures would not be predictable, applicant’s compounds are thereby novel and nonobvious.
Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 3-4 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 2 is allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANTHONY JOSEPH SEITZ/Examiner, Art Unit 1629
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