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
Applicant’s response filed on 06/23/2026 is duly acknowledged.
Claims 1-97 (originally presented) were previously canceled by the applicants.
Claims 98-113 are currently pending in this application.
Election/Restrictions
Applicant’s election with traverse of Group I (claims 98-109; directed to “A composition…”) in the reply filed on 06/23/2026 (see REM, p. 2) is acknowledged. However, it is noted that no reasonable traversal has been presented by applicants. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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Therefore, the election/restriction requirements is still deemed proper, and has been made Final.
Claims 110-113 (non-elected inventions of Groups II-IV; taken as without traverse) have been withdrawn from further considerations.
Claims 98-109 (elected invention of Group I; directed to “A composition comprising (a) a sesquiterpene…”) have been examined on their merits in this action hereinafter.
Priority
This application is a 371 of PCT/US2022/080127 (filed on 11/18/2022), which claims domestic benefit from US PRO 63/285,468 (filed on 12/02/2021) and US PRO 63/283,194 (filed on 11/24/2021).
Claim Objections
1. Claim 108 (as presented) is objected to because of the following informalities: claim 108 recites the limitation “FPP” in abbreviated form, which should be amended to recite the full form of said term (with abbreviated form in a parenthesis, if needed), at least the first time it appears in a claim set (“FPP” presumably refers to “farnesyl diphosphate”; see instant SPEC, p. 77, line 12). Appropriate correction is required.
2. Claim 109 (as presented) is objected to because of the following informalities: claim 109 (depends from claim 107) recites the limitation “GC” in abbreviated form in line 3, which should be amended to recite the full form of said term (with abbreviated form in a parenthesis, if needed), at least the first time it appears in a claim set. (“GC” presumably refers to “gas chromatography”; see instant SPEC, p. 23, line 28). Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 105 (as presented) 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 105 (directly depends form claim 103, which depends from independent claim 98) recites limitations “wherein about 50% to about 10% of the sesquiterpene is delta-guaiene”. It is noted that the term “about” has not been specifically defined by the applicants on record (see instant SPEC, p. 13, 2nd paragraph, for instance). Since, to an artisan of ordinary skill in the art, the limitation “about 50%” could encompass less than or more than 50% (in an undefined way), and since claim 98 requires the “at least 50%” of the sesquiterpene to be alpha-guaiene, the scope of claim 105 as currently presented does not appear to further limit the independent claim 98 as presented.
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. Appropriate correction is required.
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.
1. Claims 98-109 (as presented) 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 98 recites the following:
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Claim 98 recites the limitations for amount of component (a) a sesquiterpene wherein “at least 50%” of the sesquiterpene is “alpha-guaiene”, along with additional “one or more components” in the composition. However, from the recitation, it is not clear if the component “alpha-guaiene” is “at least 50%” of the total sesquiterpene by weight or volume, or by weight or volume of the total composition comprising components (a) and (b). Since, the component (b) as recited comprises a medium or a supernatant, and/or a “hydrophobic overlay” (presumably on a aqueous liquid culture medium/supernatant; see instant SPEC, p. 2, 3rd paragraph, and p. 76-77, Example 1, for instance), which comprises said sesquiterpene component (a), the amount/range of which has not been specifically provided in the claim, it is unclear as to what exact amount (by weight or volume of the total composition) the component sesquiterpene is required to meet the limitation as currently presented for the product as claimed. The composition as claimed only requires the presence of components (a) and (b), wherein the component (a) has been ambiguously qualified (in its own quantitative fractions for types of guaienes, per se). However, the exact amount of components (or range thereof) in the total composition have not been provided in the claim, and therefore, the scope of the product as claimed is uncertain and/or ambiguous because the metes and bounds of the claim cannot be properly ascertained by an artisan of ordinary skill in the art.
Since, none of the dependent claims clarify this point, they are also deemed indefinite for the same reasons as discussed above. Appropriate correction and/or explanation is required.
2. Claim 106 (as presented) is 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. Claims 98, 105 and 106 have been reproduced below (see also discussion above for instant claim 105):
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Claim 106 as presented requires “at least 15%” of the sesquiterpene to be “aciphyllene”, whereas claims 105 and 98 already require the composition to have “about 50%” and “at least 50%” of “delta-guaiene” and “alpha-guaiene”, respectively. Since, the term “about” has not been specifically defined by applicants in the instant disclosure of record, it is unclear as to how the claimed product composition would comprise of additional “at least 15%” aciphyllene where the total amount of two different component guaiene(s) already makes up to “about 100%” (see independent claim 98). Therefore, the metes and bounds of the claimed product as presented in instant claim 106 does not appear to be properly defined. Appropriate correction and/or explanation is required.
NOTE: In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claims 98-109 (as presented) are rejected under 35 U.S.C. 103 as being unpatentable over Philippe et al (WO 2020/051488 A1; cited in applicant’s IDS dated 08/23/2024) taken with Kusumaningrum et al (ID S201700794 A; NPL cited as ref. [U] on PTO 892 form, attached an English machine translation) and Goeke et al (WO 2019/110299 A1; FOR cited as ref. [N] on PTO 892 form).
Claim 98 is directed to “A composition comprising (a) a sesquiterpene, wherein at least 50% of the sesquiterpene is alpha-guaiene, and (b) one or more additional components, wherein the one or more additional components include fermentation medium, cell culture supernatant and/or a hydrophobic overlay.
See also the recitation of dependent claims 99-109, as currently presented.
Philippe et al (March, 2020), while teaching the microbial production of rotundone, an oxygenated sesquiterpenoid (the precursor of which is alpha-guaiene sesquiterpene hydrocarbon found in oil extracts from various plants including Aquilaria crassna; see Abstract, Background on p. 1; Summary of the Invention, and p. 6, 1st paragraph, for instance), disclose (regarding instant claim 98) cultured microbial host cells (such as E. coli cells in culture; see p. 17, 4th paragraph; and Example 1) expressing enzyme pathway catalyzing the conversion of substrate farnesyl diphosphate (FPP) to rotundone via alpha-guaiene (see Fig. 2), said enzyme pathway comprising an alpha-guaiene terpene synthase enzyme (α-GTPS) and an alpha-guaiene oxidase (α-GOX) enzyme (see p. 2, second paragraph); wherein the α-GTPS (or an engineered variant thereof), produces predominantly alpha-guaiene (e.g. greater than 50%; see p. 9, lines 21-29; Fig. 5-6), which is estimated using chemical analysis (such as GC/MS; see p. 18, 3rd paragraph, for instance) of the total terpenoid products from the microbial host cells; wherein they also disclose that all active Aquilaria enzymes showed alpha-bulnesene (an alternative name of delta-guaiene) in the products synthesized by microbial cultures (see p. 20, 3rd paragraph).
However, the composition wherein- (1) the sesquiterpene comprises the specific amounts of components alpha-guaiene and delta-guaiene (or alpha-bulnesene; see instant claims 102, 105); and (2) wherein “at least 15% of the sesquiterpene is aciphyllene” (see instant claims 99, 104 and 106), have not been explicitly disclosed by the cited prior art reference of Philipe et al, as discussed above.
Kusumaningrum et al (2017) disclose aromatic oil compositions obtained from patchouli leaves (in the form of patchouli oil) that were found to comprises variety of hydrocarbons (in addition to main component as patchouli alcohol), including sesquiterpenes such as alpha-guaiene, delta-guaiene or alpha-bulnesene, aciphyllene, alpha-humulene, germacrene B, D, etc. (see p. 2, last full paragraph), that were detected/quantitated using GC-MS analyses.
Goeke et al (2019), while teaching microbial production of guaiene and rotundone (see Title, Abstract, and Claims 1, 9-11), disclose the fact that sesquiterpenes rotundone and alpha-guaiene are also found as an aromatic constituents of plants extracts including patchouli oil (see p. 2, lines 6-7; p. 18, section “Sources of a-guaiene”), and disclose art known standard methods for solvent extraction and distillation of sesquiterpenes from reaction mixtures that contain such sesquiterpenes including alpha-guaiene (see p. 5, 3rd paragraph; p. 9, last paragraph; p. 19, section “Preparation of Rotundone 2 from a-Guaiene 1 (Iron Porphyrin Catalysis)”; and section “Preparation of Rotundone 2 from a-Guaiene 1 (Organocatalysis)”). Goeke et al also disclose the fact that a-Guaiene can be purified/concentrated using standard distillation and/or chromatographic methods to a purity of 10% to 95% (see p. 9, last paragraph), and analyzed using appropriate GC-MS procedures (see p. 17-18, section “Analytical Methods Employed”).
Thus, to a person of ordinary skill in the art, given the disclosure for known methods of purification and/or distillation of variety of sesquiterpenes including a-guaiene and rotundone (see Goeke et al, discussed above), and the fact that various sesquiterpenes such as delta-guaiene or alpha-bulnesene, aciphyllene, alpha-humulene are normal constituents of aromatic plant extracts, including patchouli oil, as disclosed by Kusumaningrum et al (see teachings above), it would have been obvious to modify the composition disclosed by Philipe al such that the composition comprises in addition to a-guaiene, other sesquiterpenes including suitable proportions of delta-guaiene or alpha-bulnesene, and/or aciphyllene, as per need, for instance for making part of the flavor or fragrance compositions or products (as already suggested by Philipe et al; see Abstract).
It is to be noted that the product-by-process type limitations of claim 100 (“produced using a microbial host cell”), or claim 101 (“produced using an in-vitro or an in-vivo system”) do not necessarily impart any structural difference in the sesquiterpenes per se, such as alpha-guaiene, delta-guaiene, or aciphyllene in the composition, and therefore since the methods for producing, purifying and analyzing such sesquiterpenes and compositions thereof, have already been disclosed, an artisan of ordinary skill in the art would have had a reasonable expectation of success in modifying the composition (by combining different proportions of desired sesquiterpenes, in addition to a-guaiene, for instance) disclosed by Philipe et al when taken with the disclosure form Kusumaningrum et al and Goeke et al, as discussed above.
Thus, the claim as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention as claimed.
As per MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, F.3d, 2004 WL 1067528 (Fed. Cir. May 13, 2004)(The USPTO uses a different standard for construing claims than that used by district courts; during examination the USPTO must give claims their broadest reasonable interpretation.). This means that the words of the claim must be given their plain meaning unless applicant has provided a clear definition in the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
Conclusion
NO claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657
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