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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1, 20, and 38-39 and the following within Group I with traverse: within Group IA, the plurality of the starting saponins comprising (i) quillaic acid glycoside saponins, (ii) obtainable from Quillaja saponaria, and (iii) QS-17 family components;
within Group IB, the plurality of the product saponins comprising QS-21 family components; and
within Group IC, the combination of a rhamnosidase and a glucosidase
in the reply filed on 2/17/26 is acknowledged. The traversal is on the ground(s) that PCT rule 13.2, the art cited in the restriction and the claim amendments (p15). This is not found persuasive because as discussed on p5 of the restriction mailed on 12/12/25, the groups do not comprise a special technical feature.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election without traverse of a rhamnosidase and a glucosidase, wherein the glucosidase consists of SEQ ID NO: 1179, which is SEQ ID NO: 262 except with a substitution of threonine with asparagine at position 365 (see second row of Table 16, which is on page 262 of specification as filed) and wherein the rhamnosidase consists of SEQ ID NO: 1189, which is SEQ ID NO: 1017 except with a substitution of lysine with glycine at position 219 (see Tables 17 and 18, which are on pages 266 and 267 of the specification as filed), in the reply filed on 2/17/26 is acknowledged.
Claims 7, 23, and 25 are rejoined, claims 1, 7, 20, 23, 25, 38, and 39 are under examination herein.
Priority
Application claims priority to 63/039,514 provisional application with an effective filing date of 12/9/20. Claims of the instant application are supported by the provisional application and thus have a priority date of 12/9/20.
Information Disclosure Statement
The IDS filed on 5/31/23, 10/18/23, 11/14/24, 2/27/26 have been fully considered except where references have been lined through.
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.
Claims 23, 25, 38 and 39 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 23, 25, 38 and 39, the claim requires a “functional fragment thereof”. Instant specification [1720] indicates this could be as little as 100 amino acids. The specification does not provide any specific examples of functional fragments, and also fails to provide any further guidance as to what domains or locations could be deleted while preserving the functional activity of the enzyme. Therefore, applicants have not provided sufficient disclosure (e.g., a structural-functional relationship or other guidance that would allow one of ordinary skill in the art to identify functional fragments of the claimed proteins) to demonstrate possession of a “functional fragment thereof”.
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, 20, 23, 25, 38, and 39 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.
Regarding claim 1, line 3 requires “an enzyme”, a singular enzyme. Steps c(i) and c(ii) both require the use of two enzymes, a rhamnosidase and a glucosidase. It is unclear if the claim requires an additional enzyme beyond the rhamnosidase and a glucosidase or how two enzymes meet the limitation of a singular “an enzyme”.
Claim 1, step (b) recites "the plurality of the starting saponins comprise: (i) quillaic acid glycoside saponins, (ii) obtainable from Quillaja saponaria, and (iii) QS-17 family components". It is unclear what the phrase "obtainable from Quillaja saponaria" limits within the context of the claimed starting saponins. For example, it is unclear whether "obtainable from Quillaja saponaria" is meant to limit "quillaic acid glycoside saponins", or whether it is intended to be an independent recitation, e.g. meaning all saponins obtainable from Quillaja saponaria.
Claim 1 recites the limitation "the beta glucose residue" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the glucosidase" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 23, 25, 38 and 39, the claim requires a “functional fragment thereof”. There is no definition provided for in the specification as to what level of reduced enzyme activity is needed to meet the limitation of “functional fragment”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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/TREVOR KANE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657
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