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 .
Non-Final Rejection
The Status of Claims:
Claims 1, and 5-22 are pending.
Claims 1 and 5-22 are rejected.
DETAILED ACTION
1. Claims 1 and 5-22 are under consideration in this Office Action.
Priority
2. It is noted that this application is a continuation of 18322167 05/23/2023 PAT 12084699, which is a continuation of 17680840 02/25/2022 PAT 11773419, which is a continuation of 17/070,385 10/14/2020 PAT 11401541,
which is a continuation of 16/095,444 10/22/2018 PAT 10844412, which is a 371 of PCT/EP2017/059327 (04/20/2017), which has foreign priority documents EPO PCT/2016/058987 (04/22/2016) and EPO PCT/2016/058997 (04/22/2016) which are not in file.
Drawings
3. The drawings filed on 8/7/24 are accepted by the examiner.
IDS
4. The IDS filed on 8/7/24 have been reviewed by the examiner.
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 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 § 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.
Claim 17 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.
In claim 17, the term “substantially” is recited. This expression can be vague because the claim does not elaboarate what is meant by the term “substantially”.
The examiner recommends to remove the term from 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 7-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a recombinant whole cell producing wild type SHC or variant enzymes, does not reasonably provide enablement for a biocatalyst. The specification does not enable any skilled process biochemist or pilot-plant biochemical engineer to make the invention commensurate in scope with these claims.
“The factors to be considered [in making an enablement rejection] have been summarized as the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art and the breadth of the claims”, In re Rainer, 146 USPQ 218 (1965); In re Colianni, 195 USPQ 150, Ex parte Formal, 230 USPQ 546. The three issues here are the lack of guidance in the specification, the limited working examples, and the unpredictability of the catalytic arts.
a) Determining if the (-)-Ambrox of the formula (I) would be formed under Applicants conditions would require synthesis of homofarnesol substrate and subjecting it with a variety of any biocatalysts, a small quantity of experimentation. b) The direction concerning the various " biocatalysts " is found in lines 12-13, page 14. c) There is one working example of the "biocatalyst" wild type SHC or SHC variant in line 23, page 36. d) The nature of the invention is biochemical synthesis to make the (-)-Ambrox of the formula (I) . This requires biochemical catalysis.
f) The artisan using Applicants' invention to prepare the claimed compound would be a process biochemist or pilot plant biochemical engineer with a BS degree in biochemistry or biochemical engineer and several years of experience. As suggested by Applicants in the parent application, he would know how to use wild type SHC or SHC variant with the homofarnesol reaction but be unaware of any other biocatalyst to use.
g) Chemical reactions are well-known to be unpredictable, In re Marzocchi, 169 USPQ 367, In re Fisher, 166 USPQ 18. Additionally, catalytic processes, such as are present here, are inherently unpredictable. The U.S. District Court District of Connecticut held in MOBIL OIL CORPORATION v. W.R. GRACE & COMPANY, 180 USPQ 418 that “there is an inherent mystery surrounding the unpredictability of the performance of catalysts; a mystery which is generally recognized and acknowledged by chemists in the cracking art. This is one more reason why the presumption of patent validity "should not be disregarded especially in a case of this sort where the intricate questions of [bio]chemistry involved are peculiarly within the particular competence of the experts of the Patent Office.” Merck & Co. v. Olin Mathieson Chemical Corp., 253 F.2d 156, 164, 116 USPQ 484, 490 (4th Cir. 1958)". "The catalytic action can not be forecast by its chemical composition, for such action is not understood and is not known except by actual test, Corona Cord Tire Co. v. Dovan Chemical Corp., 276 U.S. 358, 368-369 (1928). Also see, Application of Grant, 304 F.2d 676, 679, 134 USPQ 248, 250-251 (CCPA 1962); Rich Products Corp. v. Mitchell Foods, Inc., 357 F.2d 176, 181, 148 USPQ 522, 525-526 (2d Cir. 1966), cert. denied 385 U.S. 821, 151 USPQ 757 (1966); Ling-Temco-Vought, Inc. v. Kollsman Instrument Corp., 372 F.2d 263, 268, 152 USPQ 446, 450-451 (2d Cir. 1967); Georgia-Pacific Corp. v. United States Plywood Corp., 258 F.2d 124, 132-133, 118 USPQ 122, 128-129."
h) The breadth of the claims includes the presently unknown list of biocatalysts embraced by limitation "a biocatalyst". Thus, the breadth of the claims is moderate.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
5. Claims 1, 5-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,773,419 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the differences in the scope of the invention between them.
The Claims 1-4 of U.S. Patent No. 11,773,419 B2 describes the followings:
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Similarly, the current claims 1, 6-7, 9-13 disclose the followings as shown below:
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5. (New) The bioconversion reaction mixture of claim 1, wherein the solid phase comprises (-)Ambrox in a solid form.
6. (New) The bioconversion reaction mixture of claim 5, wherein the solid form of (-)-Ambrox is a crystalline form.
7. (New) The bioconversion reaction mixture of claim 1, wherein the aqueous liquid phase comprises a biocatalyst.
8. (New) The bioconversion reaction mixture of claim 7, wherein the biocatalyst is a microbial biocatalyst.
9. (New) The bioconversion reaction mixture of claim 8, wherein the microbial biocatalyst is a recombinant microorganism.
10. (New) The bioconversion reaction mixture of claim 8, wherein the microbial biocatalyst is a recombinant whole cell producing wild type SHC or variant enzymes.
11. (New) The bioconversion reaction mixture of claim 1, wherein the oily phase comprises a homofarnesol mixture enriched in the 7E, 3E isomer.
12. (New) The bioconversion reaction mixture of claim 11, wherein the ratio of biocatalyst to 7E, 3E homofarnesol substrate is in the range of about 0.5:1-2:1.
13. (New) The bioconversion reaction mixture of claim 1, wherein the oily phase comprises one or more by-products according to formulae (II), (III) or (IV)
14. (New) The bioconversion reaction mixture of claim 13, wherein the oily phasecomprises one or more by-products according to formulae II or IV and III.
15. (New) The bioconversion reaction mixture of claim 13, wherein the weight ratio (-)-Ambrox to compounds II, III and IV in the mixture is greater than 70:30.
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16. (New) The bioconversion reaction mixture of claim 11, wherein the unreacted homofarnesol is less than 30% by weight.
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17. (New) The bioconversion reaction mixture of claim 1, wherein the reaction mixture contains no, or substantially no unreacted homofarnesol.
18. (New) A solid form of (-)-Ambrox as a bioconversion product obtained by claim 1, wherein the (-)-Ambrox comprises trace amounts of compounds II, III and/or IV as oily residues on the solid form.
19. (New) A consumer product comprising the solid form of (-)-Ambrox of claim 18.
20. (New) The solid form of (-)-Ambrox of claim 18 in admixture with one or more additional perfume
However, the instant claims differ from the U.S. Patent No. 11,773,419 B2 in that the claimed limitations of a bioconversion reaction mixture containing aqueous liquid, and olily phase, a microbial, recombinant microorganism whole cell producing wild type SHC or variant enzymes biocatalyst, a homofarnesol mixture enriched in the 7E, 3E isomer, the ratio of biocatalyst to 7E, 3E homofarnesol substrate in the range of about 0.5:1-2:1, the weight ratio (-)-Ambrox to compounds II, III and IV in the mixture is greater than 70:30, unreacted homofarnesol being less than 30% by weight are unspecify in the claims of the U.S. Patent No.11,773,419 B2.
Even so, the claims 6, 10 of U.S. Patent No.11,773,419 B2 do mention the use of the bioconversion medium or mixture, an SHC biocatalyst enzyme being a wild-type squalene hopene cyclase, or its variant; furthermore, the specification does describe the SHC enzyme, such as an intact recombinant whole cell and/or fragmented cell or a membrane fraction containing the SHC enzyme(see col.9 , lines 60-62). Also, the specification disposes that the bioconversion medium obtained from the bioconversion process described generally comprises a solid phase containing a crude (−)-Ambrox and a liquid phase or phases consisting of water and an oily phase that may contain any residual homofarnesol and any other oily or oil-soluble impurities or by-products. One or more of by-products (II), (III) and (IV) may be present in such an oily phase(see col. 19, lines 21-28). crystallization was improved when the weight ratio of (−)-Ambrox to the other compounds (II), (III) and (IV) in the mixture was greater than 70:30,(see col. 21, lines 17-19) ; the level of unreacted homofarnesol is less than 30% by weight,( see col. 21, lines 26-27). Furthermore, it teaches that The ratio of biocatalyst to EEH homofarnesol substrate is in the range of about 0.5:1-2:1 (see col. 17, lines 27-28)
These limitations can be added to the corresponding dependent claims of the claims in order to emphasize the particular aspects of the claimed invention. Moreover, removing or adding or rearranging the limitations of the claims can be considered as a obvious variation of the claimed invention ; there is very little difference as to the patentable distinction.
So, it would have been obvious to the skilled artisan in the art to be motivated to emphasize the characteristics of the claimed bioconversion reaction mixture containing solid form of (-)-Ambrox so as to broaden up the scope of the current claimed invention. This is because the skilled artisan in the art would expect such a manipulation to be feasible and successful as guidance shown in the application.
Claim Rejections - 35 USC § 102
2113 Product-by-Process Claims
PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATION OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS
“Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 77 F.2d 695,698,227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive prereacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.).
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
6. Claims 1, 5-11, 13-14, 17-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated clearly by Hayase et al (JP 2009060799)
Hayase et al discloses a bioconversion reaction mixture containing (-)-ambrox and the method for producing (-)-AMBROXAN (R) from homofarnesol by means of SHC (squalene-hopene cyclase) catalyst in the followings:
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(see page 1, paragraphs#0002-0003)
Also, SHC is derived from Alicyclobacillus acidocaldarius is preferred because its gene sequence has been elucidated, and a method for expressing recombinant enzymes in E. coli and making them function stablyis known (see page 3, the last paragraph#0017).
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(see page 8, example 1) These are inherently identical with the claims because the reaction mixture may contain a solid ,aqueous , and oily phase.
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
7. Claims 1, 5-11, 13-14, 17-22 are rejected under 35 U.S.C. 103 as being unpatentable over Hayase et al (JP 2009060799) in view of Guenin et al (US 6,180,121).
Determination of the scope and content of the prior art
Hayase et al discloses a bioconversion reaction mixture containing (-)-ambrox and the method for producing (-)-AMBROXAN (R) from homofarnesol by means of SHC (squalene-hopene cyclase) catalyst in the followings:.
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(see page 1, paragraphs#0002-0003)
Also, SHC is derived from Alicyclobacillus acidocaldarius is preferred because its gene sequence has been elucidated, and a method for expressing recombinant enzymes in E. coli and making them function stablyis known (see page 3, the last paragraph#0017).
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(see page 8, example 1) These are inherently identical with the claims because the reaction mixture may contain a solid ,aqueous , and oily phase.
The current invention, however, differs from the prior art in that the claimed admixture with one or more additional perfume ingredients or applications for the personal care and the method of using the solid form of (-)-Ambrox in the fragrance application or the personal care are unspecified in the prior art.
Guenin et al teaches fragrance enhancing compositions containing ambroxan which are capable of controlling malodor from a human body to a significant extent thereby reducing the overall amount of fragrance required to achieve a satisfactory cosmetic product, especially an underarm product.
The Green Deo-Key fragrance can be used in an amount of from 25-27% of the total fragrance component (which is greater than the specifically described 2.60-14.50 amount), provided that the ratios of the individual ingredients are maintained in the same ranges as described for the 2.60-14.50 composition).
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(see col. 7, lines 30-42)
Ascertainment of the difference between the prior art and the claims
1. The difference between the current application and the applied Hayase et al art is that the applied the Hayase et al art does not expressly teach the claimed the claimed admixture with one or more additional perfume ingredients and the method of using the solid form of (-)-Ambrox in the fragrance application or the personal care. The deficiencies of the Hayase et al are cured by the Guenin et al.
2. The difference between the current application and the applied Guenin et al art is that the applied Guenin et al art does not expressly teach the claimed bioconversion reaction mixture containing compounds II, Ill or IV. The deficiency of the Guenin et al is cured by the Hayase et al.
Resolving the level of ordinary skill in the pertinent art.
Regarding the Claims 20-22, with respect to the lack of disclosing the claimed the claimed admixture with one or more additional perfume ingredients and the method of using the solid form of (-)-Ambrox in the fragrance application or the personal care, Hayase et al does mention at least that the existence of the optical isomer of (+)-ambroxan which has a weak woody odor. (see page 1, a paragraph#0003). Furthermore, Guenin et al discloses deodorant compositions containing 3aR-(3a,alpha,5a,alpha,9a,beta,9b, beta) )-dodecahydro-3a,6,6,9 a-tetrarneth ylnaphthto(2,1-b) furan (see col. 2 ,lines 62-65 ). Therefore, if the skilled artisan in the art had desired to develop the method of utilizing a fragrance composition containing the solid form of (-)-Ambrox in fragrance applications with a weak woody odor and a typical amber odor, it would have been obvious to the skilled artisan in the art to be motivated to combine the Guenin’s fragrance enhancing compositions capable of controlling malodor from a human body with Hayase et al composition . This is because the skilled artisan in the art would expect such combined compositions to be feasible and successful and that is within the purview of the skilled artisan in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Hayase et al does disclose the bioconversion reaction mixture containing (-)-ambrox and the method for producing (-)-ambrox from homofarnesol by means of SHC (squalene-hopene cyclase) catalyst.
Although Hayase et al does not teach the claimed admixture with one or more additional perfume ingredients or applications for the personal care and the method of using the solid form of (-)-Ambrox in the fragrance application or the personal care,
Guenin et al expressly discloses deodorant compositions containing 3aR-(3a,alpha,5a,alpha,9a,beta,9b, beta) )-dodecahydro-3a,6,6,9 a-tetrarneth ylnaphthto(2,1-b) furan (see col. 2 ,lines 62-65 ) and other perfume ingredient ,such as vanillin, (see col. 7, lines 30-34) which are capable of controlling malodor from a human body. Also, Hayase et al does mention that the existence of the optical isomer of (+)-ambroxan having a weak woody odor. (see page 1, a paragraph#0003). Both prior art are commonly in a close relationship between Ambroxan compound and its optical isomer for using them as fragrance.
Therefore, if the skilled artisan in the art had desired to develop the method of utilizing a fragrance composition containing the solid form of (-)-Ambrox in fragrance applications for the personal care with a weak woody odor and a typical amber odor, it would have been obvious to the skilled artisan in the art to be motivated to combine the Guenin’s fragrance enhancing compositions capable of controlling malodor from a human body with Hayase et al composition . This is because the skilled artisan in the art would expect such combined compositions to be feasible and successful and that is within the purview of the skilled artisan in the art.
Conclusion
Claims 1 and 5-22 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 6/27/2026
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