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
Amended claims 1-10 (dated 10/10/2023) are pending and is now under consideration for examination.
Priority
Acknowledgment is made of applicants’ claim for foreign priority under 35 U.S.C. 119(a)-(d). This application is a 371 of PCT/JP2022/013961 filed on 03/24/2022 and claims the priority date of Japan application 2021-051876 filed on 03/25/2021; however, no English translation of said foreign priority application has been provided. Therefore, the priority date for instant claims under consideration is deemed to be the filing date of 371 of PCT/JP2022/013961 filed on 03/24/2022.
Information disclosure statement
The information disclosure statement (IDS) submitted on 12/06/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statement is considered and initialed by the examiner.
Claims Objections
Claim 1 and claims 2-10 depending therefrom is objected to, due to the following informality: Claims 1-7 and 9 recite abbreviation "PRENCSO" in the claims. Examiner suggests expanding the abbreviations to recite the full form of what the abbreviation stands for at least in the first recitation. Appropriate correction is required. For examination purposes "PRENCSO" is interpreted as "S-1-propenyl-cysteine sulfoxide".
Double Patenting rejection
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined 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/patent/patents-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 www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Amended claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting over amended claims 1-9 (dated 09/18/2023) of co-pending Application No. 18/282,775 (US 2024/0167064 A1). This is a provisional double patenting rejection because the patentably indistinct claims have not in fact been patented.
The subject matter claimed in the instant application is fully disclosed in the referenced co-pending application and would be covered by any patent granted on that co-pending application amended claims 1-9 (dated 09/18/2023) of co-pending Application No. 18/282,775 (US 2024/0167064 A1), since the referenced co-pending application and the instant application are claiming common subject matter, as follows: “A dry PRENCSO composition comprising PRENCSO and saccharide,… a lachrymatory factor generating kit comprising: (1) the dry PRENCSO composition; and (2) a dry enzyme composition comprising alliinase and a lachrymatory factor synthase (LFS), and being dried…”, as claimed in claims 1-10 of the instant application and falls entirely within the scope amended claims 1-9 (dated 09/18/2023) of co-pending Application No. 18/282,775 (US 2024/0167064 A1). This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claim Rejections: 35 USC § 112(a)
The following is a quotation 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.
Written-Description
Claims 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, as containing subject matter which was not disclosed in the specification in such a way as to reasonably convey to one of skilled in the relevant art that the invention(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-10 as interpreted are directed to a composition comprising a genera of enzymes having alliinase and lachrymatory synthase activities i.e., a dry PRENCSO composition comprising PRENCSO and saccharide,… a lachrymatory factor generating kit comprising: (1) the dry PRENCSO composition; and (2) a dry enzyme composition comprising any alliinase and any lachrymatory factor synthase (LFS) of undefined and unlimited structures and a porous carrier carrying them and being dried (also see claims objections above for claim interpretation).
The specification discloses and is limited to a single species, a dry PRENCSO composition comprising PRENCSO and saccharide,… and lachrymatory factor synthase (LFS) polypeptide structure as disclosed in the prior art (see ¶ [0064] of specification); a preparation of alliinase obtained from specific source/garlic (see ¶ [0068-0069] of specification) and an enzyme pad comprising said PRENCSO, LFS and alliinase (see Examples, pages 15-24 of specification), which is insufficient to put one of skill in the art in possession of the attributes and features of all species within the claimed genus.
A sufficient written description of a genus of may be achieved by a recitation of structural features common to members of genus, which features constitute a substantial portion of the genus. There is no recited structural feature of the genus in the specification, i.e., a genera of enzymes having alliinase and lachrymatory synthase activities i.e., a lachrymatory factor generating kit comprising: (1) a dry PRENCSO composition comprising PRENCSO and a porous carrier carrying it and being dried; and (2) a dry enzyme composition comprising any alliinase, any lachrymatory factor synthase (LFS) of undefined and unlimited structures and a porous carrier carrying them and being dried (also see claims objections above for claim interpretation) and in the claimed method. Therefore, one skilled in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
In University of California v. Eli Lilly & Co., 43 USPQ2d 1938, the Court of Appeals for the Federal Circuit has held that “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials”. As indicated in MPEP § 2163, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show that Applicant was in possession of the claimed genus. In addition, MPEP § 2163 states that a representative number of species means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
The Federal Circuit in Lilly, Fiers, Rochester and many other cases has determined that the written description issue applies to situations where the definition of the subject matter of the claims fails to provide description commensurate with the genus. Case law directly supports this rejection. As the District Court in University of Rochester v. G.D. Searle & Co., Inc. (2003 WL 759719 W.D.N.Y., 2003. March 5, 2003) noted “In effect, then, the '850 patent claims a method that cannot be practiced until one discovers a compound that was not in the possession of, or known to, the inventors themselves. Putting the claimed method into practice awaited someone actually discovering a necessary component of the invention.”
This is similar to the current situation since the breadth of the current claims comprises a composition comprising a genera of enzymes having alliinase and lachrymatory synthase activities i.e., a dry PRENCSO composition comprising PRENCSO and saccharide,… a lachrymatory factor generating kit comprising: (1) the dry PRENCSO composition; and (2) a dry enzyme composition comprising any alliinase and any lachrymatory factor synthase (LFS) of undefined and unlimited structures and a porous carrier carrying them and being dried (also see claims objections above for claim interpretation) and in the claimed kit which the present inventors were not in the possession of, or which were not known to the inventors.
Examiner finds support for his position in the following references:
Lancaster et al., (Plant Physiol., 2000, Vol. 122: 1269-1279) disclose there are many different isoforms of alliinase(s) obtained from a specific source/onion with differing enzyme kinetics and substrate specificity (Abstract; Table II, page 1275; and entire document) and also provide evidence there are structural and functional variations and differences in biochemical properties among different alliinases obtained from different sources (Fig. 4, page 1277; col. 2, ¶ 2, page 1278).
Imai et al., (US 7,371,554 B2) disclose there are many different isoforms of lachrymatory factor synthase(s) (LFS) and differences in biochemical properties (Abstract Fig. 9; and entire document).
Hence, claims are reading on significant numbers of inoperative embodiments in the claimed process that would render claims non-enabled/lack of written-description, when the specification does not clearly identify the operative embodiments or evidence of possession and undue experimentation is involved in determining those that are operative.” Atlas Powder Co. v. E.I. duPont de Nemours & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984); In re Cook, 439 F.2d 730, 735, 169 USPQ 298, 302 (CCPA 1971); MPEP 2164.08(b).
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, published in the Official Gazette and also available at <http://www.uspto.gov>.
Claim Rejections: 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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(a) 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.
Claims 1-10 are rejected under 35 U.S.C. 103(a) as being unpatentable over Aoyanagai et al., (JP-2008-285476 A_MT, English Machine Translation) and further in view of Kamata et al., (JP-2019-076088 A_MT, English Machine Translation), Darbyshire et al., (J. Sci. Food Agric., 1979, Vol. 30: 1035-1038), Heubes et al., (US 2008/0032962 A1) and Printz et al., (US 2018/0228165 A1).
Regarding claims 1-2, 4-5, 7 and 9, The disclosure of Aoyanagai et al., (JP-2008-285476_MT, English Machine Translation) teaches kit and method of use wherein said reference kit comprises mixed enzyme powder containing alliinase and lachrymatory synthase activities and said reference kit also comprises PRENCSO (S-1-propenyl-cysteine sulfoxide) and method of synthesis of PRENCSO (see Overview, page 3; claims 1-9, pages 4-5; ¶ [0006-0009, [0040]; freeze-dried PRENCSO, ¶ [0061-0062]); and entire document); said reference teaches addition of NaCl and disaccharide/sugar during lyophilization/dry powder of enzymes increases stability (¶ [0028], [0037], 10% trehalose/sugar ¶ [0115]).
However, Aoyanagai et al., (JP-2008-285476 A_MT, English Machine Translation) are silent regarding wherein PRENCSO composition and dry enzyme composition comprising alliinase, a lachrymatory factor synthase (LFS) and a porous carrier being integrated (as in claims 3, 6 and 10); and comprising 5 parts by mass or more of sugar relative to 1 part by mass of PRENCSO (as in claim 5).
Regarding claims 1-2, 4-5 and 7, Kamata et al., (JP-2019-076088 A_MT, English Machine Translation) also provide teaching suggestion and motivation to obtain a freeze-dried/a dry PRENCSO composition (see ¶ [0069-0073]).
Regarding claims 1-6, Darbyshire et al., (J. Sci. Food Agric., 1979, Vol. 30: 1035-1038) also provide clear teaching, suggestion and motivation to include sugars/fructans/carbohydrate during drying process of onions (it is well established in the art that dried powders onions contains PRENCSO and alliinase enzyme), as association of sugars with high percentage dry weight increases storage stability of dried product and suggest optimal carbohydrate concentration during drying ranges from 83%-88% (see Abstract; Fig. 2-3, page 1037; Fig. 4, page 1038; and entire document).
Regarding claims 1-6, the following reference, analogous art Heubes et al., (US 2008/0032962 A1) disclose the structural and functional elements of the instant invention; said reference discloses the use of stabilizers such as sugars/mannitol, trehalose and polyhydric alcohols polyvinyl pyrrolidone (PVP) and wherein the stabilizer concentration can range from 5% to 80% by weight (Abstract; ¶ [0025-0027], [0049]; and entire document).
Regarding claims 3, 6 and 9, dry enzyme composition comprising alliinase, a lachrymatory factor synthase (LFS) and a porous carrier being integrated, analogous art Printz et al., (US 2018/0228165 A1) provide teaching, suggestion and motivation to a skilled artisan for an integrated method comprising dried enzymes and substrates immobilized on a porous nanoporous material (Abstract; Fig. 1-2; ¶ [0010], [0024], [0014-0016], [0060-0061], [0073]; Claims; and entire document); said reference teaches production of porous nanoporous material with immobilized lachrymatory factor synthase (LFS) and the corresponding substrate (see ¶ [0017], [0069-0084], [0093]).
As such, disclosure of strategy and methods for generating “PRENCSO composition and dry enzyme composition comprising alliinase, a lachrymatory factor synthase (LFS) and a porous carrier being integrated (as in claims 3, 6 and 10); and comprising 5 parts by mass or more of sugar relative to 1 part by mass of PRENCSO (as in claim 5)”, such as that of references of Kamata et al., Darbyshire et al., Heubes et al., and Printz et al., teaching the advantages of said modifications, clearly suggests to a skilled artisan to modify the teachings of Aoyanagai et al., and incorporate the structural and functional elements of Kamata et al., Darbyshire et al., Heubes et al., and Printz et al., in the claimed kit and method for preparing a lachrymatory factor generating kit comprising: (1) a dry PRENCSO composition comprising PRENCSO and a porous carrier carrying it and being dried; and (2) a dry enzyme composition comprising alliinase, a lachrymatory factor synthase (LFS) and a porous carrier carrying them and being dried and as claimed in the instant invention. One of ordinary skill in the art would have a reasonable expectation of success, since kit and method for preparing a lachrymatory factor generating kit comprising: (1) a dry PRENCSO composition comprising PRENCSO and a porous carrier carrying it and being dried; and (2) a dry enzyme composition comprising alliinase, a lachrymatory factor synthase (LFS) and a porous carrier carrying them and being dried including the structural and functional elements of the instant invention are well known in the art (for details see the rejection above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claimed kit and method of industrial significance and incorporate the modification to the kit and claimed process in that (1) a dry PRENCSO composition and a porous carrier carrying it and being dried; and (2) a dry enzyme composition comprising alliinase, a lachrymatory factor synthase (LFS) and a porous carrier carrying them and being dried, as suggested by Kamata et al., Darbyshire et al., Heubes et al., and Printz et al., and to modify the teachings of Aoyanagai et al. A person of ordinary skill in the art is motivated to make such change, because (1) a dry PRENCSO composition and a porous carrier carrying it and being dried; and (2) a dry enzyme composition comprising alliinase, a lachrymatory factor synthase (LFS) and a porous carrier carrying them and being dried and a skilled artisan would realize such a modification would be useful to increase the stability of the components in the claimed kit comprising the enzymes and substrates. One of ordinary skill in the art has a reasonable expectation of success at adding the step i.e., 1) a dry PRENCSO composition and a porous carrier carrying it and being dried; and (2) a dry enzyme composition comprising alliinase, a lachrymatory factor synthase (LFS) and a porous carrier carrying them and being dried as suggested in the teachings of Kamata et al., Darbyshire et al., Heubes et al., and Printz et al., and are well known in the art. Therefore, the inventions as a whole lack an inventive step over the prior art. The expectation of success is high, because the combined teachings of Aoyanagai et al., Kamata et al., Darbyshire et al., Heubes et al., and Printz et al., also provide the structural and functional elements of the instant invention (Teaching, Suggestion and Motivation).
Regarding specific choice of concentration are also provided/suggested in the combination of references, and examiner also takes the position the following position; optimization of known variables, and the examiner finds support in: MPEP 2144.05 [R-5]: A. Optimization Within Prior Art Conditions or Through Routine Experimentation Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation". As to optimization results, a patent will not be granted based upon the optimization of result effective variables when the optimization is obtained through routine experimentation unless there is a showing of unexpected results which properly rebuts the prima facie case of obviousness. See In re Boesch, 617 F.2d 272,276,205 USPQ 215,219 (CCPA 1980). See also In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936-37 (Fed. Cir. 1990), and In re Aller, 220 F2d 454,456,105 USPQ 233,235 (CCPA 1955). Furthermore, "it is prima facie obvious to combine two compositions or two methods each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition or third method to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)”. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Given this extensive teaching in prior art (Aoyanagai et al., Kamata et al., Darbyshire et al., Heubes et al., and Printz et al.,) a genera of enzymes having alliinase and lachrymatory synthase activities i.e., a dry PRENCSO composition comprising PRENCSO and saccharide,… a lachrymatory factor generating kit comprising: (1) the dry PRENCSO composition; and (2) a dry enzyme composition comprising any alliinase and any lachrymatory factor synthase (LFS) of undefined and unlimited structures and a porous carrier carrying them and being dried (also see claims objections above for claim interpretation) as taught by the instant invention and as claimed in claims 1-10 is not of innovation but of ordinary skill in the art and the expectation of success is extremely high i.e., “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at, 82 USPQ2d at 1397”.
Hence, claims 1-10 are rejected under 35 U.S.C. 103(a) as being unpatentable over Aoyanagai et al., (JP-2008-285476 A_MT, English Machine Translation) and further in view of Kamata et al., (JP-2019-076088 A_MT, English Machine Translation), Darbyshire et al., (J. Sci. Food Agric., 1979, Vol. 30: 1035-1038), Heubes et al., (US 2008/0032962 A1) and Printz et al., (US 2018/0228165 A1).
Allowable Subject Matter/Conclusion
None of the claims are allowable.
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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652