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 .
Application Status
In response to Non-Final Office Action mailed on 12/03/2025, applicants’ response and amendments dated 04/14/2026 is acknowledged; in said amendment applicants’ have amended claims 1 and 5 and added new claims 10-13. Thus, amended claims 1-13 are pending in this application and is now under consideration for examination. Rejections and/or objections not reiterated from previous office action are hereby withdrawn.
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/JP2022/013962 filed on 03/24/2022 and claims the priority date of Japan application 2021-051943 filed on 03/25/2021; English translation of said foreign priority application has been provided in the response dated 04/14/2026. Therefore, the priority date for instant claims under consideration is deemed to be the filing date of Japan application 2021-051943 filed on 03/25/2021.
Information disclosure statement
The information disclosure statement (IDS) submitted on 01/07/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statement is considered and initialed by the examiner.
Withdrawn-Claim Rejections: 35 USC § 112(a)
Previous rejection of claims 1-9 rejected under 35 U.S.C. 112(a) for written-description and enablement, is being withdrawn due to claim amendments.
Withdrawn-Claim Rejections: 35 USC § 103
Previous rejection of claims 1-9 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 Kamata et al., (JP-2019-076088 A_MT, English Machine Translation), Printz et al., (US 2018/0228165 A1) and Heubes et al., (US 2008/0032962 A1), is being withdrawn due to claim amendments.
Maintained-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 1-13 are provisionally rejected on the ground of nonstatutory double patenting over amended claims 1-12 (dated 04/06/2026) of co-pending Application No. 18/283,772 (US 2024/0182408 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 amended claims 1-12 (dated 04/06/2026) of co-pending Application No. 18/283,772 (US 2024/0182408 A1) since the referenced co-pending application and the instant application are claiming common subject matter, as follows: “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…” as claimed in claims 1-13 of the instant application and falls entirely within the scope amended claims 1-12 (dated 04/06/2026) of co-pending Application No. 18/283,772 (US 2024/0182408 A1). This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Applicants’ have traversed the above ODP rejection with the following arguments: (see page 4 of Applicants’ REMARKS dated 04/14/2026).
Applicants’ argue: “Applicant notes that the rejection is provisional in nature and will address the obviousness- type double patenting rejection upon indication that the claims are otherwise allowable”.
Reply: Applicants’ arguments have been fully considered but are not deemed persuasive for the following reasons. Examiner is maintaining the rejection for reasons made of record in the Office-action dated 12/03/2025, as none of the claims are ready for allowance.
New-Claim Rejections: 35 USC § 103
Necessitated by claim amendments
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.
Amended Claims 1-13 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kato M., (JP 2014-005296 A_MT) and further in view of Sawada et al., (US 5,788,758 A), Kamata et al., (JP-2019-076088 A_MT, English Machine Translation), Aoyanagai et al., (JP-2008-285476 A_MT, English Machine Translation) and Printz et al., (US 2018/0228165 A1).
Regarding claims 1, 3, 5, 7 and 9, Kato M., (JP 2014-005296 A_MT) disclose dry S-1-propenyl-cysteine sulfoxide (PRENCSO) composition comprising purified PRENCSO; see Abstract, Fig, 1-10; ¶ [0001], [0016-0020], [0036-0039], [0048-0052], [0066-0068]. Certain relevant sections from Kato M., (JP 2014-005296 A_MT) is reproduced below:
[0048]
7. PRENCSO stabilization step
The PRENCSO stabilization step is a step of holding the PRENCSO separated in
the PRENCSO separation step in an acidic aqueous solution.
[0052]
This newly found finding is also useful for stabilization of PRENCSO obtained by
a conventional method. That is, the present invention also provides a method for
storing PRENCSO, which comprises holding PRENCSO in an acidic aqueous
solution.
[0066]
(3) Preparation of Purified PRENCSO Solution
(3-1) Extraction of PRECNSO from Heated Onion
The outer skin of three raw onions (1000g) is peeled off, wrapped, and heated in
a microwave oven for 12 minutes. The heated onion is placed in a mixer, an
equal amount of distilled water is added thereto, the onion is crushed, and the
crushed liquid is centrifuged in a 8000rpm for 10 minutes. The supernatant is
recovered, and cation exchange IR120B is added thereto, followed by stirring.
Distilled 1L is added to the recovered resins, and concentrated ammonium water
is added thereto to prepare pH8. 5. The supernatant is recovered by vacuum
filtration and pH8. 5 of ammonium hydroxide is again added to the remaining
resins. The supernatant is collected again by suction filtration. The resulting
solutions are neutralized to pH7. 0 by the addition of 1N hydrochloride. The
solution is concentrated to dryness using an evaporator.
[0067]
(3-2) Purification of PRENCSO
The residue is dissolved in distilled 50ml. The resulting crude PRENCSO solution
is purified by medium pressure reverse phase chromatography. If necessary, the
product is further purified by HPLC (column: ODS, moving phase: acidic water
pH3. 3, temperature: 35 ° C., UV: 230nm). The eluate obtained from the column
is evaporated to dryness using an evaporator and a freeze dryer to obtain a
purified PRENCSO powder (about 100mg).
Kato M., (JP 2014-005296 A_MT) also provide teaching, suggestion and motivation for the use of saccharides as a stabilizing agent in preserving the stability of additional components required by the instant invention such as Lachrymator Factor Synthase (LFS) and Alliinase and provide clear suggestion “In order to protect alliinase, it is preferable to further allow a protective agent such as a sugar to coexist”, see ¶ [0042] and the explicit suggestion “allow a protective agent such as a sugar to coexist”, a skilled artisan will be motivated to include a saccharide in the dried composition of PRENSCO while integrating additional components Lachrymator Factor Synthase (LFS) and Alliinase comprising a saccharide as stabilizing agent in the claimed composition of PRENSCO and as claimed in the instant invention, as saccharides are shown to be protective agent for the additional components Lachrymator Factor Synthase (LFS) and Alliinase and modify the teachings of Kato M., (JP 2014-005296 A_MT). Examples of the protective agent for LFS and Alliinase include sugars, preferably disaccharides. Examples of the disaccharide include sucrose, trehalose, maltose, lactose, and cellobiose; see ¶ [0041-0047], reproduced below:
[0040]
6. LFS Stabilization Step
The LFS stabilization step is a step of bringing LFS separated in the LFS
separation step into a dry state together with alliinase.
[0041]
The present inventors have surprisingly found that LFS can be stably stored even
at room temperature when dried together with alliinase.
[0042]
In order to protect alliinase, it is preferable to further allow a protective agent
such as a sugar to coexist. Examples of the protective agent for alliinase include
sugars, preferably disaccharides. Examples of the disaccharide include sucrose, trehalose, maltose, lactose, and cellobiose. The protective agent may contain a salt in addition to the sugar. Examples of the salts include any salts, for example, KCl,MgCl2,NaCl and the like, and monovalent metallic salts are preferred, and to be specific, NaCl is preferred. In addition, the protectant can also include pyridoxal phosphate. That is, the protective agent is a component comprising (a) a sugar, or (b) a sugar and a salt and / or pyridoxal phosphate.
[0043]
The abundance ratio of alliinase and LFS can be, for example, in the range of
alliinase 0.02Units:LFS 0.5μl (specific activity 6.2 × 109 PA /μl) to alliinase
200Units:LFS 0.5μl (specific activity 6.2 × 109PA /μl). Preferably, it is about
alliinase 10Units:LFS 0.5μl (specific activity 6.2 × 109PA /μl).
[0044]
When a mixture of LFS and alliinase is dried to prepare a dry mixed enzyme,
examples of drying means include freeze-drying and hot-air drying, and freeze drying is particularly desirable. Although the mixture of LFS and alliinase can be dried as it is from the solution, for example, the mixed solution of LFS and alliinase can be absorbed by a water-absorbing body or a highly water-absorbing
carrier, followed by drying.
[0045]
The dry mixed enzyme is preferably used in the form of a powder, but may be in the form of granules or a powder as long as it can be easily rehydrated.
[0047]
When it is used as a powder or granules, a protective agent for alliinase, such as
maltose, may be used as an adjuvant.
However, Kato M., (JP 2014-005296 A_MT) are silent regarding wherein PRENCSO composition comprising 5 parts by mass or more of sugar relative to 1 part by mass of PRENCSO (as in claims 4 and 8); and PRENCSO composition porous carrier and dry enzyme composition comprising alliinase, a lachrymatory factor synthase (LFS) and a porous carrier being integrated (as in claims 2, 6 and 10-13).
Regarding claims 1, 3, 5, 7 and 9, Sawada et al., (US 5,788,758 A) also provide teaching, suggestion and motivation for a composition comprising purified and dried PRENCSO, a saccharide and Alliinase; i.e., combining the reaction product of Alliinase and PeCSO (purified trans-(+)-S-(1-propenyl)-L-cysteine sulfoxide, CAS: 3836-24-6), see Abstract; col. 1, lines 1-16; Claims 1-4 and entire document; said saccharides include glucose and sucrose and drying the mixture (col. 4,lines 30-36; and col. 6, lines 25-31).
Regarding claims 1, 3, 5, 7 and 9, 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 and 10-11, 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], [0019-0020], [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/sucrose/maltose/sugar, such as maltose ¶ [0115], [0042], [0073-0074], [0078-0079]); said components of the kit is absorbed into a water-adsorbing body or highly water-absorbing carrier, followed by drying (¶ [0040], [0072]).
Regarding claims 2 and 6, 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]); said reference lachrymatory factor synthase (LFS) is encapsulated in hydrophilic gels ([0010], [0014-0017]; claims 17-18); reproduced below:
[0010] In the present invention, these parts (mixing of a precursor with active enzymes in liquid form to produce biopesticide and/or repellent product, enhancing the lifespan of the enzymes, use of hydrophilic gels) are merged together in order to produce for the first time active mesoporous materials encapsulated in a hydrophilic gel in order to produce in situ a constant flux of biopesticide and/or repellent product.
[0014] In various embodiments, the at least one nanoporous material is a mesoporous material.
[0015] In various embodiments, the at least one nanoporous material is embedded within one hydrophilic gel.
[0016] In various embodiments, the hydrophilic gel is made of agarose, agar-agar, alginate, pectin, starch and/or gelatine, in various instances made of alginate.
[0017] In various embodiments, the at least one active enzyme is one active enzyme selected from the group of glycosidase, lyase and/or lachrymatory-factor synthase, in various instances from the group of glycosidase.
Claims
17. The preparation according to claim 16, wherein the at least one nanoporous material is embedded within one hydrophilic gel,
18. The preparation according to claim 17, wherein the hydrophilic gel is made of at least one of agarose, agar-agar, alginate, pectin, starch and gelatine.
As such, disclosure of strategy and methods for generating “S-1-propenyl-cysteine sulfoxide (PRENCSO) and a saccharide, said composition is dry enzyme composition comprising alliinase, a lachrymatory factor synthase (LFS) and a porous carrier being integrated (as in claims 2, 6 and 10-11); and comprising 5 parts by mass or more of sugar relative to 1 part by mass of PRENCSO (as in claims 4 and 8)”, such as that of references of Sawada et al., Kamata et al., and Printz et al., teaching the advantages of said modifications and said compositions in the form a kit (as in claim 1) as suggested by Aoyanagai et al., clearly suggests to a skilled artisan to modify the teachings of Kato M., and incorporate the structural and functional elements of Sawada et al., Kamata et al., Aoyanagai et al., and Printz et al., in the claimed kit and method for preparing a lachrymatory factor generating kit comprising: (1) purified and dry S-1-propenyl-cysteine sulfoxide (PRENCSO) and saccharide, composition comprising PRENCSO, a saccharide 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) purified and dry PRENCSO and saccharide, composition comprising PRENCSO, a saccharide 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) purified and dry S-1-propenyl-cysteine sulfoxide PRENCSO and saccharide, composition comprising PRENCSO, a saccharide 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 Sawada et al., Kamata et al., Aoyanagai et al., and Printz et al., and to modify the teachings of Kato et al. A person of ordinary skill in the art is motivated to make such change, because (1) purified and dry S-1-propenyl-cysteine sulfoxide PRENCSO and saccharide, composition comprising PRENCSO, a saccharide 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) purified and dry S-1-propenyl-cysteine sulfoxide PRENCSO and saccharide, composition comprising PRENCSO, a saccharide 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 Sawada et al., Kamata et al., Aoyanagai 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 Kato et al., Sawada et al., Kamata et al., Aoyanagai 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 will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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 (Kato et al., Sawada et al., Kamata et al., Aoyanagai et al., and Printz et al.,) i.e., a dry S-1-propenyl-cysteine sulfoxide 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 lachrymatory factor synthase (LFS) and a porous carrier carrying them and being dried as taught by the instant invention and as claimed in claims 1-13 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 1-13 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kato M., (JP 2014-005296 A_MT) and further in view of Sawada et al., (US 5,788,758 A), Kamata et al., (JP-2019-076088 A_MT, English Machine Translation), Aoyanagai et al., (JP-2008-285476 A_MT, English Machine Translation) and Printz et al., (US 2018/0228165 A1).
Applicants’ have traversed the above 35 U.S.C. 103(a) rejection following claim amendments and said arguments are relevant to the new rejection (see pages 4-6 of Applicants’ REMARKS dated 04/14/2026).
Applicants’ argue (A): “…Applicant respectfully disagrees that Aoyanagi in view of Kamata, Printz, and Heubes render the pending claims obvious. As discussed during the interview on March 16, 2026, pending claims 1 and 5 describe, among others, a kit and a method using "dry PRENCSO composition comprising purified PRENCSO," which is not disclosed in any of the cited references. Further, As stated in the office action, Aoyanagi fails to disclose a kit in which the claimed PRENCSO composition and dry enzyme composition are integrated. In fact, Aoyanagi teaches against such integration into a single kit, stating that dry powder prepared with the substrate (i.e., PRENCSO) and LFS makes it "difficult to produce a stable lachrymatory component" and suggests preparing dry powder with only the LFS and allinase (i.e., without PRENCSO). Given this teaching, a person of ordinary skill in the art ("POSITA") would not have been motivated to modify Aoyanagi based on any of the secondary references to arrive at the claimed invention. Furthermore, Aoyanagai is "Patent literature 3" described in paragraph [0005] of the specification of the present application, and is technically identical to the "conventional lachrymatory component generating kit" in the Examples section of this application. Therefore, as shown in Figure 1 of the present application, the production of LF (lacrymatory factor) was significantly suppressed (30-58%) compared to the conventional kit, and as shown in Figure 3, the pain intensity felt by the subject was significantly reduced. These unexpected and remarkable effects are clearly demonstrated by the present application's specification. Aoyanagai neither states nor suggests that the use of the present application's configuration enables such physiological pain suppression, and there is no rational motivation for the present application.”
Reply (A): Applicants’ arguments have been fully considered but are not deemed persuasive for the following reasons, as some of the applicants’ arguments are directed at limitations not recited in the claims, furthermore, “Although the claims are examined in the light of the specification, specification cannot be read into the claims”.
Examiner has provided a new references: (i) Kato M., (JP 2014-005296 A_MT) disclose dry S-1-propenyl-cysteine sulfoxide (PRENCSO) composition comprising purified PRENCSO; see Abstract, Fig, 1-10; ¶ [0001], [0016-0020], [0036-0039], [0048-0052], [0066-0068]; and Kato M., (JP 2014-005296 A_MT) also provide teaching, suggestion and motivation for the use of saccharides as a stabilizing agent in preserving the stability of additional components required by the instant invention such as Lachrymator Factor Synthase (LFS) and Alliinase and provide clear suggestion “In order to protect alliinase, it is preferable to further allow a protective agent such as a sugar to coexist”, see ¶ [0042] and the explicit suggestion “allow a protective agent such as a sugar to coexist”, a skilled artisan will be motivated to include a saccharide in the dried composition of PRENSCO while integrating additional components Lachrymator Factor Synthase (LFS) and Alliinase comprising a saccharide as stabilizing agent in the claimed composition of PRENSCO and as claimed in the instant invention, as saccharides are shown to be protective agent for the additional components Lachrymator Factor Synthase (LFS) and Alliinase and modify the teachings of Kato M., (JP 2014-005296 A_MT). Examples of the protective agent for LFS and Alliinase include sugars, preferably disaccharides. Examples of the disaccharide include sucrose, trehalose, maltose, lactose, and cellobiose; see ¶ [0041-0047].
Additionally, (ii) Sawada et al., (US 5,788,758 A) also provide teaching, suggestion and motivation for a composition comprising purified and dried PRENCSO, a saccharide and Alliinase; i.e., combining the reaction product of Alliinase and PeCSO (purified trans-(+)-S-(1-propenyl)-L-cysteine sulfoxide, CAS: 3836-24-6), see Abstract; col. 1, lines 1-16; Claims 1-4 and entire document; said saccharides include glucose and sucrose and drying the mixture (col. 4,lines 30-36; and col. 6, lines 25-31).
Applicants’ further argue (B): “…With respect to Printz, Applicant submits that this reference is not analogous to the claimed invention and therefore cannot be relied upon to reject the pending claims. Printz relates to "biopesticide and/or repellent for controlling plant pathogens," Printz at Abstract, paragraph [0002], and is therefore is not within the same field of lachrymatory factor that the pending claims pertain to. Moreover, Printz is not reasonably pertinent to the goal of resolving "pain [felt by a subject] in the case of using a generated lachrymatory factor to expose to the eye of the subject for collecting tears," specification at paragraph [0008], because Printz addresses an entirely different goal of "provid[ing] a preparation, able to produce a biopesticide and/or repellent for controlling plant pathogens, which is non-toxic and easy to handle." Printz at paragraph [0012]”
Reply (B): Applicants’ arguments have been fully considered but are not deemed persuasive for the following reasons. Examiner continues to maintain that 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]); said reference Printz et al., as a proof of principle provides evidence teaching the production of porous nanoporous material comprising immobilized lachrymatory factor synthase (LFS) and the corresponding substrate.
Additionally, 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], [0019-0020], [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/sucrose/maltose/sugar, such as maltose ¶ [0115], [0042], [0073-0074], [0078-0079] ); said components of the kit is absorbed into a water-adsorbing body or highly water-absorbing carrier, followed by drying (¶ [0040], [0072]).
Therefore, examiner continues to take the position that each and every element of the instant invention is taught in the combination of cited references and that the combined teachings in the cited prior art provides a reasonable expectation of success and predictability for the claimed method herein and the claimed benefits are very much expected and predictable.
The Supreme Court has acknowledged: When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation...103 likely bars its patentability...if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person's skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions ...... the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
Examiner continues to hold the position that the cited references render claims 1-13 prima facie obvious to one of ordinary skill in the art when one applies the Teaching, Suggestion and Motivation (TSM) test under the rationale for arriving at a conclusion of obviousness as suggested by the KSR ruling. The rationale applied for this rejection is as follows:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try”–choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
The combined teachings in the cited prior art provides a reasonable expectation of success and predictability for the claimed invention. In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Summary of Pending Issues
The following is a summary of issues pending in the instant application
Amended claims 1-13 are provisionally rejected on the ground of nonstatutory double patenting over amended claims 1-12 (dated 04/06/2026) of co-pending Application No. 18/283,772 (US 2024/0182408 A1).
Amended Claims 1-13 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kato M., (JP 2014-005296 A_MT) and further in view of Sawada et al., (US 5,788,758 A), Kamata et al., (JP-2019-076088 A_MT, English Machine Translation), Aoyanagai et al., (JP-2008-285476 A_MT, English Machine Translation) and Printz et al., (US 2018/0228165 A1).
Conclusion
None of the claims are allowable. Claims 1-13 are rejected for the reasons identified in the Rejections and Summary sections of this Office Action. Applicants’ must respond to the rejections in each of the sections in this Office Action to be fully responsive for prosecution.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Regarding filing an After Final amendment, Applicants are directed to MPEP 714.13, which states:
II. ENTRY NOT A MATTER OF RIGHT
It should be kept in mind that applicant cannot, as a matter of right, amend any finally rejected claims, add new claims after a final rejection (see 37 CFR 1.116) or reinstate previously canceled claims. Except where an amendment merely cancels claims, adopts examiner suggestions, removes issues for appeal, or in some other way requires ONLY A CURSORY REVIEW by the examiner (e.g., typographical errors), compliance with the requirement of a showing under 37 CFR 1.116(b)(3) is expected in all amendments after final rejection. An affidavit or other evidence filed after a final rejection, but before or on the same date of filing an appeal, may be entered upon a showing of good and sufficient reasons why the affidavit or other evidence is necessary and was not earlier presented in compliance with 37 CFR 1.116(e). See 37 CFR 41.33 and MPEP § 1206 for information on affidavit or other evidence filed after appeal. (Examiner's emphasis) If more than a cursory review is required, Applicants are referred to CFR §1.114.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHIRAMA RAGHU whose telephone number is (571)272-4533. The examiner can normally be reached on M-F 8:30am-5pm EST.
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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652
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