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 08/15/2025, applicants’ response dated 11/17/2025 is acknowledged; in said response applicants’ have amended claims 1-14 and 17. Thus, amended claims 1-19 are pending in this application, elected Group 1, claims 1-13 is now under consideration for examination, and claims 14-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Rejections and/or objections not reiterated from previous office action are hereby withdrawn.
Maintained-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/JP2020/024525 filed on 06/23/2020 and claims the priority date of Japan application 2019-131427 filed on 07/16/2019; 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/JP2020/024525 filed on 06/23/2020.
Withdrawn-Claim Rejections: 35 USC § 112(b)
Previous rejections: I. Claims 2-10 rejected under 35 U.S.C. 112(b); II. Claims 4-7 and 10 rejected under 35 U.S.C. 112(b); and III. Claim 13 rejected under 35 U.S.C. 112(b), is being withdrawn due to claim amendments and persuasive arguments.
Withdrawn-Claim Rejections: 35 USC § 112(a)
Previous rejection of claims 1-13 rejected under 35 U.S.C. 112(a) for written-description and enablement, is being withdrawn due to claim amendments and persuasive arguments.
Withdrawn-Claim Rejections: 35 USC § 102 (AIA )
Previous rejections: I. Claims 1, 3 and 11-12 rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Van Roogien1 et al., (JP 2004-527227 A, in IDS); and II. Claims 1, 3 and 11-12 rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Van Roogien2 et al., (WO 02/50289 A1, in IDS), is being withdrawn due to claim amendments and persuasive arguments.
Withdrawn-Claim Rejections: 35 USC § 103
Previous rejection of claims 1-13 rejected under 35 U.S.C. 103(a) as being unpatentable over Van Roogien1 et al., (JP 2004-527227 A, in IDS) or Van Roogien2 et al., (WO 02/50289 A1, in IDS) as applied to claims 1, 3 and 11-12 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Yamashita et al., (Biosci., Biotechnol., & Biochem., 2018, Vol. 82(6): 1011-1020) and Imayoshi et al., (US 2021/0340548 A1, priority 08/31/2018; see ¶ [0001]), is being withdrawn due to claim amendments and persuasive arguments.
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.
Claims 1-13 are provisionally rejected on the ground of nonstatutory double patenting over amended claims 1, 5-7, 10 and 13 (dated 08/25/2025) of co-pending Application No. 17/755,383 (US 2023/0002792 A1) and in view of Imayoshi et al., (US 2021/0340548 A1, priority 08/31/2018; see ¶ [0001]). 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 since the referenced co-pending application and the instant application are claiming common subject matter, as follows: “a genus of fusion proteins, said genera of fusion proteins comprising any polypeptide encoding lipid droplets, any lipid droplet-associated protein (LDAP)/small rubber particle protein (SRPP) family proteins, any prenyltransferase family proteins and any linkers; said linker sequence is any an amino acid sequence containing one or more amino acid substitutions, deletions, insertions, and/or additions relative to the amino acid sequence SEQ ID NO:5 or an amino acid sequence with at least 80% sequence identity to the amino acid sequence SEQ ID NO:5”. The recited amended claims 1, 5-7, 10 and 13 (dated 08/25/2025) of co-pending Application No. 17/755,383 (US 2023/0002792 A1) and in view of Imayoshi et al., (US 2021/0340548 A1, priority 08/31/2018; see ¶ [0001]) also encompass, “… fusion proteins comprising any polypeptide encoding lipid droplets, any lipid droplet-associated protein (LDAP)/small rubber particle protein (SRPP) family proteins, any prenyltransferase family proteins and any linkers; said linker sequence is any an amino acid sequence containing one or more amino acid substitutions, deletions, insertions, and/or additions relative to the amino acid sequence represented by SEQ ID NO:5 or an amino acid sequence with at least 80% sequence identity to the amino acid sequence represented by SEQ ID NO:5” as claimed in claims 1-13 of the instant application and falls entirely within the scope of claims 1, 5-7, 10 and 13 (dated 08/25/2025) of co-pending Application No. 17/755,383 (US 2023/0002792 A1) and in view of Imayoshi et al., (US 2021/0340548 A1, priority 08/31/2018; see ¶ [0001]). Additionally Imayoshi et al., (US 2021/0340548 A1, priority 08/31/2018; see ¶ [0001]) also provide teaching and advantages of a linker sequence having 100% sequence identity to SEQ ID NO: 5 of the instant invention (see provided sequence alignment); said reference provides Teaching, Suggestion and Motivation for adding linker sequence having 100% sequence identity to SEQ ID NO: 5 of the instant invention in the claimed fusion protein of the instant invention. Co-pending Application No. 17/755,383 (US 2023/0002792 A1) also discloses first protein of fusion protein having 100% sequence identities to SEQ ID NOs: 4, 10 and 11 of the instant invention; and a second protein of fusion protein having 100% sequence identities to SEQ ID NOs: 2 or 3 of the instant invention (see provided sequence alignments). 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 pages 11-12 of Applicants’ REMARKS dated 11/17/2025).
Applicants’ argue: “…This is a provisional rejection. To require submission of a terminal disclaimer, at this time, would place an undue burden on Applicants since, currently, there is no guidance on the subject matter that would be allowable in this and the reference applications. Therefore, it would be premature to file a terminal disclaimer now when the scope of allowable claims is not known… Finally, establishing a prima facie case of obviousness requires the Examiner to explain why a person of ordinary skill in the art would have found it obvious with a reasonable expectation of success. As previously explained while discussing the obviousness rejections, no such reason was provided in the Office Action.”
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 08/15/2025; and Co-pending Application No. 17/755,383 (US 2023/0002792 A1) also discloses first protein of fusion protein having 100% sequence identities to SEQ ID NOs: 4, 10 and 11 of the instant invention; and a second protein of fusion protein having 100% sequence identities to SEQ ID NOs: 2 or 3 of the instant invention (see provided sequence alignments).
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 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.
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.
Claims 1-13 are rejected under 35 U.S.C. 103(a) as being unpatentable over Van Horn et al., (Plant Physiol., 2013, vol. 162: 1926-1936) and further in view of Asawatreratanakul et al., (Eur. J. Biochem., 2003, Vol. 4671-4680), Roogien et al., (JP 2004-527227 A, in IDS), Yamaguchi1 et al., (US 10,000,774), Yamaguchi2 et al., (US 10,907,179), Yamaguchi3 et al., (US 10,059,780) and Imayoshi et al., (US 2021/0340548 A1, priority 08/31/2018; see ¶ [0001]).
Amended Claims 1-13 as interpreted are directed to a genus of structures in the claimed fusion protein, said genera of fusion proteins comprising any first protein encoding a lipid droplets, any lipid droplet-associated protein (LDAP)/small rubber particle protein (SRPP) comprising the amino acid sequences having at least 80% sequence identity to SEQ ID NOs: 4, 10 or 11; any second protein encoding a prenyltransferase protein having at least 80% sequence identity to SEQ ID NOs: 2 or 3; and any linkers (as in claims 1-12); said linker sequence is any an amino acid sequence containing one or more amino acid substitutions, deletions, insertions, and/or additions relative to the amino acid sequence SEQ ID NO:5 or an amino acid sequence with at least 80% sequence identity to the amino acid sequence SEQ ID NO:5 (as in claim 13).
Regarding claims 1-12, Horn et al., (Plant Physiol., 2013, vol. 162: 1926-1936) disclose construction of fusion proteins comprising lipid droplet-associated protein (LDAP)/small rubber particle protein (SRPP); said reference LDAP/ SRPP comprising the amino acid sequences having 100% sequence identity to SEQ ID NO: 4 and SEQ ID NO: 10 of the instant invention (see provided sequence alignments); and suggest the use of SRPP in the production of large quantities of energy-dense lipids in cells (col. 1, page 1934). Applicants are directed to the following sections in Horn et al., (Plant Physiol., 2013, vol. 162: 1926-1936): Abstract; col. 1-2, page 1930; Fig. 5, page 1931; Materials and Methods, col. 1, page 1935; and entire document.
Regarding claims 1-12, Asawatreratanakul et al., (Eur. J. Biochem., 2003, Vol. 4671-4680) disclose construction of fusion proteins comprising prenyltransferase protein having 99.3% sequence identity to SEQ ID NOs: 2 and exhibiting enzyme activity of the instant invention and synthesizing rubber particles/hydrophobic compound (see provided sequence alignment). Applicants are directed to the following sections in Asawatreratanakul et al., (Eur. J. Biochem., 2003, Vol. 4671-4680): Abstract; col. 1, page 4672; Construction of fusion protein comprising reference prenyltransferase protein and exhibiting enzyme activity, col. 1, page 4673; col. 2, page 4676 to page 4677, Table 1 & Fig. 5; Detection of formation of rubber particles by said reference prenyltransferase, Fig. 6, page 4678; and entire document.
Van Roogien et al., (JP 2004-527227 A, in IDS) also discloses in the Claims; ¶ [0006-007], [0025-0027], [0053] and [0106]; and in Examples 1-4, paragraphs [0199-0247] a recombinant multimeric fusion protein, comprising (i) an oil-body-targeting-protein or a fragment thereof, (ii) a first recombinant polypeptide and (iii) a second recombinant polypeptide, wherein the first and second recombinant polypeptides are capable of forming a multimeric protein complex. Van Roogien et al., also indicates that the oil-body-targeting-protein is an oil body protein such as oleosins, the first recombinant polypeptide is thioredoxin and the second recombinant polypeptide is a thioredoxin reductase, an oil-body-surface-avoiding linker amino acid sequence is positioned between the oil-body-targeting-protein and the first recombinant polypeptide, and the linker is 5, 10, 15, 20, 25, 30 or more amino acids in length, and a chimeric nucleic acid encoding the multimeric fusion protein and the nucleic acid are incorporated into a recombinant expression vector, thereby expressing the multimeric fusion protein in a cell. Van. Applicants are also directed to Abstract; Materials and Methods; and entire document. Therefore, the disclosure of Van Roogien et al., (JP 2004-527227 A, in IDS).
The disclosure of Horn et al., Asawatreratanakul et al., and Van Roogien et al., as applied to claims 1-12 is described in the rejection above. However, Horn et al., Asawatreratanakul et al., and Van Roogien et al., does not teach wherein said linker sequence is any an amino acid sequence containing one or more amino acid substitutions, deletions, insertions, and/or additions relative to the amino acid sequence represented by SEQ ID NO:5 or an amino acid sequence with at least 80% sequence identity to the amino acid sequence represented by SEQ ID NO:5 (as in claim 13).
Regarding claims 1-10, the following references teach the structural and functional elements of the instant invention:
Yamaguchi1 et al., 10,000,774), disclose a prenyltransferase protein having 100% sequence identity to SEQ ID NO: 2 of the instant invention and production of polyisoprenoids/hydrophobic compound (see provided sequence alignment; Abstract; claims and entire document);
Yamaguchi2 et al., (US 10,907,179), disclose a prenyltransferase protein having 100% sequence identity to SEQ ID NO: 3 of the instant invention and production of polyisoprenoids/hydrophobic compound (see provided sequence alignment; Abstract; claims and entire document);
Yamaguchi3 et al., (US 10,059,780) disclose a small rubber particle protein (SRPP) having 100% sequence identity to SEQ ID 11 of the instant invention and production of rubber particles utilizing said reference SRRP (see provided sequence alignment; Abstract; col. 1, lines 30-45; claims and entire document).
Regarding claim 13, analogous art Imayoshi et al., (US 2021/0340548 A1, priority 08/31/2018; see ¶ [0001]) teach linker sequence having 100% sequence identity to SEQ ID NO: 5 of the instant invention (see provided sequence alignment); said reference teaches the use of said reference linker sequence in the construction of fusion proteins (Abstract; ¶ [0225]; page 47; and entire document).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to generate plasmid constructs and encoding polypeptides comprising lipid droplets which is a class II protein, wherein the second amino acid sequence is an amino acid sequence obtained from an enzyme that has an enzymatic activity to synthesize a hydrophobic compound and that itself is not capable of binding to lipid droplets, wherein the first amino acid sequence is an amino acid sequence obtained from a lipid droplet-associated protein (LDAP)/small rubber particle protein (SRPP) family protein from Hevea brasiliensis and said lipid particle is necessary for the activity of cis-prenyltransferase and able to synthesize natural rubber particles of industrial significance, as suggested by Yamaguchi1 et al., Yamaguchi2 et al., Yamaguchi3 et al., and to include the linker of Imayoshi et al., in the construction of the claimed fusion protein and to modify the teachings of Horn et al., Asawatreratanakul et al., and Van Roogien et al., such that the fusion protein would be potentially employed for the utilization substrates in the production of rubbers. A person of ordinary skill in the art is motivated to make such change, because a fusion protein with biochemical properties for the utilization substrates in the production of rubbers and a skilled artisan would realize such a modification would be useful to increase the production of rubbers. One of ordinary skill in the art has a reasonable expectation of success at adding the nucleic acid sequences and the encoding polypeptides/fusion proteins of Yamaguchi1 et al., Yamaguchi2 et al., Yamaguchi3 et al., and comprising the linker of Imayoshi et al., to the method of constructing fusion proteins comprising lipid droplets and enzymes of interest as disclosed by Horn et al., Asawatreratanakul et al., and Van Roogien et al., because the molecular biology techniques required to construct fusion proteins comprising lipid droplets and enzymes of interest 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 Horn et al., Asawatreratanakul et al., Van Roogien et al., Yamaguchi1 et al., Yamaguchi2 et al., Yamaguchi3 et al., and Imayoshi et al., also provide the structural and functional elements of the instant invention (Teaching, Suggestion and Motivation).
Given this extensive teaching in prior art (Horn et al., Asawatreratanakul et al., Van Roogien et al., Yamaguchi1 et al., Yamaguchi2 et al., Yamaguchi3 et al., and Imayoshi et al.,) a genus of structures in the claimed fusion protein, said genera of fusion proteins comprising any first protein encoding a lipid droplets, any lipid droplet-associated protein (LDAP)/small rubber particle protein (SRPP) comprising the amino acid sequences having at least 80% sequence identity to SEQ ID NOs: 4, 10 or 11; any second protein encoding a prenyltransferase protein having at least 80% sequence identity to SEQ ID NOs: 2 or 3; and any linkers; said linker sequence is any an amino acid sequence containing one or more amino acid substitutions, deletions, insertions, and/or additions relative to the amino acid sequence represented by SEQ ID NO:5 or an amino acid sequence with at least 80% sequence identity to the amino acid sequence represented by SEQ ID NO:5 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 Van Horn et al., (Plant Physiol., 2013, vol. 162: 1926-1936) and further in view of Asawatreratanakul et al., (Eur. J. Biochem., 2003, Vol. 4671-4680), Roogien et al., (JP 2004-527227 A, in IDS), Yamaguchi1 et al., (US 10,000,774), Yamaguchi2 et al., (US 10,907,179), Yamaguchi3 et al., (US 10,059,780) and Imayoshi et al., (US 2021/0340548 A1, priority 08/31/2018; see ¶ [0001]).
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 10-11 of Applicants’ REMARKS dated 11/17/2025).
Applicants’ argue: “…The Examiner argued it would have been obvious to replace the enzyme in Van Roogien’s multimeric protein complex with Yamashita’s cis-prenyltransferase protein (e.g., HRT1) and to include Imayoshi’s linker sequence. However, the Office Action did not explain how a fusion protein would result with a reasonable expectation of success from the proposed combination of the cited references when they fail to teach the amino acid sequence of any LDAP/SRPP protein.”
Reply: Applicants’ arguments have been fully considered but are not deemed persuasive for the reasons stated in the Office-action dated 08/15/2025 and addition0ally for the following reasons.
The cited primary reference, Horn et al., (Plant Physiol., 2013, vol. 162: 1926-1936) disclose construction of fusion proteins comprising lipid droplet-associated protein (LDAP)/small rubber particle protein (SRPP); said reference LDAP/ SRPP comprising the amino acid sequences having 100% sequence identity to SEQ ID NO: 4 and SEQ ID NO: 10 of the instant invention and said reference does indeed teach, suggest and provide motivation to a skilled artisan for the construction of fusion proteins utilizing lipid droplet-associated protein (LDAP)/small rubber particle protein (SRPP) and suggest the use of SRPP in the production of large quantities of energy-dense lipids in cells (col. 1, page 1934).
Examiner in the rejection above has also provided motivation to skilled artisan by way of secondary references:
Asawatreratanakul et al., (Eur. J. Biochem., 2003, Vol. 4671-4680) disclose construction of fusion proteins comprising prenyltransferase protein having 99.3% sequence identity to SEQ ID NOs: 2 and exhibiting enzyme activity of the instant invention in synthesizing rubber particles/hydrophobic compound.
Regarding claims 1-10, the following references teach the structural and functional elements of the instant invention:
Yamaguchi1 et al., (US 10,000,774), disclose a prenyltransferase protein having 100% sequence identity to SEQ ID NO: 2 of the instant invention and production of polyisoprenoids/hydrophobic compound (see provided sequence alignment; Abstract; claims and entire document);
Yamaguchi2 et al., (US 10,907,179), disclose a prenyltransferase protein having 100% sequence identity to SEQ ID NO: 3 of the instant invention and production of polyisoprenoids/hydrophobic compound (see provided sequence alignment; Abstract; claims and entire document);
Yamaguchi3 et al., (US 10,059,780) disclose a small rubber particle protein (SRPP) having 100% sequence identity to SEQ ID 11 of the instant invention and production of rubber particles utilizing said reference SRRP (see provided sequence alignment; Abstract; col. 1, lines 30-45; claims and entire document); and motivation to modify the teachings of primary reference Horn et al.
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.
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 has provided arguments above and it is obvious to follow the teaching, suggestion or motivation in the prior art. To reject a claim based on this rationale, Office personnel must resolve the Graham factual inquiries. Then, Office personnel must articulate the following:
(1) a finding that there was some teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings;
(2) a finding that there was reasonable expectation of success; and
(3) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness. MPEP 2143(I)(G).
All of the above elements are directly discussed in the body of the rejection. Regarding element (2), the reasonable expectation of success is the expectation to produce a genus of structures in the claimed fusion protein, said genera of fusion proteins comprising any first protein encoding a lipid droplets, any lipid droplet-associated protein (LDAP)/small rubber particle protein (SRPP) comprising the amino acid sequences having at least 80% sequence identity to SEQ ID NOs: 4, 10 or 11; any second protein encoding a prenyltransferase protein having at least 80% sequence identity to SEQ ID NOs: 2 or 3; and any linkers; said linker sequence is any an amino acid sequence containing one or more amino acid substitutions, deletions, insertions, and/or additions relative to the amino acid sequence represented by SEQ ID NO:5 or an amino acid sequence with at least 80% sequence identity to the amino acid sequence SEQ ID NO:5.
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
Claims 1-13 are provisionally rejected on the ground of nonstatutory double patenting over amended claims 1, 5-7, 10 and 13 (dated 08/25/2025) of co-pending Application No. 17/755,383 (US 2023/0002792 A1) and in view of Imayoshi et al., (US 2021/0340548 A1, priority 08/31/2018; see ¶ [0001]).
Claims 1-13 are rejected under 35 U.S.C. 103(a) as being unpatentable over Van Horn et al., (Plant Physiol., 2013, vol. 162: 1926-1936) and further in view of Asawatreratanakul et al., (Eur. J. Biochem., 2003, Vol. 4671-4680), Roogien et al., (JP 2004-527227 A, in IDS), Yamaguchi1 et al., (US 10,000,774), Yamaguchi2 et al., (US 10,907,179), Yamaguchi3 et al., (US 10,059,780) and Imayoshi et al., (US 2021/0340548 A1, priority 08/31/2018; see ¶ [0001]).
Claims 14-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on 408-918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652
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