DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-74 are canceled.
Claims 75-93 are pending.
Claims 75-93 are examined herein.
Claims 75-93 are rejected.
Priority
Application No. 19/233,583 filed on 06/10/2025 is a continuation of Application No. 18/647,942 filed on 04/26/2024 which is a continuation of PCT Application No. PCT/IB2023/056287 filed 06/16/2023 which claims priority to provisional Application No. 63/367,299 filed 06/29/2022.
Claim Rejections - 35 USC § 112
Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 78 and 87 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 78 and 87 recite “wherein the composition comprises a fraction of the seed, wherein the fraction contains an extract of the recombinant hemeprotein or a purified recombinant hemeprotein”. It is unclear how a fraction of a seed can contain either an extract of the recombinant protein or a purified recombinant hemeprotein since the extract or purified product would have to have been removed from the seed. Applicant should amend the claims to address the recited deficiency.
For purposes of examination, the claims are interpreted to require the composition of claim 75 or 85, wherein the composition comprises an extract of the recombinant hemeprotein or a purified recombinant hemeprotein from the seed.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 75-78, 80-87, and 89-93 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zheng (CN-114316031-A1, published on 04/12/2022) and as evidenced by Jurgens (Jurgens et al., 2000, Myoglobin: just an oxygen store or also an oxygen transporter?, Physiology, 15(5), 269-274).
Claim 75 is drawn to a soybean seed-derived composition comprising a recombinant hemeprotein, wherein the soybean seed is genetically modified with an expression cassette to produce the hemeprotein, and wherein the soybean seed comprises between about 5% to about 30% of the hemeprotein as a percentage of the total soluble protein of the soybean seed before the composition is prepared.
Claim 76 is drawn to the composition of claim 75, wherein the soybean seed comprises a nucleic acid encoding for the recombinant hemeprotein, wherein said nucleic acid is operatively linked to: a beta-phaseolin (phas) seed-specific promoter at the 5' end of the nucleic acid encoding for the hemeprotein; an arcs terminator at the 3' end of the nucleic acid encoding for the hemeprotein; and a Rb7Mar 3' Matrix Attachment Region at the 3' end of the arcs terminator.
Claim 77 is drawn to the composition of claim 75, wherein the soybean seed-derived composition is a food composition.
Claim 78 is drawn to the composition of claim 75, wherein the composition comprises a fraction of the seed, wherein the fraction contains an extract of the recombinant hemeprotein or a purified recombinant hemeprotein (see 112(b) rejection above for interpretation).
Claim 80 is drawn to the composition of claim 75, wherein the hemeprotein is selected from a plant derived hemeprotein, a microorganism derived hemeprotein, or an animal derived hemeprotein.
Claim 81 is drawn to the composition of claim 75, wherein the hemeprotein comprises a hemeprotein involved in oxygen transport, an enzyme having a heme prosthetic group, or a hemeprotein involved in the electron transport chain.
Claim 82 is drawn to the composition of claim 75, wherein the hemeprotein is selected from hemoglobin, myoglobin, neuroglobin, cytoglobin, cytochrome P450s, cytochrome c oxidase, ligninases, catalase, peroxidases, cytochrome a, cytochrome b, or cytochrome c.
Claim 83 is drawn to the composition of claim 75, wherein the hemeprotein is an animal derived hemeprotein selected from the group consisting of hemoglobin and myoglobin.
Claim 84 is drawn to the composition of claim 75, wherein the transgenic soybean seed is a transgenic Glycine max seed.
Claim 85 is drawn a food composition comprising a recombinant hemeprotein, wherein the composition is prepared from a fraction of a transgenic soybean seed, wherein the transgenic soybean seed is genetically modified with an expression cassette to produce the hemeprotein, and wherein the hemeprotein is expressed in the transgenic soybean seed between about 5% to about 30% of the hemeprotein as a percentage of the total soluble protein of the transgenic soybean seed.
Claim 86 is drawn to the composition of claim 85, wherein the transgenic soybean seed comprises a nucleic acid encoding for the hemeprotein, wherein said nucleic acid is operatively linked to:a beta-phaseolin (phas) seed-specific promoter at the 5' end of the nucleic acid encoding for the hemeprotein;an arcs terminator at the 3' end of the nucleic acid encoding for the hemeprotein; and a Rb7Mar 3' Matrix Attachment Region at the 3' end of the arcs terminator.
Claim 87 is drawn to the composition of claim 85, wherein the composition comprises a fraction of the seed, wherein the fraction contains an extract of the recombinant hemeprotein or a purified recombinant hemeprotein.
Claim 89 is drawn to the composition of claim 85, wherein the hemeprotein is selected from a plant derived hemeprotein, a microorganism derived hemeprotein, or an animal derived hemeprotein.
Claim 90 is drawn to the composition of claim 85, wherein the hemeprotein comprises a hemeprotein involved in oxygen transport, an enzyme having a heme prosthetic group, or a hemeprotein involved in the electron transport chain.
Claim 91 is drawn to the composition of claim 85, wherein the hemeprotein is selected from hemoglobin, myoglobin, neuroglobin, cytoglobin, cytochrome P450s, cytochrome c oxidase, ligninases, catalase, peroxidases, cytochrome a, cytochrome b, or cytochrome c.
Claim 92 is drawn to the composition of claim 85, wherein the hemeprotein is an animal derived hemeprotein selected from the group consisting of hemoglobin and myoglobin.
Claim 93 is drawn to the composition of claim 85, wherein the transgenic soybean seed is a transgenic Glycine max seed.
Regarding claims 75-76, Zheng discloses a method for producing hemoglobin/myoglobin by using transgenic soybean seed, and the hemoglobin/myoglobin produced by the method can be used as coloring additive for food (¶n0020). Thus, Zheng discloses a composition that is a food coloring additive comprising recombinant hemoglobin produced from transgenic soybeans.
Regarding claim 77, Zheng discloses the composition is a food coloring additive (i.e. the composition is a food composition) (¶n0020).
Regarding claim 78, Zheng discloses the method for producing heme-binding protein comprises expressing hemoglobin or myoglobin in soybean seeds, and then separating and extracting the heme-binding protein to obtain the heme-binding protein (¶n0008).
Regarding claims 80 and 82-83, Zheng discloses the heme protein is animal-derived myoglobin (¶n0010)
Regarding claim 81, Zheng discloses the protein is myoglobin (¶n0010), which is known in the art to be involved in oxygen transport as evidenced by Jurgens (Abstract), and is also disclosed in the specification (¶0100).
Regarding claim 84, Zheng discloses the seed is soybean seed (i.e. Glycine max seed) (¶n0020).
Regarding claims 85-86, Zheng discloses a method for producing hemoglobin/ myoglobin by using transgenic soybean seed, and the hemoglobin/ myoglobin produced by the method can be used as coloring additive for food (¶n0020). Thus, Zheng discloses a food composition that is a food coloring additive comprising recombinant hemoglobin produced from transgenic soybeans.
Regarding claim 87, Zheng discloses the method for producing heme-binding protein comprises expressing hemoglobin or myoglobin in soybean seeds, and then separating and extracting the heme-binding protein to obtain the heme-binding protein (¶n0008).
Regarding claims 89 and 91-92, Zheng discloses the heme protein is animal-derived myoglobin (¶n0010).
Regarding claim 90, Zheng discloses the protein is myoglobin (¶n0010), which is known in the art to be involved in oxygen transport as evidenced by Jurgens (Abstract), and is also disclosed in the specification (¶0100).
Regarding claim 93, Zheng discloses the seed is soybean seed (i.e. Glycine max seed) (¶n0020).
Based on the above disclosure, the product that is the composition produced by the method or plant recited claim 75 or 85 is structurally identical to the composition disclosed by Zheng. The MPEP states "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)” (MPEP 2113.I). Therefore, even though Zheng does not disclose the method steps in claim 75 or 85 that is “wherein the composition is prepared from a fraction of a transgenic soybean seed, wherein the transgenic soybean seed is genetically modified with an expression cassette to produce the hemeprotein, and wherein the hemeprotein is expressed in the transgenic soybean seed between about 5% to about 30% of the hemeprotein as a percentage of the total soluble protein of the transgenic soybean seed”, the claims are only drawn to a soybean seed-derived composition comprising a recombinant hemeprotein (claim 75) and a food composition comprising a recombinant hemeprotein (claim 85) which is the same as the composition in the prior art and is therefore unpatentable. Additionally, the additional claimed limitations to the soybean seed from which the composition was produced (see, e.g. claims 76 and 86) does not structurally alter the claimed composition, and therefore does not limit the composition which is anticipated by Zheng. For these reasons, the product of the claimed composition in claims 75-78, 80-87, and 89-93 is anticipated in view of Zheng.
Claims 75, 79, 85 and 88 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Varadan (WO-2022072846-A2).
Claim 75 is drawn to a soybean seed-derived composition comprising a recombinant hemeprotein, wherein the soybean seed is genetically modified with an expression cassette to produce the hemeprotein, and wherein the soybean seed comprises between about 5% to about 30% of the hemeprotein as a percentage of the total soluble protein of the soybean seed before the composition is prepared.
Claim 79 is drawn to the composition of claim 75, wherein the composition or recombinant hemeprotein has been solubilized, precipitated, partially hydrolyzed, fully hydrolyzed, crosslinked, emulsified, or texturized.
Claim 85 is drawn a food composition comprising a recombinant hemeprotein, wherein the composition is prepared from a fraction of a transgenic soybean seed, wherein the transgenic soybean seed is genetically modified with an expression cassette to produce the hemeprotein, and wherein the hemeprotein is expressed in the transgenic soybean seed between about 5% to about 30% of the hemeprotein as a percentage of the total soluble protein of the transgenic soybean seed.
Claim 88 is drawn to the composition of claim 85, wherein the composition or recombinant hemeprotein has been solubilized, precipitated, partially hydrolyzed, fully hydrolyzed, crosslinked, emulsified, or texturized.
Regarding claims 75 and 85, Varadan discloses a plant -based food composition comprising a recombinant heme-containing polypeptide from the transgenic soybean seeds (claims 1, 21, 23, 26, 42, and 47 of Fraser). Thus, Varadan discloses the claimed soybean seed-derived composition comprising a recombinant hemeprotein (claim 75) and a food composition comprising a recombinant hemeprotein (claim 85).
Regarding claims 79 and 88, Varadan discloses to isolate the heme-containing polypeptide from seeds, the plant material can be processed by various means and discloses the heme-loaded proteins also can be separated on the basis of their solubility, for example, by ammonium sulfate precipitation or isoelectric precipitation (p. 34, lines 13-37). Thus Varadan discloses in an embodiment the recombinant hemeprotein has been precipitated.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 75-93 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 10-16, and 24-25 of U.S. Patent No. 12359214. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the patent anticipate the instant claims.
Claims 75-78, 80-87, and 89-93 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 75, 77-82, 84-85, 88-89, and 91-92 of copending Application No. 18/877,622 in view of Zheng (CN-114316031-A1).
The copending Application teaches a plant expression vector comprising a nucleic acid encoding a recombinant protein, wherein said nucleic acid is operatively linked to a beta-phaseolin (phas) seed-specific promoter, an Arcs terminator, and a Rb7Mar 3' Matrix Attachment Region;wherein, when the plant expression vector is integrated into a genome plant, induces the production of the recombinant protein in plant seeds in an amount between 3-30% of recombinant protein per total soluble protein in the seed (claim 75). The copending app also teaches a genetically modified plant, plant tissue, or plant seed comprising and expressing this vector (claim 78), and a method to produce 3-30% of recombinant proteins per total soluble protein in plant seeds by cultivating a plant expressing the expression vector (claim 85). The copending app further teaches wherein the plant is Glycine max, a seed harvest from the plant, and a recombinant protein isolated from the method (claims 81-82, 84, 88-89, and 91-92).
However, the copending application does not teach in its claims a soybean seed-derived composition comprising a recombinant protein from the transgenic seed described by the copending app, or a food composition comprising a recombinant hemeprotein (claims 75, 77, and 85). The copending app also does not teach the limitations of instant claims 80-83 and 89-92.
In analogous art, Zheng teaches an invention of a method for producing hemoglobin/myoglobin by using transgenic soybean seed, and the hemoglobin/myoglobin produced by the method can be used as coloring additive for food (¶n0020). Regarding claims 80, 82-83, 89, and 91-92, Zheng teaches the heme protein is animal-derived myoglobin (¶n0010) Regarding claims 81 and 90, Zheng teaches the protein is myoglobin (¶n0010), which is known in the art to be involved in oxygen transport as evidenced by Jurgens (Abstract), and is also disclosed in the specification (¶0100).
It would therefore be prima facie obvious to combine the methods to arrive at the instant claims with a reasonable expectation of success because one of ordinary skill in the art could produce the composition taught by Zheng using the methods and plants in the copending application without encountering any special technical difficulties. One of ordinary skill in the art would have been motivated to do so for the same purpose of generating myoglobin from transgenic soybean seeds to produce compositions comprising the myoglobin such as food coloring.
This is a provisional nonstatutory double patenting rejection.
Claims 79 and 88 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 75, 77-82, 84-85, 88-89, and 91-92 of copending Application No. 18/877,622 in view of Varadan (WO-2022072846-A2).
The copending Application teaches a plant expression vector comprising a nucleic acid encoding a recombinant protein, wherein said nucleic acid is operatively linked to a beta-phaseolin (phas) seed-specific promoter, an Arcs terminator, and a Rb7Mar 3' Matrix Attachment Region;wherein, when the plant expression vector is integrated into a genome plant, induces the production of the recombinant protein in plant seeds in an amount between 3-30% of recombinant protein per total soluble protein in the seed (claim 75). The copending app also teaches a genetically modified plant, plant tissue, or plant seed comprising and expressing this vector (claim 78), and a method to produce 3-30% of recombinant proteins per total soluble protein in plant seeds by cultivating a plant expressing the expression vector (claim 85). The copending app further teaches wherein the plant is Glycine max, a seed harvest from the plant, and a recombinant protein isolated from the method (claims 81-82, 84, 88-89, and 91-92).
However, the copending application does not teach in its claims a soybean seed-derived composition comprising a recombinant protein from the transgenic seed described by the copending app, or a food composition comprising a recombinant hemeprotein (claims 75, 77, and 85). The copending app also does not teach the limitations of instant claims 79 and 88.
In analogous art, Varadan similarly teaches a plant -based food composition comprising a recombinant heme-containing polypeptide from the transgenic soybean seeds (claims 1, 21, 23, 26, 42, and 47 of Fraser).
Regarding claims 79 and 88, Varadan teaches to isolate the heme-containing polypeptide from seeds, the plant material can be processed by various means and discloses the heme-loaded proteins also can be separated on the basis of their solubility, for example, by ammonium sulfate precipitation or isoelectric precipitation (p. 34, lines 13-37). Thus Varadan teaches the recombinant hemeprotein has been precipitated.
It would therefore be prima facie obvious to combine the methods to arrive at the instant claims with a reasonable expectation of success because one of ordinary skill in the art could produce the composition taught by Varadan using the methods and plants in the copending application without encountering any special technical difficulties. One of ordinary skill in the art would have been motivated to do so for the same purpose of producing a soybean seed-derived composition or food composition comprising a recombinant heme protein, wherein the recombinant hemeprotein has been precipitated.
This is a provisional nonstatutory double patenting rejection.
Conclusion and Inquiries
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA N STOCKDALE whose telephone number is (703)756-5395. The examiner can normally be reached M-F 8:30-5:00 CT.
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JESSICA N. STOCKDALE
Examiner
Art Unit 1663
/JESSICA NICOLE STOCKDALE/Examiner, Art Unit 1663
/CHARLES LOGSDON/Primary Examiner, Art Unit 1662
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