Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
1. Applicant’s election of Group I (claims 1-7) with traverse in the reply filed on 4/21/26 is acknowledged.
2. In traversing the restriction requirement – Applicants argue that the restriction is improper because all claimed inventions are linked by a common technical feature, namely the use of a trans-prenyltransferase (tPT) family protein to produce a trans-polyisoprenoid. This shared feature establishes a single general inventive concept under 37 CFR 1.475 and PCT Rule 13.1.
The Examiner's position that the tPT protein is known does not defeat unity, as the claims recite specific functional limitations that define a technical relationship across the groups. The remaining groups are directed to products, vectors, or uses that rely on or derive from the same core technology, and therefore should be considered together.
Upon allowance of the elected subject matter, Applicant requests that the Examiner rejoin the non-elected Groups to the extent that the claims recite all limitations of the allowable claims.
Response: The argument that “claims recite specific functional limitations that define a technical relationship across the groups” is considered and found not persuasive because the inventions listed as groups I-VI do not relate to a single general inventive
concept under PCT Rule 13.1 because, under PCT Rule 13.2, as indicated in the restriction requirement, they lack the same or corresponding special technical features for the following reasons. The technical feature linking groups I-VI appears to be that they all relate to trans-prenyltransferase (tPT) family protein. However, tPT family protein(s) were well known in the art, as will be seen in the 102 rejection applied to the claims 1-7 in this Office Action.
3. Claims withdrawn:
Claims 8-14 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
3. Priority
Receipt is acknowledged of papers (foreign priority filed 9/10/21) submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
4. 35 U.S.C. § 112, first paragraph (Written Description)
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention is directed to the following genus claims.
1. (Original) A method for producing a trans-polyisoprenoid, the method comprising binding to a lipid membrane in vitro a trans-prenyltransferase (tPT) family protein capable of producing a product with a molecular weight of 104 or more when not bound to any lipid membrane.
2. (Original) The method for producing a trans-polyisoprenoid according to claim 1 wherein the tPT family protein is a protein which has a membrane-binding domain and which can produce a product with a molecular weight of 104 or more in an aqueous layer when not bound to any lipid membrane after solubilization.
3. (Currently Amended) The method for producing a trans-polyisoprenoid according to claim 1, wherein the tPT family protein is derived from a trans rubber-producing plant.
4. (Currently Amended) The method for producing a trans-polyisoprenoid according to claim 1, wherein the tPT family protein is derived from Manilkara zapota.
5. (Original) The method for producing a trans-polyisoprenoid according to claim 1, wherein the tPT family protein is a protein to which an ability to bind to the lipid membrane has been imparted by fusing a membrane-binding peptide to a protein having no membrane-binding domain and capable of producing a product with a molecular weight of 104 or more in an aqueous layer when not bound to any lipid membrane.
6. (Original) The method for producing a trans-polyisoprenoid according to claim 5, wherein the protein having no membrane-binding domain and capable of producing a product with a molecular weight of 104 or more in an aqueous layer when not bound to any lipid membrane is derived from a trans rubber-producing plant.
7. (Currently Amended) The method for producing a trans-polyisoprenoid according to claim 1, wherein the binding comprises performing protein synthesis in the presence of both the lipid membrane and a cell-free protein synthesis solution containing an mRNA coding for the tPT family protein to bind the tPT family protein to the lipid membrane.
The claims are described by functional limitations only (see for example claim 1-7) and are devoid of a reference structure for the Sapodilla-derived tPT1 protein of SEQ ID NO: 2, or the encoding nucleic acid of SEQ ID NO: 1.
The claimed invention encompasses a genus of tPT1 protein, not adequately described.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe aninvention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what isclaimed."). Thus, an applicant complies with the written description requirement "bydescribing the invention, with all its claimed limitations, not that which makes it obvious,"and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966."Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents" of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents" of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include "level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient." MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case is discussed below.
Further, to provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include: a) the scope of the invention; b) actual reduction to practice; c) disclosure of drawings or structural chemical formulas; d) relevant identifying characteristics including complete structure, partial structure, physical and/or chemical properties, and structure/function correlation; e) method of making the claimed compounds; f) level of skill and knowledge in the art; and g) predictability in the art.
Moreover, Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir.1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus of polypeptides, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
5. 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.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miwa et al. [Miwa et al. (March 21, 2021), Annual Meeting of the Japan Society for Bioscience, Biotechnology, and Agrochemistry, 2021]. In vitro biosynthesis of isoprenoid polymers by trans-prenyltransferases identified from Manilkara zapota.
Miwa et al. describe the presence in nature of two types of polyisoprenoids, cis-1,4-polyisoprene and trans-1,4-polyisoprene - trans-Polyisoprene is a thermoplastic material used in the production of golf balls. Miwa et al. further disclose the biosynthesis of trans-polyisoprene to be catalyzed by trans-prenyltransferase (tPT), and identify the key enzyme responsible for the trans-polyisoprene biosynthesis in Sapodilla (Manilkara zapota). Based on similarity with the higher plant tPTs, two candidate genes, MzTPTI and MzTPT2, were found from the assembled transcriptome data of Sapodilla. Functional analyses revealed that MZTPT1 was a plastidial tPT synthesizing C₅₅ polyprenyl diphosphate. Meanwhile, MzTPT2 showed distinct activity synthesizing polymers (Mw=10³-10⁶) when it was introduced into rubber particles from Hevea brasiliensis by means of a cell-free translation system Heterologous transient expression of MzTPT2 in Nicotiana benthamiana resulted in formation of unknown granular structures in the cells. From these results, Miwa et al. succeeded in functional identification of the tPT that could biosynthesize trans-poly-isopreneoid from Sapodilla and inherently possess the all the characteristics or limitations of claims 1-7.
6. No claim is allowed.
7. US 20230002792 A1 is Applicants’ work, not used in any rejection.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TEKCHAND SAIDHA whose telephone number is (571)272-0940. The examiner can normally be reached on M-F 8.00-5.30. 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 B 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.
/TEKCHAND SAIDHA/
Primary Examiner, Art Unit 1652
Recombinant Enzymes, Hoteling
Telephone: (571) 272-0940
Fax: (571) 273-0940
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