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 .
Election / Restrictions
In response to the previous restriction requirement, Applicant has chosen to elect Group I for examination, consisting of claims 1-2, 4-7, 10, 14, 16 & 18, without traverse. Applicant has elected species (k), consisting of SEQ ID NO.11 and its encoded protein product (SEQ ID NO.24).
Claim Status
Claims 1-2, 4-7, 10, 14, 16 & 18 are under examination on the merits.
Claims 19-20 & 28-34 are withdrawn as directed to non-elected matter.
Claims 3, 8-9, 11-13, 15, 17 & 21-27 are canceled.
Priority
Claims 1-2, 4-7, 10, 14, 16 & 18 receive the U.S. effective filing date of 13 Apr 2022.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code [¶.228]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - Nonstatutory 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 10, 14, & 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over copending U.S. Patent Application No. US-20250197797-A1 ‘Transgenic Helichrysum Umbraculigerum Cell, Tissue, Or Plant’.
Regarding claims 10 & 16 of the instant application; these are drawn to transgenic cells or plants that possess a UDP UGT protein from Helichrysum as described in claim 6. However, the claim does not limit this to cells or plants that are not Helichrysum species. Thus, any Helichrysum cell or plant which is transgenic and having endogenous UDP UGT proteins would meet the limitations of claims 10 & 16 as currently written.
Claim 1 of the copending application recites a transgenic Helichrysum plant. Claims 2-3 & 10-19 of the copending application further recite limitations of generating or using transgenic Helichrysum plants.
These are the same limitations as drawn to by claims 10 & 16 of the instant application, which recite transgenic cells or plants comprising a Helichrysum UDP UGT protein. Therefore claims 10 & 16 of the instant application are drawn to the same products concurrently claimed in Applicant’s pending Application No.18/845,798.
Because of this, claims 10 & 16 are rejected as a nonstatutory double patenting rejection.
Regarding claim 14 of the instant application; this is drawn to an extract of a transgenic cell as recited in claim 10 from which it depends, discussed above (i.e. transgenic cells comprising Helichrysum UDP UGT protein).
Claim 7 of copending Application No.18/845,798 recites an extract or fraction derived from transgenic H. umbraculigerum cells, tissues, or plants and producing cannabinoids.
These are the same limitations of claim 14 in the instant application. Therefore, claim 14 of the instant application is drawn to the same products claimed in Applicant’s pending Application No.18/736144.
Because of this, claim 14 is rejected as a nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 4, 6-7 & 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (i.e. a product of nature) without significantly more. The claims recite an isolated DNA molecule having at least 87% homology to SEQ ID NO.11 and encoding a UDP-UGT protein. This judicial exception is not integrated into a practical application because the claim is directed to a naturally occurring genetic sequence (allele) encoding a UDP-UGT protein (i.e. SEQ ID NO.13) which is merely characterized by Applicant (i.e. it is a naturally occurring gene).
The claims are directed to products (i.e. a DNA sequence or encoded protein) which are a product of nature (i.e. a naturally occurring gene and encoded protein).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because applicant is not modifying, altering or otherwise creating any structural features that would differentiate their claimed DNA molecule from naturally occurring DNA molecules, or fragments thereof, currently existing in Helichrysum plants. Applicant describes the claimed sequence as being directly isolated from Helichrysum plants, and there is no indication that the genes or plants from which such DNA or polypeptide sequences are described are a result of directed mutagenesis, genetic engineering, or anything other than analysis of wild-collected Helichrysum plants [p.54—55, Examples 1 & 2].
Regarding claim 4; it recites ‘an artificial nucleic acid molecule’ but does not indicate the artificial molecule is different from the naturally occurring molecule, only that it is artificial (i.e. synthetic). Referring to the specification to clarify what constitutes ‘artificial’, there is no definition indicating that such a molecule requires a mutation or change from the sequence of the natural polynucleotide. As such, the claimed ‘artificial nucleic acid’ could be chemically identical to isolated DNA and therefore structure does not make such an artificial nucleic acid patentably distinct.
Regarding claim 18; it is drawn to compositions comprising the Helichrysum protein of claim 6. Broadest reasonable interpretation of such a claim is that raw plant extract of H. umbraculigerum, or plant material itself, is a composition containing proteins the plant inherently makes (i.e. the protein of claim 6). As such, this claim encompasses a naturally occurring protein, in naturally occurring plant material, and thus does not amount to more than a claim to a product of nature.
The claimed DNA sequences and encoded proteins are clearly not an inventive product of man, but merely existing genetic diversity that Applicant diagnoses and/or characterizes using modern tools of sequence analysis. Plant parts or raw extracts of Helichrysum plants are compositions which inherently contain the native genes and proteins of Helichrysum. Because of this, claims 1-2, 4, 6-7 & 18 are rejected.
Claim Rejections - 35 USC § 112
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 10 & 14 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 10 recites the broad recitation of a transgenic cell (i.e. a genus) comprising a specific isolated protein, and the claim also recites said cell is ‘optionally’ one of three categories (i.e. species) which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The use of ‘optionally’ in claim 10 appears to indicate a preference rather than merely introducing additional components. Because of this, the claim is indefinite for not clearly indicating whether Applicant is claiming the broad genus or further requires the narrow species limitations presented. As such, the metes and bounds of this claim, and how one would avoid unintentionally infringing, are unclear and claim 10 is rejected. Its dependent claim 14 is rejected for including the indefinite limitations of claim 10.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 10, 14 & 16 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 claims contain 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims recite a yeast, multicellular organism (claim 10), or transgenic plant (claim 14) comprising Applicant’s artificial nucleic acid and extracts thereof. Referring to the specification, Applicant describes manipulation of their artificial nucleic acid as a vector construct in Escherichia coli [¶.237-238]. They do not describe any use or confirmation of the expression and expected function of the artificial nucleic acid or protein products in non-bacterial cells, or generation of any transgenic plant cells validating exogenous transfer of UDP-UGT protein to any organism other than E. coli [id]. Applicant provides no description of how or if this construct would function in the intended way in multicellular organisms and/or plant cells.
At the time of filing, Applicant did not describe or validate the function of the claimed artificial or exogenous forms of UDP-UGT in the claimed transgenic hosts and it is unclear if such a construct would predictably function in anything other than endogenous biological context or in a simplified, unicellular bacterial growth system.
As such, the subject matter was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention.
Applicant is advised to amend their claims to reflect biological systems or transgenic organisms which they fully describe in their disclosure and confirmed to function as expected.
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.
Claim 14 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sayer [U.S. Patent 10,378,020; Published 13 Aug 2019].
Claim 14 is drawn to an extract derived from a transgenic cell. The claim includes limitation that the cell comprises a protein encoded by a gene of at least 87% homology to SEQ ID NO.11 (i.e. naturally occurring UDP-UGT from Helichrysum). As currently written, the limitations of the claim would include any transgenic form of Helichrysum which inherently carries the native UDP-UGT gene and protein [see discussion in ‘Nonstatuory Double Patenting’ section above, p.4, ¶.3—p.5]. Thus, an extract derived from a transgenic Helichrysum meets the limitations of claim 14.
Sayer describes transgenic plants used for production of cannabinoids, including description of transgenic Helichrysum and/or cell cultures of Helichrysum [col.11, l.15-21 & l.59-67; col.28, l.57-64]. Sayer describes cannabinoid extracts of said transgenic plants and/or cells [col.3, l.22-38; col.7, l.14-25].
Because Sayer clearly described creation of extracts from transgenic Helichrysum plants prior to Applicant’s date of filing, claim 14 is anticipated.
Conclusion
Claims 1-2, 4, 6-7, 10, 14, 16 & 18 are rejected.
Claim 5 is potentially allowable if amended to an independent claim.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEITH R WILLIAMS whose telephone number is (571)272-3911. The examiner can normally be reached Mon - Fri, 9:30 - 5:30 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, Amjad Abraham can be reached on (571)270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KEITH R. WILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
