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
This application is a 371 of PCT/IL2022/050279.
The amendment filed on July 23, 2026 has been entered.
Election/Restrictions
Applicant’s election without traverse of Group VII (claims 1-2, 4, 15-16, and 23 directed to SEQ ID NO:7) in the reply filed on July 23, 2026 is acknowledged.
Claims 6-7, 9, 19, 21, 24-25, 32, 34, 37, 45, and 47-49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 3, 2023.
Status of Claims
Claims 1-2, 4, 6-7, 9, 15-16, 19, 21, 23-25, 32, 34, 37, 45, and 47-49 are pending.
Claims 6-7, 9, 19, 21, 24-25, 32, 34, 37, 45, and 47-49 are withdrawn.
Claims 1-2, 4, 15-16, and 23 are under examination.
Claim for Domestic Priority
Applicants' claim for domestic priority under 35 USC 119(e) to US provisional application 63/159,028, filed 03/10/2021, is acknowledged.
Drawings
The drawings are objected to because Figure 3 is blurry and illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, see pages 43-44. 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 - 35 USC § 112
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 1-2, 4, 15-16, and 23 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.
MPEP 2111.01 states that ''[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow.'' In this case, the claims have been broadly interpreted to encompass (1) any isolated DNA molecule comprising an amino acid sequence having at least 91% sequence identity to SEQ ID NO:7 or (2) any isolated DNA molecule comprising an amino acid sequence having at least 91% sequence identity to SEQ ID NO:7 and having a length of 950 to 1750 nucleotides. Therefore, the claims are drawn to (1) a genus of polynucleotides having at least 91% sequence identity to SEQ ID NO:7 and encoding a polypeptide having unknown or any function and (2) a genus of polynucleotides having at least 91% sequence identity to SEQ ID NO:7, having a length of 950 to 1750 nucleotides, and encoding a polypeptide having unknown function, having any function or having prenyltransferase activity.
MPEP 2163 I. states that to “satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.
MPEP 2163. II.A.3.(a) sates that “Possession may be shown in many ways. For example, possession may be shown by describing an actual reduction to practice of the claimed invention. Possession may also be shown by a clear depiction of the invention in detailed drawings or in structural chemical formulas which permit a person skilled in the art to clearly recognize that inventor had possession of the claimed invention. An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention.
According to MPEP 2163.II.A.3.(a).ii), “Satisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus…Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’"
The recitation of “prenyl transferase” fails to provide a sufficient description of the genus of the polynucleotides as it merely describes the functional features of the genus without providing any definition of the structural features of the species within the genus. The specification does not specifically define any of the species that fall within the genus. The specification does not define any structural features commonly possessed by members of the genus that distinguish them from others. One skilled in the art therefore cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus.
Helichrysum umbraculigerum gene having the nucleic acid sequence of SEQ ID NO:7 was not known in the prior art. A search of SEQ ID NO:7 did not result in polynucleotides having any significant similarity, as shown below (Result No. 1 is not prior art as discussed below under “Other Relevant Art”).
PNG
media_image1.png
908
1307
media_image1.png
Greyscale
Fransceus (J Ind Microbiol Biotechnol. 2017 May;44(4-5):687-695. – form PTO-892) reviews protein engineering techniques, such as random mutagenesis and recombination, directed evolution and iterative or combinatory saturation “hotspots”. Fransceus states that “a recurring problem, however, is choosing which amino acid positions should be targeted. Answering this question is not an easy feat and requires substantial insight in the relationship between an enzyme’s sequence or structure and its properties.” Sanavia (Computational and Structural Biotechnology Journal, Volume 18, 2020, Pages 1968-1979. – form PTO-892) discloses challenges in the prediction of protein stability in the occurrence of multiple mutations. “Multiple-point mutations are common variations of the protein sequence that may be needed in protein engineering when a single-point mutation is not enough to yield the desired stability change. Dealing with multiple-site variations adds another level of complexity beyond the prediction of the effect of a single variant on protein stability, since it requires the learning of many types of combinatorial effects”.
The specification is limited to three polynucleotides isolated from Helichrysum umbraculigerum, HuPT1 having the nucleic acid sequence of SEQ ID NO:1 encoding a polypeptide having prenyltransferase activity, HuPT3 having the nucleic acid sequence of SEQ DI NO:3 encoding a polypeptide having prenyltransferase activity, and HuPTx having the nucleic acid sequence of SEQ ID NO:7 encoding a polypeptide having prenyltransferase activity (Figures 2 and 4 and Example 1). While MPEP 2163 acknowledges that in certain situations “one species adequately supports a genus,” it also acknowledges that “[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.” In view of the widely variant species encompassed by the genus, the three polynucleotides isolate from Helichrysum umbraculigerum described above are not enough and does not constitute a representative number of species to describe the whole genus. Therefore, the specification fails to describe a representative species of the claimed genus.
One of skill in the art could identify polynucleotide having 91% sequence identity with SEQ ID NO:1. However, there is no teaching regarding which 9% of the nucleic acids of SEQ ID NO:7 can be modified and result in a polynucleotide encoding a polypeptide having any function, unknown function, or prenyltransferase activity.
An important consideration is that structure is not necessarily a reliable indicator of function. In the instant case, there is no disclosure relating similarity of structure to conservation of function. Conservation of structure is not necessarily a surrogate for conservation of function.
Further, many functionally unrelated polynucleotides are encompassed within the scope of these clams, including partial sequences, resulting in a substantial variation within the genus. The genus of these polynucleotides comprise a large variable genus with the potentiality of having different function, any function, or unknown function. The specification is limited three polynucleotides isolated from Helichrysum umbraculigerum, HuPT1 having the nucleic acid sequence of SEQ ID NO:1 encoding a polypeptide having prenyltransferase activity, HuPT3 having the nucleic acid sequence of SEQ DI NO:3 encoding a polypeptide having prenyltransferase activity, and HuPTx having the nucleic acid sequence of SEQ ID NO:7 encoding a polypeptide having prenyltransferase activity (Figures 2 and 4 and Example 1).. While MPEP 2163 acknowledges that in certain situations “one species adequately supports a genus,” it also acknowledges that “[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.” In view of the widely variant species encompassed by the genus, the three polynucleotides isolate from Helichrysum umbraculigerum described above are not enough and does not constitute a representative number of species to describe the whole genus. The specification also fails to describe additional representative species of the polynucleotides or encoded polypeptides by any identifying characteristics or properties of the polypeptides, for which no predictability of function is apparent. Therefore, one skilled in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
Given this lack of description of the representative species encompassed by the genus of the claims, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that applicants were in possession of the inventions of claims 1-2, 4, 15-16, and 23.
Claims 1-2, 4, 15-16, and 23. are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for HuPT1 of SEQ ID NO:1, HuPT3 of SEQ DI NO:3, and HuPTx of SEQ ID NO:7, wherein said HuPT1, HuPT3, and HuPTx encodes polypeptides having prenyltransferase activity (Figures 2 and 4 and Example 1), does not reasonably provide enablement for (1) any polynucleotide having at least 91% sequence identity to SEQ ID NO:7 and encoding a polypeptide having unknown or any function and (2) any polynucleotide having at least 91% sequence identity to SEQ ID NO:7, having a length of 950 to 1750 nucleotides, and encoding a polypeptide having unknown function, having any function or having prenyltransferase activity. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
The breadth of the claims.
MPEP 2111.01 states that ''[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow.'' In this case, the claims have been broadly interpreted to encompass (1) any isolated DNA molecule comprising an amino acid sequence having at least 91% sequence identity to SEQ ID NO:7 or (2) any isolated DNA molecule comprising an amino acid sequence having at least 91% sequence identity to SEQ ID NO:7 and having a length of 950 to 1750 nucleotides. Therefore, the claims are drawn to (1) any polynucleotide having at least 91% sequence identity to SEQ ID NO:7 and encoding a polypeptide having unknown or any function and (2) any polynucleotide having at least 91% sequence identity to SEQ ID NO:7, having a length of 950 to 1750 nucleotides, and encoding a polypeptide having unknown function, having any function or having prenyltransferase activity.
The claims are not commensurate with the enablement provided by the disclosure with regard to the extremely large number of polynucleotides encoding polypeptides having unknow function, no function, or having prenyltransferase activity. In the instant case, the specification is limited to three polynucleotides isolated from Helichrysum umbraculigerum, HuPT1 having the nucleic acid sequence of SEQ ID NO:1 encoding a polypeptide having prenyltransferase activity, HuPT3 having the nucleic acid sequence of SEQ DI NO:3 encoding a polypeptide having prenyltransferase activity, and HuPTx having the nucleic acid sequence of SEQ ID NO:7 encoding a polypeptide having prenyltransferase activity (Figures 2 and 4 and Example 1).
The quantity of experimentation required to practice the claimed invention based on the teachings of the specification.
While enzyme isolation techniques, recombinant and mutagenesis techniques were known in the art at the time of the invention, e.g. mutagenesis, and it is routine in the art to screen for variants comprising multiple substitutions or multiple modifications as encompassed by the instant claims, the specific amino acid positions within the protein's sequence where amino acid modifications can be made with a reasonable expectation of success in obtaining the desired activity/utility are limited in any protein and the result of such modifications is unpredictable. In addition, one skilled in the art would expect any tolerance to modification for a given protein to diminish with each further and additional modification, e.g. multiple substitutions.
In the absence of: (a) rational and predictable scheme for making any polynucleotide having at least 91% sequence identity to SEQ ID NO:7 and having prenyltransferase activity and (b) a correlation between structure and function of having prenyltransferase activity, the specification provides insufficient guidance as to which of the essentially infinite possible choices is likely to be successful. One of skill in the art would have to test these infinite possible polypeptides to determine which polynucleotides encode polypeptides having prenyltransferase activity While enablement is not precluded by the necessity for routine screening, if a large amount of screening is required, as is the case herein, the specification must provide a reasonable amount of guidance which respect to the direction in which the experimentation should proceed so that a reasonable number of species can be selected for testing. In view of the fact that such guidance has not been provided in the instant specification, it would require undue experimentation to enable the full scope of the claims.
The state of prior art, the relative skill of those in the art, and predictability or unpredictability of the art.
Since the amino acid sequence of the encoded polypeptide determines its structural and functional properties, predictability of which changes can be tolerated in a protein's amino acid sequence and obtain the desired activity requires a knowledge of and guidance with regard to which amino acids in the protein's sequence, if any, are tolerant of modification and which are conserved (i.e. expectedly intolerant to modification), and detailed knowledge of the ways in which the proteins' structure relates to its function. In the instant case, neither the specification or the art provide a correlation between structure and activity such that one of skill in the art can envision the structure of any polypeptides having prenyltransferase activity or predict said function of a polypeptide from its primary structure. In addition, the art does not provide any teaching or guidance as to (1) which amino acids within the polypeptide encoded by SEQ ID NO:7 that can be modified and which ones are conserved such that one of skill in the art can make the recited polynucleotide encoding a polypeptide having prenyltransferase activity, (2) which segments of the polypeptide encoded by SEQ ID NO:7 are essential for having prenyltransferase activity, and (3) the general tolerance of the polypeptide encoded by SEQ ID NO:7 to structural modifications and the extent of such tolerance. The art clearly teaches that changes in a protein's amino acid sequence to obtain the desired activity without any guidance/knowledge as to which amino acids in a protein are required for that activity is highly unpredictable. At the time of the invention there was a high level of unpredictability associated with altering a polypeptide sequence with an expectation that the polypeptide will maintain the desired activity. For example, Studer (Residue mutations and their impact on protein structure and function: detecting beneficial and pathogenic changes. Biochem. J. (2013) 449, 581–594. – form PTO-892) teach that (1) protein engineers are frequently surprised by the range of effects caused by single mutations that they hoped would change only one specific and simple property in enzymes, (2) the often surprising results obtained by experiments where single mutations are made reveal how little is known about the rules of protein stability, and (3) the difficulties in designing de novo stable proteins with specific functions.
Helichrysum umbraculigerum gene having the nucleic acid sequence of SEQ ID NO:7 was not known in the prior art. A search of SEQ ID NO:7 did not result in polynucleotides having any significant similarity, as shown below (Result No. 1 is not prior art as discussed below under “Other Relevant Art”).
PNG
media_image1.png
908
1307
media_image1.png
Greyscale
Fransceus (J Ind Microbiol Biotechnol. 2017 May;44(4-5):687-695. – form PTO-892) reviews protein engineering techniques, such as random mutagenesis and recombination, directed evolution and iterative or combinatory saturation “hotspots”. Fransceus states that “a recurring problem, however, is choosing which amino acid positions should be targeted. Answering this question is not an easy feat and requires substantial insight in the relationship between an enzyme’s sequence or structure and its properties.” Sanavia (Computational and Structural Biotechnology Journal, Volume 18, 2020, Pages 1968-1979. – form PTO-892) discloses challenges in the prediction of protein stability in the occurrence of multiple mutations. “Multiple-point mutations are common variations of the protein sequence that may be needed in protein engineering when a single-point mutation is not enough to yield the desired stability change. Dealing with multiple-site variations adds another level of complexity beyond the prediction of the effect of a single variant on protein stability, since it requires the learning of many types of combinatorial effects”.
In addition, since the claims encompass polynucleotide encoding polypeptides having any function or unknown function, one of skill in the art cannot envision the function of these polypeptides from the structure of the polypeptide encoded by SEQ ID NO:7. Further, the function of a polypeptide cannot be predicted from its structure and the specification does not teach how to use polypeptides having any function or having no activity. The quantity of experimentation in this area is extremely large since there is significant variability in the activity of the polynucleotides in the claims. It would require significant study to identify the actual function of the encoded polypeptides and identifying a use for the polypeptide would be an inventive, unpredictable and difficult undertaking. This would require years of inventive effort, with each of the many intervening steps, upon effective reduction to practice, not providing any guarantee of success in the succeeding steps.
The art is extremely unpredictable with regard to protein function in the absence of realizable information regarding its activity. Even very similar proteins may have every different functions. In the current case, where no specific information is known regarding the function, it is entirely unpredictable what function and activity will be found for the protein.
The amount of direction or guidance presented and the existence of working examples.
The specification is limited to three polynucleotides isolated from Helichrysum umbraculigerum, HuPT1 having the nucleic acid sequence of SEQ ID NO:1 encoding a polypeptide having prenyltransferase activity, HuPT3 having the nucleic acid sequence of SEQ DI NO:3 encoding a polypeptide having prenyltransferase activity, and HuPTx having the nucleic acid sequence of SEQ ID NO:7 encoding a polypeptide having prenyltransferase activity (Figures 2 and 4 and Example 1). However, the specification fails to provide any information as to (1) specific substrates associated with any polypeptide encoded by a polynucleotide having 91% sequence identity to SEQ ID NO:7 or (2) structural elements required in a polypeptide having prenyltransferase activity. No correlation between structure and function of having prenyltransferase activity has been presented.
Thus, in view of the overly broad scope of the claims, the lack of guidance and working examples provided in the specification, the high level of unpredictability of the prior art in regard to structural changes and their effect on function and the lack of knowledge about a correlation between structure and function, an undue experimentation would be necessary one having ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims. The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, determination of polypeptides having the desired biological characteristics recited in the claims are unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988).
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 and 23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim interpretation
Claims 1-2 are directed to a HuPTx gene isolated from Helichrysum umbraculigerum, wherein said HuPTx gene has the nucleic acid sequence of SEQ ID NO:7 and encoding a polypeptide having prenyltransferase activity (Example 1), which occurs in nature.
Claim 23 is directed to a composition comprising the polynucleotide of claim 1 and an acceptable carrier, such as water, which occurs in nature.
Therefore, claims 1-2 and 23 are directed to (A) HuPTx gene of SEQ ID NO:7, a nature-based product, and (B) water, a nature-based product.
Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category (see MPEP 2106.03). Since the claims are directed to a composition comprising nature-base product, the claims are directed to a composition of matter, which is one of the statutory categories of invention. (Step 1: YES)
Step 2A Prong 1: This part of the eligibility analysis evaluates whether the claim recites a judicial exception (see MPEP 2106.04). The isolated polynucleotide of SEQ ID NO:7 and the isolated polynucleotide of SEQ ID NO:7 comprised in a composition are not considered to have markedly different characteristics from what occurs in nature, a naturally occurring HuPTx, of SEQ ID NO:7, and are considered to be a law of nature exception. There is no indication in the specification that isolating HuPTx of SEQ ID NO:7 or placing HuPTx, of SEQ ID NO:7 into a composition comprising water result in the HuPTx, of SEQ ID NO:7 having any characteristics (structural, functional, or otherwise) that are different from the naturally occurring HuPTx, of SEQ ID NO:7. Because there is no difference in characteristics (structural, functional, or otherwise) between the isolated polynucleotide comprised in the claimed composition and the naturally occurring HuPTx, of SEQ ID NO:7 , the claimed polynucleotide and composition comprising said polynucleotide are directed to a judicial exception.
Step 2A Prong 2: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. There is no indication in the specification that isolating the HuPTx, of SEQ ID NO:7 or combining HuPTx, of SEQ ID NO:7 and water in a composition result in a transformation of the HuPTx, of SEQ ID NO:7 and water (Step2 A: YES)
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05). The claim only recites the laws of nature and do not include any additional elements that could add significantly more to the judicial exceptions. Isolating HuPTx, of SEQ ID NO:7 or combining HuPTx, of SEQ ID NO:7 and water does not markedly change the characteristics of either component, because each component continues to have the same properties in the mixture as it had alone. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the HuPTx, of SEQ ID NO:7 is not markedly different form its naturally occurring counterpart because it conveys the same structural and functional information. Thus, the isolation and combination of HuPTx, of SEQ ID NO:7 does not meaningfully limit the claims, and the claims as a whole do not amount to significantly more than each “product of nature by itself (Step 2B: NO).
As such, the claims do not qualify as eligible subject matter.
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 1-2, 4, 15-16, and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-10, 12, 14, 16, 21, 23, 25-28, 33, 39, and 42 of copending Application No.19/072,119 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because they are claiming common subject matter, as follows:
Regarding claims 1-2 of the instant application, claims 1 and 6 of the reference application recites a DNA molecule of SEQ ID NO:53 encoding a prenyltransferase (PT). The polynucleotide of SEQ ID NO:7 of the instant application is identical to the polynucleotide of SEQ ID NO:53 of the reference application. Therefore, claims 1-2 of the instant application are anticipated by claims 1 and 6 of the reference application.
Regarding claim 4 of the instant application, claim 14 of the reference application recites an artificial nucleic acid molecule, plasmid or an agrobacterium comprising the DNA molecule. Therefore, claim 4 of the instant application is anticipated by claims 1, 6, and 14 of the reference application.
Regarding claims 15-16 of the instant application, claim 16 of the reference application recites a transgenic Cannabis sativa cell, a multicellular organism, comprising the DNA molecule. Therefore, claims 15-16 of the instant application are anticipated by claims 1, 6, and 15-16 f the reference application.
Regarding claim 23 of the instant application, claim 25 of the reference application recites a composition comprising the DNA molecule and an acceptable carrier. Therefore, claim 23 of the instant application is anticipated by claims 1, 6, and 23 of the reference application.
Therefore, the conflicting claims are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Other Relevant Art
OQ673109 (GenBank Database. April 15, 2023 – form PTO-892) discloses a polynucleotide having 99.6% sequence identity to SEQ ID NO:7 of the instant application, wherein the polynucleotide encodes a prenyltransferase. However, OQ673109 is not available as prior art because the reference was published or made known to the public after the instant invention was effectively filed.
Conclusion
Claims 1-2, 4, 6-7, 9, 15-16, 19, 21, 23-25, 32, 34, 37, 45, and 47-49 are pending.
Claims 6-7, 9, 19, 21, 24-25, 32, 34, 37, 45, and 47-49 are withdrawn.
Claims 1-2, 4, 15-16, and 23 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YONG D PAK whose telephone number is (571)272-0935. The examiner can normally be reached M-Th: 5:30 am - 3:30 pm.
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 published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YONG D PAK/Primary Examiner, Art Unit 1652
Sequence alignment of SEQ ID NO:7 of the instant application (“Qy”) and the polynucleotide of OQ673109 (“Db”)
RESULT 1
OQ673109
LOCUS OQ673109 1221 bp mRNA linear PLN 15-APR-2023
DEFINITION Helichrysum umbraculigerum CBGAS4 mRNA, complete cds.
ACCESSION OQ673109
VERSION OQ673109.1
KEYWORDS .
SOURCE Helichrysum umbraculigerum
ORGANISM Helichrysum umbraculigerum
Eukaryota; Viridiplantae; Streptophyta; Embryophyta; Tracheophyta;
Spermatophyta; Magnoliopsida; eudicotyledons; Gunneridae;
Pentapetalae; asterids; campanulids; Asterales; Asteraceae;
Asteroideae; Gnaphalieae; Helichrysum.
REFERENCE 1 (bases 1 to 1221)
AUTHORS Berman,P., de Haro,L.A., Jozwiak,A., Sonawane,P.D. and Aharoni,A.
TITLE Parallel Evolution of Cannabinoid Biosynthesis
JOURNAL Unpublished
REFERENCE 2 (bases 1 to 1221)
AUTHORS Berman,P., de Haro,L.A., Jozwiak,A., Sonawane,P.D. and Aharoni,A.
TITLE Direct Submission
JOURNAL Submitted (20-MAR-2023) Plant and Environmental Sciences, Weizmann
Institute of Science, Rehovot 7610001, Israel
COMMENT ##Assembly-Data-START##
Assembly Method :: hifiasm v. v0.15.5-r350
Assembly Name :: Humb_v1
Coverage :: 44x
Sequencing Technology :: Illumina; PacBio
##Assembly-Data-END##
FEATURES Location/Qualifiers
source 1..1221
/organism="Helichrysum umbraculigerum"
/mol_type="mRNA"
/db_xref="taxon:630343"
CDS 1..1221
/note="prenyltransferase"
/codon_start=1
/product="CBGAS4"
/protein_id="WFP21564.1"
/translation="MASLAIGSLGSPSSRQCSSPVASSSSFAIGSQIASKFLRISKFD
KTKNSPLALQQKHINKSIDQSFFEPLPLHKINKDKFKLYATSTNNPQFDATHDLKTPE
VSIINFVDALYRLIRPYTAVVTIVSVVAMSLLTVNSLSDFSPLFFIKVVQALIGGIFM
QMYVSGFNQICDIELDKVNKQSLPLAAGELSMKTAIVIASLSAIMSLSIGWFVGSPPL
LWCLVWWFIVGTAYSANVLPYLRWKRFPFTAAFCAMTSRALVLPIGYYLHMQNSIPGV
SALLSRPILFAVAMLSAFSLSAMFFKDIPDIKGDRMHGIKSLAIKLGEKRVYWISISI
IEIAYIAAAFIGATSPISWSKYVTIIGHLGMGLLLWVRARSVDPTNTVAVQSMYMFLI
KLVYAEYGLISLVR"
ORIGIN
Query Match 99.6%; Score 1216.2; Length 1221;
Best Local Similarity 99.8%;
Matches 1218; Conservative 0; Mismatches 3; Indels 0; Gaps 0;
Qy 1 ATGGCATCTCTAGCTATTGGTTCACTTGGTAGCCCAAGCTCACGTCAGTGTTCTAGCCCC 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ATGGCATCTCTAGCTATTGGTTCACTTGGTAGCCCAAGCTCACGTCAGTGTTCTAGCCCC 60
Qy 61 GTTGCATCATCTTCTTCATTTGCGATAGGGTCACAAATAGCTTCAAAGTTTCTTCGGATA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GTTGCATCATCTTCTTCATTTGCGATAGGGTCACAAATAGCTTCAAAGTTTCTTCGGATA 120
Qy 121 TCAAAATTTGATAAGACTAAGAACAGCCCCTTAACATTGCAACAAAAGCATATAAACAAA 180
|||||||||||||||||||||||||||||||| ||||||||||||||||||||||||||
Db 121 TCAAAATTTGATAAGACTAAGAACAGCCCCTTGGCATTGCAACAAAAGCATATAAACAAA 180
Qy 181 AGCATAGATCAAAGCTTCTTTGAGCCGCTTCCATTGCACAAAATAAACAAAGACAAGTTT 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 AGCATAGATCAAAGCTTCTTTGAGCCGCTTCCATTGCACAAAATAAACAAAGACAAGTTT 240
Qy 241 AAGTTGTATGCAACATCTACAAACAATCCTCAGTTTGATGCAACTCATGATTTGAAGACT 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 AAGTTGTATGCAACATCTACAAACAATCCTCAGTTTGATGCAACTCATGATTTGAAGACT 300
Qy 301 CCGGAAGTATCCATTATCAACTTTGTGGACGCTCTTTATAGGTTAATAAGGCCGTATACA 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 CCGGAAGTATCCATTATCAACTTTGTGGACGCTCTTTATAGGTTAATAAGGCCGTATACA 360
Qy 361 GCAGTTGTAACGATCGTAAGTGTAGTCGCGATGTCCCTTCTTACAGTTAATAGCCTTTCA 420
||||||||||||||||||||||||||||||||||||||||| ||||||||||||||||||
Db 361 GCAGTTGTAACGATCGTAAGTGTAGTCGCGATGTCCCTTCTCACAGTTAATAGCCTTTCA 420
Qy 421 GATTTTTCCCCATTGTTCTTCATCAAAGTGGTACAGGCTCTTATTGGAGGCATATTCATG 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 GATTTTTCCCCATTGTTCTTCATCAAAGTGGTACAGGCTCTTATTGGAGGCATATTCATG 480
Qy 481 CAAATGTATGTTAGTGGTTTCAATCAAATTTGTGATATAGAACTCGACAAGGTTAACAAA 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 CAAATGTATGTTAGTGGTTTCAATCAAATTTGTGATATAGAACTCGACAAGGTTAACAAA 540
Qy 541 CAGTCTCTTCCATTAGCGGCTGGAGAACTATCTATGAAAACTGCGATCGTCATCGCATCA 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 CAGTCTCTTCCATTAGCGGCTGGAGAACTATCTATGAAAACTGCGATCGTCATCGCATCA 600
Qy 601 CTATCAGCTATCATGAGCTTATCGATTGGTTGGTTTGTTGGCTCCCCACCATTATTGTGG 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 CTATCAGCTATCATGAGCTTATCGATTGGTTGGTTTGTTGGCTCCCCACCATTATTGTGG 660
Qy 661 TGTCTTGTTTGGTGGTTTATTGTTGGGACTGCATATTCGGCCAACGTGCTGCCTTATTTG 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 TGTCTTGTTTGGTGGTTTATTGTTGGGACTGCATATTCGGCCAACGTGCTGCCTTATTTG 720
Qy 721 CGATGGAAAAGGTTTCCTTTCACAGCAGCATTTTGCGCCATGACGTCTCGGGCACTAGTT 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 CGATGGAAAAGGTTTCCTTTCACAGCAGCATTTTGCGCCATGACGTCTCGGGCACTAGTT 780
Qy 781 CTTCCTATTGGATATTACTTGCATATGCAGAATTCCATCCCGGGAGTATCTGCATTACTT 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 CTTCCTATTGGATATTACTTGCATATGCAGAATTCCATCCCGGGAGTATCTGCATTACTT 840
Qy 841 TCAAGGCCAATATTATTTGCAGTCGCAATGCTCAGTGCATTTTCTTTATCAGCGATGTTC 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 841 TCAAGGCCAATATTATTTGCAGTCGCAATGCTCAGTGCATTTTCTTTATCAGCGATGTTC 900
Qy 901 TTTAAGGACATCCCTGATATTAAGGGAGATAGGATGCATGGAATCAAGTCTCTAGCAATT 960
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 901 TTTAAGGACATCCCTGATATTAAGGGAGATAGGATGCATGGAATCAAGTCTCTAGCAATT 960
Qy 961 AAACTGGGTGAAAAACGGGTGTATTGGATTTCCATTTCGATTATTGAAATTGCTTATATT 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 961 AAACTGGGTGAAAAACGGGTGTATTGGATTTCCATTTCGATTATTGAAATTGCTTATATT 1020
Qy 1021 GCTGCTGCATTTATTGGAGCAACTTCACCCATAAGCTGGAGCAAGTATGTAACGATTATC 1080
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1021 GCTGCTGCATTTATTGGAGCAACTTCACCCATAAGCTGGAGCAAGTATGTAACGATTATC 1080
Qy 1081 GGTCATCTTGGAATGGGATTACTACTTTGGGTACGAGCCAGATCAGTAGATCCGACGAAC 1140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1081 GGTCATCTTGGAATGGGATTACTACTTTGGGTACGAGCCAGATCAGTAGATCCGACGAAC 1140
Qy 1141 ACGGTAGCCGTTCAATCGATGTATATGTTCCTTATTAAGCTAGTATATGCAGAATACGGA 1200
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1141 ACGGTAGCCGTTCAATCGATGTATATGTTCCTTATTAAGCTAGTATATGCAGAATACGGA 1200
Qy 1201 CTTATCTCGCTTGTACGCTGA 1221
|||||||||||||||||||||
Db 1201 CTTATCTCGCTTGTACGCTGA 1221
Prosecution Insights