DETAILED ACTION
Applicant’s response to the restriction/election requirement received on 2/18/26 has been entered. Claims 1-20 are pending in this application. Applicant’s election with traverse of the following species: heat shock as the species of first stressor, heat shock as the species of second stressor, insulin as the species of first target sequence, and fibroblast growth factor as the species of second target sequence. After further consideration, the election of species for the first and second target sequences is withdrawn. The election of species requirements for the first stressor and the second stressor is maintained.
The applicant traverses the election of species requirement based on their understanding that a species election cannot be based on generic claims, where species are identified from the specification. The applicant also argues that such an election requirement would, in their opinion, preemptively limit applicant’s ability to amend claims in the future to encompass subject matter disclosed in the specification, which would improperly restrict applicant’s right to amend the claims.
In response, while the applicant has cited from various sections of MPEP 800, including sections related to restriction between inventions rather than election of species, the relevant sections of the MPEP that relate to election of species for a generic claim, not a markush claim, are as follows.
MPEP 803.02 (III) states:
An election of species requirement is a type of restriction requirement. An examiner should set forth a requirement for election of a single disclosed species (or a grouping of patentably indistinct species) in a Markush claim using form paragraph 8.01 when claims limited to species are present or using form paragraph 8.02 when no species claims are present. See MPEP § 808.01(a) and § 809.02(a). (emphasis added by examiner)
MPEP 809.02(a) Election of Species Required [R-07.2022] states:
Where restriction between species is appropriate (see MPEP § 808.01(a)) the examiner should send a letter including only a restriction requirement or place a telephone requirement to restrict (the latter being encouraged). See MPEP § 812.01 for telephone practice in restriction requirements.
Action as follows should be taken:
(A) Identify generic claims or indicate that no generic claims are present. See MPEP § 806.04(d) for definition of a generic claim.
(B) Clearly identify each (or in aggravated cases at least exemplary ones) of the disclosed species, to which claims are to be restricted. The species are preferably identified as the species of figures 1, 2, and 3 or the species of examples I, II, and III, respectively. In the absence of distinct figures or examples to identify the several species, the mechanical means, the particular material, or other distinguishing characteristic of the species should be stated for each species identified. If the species cannot be conveniently identified, the claims may be grouped in accordance with the species to which they are restricted. Provide reasons why the species are independent or distinct.
(C) Applicant should then be required to elect a single disclosed species under 35 U.S.C. 121, and advised as to the requisites of a complete reply and their rights under 37 CFR 1.141.
To be complete, a reply to a requirement made according to this section should include a proper election along with a listing of all claims readable thereon, including any claims subsequently added. (emphasis added by examiner)
In addition, Form paragraph 8.02 referred to in MPEP 803.02 above reads as follows:
¶ 8.02 Requiring an Election of Species; No Species Claim Present
Claim(s) [1] is/are generic to the following disclosed patentably distinct species: [2]. The species are independent or distinct because [3]. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable (emphasis added by examiner).
Thus, the MPEP makes clear that an election of species requirement can be made where there are claims to distinct species or when there is a generic claim and multiple patentably distinct species are disclosed in the specification, including the Figures. However, in the instant case, there are both claims drawn to a single species – claims 1-13 and 19-20, a generic claim, claim 14, and claims 16 and 17 which are dependent on generic claim 14 which recited specific species. The election of species requirement made in the office action mailed on 12/18/25 clearly indicated that claim 14 was the generic claim which formed the basis of the election of species requirements- see page 4. Thus, it is maintained that the election of species requirement properly identified both the specifically claimed and disclosed species following the MPEP guidance set forth above and further provides specific explanations and reasoning as to why the individual species of stressors were patentably distinct and why an examination of all the species would place and undue burden on the examiner. In particular, the election of species requirement explained that the species of stressors listed for the first and second stressor are independent or distinct because each of the stressors are physical phenomena, or a nutrient deficiency or a chemical additive which are unrelated in physical, chemical, and/or functional effects, and further are not obvious variants of each other based on the current record. In addition, it was explained that restriction for examination purposes as indicated is proper because all these inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and examination burden if restriction were not required because one or more of the following reasons apply: (a) the inventions have acquired a separate status in the art due to their recognized divergent subject matter; (b) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries); (c) the prior art applicable to one invention would not likely be applicable to another invention; (d) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph. It is noted in particular that each of the species would require a separate and distinct search and that the species would be likely to raise various non-prior art issues under 35 U.S.C. 112, first paragraph. Thus, the election of species requirement met all of the requirements set forth in the MPEP and is considered proper.
Finally, as indicated in the previous office action and in the MPEP sections cited above, an election of species requirement clearly does not constrain applicant from making amendments to the claims, including the addition of claims to additional subject matter disclosed in the specification. The applicant is free to make any amendments to the claims that they see fit. Further, in regards to generic claim 14, the MPEP is clear that if the elected species is found to be allowable, the generic claim will then be considered for patentability. If the generic claim is then found to be allowable, examination of other claimed non-elected species would then proceed.
Therefore, for the reasons set forth above, applicant’s traversal has not been found persuasive and the election of species requirements are considered proper and made FINAL.
Claim 17 is hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the election requirement in the reply filed on 2/18/26.
Claims 1-16, and 18-20 are currently under examination based on the elected species of heat shock as the species of first and second stressor. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . An action on the merits follows.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/6/23 is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the information disclosure statement has been considered by the examiner, and an initialed and signed copy of the 1449 is attached to this action.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/086,226, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The instant application has been filed as a continuation-in-part (CIP) of parent application 17/086,226, filed on 10/30/2020, which claim benefit of priority to provisional application 62/927,788, filed on 10/30/2019. Separately, this application also claims benefit of priority to provisional application 63/285,938, filed on 12/3/2021. The 17/086,226 application does not disclose certain elements of claims 6, 10, 14-16, and 18-20. Specifically, the 17/086,226 specification does not disclose a promoter sequence inducible by a first stressor and associated with cell tissue of a first tissue or a second tissue type. The 17/086,226 application specification does not disclose any promoter with cell or tissue type specificity or any other “association” between any promoter and any cell or tissue type. Further, the specification of the 17,086,226 application does not disclose a promoter associated with a stressor and corresponding to a set of target characteristics of a target compound. The 17/086,226 specification is silent as to promoter which corresponds to a set of target characteristics of a target compound. As such, claims 6, 10, 14-16, and 18-20 are not entitled to benefit of priority to parent application 17/086,226. Thus, the effective filing date for claims 6, 10, 14-16, and 18-20 is the filing date of provisional application 63/285,938, filed on 12/3/2021.
Claims 1-5, 7-9, and 11-13 have benefit of priority to the 17/086,226 application and to provisional application 62/927,788, and thus are entitled to an effective filing date of 10/30/2019.
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 6, 10, 14-16, and 18-20 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 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.
Independent claim 14 and dependent claims 6, 15-16, and 18-20 recite a method of producing a target compound comprising in part the modification of a Drosophila to a produce a target compound where the genome is modified to comprise a promoter sequence inducible by a first stressor and associated with cell tissue of a first tissue, and a first target sequence coupled to the first promoter sequence and corresponding to the first compound. Independent claim 19 and dependent claims 10 and 20 recite a method of producing a target compound comprising in part cultivating a first population of Drosophila wherein the genome comprises a first promoter associated with a first stressor and corresponding to a set of target characteristics of a target compound, and a first target sequence coupled to the first promoter sequence and corresponding to the first target compound.
The as filed specification does not provide sufficient written description for the genus of promoters inducible by a first stressor and associated with cell tissue of a first tissue, or for a genus of promoter sequences associated with a first stressor and corresponding to a set of target characteristics of a target compound. The specification provides only a limited description of the genetic modification of flies, and in particular, Drosophila, in which a transgene comprising a nucleic acid sequence encoding a target polypeptide is operatively linked to a promoter/regulatory element inducible by an environmental “stressor”. Note that the elected species of stressor is “heat shock”. The specification does disclose several heat inducible promoters which are HSP (heat shock protein) promoters including HSP70, HSP60, and HSP 90, alone or combined with the use of an HSP70 5’UTR and provides two depictions of expression constructs which include the HSP70 promoter and HSP70 5’ UTR operably linked to a sequence encoding a target compound- see Figures 6 and 7. The specification does not teach or identify any promoter which is both heat inducible and cell specific to any particular cell tissue, or which is capable of being induced by heat and “associated” with a set of target characteristics of a target compound. As noted above, the only actual promoters disclosed in specification are the heat shock promoters HSP70, HSP90, and HSP60 which are responsive/activated by increased temperature, e.g. 37OC (specification, pages 20-21). However, heat shock promoters are not induced in a tissue specific fashion, but are rather globally induced by heat. Halfon et al. teaches that, “[u]se of the heat-shock promoter allows expression of the transgene to be induced at any time during development. Moreover, by varying the temperature or duration of heat shock, the level of transgene expression can be regulated. However, heat-shock induction causes transgene expression throughout the organism; specific cells or tissues cannot be targeted” (Halfon et al. (1997) PNAS, Vol. 94, 6255-6260, see page 6255, column 2). While the specification does separately teach that a set of tissue-specific drivers such as GAL4 or QF can be configured to promote tissue-specific expression of the target compound -specification, page 29- the specification does not teach that GAL4 or QF are both heat inducible and capable of tissue-specific expression of the target compound. It is also noted that the working examples are prophetic and provide descriptions of following the flow charts depicted in Figures 1-5, but include no actual data regarding any transgenic drosophila. Likewise, in regards to promoter sequences associated with a first stressor and corresponding to a set of target characteristics of a target compound, the specification fails to provide adequate guidance for promoters which meet the functional requirements. In regards to the phrase “corresponding to a set of target characteristics of a target compound”, the specification discloses that the promoter is selected based on a set of target characteristics for the compound “such as target structure and/or target functionality” (specification, page 21). However, the specification does not identify any promoter which is capable of affecting the structure of expressed target compound or the functionality of the expressed target compound. Promoters act by initiating transcription of a DNA sequence with an open reading frame to produce an mRNA which is then translated into a polypeptide. The art at the time of filing does not teach that promoters affect the structure or function of any translated protein.
As set forth in MPEP 2163:
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. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings.
An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). "Compliance with the written description requirement is essentially a fact-based inquiry that will ‘necessarily vary depending on the nature of the invention claimed.’" Enzo Biochem, 323 F.3d at 963, 63 USPQ2d at 1612.
In regards to the written description requirement for genuses, MPEP 2163 states:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014)
While the claims recite the use of a genus of promoters inducible by a first stressor which is heat shock and associated with cell tissue of a first tissue, or the use of a genus of promoter sequences associated with a first stressor which is heat shock and corresponding to a set of target characteristics of a target compound, the applicant has not provided any description or reduction to practice of any species within either genus of promoters. Further, the prior art at the time of filing does not teach promoters which have both heat responsiveness and tissue specificity, or heat responsiveness and the ability to affect the structure or function of an expressed polypeptide. Akmammedov et al., for example, reviews the state of the art for inducible transgenic expression systems and associated problems in Drosophila circa 2017 (Akmammedov et al. (7/31/17) Scientific Reports, Vol. 7:6899.DOI:10.1038/s41598-017-07282-w, pages 1-12). Akmammedov et al. teaches that the state of the art for inducible expression is Drosophila is largely based on polypeptide or chemical induction (doxycycline/tetracycline or GAL4) of the activity of a promoter operably linked to the transgene of interest, or the use of heat shock- where the transgene is operably linked to a heat shock inducible promoter such as HSP70 (Akmammedov et al., Table I). Beech et al., in a broader review of transgenic insects, teaches that while a number transgenic insects other than Drosophila flies had been made at the time of filing, such as species of mosquitoes or silkworms, the use of such insects for protein production was mostly speculative and at the earliest stage of development (Beech et al. (2012) Collection of Biosafety Reviews, Vol. 6, 66-124, see pages 81-83). Thus, the state of the prior does not establish that the use of a promoter with heat responsiveness and tissue specificity, or heat responsivenss and the ability to affect the structure or function to express a target polypeptide in transgenic insects including Drosophila was either well known or well developed at the time of filing.
Therefore, based on the limited description provided in applicant's specification as discussed in detail above for the genus of promoters capable of heat responsiveness and tissue specificity, or heat responsivenss and the ability to affect the structure or function of an expressed polypeptide which can be used in methods of producing a target compound in a Drosophila, and the undeveloped state of the prior art with respect to promoters with the claimed functionalities, the skilled artisan cannot envision the detailed chemical structure of the transgenic Drosophila or the expression construct as defined by the specification or the detailed chemical structure of the genus of promoters encompassed by the claims. As such, the specification does not demonstrate that applicant was in possession of and/or had reduced to practice the invention as claimed. Applicant is reminded that adequate written description requires more than a mere statement that it is part of the invention. See Fiers v. Revel, 25 USPQ2d 1602 at 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Thus, for the reasons outlined above, claims 14-16 and 18-20 do not meet the requirements for written description under 35 U.S.C. 112, first paragraph.
Claims 6, 10, 14-16 and 18-20 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 1) a method for heat induced polypeptide production in a Drosophila fly comprising providing a population of transgenic Drosophila flies whose genome comprises a transgene comprising a heat shock promoter operably linked to a nucleic acid sequence encoding a polypeptide of interest, cultivating the population of transgenic Drosophila, exposing the population of transgenic Drosophila to at least 37OC for a period of time sufficient to induce expression of the polypeptide of interest and either harvesting the population of transgenic Drosophila or applying a second heat treatment of at least 37OC for a second period of time sufficient to induce expression of the polypeptide of interest, homogenizing the Drosophila to form a homogenized mixture, and separating a portion of the mixture which comprises the polypeptide of interest from a portion of the mixture which does not comprise the polypeptide of interest, and 2) practice of the methods of 1) set forth above, where the transgenic Drosophila genome further comprises a second target sequence operatively linked to either the first heat shock promoter or to a second heat shock promoter, does not reasonably provide enablement for providing or generating any population of transgenic Drosophila capable of expressing any target compound using the genus of promoters as claimed. 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 or use the invention commensurate in scope with these claims.
Independent claim 14 and dependent claims 6, 15-16, and 18 recite a method of producing a target compound comprising in part the modification of a Drosophila to a produce a target compound where the genome is modified to comprise a promoter sequence inducible by a first stressor and associated with cell tissue of a first tissue, and a first target sequence coupled to the first promoter sequence and corresponding to the first compound. Independent claim 19 and dependent claims 10 and 20 recite a method of producing a target compound comprising in part cultivating a first population of Drosophila wherein the genome comprises a first promoter associated with a first stressor and corresponding to a set of target characteristics of a target compound, and a first target sequence coupled to the first promoter sequence and corresponding to the first target compound.
The as filed specification does not provide an enabling disclosure for the genus of promoters inducible by a first stressor and associated with cell tissue of a first tissue, or for a genus of promoter sequences associated with a first stressor and corresponding to a set of target characteristics of a target compound. The specification provides only limited specific guidance for the genetic modification of flies, and in particular, Drosophila, in which a transgene comprising a nucleic acid sequence encoding a target polypeptide is operatively linked to a promoter/regulatory element inducible by an environmental “stressor”. Note that the elected species of stressor is “heat shock”. The specification does disclose several heat inducible promoters which are HSP (heat shock protein) promoters including HSP70, HSP60, and HSP 90, alone or combined with the use of an HSP70 5’UTR and provides two depictions of expression constructs which include the HSP70 promoter and HSP70 5’ UTR operably linked to a sequence encoding a target compound- see Figures 6 and 7. The specification does not teach or identify any promoter which is both heat inducible and cell specific to any particular cell tissue, or which is capable of being induced by heat and “associated” with a set of target characteristics of a target compound. As noted above, the only actual promoters disclosed in specification are the heat shock promoters HSP70, HSP90, and HSP60 which are responsive/activated by increased temperature, e.g. 37OC (specification, pages 20-21). However, heat shock promoters are not induced in a tissue specific fashion, but are rather globally induced by heat. Halfon et al. teaches that, “[u]se of the heat-shock promoter allows expression of the transgene to be induced at any time during development. Moreover, by varying the temperature or duration of heat shock, the level of transgene expression can be regulated. However, heat-shock induction causes transgene expression throughout the organism; specific cells or tissues cannot be targeted” (Halfon et al. (1997) PNAS, Vol. 94, 6255-6260, see page 6255, column 2). While the specification does separately teach that a set of tissue-specific drivers such as GAL4 or QF can be configured to promote tissue-specific expression of the target compound -specification, page 29- the specification does not teach that GAL4 or QF are both heat inducible and capable of tissue-specific expression of the target compound. It is also noted that the working examples are prophetic and provide descriptions of following the flow charts depicted in Figures 1-5, but include no actual data regarding any transgenic drosophila. Likewise, in regards to promoter sequences associated with a first stressor and corresponding to a set of target characteristics of a target compound, the specification fails to provide adequate guidance for promoters which meet the functional requirements. In regards to the phrase “corresponding to a set of target characteristics of a target compound”, the specification discloses that the promoter is selected based on a set of target characteristics for the compound “such as target structure and/or target functionality” (specification, page 21). However, the specification does not identify any promoter which is capable of affecting the structure of expressed target compound or the functionality of the expressed target compound. Promoters act by initiating transcription of a DNA sequence with an open reading frame to produce an mRNA which is then translated into a polypeptide. The art at the time of filing does not teach that promoters affect the structure or function of any translated protein.
Further, at the time of filing, does not teach promoters which have both heat responsiveness and tissue specificity, or heat responsivenss and the ability to affect the structure or function of an expressed polypeptide. In addition, at the time of filing, inducible protein expression in transgenic insects, including Drosophila, for protein production and purification was not considered either well developed or predictable. Akmammedov et al., for example, reviews the state of the art for inducible transgenic expression systems and associated problems in Drosophila circa 2017 (Akmammedov et al. (7/31/17) Scientific Reports, Vol. 7:6899.DOI:10.1038/s41598-017-07282-w, pages 1-12). Akmammedov et al. teaches that the state of the art for inducible expression is Drosophila is largely based on polypeptide or chemical induction (doxycycline/tetracycline or GAL4) of the activity of a promoter operably linked to the transgene of interest, or the use of heat shock- where the transgene is operably linked to a heat shock inducible promoter such as HSP70 (Akmammedov et al., Table I). Beech et al., in a broader review of transgenic insects, teaches that while a number transgenic insects including Drosophila flies had been made at the time of filing, the use of such insects for protein production was mostly speculative and at the earliest stage of development (Beech et al. (2012) Collection of Biosafety Reviews, Vol. 6, 66-124, see pages 81-83). Beech et al. further does not teach the use of inducible gene expression in transgenic insects based on the use of any non-heat “stressors” for inducing gene expression including UV light. Thus, the state of the prior does not establish that the use of a promoter with heat responsiveness and tissue specificity, or heat responsivenss and the ability to affect the structure or function to express a target polypeptide in transgenic insects including Drosophila was either well known or well developed at the time of filing.
Therefore, in view of the art recognized underdeveloped state of the prior art for using transgenic Drosophila to produce proteins, particularly pharmaceutical or therapeutic proteins, the lack of guidance in the prior art for promoters which are both heat inducible and cell tissue specific, the lack of guidance in the prior art for the ability of promoters to affect expressed protein structure or function, the lack of guidance provided by the specification for a genus of promoters inducible by a first stressor and associated with cell tissue of a first tissue, or for a genus of promoter sequences associated with a first stressor and corresponding to a set of target characteristics of a target compound, the lack of any working examples, and the breadth of the claims, it would have required undue experimentation to practice the breadth of the instant methods as claimed in claims 14-16 and 18-20.
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 1-5, 7-9, and 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,991,994, hereafter referred to as the ‘994 patent. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Claims 1-16 of the ‘994 patent recite a largely similar method as that claimed in the instant claims with the exception that the ‘994 patent claims are broader than the instant claims and do not recite that the target compound is insulin as recited in instant claim 2, or fibroblast growth factor (FGF) as recited in instant claims 3-4, or that the expression cassette further comprises a leader sequence as recited in claim 9. However, the ‘994 patent claim methods clearly encompass these particular additional species and/or limitations. This is evidenced by the specification of the ‘994 patent which specifically recite that the target compound can be insulin or FGF, or where a leader can be included in the expression cassette 5’ of the sequence encoding the target compound.
The MPEP 804(II)(2)(a) sets forth instances where it is acceptable to utilize the disclosure of a U.S. patent document in conjunction with its claims for obvious-type double patenting rejections. In particular, the MPEP notes that the portion of the specification that supports the patent claims may be considered. See In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014). The court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003). In particular, those portions of the specification which provide support for the reference claims may be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “[t]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.” In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014). The MPEP gives the example that if the reference patent discloses several species within the scope of the reference genus claim, that portion of the disclosure should be analyzed to properly construe the reference patent claim and determine whether it anticipates or renders obvious the claim in the application being examined. Because that portion of the disclosure of the reference patent is an embodiment of the reference patent claim, it may be helpful in determining the full scope and obvious variations of the reference patent claim. As such, the portions of the ‘994 specification which discuss species of the target compound which in the ‘994 patent claims, elements of the expression construct recite in the ‘994 patent claims, and other minutiae regarding protein purification, have been analyzed as indicated by the MPEP above to determine obvious variants.
Based on the above analysis, it has been determined that the instant claims constitute obvious variants of the broader methods recited in the ‘994 patent claims, such that the ‘994 patent claims 1-16 render obvious the invention as set forth in instant claims 1-5, 7-9, and 11-13.
Claims 1-5, 7-9, and 11-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/643,639, hereafter referred to as the ‘639 application. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Claims 1 of the ‘639 application recites a largely similar method as that claimed in the instant claims with the exception that the ‘639 application claim is broader than the instant claims and do not recite that the target compound is insulin as recited in instant claim 2, or FGF as recited in instant claims 3-4, or that the expression cassette further comprises a leader sequence as recited in claim 9. However, the ‘639 application claim method clearly encompass these particular additional species and/or limitations. This is evidenced by the specification of the ‘639 application which specifically recite that the target compound can be insulin or FGF, or where a leader can be included in the expression cassette 5’ of the sequence encoding the target compound.
The MPEP 804(II)(2)(a) sets forth instances where it is acceptable to utilize the disclosure of a U.S. patent document in conjunction with its claims for obvious-type double patenting rejections. In particular, the MPEP notes that the portion of the specification that supports the patent claims may be considered. See In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014). The court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003). In particular, those portions of the specification which provide support for the reference claims may be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “[t]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.” In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014). The MPEP gives the example that if the reference patent discloses several species within the scope of the reference genus claim, that portion of the disclosure should be analyzed to properly construe the reference patent claim and determine whether it anticipates or renders obvious the claim in the application being examined. Because that portion of the disclosure of the reference patent is an embodiment of the reference patent claim, it may be helpful in determining the full scope and obvious variations of the reference patent claim. As such, the portions of the ‘639 application specification which discuss species of the target compound recited in the ‘639 application claim, elements of the expression construct recite in the ‘639 application claim, and other minutiae regarding protein purification, have been analyzed as indicated by the MPEP above to determine obvious variants.
Based on the above analysis, it has been determined that the instant claims constitute obvious variants of the broader methods recited in the ‘639 application claim, such that the ‘639 application claim 1 render obvious the invention as set forth in instant claims 1-5, 7-9, and 11-13.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claims are allowed.
Any inquiry concerning this communication from the examiner should be directed to Anne Marie S. Wehbé, Ph.D., whose telephone number is (571) 272-0737. If the examiner is not available, the examiner’s supervisor, Maria Leavitt, can be reached at (571) 272-1085. For all official communications, the technology center fax number is (571) 273-8300. Please note that all official communications and responses sent by fax must be directed to the technology center fax number. For informal, non-official communications only, the examiner’s direct fax number is (571) 273-0737. For any inquiry of a general nature, please call (571) 272-0547.
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Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634
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