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 .
Application Status
This action is written in response to applicant’s correspondence received on 4/21/2026. Claims 1-4 and 7-14 are pending. Claims 1-4 and 7-9 have been amended. Claims 5-6 have been cancelled. Claims 11-14 are newly added All pending claims are currently under examination.
Any rejection or objection not reiterated herein has been overcome by amendment. Applicant’s amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for
allowance for the reasons that follow. This Office Action is Final.
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.
Claim 2 is 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.
Regarding claim 2, claim 2 recites “at least 3 full 4 to 16 sets of yeast chromosomes.” Claim 2 is unclear because it the phrase “at least 3 full 4 to 16 sets of yeast chromosomes” renders the metes and bounds of the claim undefined; it is unclear how many “full” sets of chromosomes are being recited in claim 2 because claim 2 recites “at least 3 full” and also “4 to 16” sets of chromosomes, where the specification defines “set of chromosome” as a complete set of chromosomes (page 4, first paragraph). It is unclear how many chromosomes, or their degree of completeness/fulness are being recited in claim 2. Claim 2 may be clarified by redrafting the claim to indicate that 4 to 16 sets of chromosomes are present, 3 of which are complete.
Claim Rejections - 35 USC § 112 – New Rejection Necessitated by Amendment
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3-4, and 8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 3, claim 3 recites “at least 6 to 12 sets of Saccharomyces yeast species” and therefore includes upwards of 12 different species. However, claim 3 depends from claim 1, which recites “not more than 8 Saccharomyces yeast species.” Claim 3 therefore fails to further limit claim 1 because it expands the limitations of claim 1 to include 12 different yeast species where claim 1 is drawn to only 8 yeast species.
Regarding claims 4 and 8, claims 4 and 8 recite “chromosomes or chromosomal segments.” However, claims 4 and 8 depend from claim 1, which requires “chromosomes” and not “chromosomal segments.” By reciting “chromosomes” or “chromosomal segments” claims 4 and 8 recite alternative embodiments wherein “chromosomes” is not required. However, claim 1, from which claims 4 and 8 depend, require “chromosomes”
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112 – Maintained/Updated in Response to Amendment
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 1-4 and 7-14 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.
MPEP 2163.II.A.3.(a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention”.
For claims drawn to a genus, 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, reduction to drawings, 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 Regents of the University of California v. Eli Lilly & Co, 119 F.3d at 1568, 43 USPQ2d at 1406.
Summary of the Rejection
The present claims suffer 112(a) written description issues. Firstly, claim 1 encompasses embodiments of yeast cells with upwards of 7 complete chromosome sets, where at most the specification has demonstrated that 3 complete chromosome sets are present in the cell where the genetic material from the fourth yeast species was not a complete chromosome set (see below). The applicant was therefore not in possession of a yeast cell with upwards of 7 complete chromosome sets from 8 different species, where the 8th species is an incomplete set, as encompassed by claim 1 (see below)
Secondly, the specification does not show possession of embodiments where the yeast cell would have, for instance, two complete sets of chromosomes from two different species and only one complete chromosome from two other species because no embodiment with such a configuration is demonstrated in the specification, nor is it likely that such a configuration could be made owing to evidence in the art which teaches that chromosomal loss over time is highly unpredictable. The Applicant has therefore not demonstrated that a yeast cell comprising two full sets of chromosomes and only one single chromosome from two other species.
Thirdly, the genus of yeast cell that the applicant is presently reciting is incredibly broad and unpredictable. The Applicant has developed a method to generate yeast cells with multiple copies of yeast chromosomal sets from different species. However, the yeast cells that are generated by the method are incredibly unstable with respect to what their genetic material comprises, where furthermore such instability generates unpredictable genotypic and phenotypic traits. The Applicant has therefore developed a method to create a highly unstable cell and is claiming possession of cells which could be made by the method. The art teaches that yeast cells evolve and develop in unpredictable ways over time with unique characteristics. The Applicant was not in possession of such an unpredictable and uncharacterized genus as presently recited and is therefore not entitled to the claimed subject matter.
Regarding the nature of the invention, claim 1 recites a synthetic yeast Saccharomyces cell comprising at least one chromosome from each of at least 4 different Saccharomyces yeast species and not more than 8 different Saccharomyces yeast species, wherein the synthetic yeast comprises a full set of chromosomes from at least 2 of the different yeast species and comprises less than a full set of chromosomes from at least 1 of the different yeast species. Claim 1 is therefore claiming a yeast cell, where the required limitations encompass a yeast cell with at least two full sets of chromosomes, where the cell further comprises at least one chromosome from 2-6 additional yeast species, where the cell can comprise embodiments including for instance a yeast cell with two sets of full chromosomes and a partial set of chromosomes from one other yeast species, or upwards of 7 complete full sets of chromosomes where the 8th species chromosomes set is incomplete. Claim 1 limits one set of chromosomes to comprise less than a full set of chromosomes, but the remaining 7 species and their chromosomes can be full sets, per the claim. This claim language is not commensurate with the scope of the specification for the reasons detailed below. Furthermore, as discussed above in the Summary, the Applicant was not in possession of the highly diverse population of cells generated by their method (see Summary above, and discussion on State of the Art, below).
Regarding the guidance provided in the specification, as an initial matter, the specification defines the phrase “set of chromosome” to refer to a “complete” or “substantially complete” set of chromosomes (page 4, first paragraph). By reciting “a full set of chromosomes from at least 2 of the different yeast species,” where upwards of 8 species are recited in the claim where only one of said sets of chromosomes is required to be incomplete, claim 1 includes embodiments with 7 complete sets of chromosomes, per the specification at page 4, first paragraph.
Regarding the additional guidance in the specification, the Applicant recites a method to generate allotetraploid yeast cells (Example 1, pages 20 to top of page 39). The Applicant also recites Example 2, where generation of higher order polyploid yeast cells were generated (page 39, beginning line 5 to page 40). While the Applicant recites that triple hybrid strains were created in Example 2 and Table 1, these hybrids appear to have been confirmed using only a PCR-RFLP strategy; such a tool does not confirm that the hybrids comprise “whole genomes” from the three different strains (see Table 1 and page 39, second paragraph). The single specific digestion pattern of a PCR amplification product from a single gene does not sufficiently describe whether the genomes of the hybrids were “whole” or “substantially complete” as embodiments of the phrase “sets of chromosomes” as encompassed by the claims (See Figure 8). Note that the strains in Table 1 are described as “putative hexaploid” cells because confirmation that they in fact comprise whole genomes for each of these strains is not provided (final column of Table 1, page 25). The Applicants further recite that even higher order ploidy cells were made, including both four and six species hybrids (page 39, third paragraph). For instance, the Applicants recite that a four-species hybrid was created and here refers to Figure 9 for Illumina sequencing data. However, Figure 9 in fact shows that not all chromosomes from the four species are represented in the strain (Figure 9). For instance, the second line of Figure 9, to the left of the first bar, shows that the first chromosome from the contributing strain is lost (Figure 9, line 2). There also appears to be partial chromosomal loss from the third chromosome of the contributing strain in line 1 of Figure 9 (see Figure 9, line 1, between the second and third vertical bar). Thus, the Applicant was certainly not in possession of a yeast hybrid strain with upwards of 7 whole chromosome sets from 7 different species, as is reasonably encompassed by the language of claim 1, and arguably was not in possession of a yeast hybrid strain with three whole chromosomes either according to Figure 9. This is problematic because, although the Applicant has amended claim 1 to recite “at least one chromosome from each of at least 4 different yeast species,” this claim language still encompasses embodiments comprising 4 complete genomes because “at least one chromosome” reasonably includes all of the chromosomes of a given species. Furthermore, with regards to claim 2, “sets of chromosomes” still includes “complete” chromosomes, per the Applicant’s definition of “set of chromosome” at page 4, first paragraph. The Applicant has not demonstrated possession of “16” sets of yeast chromosomes, as recited in claim 2.
Thus, the Applicant has not shown possession of the breadth of the claims, which reasonably include complete sets of chromosomes from 2-7 different yeast species, per the language of the specification and dependent claim 2.
Furthermore, even if claim 1 were interpreted to mean a synthetic yeast cell where complete chromosome structures from 4 different species is not required, where pieces of the chromosomes and/or entire chromosomes can be lost from the 4 contributing species, the Applicant was still not in possession of this broad genus of yeast cells because they have not provided a common structure or yeast cell which would encompass such a genus which would accurately predict or model what chromosomal loss may occur. As discussed further below, it is unpredictable as to how polypoidal yeast cells lose chromosomal components over time; the Applicant has not characterized the genus as a whole by providing only Figure 9 as an example of one single yeast cell with two full sets of chromosomes from two species and at least one chromosome from two additional species.
Furthermore, the Applicant has not shown that it is possible to create yeast cells encompassed by the breadth of the claims. For instance, the Applicant has not shown a yeast cell with two complete sets of chromosomes from two species, one single chromosome from a third species, and one single chromosome from a fourth species, as presently encompassed by claim 1. The Applicant has not shown that such a cell can be made using their method, or evidence that such a cells was made. Furthermore, the art teaches (see below) that chromosomal loss in higher ploidy yeast cells is incredibly unstable and unpredictable, which means that the Applicant’s method is not likely to be able to generate such unique embodiments as presently recited.
Furthermore, the specification appears to corroborate the idea that higher order ploidy cells are unstable. For instance, the specification itself states that the RFLP analysis of the six-species hybrid only indicates “the presence of at least 5 of the parental lines” (page 6, lines 25-29). The specification further teaches that the diverse morphology of the 6 species hybrid as illustrated in Figure 11A “suggests chromosome instability” (page 40, line 1). The specification further states that extensive prior work has shown that yeast polyploid strains are relatively unstable, and rapidly lose chromosomes to form aneuploid strains (page 17, lines 16-18). Thus, the teachings and data of the specification itself speak to the instability of higher order polyploid yeast cells (Figure 9, Table 1, page 6 lines 25-29, page 40 line 1, and page 17 lines 16-18).
Importantly, as seen in Figure 9, the first chromosome of the second yeast species (line 2 of Figure 9, to the left of the first bar of this line) has completely dropped out of the yeast cell. The Applicant does not offer mechanistic insight into how or why such chromosomal drop-out occurred, and there is no evidence in the specification that such chromosomal loss can be forecasted or predicted in a reliable way using structural or functional predictions from the yeast cell’s chromosomal composition. For instance, the specification offers no guidance concerning what potential chromosomes may be lost upon the generation of a synthetic cell using four different yeast species from those of Figure 9. For instance, there is no guidance concerning whether or not it would be possible to further modify the yeast cell shown in Figure 9 to comprise 1) complete sets of chromosomes from the species in rows 3-4 of Figure 9 and 2) any one specific chromosome from the species shown in rows 1-2, as presently encompassed by the claim.
It is known in the art that chromosomal loss and instability, as also recited in the specification (above), is uncharacterized and unpredictable (see below). The Applicant has thus not shown representative species of the genus of yeast cells comprising two full sets of chromosomes and at least one chromosome from two other species or upwards of 8 different species to show possession of the claimed invention because such polypoidal/aneuploid cells are known to be unpredictable regarding chromosomal loss and instability (see discussion below).
It is known in the art that higher order yeast ploidy cells are genetically unstable. For instance, the post-filing research article Hirota (Hirota S et al. J Biosci Bioeng. 2024 Feb;137(2):77-84), teaches that polyploid genomes are known to be unstable in Saccharomyces cerevisiae (Abstract). Furthermore, Hirota teaches that high levels of chromosome instability occur in polyploid strains of S. cerevisiae when diploid (2N), triploid (3N), and tetraploid (4N) are compared with haploid (1N) cells, where the frequency of chromosome non-disjunction in triploid (3N) and tetraploid (4N) increased 30- and 1000-fold compared with diploid cells, respectively (Introduction, third paragraph). Hirota further teaches that higher order ploidy yeast cells of 8N, 16N, and 32N have drastically increased chromosome loss or nondisjunction events: it is therefore known in the art that higher order polyploid yeast cells are genetically unstable, and it is unpredictable as to how or what chromosomal loss may occur in higher order yeast ploidy cells (Introduction, fifth paragraph).
Additionally, Zhu (Zhu J et al. PLoS Genet. 2012;8(5):e1002719) teaches that aneuploid yeast cells, i.e., cells with abnormal chromosome numbers, correlate with an increase in genetic instability and elevated chromosomal instability, or the propensity to gain or lose a chromosome (Abstract). Zhu teaches that:
“[s]everal studies have shown that aneuploid yeast cells not only are characterized by phenotypic variation but also exhibit genome instability. For example, two independent studies with congenic aneuploid strains obtained by sporulation of triploid or pentaploid yeast found that, while some of the aneuploid strains were relatively stable, the majority of the strains were chromosomally unstable,” (page 1, right column, second paragraph).
Thus, Zhu teaches that yeast cells comprising aberrant numbers of chromosomes are characterized by phenotypic variation and genomic instability. Given that such phenotypic and chromosomal variations exist, the Applicant has not shown possession of the diverse genus of yeast cells presently recited simply by the one example offered in Figure 9. Furthermore, Zhu teaches that the underlying mechanism governing chromosomal instability and the products (cells) generated by such instability are still uncharacterized (page 2, left column, second paragraph). Thus, both the given phenotype or chromosomal composition of a given synthetic cell presently recited is unpredictable as taught in the art.
The art and specification therefore speak to the unpredictability synthetic yeast strains with higher order ploidy (see discussion of Hirota and the specification, above). The Applicant was therefore not in possession of the claimed invention at the time of filing.
Claims 2-4 and 7-14 which depend from claim 1, do not resolve this 112(a) issue and are therefore also rejected.
Furthermore, the Applicant has not offered species commensurate in scope with the claims. For instance, Figure 9 shows chromosomal loss in both lines 1 and 2, but the Applicant has not demonstrated or taught a mechanism to predict chromosomal loss and instability in higher order polyploid yeast cells, or which parts of the chromosome/genes will be lost in different growth conditions. Given that the art and specification teach unpredictability concerning chromosomal stability in higher order yeast ploidy cells, the Applicant was not in possession of the genus of synthetic yeast cells as recited in claims 1-3, which are not required to be complete sets of chromosomes (specification, page 4, first paragraph, and see discussion of the rejection of claim 1, above). In other words, the embodiment in Figure 9, comprising “sets of chromosomes” from at least four yeast cells, where “sets of chromosomes” is interpreted to mean “substantially complete” genomes, does not predictably describe the genus as a whole because chromosomal decay is unpredictable in higher order aneuploids. The Applicant is not in possession of the broadly claimed genus because it is unknown what chromosomal information will be lost to render “substantially complete” genomes, as chromosomal instability is unpredictable as taught by Hirota and Zhu (above).
The specification further recites that unstable polyploid strains in different conditions will result in the creation of different strains depending on that condition (page 17, third paragraph). Claims 1-3 appear to be claiming any strain that could result from placing, for instance, a 6N yeast strain in different conditions, where chromosomal loss is encompassed by the claim language by use of the phrase “at least one chromosome.” The Applicant was not in possession of this genus because chromosomal loss is not predictable as discussed above.
With regards to the unpredictability of chromosomal stability/loss in different environmental conditions such as fermentation (e.g., claims 9-10), it is known in the art that yeast cells undergo unpredictable chromosomal changes dependent growth conditions in fermentation reactions such as those recited in claims 9-10. For instance, Lucena (Lucena BT et al. Genet Mol Res. 2007 Oct 5;6(4):1072-84) teaches that:
“[t]he bioethanol fermentation process can be considered a very stressing industrial environment, in which yeast cells are constantly submitted to oscillations in sucrose and ethanol concentrations, as well as temperature fluctuations and variations of the pH in the medium. In such an environment, cells are continuously recycled in the course of the harvesting period, which can last over six months. This imposes a continuous periodic selection that favors the establishment of dominant strains that are more adapted than their counterparts. Industrial yeast strains have a complex genome constitution with variable chromosome number and a ploidy state that may contribute to that adaptation. While laboratory strains of S. cerevisiae tend to present 16 chromosomes, this number may vary in industrial strains. Whether chromosome polymorphism is a cause or a consequence of such an adaptation is still a matter of divergence among scientific reports,” (Discussion, first paragraph)
Thus, Lucena teaches that industrial fermentation conditions involve constant changes of cellular stressors to yeast cells, where such cells adapt and change in such environments, where furthermore industrial yeast strains comprise complex genomes with variable adaptations (above). The Applicant has not offered species of such synthetic yeast cells to show possession of complex aneuploidal/polypoidal cells encompassed by for instance claim 9, which involves culturing high order polyploid yeast cells in fermentation environments with constantly oscillating conditions. The Applicant has not shown possession of how such unique environmental changes would affect synthetic cells recited in claim 1 (i.e., it is unknown what synthetic yeast cells would result after such fermentation culturing methods). Furthermore, Lucena teaches that chromosomal changes in industrial fermentation yeasts are specific to the genetic background (Abstract) and therefore teaches that each genetic background would need to be specifically evaluated empirically.
Lucena further teaches that:
“a high degree of chromosome polymorphism has been detected among yeast isolates collected from sugar cane fermentation tanks. These different chromosome patterns could be a result of GCR in the yeast genome induced by the environmental conditions,” (Introduction, second paragraph).
Thus, Lucena teaches that environmental conditions, and chromosome polymorphism which result from culturing in such conditions, produce high degrees of variability within a yeast strain/population. The Applicant has not shown possession of a representative number of species of such diverse yeast strains which are involved in fermentation processes but is claiming the genus of these unknown polymorphic cells as a whole.
Similarly, claims 4 and 8 recite “chromosomal segments,” however, the specification does not recite a common structure of what chromosomal segments are encompassed by the synthetic yeast strains recited. As discussed above, chromosomal stability is unpredictable, and further the specification recites that different environments and growth conditions can yield different components of the genome after chromosomal loss occurs (i.e., the loss of “chromosomal segments”); the Applicants have not identified a core mechanism or structure that would predict the creation of new strains as chromosomal loss occurs, and were therefore not in possession of the genus of “chromosomal segments” as recited (page 17, third paragraph).
Response to Arguments
The Applicant’s arguments filed 4/21/2026 have been considered but are not persuasive. The Applicant argues that their amendments narrow the claim. While the present amendments narrow the limitations from the previous claim set, the amendments render similar 112(a) issues as discussed in the previous rejection mailed 10/21/2025, where the claims still include embodiments which were not shown to be in possession by the Applicant. For instance, claim 1 broadly includes a yeast cell with chromosomes from 8 different species, where one of the sets of chromosomes is incomplete. This includes embodiments with 7 complete chromosomes, which was not demonstrated by the Applicant (see above). The Applicant further did not show possession of lower limits of the claims, including an embodiment where the yeast cell comprises 2 complete sets of chromosomes from two different species, and exactly 1 chromosome from two additional species, as encompassed by the claims. Owing to the unpredictability in the art regarding chromosomal and genetic loss and its unpredictability in higher ploidy yeast cells, the art teaches that such an embodiment is unlikely to be made.
The Applicant argues that multiple example of yeast cells have been reduced to practice in order to show possession of the claimed invention. This argument is not persuasive. As an initial matter, the strains in Table 1 are described as “putative hexaploid” cells because confirmation that they in fact comprise whole genomes for each of these strains is not provided (final column of Table 1, page 25). The Examples are largely drawn to RFLP analysis which does not measure the status or presence of complete sets of chromosomes. The arguments with respect to Figure 11B and Table 1 are therefore not persuasive.
Regarding Figure 9, the Applicant argues that this is a representative species of the recited genus. This argument is not persuasive. Owing to the highly unpredictable and highly unstable nature of the claimed subject matter as taught in the art and also recited in the specification itself, Figure 9 is not considered to be a representative species of the claimed genus. Instead, Figure 9 is simply one example, or one species of the genus. However, this should not be conflated with a representative species of the genus because the genus itself is highly unpredictable, uncharacterized, and unstable (see discussion of prior art, above). Thus, while the yeast cell represented in Figure 9 is one example of the recited genus, the example itself is not representative of the entire genus, nor would a practitioner of skill in the art recognize this as a representative embodiment of the entire genus owing to the complex and unpredictable nature of the subject matter that is being claimed (see discussion of the state of the art, above).
MPEP 2163 makes clear that:
“"[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."
and
“Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the inventor 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. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 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 present application does not show representative species of the claimed genus because the genus is art-recognized to be highly unpredictable owing to the known instability of yeast chromosomes when in higher order numbers (polyploids, see state of the art discussion, 112(a) rejection above).
The Applicant argues that the unpredictability surrounding chromosomal loss does not constitute a written description rejection. This argument is not persuasive. As the art teaches that chromosomal loss is the be expected in the recited genus of cells, concerns regarding what chromosomes will be lost are directly relevant to the claimed subject matter because chromosomal composition is part of the structure of the recited cells. The fact that the cells are highly unstable and lose genetic material with a high degree of unpredictability as taught in the art means that the scope of the recited genus is itself highly unpredictable. The Applicant argues that “the claims do not require prediction of which specific chromosome will be lost, but instead define the genus by the structural characteristics that are present.” This argument is not persuasive. The MPEP makes clear that:
“"[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention,” (MPEP 2163, 3A, subsection ii).
The argument that the claims do not require prediction of the loss of chromosomes is therefore not persuasive because the MPEP clarifies that the scope of what is claimed has to be shown to be in possession by the inventor. In the present case, claim 1 broadly encompasses, within its scope, yeast cells which are for instance used in industrial reactions such as those presently recited in claims 9-10. The Applicant has not shown possession of the scope of the claims because the breadth of the claim indeed includes yeast cells and their embodiments which lose chromosomal material over time in various conditions, which is a highly unpredictable and unstable genus. The specification speaks to such embodiments of the recited cells, where the inherent instability of the cells “could, in fact, be a desirable trait for many applications, as placing an unstable tetraploid strain in a selective condition will influence which components of the genome are retained or lost from which parent, allowing for more rapid adaptation to that condition" (Specification, pg. 32, lines 23-25). Thus, the scope of the claims and the invention reasonably include yeast cells grown in highly diverse environments to generate unpredictable cell types in diverse environments. The Applicant has not shown possession of such a scope as recited in the claims.
Furthermore, the MPEP clarifies that:
“'[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification,” (MPEP 2163, 3A, subsection ii).
In the present case, the scope of the presently claimed cells overreaches the scope of the inventor’s contribution as outlined in the specification. For instance, the scope of the right to exclude would disallow other inventors from developing novel, independent methods to generate yeast cells that would fall under the present scope of the claims and to claim such cells.
The Applicant argues that the genus is defined in the claims by structural characteristics, namely, chromosomes and the loss of chromosomes. The Applicant argues that a person of ordinary skill in the art would recognize the scope of the genus was shown to be in possession by the Applicant. This argument is not persuasive because a person of ordinary skill in the art would understand that the art teaches that the claimed genus is highly unstable and unpredictable, where the specific chromosomes that are present or lost are also unpredictable (as discussed in the 112(a0 rejection, above). The Applicant did not characterize the genus of yeast cells claimed by showing one such example because there is no way to predict what the composition of untested yeast cells would comprise, or which chromosomes would be lost. Furthermore, the Applicant acknowledges that “specific chromosomal loss is unpredictable.” The Applicant therefore acknowledges that specific species within the genus claimed, which is structurally defined by the presence or absence of unstable chromosomes, is not predictable. Thus, the assertion by the Applicant that “but the structure of the genus of synthetic yeast cells is predictable” is not persuasive, as the Applicant themselves acknowledge that individual embodiments (i.e., species) of the claimed genus are “unpredictable.”
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS CHARLES RYAN whose telephone number is (571)272-8406. The examiner can normally be reached M-F 8AM - 5PM.
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/D.C.R./Examiner, Art Unit 1635
/RAM R SHUKLA/Supervisory Patent Examiner, Art Unit 1635
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