DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Group I, claims 1-3, 5, 7-15, 34-36, and 40, in the reply filed on Dec. 12, 2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 1-40 are pending, claims 4, 6, 16-33, and 37-39 are withdrawn for being directed to non-elected inventions, and claims 1-3, 5, 7-15, 34-36, and 40 are examined in this Office Action.
NOTE: the Examiner had incorrectly included claim 37 in Group I and it belonged in Group II with the other claims that recited the markers.
Unable to Establish the Fact Pattern
There are multiple inconsistencies between the specification, the claims, and the drawings, and this makes it impossible for the Examiner to clearly establish the fact pattern for the instant application. Examples:
Claim 5 recites “wherein a representative deposit of a plant comprising said first, second, and third alleles has been deposited under NCMA Accession No. 202110015”; compare to “Deposit Information”: a deposit of representative sample of plant tissue … which comprises the chromosomal segments on chromosomes 9 and 18 … was made … assigned NCMA Accession No. 202110015 (Spec 24). Which of these is true? Does the deposit contain all three alleles? Or just the alleles on chromosomes 9 and 18?
Table 1 says the SNP at bp 17,373,984 on chromosome 5 has a “G” as the favorable allele (M3) and a “C” as the favorable allele (M4) (Spec 27). How can there be two favorable alleles which are the opposite at the exact same position? The same issue is present for the chromosome 18 markers for position 27,007,362 (M14 and M15) which recites two favorable alleles, “A” and “C”.
The markers on chromosomes 9 and 18 were identified using an additive genetic model, and the marker on chromosome 5 was identified using a model allowing for dominance (Spec 26 ¶88). This implies that the allele on chromosome 5 is a dominant allele, while the alleles on chromosomes 9 and 18 are recessive. Compare to the data in the figures: on the y-axis 100% represents no berry browning and 0% represents complete browning (Spec 7 ¶¶ 13-15). In Figure 3, the column graph which provides data for chromosome 5, the marker call that gave the closest to no browning (favorable) was heterozygous (gc), whereas if the marker was homozygous for either c or g, there was more browning (not favorable). This is not what would be expected for a dominant allele for reduced browning. In Figure 4 which provides data for the allele on chromosome 9, there was reduced browning for “ct” or “tt” and more browning with “cc”; and this appears to show the “t” allele is dominant for reduced browning, but it was not identified using the model that allows for dominance. In Figure 5 which provides data for the allele on chromosome 18, there is reduced browning for the plants heterozygous for “ac”, and more browning for plants that are homozygous for either a or c. This appears to show that if either call is homozygous there will be more browning. This does not point to either allele being a “favorable” allele; they are both unfavorable.
In trying to establish the fact pattern around the 76 plant selections used in the study for Example 1 and for the plant line that was deposited with the NCMA, there is also some confusion. Example 4 refers to: “ … a large panel of Vitis vinifera selections and interspecific hybrids analogous to the panel described in Example 1” (Spec 28 ¶90). This implies that the 76 plant selections used in Example 1 (Spec 25 ¶84) are a mixture of Vitis vinifera selections and interspecific hybrids. The deposit information states that a sample of plant tissue of Vitis vinifera line ‘04009-039-230’ which comprises the chromosomal segments on chromosomes 9 and 18 as described herein was made with the NCMA (Spec 24 ¶83). It is impossible to determine how the deposited line was arrived at from the starting panel which is a mixture of Vitis vinifera selections and interspecific hybrids.
Because the Examiner is unable to clearly establish the fact pattern for these issues, Examination was difficult. The Examiner is including a request for information under 37 CFR 1.105, appended to this Office Action, to provide clarity on these issues. A complete response to this Office Action must include a response to this request for information.
Specification
The disclosure is objected to because it contains 2 embedded hyperlinks and/or other forms of browser-executable code on page 8 ¶ 18. Applicant is required to delete the embedded hyperlinks and/or other forms 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.
The title of the invention is not descriptive and it contains the word “novel”. A new title is required that is clearly indicative of the invention to which the claims are directed. Titles are not allowed to use the words “novel” or “new” (MPEP 606).
The following title is suggested: - - GRAPE QTLS AFFECTING BROWINING - - .
Appropriate correction is requested
Claim Rejections - 35 USC § 112
Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 5, 7-15, 34-36, and 40 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
Claim 1 is directed to a Vitis vinifera plant comprising at least a first introgressed allele on a first chromosome selected from the group consisting of chromosomes 5, 9, and 18, and wherein said first introgressed allele confers to said plant a reduction in berry browning compared to a plant not comprising said allele.
The instant specification discloses that interspecific hybrids were utilized for their genome wide association study (Spec 28 ¶ 90). Multiple claims, however, require the plant to be a Vitis vinifera plant rather than an interspecific hybrid. This renders the claims indefinite because it is unclear how many backcrosses to Vitis vinifera plants would be required to convert an interspecific hybrid back into a Vitis vinifera plant. See, for example, Foria et al (Horticulture Research (2022) Vol. 9; pp. 1-16) who teach that interspecific hybrids are being used to introgress resistance genes into Vitis vinifera, and this leads to a lot of debate about whether wine laws based on classification should be revised (Foria, abstract). Recent releases have from 76.5% - 94.8% Vitis vinifera DNA with the remainder coming from the grape species that donated resistance genes (Id.). This raises the question about how much of the genomic DNA is required to be Vitis vinifera DNA for a plant to be considered a Vitis vinifera plant? 90%? 75%? Anything over 50%? For this reason, the limitation that the claimed plant is a Vitis vinifera plant raises indefiniteness because the metes and bounds of this limitation are not clear.
Claims 1-3 and 13 require a reduction in berry browning compared to a plant not comprising the introgressed allele. This raises issues of indefiniteness because different grape varieties have different degrees of berry browning. See, for example, Romeyer et al (J. Agrie. Food Chem. (1983) Vol. 31; pp. 346-349) who teach that Grenache and Ugni blanc grape varieties are known to possess a high browning capacity whereas Carignane and Maccabeo varieties have a low browning capacity (Romeyer 348). If one were to compare to a Grenache or Ugni plant lacking the introgressed allele, there is a good chance the plant with the introgressed allele would have a reduction in berry browning, but if one were to compare to a Carignane or Maccabeo plant lacking the introgressed allele, then the claimed plant might not have a reduction in browning. For this reason, the standard for what would constitute a reduction in berry browning is unclear. Claim 36 has an even bigger issue, because it requires reduced oxidative browning without reciting any comparison plant at all.
Furthermore, the claims do not require that the reduced browning be compared to a plant grown under the same environmental conditions, and this can impact the level of browning. Browning can be classified under several different browning phenotypes because it is multifaceted and may arise from a combination of factors (Spec 2 ¶ 4). The browning can be external, internal, low temperature, chemical, physical, and pathogenic; including browning from berries rubbing (Spec 7 ¶16). If the claimed plant comprises the required allele(s) but was infected by a pathogen, it may have more browning than a plant lacking the allele(s) that was not infected by a pathogen. Same issue could arise for temperature or chemical exposure, etc.
Claim 5 recites “wherein a representative deposit of a plant comprising said first, second, and third alleles has been deposited under NCMA Accession No. 202110015” and this is confusing because the deposit statement says this deposited line only comprises chromosomal segments on chromosomes 9 and 18 (Spec 24 ¶ 83).
Inadequate Written Description
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 1-3, 5, 7-15, 34-36, and 40 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
The claims are directed to a Vitis vinifera plant comprising at least a first introgressed allele on a first chromosome selected from the group consisting of chromosomes 5, 9, and 18, and wherein said first introgressed allele confers to said plant a reduction in berry browning compared to a plant not comprising said allele (claim 1); and to a plant having two introgressed alleles (claim 2), and a plant having three introgressed alleles (claims 3 and 5); including wherein each of the alleles is present in either heterozygous or homozygous form (claims 7-12 and 13); and to plant parts of said plant (claims 14, 15, 34, 35) and progeny of said plant (claim 40); including wherein the browning is oxidative browning (claim 36).
Applicant describes 76 green seedless selections which were unreleased numbered selections from the International Fruit Genetics table grape breeding program (Spec 25 ¶ 84). Applicant prophetically describes further validation using a large panel of Vitis vinifera selections and interspecific hybrids analogous to these 76 green seedless selections (Id. 28 ¶ 90). This implies that the panel of 76 green seedless selections is a mixture of Vitis vinifera selections and interspecific hybrids.
Applicant does not describe any interspecific hybrids with any detail. Applicant mentions that interspecific hybrids can be used as one embodiment, and mentions Vitis labrusca, cinerea, aestivalis, riparia, rupestris, romanetti, piasezkii, mustangensis, montibola, girdiana, arizonica, rotundifolia, and acerifolia (Spec 9-10 ¶ 22). Applicant does not describe which Vitis species were crossed with Vitis vinifera to provide interspecific hybrids for the panel of 76 green seedless grapes. Applicant does not describe how many of the 76 grapes in this panel are Vitis vinifera and how many are interspecific hybrids.
With regard to the biological deposit taught on page 24 and recited in claim 5, Applicant does not describe how Vitis vinifera line ‘04009-039-230’ was generated. Was this line produced by a series of backcrosses to introgress the two chromosomal segments on chromosomes 9 and 18, respectively? If so, what was used as the recurrent parent? What germplasm was the source for the introgressed chromosomal segments? Was it backcrossed to an inbred Vitis vinifera line a sufficient number of times to arrive at a true-breeding, stable, and uniform line?
The claims encompass Vitis vinifera plants that have one, two, or three alleles introgressed on chromosome, 5, 9, and/or 18 wherein the allele(s) confer a reduction in berry browning compared to a plant not comprising the allele(s). These alleles can be found anywhere on one of the recited chromosomes and can confer a reduction in any type of browning relative to any plant that lacks the allele grown in any environment.
Applicant describes a population of “approximately” 76 green seedless numbered selections that could be Vitis vinifera or could be interspecific hybrids, each of which were scored for the level of browning of berries after 24 hours at room temperature after the berries were removed from the rachis (stem) (Spec 25). Applicant states that loci associated with decreased berry browning were detected on chromosomes 9 and 18 using an additive genetic model and on chromosome 5 using a model allowing for dominance (Spec 26). Therefore, Applicant describes an unknown number of plants of unknown species of grape having less browning relative to other plants of unknown species. Applicant describes the alleles indirectly by co-segregating SNPs at specific positions relative to “public” genetic map (Spec 27).
Applicant does not describe the alleles themselves. Applicant does not describe any “candidate genes” proximal to the identified SNPs. Applicant does not describe the genetic background of the particular numbered selection(s) that were identified as having any one of the alleles. Applicant does not describe the genetic distance (cM) between the SNPs and the causative allele(s). Applicant does not describe any alleles on the recited chromosomes that are distal to the SNPs disclosed in Table 1. The current claims encompass any allele anywhere on the chromosome, and Applicant has not described more than one allele for each of the chromosomes wherein the alleles are proximal to a particular position on the chromosomes.
Applicant does not describe any particular plant having all three alleles (as in claim 3). Applicant only describes one plant having two alleles (as in claim 2), Vitis vinifera line ‘04009-039-230’, which has the alleles on chromosomes 9 and 13. Applicant does not provide a description of the genetic background of Vitis vinifera line ‘04009-039-230’. Applicant does not describe which grape species were the donors of any of the claimed alleles.
With regard to claim 5, specifically, the claim recites “wherein a representative deposit of a plant comprising said first, second, and third alleles has been deposited under NCMA Accession No. 202110015”, but the specification describes this biological deposit as only comprising two of the alleles, the alleles on chromosomes 9 and 18. Applicant does not describe the deposited biological material sufficiently, therefore, it is unclear how the deposit is “representative”. Is the deposited material from a plant that is sufficiently inbred to have uniformity at the genomic level? Are the alleles present in the biological material in homozygous form? How is the third allele represented when it appears the deposit does not have the allele on chromosome 5?
For at least the reasons stated above, the specification does not provide an adequate description for the claimed plants.
Lack of Scope of Enablement
Claims 1-3, 5, 7-15, 34-36, and 40 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 a Vitis vinifera plant comprising one or two introgressed alleles on chromosome 9 and/or chromosome 18 that confer a reduction in berry browning compared to a control plant of the same genetic background lacking the allele and grown under the same environment conditions, wherein the alleles are introgressed from a plant of Vitis vinifera line ‘04009-039-230’, wherein representative plant tissue of Vitis vinifera line ‘04009-039-230’ has been deposited at the NCMA under NCMA Accession No. 202110015, does not reasonably provide enablement for a Vitis vinifera plant comprising three introgressed alleles on chromosomes 5, 9, and 18 that confer a reduction in berry browning, or for a Vitis vinifera plant comprising an allele on chromosome 5 that confers a reduction in berry browning, or a Vitis vinifera plant comprising one, two, or three introgressed allele(s) on chromosome 5, 9, and/or 18 that confer a reduction in berry browning wherein the alleles are introgressed from any source other than from Vitis vinifera line ‘04009-039-230’. 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
Applicant teaches Vitis vinifera line ‘04009-039-230’ wherein a representative sample of plant tissue of said line has been deposited with the NCMA under NCMA Accession No. 202110015 (Spec 24). Applicant teaches that this line comprises the chromosomal segments on chromosomes 9 and 18 that are described in the specification as conferring reduced browning (Id.).
Applicant teaches SNPs that are “associated” with reduced browning alleles on chromosomes 5, 9, and 18 in plants found in a population of approximately 76 Vitis vinifera selections and interspecific hybrids.
Applicant does not teach a germplasm source for the allele disclosed on chromosome 5. Applicant does not teach SNPs that co-segregated with the alleles on chromosomes 9 and 18 in Vitis vinifera line ‘04009-039-230’. Applicant does not teach how Vitis vinifera line ‘04009-039-230’ is related to or is derived from the plants found in a population of approximately 76 Vitis vinifera selections and interspecific hybrids. Applicant does not teach the particular species of grape(s) that the alleles came from.
It is known in the art that marker-QTL linkages do not always remain in different genetic backgrounds or in different testing environments (Collard et al. Euphytica (2005) Vol. 142; pp. 169-196; page 186). Markers should be validated by testing their effectiveness in different genetic backgrounds to make sure the marker is reliable across a range of cultivars (Id.). In the instant case, the recited alleles could have come from any grape species that may have been used for interspecific hybrids included in the approximately 76 numbered lines utilized by the inventors. If, for example, one of the alleles came from Vitis riparia, then there is no guarantee that the SNPs which were co-segregating in the Vitis riparia genome would be present in a grape of Vitis vinifera.
Applicant did not teach any of the SNPs as the “causative” nucleotide substitution (i.e. causing a change in gene expression or a change in amino acid sequence encoded for the gene that causes a reduction in browning). Applicant does not teach the genetic distance between the SNPs and the causative allele. Applicant does not teach any of the SNP markers as “flanking” the causative allele, meaning one marker upstream of the allele and one marker downstream of the allele to define the chromosomal segment that was introgressed.
Applicant did not teach introgressing any of the alleles into a Vitis vinifera line that previous lacked the alleles. It is possible that is how Vitis vinifera line ‘04009-039-230’ was generated, but that is not expressly taught in the specification.
Given the lack of guidance in the specification and the unpredictability in the art, it would require undue experimentation for one of skill in the art to make the claimed plants.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 7, 8, 14, 15, 34, 35, and 40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Foria et al (Horticulture Research (2022) Vol. 9; pp. 1-16) taken with the evidence of Ash, G. (The Plant Health Instructor (2000) Vol. 1; pp. 1-11).
Foria teaches the Rpv3-1 locus on chromosome 18 (Foria 7). Foria teaches that the Rpv3-1 resistance locus stems from Asian Vitis lineages and is used as a donor for introgressing resistance to Plasmopara viticola (Id.). Foria teaches that resistance genes have been introgressed through controlled crosses in breeding programs and have also been introduced by spontaneous introgressive hybridization (Id. 1) the result being a Vitis vinifera plant comprising an introgressed allele on chromosome 18 which confers resistance to the downy mildew disease caused by Plasmopara viticola. Downy mildew disease causes browning (Ash 3, Figure 7), therefore resistance to downy mildew inherently confers a reduction in browning.
With regard to claims 7, 8, and 40 when a Vitis vinifera plant is crossed with a plant containing the Rpv3-1 allele, the result is a hybrid that will have one copy of the allele (heterozygous). When the hybrid self-pollinates, 25% of the progeny will lose the allele, 25% will be homozygous for the allele, and 50% will be heterozygous for the allele. Although Foria is silent regarding self-pollination of the initial hybrid, this would inherently be part of a breeding program or part of the spontaneous introgressive hybridization.
With regard to claims 14 and 15, Foria teaches grape plant parts of berries, vines, and roots (Foria 2).
With regard to claims 34 and 35, a seed and an embryo are inherent parts of the grapes used in controlled crosses and grapes involved in spontaneous introgression.
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, 7, 8, 14, 15, 34, 35, and 40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) a Vitis vinifera plant with an introgressed allele and progeny and parts thereof. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as taught by Foria, grapes have undergone spontaneous introgression of resistance alleles without any assistance or intervention from humans (Foria 1). See mapping of limitations in rejection under 35 USC 102, above.
Summary
No claim is allowed.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHY KINGDON whose telephone number is (571)272-8784. The examiner can normally be reached M-F 9:00 - 5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A Abraham can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CATHY KINGDON
Primary Examiner
Art Unit 1663
/CATHY KINGDON/Primary Examiner, Art Unit 1663
Request for Information under 37 CFR § 1.105
Applicant and the assignee of this application are required under 37 CFR § 1.105 to provide the following information that the examiner has determined is reasonably necessary to the examination of this application.
This request is being made for the following reasons:
There are inconsistencies between the specification, the drawings, and the claims that make it difficult to evaluate the data and the biological deposit. There is also no information given regarding how the grape line of the biological deposit was generated. It is important for the understanding of the claimed invention to correctly establish the fact pattern.
In response to this requirement, if known, please provide answers to each of the following interrogatories eliciting factual information:
Please supply the breeding methodology and history regarding the development of Vitis vinifera line ‘04009-039-230’.
a) Such information should include all of the public or commercial designations/denominations used for the original parental lines.
b) Information pertaining to the public availability of the original parental lines should be set forth.
c) The breeding method used should be set forth, such as whether single seed descent, bulk method, backcross method, or some other method was used.
d) The filial generation in which the plant used for the biological deposit was chosen should be set forth.
e) Information pertaining to the homozygosity or heterozygosity of the parents as well as the instant plant should be set forth.
f) Are there any patent applications or patents in which siblings or parents of the instant plant are claimed? If so, please set forth serial numbers and names of the siblings or parents.
g) Which of the claimed alleles are contained in the genome of the deposited line?
h) How many of the approximately 76 selections were Vitis vinifera? How many were interspecific hybrids? For each interspecific hybrid, which species were crossed to produce the hybrid?
i) What species of grape was the source for each of the three claimed alleles?
j) How many of the approximately 76 selections were identified as comprising each one of the claimed alleles? What species of grape were the selections that were identified as comprising each of the favorable alleles?
k) Please explain the data in Table 1 and in Figures 3, 4, and 5, including explaining whether each allele is dominant or recessive and what is meant when two different nucleotides are designated as “favorable” at the same position of the SNP.
l) Is the deposited line seedless? If so, does it produce pollen?
m) Example 4 discusses using the markers to perform Marker Assisted Selection for staking the QTLs to create lines. Because the 76 selections that were utilized in Example 1 are all seedless, how can they be used in a breeding program? What is the fertile source for the claimed alleles?
If Applicant views any or all of the above requested information as a Trade Secret, then Applicant should follow the guidance of MPEP § 724.02 when submitting the requested information.
In responding to those requirements that require copies of documents, where the document is a bound text or a single article over 50 pages, the requirement may be met by providing copies of those pages that provide the particular subject matter indicated in the requirement, or where such subject matter is not indicated, the subject matter found in applicant’s disclosure. Please indicate where the relevant information can be found.
The fee and certification requirements of 37 CFR § 1.97 are waived for those documents submitted in reply to this requirement. This waiver extends only to those documents within the scope of this requirement under 37 CFR § 1.105 that are included in the applicant’s first complete communication responding to this requirement. Any supplemental replies subsequent to the first communication responding to this requirement and any information disclosures beyond the scope of this requirement under 37 CFR § 1.105 are subject to the fee and certification requirements of 37 CFR § 1.97 if submitted subsequent to a first Office action on the merits.
7. This requirement is subject to the provisions of 37 CFR 1.134, 1.135 and 1.136. The response to this requirement is due at the same time as the Office Action to which it is appended which is three months from the mail date. EXTENSIONS OF THIS TIME PERIOD MAY BE GRANTED UNDER 37 CFR 1.136(a).
8. The applicant is reminded that the reply to this requirement must be made with candor and good faith under 37 CFR § 1.56. Where the applicant does not have or cannot readily obtain an item of required information, a statement that the item is unknown or cannot be readily obtained may be accepted as a complete reply to the requirement for that item.
/Amjad Abraham/SPE, Art Unit 1663