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 .
Please note: The Examiner handling this application has changed and is now Stephen Kapushoc, Primary Examiner – AU 1683
Election/Restrictions
Applicant's election with traverse of the invention of Group I (claims directed to methods of testing a brain tumor), and the particular miRNA biomarker that is miR-6070 in the reply filed on 10/03/2025 is acknowledged. The traversal is on the ground(s) that “in national stage cases where unity of invention has already been determined, the Office is precluded from independently revisiting the inquiry”, and “searching all claimed inventions would not impose an undue burden on the Office”. This is not found persuasive. Initially it is noted that MPEP 1893.03(d) provides:
When making a lack of unity requirement, the examiner must (1) list the different groups of claims and (2) explain why each group lacks unity with each other group (i.e., why there is no single general inventive concept) specifically describing the unique special technical feature in each group. The examiner may make a lack of unity requirement in a national stage application even if no such requirement was made by the ISA or IPEA.
Additionally, where the instant application is a 371 national stage application, the relevant inquiry is unity of invention, not search burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 3-6 and 9 (requiring non-elected miRNA markers and non-elected combinations thereof) and claims 13-15 (directed to non-elected inventions) are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species and inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/03/2025.
The claims of the elected invention are examined to the extent that the claims require on the elected biomarkers (i.e.: miR-6070). The additionally recited miRNAs are withdrawn from consideration as being directed to a non-elected invention. Prior to allowance claims, any non-elected subject matter that is not rejoined with any allowed elected subject matter will be required to be removed from the claims.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on Sept. 27, 2019. It is noted, however, that the foreign priority date is the effective filing date of the claimed invention if:
-the foreign application supports the claimed invention under 112(2), AND
-the applicant has perfected the right of priority by providing:
-a certified copy of the priority application, and
-a translation of the priority application (if not in English).
In the instant case Applicant has submitted a certified copy of the priority application (JP2019-177615) but it is not in English, and there is no certified translation of the document. The effective filing date of the Application is considered to be 09/24/2020, which is the filing date of the parent international application PCT/JP2020035899.
Claim Objections
Claims 2, 7, 8, 10, 11, and 12 are each objected to because of the following informalities: each claim recites “according to Claim 1”, where the phrase “according to [[C]]claim 1” is likely intended.
Appropriate correction is required.
Improper Markush Group
Claims 1, 2, 7, 8 and 10-12 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117(II).
The claims recite the following Markush groups:
Claim 1 “at least one biomarker selected from the group consisting of: miR-34S-3p, miR-208a-Sp, miR-188-3p, miR-S04-Sp, miR-199a-Sp, miR-93-3p, miR-328-Sp, miR-483-3p, miR-204-3p, miR-41 l-3p, miR-12Sl-Sp, miR-30c-2-3p, miR-26a-1-3p, miR-27b-3p, miR-338-Sp, miR-S41-3p, miR-224-3p, miR-143-3p, miR-32-3p, miR-202-5p, miR-296-3p, miR-598-5p, miR-125b-2-3p, miR-20b-3p, miR-181b-2-3p, miR-29b-2-5p, miR-301a-5p, miR-140-3p, miR-122-5p, miR-335-3p, miR-539-5p, miR-374b-5p, miR-144-5p, miR-196a-5p, miR-124-3p, miR-363-5p, miR-376b-5p, miR-367-5p, miR-29a-3p, miR-146a-3p, miR-216a-5p, miR-148a-5p, miR-99a-5p, miR-509-5p, miR-6070, miR-450a-2-3p, miR-4638-3p, miR-20a-3p, miR-646, miR-151a-5p, miR-151b, miR-146a-5p, miR-371a-3p, miR-21-3p, miR-578, miR-4428, miR-5095, miR-193a-3p, miR-4538, miR-492, miR-4482-5p, and miR-4768-3p”
Claim 7 “at least one selected from the group consisting of: miR-6070, miR-450a-2-3p, miR-4638-3p, miR-20a-3p, miR-646, miR-151a-5p, miR-151b, miR-146a-5p, miR-371a-3p, miR-21-3p, miR-578, miR-4428, miR-5095, miR-193a-3p, miR-4538, miR-492, miR-4482-1p, and miR-4768-3p”
Claim 8 “at least one selected from the group consisting of miR-6070, miR-450a-2-3p, miR-4638-3p, and miR-20a-3p”
The Markush group in each case is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
It is first noted that MPEP 2117(II) states that “A Markush claim may be rejected under judicially approved “improper Markush grouping” principles when the claim contains an improper grouping of alternatively useable members. A Markush claim contains an “improper Markush grouping” if either: (1) the members of the Markush group do not share a “single structural similarity” or (2) the members do not share a common use. Supplementary Guidelines at 7166 (citing In re Harnisch, 631 F.2d 716, 721-22, 206 USPQ 300, 305 (CCPA 1980)). “Members of a Markush group share a “single structural similarity” when they belong to the same recognized physical or chemical class or to the same art-recognized class (prong 1) and the members of a Markush group share a common function or use when they are disclosed in the specification or known in the art to be functionally equivalent (prong 2).
The phrase “significant structural element is shared by all of the alternatives” refers to cases where the compounds share a common chemical structure which occupies a large portion of their structures, or in case the compounds have in common only a small portion of their structures, the commonly shared structure constitutes a structurally distinctive portion in view of existing prior art, and the common structure is essential to the common property or activity.
A recognized physical class, a recognized chemical class, or an art-recognized class is a class wherein “there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved” (see MPEP 2117(II)).
Herein, the recited alternative species do not share a single structural similarity, as each miRNA has a different chemical structure in that it consists of a different nucleotide sequence. The only structural similarity present is that all of the miRNA comprise nucleotides. The fact that the miRNA comprise nucleotides per se does not support a conclusion that they have a common single structural similarity because the structure of comprising nucleotides alone is not essential to the asserted common activity of being correlated with the presence of a brain tumor. Accordingly, while the different miRNA are asserted to have the property of being correlated with the presence of a brain tumor, they do not share a substantial structural similarity essential to this activity.
Further, there is no expectation from the knowledge in the prior art that miRNA behave in the same manner and can be substituted for one another with the same intended result achieved. There is no evidence of record to establish that it is clear from their very nature that the recited miRNA possesses the common property of being correlated with the presence of a brain tumor.
Following this analysis, the claims are rejected as containing an improper Markush grouping.
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, 2, 7, 8, and 10-12 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.
Claims 1, 2, 7, 8, and 10-12 are unclear over the purpose of the claimed methods as “a method of testing a brain tumor”, as recited in the preamble of claim 1 from which claims 2, 7, 8 and 10-12 depend, in light of the steps of the claims which require only detecting a biomarker (recited as step (1) in claim 1). Claim 1 does not recite any step related to brain tumor testing (e.g.: determining the presence or absence of; detecting a stage or a tumor), nor does claim 1 require that the method is in fact performed on a subject that has a brain tumor. It is unclear how the recited process steps accomplish “testing a brain tumor”. This aspect of the claims with regard to lack of clarity is demonstrated by the recitation in claim 2 of “determining whether the subject has a brain tumor”, which appears to encompass a lack of the tumor in the subject (i.e.: “determining whether” includes concluding that the subject does not have the tumor).
Claim 2 is unclear over recitation of the limitation “based on the amount or concentration of the biomarker detected in (1 )”, because step (1), as recited in claim 1, does not require any collection of data or information specifically related to any “amount or concentration”. As such there is not proper antecedent basis for any “amount or concentration” of a biomarker.
Claim 11 is unclear over recitation of the limitation “said body fluid sample is an extracellular vesicle of urine”, because a “vesicle” is not a “fluid”. The claims may be made more clear in this regard if amended to recite “said body fluid sample is [[an extracellular vesicle of]] urine that comprises urinary extracellular vesicles”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 7, 8, and 10-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions including abstract ideas and natural phenomena without significantly more.
The claim(s) recite(s) a method of testing a brain tumor (claim 1), which indicates that the claims are directed to an evaluation of data or information to reach a conclusion or make a judgment, which is a mental process that is an abstract idea. The recitation of claim 2 which requires a determination based on collected data clearly is directed to such a a mental process that is an abstract idea (see MPEP 2106.04(a) III). Additionally, where claim 2 recites a correlation between biomarker expression and the presence of a brain tumor, the claim is directed to the natural association between gene expression and pathology, and thus is directed to a natural phenomenon (see MPEP 2106.04(b) I).
This judicial exception is not integrated into a practical application because the claims do not practically apply the judicial exception(s), as noted above, by including one or more additional elements that the courts have stated integrate the exception into a practical application:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
An additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
An additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
An additional element effects a transformation or reduction of a particular article to a different state or thing; and
An additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
Here it is noted that while the claims broadly recite steps of detecting miR-6070 in a body fluid (as consonant with the Election), and detection of the biomarker in urine or extracellular vesicles, these steps are not considered to integrate the judicial exception(s) into a practical application because they merely add insignificant extra-solution activity (data gathering) to the judicial exception (see MPEP 2106.05(g)).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because a step of a known miRNA in a sample is well understood, routine and convention activity in the related prior art.
The teachings in the specification demonstrate the well understood, routine, conventional nature of additional elements because it teaches that the additional elements are well known or commercially available. For example, the specification teaches the following:
[0032] Extracellular vesicles may be purified, separated, concentrated, and the
like, from urine according to or following known methods.
[0047] The base sequences and the like of the target biomarkers can be specified by known databases (for example, miRBase:http://www.mirbase.org/).
[0051] The method of detecting target biomarkers is not particularly limited as
long as it is a method capable of specifically detecting part or all of the target
biomarkers. Specific examples of the detecting method include RNA-seq analysis
methods, RT-PCR methods, nucleic acid chip analysis methods, Northern blot
method, and the like.
The prior art also demonstrates the well understood, routine, conventional nature of additional elements because it teaches that the additional elements are well known or commercially available. For example, the miScript™ miRNA PCR Array (384-well, 384HC) Human miRBase Profiler HC Plate 6 from Qiagen (2012) is a commercially available product for miRNA detection using primers, and includes reagents for the detection of mir-6070 (at position B01). And the prior art 3D-Gene Human miRNA V21_1.0.0 array (2015) from Toray includes probes for the detection of miR-6070. And Yasui et al (2017) teaches an analysis of miRNA isolated form urinary microvesicles using the same 3D-Gene Human miRNA Oligo chip ver.21 (Toray Industries).
For the reasons set forth above the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 112 – Scope of Enablement
It is noted that the claims are rejected above in this Office Action under 35 USC 112(b) for issues related to the required steps of the claims in light of the recited intended use of the claims. In the interests of customer service and compact prosecution, the intended use of the claims, in light of the particular teachings of the specification and the teachings of the related art, is addressed here.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 7, 8, and 10-12 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 method of diagnosing a brain tumor in a human subject, comprising:
(a) providing a sample of urinary extracellular vesicles obtained from a human subject;
(b) detecting the level of miR-6070 in the sample from the human subject;
(c) comparing the level of miR-6070 in the sample from the human subject to a level of miR-6070 in a sample of urinary extracellular vesicles obtained from a healthy human without a brain tumor;
(d) determining that the level of miR-6070 in the sample from the human subject is higher than the level of miR-6070 the sample from the healthy human, and;
(e) diagnosing the human subject as having a glioma brain tumor.
does not reasonably provide enablement for the claims as broadly written. 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/or use the invention commensurate in scope with these claims.
Scope of the Claims/Nature of the Invention
The claims encompass any sort of “testing” (as retied in claim 1) such as the simple detection of the presence of a tumor, or the staging or clinical classification of a brain tumor. The claims encompass the analysis of any subject organism, and the detection of any level, or any compared level, of mir-6070.
The nature of the invention requires a reliable correlation between the level of miR-6070 in a urine sample and the brain tumor phenotype.
Teachings in the Specification and Examples
The specification (paras 108-114) teaches an example of the analysis of miRNA levels in urinary extracellular vesicles from human brain tumor patients (including both glioma patients and healthy human subjects. Relevant to the claims, and the elected invention, the specification teaches that mir-6070 showed higher expression levels (mean expression levels) in the brain tumor patients than the expression levels (mean expression levels) in the healthy subjects (para 0111; Table 2).
The specification does not teach the analysis of any non-urine samples, the analysis of any non-human subjects, or any associations of miR-6070 other than increased levels of miR-6070 in the affected subjects as compared to the control subjects.
State of the Art and the Unpredictability of the Art
While methods of measuring miRNA are known in the art, methods of correlating the level of miRNA with a phenotype (i.e.: the presence of brain cancer) are highly unpredictable.
Because the specification asserts that the methods are applicable to any subject organism (e.g.: para 0027), but teaches only the analysis of human samples, it is relevant to point out that it is highly unpredictable as to whether the results obtained in human subjects could be extrapolated to non-human subjects. Knowledge that a particular miRNA is present in the human genome and is correlated with a brain tumor does not allow one to conclude that this miRNA will also be present in the genomes of non-human subjects and be correlated with a brain tumor. Relevant to the instant claims Ghorai (Frontiers in Genetics April 2014 Vol 5 article 100) discloses the number of miRNAs of different species. Notably, the reference teaches 1876 miRNA in the H. sapiens genome, 327 miRNA in the G. gorilla genome, 558 miRNA in the mulatta genome, 801 miRNA in the B. taurus genome etc. (see Table 1). Thus is appears that human subjects have different miRNAs than non-human subjects. As such it is unpredictable as to whether miR-6070, which is disclosed in the specification as being present at higher levels in urine samples of human subjects with brain tumors, will also be present in a representative number of non-human subjects and will be higher in urine samples from those non-human subjects with a brain tumor.
Because the claims encompass examining samples from any body fluid (e.g.: blood, serum, plasma, cerebrospinal fluid, saliva, sweat, tears, bile, pancreatic juice, urine), while the specification teaches only an analysis of urine, it is relevant to point out the unpredictability with regard to the analysis of gene expression profiles obtained from different sample types. Cobb et al (2002) teaches the analysis of gene expression in spleen and liver samples from septic mice. Notably, the reference teaches that, when compared to a non-septic sample, the relevant expression profiles of the septic mouse spleen and the septic mouse liver contain different nucleic acids at different levels (Table 1; p.2714, middle col., lns.2-8). It is thus unpredictable as to how one might extrapolate gene expression levels from a urine sample (as provided in the instant specification) to the analysis of gene expression in a sample obtained from any other body fluid source.
Because the claims encompass detecting any level of miR-6070, where the specification teaches only a relevant comparison that detects increased miR-6070 in subject urine as compared to control urine from a healthy human, it is relevant to point out that Cheung et al (2003) teaches that there is natural variation in gene expression among different individuals. The reference teaches an assessment of natural variation of gene expression in lymphoblastoid cells in humans, and analyzes the variation of expression data among individuals and within individuals (replicates) (p.422, last paragraph; Fig 1). The data indicates that, for example, expression of ACTG2 in 35 individuals varied by a factor of 17; and that in expression of the 40 genes with the highest variance ratios, the highest and lowest values differed by a factor of 2.4 or greater (Fig 3). It is thus unpredictable as to whether or not any level of miR-6070, as encompassed by the claims would effectively test a brain tumor.
Quantity of Experimentation
The quantity of experimentation necessary is great, on the order of many man-years, and then with little if any reasonable expectation of successfully enabling the full scope of the claims. The experimentation would require case:control analysis of any levels of miR-6070 in any body fluid samples from any subject organisms. Even if such extensive experimentation were to be performed, there is no indication that any associations, beyond those particular associations disclosed in the specification, would be found.
Conclusion
Herein, although the level of skill in the art is high, given the lack of disclosure in the specification and in the prior art and the unpredictability of the art, it would require undue experimentation for one of skill in the art to make and use the invention as broadly claimed.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 7, 8, and 10-12 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yasui et al (2017).
Relevant to the limitations of the rejected claims, Yasui et al teaches methods including the evaluation of miRNA levels in samples of urinary extracellular vesicles (e.g.: Fig. 3; p.15 - Nanowire-anchored microfluidic device for in situ extraction of urine EV–encapsulated miRNAs) and using the 3D-Gene Human miRNA Oligo chip ver.21 (Toray Industries) to measure miRNA levels (p. 15 - Microarray analysis of miRNA expression). The ver.21 chip includes probes for detection of level of miR-6070 (provided in the “data S1” file of the Supplementary Material).
Claim(s) 1, 7, 8, and 12 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Keuren-Jensen, et al (US PG Pub 2018/0258483).
Relevant to the limitations of the rejected claims, Van Keuren-Jensen, et teaches methods including the evaluation of miRNA levels in samples of body fluids from humans, including miR-6070 measured in plasma (e.g.: para 0025; Table 1 on p.11, left col).
Claim(s) 1, 7, 8, and 10-12 are is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Yasui, et al (US PG Pub 2020/0255906).
Please note that the applied reference is available as prior art because the reference includes additional inventors (i.e.: the applied reference includes Daiki Takeshita, who is not an inventor of the instantly examined application). The applied reference has an effective filing date of Dec. 12, 2018 (the date of the foreign application JP 2018-248924) and a publication date of Aug 13, 2020. As noted earlier in this Office Action, the instantly examined application is afforded the effective filing date of 09/24/2020, which is the filing date of the parent international application PCT/JP2020035899. If the instantly examined application is afforded the date of its earlier filed foreign application (Sept. 27, 2019, the date of JP2019-177615), the applied reference is still available under 35 USC 102(a)(2) as a published US patent application with a prior filing date.
Relevant to the limitations of the rejected claims, Yasui et al teaches methods including the evaluation of miRNA levels in samples of urinary extracellular vesicles (e.g.: Fig. 3; para 0520-0537) and using the 3D-Gene Human miRNA Oligo chip ver.21 (Toray Industries) to measure miRNA levels (para 0534). The reference teaches expression levels of miR-6070 (e.g.: p.39; p.69).
Requirement for Information
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.
The IDS of 03/25/2022 provides a non-patent literature citation (citation #2; cited as Kitano, et al, with a copy provided as:
Yotaro Kitano, Kosuke Aoki, Takao Yasui, et al. PATH-36. MACHINE LEARNING TO DETECT GLIOMAS IN URINE-BASED LIQUID BIOPSY, published in NEURO-ONCOLOGY, (NOV 2019) Vol. 21, pp. 151-151
The reference is an abstract presented at the 24th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology November 22 – 24, 2019 Phoenix, Arizona).
The authorship of the cited reference includes inventors of the instant application, and additional authors that are not inventors, and is applicable as prior art given the effective filing date afforded to the instantly examined application.
The Examiner requires additional information in order to make further determinations about the patentability to the instant claims. In response to this requirement, please provide:
1. Any material (e.g.: slides; poster panels; figures; descriptive paragraphs) that was presented in association with the cited abstract as a part of the presentation at the Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology.
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.
The applicant is reminded that the reply to this requirement must be made with candor and good faith under 37 CFR 1.58. 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.
This requirement is an attachment of the enclosed Office action. A complete reply to the enclosed Office action must include a complete reply to this requirement. The time period for reply to this requirement coincides with the time period for reply to the enclosed Office action.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN THOMAS KAPUSHOC whose telephone number is (571)272-3312. The examiner can normally be reached M-F, 8am-5pm.
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Stephen Kapushoc
Primary Examiner
Art Unit 1683
/STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683