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 .
The claims filed 6/25/2024 are under consideration.
Priority
The present application is a 371 national stage entry of PCT/US2022/012423 (filed 1/14/2022), which claims benefit of US provisional 63/137,546 (filed 1/14/2021).
Priority to the ‘546 provisional application is not fully recognized. The priority document does not disclose gains and/or losses in chromosome regions 8p and/or 17q. It is also noted the present specification is 117 pages, while the specification of the ‘546 provisional application is only 68 pages.
Information Disclosure Statement
The listing of references in the specification or the citation of references throughout the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because of the following informalities: the specification cites a PNAS article with a date of “201” in paragraph 104.
Appropriate correction is required.
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.
Claims 1, 4, 5, 6, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 21 and 22are 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 1, it is not clear how the recited preamble is intended to breathe life and meaning into the claims. The preamble of the claim recites a method of detecting Barrett's esophagus with low grade dysplasia, or Barrett's esophagus with high grade dysplasia, or adenocarcinoma of the esophagus. However, the method steps in the claim only require applying a parallel sequencing methodology to a biological sample from the esophagus of the subject. Thus, it is unclear if applicant intends to cover any method of applying a parallel sequencing methodology to a biological sample from the esophagus of the subject, or if the method is intended to somehow require more to accomplish the goal set forth in the preamble. If it is the later, then it appears that the claims are incomplete, as they fail to provide any active steps that clearly accomplish the goal of detecting Barrett's esophagus with low grade dysplasia, or Barrett's esophagus with high grade dysplasia, or adenocarcinoma of the esophagus as set forth by the preamble of the claim. Amending the claim to include an active process step directed towards detecting chromosome gains and losses, for example those of claims 10 and/or 11, and detecting Barrett's esophagus with low grade dysplasia, or Barrett's esophagus with high grade dysplasia, or adenocarcinoma of the esophagus based on the detected gains or losses in the chromosomes.
Claims 4, 5, 16, 17, 18, 20, 21 and 22 are similarly indefinite because they directly or indirectly depend from claim 1.
Regarding claim 1, the claim recites the “applying a parallel sequencing methodology” is done in order to detect Barrett's esophagus with low grade dysplasia, or Barrett's esophagus with high grade dysplasia, or adenocarcinoma of the esophagus. It is unclear how this purpose further limits the “parallel sequencing methodology”, if at all.
Claims 4, 5, 16, 17, 18, 20, 21 and 22 are similarly indefinite because they directly or indirectly depend from claim 1.
Regarding claim 5, the claim recites for each “non-acrocentric chromosome arms” in the context of “calculating” step (iii). The recitation lacks proper antecedent and the claim is incomplete as an analysis of “non-acrocentric chromosome arms” is not previously set forth or required such that the “calculating” step can be carried out.
Regarding claim 5, the claim recites “quantifying chromosome arm levels” and “querying focal changes of interest”. The recitation lacks proper antecedent basis and the claim is incomplete as an analysis of “chromosome arm levels” and “focal changes of interest” are not previously set forth or required such that the “calculating” step can be carried out.
Regarding claim 6, it is unclear if the language “in a panel of chromosome alterations” is in reference to “determine the global aneuploidy score” or to “identify copy number alterations” or to both aspects.
Claims 9, 10, 11, 12, 13, 14, 15 and 19 depend from claim 6 and are rejected for the same reason.
Regarding claim 6, the claims recites the “applying a parallel sequencing methodology” is done in order “to determine the global aneuploidy score (GAS)”and/or “to identify copy number alterations in a panel of chromosome alterations”. It is unclear how these purposes further limit the “parallel sequencing methodology”, if at all.
Claims 9, 10, 11, 12, 13, 14, 15 and 19 depend from claim 6 and are rejected for the same reason.
Regarding claims 10, 11, 12, 13 and 14, the claim further describes the intended purpose of “applying a parallel sequencing methodology”. It is unclear how these purposes further limit the “parallel sequencing methodology”, if at all.
Regarding claim 15, the claim recites in parentheticals “also denoted as Z”. It is unclear if this is a required element or merely exemplary.
Regarding claim 20, the claim is incomplete because it refers to a determination about a subject that is not required by the claim.
Regarding claim 21, the claim contains trademarks/trade names, such as “Navelbine®”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a therapeutic agent and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 112
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 9, 11, 12, 13 and 14 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 9, the claim recites information about the “global aneuploidy score” but does not recite any further or additional active method steps, nor does is limit how the step of claim 6 is performed. Claim 9 thus fails to further limit the scope of claim 6.
Regarding claim 11, the claim includes a reference to “7q”, which is not included with claim 6. Thus, claim 11 is broader than claim 6 and fails to further limit the claim.
Regarding claims 12, 13 and 14, the claims recite information about the “global aneuploidy score” or the “copy number alterations” determined but do not recite any further or additional active method steps, nor do they limit the active method steps of the claims they depend from.
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 § 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, 4-6 and 9-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Douville (PNAS. 2018. 115(8):1871-1876 with Supporting Information and Dataset).
Claim 1 is drawn to a “method of detecting Barrett's esophagus with low grade dysplasia, or Barrett's esophagus with high grade dysplasia, or adenocarcinoma of the esophagus”; however, the active method steps do not explicitly require an active method step of “detecting” any type of dysplasia or adenocarcinoma. MPEP 2111.02 states:
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
Accordingly, the claim language of "detecting Barrett's esophagus with low grade dysplasia, or Barrett's esophagus with high grade dysplasia, or adenocarcinoma of the esophagus" in the preamble merely sets forth the intended use or purpose of the claimed methods, but does not limit the scope of the claims. The claims are given the broadest reasonable interpretation as requiring an active method step of “applying a parallel sequencing methodology to a biological sample from the esophagus of the subject”.
Regarding claim 1, Douville teaches applying parallel sequencing methodology to biological samples of tumor using FAST-SeqS (Supporting Information, p. 1, Fast-SeqS).
The tumor samples include those from the esophagus as demonstrated by the Dataset. It is noted the DataSet has been truncated by the Examiner to provide information about esophagus samples. For example the following samples were analyzed:
Sample Name
Cancer Type
Histopathology
Stage
Grade
INDI 076
Esophagus
Squamous Cell Carcinoma
IIA
G3
INDI 112
Esophagus
Squamous cell carcinoma, NOS
IIA
G2
INDI 119
Esophagus
Adenocarcinoma, NOS
IB
G3
The claim recites the intended purpose of the “applying a parallel sequencing methodology” is to “detect Barrett's esophagus with low grade dysplasia, or Barrett's esophagus with high grade dysplasia, or adenocarcinoma of the esophagus”. There is no indication in the claim or the specification that such language limits the manner in which the “parallel sequencing methodology” is performed. Thus, the sequencing of Douville is encompassed by the full scope of claim 1.
PNG
media_image1.png
948
918
media_image1.png
Greyscale
Regarding claim 4, Douville teaches determining a global aneuploidy score as depicted in panel C of Figure S2, which is reproduced below:
The data is presented as a “global aneuploidy score” because it presents date regarding the loss and gain of chromosomes arm across all chromosomes.
Regarding claim 5, Douville teaches:
Amplifying genomic nucleic acid of the sample targeted by a single primer pair (Supporting Information, p. 1, Fast-SeqS);
Matching the unique loci to a control by aligning the sequences to a human reference genome as a “control” (Supporting Information, p. 1, Sample alignment and genomic interval grouping);
Calculating the statistical gains and losses for each non-acrocentric chromosome arms as presented in Table S4 and calculating Z-scores (Supporting Information, p. 2, Identifying chromosome arm gains or losses in a test sample);
Integrating the chromosome arms into a “global aneuploidy score” by performing Genome-wide aneuploidy detection using a two-class support vector machine (Supporting Information, p. 4, Genome-wide aneuploidy detection); and
Quantifying chromosome arm levels and querying focal changes of interest by determining allelic imbalances and analyzing somatic sequence mutations and microsatellite instability (Supporting Information, p. 4 and 5).
Claim 6 is drawn to a “method of detecting Barrett's esophagus with low grade dysplasia, or Barrett's esophagus with high grade dysplasia, or adenocarcinoma of the esophagus”; however, the active method steps do not explicitly require an active method step of “detecting” any type of dysplasia or adenocarcinoma. MPEP 2111.02 states:
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
Accordingly, the claim language of "detecting Barrett's esophagus with low grade dysplasia, or Barrett's esophagus with high grade dysplasia, or adenocarcinoma of the esophagus" in the preamble merely sets forth the intended use or purpose of the claimed methods, but does not limit the scope of the claims. The claims are given the broadest reasonable interpretation as requiring an active method step of “applying a parallel sequencing methodology to a biological sample from the esophagus of the subject”.
Regarding claim 6, Douville teaches applying parallel sequencing methodology to biological samples of tumor using FAST-SeqS (Supporting Information, p. 1, Fast-SeqS).
The tumor samples include those from the esophagus as demonstrated by the Dataset. It is noted the DataSet has been truncated by the Examiner to provide information about esophagus samples. For example the following samples were analyzed:
Sample Name
Cancer Type
Histopathology
Stage
Grade
INDI 076
Esophagus
Squamous Cell Carcinoma
IIA
G3
INDI 112
Esophagus
Squamous cell carcinoma, NOS
IIA
G2
INDI 119
Esophagus
Adenocarcinoma, NOS
IB
G3
The claim recites the intended purpose of the “applying a parallel sequencing methodology” is to “determine the global aneuploidy score (GAS) and/or to identify copy number alterations in a panel of chromosome alterations, the chromosomal alterations including chromosome gains and/or losses of any of chromosome regions 8p, 8q24, 1q, 7p, 20q, 2q, 13q, 5p, 12p, 5q, 17p, 4p, 4q, 9p, 17q, 18q, 16q, 21q, 22q, or 10p”. There is no indication in the claim or the specification that such language limits the manner in which the “parallel sequencing methodology” is performed. Thus, the sequencing of Douville is encompassed by the full scope of claim 6.
It is further noted that Douville does detect gains and losses in some the claimed chromosome regions as demonstrated in the DataSet:
Sample Name
chr1q
chr8p
chr8q
chr20q
Cancer Type
Histopathology
INDI 076
0.839
-1.245
11
3.042
Esophagus
Squamous Cell Carcinoma
INDI 112
3.035
0.149
1.452
0.027
Esophagus
Squamous cell carcinoma, NOS
INDI 119
4.5
1.27
11
5.838
Esophagus
Adenocarcinoma, NOS
It is further noted that Douville teaches determining a global aneuploidy score as depicted in panel C of Figure S2 as described in the rejection of claim 4 above.
Regarding claim 9, the claim provides information regarding the intended use of the global aneuploidy score. As noted above, the claim does not require any active method steps of detecting or indicating the presence of any dysplasia or cancer. The claim does not limit how the only active method step of claim 6 is performed. Claim 9 is anticipated for the same reason as claim 6.
Regarding claims 10 and 11, Douville teaches determining in panel of chromosomes including at least a gain chromosome region 5q and a loss in chromosome region 18q:
Sample Name
chr5q
chr18q
Cancer Type
INDI 076
0.984
-1.599
Esophagus
Regarding claim 12, the claim provides information regarding the intended use of the global aneuploidy score. As noted above, the claim does not require any active method steps of detecting or indicating the presence of any dysplasia or cancer or increased risk of any type of progression. The claim does not limit how the only active method step of claim 6 is performed. Claim 12 is anticipated for the same reason as claim 6.
Regarding claim 13, the claim provides information regarding the intended use of the global aneuploidy score. As noted above, the claim does not require any active method steps of detecting or indicating the presence of any dysplasia or cancer or increased risk of any type of progression. The claim does not limit how the only active method step of claims 6 or 12 is performed. Claim 13 is anticipated for the same reason as claims 6 and 12.
Regarding claim 14, the claim provides information regarding the intended use of the global aneuploidy score. As noted above, the claim does not require any active method steps of detecting or indicating the presence of any dysplasia or cancer or increased risk of any type of progression. The claim does not limit how the only active method step of claims 6, 12 or 13 is performed. Claim 14 is anticipated for the same reason as claims 6, 12 and 13.
Regarding claim 15, the claim describes how chromosomal gains are identified, which is an intended use of the sequencing data obtained. The claim does not require any active method steps of detecting or indicating the presence of any dysplasia or cancer or increased risk of any type of progression. The claim does not limit how the only active method step of claim 6 is performed. Claim 15 is anticipated for the same reason as claim 6.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 16, 17, 18, 19, 20 and 31-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Douville (PNAS. 2018. 115(8):1871-1876 with Supporting Information and Dataset) in view of Ahlquist (WO 2016/160454 A1).
Claims 16, 17, 18, 19 and 20 are drawn to a “method of detecting Barrett's esophagus with low grade dysplasia, or Barrett's esophagus with high grade dysplasia, or adenocarcinoma of the esophagus”; however, the active method steps do not explicitly require an active method step of “detecting” any type of dysplasia or adenocarcinoma. MPEP 2111.02 states:
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
Accordingly, the claim language of "detecting Barrett's esophagus with low grade dysplasia, or Barrett's esophagus with high grade dysplasia, or adenocarcinoma of the esophagus" in the preamble merely sets forth the intended use or purpose of the claimed methods, but does not limit the scope of the claims. The claims are given the broadest reasonable interpretation as requiring an active method step of “applying a parallel sequencing methodology to a biological sample from the esophagus of the subject”.
Regarding claims 16, 17, 18, 19 and 20, Douville teaches applying parallel sequencing methodology to biological samples of tumor using FAST-SeqS (Supporting Information, p. 1, Fast-SeqS).
The tumor samples include those from the esophagus as demonstrated by the Dataset. It is noted the DataSet has been truncated by the Examiner to provide information about esophagus samples. For example the following samples were analyzed:
Sample Name
Cancer Type
Histopathology
Stage
Grade
INDI 076
Esophagus
Squamous Cell Carcinoma
IIA
G3
INDI 112
Esophagus
Squamous cell carcinoma, NOS
IIA
G2
INDI 119
Esophagus
Adenocarcinoma, NOS
IB
G3
The claim recites the intended purpose of the “applying a parallel sequencing methodology” is to “detect Barrett's esophagus with low grade dysplasia, or Barrett's esophagus with high grade dysplasia, or adenocarcinoma of the esophagus”. There is no indication in the claim or the specification that such language limits the manner in which the “parallel sequencing methodology” is performed. Thus, the sequencing of Douville is encompassed by the full scope of claims 16-20.
Regarding claims 20, 21 and 22, Douville further teaches it was determined at some point the patient had adenocarcinoma as depicted in the rejection of claims 1 and 6 described above.
The patients would have been treated for their esophagus cancer given that some had stage II1 and grade 2 to grade 3 as noted above.
Claims 31-33 are drawn to a “method of detecting progression or increased risk of progression of Barrett’s esophagus”; however, the active method steps do not explicitly require an active method step of “detecting” any type of progression or risk. MPEP 2111.02 states:
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
Accordingly, the claim language of "method of detecting progression or increased risk of progression of Barrett’s esophagus" in the preamble merely sets forth the intended use or purpose of the claimed methods, but does not limit the scope of the claims. The claims are given the broadest reasonable interpretation as requiring an active method step of: 1) obtaining a brushing sample of the esophagus; 2) extracting DNA from the sample; and 3) assaying the DNA for chromosomal gains and losses on any of chromosomes 8p, 8q24, 1q, 7p, 20q, 2q, 13q, 5p, 12p, 5q, 17p, 4p, 4q, 9p, 17q, 18q, 16q, 21q, 22q, or 10p
Regarding claims 31-33, Douville teaches obtaining a sample, extracting DNA from the sample and assay chromosomal DNA by applying parallel sequencing methodology to biological samples of tumor using FAST-SeqS (Supporting Information, p. 1, Fast-SeqS).
The tumor samples include those from the esophagus as demonstrated by the Dataset. It is noted the DataSet has been truncated by the Examiner to provide information about esophagus samples. For example the following samples were analyzed:
Sample Name
Cancer Type
Histopathology
Stage
Grade
INDI 076
Esophagus
Squamous Cell Carcinoma
IIA
G3
INDI 112
Esophagus
Squamous cell carcinoma, NOS
IIA
G2
INDI 119
Esophagus
Adenocarcinoma, NOS
IB
G3
Douville teaches determining detecting gains and losses in the recited chromosomes as demonstrated panel C of Figure S2, which is reproduced below:
PNG
media_image2.png
654
633
media_image2.png
Greyscale
It is further noted that Douville does detect gains and losses in some the claimed chromosome regions as demonstrated in the DataSet:
Sample Name
chr1q
chr8p
chr8q
chr20q
Cancer Type
Histopathology
INDI 076
0.839
-1.245
11
3.042
Esophagus
Squamous Cell Carcinoma
INDI 112
3.035
0.149
1.452
0.027
Esophagus
Squamous cell carcinoma, NOS
INDI 119
4.5
1.27
11
5.838
Esophagus
Adenocarcinoma, NOS
Regarding claim 33, Douville teaches:
Amplifying genomic nucleic acid of the sample targeted by a single primer pair (Supporting Information, p. 1, Fast-SeqS);
Matching the unique loci to a control by aligning the sequences to a human reference genome as a “control” (Supporting Information, p. 1, Sample alignment and genomic interval grouping);
Calculating the statistical gains and losses for each non-acrocentric chromosome arms as presented in Table S4 and calculating Z-scores (Supporting Information, p. 2, Identifying chromosome arm gains or losses in a test sample);
Integrating the chromosome arms into a “global aneuploidy score” by performing Genome-wide aneuploidy detection using a two-class support vector machine (Supporting Information, p. 4, Genome-wide aneuploidy detection); and
Quantifying chromosome arm levels and querying focal changes of interest by determining allelic imbalances and analyzing somatic sequence mutations and microsatellite instability (Supporting Information, p. 4 and 5).
It is noted that the instant specification in paragraph 16 describes “RealSeqS” as involving the above identified steps.
Douville does not teach the specific samples of claims 16-19 and 31-33, the treatments of claims 20-22.
However, Ahlquist teaches elements relative to evaluating esophagus samples.
Regarding claims 16-19 and 31-33, Ahlquist teaches esophagus samples are obtained through endoscopic brushing or nonendoscopic whole esophageal brushing or swabbing using a tethered device, such as a capsule sponge, balloon, or other device (p. 3, lines 9-17). Ahlquist further teaches the samples may be frozen (p. 36, lines 13-29).
Regarding claims 20-22, Ahlquist teaches treatments with histamine 2-receptor blocking agents (p. 1, lines 30-33) and anti-reflex surgery (p. 1, lines 27-29).
It would have been prima facie obvious to the ordinary artisan at the time of filing to have modified the methods of Douville by treating those patients known to have Barrett's esophagus with low grade dysplasia, or Barrett's esophagus with high grade dysplasia, or adenocarcinoma of the esophagus with known treatments and to have used the known sources of esophagus samples taught by Ahlquist. The modifications have a reasonable expectation of success as they simply involve implementing well known sample sources and treatments relevant to the context of the patients analyzed by Douville.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
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, Wu-Cheng Winston Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSEPH G. DAUNER/Primary Examiner, Art Unit 1682