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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “the depth markings on the device” of claim 15, line 15 must be shown or the feature canceled from the claim. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 15 is objected to because of the following informalities:
in claim 15, line 12: “the” should be inserted before “EoE cells”.
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, 3-11, and 15 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.
Claim 1 recites “a sample” in line 1 and “the sample” in lines 12-13, but it is not clear if these recitations are referring to the EoE cells that are collected in claim 1, line 8. Different terminology is used which suggests that they are different, but the EoE cells appear to be a sample. The relationship among these recitations should be made clear. Also, the recitations “the collected sample” of claim 3, line 1; “the sample” of claim 8, line 2; and “the sample” of claim 11, in line 2 suffer from the same issues as “a sample” in claim 1, line 1 and “the sample” in claim 1, lines 12-13.
Claims 3-11 are rejected by virtue of their dependence from claim 1.
Claim 9 recites “the removing step” in line 2 in which there is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites “an area different from the location associated with the EoE” in lines 3-4, but it is not clear if this recitation is the same as, related to, a subset of, or different from “areas within the esophagus different than the location associated with the EoE” of claim 1, line 14. The recitation in claim 9 is singular with an indefinite article which suggest that this recitation is not the same as the recitation in claim 1 which is plural. Clarification is required.
Claim 15 recites “the EoE” in line 12-13 and “the depth markings on the device” in line 15 in which there are insufficient antecedent bases for these limitations in the claim.
Claim Rejections - 35 USC § 103
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.
Claims 1, 3-11, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/204659 (Markowitz)(previously cited), in view of U.S. Patent Application Publication No. 2015/0057517 (Pease)(previously cited).
Markowitz teaches the steps of:
positioning a collection portion (the collection portion 12 of Markowitz) of a device within a stomach (paragraph 0041 of Markowitz: “moved past a lower esophageal sphincter (LES)”), the collection portion having a first axial end portion (the proximal axial end portion 14 of Markowitz) and a second axial end portion (the distal axial end portion 16 of Markowitz);
withdrawing the collection portion across the GEJ (paragraph 0041 of Markowitz: “[t]he collection portion 12 may be moved past a lower esophageal sphincter (LES) and pulled in a proximal direction toward the LES” so as to reach a collection site within the esophagus; the LES is sometimes called the gastroesophageal junction1. The gastroesophageal junction is another name for the esophagogastric junction2.) and
determining, via tactile feedback that the collection portion engages the junction (paragraph 0041 of Markowitz: “The operator or physician may sense the increased tension in the catheter 20 when the collection portion 12 engages the LES.”).
Markowitz also teaches that the distal end portion 16 is moved from the collapsed position to the expanded position when the collection portion 12 is at the collection site (paragraph 0041 of Markowitz). After the biological sample is collected, the distal end portion 16 is moved from the expanded position to the collapsed or inverted position (paragraph 0042 of Markowitz). As the collection portion 12 moves out of the body lumen, the distal end portion 16 does not engage the body lumen and prevents the collected biological samples from being contaminated by tissue from areas along the body lumen different from the collection site (paragraph 0042 of Markowitz).
Markowitz teaches the collection of cells in the esophagus (paragraph 0003, 0023, and 0042 of Markowitz), but does not explicitly state that the location site is at a location associated with eosinophilic esophagitis (EoE). Pease teaches the collection of cells at a particular depth in the esophagus (paragraph 0118 of Pease) for the analysis of those cells with respect to diagnosis of eosinophilic esophagitis (abstract and paragraphs 0015-0016, 0045, and 0122 of Pease) including sample collection during and after treatment (paragraphs 0059 and 0132 of Pease) so as to monitor the effectiveness of the treatment (paragraphs 0045 and 0132 of Pease). The collection may be a single tissue sample (paragraph 0118 and 0128 of Pease) and a single sample may comprise one or more of individual or clumped cells (paragraph 0123 of Pease). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the collection device and collection method of Markowitz to collect cells at a particular location where eosinophilic esophagitis cells are located so that the status of these eosinophilic esophagitis cells are analyzed so as to monitor the effectiveness of the treatment in the subject in order to decrease suffering and cost and to increase subject compliance (paragraph 0045 of Pease).
With respect to claim 1, the combination teaches or suggest a method for collecting a sample, the method comprising:
positioning a collection portion (the collection portion 12 of Markowitz) of a device within a stomach (paragraph 0041 of Markowitz: “moved past a lower esophageal sphincter (LES)”) so that the collection portion engages against an esophagogastric junction (GEJ)(paragraph 0041 of Markowitz: “[t]he collection portion 12 may be moved past a lower esophageal sphincter (LES) and pulled in a proximal direction toward the LES” so as to reach a collection site within the esophagus; the LES is sometimes called the gastroesophageal junction2. The gastroesophageal junction is another name for the esophagogastric junction3), the collection portion having a first axial end portion (the proximal axial end portion 14 of Markowitz) and a second axial end portion (the distal axial end portion 16 of Markowitz);
withdrawing the collection portion across the GEJ into an esophagus (paragraph 0041 of Markowitz: “[t]he collection portion 12 may be moved past a lower esophageal sphincter (LES) and pulled in a proximal direction toward the LES” so as to reach a collection site within the esophagus) to position the collection portion at a location associated with eosinophilic esophagitis (EoE) (the distal end portion 16 is moved to the collection site (paragraph 0041 of Markowitz); the location site is at a location associated with eosinophilic esophagitis (EoE) as suggested by Pease); and
collecting EoE cells (the collection of cells for diagnosing/monitoring eosinophilic esophagitis in a subject as suggested by Pease) by: (i) everting, from within the first axial end portion (paragraphs 0006-0008 and 0041-0042 of Markowitz; FIGS. 2-3, 10, and 12-13 of Markowitz), the second axial end portion into an expanded position (paragraphs 0006-0008 and 0041-0042 of Markowitz; FIGS. 1, 8, and 11 of Markowitz), once in the esophagus (the distal end portion 16 is moved from the collapsed position to the expanded position when the collection portion 12 is at the collection site (paragraph 0041 of Markowitz)), (ii) dragging the collection portion across the location associated with the EoE so as to avoid moving beyond the location associated with the EoE (the collection portion is moved in a proximal direction at the collection site during collection; the distal end portion 16 in the collapsed position does not engage the body lumen and prevents the collected biological samples from being contaminated by tissue from areas along the body lumen different from the collection site (paragraphs 0041-0042 of Markowitz). As such, the dragging does not move beyond the collection location where the EoE cells are), and (iii) inverting the second axial end portion, into the first axial end portion, to a collapsed position, to protect the sample disposed on the second axial end portion from contacting non-EoE cells from areas within the esophagus different than the location associated with the EoE (paragraphs 0006-0008, 0027, 0039, 0041-0043, 0046, 0048, and 0051 of Markowitz; FIGS. 1-3 and 10-13 of Markowitz; the distal end portion 16 in the collapsed position does not engage the body lumen and prevents the collected biological samples from being contaminated by tissue from areas along the body lumen different from the collection site (paragraphs 0041-0042 of Markowitz)).
With respect to claim 3, the combination teaches or suggests that the collected sample includes eosinophil white blood cells (paragraphs 0006-0008 of Pease).
With respect to claim 4, the combination teaches or suggests that the step of everting the second axial end portion includes moving the second axial end portion from a concave shape to a convex shape (paragraphs 0006-0008, 0027, 0039, 0041-0043, 0046, 0048, and 0051 of Markowitz; FIGS. 1-3 and 10-13 of Markowitz).
With respect to claim 5, the combination teaches or suggests that the step of inverting the second axial end portion from the expanded position into the collapsed position includes moving the second axial end portion from a convex shape to a concave shape (paragraphs 0006-0008, 0027, 0039, 0041-0043, 0046, 0048, and 0051 of Markowitz; FIGS. 1-3 and 10-13 of Markowitz).
With respect to claim 6, the combination teaches or suggests that the step of inverting the second axial end portion from the expanded position into the collapsed position includes causing an outer surface of the second axial end portion facing radially outwardly when the second axial end portion is in the expanded position to face radially inwardly when the second axial end portion is in the collapsed position (paragraphs 0006-0008, 0027, 0039, 0041-0043, 0046, 0048, and 0051 of Markowitz; FIGS. 1-3 and 10-13 of Markowitz).
With respect to claim 7, the combination teaches or suggests that the step of positioning the collection portion of the device includes swallowing the collection portion into the esophagus (paragraphs 0008, 0037, 0041-0043, and 0053 of Markowitz).
With respect to claim 8, the combination teaches or suggests providing the second axial end portion with a plurality of tissue collecting projections designed to capture the sample including eosinophil white blood cells (the projections 40, 60, 152, 172, 192, and 212 of Markowitz).
With respect to claim 9, the combination teaches or suggests the removing step includes preventing the second axial end portion of the collection portion from engaging the esophagus at an area different from the location associated with the EoE (the collapse of the distal axial end portion 16 after sampling but before withdraw prevents the distal end portion 16 from engaging in any areas of the esophagus other than the sampled area; paragraphs 0006-0008, 0027, 0039, 0041-0043, 0046, 0048, and 0051 of Markowitz; the distal end portion 16 does not engage the body lumen and prevents the collected biological samples from being contaminated by tissue from areas along the body lumen different from the collection site (paragraphs 0041-0042 of Markowitz)).
With respect to claim 10, the combination teaches or suggests that the step of everting the second axial end portion includes applying pressurized air to the second axial end portion (paragraphs 0026, 0039, and 0041-0043 of Markowitz) and the step of inverting the second axial end portion from the expanded position into the collapsed position includes applying a vacuum to the collection portion (paragraphs 0026, 0029, 0039, and 0041-0044 of Markowitz).
With respect to claim 11, the combination teaches or suggests performing at least one of pathological analysis, diagnostic analysis, and cell analysis on the sample including eosinophil white blood cells (abstract and paragraphs 0006-0008, 0015-0016, 0045, 0122, and 0125 of Pease).
With respect to claim 15, Markowitz teaches the use of depth markings on the support member or catheter in addition to the tactile feedback to determine that a collection site within the patient’s anatomy (paragraph 0041 of Markowitz). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the depth markings on the support member or catheter in additional to the tactile feedback of Markowitz since it ensures a more accurate determination of the collection site in the esophagus.
Additionally, Markowitz provides the following teachings:
CHART 1
No.
Markowitz Citation
Implication
1
“The support member 20 or catheter may have depth markings to determine the collection site within the patient's anatomy.” (paragraph 0041).
The support member or catheter has depth markings to determine when the device is at the collection site and when it is not.
2
“The distal end portion 16 is moved from the collapsed position to the expanded position when the collection portion 12 is at or near the collection site.” (paragraph 0041).
At the collection site, the second axial end portion is everted.
3
“It is contemplated that the collection portion 12 is only moved in a proximal direction so that the expanded distal end portion 16 engages the collection site to collect biological samples…After the biological sample is collected, the distal end portion 16 is moved from the expanded position to the collapsed or inverted position…As the collection portion 12 moves out of the body lumen, the distal end portion 16 does not engage the body lumen and prevents the collected biological samples from being contaminated by tissue from areas along the body lumen different from the collection site.” (paragraph 0042)
The second axial end portion is dragged at the collection site and then inverted into the first axial end portion at the end of collection site.
4
“The depth markings on the support member 20 or catheter may be used as a guide.” (paragraph 0042).
This teaching is placed at the ellipsis in citation 3. The depth markings are used as a guide when the collection portion is moved in a proximal direction at the collection site.
The four citations and the four implications show that the depth markings on the support member or catheter of Markowitz:
(A) are observed when the device is moved toward and away the collection site so as to fulfill the function of the determination of when the device is at the collection site (citation 1 and implication 1);
(B) are observed when the collection portion is moved in a proximal direction at the collection site during collection so as to fulfill its function of acting as a guide when the collection portion is moved in a proximal direction so that the second axial end portion engages the collection site (citations 3 and 4 and implications 3 and 4); and
(C) are observed at the end of the collecting step where the second axial end portion is then inverted such that the functions of the determination of when the device is at the collection site (citation 1 and implication 1) and of the prevention of contamination of the collected biological samples by tissue from areas along the body lumen different from the collection site (citation 3).
Alternatively or additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to observe the depth markings on the support member or catheter of Markowitz when the device is moved toward and away the collection site, to observe the depth markings on the support member or catheter of Markowitz when the collection portion is moved in a proximal direction at the collection site during collection, and to observe the depth markings on the support member or catheter of Markowitz at the end of the collecting step where the second axial end portion is then inverted since the observation of the depth markings at these times fulfill the disclosed function of the determination of when the device is at the collection site; the disclosed function of acting as a guide when the collection portion is moved in a proximal direction so that the second axial end portion engages the collection site during collection; and the disclosed function of the prevention of contamination of the collected biological samples by tissue from areas along the body lumen different from the collection site.3
With respect to claim 15, the combination teaches or suggest a method for collecting a sample, the method comprising:
positioning a collection portion (the collection portion 12 of Markowitz) of a device within a stomach (paragraph 0041 of Markowitz: “moved past a lower esophageal sphincter (LES)”), the collection portion having a first axial end portion (the proximal axial end portion 14 of Markowitz) and a second axial end portion (the distal axial end portion 16 of Markowitz);
pulling the collection portion proximally across an esophagogastric junction (GEJ)(paragraph 0041 of Markowitz: “[t]he collection portion 12 may be moved past a lower esophageal sphincter (LES) and pulled in a proximal direction toward the LES” so as to reach a collection site within the esophagus; the LES is sometimes called the gastroesophageal junction2. The gastroesophageal junction is another name for the esophagogastric junction3.) and determining, via tactile feedback once the collection portion engages the junction (paragraph 0041 of Markowitz: “The operator or physician may sense the increased tension in the catheter 20 when the collection portion 12 engages the LES.”), a predetermined distance to pull the collection portion into an esophagus to a location associated with eosinophilic esophagitis (EoE) cells (the location of EoE cells as suggested by Pease);
extending the second axial end portion, relative to the first axial end portion, from a collapsed position within the first axial end portion (paragraphs 0006-0008 and 0041-0042 of Markowitz; FIGS. 2-3, 10, and 12-13 of Markowitz) into an expanded position by everting the second axial end portion from within the first axial end portion to a length greater than the first axial end portion (paragraphs 0006-0008 and 0041-0042 of Markowitz; FIGS. 1, 8, and 11 of Markowitz; paragraph 0027 which teaches that “[t]he distal end portion 16 may extend radially outward a greater distance than the proximal end portion 14 when in the expanded position”) to collect the sample, including EoE cells, at the location associated with the EoE into the second axial end portion (the collection of cells for diagnosing/monitoring eosinophilic esophagitis in a subject as suggested by Pease); and
collecting the EoE cells (the collection of cells for diagnosing/monitoring eosinophilic esophagitis in a subject as suggested by Pease) with the second axial end portion in the expanded position (paragraphs 0006-0008 and 0041-0042 of Markowitz; FIGS. 1, 8, and 11 of Markowitz) by: (i) observing the depth markings on the device while withdrawing the device so as to avoid moving beyond the location associated with the EoE cells (observing the depth markings on the support member or catheter of Markowitz when the collection portion is moved in a proximal direction at the collection site during collection and at the end of the collecting step; the collection portion is moved in a proximal direction at the collection site during collection), and (ii) inverting the second axial end portion into the first axial end portion to protect the sample, collected on the second axial end, from contacting non-EoE cells from areas within the esophagus different than the location associated with the EoE cells (paragraphs 0006-0008, 0027, 0039, 0041-0043, 0046, 0048, and 0051 of Markowitz; FIGS. 1-3 and 10-13 of Markowitz; the distal end portion 16 in the collapsed position does not engage the body lumen and prevents the collected biological samples from being contaminated by tissue from areas along the body lumen different from the collection site (paragraphs 0041-0042 of Markowitz). As such, the dragging does not move beyond the collection location where the EoE cells are).
Response to Arguments
The Applicant's arguments filed 12/9/2025 have been fully considered.
Drawing Objections
In view of the claim amendments filed on 12/9/2025, the drawing objection based on the recited length marking on the device in claim 1 is withdrawn.
The drawing objection based on the recited depth marking in claim 15 remains. Although the Applicant asserts that claim 15 has been amended to remove the recited depth markings, claim 15, in fact, still recites the depth markings in line 15 and the drawings do not show such features.
Claim objections
In view of the claim amendments filed on 12/9/2025, the previous claim objections are withdrawn. There are new grounds of claim objections that were necessitated by the claim amendments filed on 12/9/2025.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 12/9/2025, the previous claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph are withdrawn.
There are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, that were necessitated by the claim amendments filed on 12/9/2025.
The Applicant asserts that
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This argument is not persuasive since it is still not clear if “a sample” in claim 1, line 1 and “the sample” in claim 1, lines 12-13 are referring to the EoE cells that are collected in claim 1, line 8. Different terminology is used which suggests that they are different, but the EoE cells appear to be a sample.
Prior art rejections
The Applicant asserts:
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This argument is not persuasive. Pease teaches the collection of cells at a particular depth in the esophagus (paragraph 0118 of Pease) for the analysis of those cells with respect to diagnosis of eosinophilic esophagitis (abstract and paragraphs 0015-0016, 0045, and 0122 of Pease) including sample collection during and after treatment (paragraphs 0059 and 0132 of Pease) so as to monitor the effectiveness of the treatment (paragraphs 0045 and 0132 of Pease). Pease also teaches that the collection may be a single tissue sample (paragraph 0118 and 0128 of Pease) and a single sample may comprise one or more of individual or clumped cells (paragraph 0123 of Pease).
As such, Pease contemplates the collection of cells at a particular location without the requirement of the collection of cells along the length of the esophagus. Given this broader view of Pease, the teachings of Pease are not incompatible with Markowitz which teaches that the distal end portion 16 is moved from the collapsed position to the expanded position when the collection portion 12 is at the collection site (paragraph 0041 of Markowitz), and, after the biological sample is collected, the distal end portion 16 is moved from the expanded position to the collapsed or inverted position (paragraph 0042 of Markowitz) such that, as the collection portion 12 moves out of the body lumen, the distal end portion 16 does not engage the body lumen and prevents the collected biological samples from being contaminated by tissue from areas along the body lumen different from the collection site (paragraph 0042 of Markowitz).
Markowitz teaches the collection of cells in the esophagus (paragraph 0003, 0023, and 0042 of Markowitz), but does not explicitly state that the location site is at a location associated with eosinophilic esophagitis (EoE). Pease teaches the collection of cells at a particular depth in the esophagus (paragraph 0118 of Pease) for the analysis of those cells with respect to diagnosis of eosinophilic esophagitis (abstract and paragraphs 0015-0016, 0045, and 0122 of Pease) including sample collection during and after treatment (paragraphs 0059 and 0132 of Pease) so as to monitor the effectiveness of the treatment (paragraphs 0045 and 0132 of Pease). The collection may be a single tissue sample (paragraph 0118 and 0128 of Pease) and a single sample may comprise one or more of individual or clumped cells (paragraph 0123 of Pease). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the collection device and collection method of Markowitz to collect cells at a particular location where eosinophilic esophagitis cells are located so that the status of these eosinophilic esophagitis cells are analyzed so as to monitor the effectiveness of treatment in the subject in order to decrease suffering and cost and to increase subject compliance (paragraph 0045 of Pease). Thus, the combination would result in a method where the device is positioned at a single location associated with EoE for collection of cells.
The Applicant asserts:
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This argument is not persuasive. Markowitz explicitly teaches that the distal end portion 16 in the collapsed position does not engage the body lumen and prevents the collected biological samples from being contaminated by tissue from areas along the body lumen different from the collection site (paragraphs 0041-0042 of Markowitz). As such, the dragging does not move beyond the collection location where the EoE cells are. Also, Pease teaches the collection of cells at a particular depth in the esophagus (paragraph 0118 of Pease) for the analysis of those cells with respect to diagnosis of eosinophilic esophagitis (abstract and paragraphs 0015-0016, 0045, and 0122 of Pease) including sample collection during and after treatment (paragraphs 0059 and 0132 of Pease) so as to monitor the effectiveness of the treatment (paragraphs 0045 and 0132 of Pease). The collection may be a single tissue sample (paragraph 0118 and 0128 of Pease) and a single sample may comprise one or more of individual or clumped cells (paragraph 0123 of Pease). As such, Pease contemplates the collection of cells at a particular location without the requirement of the collection of cells along the length of the esophagus. Thus, the teaching of Pease is compatible with the teachings of Markowitz.
The Applicant asserts:
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This argument is not persuasive. As previously mentioned, Pease teaches the collection of cells at a particular depth in the esophagus (paragraph 0118 of Pease) for the analysis of those cells with respect to diagnosis of eosinophilic esophagitis (abstract and paragraphs 0015-0016, 0045, and 0122 of Pease) including sample collection during and after treatment (paragraphs 0059 and 0132 of Pease) so as to monitor the effectiveness of the treatment (paragraphs 0045 and 0132 of Pease). Pease also teaches that the collection may be a single tissue sample (paragraph 0118 and 0128 of Pease) and a single sample may comprise one or more of individual or clumped cells (paragraph 0123 of Pease). As such, Pease contemplates the collection of cells at a particular location without the requirement of the collection of cells along the length of the esophagus. Given this broader view of Pease, the teachings of Pease are not incompatible with Markowitz which teaches that the distal end portion 16 is moved from the collapsed position to the expanded position when the collection portion 12 is at the collection site (paragraph 0041 of Markowitz), and, after the biological sample is collected, the distal end portion 16 is moved from the expanded position to the collapsed or inverted position (paragraph 0042 of Markowitz) such that, as the collection portion 12 moves out of the body lumen, the distal end portion 16 does not engage the body lumen and prevents the collected biological samples from being contaminated by tissue from areas along the body lumen different from the collection site (paragraph 0042 of Markowitz).
The Applicant asserts:
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This argument is not persuasive. As previously mentioned, Pease teaches the collection of cells at a particular depth in the esophagus (paragraph 0118 of Pease) for the analysis of those cells with respect to diagnosis of eosinophilic esophagitis (abstract and paragraphs 0015-0016, 0045, and 0122 of Pease) including sample collection during and after treatment (paragraphs 0059 and 0132 of Pease) so as to monitor the effectiveness of the treatment (paragraphs 0045 and 0132 of Pease). Pease also teaches that the collection may be a single tissue sample (paragraph 0118 and 0128 of Pease) and a single sample may comprise one or more of individual or clumped cells (paragraph 0123 of Pease). As such, Pease contemplates the collection of cells at a particular location without the requirement of the collection of cells along the length of the esophagus. Given this broader view of Pease, the teachings of Pease are not incompatible with Markowitz which teaches that the distal end portion 16 is moved from the collapsed position to the expanded position when the collection portion 12 is at the collection site (paragraph 0041 of Markowitz), and, after the biological sample is collected, the distal end portion 16 is moved from the expanded position to the collapsed or inverted position (paragraph 0042 of Markowitz) such that, as the collection portion 12 moves out of the body lumen, the distal end portion 16 does not engage the body lumen and prevents the collected biological samples from being contaminated by tissue from areas along the body lumen different from the collection site (paragraph 0042 of Markowitz).
Also, Pease discloses that sample collection takes place before, during, and after treatment (paragraphs 0059 and 0132 of Pease) or monitoring the effectiveness of the treatment (paragraphs 0045 and 0132 of Pease). Pease also teaches that the collection may be a single tissue sample (paragraph 0118 and 0128 of Pease) and a single sample may comprise one or more of individual or clumped cells (paragraph 0123 of Pease). As such, Pease does teach the collection of a particular depth, that which EoE cells have been located, when cells are collecting during or after treatment so as to determine effectiveness of treatment.
For at least the above reasons, claim 1 and its dependent claims are properly rejected.
The rejection of claim 15 is proper for at least the same and/or analogous reasons as to why the rejection of claim 1 is proper.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 See page 2 of Dellwo, Adrienne, "The Anatomy of the Lower Esophageal Sphincter: Part of the swallowing process that’s involved in acid reflux and GERD", Verywell Health, www.verywellhealth.com, 17 pages, printed on 12/19/2024 (previously cited).
Also, see page 1 of Chandrasoma, Parakrama et al., "CHAPTER 4 - Normal Anatomy; Present Definition of the Gastroesophageal Junction", Summary from ScienceDirect, www.sciencedirect.com/science/article/abs/pii/B9780123694164500042, 2 pages, 2006 (previously cited).
2 See page 1 of Botz, Bálint, "Gastro-esophageal junction", Radiopaedia, radiopaedia.org/articles/gastro-oesophageal-junction?lang=us, 5 pages, 2021 (previously cited).
3 See also, U.S. Patent No. 5,715,816 (Mainiero)(previously cited) teaches a depth marker 120 which can serve as an indicator when a probe 110 is inserted at a proper distance so as to aid in the proper insertion of such a probe (col. 19, lines 35-55 of Mainiero).
See also, U.S. Patent Application Publication No. 2013/0146051 (Nolan)(previously cited( teaches a plurality of graduated markings 134 on an exterior surface of an insertion tube so as to advance the device to a depth determined by one or more markings to assist the caregiver in properly advancing the device into the patient (paragraphs 0024 and 0043 of Nolan).