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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. The Applicant's submission filed on 4/17/2026 has been entered.
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 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 15-17 and 20 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 15 recites “the sample, including the EoE cells” in line 12-13, but it is not clear if this recitation is the same as, related to, or different from “a sample of eosinophilic esophagitis (EoE) cells” of claim 15, lines 1-2. The sample of lines 1-2 are the EoE cells while the sample of lines 12-13 seems to connote that the sample has more than just the EoE cells since the sample “includes” the EoE cells which suggests elements that are not EoE cells. This divergence in phraseology creates confusion as to what the sample of lines 12-13 contains. This confusion renders claim 15 indefinite.
Claim 15 recites “the location associated with EoE” in line 13, but it is not clear if this recitation is the same as, related to, or different from “a location associated with the EoE cells” of claim 15, lines 7-8. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). Also, if they are different, there is insufficient antecedent basis for “the location associated with EoE” in claim 15.
Claim 15 recites “by everting the second axial end portion from within the first axial end portion to a longitudinal length greater than a longitudinal length of the first axial end portion to collect the sample, including the EoE cells, at the location associated with EoE into the second axial end portion” in lines 10-13, which is so grammatically awkward that its meaning is not clear. Clarification is required.
Claim 15 recites “the second axial end” in line 17, but it is not clear if this recitation is the same as, related to, or different from “a second axial end portion” of claim 15, line 4. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). Also, if they are different, there is insufficient antecedent basis for “the second axial end” in claim 15.
Claim 16 recites “wherein the second axial end portion has a longitudinal length greater than a longitudinal length of the first axial end portion” in lines 1-2, but it is not clear if this recitation is referring to the condition of the expanded position in claim 1, line 9 or the condition of the collapsed position of claim 1, line 12. This ambiguity renders claim 16 indefinite.
Claim 17 recites “the expanding includes…” in line 1 in which there is insufficient antecedent basis for this recitation in the claims. Also, it is not clear how this expanding step relates to the other steps of claim 1, e.g., when does this expanding step occur?
Claim 20 recites “the selecting the size of the second axial end portion includes…” in lines 1-2 in which there is insufficient antecedent basis for this recitation in the claims. Also, it is not clear how this selecting step relates to the other steps of claim 1, e.g., when does this selecting step occur?
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, 3-8, and 10-11 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 (1) 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) and/or (2) because Markowitz teaches the collection of cells in the esophagus and Pease teaches a type of cell for collection and an analytical purpose for the collection of such cells.
With respect to claim 1, the combination teaches or suggest a method for collecting a sample of eosinophilic esophagitis (EoE) cells, 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 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 the sample of 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 of EoE cells 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 of EoE cells 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 of EoE cells (the projections 40, 60, 152, 172, 192, and 212 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 of EoE cells (abstract and paragraphs 0006-0008, 0015-0016, 0045, 0122, and 0125 of Pease).
Claims 15-17 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), and further in view of WO 2015/089422 (Markowitz 422), and further in view of U.S. Patent Application Publication No. 2014/0214085 (Druma).
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 junction3. The gastroesophageal junction is another name for the esophagogastric junction4.) 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 (1) 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) and/or (2) because Markowitz teaches the collection of cells in the esophagus and Pease teaches a type of cell for collection and an analytical purpose for the collection of such cells.
The combination teaches or suggests 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 longitudinal length to collect the sample (paragraphs 0006-0008 and 0041-0042 of Markowitz; FIGS. 1, 8, and 11 of Markowitz). Paragraph 0027 of Markowitz teaches that the expanded position shown in Fig. 1 may be one of many expanded positions for the distal end portion 16 (paragraph 0027 of Markowitz). FIG. 8 of Markowitz 422 shows a pictorial view of a collection device in which a distal end portion 316 is shown to have a longitudinal length longer than the longitudinal length of the proximal end portion 314 (FIG. 8 and paragraphs 0053-0058 of Markowitz 422). Also, FIG. 11 of Markowitz 422 shows a pictorial view of a collection device in which a distal end portion 516 is shown to have a longitudinal length longer than the longitudinal length of the proximal end portion 514 (FIG. 11 and paragraphs 0069-0074 of Markowitz 422). Further, FIG. 15 of Markowitz 422 shows a pictorial view of a collection device in which a distal end portion 816 is shown to have a longitudinal length longer than the longitudinal length of the proximal end portion 814 (FIG. 15 and paragraphs 0091-0095 of Markowitz 422). These depictions are shown alongside depictions in which a distal end portion 16, 116, 716 is shown to have a longitudinal length shorter than the proximal end portion 14, 114, 714 (FIGS. 1-3, 6, and 13 of Markowitz 422). Though these drawings are not drawn to scale, these figures suggest that the longitudinal length of the distal end portion can be longer than the longitudinal length of the proximal end portion. Druma teaches that such lengths are possible when the expandable portion is folded inside the corresponding tube portion (abstract, paragraphs 0037 and 0042-0044, and FIGS. 1, 6A-6D, and 10-12 of Druma). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the second axial end portion have a longitudinal length greater than a longitudinal length of the first axial end portion when expanded, as suggested by Markowitz 422 and Druma, since it permits a larger sample collection with a more compact configuration during insertion and withdrawal from the patient.
Additionally or alternatively, the depictions of Markowitz 422 and Druma suggests that the relative longitudinal dimensions between the first and second axial end portions are subject to change based on the factors of sample collection and compactness during insertion and withdrawal from the patient. As such, the relative longitudinal dimensions between the first and second axial end portions are results-effective variables that would have been optimized through routine experimentation based on the sample collection and compactness during insertion and withdrawal from the patient. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the relative longitudinal dimensions between the first and second axial end portions, using the depictions in Markowitz 422 and Druma as a starting point, so as to obtain the desired sample collection and compactness during insertion and withdrawal from the patient.
Additionally or alternatively, it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04 citing Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
With respect to claim 15, the combination teaches or suggest a method for collecting a sample of eosinophilic esophagitis (EoE) cells, 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 the 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 longitudinal length greater than a longitudinal length of the first axial end portion (paragraphs 0006-0008 and 0041-0042 of Markowitz; FIGS. 1, 8, and 11 of Markowitz; it would have been obvious to have the second axial end portion have a longitudinal length greater than a longitudinal length of the first axial end portion when expanded, as suggested by Markowitz 422 and Druma, for increased sample collection and compact insertion and withdrawal dimensions; it would have been obvious by routine optimization using the depictions by Markowitz 422 and Druma as a starting point; and/or it would have been obvious by caselaw as outlined in the above 103 analysis) to collect the sample, including the EoE cells, at the location associated with 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) withdrawing the device so as to avoid moving beyond the location associated with the EoE cells (the collection portion is moved in a proximal direction at the collection site during collection and at the end of the collecting step), 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).
With respect to claim 16, the combination teaches or suggest that the second axial end portion has a longitudinal length greater than a longitudinal length of the first axial end portion (paragraphs 0006-0008 and 0041-0042 of Markowitz; FIGS. 1, 8, and 11 of Markowitz; it would have been obvious to have the second axial end portion have a longitudinal length greater than a longitudinal length of the first axial end portion when expanded, as suggested by Markowitz 422 and Druma, for increased sample collection and compact insertion and withdrawal dimensions; it would have been obvious by routine optimization using the depictions by Markowitz 422 and Druma as a starting point; and/or it would have been obvious by caselaw as outlined in the above 103 analysis).
With respect to claim 17, the combination teaches or suggest that the expanding includes expanding the second axial end portion to a longitudinal length greater than a longitudinal length of the first axial end portion (paragraphs 0006-0008 and 0041-0042 of Markowitz; FIGS. 1, 8, and 11 of Markowitz; it would have been obvious to have the second axial end portion have a longitudinal length greater than a longitudinal length of the first axial end portion when expanded, as suggested by Markowitz 422 and Druma, for increased sample collection and compact insertion and withdrawal dimensions; it would have been obvious by routine optimization using the depictions by Markowitz 422 and Druma as a starting point; and/or it would have been obvious by caselaw as outlined in the above 103 analysis).
Claim 18 is 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), and further in view of U.S. Patent Application Publication No. 2005/0228312 (Surti).
The combination teaches or suggests a method for collecting a sample in an esophagus 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). Surti teaches the use of indentations 46 on the outer structure that serves to produce an image in response to a sonic beam from imaging equipment so as to assist the operator in guiding the device through a passageway of a patient (paragraph 0036 of Surti). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include indentations of Surti on the first axial end portion and use a sonic beam and imaging equipment of Surti so as to assist the operator in guiding the device to the target area before sampling.
With respect to claim 18, the combination teaches or suggests that, before everting the second axial end portion into the expanded position, verifying that the collection portion is at the location associated with the EoE using fluoroscopic guidance or assisted imaging (using the indentations on the first axial end portion, the sonic beam, and the imaging equipment of Surti so as to assist the operator in guiding the device to the target area before sampling).
Claims 19-20 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), and further in view of CN 2882539 (Huang)(previously cited). Citations to Huang will refer to the machine English translation that accompanied the Office Action mailed on 12/27/2024.
The combination teaches or suggests a method for collecting a sample in an esophagus 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). Huang teaches that children have smaller diameter esophagi than adults such that the implements used in their esophagi should be smaller than the adult version (page 3 of Huang). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the proximal and distal axial end portions to have larger diameters for adults and smaller diameters for children since it better tailors the device to the patient.
With respect to claim 19, the combination teaches or suggests that, prior to the positioning step, selecting a size of the second axial end portion based on one or more of an age of a subject, a weight of the subject, a height of the subject, and combinations thereof (selecting the larger diameters for the proximal and distal axial end portions for an adult patient and the smaller diameters for the proximal and distal axial end portions for children, as suggested by Huang. Such a selection is based on the age of the subject).
With respect to claim 20, the combination teaches or suggests that the selecting the size of the second axial end portion includes selecting a diameter of the second axial end portion (selecting the larger diameters for the proximal and distal axial end portions for an adult patient and the small diameters for the proximal and distal axial end portions for children, as suggested by Huang).
Response to Arguments
The Applicant's arguments filed 4/17/2026 have been fully considered.
Drawing Objections
In view of the claim amendments filed on 4/17/2026, the drawing objection is withdrawn.
Claim objections
In view of the claim amendments filed on 4/17/2026, the claim objections are withdrawn.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 4/17/2026, 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.
Prior art rejections
The Applicant asserts that Pease is directed to obtaining multiple samples from different esophageal regions which is materially different from the single-site collection-and-protection device of Markowitz and one of ordinary skill in the art would not have taken Pease's disease-monitoring concept and apply it to Markowitz's single-site collection-and-protection device. In particular, the Applicant asserts that “Markowitz is directed to a single-site collection followed by protection of that collected sample during withdrawal” and asserts the following:
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These arguments are not persuasive. First, the Applicant admits that multi-region sampling is not required by Pease. Indeed, Pease 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). These teachings alone show that Pease is not solely used for taking multiple samples. Quite the contrary, Pease clearly and unambiguously 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 teachings of Pease are not incompatible with Markowitz.
Next, the Applicant seems to assert that the teachings of Pease must be incorporated in their entirety for its teachings to be applicable to Markowitz. The Examiner respectfully disagrees. Although the teachings of Pease are to be considered as a whole, it does not follow that every single teaching of Pease must be combined into the teachings of Markowitz to form a valid combination. Rather, the test for obviousness is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, 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). These teachings of Pease are pertinent to the teachings of Markowitz and are instructive since Markowitz teaches the collection of cells in the esophagus (paragraph 0003, 0023, and 0042 of Markowitz) and Pease provides a purpose for the collection of such cells. Thus, 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 (1) 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) and/or (2) because Markowitz teaches the collection of cells in the esophagus and Pease teaches a type of cell for collection and an analytical purpose for the collection of such cells.
The fact that Pease has teachings that are less pertinent to the teachings of Markowitz does not make the teachings that are pertinent to the teachings of Markowitz invalid. Since Pease 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) and teaches 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). Pease clearly and unambiguously teaches that collection from a single tissue site may be used to monitor the effectiveness of treatment in the subject in order to decrease suffering and cost and to increase subject compliance. One of ordinary skill in the art would have understood the plain and unambiguous teachings of Pease to mean this and apply it to the teachings of Markowitz.
The Applicant asserts that the Examiner did not sufficiently show why one of ordinary skill in the art would combine the teachings of Markowitz and Pease. In particular, the Applicant asserts:
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This argument is not persuasive because it is not commensurate with the rejection. The Applicant’s argument supposes to start with the teachings of Pease and the modify the teachings of Pease with the teachings of Markowitz. This is not the rejection. The combination starts with the teachings of Markowitz. Markowitz teaches a collection portion that is moved in the esophagus to collect a biological sample, such as tissue, cells, protein, RNA, and/or DNA (paragraph 0042 of Markowitz). One of ordinary skill in the art would not simply stop there because the types of cells, tissue, etc. are unspecified or what is to be done with the cells, tissue, etc. is unspecified. One of ordinary skill in the art would consider the types of cells, tissue, etc. and the types of activities to do with such cells, tissues, etc. Pease has answers to these issues and therefore is pertinent to the problems of Markowitz. That is, 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 (1) 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) and/or (2) because Markowitz teaches the collection of cells in the esophagus and Pease teaches a type of cell for collection and an analytical purpose for the collection of such cells.
In view of the above, there is sufficient reason why one of ordinary skill in the art would combine the teachings of Markowitz and Pease as outlined in the above rejections.
The Applicant asserts:
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These arguments are not persuasive. First, the Applicant is only arguing against Pease when the rejection is based on the combination of Markowitz and Pease. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Second, the arguments are not commensurate with the rejection. The combination starts with the teachings of Markowitz. Markowitz teaches a collection portion that is moved in the esophagus to collect a biological sample, such as tissue, cells, protein, RNA, and/or DNA (paragraph 0042 of Markowitz). One of ordinary skill in the art would not simply stop there further because the types of cells, tissue, etc. are unspecified or what is to be done with the cells, tissue, etc. is unspecified. One of ordinary skill in the art would consider the types of cells, tissue, etc. and the types of activities to do with such cells, tissues, etc. Pease has answers to these issues and therefore is pertinent to the problems of Markowitz. This same point is detailed above.
Third, the fact that Pease has teachings that are less pertinent to the teachings of Markowitz does not make the teachings that are pertinent to the teachings of Markowitz invalid. Since Pease 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) and teaches 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). Pease clearly and unambiguously teaches that collection from a single tissue site may be used to monitor the effectiveness of treatment in the subject in order to decrease suffering and cost and to increase subject compliance. One of ordinary skill in the art would have understood the plain and unambiguous teachings of Pease to mean this and apply it to the teachings of Markowitz.
In view of the above, the rejection of claims 1 and 15 are proper. Also, the rejection of claims 3-8, 10-11, and 16-20 are proper since the rejection of claim 1 is proper and the prior art teaches or suggests all the features of these claims, as outlined above.
With respect to claim 18, there are new grounds of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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 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).
4 See page 1 of Botz, Bálint, "Gastro-esophageal junction", Radiopaedia, radiopaedia.org/articles/gastro-oesophageal-junction?lang=us, 5 pages, 2021 (previously cited).
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