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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 13 January 2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 13 January 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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, 35, 37-51 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999).
The term “closed”, first recited in claim 1 is used by the claim to mean “generally more closed than open,” while the accepted meaning is “not open” (https://dictionary.cambridge.org/dictionary/essential-american-english/closed and https://www.merriam-webster.com/dictionary/closed).
The term “open”, first recited in claim 1, is used by the claim to mean “having no structure or covering whatsoever”, while the accepted meaning is “presenting no obstacle to passage or view: not enclosed, obstructed, or filled with objects” (https://www.merriam-webster.com/dictionary/open) or “able to have something pass through or along it; having an opening or aperture showing what is inside” (https://en.wiktionary.org/wiki/open)
The term is indefinite because the specification does not clearly redefine the term and uses the terms apparently interchangeably where objects described as “closed” are shown as being technically “open”, see figures 1A and 1C as filed:
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Applicant’s remarks attempt to show that closed vs open is represented by only one of the two components that apparently comprises a “capsule” – as one version of a “capsule” in figures 1A and 1C comprises two pieces and the other version of a capsule in figures 1B and 1D comprises only a single piece, there is no readily apparent equivalence between these two designs that could convey any sort of distinction between “open” and “closed” ends when defining a “capsule” when all of these ends in all of the pieces of capsules each comprise an opening. Figures 1A and 1C show a 2-piece “capsule” with ostensibly closed ends, where each piece comprises two ends with openings and when assembled results in a “capsule” with two ends each having “openings”, whereas figures 1B and 1D show a 1-piece “capsule” with two ends each having openings, where only the single piece represents a “capsule” even though figures 1A and 1C show a “capsule” comprised of two pieces. Again, if the intent is for “closed” to represent something other than being closed, it should be clearly defined as such as the drawing alone do not readily convey what is considered open or closed particularly when there is no equivalency between structures theoretically showing contrast.
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.
Claim 37 is 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. Claim 1 defines that the cap interior surface is attached to the abrasive sponge; option d of claim 37 merely repeats this limitation, and as claim 37 does not require more than one of the conditions to be met, claim 37.d does not further limit claim 1. 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 § 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.
Claim(s) 1, 3, 37-39, 41-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaz (Kaz AM, Grady WM. Novel Barrett's esophagus screening assays based on swallowable devices: will they change the game? Transl Gastroenterol Hepatol. 2019 Apr 19;4:25. doi: 10.21037/tgh.2019.04.01. PMID: 31143846; PMCID: PMC6509432.) in view of Lubinski (US 2016/0081672).
Regarding claim 1, Kaz discloses an ingestible cell sampling device (see annotated figure below) comprising:
i) an abrasive sponge housed within a dissolvable capsule, the dissolvable capsule comprising a “closed end”, an “open end”, and an exterior surface exposed to an external environment (p. 2, the EsophaCap “As noted above, the EsophaCap, which has also been evaluated in another recent study (11), consists of a polyurethane foam sphere attached to a filament. The sphere is compressed and packaged within a gelatin capsule. After it is swallowed, the capsule dissolves in the patient’s stomach after several minutes, and then the foam sphere is retrieved using the tethered string, capturing gastric and esophageal cells during its egress.”);
ii) a molded cap covering the “open end” of the dissolvable capsule, the molded cap comprising a cap interior surface in contact with the sponge and a cap exterior surface in contact with the external environment (the labeled white object in annotated figure 1C); and
iii) a string comprising a first end attached to the molded cap (figure 1C) and a second end, wherein between the first end and the second end, the string passes through the abrasive sponge and the dissolvable capsule (figure 1C).
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The Examiner notes that Kaz’s “open end” is an end with an opening, thus making it “open”, as the string inherently passes through to reach the cap; Kaz’s “closed” end also has an opening, as do the “closed” ends of the instant invention.
Kaz does not disclose the cap interior surface being attached to the abrasive sponge by an adhesive; Lubinski teaches an ingestible cell sampling device comprising an abrasive sponge (element 105) attached to a cap (paragraph [0129], “a plug or washer-like element is attached to the free end of the retrieval string 110 such that the string is not able to be pulled back through top end 1005”) and a string which passes through the sponge to the cap (element 110), where the sponge is attached to the cap via an adhesive (paragraph [0107], the various regions of the collection device may be joined by “any appropriate mechanical, chemical or adhesive process” which include “glues or other adhesives”). As such, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Kaz with the cap’s interior surface attached to the adhesive sponge by adhesive, as taught by Lubinski, in order to ensure the components are not separated during use.
Regarding claim 3, Kaz further discloses that the abrasive sponge is compressible and the abrasive sponge is retained in a compressed state by the dissolvable capsule (p. 2, “As noted above, the EsophaCap, which has also been evaluated in another recent study (11), consists of a polyurethane foam sphere attached to a filament. The sphere is compressed and packaged within a gelatin capsule.”), and in an uncompressed state, the abrasive sponge has an external shape selected from a cylinder, a portion of a cylinder, a sphere, and a portion of a sphere (figure 1C).
Regarding claim 37, Kaz further discloses wherein the molded cap or a portion of the molded cap comprises a shape selected from a sphere or a portion thereof, a hemisphere or a portion thereof, and a cylinder or a portion thereof (figure 1C) and the cap interior surface is attached to the abrasive sponge (figure 1C).
Regarding claim 38, Kaz further discloses that the dissolvable capsule comprises gelatin (p. 2, the EsophaCap “As noted above, the EsophaCap, which has also been evaluated in another recent study (11), consists of a polyurethane foam sphere attached to a filament. The sphere is compressed and packaged within a gelatin capsule.”).
Regarding claim 39, Kaz further discloses that the string comprises one or more elements selected from the group consisting of cord, thread, filament, cable, strand, fiber, ribbon, webbing, suture, and lacing (p. 2, the EsophaCap “As noted above, the EsophaCap, which has also been evaluated in another recent study (11), consists of a polyurethane foam sphere attached to a filament.”).
Regarding claim 41, Kaz discloses a method of collecting a cell sample from a subject, comprising:
a) orally administering an ingestible cell sampling device (p. 2, “The sphere is compressed and packaged within a gelatin capsule. After it is swallowed, the capsule dissolves in the patient’s stomach after several minutes…”) comprising:
i) an abrasive sponge housed within a dissolvable capsule, the dissolvable capsule comprising a “closed end”, an “open end”, and an exterior surface exposed to an external environment (p. 2, the EsophaCap “As noted above, the EsophaCap, which has also been evaluated in another recent study (11), consists of a polyurethane foam sphere attached to a filament. The sphere is compressed and packaged within a gelatin capsule. After it is swallowed, the capsule dissolves in the patient’s stomach after several minutes, and then the foam sphere is retrieved using the tethered string, capturing gastric and esophageal cells during its egress.”);
ii) a molded cap covering the “open end” of the dissolvable capsule, the molded cap comprising a cap interior surface and a cap exterior surface in contact with the external environment (the labeled white object in annotated figure 1C); and
iii) a string comprising a first end attached to the molded cap (figure 1C) and a second end, wherein between the first end and the second end, the string passes through the abrasive sponge and the dissolvable capsule (figure 1C)and b) withdrawing from the subject the cell sampling device (p. 2, “then the foam sphere is retrieved using the tethered string”), wherein the abrasive sponge collects a cell sample from the subject during the withdrawing (p. 2, “capturing gastric and esophageal cells during its egress”).
The Examiner notes that Kaz’s “open end” is an end with an opening, thus making it “open”, as the string inherently passes through to reach the cap; Kaz’s “closed” end also has an opening, as do the “closed” ends of the instant invention.
Kaz does not disclose the cap interior surface being attached to the abrasive sponge by an adhesive; Lubinski teaches an ingestible cell sampling device comprising an abrasive sponge (element 105) attached to a cap (paragraph [0129], “a plug or washer-like element is attached to the free end of the retrieval string 110 such that the string is not able to be pulled back through top end 1005”) and a string which passes through the sponge to the cap (element 110), where the sponge is attached to the cap via an adhesive (paragraph [0107], the various regions of the collection device may be joined by “any appropriate mechanical, chemical or adhesive process” which include “glues or other adhesives”). As such, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Kaz with the cap’s interior surface attached to the adhesive sponge by adhesive, as taught by Lubinski, in order to ensure the components are not separated during use.
Regarding claim 42, Kaz further discloses that the withdrawing is within minutes of the orally administering (p. 2, “the capsule dissolves in the patient’s stomach after several minutes, and then the foam sphere is retrieved using the tethered string”), but does not specifically call for the withdrawing to be within 10 minutes of the orally administering. However, "a prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005) – see MPEP 2144.05(I). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have followed Kaz and limited the duration to less than 10 minutes in order to reduce the duration of potential discomfort for the subject.
Regarding claim 43, Kaz further discloses that, during the orally administering, the subject swallows the dissolvable capsule of the ingestible cell sampling device (p. 2, “After it is swallowed…”).
Regarding claim 44, Kaz discloses a method comprising,
(A) obtaining a cell sample collected from a subject (abstract) by a method comprising:
a) orally administering an ingestible cell sampling device (“p. 2, “The sphere is compressed and packaged within a gelatin capsule. After it is swallowed, the capsule dissolves in the patient’s stomach after several minutes…”) comprising:
i i) an abrasive sponge housed within a dissolvable capsule, the dissolvable capsule comprising a “closed end”, an “open end”, and an exterior surface exposed to an external environment (p. 2, the EsophaCap “As noted above, the EsophaCap, which has also been evaluated in another recent study (11), consists of a polyurethane foam sphere attached to a filament. The sphere is compressed and packaged within a gelatin capsule. After it is swallowed, the capsule dissolves in the patient’s stomach after several minutes, and then the foam sphere is retrieved using the tethered string, capturing gastric and esophageal cells during its egress.”);
ii) a molded cap covering the “open end” of the dissolvable capsule, the molded cap comprising a cap interior surface and a cap exterior surface in contact with the external environment (the labeled white object in annotated figure 1C); and
iii) a string comprising a first end attached to the molded cap (figure 1C) and a second end, wherein between the first end and the second end, the string passes through the abrasive sponge and the dissolvable capsule (figure 1C); and
b) withdrawing from the subject the cell sampling device (p. 2, “then the foam sphere is retrieved using the tethered string”), wherein the abrasive sponge collects a cell sample from the subject during the withdrawing p. 2, “capturing gastric and esophageal cells during its egress”), and
(B) assaying the cell sample for at least one biomarker (p. 2, “Wang et al. report on the accuracy of an assay using methylated DNA biomarkers collected with the EsophaCap swallowable device”).
The Examiner notes that Kaz’s “open end” is an end with an opening, thus making it “open”, as the string inherently passes through to reach the cap; Kaz’s “closed” end also has an opening, as do the “closed” ends of the instant invention.
Kaz does not disclose the cap interior surface being attached to the abrasive sponge by an adhesive; Lubinski teaches an ingestible cell sampling device comprising an abrasive sponge (element 105) attached to a cap (paragraph [0129], “a plug or washer-like element is attached to the free end of the retrieval string 110 such that the string is not able to be pulled back through top end 1005”) and a string which passes through the sponge to the cap (element 110), where the sponge is attached to the cap via an adhesive (paragraph [0107], the various regions of the collection device may be joined by “any appropriate mechanical, chemical or adhesive process” which include “glues or other adhesives”). As such, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Kaz with the cap’s interior surface attached to the adhesive sponge by adhesive, as taught by Lubinski, in order to ensure the components are not separated during use.
Regarding claim 45, Kaz further discloses that the at least one biomarker comprises one or more of a protein and a nucleic acid p. 2, “Wang et al. report on the accuracy of an assay using methylated DNA biomarkers collected with the EsophaCap swallowable device”).
Regarding claim 46, Kaz further discloses that the at least one biomarker comprises DNA comprising at least a portion of a CDKN2A gene (p. 2, “lasso regression model consisting of four biomarkers (CDKN2A/p16, NELL1, AKAP12, TAC1)”).
Regarding claim 47, Kaz further discloses that assaying the at least one biomarker comprises determining a methylation state of a gene (p. 2, “Wang et al. report on the accuracy of an assay using methylated DNA biomarkers collected with the EsophaCap swallowable device”).
Regarding claim 48, Kaz further discloses that assaying the at least one biomarker comprises assaying at least CDKN2A (p. 2, “lasso regression model consisting of four biomarkers (CDKN2A/p16, NELL1, AKAP12, TAC1)”).
Regarding claims 49-51, Kaz further discloses that assaying the at least one biomarker comprises assaying at least the methylation state of VAV3 (Table 1, the Iyer study, where VAV3 is a member of each group that is potentially assayed).
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.
Claim(s) 2 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaz, as modified by Lubinski above, and further in view of Wang (US 2023/0061826).
Regarding claim 2, Kaz does not disclose ingestible cell sampling device further comprising a handle attached to the string. Wang teaches an ingestible cell sampling device (paragraphs [0373]-[0377]) comprising a capsule and a string (paragraph [0373]), with a handle attached to the string (element 574). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Kaz, as modified above, with a handle attached to the string, as taught by Wang, in order to aid with retrieval of the device.
Regarding claim 35, Wang further teaches that the handle is attached to an end of the string opposite the capsule (figure 42); as modifying Kaz this would be the “second end” of the string. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Kaz, as modified by Lubinski and Wang, with the handle attached to the “second” end of the string, as further taught by Wang, in order to allow the first end to be swallowed.
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fitzgerald (US 2012/0226189) in view of Kaz and Lubinski.
Regarding claim 40, Fitzgerald discloses a system or kit for obtaining a cell sample from a subject, comprising
an ingestible cell sampling device (paragraph [0006]) comprising:
an abrasive sponge housed within a dissolvable capsule, the dissolvable capsule comprising an exterior surface exposed to an external environment (paragraph [0021]); and
a string having a first end attached to the sponge (paragraph [0006])
the system or kit further comprising a container to receive an abrasive sponge comprising collected cells (paragraph [0186]), a buffer reagent (paragraph [0207]), a microscope slide (paragraph [0204]), a local anesthetic treatment in the form of a spray (paragraph [0185]), a component of a drinkable solution (paragraph [0188]), and a lubricant gel or liquid (paragraph [0187]).
Fitzgerald does not specifically disclose the ingestible cell sampling device’s capsule comprising an “open end” and a “closed end”, or further comprising a molded cap covering the “open end” and the string having a first end attached to the cap and a second end and the string between the ends passing through the sponge and capsule, the molded cap being attached to the sponge by an adhesive.
Kaz teaches an ingestible cell sampling device (see annotated figure below) comprising:
i) an abrasive sponge housed within a dissolvable capsule, the dissolvable capsule comprising a “closed end”, an “open end”, and an exterior surface exposed to an external environment (p. 2, the EsophaCap “As noted above, the EsophaCap, which has also been evaluated in another recent study (11), consists of a polyurethane foam sphere attached to a filament. The sphere is compressed and packaged within a gelatin capsule. After it is swallowed, the capsule dissolves in the patient’s stomach after several minutes, and then the foam sphere is retrieved using the tethered string, capturing gastric and esophageal cells during its egress.”);
ii) a molded cap covering the “open end” of the dissolvable capsule, the molded cap comprising a cap interior surface and a cap exterior surface in contact with the external environment (the labeled white object in annotated figure 1C, at least some portion of the “interior” surface will be in contact in the area where the string passes through the capsule); and
iii) a string comprising a first end attached to the molded cap (figure 1C) and a second end, wherein between the first end and the second end, the string passes through the abrasive sponge and the dissolvable capsule (figure 1C).
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It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Fitzgerald and included a molded cap attached to the string, as taught by Kaz, in order to ensure the sponge is not separated from the string during use, and used a capsule with an “open end” and a “closed end” , with the string passing through the capsule, as also taught by Kaz, in order to ensure the capsule remains compressed during ingestion.
The Examiner notes that Kaz’s “open end” is an end with an opening, thus making it “open”, as the string inherently passes through to reach the cap; Kaz’s “closed” end also has an opening, as do the “closed” ends of the instant invention.
Kaz does not disclose the cap interior surface being attached to the abrasive sponge by an adhesive; Lubinski teaches an ingestible cell sampling device comprising an abrasive sponge (element 105) attached to a cap (paragraph [0129], “a plug or washer-like element is attached to the free end of the retrieval string 110 such that the string is not able to be pulled back through top end 1005”) and a string which passes through the sponge to the cap (element 110), where the sponge is attached to the cap via an adhesive (paragraph [0107], the various regions of the collection device may be joined by “any appropriate mechanical, chemical or adhesive process” which include “glues or other adhesives”). As such, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Kaz with the cap’s interior surface attached to the adhesive sponge by adhesive, as taught by Lubinski, in order to ensure the components are not separated during use.
Response to Arguments
Applicant's arguments filed 13 January 2026 have been fully considered but they are not persuasive.
Regarding the rejections under 112, Applicant argues that figures 1B and 1D as compared to figures 1A and 1C clearly show the difference between “closed” and “open” such that there is no need to redefine the term “closed” to mean anything other than closed despite it being used to identify something that is open. As noted above, there is no clear structural equivalence between the “capsules” of figures 1A/1C as compared to 1B/1D, such that this still does not resolve the issue of the term “closed” being used in a manner that is apparently contradictory to its given definition.
Applicant’s arguments with respect to the art rejections of the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant’s arguments are based on the erroneous definition of “closed”, as discussed above, and whether Kaz discloses the newly added feature of an adhesive. As this is taught by Lubinski, these arguments are moot.
Applicant addresses Wang and Fitzgerald only to assert that they do not teach features which they are not relied upon to teach, such that these arguments are also moot.
Conclusion
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/KAREN E TOTH/Examiner, Art Unit 3791