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 .
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, 41-45, 47 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 first end, a second end, and a cylindrical wall comprising an exterior surface exposed to an external environment, wherein the first end comprises an opening in the dissolvable capsule (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 opening of the first 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 of the string, the string passes through the abrasive sponge and the dissolvable capsule (figure 1C).
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Kaz does not specifically disclose the first opening in the first end being defined by the cylindrical wall of the capsule; however, it would have been a mere matter of design choice for one of ordinary skill in the art at the time the invention was made to have formed the opening to be defined by the cylindrical wall, since Applicant has not disclosed use of this particular configuration as providing a particular advantage, solving a stated problem, or serving a different purpose than that of the numerous alternative configurations also disclosed by Applicant, see figures 11A-11D as filed. Moreover, it appears that any configuration where the cap closes off the interior of the capsule would perform equally well to prevent premature expansion of the sponge. As such, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have made the system of Kaz with the opening being defined by the cylindrical wall of the capsule, because such a modification would have been considered a mere design consideration that fails to patentably distinguish over Kaz.
Kaz does not disclose the cap being at least partially received in the opening and its 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”; plug, a piece of solid material fitting tightly into a hole or aperture https://www.oed.com/dictionary/plug_n?tab=meaning_and_use&tl=true#29702903; a blockage consisting of an object designed to fill a hole tightly, https://www.vocabulary.com/dictionary/plug; an object, such as a cork or a wad of cloth, used to fill a hole tightly; a stopper; a dense mass of material that obstructs a passage https://www.ahdictionary.com/word/search.html?q=plug) 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 at least partially received in the opening and with its interior surface attached to the 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 first end, a second end, and a cylindrical wall comprising an exterior surface exposed to an external environment, wherein the first end comprises an opening in the dissolvable capsule (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 opening of the first 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)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”).
Kaz does not specifically disclose the first opening in the first end being defined by the cylindrical wall of the capsule; however, it would have been a mere matter of design choice for one of ordinary skill in the art at the time the invention was made to have formed the opening to be defined by the cylindrical wall, since Applicant has not disclosed use of this particular configuration as providing a particular advantage, solving a stated problem, or serving a different purpose than that of the numerous alternative configurations also disclosed by Applicant, see figures 11A-11D as filed. Moreover, it appears that any configuration where the cap closes off the interior of the capsule would perform equally well to prevent premature expansion of the sponge. As such, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have made the system of Kaz with the opening being defined by the cylindrical wall of the capsule, because such a modification would have been considered a mere design consideration that fails to patentably distinguish over Kaz.
Kaz does not disclose the cap being at least partially received in the opening and its 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”; plug, a piece of solid material fitting tightly into a hole or aperture https://www.oed.com/dictionary/plug_n?tab=meaning_and_use&tl=true#29702903; a blockage consisting of an object designed to fill a hole tightly, https://www.vocabulary.com/dictionary/plug; an object, such as a cork or a wad of cloth, used to fill a hole tightly; a stopper; a dense mass of material that obstructs a passage https://www.ahdictionary.com/word/search.html?q=plug) 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 at least partially received in the opening and with its interior surface attached to the 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) an abrasive sponge housed within a dissolvable capsule, the dissolvable capsule comprising a first end, a second end, and a cylindrical wall comprising an exterior surface exposed to an external environment, wherein the first end comprises an opening in the dissolvable capsule (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 opening of the first 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); 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”).
Kaz does not specifically disclose the first opening in the first end being defined by the cylindrical wall of the capsule; however, it would have been a mere matter of design choice for one of ordinary skill in the art at the time the invention was made to have formed the opening to be defined by the cylindrical wall, since Applicant has not disclosed use of this particular configuration as providing a particular advantage, solving a stated problem, or serving a different purpose than that of the numerous alternative configurations also disclosed by Applicant, see figures 11A-11D as filed. Moreover, it appears that any configuration where the cap closes off the interior of the capsule would perform equally well to prevent premature expansion of the sponge. As such, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have made the system of Kaz with the opening being defined by the cylindrical wall of the capsule, because such a modification would have been considered a mere design consideration that fails to patentably distinguish over Kaz.
Kaz does not disclose the cap being at least partially received in the opening and its 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”; plug, a piece of solid material fitting tightly into a hole or aperture https://www.oed.com/dictionary/plug_n?tab=meaning_and_use&tl=true#29702903; a blockage consisting of an object designed to fill a hole tightly, https://www.vocabulary.com/dictionary/plug; an object, such as a cork or a wad of cloth, used to fill a hole tightly; a stopper; a dense mass of material that obstructs a passage https://www.ahdictionary.com/word/search.html?q=plug) 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 at least partially received in the opening and with its interior surface attached to the 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 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”).
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 a first end, a second end, and a cylindrical wall defining an opening in the first end, or further comprising a molded cap covering the opening and being at least partially received in the opening 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 first end, a second end, and a cylindrical wall comprising an exterior surface exposed to an external environment, wherein the first end comprises an opening in the dissolvable capsule (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 opening of the first 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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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.
Kaz does not specifically disclose the first opening in the first end being defined by the cylindrical wall of the capsule; however, it would have been a mere matter of design choice for one of ordinary skill in the art at the time the invention was made to have formed the opening to be defined by the cylindrical wall, since Applicant has not disclosed use of this particular configuration as providing a particular advantage, solving a stated problem, or serving a different purpose than that of the numerous alternative configurations also disclosed by Applicant, see figures 11A-11D as filed. Moreover, it appears that any configuration where the cap closes off the interior of the capsule would perform equally well to prevent premature expansion of the sponge. As such, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have made the system of Kaz with the opening being defined by the cylindrical wall of the capsule, because such a modification would have been considered a mere design consideration that fails to patentably distinguish over Kaz.
Kaz does not teach the cap being at least partially received in the opening and its 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”; plug, a piece of solid material fitting tightly into a hole or aperture https://www.oed.com/dictionary/plug_n?tab=meaning_and_use&tl=true#29702903; a blockage consisting of an object designed to fill a hole tightly, https://www.vocabulary.com/dictionary/plug; an object, such as a cork or a wad of cloth, used to fill a hole tightly; a stopper; a dense mass of material that obstructs a passage https://www.ahdictionary.com/word/search.html?q=plug) 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 Fitzgerald and Kaz with the cap at least partially received in the opening and with its interior surface attached to the 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 May 2026 have been fully considered but they are not persuasive.
Applicant initially argues that Kaz does not disclose a capsule having an opening defined by the capsule’s cylindrical wall, as Kaz illustrates the opening as being in a tapered section of the capsule. As noted above, the disclosure of the instant invention does not provide any indication that this embodiment of the potential capsule configuration provides any particular advantage or would be selected for any particular purpose relative to the numerous other disclosed configurations which include, for example, an opening in a tapered end of the capsule - see figures 11A vs 11B, which are disclosed equally as potential configurations for these components. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), the court held that the configuration of the claimed container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant. See MPEP 2144.04.
Applicant next argues that Kaz’s filament “rests on the exterior surface of the rounded end of the dissolvable capsule”; it is entirely unclear how or why Applicant has made this assertion, as it is not supported by any evidence in Kaz nor is this actually disclosed anywhere by Kaz. Rather, Kaz clearly states “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.”, such that it would be entirely impossible to somehow attach that filament to the exterior of the capsule given the description of the foam attached to the filament and then that combination being within the capsule.
Applicant then asserts that one of ordinary skill in the art could not use adhesive to join the cap and sponge of Kaz because of the erroneous interpretation of the location of Kaz’s string/filament; as this interpretation has no basis in Kaz’s disclosures, it cannot be relied upon as evidence that adhesive could not be used to secure the joining of two adjacent components.
Applicant continues by addressing various configurations of Lubinski’s device, where Lubinski discloses a number of potential, non-limiting configurations for that reference’s capsule, not the cap. See paragraph [0159] of Lubinski, which indicates that all of the figures reproduced by Applicant are “capsule 115”, not the “plug or washer-like element [which] is attached to the free end of the retrieval string” (paragraph [0129]). Lubinski’s teaching of various capsule configurations is unrelated to Lubinski’s teaching of also including a cap structure as part of the device, where that cap is described in the form of a plug, thereby being configured to fit inside an opening as noted above.
Applicant concludes by generally asserting that the use of adhesive to attach two components is “advantageous” in preventing separation; Lubinski also teaches using adhesive for this purpose (see paragraph [0107]), such that this general assertion of patentability due to an “advantageous” use of adhesive is entirely unpersuasive.
The Examiner notes that Applicant addresses Wang and Fitzgerald only to reiterate the supposed deficiencies of Kaz as modified by Lubinski; as these deficiencies are not present these general assertions are moot.
The claims remain rejected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 5738110 to Beale, 2001/0027311 to Chen
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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/KAREN E TOTH/Examiner, Art Unit 3791
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