DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restriction
2. Applicant’s election without traverse of Group I, claims 1-16, in the reply filed on 13 April 2026 is acknowledged.
Claim 17 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
3. Applicant's election with traverse of Group III, claims 18-20, in the reply filed on 13 April 2026 is acknowledged. The traversal is on the ground(s) that:
Moreover, the apparatus of claim 1 is specifically configured for administering a swallowable cell collection device to a patient, which directly corresponds to the method recited in claim 18. Accordingly, the claims are not directed to distinct inventions.
Further, the Office Action does not provide a specific explanation as to why examination of Groups I and III would impose a serious search or examination burden, nor does it otherwise establish that such examination would present an undue burden, as required under MPEP § 808.02.
Both Groups I and III are classified in A61B 10/02 (and thus are not in separate fields of search) and are closely aligned, such that examination of claims 18-20 would not impose an undue burden.
This is found persuasive, and the Restriction, mailed on 11 February 2026, of Group III, claims 18-20, is withdrawn. Thus, claims 18-20 are being examined along with claims 1-16.
Claim Objections
4. Claim 1 is objected to because of the following informalities:
In lines 1 and 3, “a swallowable cell collection device” is defined twice, thus lacking proper antecedent basis, and should be amended to “the [[a ]]swallowable cell collection device” in line 3.
Appropriate correction is required.
Claim Interpretation
5. 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.
6. 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.
7. This application includes one or more claim limitations that us the word “means”, and thus, is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Such claim limitation(s) is/are:
“means for stowing the cell collection device and first portion of the retrieval thread at an opposite end” in lines 2-3 of claim 9.
8. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a swallowable cell collection device” in lines 1 and 3 of claim 1, and line 1 of claim 18, which refers to a “swallowable cell collection device 100b” (see para. [0031] of the filed Specification);
“an applicator device” in line 5 of claim 1, and line 3 of claim 18, which refers to an “applicator device 100a” (see para. [0030] of the filed Specification);
“a mechanical release mechanism” in line 2 of claim 4, which refers to “first hook 207a” (see para. [0043] of the filed Specification);
“a movable hook arrangement” in line 2 of claim 6, which refers to “second hook 207b” (see para. [0043] of the filed Specification);
“a slider release mechanism” in line 2 of claim 7, which refers to “a first hook 207a on the main body and a second hook 207b on the slider 102” (see para. [0043] of the filed Specification);
“a piston mechanism” in line 2 of claim 8;
“an abrasive material” in line 2 of claim 10, which refers to “a sponge” (see para. [0012] of the filed Specification);
“a transparent section” in line 2 of claim 14, which refers to “glass or plastic” (see para. [0038] of the filed Specification); and
“a strain release mechanism” in line 2 of claim 15, which refers to “a first post 208a on the main body 101 and a second post 208b on the slider 102” (see para. [0045] of the filed Specification).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
9. 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.
10. Claims 8 and 10 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.
Regarding claim 8, claim limitation “a piston mechanism for administering the cell collection device” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
The filed Specification fails to disclose a corresponding structure to the “piston mechanism” as claimed. The Specification merely refers to “In other embodiments, the applicator device comprises a piston mechanism for administering the cell collection device.” (see para. [0010]), but no actual structure is described.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Regarding claim 10, the phrase “preferably” renders the claim indefinite because it is unclear whether the limitation, “a sponge material”, following the phrase is part of the claimed invention as the phrase refers to a person’s preferred choice.
Claim Rejections - 35 USC § 102
11. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
12. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
13. Claims 1-7, 9-16, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maguire et al., U.S. Patent Application Publication No. 2016/0045189 A1 (“Maguire”).
As to Claim 1, Maguire teaches the following:
A packaging apparatus (“packaged cell collection device assembly”) 100 for administering a swallowable cell collection device (“swallowable cell collection device”) 105 to a patient (see “FIG. 1A illustrates an example of a packaged cell collection device assembly 100. In general, a packaged cell collection device assembly may include a swallowable cell collection device 105 and a packaging apparatus 110.” in para. [0037]), comprising:
a swallowable cell collection device (“swallowable cell collection device”) 105 comprising a retrieval thread (“retrieval string”) 120 tethered to a swallowable capsule (“swallowable capsule”) 115 at a distal end of the thread 120, with a first portion of the retrieval thread 120 packaged in a bundled state (“pre-deployed or packaged configuration”) together with the swallowable capsule 115 (see “According to various embodiments, the packaging apparatus 110 is configured to retain the cell collection 105 in a pre-deployed or packaged configuration until the cell collection device 105 is ready for use on a patient. The swallowable cell collection device 105 is shown in a pre-deployed configuration in FIG. 1A. A pre-deployed configuration refers to the cell collection device 105 being stored or packaged before being administered to a patient. In a pre-deployed configuration, the cell collection device 105 may be attached or coupled with the packaging apparatus 110 in a variety of ways as explained in further detail below. For example, the cell collection device 105 may be wrapped around a portion of the packaging apparatus 110 and may be retained in place by one or more retention features such as a slit, a removable tab, a hook or any combination of these features.” in para. [0037], and see fig. 1); and
an applicator device (“packaging apparatus ”) 110 tethered to a proximal end of the retrieval thread 120 and configured to releasably stow the cell collection device 105 and first portion of the retrieval thread 120 for direct administration to the patient within the mouth of the patient by partial insertion of the applicator device 110 into the mouth (see “A bundle 130 of string 120 may be formed by wrapping a portion of the string 120 around one or more bundling features such as one or more shafts, posts, or some other portion of the packaging apparatus 110. For example, a portion of string 120 may be helically wrapped around a shaft 125 of the packaging apparatus 110 to form a swallowable bundle 130. The shaft 125 may be substantially planar with a generally rectangular cross section. In other embodiments, such as FIG. 2, the shaft 125 may be rounded with a circular or oval cross section. Moreover, in some embodiments, the string 120 is wrapped around multiple shafts 125 to form a swallowable bundle 130. In general, the shape and size of shaft 125 is configured to facilitate the formation of a swallowable bundle 130 of string 120 with a length and cross sectional dimension to allow the bundle 130 to be placed on the tongue of a patient and swallowed. In other embodiments, the swallowable bundle 130 may be formed by looping or folding the string 120 back on itself multiple times, as shown in FIG. 12. In yet other embodiments, the string 120 may be formed into a swallowable bundle 130 by wrapping the string 120 into a cylindrical or spherical shape as shown in FIG. 13.” in para. [0042]).
As to Claim 2, Maguire teaches the following:
wherein the applicator device 110 is configured to releasably stow a second portion of the retrieval thread 120 packaged in a bundled state for deployment outside the mouth of the patient (see “A bundle 130 of string 120 may be formed by wrapping a portion of the string 120 around one or more bundling features such as one or more shafts, posts, or some other portion of the packaging apparatus 110.” in para. [0042]).
As to Claim 3, Maguire teaches the following:
wherein the applicator device 110 is configured to administer the cell collection device 105 to the patient and, substantially simultaneously, release the second portion of the retrieval thread 120 (see “A bundle 130 of string 120 may be formed by wrapping a portion of the string 120 around one or more bundling features such as one or more shafts, posts, or some other portion of the packaging apparatus 110. For example, a portion of string 120 may be helically wrapped around a shaft 125 of the packaging apparatus 110 to form a swallowable bundle 130. … Moreover, in some embodiments, the string 120 is wrapped around multiple shafts 125 to form a swallowable bundle 130. …” in para. [0042]).
As to Claim 4, Maguire teaches the following:
wherein the applicator device 110 comprises a mechanical release mechanism (“shaft”) 125 for administering the cell collection device 105 (see “The cell collection device 105 is in a deployed configuration when it is ready to be administered to the patient. For example, the cell collection device 105 may be transitioned from a pre-deployed configuration to a deployed configuration by removing, detaching, or otherwise decoupling at least a portion of the cell collection device 105 from at least a portion of the packaging apparatus 110. In some embodiments, the swallowable bundle 130 is released from a bundling feature, material, apparatus, or other bundling means when the cell collection device 105 is in a deployed configuration. For example, the cell collection device 105 may be deployed by sliding the swallowable bundle 130 off the distal end 140 of shaft 125. Additionally or alternatively, the cell collection device 105 is transitioned from a pre-deployed configure to a deployed configuration by removing the swallowable capsule 115 from a capsule retention member such as a capsule housing, as described in more detail below.” in para. [0045]).
As to Claim 5, Maguire teaches the following:
wherein the applicator device 110 is configured to releasably stow a second portion of the retrieval thread 120 packaged in a bundled state (“swallowable bundle”) 130 for deployment outside the mouth of the patient, and the mechanical release mechanism 125 is configured to release the second portion of the retrieval thread 120 (see “The cell collection device 105 is in a deployed configuration when it is ready to be administered to the patient. For example, the cell collection device 105 may be transitioned from a pre-deployed configuration to a deployed configuration by removing, detaching, or otherwise decoupling at least a portion of the cell collection device 105 from at least a portion of the packaging apparatus 110. In some embodiments, the swallowable bundle 130 is released from a bundling feature, material, apparatus, or other bundling means when the cell collection device 105 is in a deployed configuration. For example, the cell collection device 105 may be deployed by sliding the swallowable bundle 130 off the distal end 140 of shaft 125. Additionally or alternatively, the cell collection device 105 is transitioned from a pre-deployed configure to a deployed configuration by removing the swallowable capsule 115 from a capsule retention member such as a capsule housing, as described in more detail below.” in para. [0045]).
As to Claim 6, Maguire teaches the following:
wherein the mechanical release mechanism 125 comprises a movable hook (“hook”, not labeled) arrangement for stowing and releasing the second portion of the retrieval thread 120 (see “For example, the cell collection device 105 may be wrapped around a portion of the packaging apparatus 110 and may be retained in place by one or more retention features such as a slit, a removable tab, a hook or any combination of these features.” in para. [0037]).
As to Claim 7, Maguire teaches the following:
wherein the applicator device 110 comprises a slider release mechanism (“distal end retaining member”) 150 for administering the cell collection device 105 (see “Similarly, the distal end 140 of the shaft 125 may include a distal end retaining member 150 configured to prevent the swallowable bundle 130 from sliding off the distal end 140 of the shaft 125 when the cell collection device 105 is in a pre-deployed configuration. In some embodiments, the distal end retaining member 150 includes a slit 151 cut into the distal end retaining member 150. The width and depth of the slit 151 is configured to grasp the string 120, thereby preventing the swallowable bundle 130 from unbundling or sliding off the distal end 140 of shaft 125 while in a pre-deployed configuration.” in para. [0044]).
As to Claim 9, Maguire teaches the following:
wherein the applicator 110 comprises an elongate body having a handle (“retaining member”) 145 at one end (“proximal end”, not labeled) and means (“shaft”) 125 for stowing the cell collection device 105 and first portion of the retrieval thread 120 at an opposite end (“distal end”) 140 (see para. [0043]-[0044], and fig. 1A).
As to Claim 10, Maguire teaches the following:
wherein the cell collection device 105 comprises a capsule housing an abrasive material for collecting cells, preferably a sponge material (“expandable sponge (not shown)”, not labeled) (see “The swallowable capsule 115 may contain an expandable sponge (not shown) or other similar material or device configured to collect cells from the stomach or esophagus of the patient.” in para. [0038]).
As to Claim 11, Maguire teaches the following:
wherein the abrasive material is tethered to the retrieval thread 120 by an overhand loop knot (see “In general, the cell collection device 105 includes a swallowable capsule 115 coupled with a retrieval string 120. The swallowable capsule 115 may contain an expandable sponge (not shown) or other similar material or device configured to collect cells from the stomach or esophagus of the patient.” in para. [0038]).
As to Claim 12, Maguire teaches the following:
in which the first portion of the retrieval thread has a length of at least 450mm (see “Furthermore, the length of the string 120 is selected to allow the swallowable capsule 115 to enter the stomach of a patient and to be retrieved back through the esophagus of the patient.” in para. [0039], in which the claimed length is within the scope of Maguire’s teaching).
As to Claim 13, Maguire teaches the following:
wherein the second portion of the retrieval thread has a length of at least 200mm (see “Furthermore, the length of the string 120 is selected to allow the swallowable capsule 115 to enter the stomach of a patient and to be retrieved back through the esophagus of the patient.” in para. [0039], in which the claimed length is within the scope of Maguire’s teaching).
As to Claim 14, Maguire teaches the following:
wherein the applicator device 110 comprises a transparent section (“capsule housing”) 505 for viewing the stowed cell collection device (matter of intended use of the “capsule housing 505”, which is capable hold the “cell collection device 105” for viewing, see fig. 5A).
As to Claim 15, Maguire teaches the following:
wherein the applicator device 110 comprises a strain release mechanism (“distal end retaining member”) 150 configurable to transfer load from the retrieval thread into the applicator device (see “For example, the cell collection device 105 may be wrapped around a portion of the packaging apparatus 110 and may be retained in place by one or more retention features such as a slit, a removable tab, a hook or any combination of these features.” in para. [0037]; and see “In some embodiments, the distal end retaining member 150 includes a slit 151 cut into the distal end retaining member 150. The width and depth of the slit 151 is configured to grasp the string 120, thereby preventing the swallowable bundle 130 from unbundling or sliding off the distal end 140 of shaft 125 while in a pre-deployed configuration.” in para. [0044]).
As to Claim 16, Maguire teaches the following:
wherein the strain release mechanism 150 is configured to releasably pinch the retrieval thread 120 (see “For example, the cell collection device 105 may be wrapped around a portion of the packaging apparatus 110 and may be retained in place by one or more retention features such as a slit, a removable tab, a hook or any combination of these features.” in para. [0037]; and see “In some embodiments, the distal end retaining member 150 includes a slit 151 cut into the distal end retaining member 150. The width and depth of the slit 151 is configured to grasp the string 120, thereby preventing the swallowable bundle 130 from unbundling or sliding off the distal end 140 of shaft 125 while in a pre-deployed configuration.” in para. [0044]).
As to Claim 18, Maguire teaches the following:
A method of administering a swallowable cell collection device (“swallowable cell collection device”) 105 to a patient (see “Methods, apparatuses and systems are described for administering a swallowable cell collection device to a patient. Methods include releasing a swallowable bundle of string of the cell collection device from a bundling apparatus, maintaining the string in a swallowable bundle while releasing the swallowable bundle from the bundling apparatus, and placing the swallowable bundle on the tongue of the patient.” in Abstract), the method comprising the steps of:
providing an applicator device (“packaging apparatus”) 110 and swallowable cell collection device (“swallowable cell collection device”) 105, the swallowable cell collection device 105 comprising a retrieval thread (“retrieval string”) 120 tethered to a swallowable capsule (“swallowable capsule”) 115 at a distal end of the thread 120, with a first portion of the retrieval thread 120 packaged in a bundled state (“pre-deployed or packaged configuration”) together with the swallowable capsule (see “According to various embodiments, the packaging apparatus 110 is configured to retain the cell collection 105 in a pre-deployed or packaged configuration until the cell collection device 105 is ready for use on a patient. The swallowable cell collection device 105 is shown in a pre-deployed configuration in FIG. 1A. A pre-deployed configuration refers to the cell collection device 105 being stored or packaged before being administered to a patient. In a pre-deployed configuration, the cell collection device 105 may be attached or coupled with the packaging apparatus 110 in a variety of ways as explained in further detail below. For example, the cell collection device 105 may be wrapped around a portion of the packaging apparatus 110 and may be retained in place by one or more retention features such as a slit, a removable tab, a hook or any combination of these features.” in para. [0037], and see fig. 1); and
the applicator device 110 being tethered to a proximal end of the retrieval thread 120 and configured to releasably stow the cell collection device 105 and first portion of the retrieval thread 120 (see “A bundle 130 of string 120 may be formed by wrapping a portion of the string 120 around one or more bundling features such as one or more shafts, posts, or some other portion of the packaging apparatus 110. For example, a portion of string 120 may be helically wrapped around a shaft 125 of the packaging apparatus 110 to form a swallowable bundle 130. The shaft 125 may be substantially planar with a generally rectangular cross section. In other embodiments, such as FIG. 2, the shaft 125 may be rounded with a circular or oval cross section. Moreover, in some embodiments, the string 120 is wrapped around multiple shafts 125 to form a swallowable bundle 130. In general, the shape and size of shaft 125 is configured to facilitate the formation of a swallowable bundle 130 of string 120 with a length and cross sectional dimension to allow the bundle 130 to be placed on the tongue of a patient and swallowed. In other embodiments, the swallowable bundle 130 may be formed by looping or folding the string 120 back on itself multiple times, as shown in FIG. 12. In yet other embodiments, the string 120 may be formed into a swallowable bundle 130 by wrapping the string 120 into a cylindrical or spherical shape as shown in FIG. 13.” in para. [0042]);
partially inserting the applicator device 110 into the mouth of the patient such that the swallowable capsule 115 and first portion of the retrieval thread 120 are positioned behind the teeth of the patient (see “In general, the shape and size of shaft 125 is configured to facilitate the formation of a swallowable bundle 130 of string 120 with a length and cross sectional dimension to allow the bundle 130 to be placed on the tongue of a patient and swallowed.” in para. [0042]; and see “The swallowable bundle 130 can then be administered to the patient by carefully placing the swallowable bundle 130 on the patient's tongue.” in para. [0046]);
releasing the swallowable capsule 115 and first portion of the retrieval thread 120 from the applicator device 110 for swallowing by the patient (see “In some embodiments, the swallowable bundle 130 is released from a bundling feature, material, apparatus, or other bundling means when the cell collection device 105 is in a deployed configuration. For example, the cell collection device 105 may be deployed by sliding the swallowable bundle 130 off the distal end 140 of shaft 125. Additionally or alternatively, the cell collection device 105 is transitioned from a pre-deployed configure to a deployed configuration by removing the swallowable capsule 115 from a capsule retention member such as a capsule housing, as described in more detail below.” in para. [0045]);
collecting a cell sample from an internal location within the patient using the swallowable capsule 115 (see “The swallowable capsule 115 may contain an expandable sponge (not shown) or other similar material or device configured to collect cells from the stomach or esophagus of the patient.” in para. [0039]); and
manipulating the applicator device 110 to retrieve the swallowable capsule 115 together with the collected cell sample from the patient (see “… In some embodiments, the string 120 is coated or otherwise treated to make the surface of the string 120 more slippery and easier to swallow and withdraw. … Furthermore, the length of the string 120 is selected to allow the swallowable capsule 115 to enter the stomach of a patient and to be retrieved back through the esophagus of the patient.” in para. [0039]).
As to Claim 19, Maguire teaches the following:
retracting the applicator device 110 from the mouth and releasing a second portion of retrieval thread from the applicator device outside the teeth of the patient (see “In some embodiments, the string 120 is coated or otherwise treated to make the surface of the string 120 more slippery and easier to swallow and withdraw. Additionally, the string 120 may also be coated or otherwise treated to manipulate the elasticity and resilience of the string 120. For example, the string 120 may be heat treated such that the string 120 retains a desired shape or configuration (such as a swallowable bundle) in the absence of external constraints or forces. Furthermore, the length of the string 120 is selected to allow the swallowable capsule 115 to enter the stomach of a patient and to be retrieved back through the esophagus of the patient.” in para. [0039]).
As to Claim 20, Maguire teaches the following:
withdrawing the applicator device 110 from the mouth of the patient (see “… In some embodiments, the string 120 is coated or otherwise treated to make the surface of the string 120 more slippery and easier to swallow and withdraw. … Furthermore, the length of the string 120 is selected to allow the swallowable capsule 115 to enter the stomach of a patient and to be retrieved back through the esophagus of the patient.” in para. [0039]).
Claim Rejections - 35 USC § 103
14. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
15. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
16. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Maguire, as applied to claim 1 above, and further in view of Wang et al., WO Patent No. 2021/232394 A1 (“Wang”).
As to Claim 8, Maguire teaches the subject matter of claim 1 above. Maguire does not teach the following:
wherein the applicator device comprises a piston mechanism for administering the cell collection device.
However, Wang teaches the following:
an applicator device (“delivery tube”) 5 comprises a piston mechanism (“push rod”) 4 for administering a cell collection device (“filter material”) 3 (see “An embodiment of the present invention provides a digestive tract exfoliated cell enricher, which includes: a delivery tube 5, a push rod 4, a connecting line 2 and a filter material 3, wherein: The conveying pipe 5 has a hollow inside and holes at both ends; The filter material 3 is located inside the empty channel of the delivery pipe 5 and is placed on the top end of the push rod 4, and includes a plurality of through holes. After being in full contact with the inner wall of the digestive tract, it is enriched in the mucus in the digestive tract cavity.” in p. 3).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Maguire’s applicator device (“packaging apparatus 110”) to include Wang’s applicator device (“delivery tube 5”) comprises a piston mechanism (“push rod”) 4 for administering the cell collection device because it is a matter of a simple substitution of one known mechanism, i.e. “packaging apparatus 110”, with another known mechanism, i.e. applicator device (“delivery tube 5”) comprises a piston mechanism (“push rod”) 4, in order to provide the same predictable result, i.e. “conveying” or “delivering” the cell collection device (Maguire’s “swallowable cell collection device 105” or Wang’s “filter material 3”) (see “By applying force to the part placed outside the conveying pipe 5, the push rod 4 can push the filter material 3 to the outside of the conveying pipe 5.” in Wang, p. 3; and see “The push rod 4 pushes the filter material 3 through the opening of the delivery pipe 5 to the outside of the delivery pipe 5.” in Wang, p. 4).
Conclusion
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 04/30/2026
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