DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. The Applicant’s submission filed on 1/21/2026 has been entered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1, 3, 16-18, and 23 are objected to because of the following informalities:
in claim 1, line 6: “the” should be inserted before “urine”;
in claim 1, line 11: “the” should be inserted before “urine”;
in claim 3, line 4: “the” should be inserted before “urine and”;
in claim 3, line 4: “the” should be inserted before “urine from”;
in claim 16, line 11: “the” should be inserted before “urine”;
in claim 16, line 12: “the” should be inserted before “urine”;
in claim 16, line 13: “the” should be inserted before “urine”;
in claim 16, line 16: “the” should be inserted before “urine”;
in claim 17, line 2: “the” should be inserted before “urine”;
in claim 18, line 2: “the” should be inserted before “urine”; and
in claim 23, line 3: “the” should be inserted before “urine”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-4, 6-7, 10-12, 15-18, 20-21, and 23-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a midstream sample of urine” in line 4, but it is not clear if this recitation is the same as, related to, or different from “a midstream sample of urine” of claim 1, lines 1-2. If they are the same, “a midstream sample of urine” in line 4 should be used “the midstream sample of the urine”. If they are different, their relationship should be made clear, they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent recitation of the midstream sample should make it clear which recitation is being referred to.
Claim 1 recites “wherein said lip includes a tactile position marker protruding from said lip” in lines 12-13, which renders the claim indefinite. The recitation connotes that the tactile position marker is part of the lip while at the same time connoting that the tactile position marker is separate and distinct from the lip so as to protrude from the lip. This is a contradiction since the tactile position marker cannot protrude from the lip if the tactile position marker is part of the lip. This contradiction renders claim 1 indefinite.
Claims 3-4, 6-7, 10-12, and 15 are rejected by virtue of their dependence from claim 1.
Claim 11 recites “said first stream of urine sample” in line 2, but it is not clear if this recitation is the same as, related to, or different from “a first stream of urine from the midstream sample of the urine” of claim 1, lines 6-7. If they are the same, “said first stream of urine sample” in claim 11 should be “said first stream of the urine”. If they are different, it is not clear where the first stream of urine sample of claim 11 comes from. Also, if they are different, there is insufficient antecedent basis for “said first stream of urine sample” in the claim.
Claim 15 recites “a position marker” in line 9, but it is not clear if this recitation is the same as, related to, or different from “a tactile position marker” of claim 1, line 13. If they are the same, “a position marker” in claim 15 should be “the tactile [[a]] position marker”. However, if they are the same, the claim is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph (see below rejection). If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claim 16 recites “urine of said urine stream” in line 17, but it is not clear if this recitation is the same as, related to, or different from “urine” of claim 16, line 1. If they are the same, “urine of said urine stream” in line 17 should be “the urine ”. If they are different, their relationship should be made clear. Also, if they are different, there is insufficient antecedent basis for “said urine stream” in claim 16.
Claim 16 recites “wherein said lip includes a tactile position marker protruding from said lip” in lines 9-10, which renders the claim indefinite. The recitation connotes that the tactile position marker is part of the lip while at the same time connoting that the tactile position marker is separate and distinct from the lip so as to protrude from the lip. This is a contradiction since the tactile position marker cannot protrude from the lip if the tactile position marker is part of the lip. This contradiction renders claim 16 indefinite.
Claims 17-18, 20, and 23-24 are rejected by virtue of their dependence from claim 16.
Claim 21 recites “a midstream sample of urine” in lines 4-5, “the midstream sample of urine” in line 9, and “said midstream sample of urine” in lines 15-16, but it is not clear if these recitations are the same as, related to, or different from “a midstream urine sample” of claim 21, line 1. If they are the same, consistent terminology should be used. For example, “a midstream urine sample” of claim 21, line 1 should be “a midstream sample of urine” and the recitations in lines 4-5, line 9, and lines 15-16 should be “the midstream sample of the urine”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
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 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth 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.
According to one interpretation, “a position marker” in claim 15, line 9 is the same as, related to, or different from “a tactile position marker” of claim 1, line 13. According to this interpretation, the recitation “further comprising at least one of: a. an opening tab; b. a dipstick port; c. a connector to a lab apparatus, d. a stabilizer axis; e. a vacuum mechanism; f. a sanitary sticker; and g. a position marker” of claim 15 does not further limit the scope of claim 1 since it is interpreted to mean “further comprising at least one of [the tactile] position marker”, which claim 1 already requires. As a result, claim 15 has a scope that does not further limit the scope of claim 1, which is improper.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3, 10-11, 15-16, 18, 20, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2014/0213934 (Ellis)(previously cited), in view of U.S. Patent No. 3,172,130 (Lange)(previously cited), and further in view of WO 2021/211568 (Martin).
Ellis teaches a specimen collection container 10 including a first chamber 12 having an open top portion 18, a sidewall 20, and a bottom portion 22 (FIGS. 3A-3B of Ellis; paragraph 0041 of Ellis). The sidewall 20 is sloped toward the bottom portion 22 giving the first chamber 12 a funnel shape (paragraph 0041 of Ellis). The first chamber 12 is covered by a removable lid 24 which can be placed over the open top 18 of the first chamber 12 after the fluid sample is introduced to the chamber 12 (paragraph 0042 of Ellis).
Lange teaches funneled walls in a triangular form so as to make it possible to position the collector relative to the female genital organs so that the urine may be received in the collector without splashing (col. 2, lines 40-70 of Lange). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the first chamber 12 and the lid of Ellis triangular, as suggested by Lange, so that the urine may be received in the collector without splashing when used by female users.
Lange also teaches a lid 32 that is positionable as a handle in the open configuration during the receipt of urine such that the holder’s hand is positioned to avoid contact with the urine (FIG. 1 of Lange; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the lid of Ellis as being positionable as a handle in the open configuration so that the holder’s hand is positioned so as to avoid contact with the urine during collection.
Martin teaches a female urinary capture device 500 that includes a positioning feature 524 or protrusion that protrudes from the lip 522 to assist the user in centering and securing the device. The positioning feature 524 may include a raised portion on the lip 522 of the fluid collection device 500 surrounding the opening 506 of the fluid impermeable pouch 502. The raised and/or curved positioning feature 524 may be used for locating the cup properly to the anatomy of the user (paragraph 0064 and FIGS. 5A-5B of Martin).1 It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a positioning feature 524 or protrusion that protrudes from the lip, as suggested by Martin, so as to locate the cup properly to the anatomy of the user.
With respect to claim 1, the combination teaches or suggests a device enabling a female user to collect a midstream sample of urine, the device comprising:
a urine collection container body comprising:
a sample compartment (the first triangular chamber 12 of Ellis) for collecting a midstream sample of urine from the female user; and
a first stream separator (the channel 32 of Ellis) for separating a first stream of urine from the midstream sample of the urine, and directing the first stream of the urine to a first stream compartment (the second chamber 14 of Ellis), wherein said first stream compartment includes a cut off valve (the valve 16 of Ellis; paragraphs 0041-0050 of Ellis) configured for closing said first stream compartment after receiving a predetermined quantity of said first stream of urine; and
a lip (the top portion 18 of the first triangular chamber 12 of Ellis) configured to contact a body of the female user, wherein said lip includes a tactile position marker (the positioning feature 524 or protrusion of Martin) protruding from said lip; and
a lid (the attached triangular lid suggested by Lange) attached to the urine collection container body,
wherein the lid is movable between an open configuration and a closed configuration (col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange),
wherein when in the closed configuration the lid closes the sample compartment after the midstream sample has been received (paragraph 0042 of Ellis; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange), and when the lid is in the open configuration said lid projects from an anterior edge of the sample compartment and is configured for use as an ergonomic handle (the attached triangular lid suggested by Lange is positionable as a handle in the open configuration so projects).
With respect to claim 3, the combination teaches or suggests that, when in the open configuration, the lid is configured for use as the ergonomic handle for holding the urine collection container body in a position to receive the first stream of urine and the midstream sample of urine from the female user (the attached triangular lid suggested by Lange is positionable as a handle in the open configuration so projects; paragraph 0042 of Ellis; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange).
With respect to claim 10, the combination teaches or suggests that the urine collection container body has a wide proximal end configured to face anteriorly during use by the female user and a distal end configured to fit between legs of the female user and face posteriorly (the triangular shape of the first chamber 12 of modified Ellis is so configured) and wherein the tactile position marker is disposed at a distal portion of the urine collection container body (the positioning feature 524 or protrusion of Martin is placed at an end of the chamber 504 in FIGS. 5A-5B of Martin. The shape of the feature 524 conveys that it is placed in a distal portion of the collection device since it reflects the anatomy distal to the urethra more so than proximate to the urethra. However, to the extent it might be argued that Martin does not explicitly state if the feature 524 or protrusion is at the distal or proximal portion of the collection device, it is clearly one of those two choices given the shape of the collection device and its described use. Thus, at the relevant time, there had been a recognized problem of choosing where to place the feature 524 or the protrusion in the art. Also, there is a finite number of identified, predictable potential solutions (either distally or proximally) to this recognized problem. Further, one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success. Thus, the placement of the feature 524 or protrusion at the distal portion of the collection device would have been obvious.).
With respect to claim 11, the combination teaches or suggests that the first stream compartment is configured for storing said first stream of urine sample (the second chamber 14 of Ellis is so configured).
With respect to claim 15, the combination teaches or suggests at least one of: a. an opening tab; b. a dipstick port; c. a connector to a lab apparatus, d. a stabilizer axis; e. a vacuum mechanism; f. a sanitary sticker; and g. a position marker (the positioning feature 524 or protrusion of Martin).
With respect to claim 16, the combination teaches or suggests a method collecting a midstream sample of urine from a female user, the method comprising:
providing a device including a urine collection container body with a lid (the attached triangular lid suggested by Lange), wherein the urine collection container body comprises a midstream sample compartment (the first triangular chamber 12 of modified Ellis) and a first stream separator (the channel 32 of Ellis), and wherein when the lid is in an open configuration said lid projects from an anterior edge of the sample compartment and is configured for use as an ergonomic handle (paragraph 0042 of Ellis; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange; the attached triangular lid suggested by Lange so projects) and wherein said urine collection container body includes a lip (the top portion 18 of the first triangular chamber 12 of modified Ellis) configured for contacting a body of the user and wherein said lip includes a tactile position marker (the positioning feature 524 or protrusion of Martin) protruding from said lip;
directing a stream of urine from said female user into said device (directing the stream; paragraphs 0041-0050 of Ellis; FIG. 3A of Ellis);
separating a first part of said stream of urine from the midstream sample of the urine, and directing the first part of said stream of urine into a first stream compartment (separating the stream; paragraphs 0041-0050 of Ellis; FIG. 3A of Ellis);
closing a cut off valve when a predefined volume of the first part of said stream of urine has been directed into said first stream compartment (using the valve 16 of Ellis; paragraphs 0041-0050 of Ellis); and
collecting said midstream sample of urine of said urine stream into said midstream sample compartment (collecting the midstream volume; paragraphs 0041-0050 of Ellis; FIG. 3B of Ellis).
With respect to claim 18, Ellis teaches the use of a channel 74 in the lid defined through the nozzle 72 allowing access to the first chamber 12 (paragraph 0057 of Ellis). An elastomeric seal 76 covers the channel 74 preventing fluid from leaking from the port 70 until a user is prepared to collect the fluid in a specimen collection tube 410, as shown in FIG. 9 (paragraph 0057 of Ellis). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the channel 74, the nozzle 72, the seal 76, and the port 70 in the attached triangular lid of the combination so that the user can pour the fluid in a tube in a secure and leak-proof manner for analysis handling. Thus, the combination teaches or suggests transferring said midstream sample of urine directly from said midstream sample compartment to a sample tube (paragraph 0057 and FIG. 9 of Ellis).
With respect to claim 20, the combination teaches or suggests: a. opening the lid of the device to the open configuration (opening the lid; paragraph 0042 of Ellis; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange); b. holding said device with said lid in said open configuration during said directing (using the lid as a handle; paragraph 0042 of Ellis; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange); and c. closing said lid after said directing to seal said device (closing the lid; paragraph 0042 of Ellis; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange).
With respect to claim 23, the combination teaches or suggests that said contacting is placing the tactile position marker on a lower buttock’s cheek of the female user for properly positioning the device for receiving the midstream sample of urine (the positioning feature 524 or protrusion of Martin is placed at an end of the chamber 504 in FIGS. 5A-5B of Martin. The shape of the feature 524 conveys that it is placed in a distal portion of the collection device since it reflects the anatomy distal to the urethra (i.e., the lower buttock’s cheek) more so than proximate to the urethra. However, to the extent it might be argued that Martin does not explicitly state if the feature 524 or protrusion is at the distal or proximal portion of the collection device, it is clearly one of those two choices given the shape of the collection device and its described use. Thus, at the relevant time, there had been a recognized problem of choosing where to place the feature 524 or the protrusion in the art. Also, there is a finite number of identified, predictable potential solutions (either distally or proximally) to this recognized problem. Further, one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success. Thus, the placement of the feature 524 or protrusion at the distal portion of the collection device would have been obvious which would result in said contacting placing the tactile position marker on a lower buttock’s cheek of the female user for properly positioning the device for receiving the midstream sample of urine.).
Claims 1, 3-4, 10-11, 15-16, 18, 20, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Ellis, in view of U.S. Patent Application Publication No. 2006/0111647 (Starling)(previously cited), and further in view of Lange, and further in view of Martin.
Ellis teaches a specimen collection container 10 including a first chamber 12 having an open top portion 18, a sidewall 20, and a bottom portion 22 (FIGS. 3A-3B of Ellis; paragraph 0041 of Ellis). The sidewall 20 is sloped toward the bottom portion 22 giving the first chamber 12 a funnel shape (paragraph 0041 of Ellis). The first chamber 12 may be covered by a removable lid 24 which can be placed over the open top 18 of the first chamber 12 after the fluid sample is introduced to the chamber 12 (paragraph 0042 of Ellis).
Starling teaches a generally triangular shape with rounded corners so as to better fit the female anatomy (abstract, paragraphs 0008 and 0017 of Starling). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the overall shape of the collection portion including the first chamber 12 and the second chamber 14 and the lid of Ellis have a generally triangular shape with rounded corners, as suggested by Starling, so as to better fit the female anatomy .
Lange also teaches a lid 32 that is positionable as a handle in the open configuration during the receipt of urine such that the holder’s hand is positioned to avoid contact with the urine (FIG. 1 of Lange; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the lid of Ellis as being positionable as a handle in the open configuration so that the holder’s hand is positioned so as to avoid contact with the urine during collection.
Martin teaches a female urinary capture device 500 that includes a positioning feature 524 or protrusion that protrudes from the lip 522 to assist the user in centering and securing the device. The positioning feature 524 may include a raised portion on the lip 522 of the fluid collection device 500 surrounding the opening 506 of the fluid impermeable pouch 502. The raised and/or curved positioning feature 524 may be used for locating the cup properly to the anatomy of the user (paragraph 0064 and FIGS. 5A-5B of Martin).2 It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a positioning feature 524 or protrusion that protrudes from the lip, as suggested by Martin, so as to locate the cup properly to the anatomy of the user.
With respect to claim 1, the combination teaches or suggests a device enabling a female user to collect a midstream sample of urine, the device comprising:
a urine collection container body comprising:
a sample compartment (the first chamber 12 of Ellis with the shape suggested by Starling) for collecting a midstream sample of urine from the female user; and
a first stream separator (the channel 32 of Ellis) for separating a first stream of urine from the midstream sample of the urine, and directing the first stream of the urine to a first stream compartment (the second chamber 14 of Ellis), wherein said first stream compartment includes a cut off valve (the valve 16 of Ellis; paragraphs 0041-0050 of Ellis) configured for closing said first stream compartment after receiving a predetermined quantity of said first stream of urine;
a lip (the top portion 18 of the first triangular chamber 12 of Ellis) configured to contact a body of the female user, wherein said lip includes a tactile position marker (the positioning feature 524 or protrusion of Martin) protruding from said lip; and
a lid (the attached generally triangular lid of the combination) attached to the urine collection container body,
wherein the lid is movable between an open configuration and a closed configuration (col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange),
wherein when in the closed configuration the lid closes the sample compartment after the midstream sample has been received (paragraph 0042 of Ellis; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange), and when the lid is in the open configuration said lid projects from an anterior edge of the sample compartment and is configured for use as an ergonomic handle (the attached generally triangular lid of the combination so projects).
With respect to claim 3, the combination teaches or suggests that, when in the open configuration, the lid is configured for use as the ergonomic handle for holding the urine collection container body in a position to receive the first stream of urine and the midstream sample of urine from the female user (the attached generally triangular lid of the combination is so configured; paragraph 0042 of Ellis; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange).
With respect to claim 4, the combination teaches or suggests that the sample compartment and the first stream separator are included in the urine collection container body having a saddle shape (the collection portion including the first chamber 12 and the channel 32 of Ellis is generally triangular with rounded corners).
With respect to claim 10, the combination teaches or suggests that the urine collection container body has a wide proximal end configured to face anteriorly during use by the female user and a distal end configured to fit between legs of the female user and face posteriorly (the generally triangular shape of the collection portion including the first chamber 12 is so configured) and wherein the tactile position marker is disposed at a distal portion of the urine collection container body (the positioning feature 524 or protrusion of Martin is placed at an end of the chamber 504 in FIGS. 5A-5B of Martin. The shape of the feature 524 conveys that it is placed in a distal portion of the collection device since it reflects the anatomy distal to the urethra more so than proximate to the urethra. However, to the extent it might be argued that Martin does not explicitly state if the feature 524 or protrusion is at the distal or proximal portion of the collection device, it is clearly one of those two choices given the shape of the collection device and its described use. Thus, at the relevant time, there had been a recognized problem of choosing where to place the feature 524 or the protrusion in the art. Also, there is a finite number of identified, predictable potential solutions (either distally or proximally) to this recognized problem. Further, one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success. Thus, the placement of the feature 524 or protrusion at the distal portion of the collection device would have been obvious.).
With respect to claim 11, the combination teaches or suggests that the first stream compartment is configured for storing said first stream of urine sample (the second chamber 14 of Ellis is so configured).
With respect to claim 15, the combination teaches or suggests at least one of: a. an opening tab; b. a dipstick port; c. a connector to a lab apparatus, d. a stabilizer axis; e. a vacuum mechanism; f. a sanitary sticker; and g. a position marker (the positioning feature 524 or protrusion of Martin).
Alternatively, with respect to claim 15, Ellis teaches the use of an outflow port 50 for removing the sample (e.g., the midstream urine) from the sample container 10 (paragraphs 0055-0056 of Ellis). The outflow port 50 comprises a needle 52 having a needle cannula 59 for accessing the sample contained in the first chamber 12. The needle 52 may be located in a cut-away portion 56 of the sidewall 20 such that a proximal end 83 of the needle 52 is recessed from the surfaces of the container 10. The needle 52 is in contact with an access tube 58 that extends into the first chamber 12 of the container 10. Fluid passes through the access tube 58 before entering the needle cannula 54 for removal from the container 10 (paragraphs 0055-0056 of Ellis). To extract a sample from the container 10, a user places a sample collection tube 510 (e.g., a test tube) over the needle 52. Generally, the tube 510 includes an open end 512 covered by a stopper 514 having a pierceable septum 516. The needle 52 pierces the septum 516 accessing an interior portion 518 of the tube 510 and creating a fluid connection between the first chamber 12 and the tube 510 through the needle cannula 54. The sample collection tube 510 is evacuated such that, upon engagement with the container 10, fluid is drawn from the container interior into the sample collection tube 510 by vacuum draw (paragraphs 0055-0056 of Ellis). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use this outflow arrangement including the outflow port 50 in the sidewall 20 and the sample collection tube 510 so that the user can transfer the fluid into a test tube in a secure and leak-proof manner for analysis handling. Thus, the combination teaches or suggests at least one of: a. an opening tab; b. a dipstick port; c. a connector to a lab apparatus, d. a stabilizer axis; e. a vacuum mechanism (the port 50 and the evacuated tube of Ellis; paragraphs 0055-0056 of Ellis); f. a sanitary sticker; and g. a position marker.
With respect to claim 16, the combination teaches or suggests a method collecting a midstream sample of urine from a female user, the method comprising:
providing a device including a urine collection container body with a lid (the attached generally triangular lid of the combination), wherein the urine collection container body comprises a midstream sample compartment (the first chamber 12 of Ellis) and a first stream separator (the channel 32 of Ellis), and wherein when the lid is in an open configuration said lid projects from an anterior edge of the sample compartment and is configured for use as an ergonomic handle (paragraph 0042 of Ellis; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange; the attached generally triangular lid of the combination so projects) and wherein said urine collection container body includes a lip (the top portion 18 of the first triangular chamber 12 of Ellis) configured for contacting a body of the user and wherein said lip includes a tactile position marker (the positioning feature 524 or protrusion of Martin) protruding from said lip;
directing a stream of urine from said female user into said device (directing the stream; paragraphs 0041-0050 of Ellis; FIG. 3A of Ellis);
separating a first part of said stream of urine from the midstream sample of the urine, and directing the first part of said stream of urine into a first stream compartment (separating the stream; paragraphs 0041-0050 of Ellis; FIG. 3A of Ellis);
closing a cut off valve when a predefined volume of the first part of said stream of urine has been directed into said first stream compartment (using the valve 16 of Ellis; paragraphs 0041-0050 of Ellis); and
collecting said midstream sample of urine of said urine stream into said midstream sample compartment (collecting the midstream volume; paragraphs 0041-0050 of Ellis; FIG. 3B of Ellis).
With respect to claim 18, Ellis teaches the use of a channel 74 in the lid defined through the nozzle 72 allowing access to the first chamber 12 (paragraph 0057 of Ellis). An elastomeric seal 76 covers the channel 74 preventing fluid from leaking from the port 70 until a user is prepared to collect the fluid in a specimen collection tube 410, as shown in FIG. 9 (paragraph 0057 of Ellis). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the channel 74, the nozzle 72, the seal 76, and the port 70 in the attached generally triangular lid of the combination so that the user can pour the fluid in a tube in a secure and leak-proof manner for analysis handling. Thus, the combination teaches or suggests transferring said midstream sample of urine directly from said midstream sample compartment to a sample tube (paragraph 0057 and FIG. 9 of Ellis).
Alternatively, with respect to claim 18, Ellis teaches the use of an outflow port 50 for removing the sample (e.g., the midstream urine) from the sample container 10 (paragraphs 0055-0056 of Ellis). The outflow port 50 comprises a needle 52 having a needle cannula 59 for accessing the sample contained in the first chamber 12. The needle 52 may be located in a cut-away portion 56 of the sidewall 20 such that a proximal end 83 of the needle 52 is recessed from the surfaces of the container 10. The needle 52 is in contact with an access tube 58 that extends into the first chamber 12 of the container 10. Fluid passes through the access tube 58 before entering the needle cannula 54 for removal from the container 10 (paragraphs 0055-0056 of Ellis). To extract a sample from the container 10, a user places a sample collection tube 510 (e.g., a test tube) over the needle 52. Generally, the tube 510 includes an open end 512 covered by a stopper 514 having a pierceable septum 516. The needle 52 pierces the septum 516 accessing an interior portion 518 of the tube 510 and creating a fluid connection between the first chamber 12 and the tube 510 through the needle cannula 54. The sample collection tube 510 is evacuated such that upon engagement with the container 10, fluid is drawn from the container interior into the sample collection tube 510 by vacuum draw (paragraphs 0055-0056 of Ellis). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use this outflow arrangement including the outflow port 50 in the sidewall 20 and the sample collection tube 510 so that the user can transfer the fluid into a test tube in a secure and leak-proof manner for analysis handling. Thus, the combination teaches or suggests transferring said midstream sample of urine directly from said midstream sample compartment to a sample tube (paragraphs 0055-0056 of Ellis).
With respect to claim 20, the combination teaches or suggests: a. opening the lid of the device to the open configuration (opening the lid; paragraph 0042 of Ellis; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange); b. holding said device with said lid in said open configuration during said directing (using the lid as a handle; paragraph 0042 of Ellis; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange); and c. closing said lid after said directing to seal said device (closing the lid; paragraph 0042 of Ellis; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange).
With respect to claim 23, the combination teaches or suggests that said contacting is placing the tactile position marker on a lower buttock’s cheek of the female user for properly positioning the device for receiving the midstream sample of urine (the positioning feature 524 or protrusion of Martin is placed at an end of the chamber 504 in FIGS. 5A-5B of Martin. The shape of the feature 524 conveys that it is placed in a distal portion of the collection device since it reflects the anatomy distal to the urethra (i.e., the lower buttock’s cheek) more so than proximate to the urethra. However, to the extent it might be argued that Martin does not explicitly state if the feature 524 or protrusion is at the distal or proximal portion of the collection device, it is clearly one of those two choices given the shape of the collection device and its described use. Thus, at the relevant time, there had been a recognized problem of choosing where to place the feature 524 or the protrusion in the art. Also, there is a finite number of identified, predictable potential solutions (either distally or proximally) to this recognized problem. Further, one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success. Thus, the placement of the feature 524 or protrusion at the distal portion of the collection device would have been obvious which would result in said contacting placing the tactile position marker on a lower buttock’s cheek of the female user for properly positioning the device for receiving the midstream sample of urine.).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Ellis, in view of Lange, and further in view of Martin, and further in view of U.S. Patent Application Publication No. 2002/0193760 (Thompson)(previously cited).
The combination teaches a first chamber 12 in triangular form having an open top portion 18, a sidewall 20, and a bottom portion 22 (FIGS. 3A-3B of Ellis; paragraph 0041 of Ellis) for female users. Thompson teaches a receiving receptacle 12 that is designed for female urine collection (paragraph 0020 of Thompson) and having horizontally accordion pleats 18 to be used in an open position when urine is collected and in a collapsed position when stored or shipped (paragraph 0020 of Thompson). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the triangular first chamber 12 of Ellis have horizontally accordion pleats since it permits compactness of the device before usage.
With respect to claim 6, the combination teaches or suggests that the sample compartment is expandable (the triangular first chamber 12 of modified Ellis having horizontally accordion pleats).
With respect to claim 7, the combination teaches or suggests that the sample compartment includes an accordion-like expandable wall (the pleated wall of the triangular first chamber 12 of modified Ellis having horizontally accordion pleats).
Claims 1, 3-4, 10-12, 15-16, 20, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. CN 111419288 (Yu), in view of Lange, and further in view of Martin. Citations to Yu will refer to the machine English translation that accompanies this Office Action.
Yu teaches a urine collection container 10 including a top chamber 2 having an open top portion, a bottom chamber 1, a connecting channel 6, and a floating ball 5 (FIGS. 1-3 of Yu; page 4 of Yu). The top chamber 2 has a generally triangular form (FIGS. 1-3 of Yu). Yu also teaches a holding part 3 (page 4 of Yu).
Lange teaches a lid 32 for a urine receiver and container that is positionable as a handle in the open configuration during the receipt of urine such that the holder’s hand is positioned to avoid contact with the urine (FIG. 1 of Lange; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form a lid that is also positionable as a handle in the open configuration and positionable to seal the container in the closed configuration and form the rim to accept such a lid since it allows the device of Yu to store the urine sample itself without extra containers while still allowing the user to hold the device during use.
Martin teaches a female urinary capture device 500 that includes a positioning feature 524 or protrusion that protrudes from the lip 522 to assist the user in centering and securing the device. The positioning feature 524 may include a raised portion on the lip 522 of the fluid collection device 500 surrounding the opening 506 of the fluid impermeable pouch 502. The raised and/or curved positioning feature 524 may be used for locating the cup properly to the anatomy of the user (paragraph 0064 and FIGS. 5A-5B of Martin).3 It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a positioning feature 524 or protrusion that protrudes from the lip, as suggested by Martin, so as to locate the cup properly to the anatomy of the user.
With respect to claim 1, the combination teaches or suggests a device enabling a female user to collect a midstream sample of urine, the device comprising:
a urine collection container body comprising:
a sample compartment (the top chamber 2 of Yu) for collecting a midstream sample of urine from the female user; and
a first stream separator (the connecting channel 6 of Yu) for separating a first stream of urine from the midstream sample of the urine, and directing the first stream of the urine to a first stream compartment (the bottom chamber 1 of Yu), wherein said first stream compartment includes a cut off valve (the floating ball 5 of Yu) configured for closing said first stream compartment after receiving a predetermined quantity of said first stream of urine; and
a lip (the rim of the top chamber 2 of Yu) configured to contact a body of the female user, wherein said lip includes a tactile position marker (the positioning feature 524 or protrusion of Martin) protruding from said lip; and
a lid (the attached lid suggested by Lange) attached to the urine collection container body,
wherein the lid is movable between an open configuration and a closed configuration (col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange),
wherein when in the closed configuration the lid closes the sample compartment after the midstream sample has been received (col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange), and when the lid is in the open configuration said lid projects from an anterior edge of the sample compartment and is configured for use as an ergonomic handle (the attached lid suggested by Lange as being positionable as a handle in the open configuration so projects).
With respect to claim 3, the combination teaches or suggests that, when in the open configuration, the lid is configured for use as the ergonomic handle for holding the urine collection container body in a position to receive the first stream of urine and the midstream sample of urine from the female user (the attached lid suggested by Lange is so configured; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange).
With respect to claim 4, the combination teaches or suggests that the sample compartment and the first stream separator are included in the urine collection container body having a saddle shape (the collection portion has a saddle shape in FIGS. 1-3 of Yu).
With respect to claim 10, the combination teaches or suggests that the urine collection container body has a wide proximal end configured to face anteriorly during use by the female user and a distal end configured to fit between legs of the female user and face posteriorly (the shape of the top chamber 2 of Yu is so configured) and wherein the tactile position marker is disposed at a distal portion of the urine collection container body (the positioning feature 524 or protrusion of Martin is placed at an end of the chamber 504 in FIGS. 5A-5B of Martin. The shape of the feature 524 conveys that it is placed in a distal portion of the collection device since it reflects the anatomy distal to the urethra more so than proximate to the urethra. However, to the extent it might be argued that Martin does not explicitly state if the feature 524 or protrusion is at the distal or proximal portion of the collection device, it is clearly one of those two choices given the shape of the collection device and its described use. Thus, at the relevant time, there had been a recognized problem of choosing where to place the feature 524 or the protrusion in the art. Also, there is a finite number of identified, predictable potential solutions (either distally or proximally) to this recognized problem. Further, one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success. Thus, the placement of the feature 524 or protrusion at the distal portion of the collection device would have been obvious.).
With respect to claim 11, the combination teaches or suggests that the first stream compartment is configured for storing said first stream of urine sample (the bottom chamber 1 of Yu is so configured).
With respect to claim 12, the combination teaches or suggests that said cut off valve is ball shaped (the floating ball 5 of Yu is so shaped).
With respect to claim 15, the combination teaches or suggests at least one of: a. an opening tab; b. a dipstick port; c. a connector to a lab apparatus, d. a stabilizer axis; e. a vacuum mechanism; f. a sanitary sticker; and g. a position marker (the positioning feature 524 or protrusion of Martin).
With respect to claim 16, the combination teaches or suggests a method collecting a midstream sample of urine from a female user, the method comprising:
providing a device including a urine collection container body with a lid (the attached lid suggested by Lange), wherein the urine collection container body comprises a midstream sample compartment (the top chamber 2 of Yu) and a first stream separator (the connecting channel 6 of Yu), and wherein when the lid is in an open configuration said lid projects from an anterior edge of the sample compartment and is configured for use as an ergonomic handle (col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange; the attached lid suggested by Lange so projects) and wherein said urine collection container body includes a lip (the rim of the top chamber 2 of Yu) configured for contacting a body of the user and wherein said lip includes a tactile position marker (the positioning feature 524 or protrusion of Martin) protruding from said lip;
directing a stream of urine from said female user into said device (directing the stream; page 4 of Yu);
separating a first part of said stream of urine from the midstream sample of the urine, and directing the first part of said stream of urine into a first stream compartment (separating the stream; page 4 of Yu);
closing a cut off valve when a predefined volume of the first part of said stream of urine has been directed into said first stream compartment (using the floating ball 5 of Yu; page 4 of Yu); and
collecting said midstream sample of urine of said urine stream into said midstream sample compartment (collecting the midstream volume; page 4 of Yu).
With respect to claim 20, the combination teaches or suggests: a. opening the lid of the device to the open configuration (opening the lid; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange); b. holding said device with said lid in said open configuration during said directing (using the lid as a handle; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange); and c. closing said lid after said directing to seal said device (closing the lid; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange).
With respect to claim 23, the combination teaches or suggests that said contacting is placing the tactile position marker on a lower buttock’s cheek of the female user for properly positioning the device for receiving the midstream sample of urine (the positioning feature 524 or protrusion of Martin is placed at an end of the chamber 504 in FIGS. 5A-5B of Martin. The shape of the feature 524 conveys that it is placed in a distal portion of the collection device since it reflects the anatomy distal to the urethra (i.e., the lower buttock’s cheek) more so than proximate to the urethra. However, to the extent it might be argued that Martin does not explicitly state if the feature 524 or protrusion is at the distal or proximal portion of the collection device, it is clearly one of those two choices given the shape of the collection device and its described use. Thus, at the relevant time, there had been a recognized problem of choosing where to place the feature 524 or the protrusion in the art. Also, there is a finite number of identified, predictable potential solutions (either distally or proximally) to this recognized problem. Further, one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success. Thus, the placement of the feature 524 or protrusion at the distal portion of the collection device would have been obvious which would result in said contacting placing the tactile position marker on a lower buttock’s cheek of the female user for properly positioning the device for receiving the midstream sample of urine.).
With respect to claim 24, the combination teaches or suggests that the cut off valve is a ball valve (the floating ball 5 of Yu is such a valve).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ellis, in view of Lange, and further in view of Martin, and further in view of U.S. Patent Application Publication No. 3,635,091 (Linzer)(previously cited).
Ellis teaches a specimen collection container 10 including a first chamber 12 having an open top portion 18, a sidewall 20, and a bottom portion 22 (FIGS. 3A-3B of Ellis; paragraph 0041 of Ellis). Linzer teaches that such containers are sterile (col. 3, lines 20-35 of Linzer). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the modified specimen collection container 10 of Ellis sterile so as to prevent contaminants from interfering with the analysis of the sample.
With respect to claim 17, the combination teaches or suggests retaining a sterility of said midstream sample of urine (paragraph 0042 of Ellis; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange; the attached triangular lid of the combination retains the sterility of the collected urine since the specimen collection container 10 is sterile before the collection).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Ellis, in view of Starling, and further in view of Lange, and further in view of Martin, and further in view of Thompson.
Ellis teaches a specimen collection container 10 including a first chamber 12 having an open top portion 18, a sidewall 20, and a bottom portion 22 (FIGS. 3A-3B of Ellis; paragraph 0041 of Ellis). The sidewall 20 is sloped toward the bottom portion 22 giving the first chamber 12 a funnel shape (paragraph 0041 of Ellis). The first chamber 12 may be covered by a removable lid 24 which can be placed over the open top 18 of the first chamber 12 after the fluid sample is introduced to the chamber 12 (paragraph 0042 of Ellis).
Starling teaches a generally triangular shape with rounded corners so as to better fit the female anatomy (abstract, paragraphs 0008 and 0017 of Starling). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the overall shape of the collection portion including the first chamber 12 and the second chamber 14 and the lid of Ellis have a generally triangular shape with rounded corners, as suggested by Starling, so as to better fit the female anatomy.
Lange also teaches a lid 32 that is positionable as a handle in the open configuration during the receipt of urine such that the holder’s hand is positioned to avoid contact with the urine (FIG. 1 of Lange; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the lid of Ellis as being positionable as a handle in the open configuration so that the holder’s hand is positioned so as to avoid contact with the urine during collection.
Martin teaches a female urinary capture device 500 that includes a positioning feature 524 or protrusion that protrudes from the lip 522 to assist the user in centering and securing the device. The positioning feature 524 may include a raised portion on the lip 522 of the fluid collection device 500 surrounding the opening 506 of the fluid impermeable pouch 502. The raised and/or curved positioning feature 524 may be used for locating the cup properly to the anatomy of the user (paragraph 0064 and FIGS. 5A-5B of Martin).4 It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a positioning feature 524 or protrusion that protrudes from the lip, as suggested by Martin, so as to locate the cup properly to the anatomy of the user.
The combination teaches or suggests a specimen collection container 10 including a generally triangular first chamber 12 having an open top portion 18, a sidewall 20, and a bottom portion 22 (FIGS. 3A-3B of Ellis; paragraph 0041 of Ellis) for female users. Thompson teaches a receiving receptacle 12 that is designed for female urine collection (paragraph 0020 of Thompson) and having horizontally accordion pleats 18 to be used in an open position when urine is collected and in a collapsed position when stored or shipped (paragraph 0020 of Thompson). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the triangular first chamber 12 of modified Ellis have horizontally accordion pleats since it permits compactness of the device before usage.
Ellis teaches the use of an outflow port 50 for removing the sample (e.g., the midstream urine) from the sample container 10 (paragraphs 0055-0056 of Ellis). The outflow port 50 comprises a needle 52 having a needle cannula 59 for accessing the sample contained in the first chamber 12. The needle 52 may be located in a cut-away portion 56 of the sidewall 20 such that a proximal end 83 of the needle 52 is recessed from the surfaces of the container 10. The needle 52 is in contact with an access tube 58 that extends into the first chamber 12 of the container 10. Fluid passes through the access tube 58 before entering the needle cannula 54 for removal from the container 10 (paragraphs 0055-0056 of Ellis). To extract a sample from the container 10, a user places a sample collection tube 510 (e.g., a test tube) over the needle 52. Generally, the tube 510 includes an open end 512 covered by a stopper 514 having a pierceable septum 516. The needle 52 pierces the septum 516 accessing an interior portion 518 of the tube 510 and creating a fluid connection between the first chamber 12 and the tube 510 through the needle cannula 54. The sample collection tube 510 is evacuated such that upon engagement with the container 10, fluid is drawn from the container interior into the sample collection tube 510 by vacuum draw (paragraphs 0055-0056 of Ellis). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use this outflow arrangement including the outflow port 50 in the sidewall 20 and the sample collection tube 510 so that the user can transfer the fluid into a test tube in a secure and leak-proof manner for analysis handling.
With respect to claim 21, the combination teaches or suggests a device for collecting a midstream urine sample from a female subject comprising:
a saddle shaped urine collection container body including an expandable sample compartment configured to expand to receive a midstream sample of urine (the first chamber 12 of Ellis being generally triangular as suggested by Starling and having horizontally accordion pleats as suggested by Thomson);
a lid (the attached generally triangular lid of the combination) attached to the urine collection container body, wherein the lid is movable between an open configuration and a closed configuration (col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange), wherein when in the closed configuration the lid closes the expandable sample compartment after the midstream sample of urine has been received (paragraph 0042 of Ellis; col. 1, lines 55-65, col. 2, lines 5-11; col. 3, lines 10-25 of Lange), and when the lid is in the open configuration said lid projects from an anterior edge of the expandable sample compartment and is configured for use as an ergonomic handle (the attached generally triangular lid of the combination so projects) and wherein said urine collection container body includes a lip (the top portion 18 of the first triangular chamber 12 of Ellis) with a tactile position marker (the positioning feature 524 or protrusion of Martin) protruding from said lip; and
a vacuum extractor port opening (the outflow port 50 of Ellis) to said expandable sample compartment and configured for draining said midstream sample of urine directly from said expandable sample midstream compartment to a vacuum sampler (the sample collection tube 510 of Ellis).
Response to Arguments
The Applicant’s arguments filed 1/21/2026 have been fully considered.
Claim objections
In view of the claim amendments filed on 1/21/2026, the previous claim objections have been withdrawn. There are new grounds of claim objections.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 1/21/2026, the previous claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph have been withdrawn. There are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph
There are new grounds of claim rejections under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph.
35 U.S.C. 101
In view of the claim amendments filed on 1/21/2026, the previous claim rejections under 35 U.S.C. 101 have been withdrawn.
Prior art rejection
The Applicant’s arguments with respect to the rejections of claims 1, 3-4, 6-7, 10-12, 15-18, 20-21, and 23-24 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. That is, there are new grounds of rejections.
The Applicant asserts:
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This argument is not persuasive. First, the claim does not require that a reliable seal is formed regardless of the angle at which the device is held. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Second, the cutoff valve 16 is tilt-insensitive since the absorbent material 34 expands when wetted regardless of the angle at which the device is held.
In response to the Applicant’s argument that the claimed invention results in a lack of bacterial contamination due to a lack of contact of the lip of the container with the skin, the claim does not require such a result. Indeed, the claim language of claims 1 and 16 run counter to the Applicant’s argument since claim 1 recites “a lip configured to contact a body of the female user” and claim 16 recites “a lip configured for contacting a body of the user”. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to the Applicant’s arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 This subject matter is also supported in paragraphs 0014 and FIG. 4 of the U.S. provisional application 63/011445 (filed 4/17/2020) from which Martin claims priority.
2 This subject matter is also supported in paragraphs 0014 and FIG. 4 of the U.S. provisional application 63/011445 (filed 4/17/2020) from which Martin claims priority.
3 This subject matter is also supported in paragraphs 0014 and FIG. 4 of the U.S. provisional application 63/011445 (filed 4/17/2020) from which Martin claims priority.
4 This subject matter is also supported in paragraphs 0014and FIG. 4 of the U.S. provisional application 63/011445 (filed 4/17/2020) from which Martin claims priority.