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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/30/2024 and 6/7/2024 was received and placed in the record on file. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
In the instant application, currently no limitations are being interpreted as invoking 35 USC 112(f).
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Paragraph [0024] recites “In some aspects, the drainage tube may be configured for coupling to the open proximal end of the stem, and the collapsible collection bag may be configured for receiving fluid from the fluid collection funnel by way of the drainage tube.” However, in light of the coordinate directions set up throughout the specification, this does not appear to be the correct recitation of where the drainage tube is configured to be coupled to the stem. Specifically, in the claims, figures and specification, the proximal direction is described in relation to the open end of the funnel which is defined by the rim which receives blood from the body, and the distal direction is defined as the direction the blood flows through the collection device out of the body toward the collection bag. Further, paragraph [0070] discloses “The distal open end 25 of the stem 22 accepts a conical connector at the proximal end 18 of the drainage tubing 14.”
As such, it appears that paragraph [0024] errors in reciting “the drainage tube may be configured for coupling to the open proximal end of the stem”, and instead should recite “the drainage tube may be configured for coupling to the open distal end of the stem.” Or similar.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 16 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Specifically, claim 16, recites the limitation “the drainage tube is configured for coupling to the open proximal end of the stem” which is not adequately supported in the specification to show that the applicant had possession at the time of filing. As noted in the specification objection above, the specification and drawings establish the proximal direction to be the direction towards the open end of the large funnel which is inserted into the patient and the distal direction is the direction the collected blood flows out of the body toward the collection bag. This is supported throughout the description of the fluid collection device in the specification and drawings. However, claim 16 recites that the drainage tube is configured for coupling to the open proximal end of the stem; which is not shown or supported in the spirit of the specification. Paragraph [0070] and drawings which depict the drainage tube (figures 1 and 23-27) only ever show the drainage tube (element 14, 514, 614) being configured for coupling to the distal end of the stem (stem elements 22, 522, 622). As such, there does not appear to be adequate written description to show possession of a drainage tube configured for coupling to the proximal end of the stem.
The examiner encourages the applicant to amend claim 16 to appropriately recite the supported language of the spec that the “the drainage tube is configured for coupling to the open distal end of the stem” to overcome the 35 USC 112(a) rejection.
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 16 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 16; it recites the limitation “the drainage tube is configured for coupling to the open proximal end of the stem”. However, as noted in the specification objection and 35 USC 112(a) above, this appears to be in error as the remainder of the specification and drawings makes it clear that the drainage tube is configured for coupling to the open distal end of the stem. This causes an indefinite issue as it is unclear in light of the specification if the stem is configured for connecting to the proximal end or the distal end of the stem.
For the purpose of advancing prosecution and examining on the basis of prior art, the examiner will interpret the indefinite limitation of claim 16 as reciting “the drainage tube is configured for coupling to the open distal end of the stem”.
Regarding claim 20; the claim recites “further comprising a drainage tube and a self-expandable fluid collection bag…”; however, claim 15, to which claim 20 is dependent upon, also recites “a drainage tube” and “a collapsible collection bag…” As such, the claim is indefinite because it is unclear if claim 20 is further requiring an additional drainage tube and an addition collection bag; or if the claim is merely attempting to further define the collection bag to be “a self-expandable fluid collection bag configured to be free-standing and self-supporting upon expansion.”
A review of the specification appears to show that there appears that the invention only contemplates a single drainage tube and collection bag (figures 1 and 23-27).
Accordingly, for the purpose of advancing prosecution and examining the claims on the basis of prior art, the examiner will interpret claim 20 as reciting: “The system of claim 15, wherein the collapsible collection bag is self-expandable and configured to be free-standing and self-supporting upon expansion.”
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/539672 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 2 of 18/539672 teaches all limitations of claims 1 and 2 of the instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claims 1 and 2; claim 2 of 18/539672 recites a fluid collection device of a postpartum hemorrhage monitoring system (lines 1-2), the device comprising:
a funnel body (line 3) comprising:
an open proximal end (line 3),
an interior configured for receiving a fluid (lines 2-3),
a rim extending exteriorly from the open proximal end (lines 8-9),
an anterior outer surface configured for placement adjacent an anterior vaginal wall of a patient (lines 5-6),
a posterior outer surface configured for placement adjacent a posterior vaginal wall of the patient (lines 6-7), and
an open distal end (line 3); and
a stem having an open proximal stem end, an open distal stem end, and a lumen extending therebetween, the stem extending from the open distal end of the funnel body and configured for receiving fluid from the interior of the funnel body (lines 10-13);
wherein the anterior surface tapers to the proximal stem end and the posterior outer surface is flush with the stem such that the stem is rearward of a geometric center of the funnel body to facilitate movement of fluid into and through the stem and minimize accumulation of fluid within the funnel body when the patient is in a supine position (claim 2 and wherein the structure of the surface is the same would thus provide the same effect).
Claims 3-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-6 of copending Application No. 18/539672 in view of Slove et al (WO 2023/199003 A1, wherein the examiner will rely on Slove’s US National Stage entry, US 2024/0415394 A1, for the English translation and citation in the rejection below).
This is a provisional nonstatutory double patenting rejection.
Regarding claims 3-14 of the instant application; Claims 3-6 of 18/539672 teach all of the limitations of the claims except that the anterior surface tapers to the proximal end of the stem and the posterior surface is flush with the stem such that the stem is disposed rearward a geometric center of the cup.
Slove teaches a similar fluid collection device wherein the funnel body anterior surface (element 21) tapers to the proximal stem end and the posterior outer surface (element 22) is flush with the stem such that the stem is rearward of a geometric center of the funnel body (paragraph [0103]; figures 2) to facilitate movement of fluid into and through the stem and minimize accumulation of fluid within the funnel body when the patient is in a supine position (paragraph [0033]-[0035]; figures 1 and 2).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify claims 3-6 of 18/539672 such that the funnel has the geometric shape as taught by Slove in order to minimize accumulation of fluid within the funnel body when the patient is in a supine position.
Further regarding claims 3-7 and 10-17; Claims 3-6 of 18/539672 teach the corresponding pressure point limitations recited therein.
Further regarding claims 8, 9 and 15-17; Slove further teaches the device includes a drainage tube, a collapsible collection bag, and a second funnel body extending from the open distal stem end wherein the second funnel body is smaller than the funnel body for providing ease of connection to a drainage tube to a collection bag (see rejection with Slove below). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the 18/539672/Slove combination to further include a drainage tube, a collapsible collection bag and the second funnel as taught by Slove to provide ease of connection to a drainage tube of a collection bag for collecting the bodily fluid from the collection device.
Claim 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 5 of copending Application No. 18/539672 in view of Slove (as applied to claim 15 and 17 above) and further in view of Nahary et al (WO 2021/165967 A1).
This is a provisional nonstatutory double patenting rejection.
Regarding claims 18-20; the combination of claims 3 and 5 18/539672 and Slove are described in the double patenting rejection of claims 15 and 17 above; but the combination is silent to the details of the collapsible collection bag. Nahary teaches the details of a known collection bag which meets the limitations of claims 18-20 as described in the 103 rejection of claims 18-20 below.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the combination of claims 3 and 5 18/539672 and Slove to utilize the collection bag as taught by Nahary as simple substitution of one known element for another to yield a predictable result to arrive at the limitations of claims 18-20.
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 8 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Slove et al (WO 2023/199003 A1, wherein the examiner will rely on Slove’s US National Stage entry, US 2024/0415394 A1, for the English translation and citation in the rejection below).
Regarding claims 1, 2, 8 and 9; Slove discloses a fluid collection device (figures 1 and 2) of a postpartum hemorrhage monitoring system (figure 3), the device comprising:
a funnel body (element 20) comprising:
an open proximal end (element 13),
an interior configured for receiving a fluid (interior of funnel element 20),
a rim extending exteriorly from the open proximal end (thickened part of funnel body element 20 defining open end proximal element 13),
an anterior outer surface (element 21) configured for placement adjacent an anterior vaginal wall of a patient (paragraph [0035]),
a posterior outer surface (element 22) configured for placement adjacent a posterior vaginal wall of the patient (paragraph [0035), and
an open distal end (bottom of funnel body element 20 which transitions into lumen element 32); and
a stem (flow section, element 32) having an open proximal stem end (end connected to distal end of funnel body element 20), an open distal stem end (distal end of element 32 connected to connection end piece element 31), and a lumen (flow section element 32) extending therebetween, the stem extending from the open distal end of the funnel body (figures 1 and 2) and configured for receiving fluid from the interior of the funnel body ;
wherein the anterior surface (element 21) tapers to the proximal stem end and the posterior outer surface (element 22) is flush with the stem such that the stem is rearward of a geometric center of the funnel body (paragraph [0103]; figures 2) to facilitate movement of fluid into and through the stem and minimize accumulation of fluid within the funnel body when the patient is in a supine position (paragraph [0033]-[0035]; figures 1 and 2).
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Further regarding claim 2; Slove discloses the stem is entirely rearward of the geometric center of the funnel body (paragraph [0103]; figures 2 above).
Further regarding claim 8; Slove discloses a second funnel body (connection endpiece element 31) extending from the open distal stem end (paragraphs [0096], figures 1 and 2)
Further regarding claim 9; Slove discloses the second funnel body is smaller than the funnel body (see figures 1 and 2).
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.
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.
Claims 3, 10, 11, 12 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Slove as applied to claim 1 above, and further in view of Brown (US 11,096,819 B2).
Regarding claim 3; Slove is described in the rejection of claim 1 above, however Slove does not explicitly disclose a pressure point disposed adjacent the rim to facilitate folding of the rim and the funnel body for placement within a patient.
Brown teaches a similar funnel shaped device (element 500; figure 5) for placement within the vagina for collecting fluid wherein the funnel shaped device comprises a pressure point (element 570) disposed adjacent the rim (wherein pressure point 570 is below the rim, which meets BRI of adjacent) to facilitate folding of the rim and the funnel body for placement within a patient’s vagina (column 7, lines 19-43; figures 5, 7-12 and 14).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Slove’s fluid collection device to include a pressure point disposed adjacent the rim as taught by Brown in order to facilitate folding of the rim and the funnel body for placement within the patient.
Regarding claims 10-12; Slove discloses a fluid collection device (figures 1 and 2) of a postpartum hemorrhage monitoring system (figure 3), the device comprising:
a funnel body (element 20) comprising:
an open proximal end (element 13),
an interior configured for receiving a fluid (interior of funnel element 20),
a rim extending exteriorly from the open proximal end (thickened part of funnel body element 20 defining open end proximal element 13),
an anterior outer surface (element 21) configured for placement adjacent an anterior vaginal wall of a patient (paragraph [0035]),
a posterior outer surface (element 22) configured for placement adjacent a posterior vaginal wall of the patient (paragraph [0035), and
an open distal end (bottom of funnel body element 20 which transitions into lumen element 32);
a stem (flow section, element 32) having an open proximal stem end (end connected to distal end of funnel body element 20), an open distal stem end (distal end of element 32 connected to connection end piece element 31), and a lumen (flow section element 32) extending therebetween, the stem extending from the open distal end of the funnel body (figures 1 and 2) and configured for receiving fluid from the interior of the funnel body; and
wherein the anterior surface (element 21) tapers to the proximal stem end and the posterior outer surface (element 22) is flush with the stem such that the stem is rearward of a geometric center of the funnel body (paragraph [0103]; figures 2) to facilitate movement of fluid into and through the stem and minimize accumulation of fluid within the funnel body when the patient is in a supine position (paragraph [0033]-[0035]; figures 1 and 2).
Slove does not explicitly disclose a pressure point disposed adjacent the rim to facilitate folding of the rim and the funnel body for placement within a patient.
Brown teaches a similar funnel shaped device (element 500; figure 5) for placement within the vagina for collecting fluid wherein the funnel shaped device comprises a pressure point (element 570) disposed adjacent the rim (wherein pressure point 570 is below the rim, which meets BRI of adjacent) to facilitate folding of the rim and the funnel body for placement within a patient’s vagina (column 7, lines 19-43; figures 5, 7-12 and 14).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Slove’s fluid collection device to include a pressure point disposed adjacent the rim as taught by Brown in order to facilitate folding of the rim and the funnel body for placement within the patient.
Further regarding claim 11; the Slove/Brown combination as described above disclose the stem is entirely rearward of the geometric center of the funnel (see annotated figure 2 of Slove provided above).
Further regarding claim 12; Brown teaches the pressure point is disposed adjacent the rim. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing that the pressure point in the Slove/Brown combination would also be disposed adjacent to the rim in order to provide the same folding effect.
Regarding claims 15-17; Slove discloses a postpartum hemorrhage monitoring system (figures 1-3), the device comprising:
a drainage tube (element 42; figure 3)
a collapsible collection bag (element 41; wherein the examiner notes that the bag is collapsible in that there is an evacuated state where it is empty and thus collapsed; and a filled state where it is holding fluid and thus expanded) configured for coupling to the drainage tube (paragraph [0145]; figure 3)
a fluid collection funnel configured for coupling to the drainage tube (paragraph [0145]), the fluid collection funnel (element 20) comprising:
an open proximal end (element 13),
an interior configured for receiving a fluid (interior of funnel element 20),
a rim extending exteriorly from the open proximal end (thickened part of funnel body element 20 defining open end proximal element 13),
an anterior outer surface (element 21) configured for placement adjacent an anterior vaginal wall of a patient (paragraph [0035]),
a posterior outer surface (element 22) configured for placement adjacent a posterior vaginal wall of the patient (paragraph [0035), and
an open distal end (bottom of funnel body element 20 which transitions into lumen element 32);
a stem (flow section, element 32) having an open proximal stem end (end connected to distal end of funnel body element 20), an open distal stem end (distal end of element 32 connected to connection end piece element 31), and a lumen (flow section element 32) extending therebetween, the stem extending from the open distal end of the funnel body (figures 1 and 2) and configured for receiving fluid from the interior of the funnel body; and
wherein the anterior surface (element 21) tapers to the proximal stem end and the posterior outer surface (element 22) is flush with the stem such that the stem is rearward of a geometric center of the funnel body (paragraph [0103]; figures 2) to facilitate movement of fluid into and through the stem and minimize accumulation of fluid within the funnel body when the patient is in a supine position (paragraph [0033]-[0035]; figures 1 and 2).
Slove does not explicitly disclose a pressure point disposed adjacent the rim to facilitate folding of the rim and the funnel body for placement within a patient.
Brown teaches a similar funnel shaped device (element 500; figure 5) for placement within the vagina for collecting fluid wherein the funnel shaped device comprises a pressure point (element 570) disposed adjacent the rim (wherein pressure point 570 is below the rim, which meets BRI of adjacent) to facilitate folding of the rim and the funnel body for placement within a patient’s vagina (column 7, lines 19-43; figures 5, 7-12 and 14).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Slove’s fluid collection device to include a pressure point disposed adjacent the rim as taught by Brown in order to facilitate folding of the rim and the funnel body for placement within the patient.
Further regarding claim 16; Slove discloses the drainage tube (element 42) is configured for coupling (via element 43) to the open distal end (at element 31) of the stem (paragraph [0145]), and the collapsible collection bag (element 41) is configured for receiving fluid from the fluid collection funnel by way of the drainage tube (paragraph [0145]; figure 3). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing that the Slove/Brown combination as described above would be similarity configured.
Further regarding claim 17; Slove discloses the collapsible collection bag (element 41) has a collapsed configuration and an expanded configuration (wherein the examiner notes that the bag is in a collapsed configuration when it is evacuated/empty and an expanded configuration when it received a bodily fluid and achieves a filled state and thus expanded). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing that the Slove/Brown combination as described above would be similarity configured.
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Slove in view of Brown as applied to claims 1 and 10 above, and further in view of Melsheimer (US 2019/0110797 A1).
The Slove/Brown combination is described in the rejection of claims 1, 3 and 10 above; however, the Slove/Brown combination does not explicitly disclose how the pressure point is created on the funnel body.
Melsheimer teaches a similar device for positioning within the vagina of a patient that teaches that that a pressure point can be created in an area of the cup that is thinner than the remainder of the cup (wherein living hinge element 39 being thinner than rest of cup) to facilitate folding at specific locations (wherein the thinned out living hinge facilitate folding along the hinge locations for placing in the body).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Slove/Brown combination to use known techniques of creating a pressure point, including providing a pressure point in an area of the funnel body that is thinner than the remainder of the body as taught by Melsheimer, as use of known technique on a known device to yield a predictable result (in this case, the Slove/Brown combination where the pressure point is created by having a location of the funnel body being thinner than the remainder of the funnel body as taught by Melsheimer).
Claims 4, 6, 7 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Slove in view of Brown as applied to claims 1 and 10 above, and further in view of Boatman et al (US 2003/0195490 A1).
Regarding claims 4, 6, 7 and 13; The Slove/Brown combination is described in the rejection of claims 1 and 10 above but does not explicitly disclose the pressure point is formed by providing an area of the funnel body having a durometer less than a durometer of a remainder of the funnel body.
Boatman teaches that it is known that varying durometer along the material of a medical device including having locations with rapid or abrupt durometer changes creates pressure points which makes the material subject to folding during use (paragraphs [0010]).
Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to create the pressure point in the Slove/Brown combination by having durometer less than the remainder of the funnel body to create a pressure point as taught by Boatman as use of a known technique to a known device to yield a predictable result (the Slove/Brown combination wherein the pressure point is present based on the material at the pressure point having a lower durometer than the remainder of the body as taught by Boatman).
Further regarding claim 6; Brown teaches the pressure point is disposed adjacent to the rim to facilitate folding. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing for the Slove/Brown/Boatman combination to also have the pressure point adjacent to the rim to facilitate similar folding for placement in the body.
Further regarding claim 7; the Slove/Brown/Boatman combination as described above discloses the pressure point comprises an indentation (wherein the examiner notes that when the pressure point is pressed, it becomes an indentation in the cup where it is folded, thus meeting the BRI of the pressure point comprising an indentation).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Slove in view of Brown as applied to claims 15 and 17 above, and further in view of Nahary et al (WO 2021/165967 A1).
The Slove/Brown combination is described in the rejection of claims 15 and 17 above; however it is silent to the specifics of the collapsible collection bag, specifically wherein in the expanded configuration, the collapsible collection bag is freestanding (claim 18); wherein the collapsible collection bag is self-expanding upon release from the collapsed configuration (claim 19); or wherein the collapsible collection bag is self-expandable and configured to be free-standing and self-supporting upon expansion (claim 20).
Nahary teaches an expandable blood collection bag for collecting blood, wherein the collapsible blood collection bag is self-expanding upon release from the collapsed configuration and free-standing in the expanded configuration (page 15, line 6 – page 16, line 19; figures 2a-5f).
Regarding claims 18-20; the Slove/Brown combination described above teaches the use of a collapsible blood collection bag. Nahary teaches a known blood collection bag which is self-expandable upon release from the collapsed configuration and free standing in the expanded configuration. Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Slove/Brown combination to use Nahary’s expandable blood collection bag as simple substitution of one known element with another to yield a predictable result (in this case the Slove/Brown combination wherein the drainage tube is connected to Nahary’s blood collection back to collect the postpartum blood) thus teaching the limitations of claims 18-20.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2019/0069929 A1 to Isch et al; discloses a postpartum hemorrhage balloon system.
US 2018/0055523 A1 to Blair et al; discloses a uterine hemorrhage controlling system and method.
WO 2021/156885 to Patil; discloses a device for measuring real time obstetric blood loss.
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791