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 statements (IDS) submitted on 1/30/2024 and 6/7/2024 were 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 statements are 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).
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 11, 12, 15 and 16 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.
The term “superabsorbent material” in claims 11, 12, 15 and 16 is a relative term which renders the claim indefinite. The term “superabsorbent” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The examiner notes that the applicant’s specification gives an example of sodium polyacrylate as a known superabsorbent material, but does not clearly define what differentiates a superabsorbent material from a regular absorbent material, such that the scope of the claim becomes there are no clear meets of the bounds for a “superabsorbent material”.
For the purpose of advancing prosecution for applying prior art, the examiner will interpret the indefinite limitation of “superabsorbent material” to be any absorbent polymer material.
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 1-10, 13 and 14 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 10-14 of copending Application No. 18/539592 in view of Zhang et al (CN 213048510 U, examiner will refer to supplied English translation for citation).
This is a provisional nonstatutory double patenting rejection.
Regarding claims 1-10, 13 and 14; Claims 1-7 and 10-14 of 18/539592 teach each and every limitation of the claims except that claims 1-7 and 10-14 of 18/539592 does not discloses the ring is incrementally expandable and contractable, and moveable between a collapsed configuration and an expanded configuration.
However, Zhang teaches a similar fluid collection device (figures 1 and 2) having a funnel body (element 3) wherein the funnel includes a ring extending radially exteriorly (element 6) from the open proximal end of the funnel, wherein the ring is incrementally expandable and contractable wherein the ring (element 6) is movable between a collapsed configuration (when airbag element 6 is uninflated) to an expanded configuration upon receiving a fluid within the ring (when airbag element 6 is inflated; see 102 rejection below for further details and citation).
Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to modify the rim of the invention recited in claims 1-7 and 10-14 of 18/539592 to be a ring extending radially exteriorly from the from the open proximal end of the funnel, wherein the ring is incrementally expandable and contractable wherein the ring is movable between a collapsed configuration to an expanded configuration upon receiving a fluid within the ring as taught by Zhang in order to provide a better seal for conforming to the patent’s vaginal wall.
Claims 2-10, 13 and 14 match up with the limitations of claims 2-7 and 10-14.
Claims 11, 12 and 15-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims claims 1-7 and 10-14 of copending Application No. 18/539592 in view of Zhang et al (CN 213048510 U, examiner will refer to supplied English translation for citation) and Norred et al (US 2013/0245637 A1).
This is a provisional nonstatutory double patenting rejection.
Regarding claims 11, 12 and 15-20; Claims 1-7 and 10-14 of 18/539592 teach each and every limitation of the claims except that claims 1-7 and 10-14 of 18/539592 do not discloses the ring is incrementally expandable and contractable, and moveable between a collapsed configuration and an expanded configuration, wherein the ring comprises a superabsorbent material, and the ring is configured to expand upon contact with the bodily fluid.
However, Zhang teaches a similar fluid collection device (figures 1 and 2) having a funnel body (element 3) wherein the funnel includes a ring extending radially exteriorly (element 6) from the open proximal end of the funnel, wherein the ring is incrementally expandable and contractable wherein the ring (element 6) is movable between a collapsed configuration (when airbag element 6 is uninflated) to an expanded configuration upon receiving a fluid within the ring (when airbag element 6 is inflated; see 102 rejection below for further details and citation).
Norred teaches a device (figures 5a and 5b) for insertion into the vagina which is configured to expand to conform to the vagina in order to control hemorrhaging wherein the device includes an expandable part for expanding to conform to the vagina can be provided via inflation of a balloon area (paragraph [0036]-[0037]) or in an alternative embodiment wherein the expandable element (seal element 141) comprises a porous material that is configured to deform into an expanded configuration upon absorption of a fluid and be in a non-expanded configuration in the absence of a fluid (paragraph [0041]).
Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to modify the rim of the invention recited in claims 1-7 and 10-14 of 18/539592 to be a ring extending radially exteriorly from the from the open proximal end of the funnel, wherein the ring is incrementally expandable and contractable wherein the ring is movable between a collapsed configuration to an expanded configuration upon receiving a fluid within the ring as taught by Zhang in order to provide a better seal for conforming to the patent’s vaginal wall.
Furthermore regarding claims 11, 12, and 15-20, 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 1-7 and 10-14 of 18/539592 and Zhang to substitute Zhang’s inflatable ring seal with Norred’s absorbent expandable ring seal as simple substitution of one known element for another to yield a predictable result (in this case, 18/539592/Zhang combination wherein the ring element is a superabsorbent material which is configured to expand and contract based on the ring seal absorbing the bodily fluid and expelling the bodily fluid).
Claims 19 and 20 match up with claims 4-7, 10 and 12-14 of 18/539592.
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, 7-10, 13 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al (CN 213048510 U, examiner will refer to supplied English translation for citation).
Regarding claims 1, 7-10 and 13; Zhang discloses a fluid collection device for a postpartum hemorrhage monitoring system (abstract), the device comprising:
a cup (element 3) comprising an open proximal end (top receiving end of element 3), an open distal end (lower open end of element 3), and an interior extending between the open proximal end and the open distal end (see annotated figure 2 below), the interior configured to receive a bodily fluid (collects postpartum blood; abstract), the cup comprising an anterior surface configured for placement adjacent an anterior vaginal wall of a patient and a posterior surface configured for placement adjacent a posterior vaginal wall of a patient (wherein element 3 is inserted into the vagina, one side of the pipe will be closer to the anterior surface of the vaginal wall and the opposite will be closer to the posterior surface of the vaginal wall; see annotated figure 2 below);
a ring (element 6) extending radially exteriorly from the open proximal end of the cup (see annotated figure 2), wherein the ring is incrementally expandable and contractible (page 4, paragraphs 2 and 3; specifically “repeatedly holding pressure loosening inflation ball 19, gas in the air bag 6 is gradually increased, the air bag 6 is gradually expanded, after expanding for a certain distance, the outer surface of the air bag 6 and vagina inner wall contact the lying-in vagina and extruding the inner wall of the vagina, realizing the location of the bearing pipe 3…” and “after using, medical staffs pressing the supporting plate 12; the supporting plate 12 drives the baffle 11 to move upwards through the tamping column 10, releasing the shielding of the inflation tube 7; the gas in the air bag 6 flows out”); and
a stem (element 4) having an open proximal end (upper end inserted into distal end of cup element 3), an open distal end (lower end of element 4), and a lumen extending therebetween (body of element 4), the stem extending between the open distal end of the cup and configured to receive the bodily fluid from the interior of the cup (wherein bodily fluid enters through element 3 and flows down through stem element 4; see annotated figured 2 below); and
wherein the ring (element 6) is movable between a collapsed configuration to an expanded configuration upon receiving a fluid within the ring (page 4, paragraphs 2 and 3; specifically “repeatedly holding pressure loosening inflation ball 19, gas in the air bag 6 is gradually increased, the air bag 6 is gradually expanded, after expanding for a certain distance, the outer surface of the air bag 6 and vagina inner wall contact the lying-in vagina and extruding the inner wall of the vagina, realizing the location of the bearing pipe 3…” and “after using, medical staffs pressing the supporting plate 12; the supporting plate 12 drives the baffle 11 to move upwards through the tamping column 10, releasing the shielding of the inflation tube 7; the gas in the air bag 6 flows out”).
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Further regarding claim 7; Zhang discloses an inflation lumen (element 7) configured to provide inflation fluid to the ring (wherein charging pipe element 7 receives connecting pipe element 8 in connection to charging ball element 19 to provide inflation fluid to the airbag element 6; page 4, paragraph 2).
Further regarding claim 8; Zhang discloses the inflation lumen (element 7) is integrally formed with the cup (page 3, paragraph 8, specifically “the bearing pipe 3 outer edge surface is provided with an air bag 6 above the bearing belt 2; the lower end of the air bag 6 is provided with an upper and lower axial charging pipe 7”; wherein examiner notes that inflation tube element 7 is part of air bag element 6 which is part of the exterior surface of the cup element 3, thus meeting BRI of integrally formed with the cup since they are all together; see annotated figure 2).
Further regarding claim 9; Zhang discloses the inflation lumen (element 7) is disposed within a sidewall of the cup, and wherein the cup has a smooth outer surface adjacent the inflation lumen (page 3, paragraph 8, specifically “the bearing pipe 3 outer edge surface is provided with an air bag 6 above the bearing belt 2; the lower end of the air bag 6 is provided with an upper and lower axial charging pipe 7” wherein the examiner notes that the inflation lumen element 7 is incorporated into airbag element 6 defined by the sidewall of element 3, and thus meets BRI of being disposed in the sidewall of the cup; see annotated figure 2 above).
Further regarding claim 10; Zhang discloses the inflation lumen (element 7) extends from the ring (element 6) to one of the open proximal end and the open distal end of the stem (see annotated figure 2 above).
Further regarding claim 13; Zhang discloses the ring (element 6) is an expandable balloon (wherein examiner notes that and expandable/contractable airbag element 6 meets the BRI of an expandable balloon; page 3, paragraph 8)
Regarding claims 14; Zhang discloses a postpartum hemorrhage monitoring device (annotated figure 2) comprising:
a cup (element 3) comprising an open proximal end (top receiving end of element 3), an open distal end (lower open end of element 3), and an interior disposed between the open proximal and distal ends (body of element 3), the interior being configured for receiving a bodily fluid (collects postpartum blood; abstract), the cup comprising an anterior surface configured for placement adjacent an anterior vaginal wall of a patient and a posterior surface configured for placement adjacent a posterior vaginal wall of a patient (wherein element 3 is inserted into the vagina, one side of the pipe will be closer to the anterior surface of the vaginal wall and the opposite will be closer to the posterior surface of the vaginal wall; see annotated figure 2 above);
a ring (element 6) extending exteriorly from the open proximal end of the cup (element 3; see annotated figure 2 above);
a stem (element 4) having an open proximal end (upper receiving end of element 4 in the distal end of element 3), an open distal end (lower end of element 4), and a lumen extending therebetween (body of element 4 between open ends), the stem extending from the open distal end of the cup (element 4 is inserted into lower open end of element 3) and configured to receive the bodily fluid from the interior of the cup (postpartum fluid flows through element 3 into element 4; see annotated figure 2);
wherein the ring (element 6) is incrementally inflatable from a collapsed configuration to a first expanded configuration in response to receiving a fluid within the ring (page 4, paragraphs 2; specifically “repeatedly holding pressure loosening inflation ball 19, gas in the air bag 6 is gradually increased, the air bag 6 is gradually expanded, after expanding for a certain distance, the outer surface of the air bag 6 and vagina inner wall contact the lying-in vagina and extruding the inner wall of the vagina, realizing the location of the bearing pipe 3…”), and is incrementally deflatable from the first expanded configuration to a second configuration upon removal of the fluid from the ring (page 4, paragraph 3; “after using, medical staffs pressing the supporting plate 12; the supporting plate 12 drives the baffle 11 to move upwards through the tamping column 10, releasing the shielding of the inflation tube 7; the gas in the air bag 6 flows out”).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang as applied to claim 1 above, and further in view of Slove et al (US 2024/0415394 A1).
Regarding claims 2; Zhang is described in the rejection of cla above; however, Zhang does not explicitly disclose wherein 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 of geometric center of the cup.
Slove teaches a similar device for collecting fluid loss from the vagina comprising a cup (element 20), a ring (element 21) and a stem (element 32) wherein 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 (paragraph [0103]; see annotated figures 1 and 2 below) wherein the asymmetric shape of the flared section reduces the step/siphon effect to promote flow into the conduit with minimal dead volume (paragraphs [0033]—[0035]; figures 1-2).
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Regarding claim 2; Zhang discloses a cup for collecting postpartum blood from the vagina using a cup with a stem. Slove teaches a similar cup with a stem for collecting postpartum blood from the vagina having a unique geometry to promote flow and reduce dead volume. Therefore it would have been obvious to one of ordinary skill in the art at the time of filing obvious to one of ordinary skill in the art at the time of the invention to modify the shape of Zhang’s cup such 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 of the geometric center of the cup as taught by Slove in order to promote flow and reduce dead volume when collecting postpartum blood with Zhang’s system.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang as applied to claim 1 above, and further in view of Brown (US 11,096,819) and Melsheimer (US 2019/0110797 A1).
Regarding claims 3 and 4; Zhang is described in the rejection of claim 1 above. Furthermore, Zhang discloses that the cup is inserted into the patient’s vagina for collecting postpartum blood.
However, Zhang does not explicitly disclose the cup comprises a pressure point disposed adjacent the ring to facilitate folding of the ring and the cup for placement within a patient or the specifics of how the pressure point is created.
Brown teaches a similar cup shaped device for placement within the vagina for collecting fluid wherein the cup comprises a pressure point (element 570) disposed adjacent the ring of the cup to facilitate folding of the ring and the cup 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 Zhang to include a pressure point disposed adjacent the ring as taught by Brown in order to facilitate folding of the cup and ring for placement within the patient.
Further regarding claims 4; The Zhang/Brown combination as described above discloses a cup with a pressure point adjacent the ring to facilitate folding for placement in the body, but is silent to how the pressure point is created. Melsheimer teaches that a pressure point can be created in an area of the cup that is thinner than the remainder of the cup (living hinge element 39 being thinner than rest of cup) to facilitate folding at specific locations. Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the Zhang/Brown combination to provide the pressure point utilizing an area of the cup that is thinner than a remainder of the cup as taught by Melsheimer in order to facilitate folding at specific locations into specific shapes.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang as applied to claim 1 above, and further in view of Brown (previously cited) and Boatman (US 2003/0195490 A1).
Regarding claims 5 and 6; Zhang is described in the rejection of claim 1 above. Furthermore, Zhang discloses that the cup is inserted into the patient’s vagina for collecting postpartum blood.
However, Zhang does not explicitly disclose the cup comprises a pressure point disposed adjacent the ring to facilitate folding of the ring and the cup for placement within a patient or the specifics of how the pressure point is created.
Brown teaches a similar cup shaped device for placement within the vagina for collecting fluid wherein the cup comprises a pressure point (element 570) disposed adjacent the ring of the cup to facilitate folding of the ring and the cup 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 Zhang to include a pressure point disposed adjacent the ring as taught by Brown in order to facilitate folding of the cup and ring for placement within the patient.
Further regarding claims 5 and 6; The Zhang/Brown combination is described above, however Brown is silent as to how the pressure point is created.
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 Zhang/Brown combination by having durometer at the pressure point less than the remainder of the cup 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 Zhang/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 adjacent the ring to facilitate folding of the ring and the cup for placement within a patient. It would have been obvious to one of ordinary skill in the art at the time of filing for the Zhang/Brown/Boatman combination to have the pressure point located in the same location as taught by Brown to facilitate folding for insertion into the patient.
Claims 11, 12 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang as applied to claims 1 and 14 above, and further in view of Norred et al (US 2013/0245637 A1).
Zhang is described in the rejections of claims 1 and 14 above; however Zhang does not explicitly disclose wherein the ring comprises a superabsorbent material and that the ring comprising the superabsorbent material is configured to expand upon contact with the bodily fluid.
Norred teaches a device (figures 5a and 5b) for insertion into the vagina which is configured to expandto conform to the vagina in order to control hemorrhaging wherein the device includes an expandable part for expanding to conform to the vagina can be provided via inflation of a balloon area (paragraph [0036]-[0037]) or in an alternative embodiment wherein the expandable element (seal element 141) comprises a porous material that is configured to deform into an expanded configuration upon absorption of a fluid and be in a non-expanded configuration in the absence of a fluid (paragraph [0041]).
Regarding claims 11, 12 and 15-17; Zhang discloses a cup having a ring which is inflatable and deflatable via an inflation tube to expand or contract the ring to conform to the vagina in order to place the cup and seal the canal to collect blood. Norred teaches an alternative ring sealing configuration which utilizes a porous superabsorbent material (e.g. sponge, polymer hydrogel) wherein the ring seal is configured to expand upon contact with and absorption of the bodily fluid (paragraph [0041]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to substitute Zhang’s inflatable ring seal with Norred’s absorbent ring seal as simple substitution of one known element for another to yield a predictable result (in this case, Zhang’s device wherein the ring element is a superabsorbent material which is configured to expand and contract based on the ring seal absorbing the bodily fluid and expelling the bodily fluid).
Further regarding claim 17; Zhang discloses the ring is an expandable balloon. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing for the Zhang/Norred combination as described above to have the ring as an expandable balloon filled with the superabsorbent material.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Norred as applied to claims 14 and 15 above, and further in view of Slove (previously cited).
The Zhang/Norred combination is described in the rejection of claims 14 and 15 above, however the Zhang/Norred combination is silent to the ring being asymmetrical.
Slove teaches a similar device for collecting fluid loss from the vagina comprising a cup (element 20), a ring (element 21) and a stem (element 32) wherein 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 (paragraph [0103]; see annotated figures 1 and 2 below) wherein the asymmetric shape of the flared section reduces the step/siphon effect to promote flow into the conduit with minimal dead volume (paragraphs [0033]—[0035]; figures 1-2).
Regarding claim 2; the Zhang/Norred combination as described in the rejection of claim 15 discloses a cup for collecting postpartum blood from the vagina using a cup with a stem with ring extending exteriorly cup. Slove teaches a similar cup with a stem for collecting postpartum blood from the vagina having a unique asymmetrical geometry to promote flow and reduce dead volume. Therefore it would have been obvious to one of ordinary skill in the art at the time of filing obvious to one of ordinary skill in the art at the time of the invention to modify the shape of Zhang’s cup such 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 of the geometric center of the cup as taught by Slove in order to promote flow and reduce dead volume when collecting postpartum blood with Zhang’s system.
Further regarding claim 2; Zhang discloses the ring extends around the inserted portion of the cup for pressing against the vaginal walls. The Zhang/Norred/Slove combination as described above discloses a unique geometry cup wherein the cup is asymmetrical (when looking at shape from side as depicted in sections A and B of annotated figure 2 of Slove above). Therefore it would have been obvious to one of ordinary skill in the art at the time of filing for the ring extending around the cup of the Zhang/Norred/Slove combination would also be the same asymmetrical shape (from a side profile) in order to conform in the vagina and reduce dead volume of collected postpartum blood.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Norred as applied to claims 14 and 15 above, and further in view of Brown (previously cited).
The Zhang/Norred combination is described in the rejection of claims 14 and 15 above, however the Zhang/Norred combination is silent to the cup comprising a pressure point that is disposed adjacent to the ring to facilitate folding of the ring and the cup for placement within a patient, wherein the pressure point comprises an indentation.
Brown teaches a similar cup shaped device for placement within the vagina for collecting fluid wherein the cup comprises a pressure point (element 570) disposed adjacent the ring of the cup to facilitate folding of the ring and the cup for placement within a patient’s vagina (column 7, lines 19-43; figures 5, 7-12 and 14)
Regarding claims 19 and 20; it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Zhang/Norred combination to include a pressure point disposed adjacent the ring as taught by Brown in order to facilitate folding of the cup and ring for placement within the patient.
Further regarding claim 20; the Zhang/Norred/Brown 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).
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