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 .
Specification
The disclosure is objected to because of the following informalities:
The word “anti-anti-coagulating agents” appears to be a double negative. This double-negative construction creates ambiguity as to whether the term refers to agents that prevent anticoagulation (i.e., pro-coagulants) or agents that counteract anticoagulants already present in the blood. The applicant should clarify this term or replace it with “anti-anticoagulating agents” for clarity.
The double negative appears in the specification of this application on page 3, line 2; page 4, line 31; page 5, line 17; page 6, line 8; and page 8, line 20.
Appropriate correction is required.
Claim Objections
Claims 5, 10, 19, 23, 27, and 30 are is objected to because of the following informalities:
Claim 5 recites “anti-anti-coagulating agents.” This double-negative construction creates ambiguity as to whether the term refers to agents that prevent anticoagulation (i.e., pro-coagulants) or agents that counteract anticoagulants already present in the blood. The applicant should clarify this term or replace it with “anti-anticoagulating agents” or “coagulation-restoring agents” for clarity. This error does not independently render the claim indefinite but should be corrected.
Claim 10 recites “wherein the piston element is at end of a plunger defining a coagulating space between it and one an end of the tube.” The phrase “one an end of the tube” contains an extraneous word “an” and should read “one end of the tube.” As written, the phrase “one an end” is grammatically incoherent and renders the scope of the claim unclear.
Claim 10 recites “the piston element is at end of a plunger.” The claim should read “the piston element is at an end of a plunger.” The missing article “an” is a typographical error that should be corrected.
Claim 19 recites “anti-anti-coagulating agents.” As noted above for claim 5, this double-negative terminology creates ambiguity as to the scope of the claim. The applicant should clarify whether these are agents that counteract anticoagulants or agents that promote coagulation.
Claim 23 recites “anti-anti-coagulating agents.” The same indefiniteness issues noted for claims 5 and 19 apply here.
Claim 27 recites “The device of claim 16.” Claim 16 is cancelled. A dependent claim that depends from a cancelled claim lacks proper antecedent basis and is therefore indefinite. The claim should be amended to depend from an active claim, such as claim 24.
Claim 30 recites “anti-anti-coagulating agents.” The same indefiniteness issues noted for claims 5, 19, and 23 apply here.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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, 13, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kushnir et al. (US 2015/0044272A1; hereinafter “Kushnir III”) in view of Harrison et al. (US 6,572,874B1; hereinafter “Harrison”).
In relation to independent claim 1, this claim recites: A method for treating vaginal lesions in a subject, comprising: maintaining an elongated coagulated blood mass within the vaginal lumen for a time sufficient for exerting a therapeutic effect, said mass being prepared from the subject’s whole blood and being either (i) a priori coagulated and introduced into said vaginal lumen after coagulation or (ii) introduced into the vaginal lumen after mixing with a coagulating agent and permit to coagulate in situ.
A method for treating vaginal lesions in a subject,
Kushnir III discloses a method for treating lesions of a subject using a coagulated blood mass. Specifically, Kushnir III discloses: “A broad aspect of the invention relates to treatment of skin injuries using clotted blood. The clotted blood is formed so it can be applied onto a skin injury.” (Kushnir III ¶ [0027].) To the extent Kushnir III does not expressly disclose treating vaginal lesions specifically, Harrison fills this gap by disclosing intravaginal treatment of a subject. Specifically, Harrison discloses: “[a] targeted site delivery of bisphosphonates to the vagina using a medicated intravaginal device comprising a bisphosphonate composition formulated for transvaginal delivery” and “[a] method for treatment of osteoporosis and related bone and skeleton diseases… by intravaginal administration.” (Harrison, Abstract.) The concept of introducing a therapeutic agent into the vaginal lumen for treatment of a vaginal condition was thus well known in the art.
maintaining an elongated coagulated blood mass within the vaginal lumen for a time sufficient for exerting a therapeutic effect,
Kushnir III discloses maintaining a coagulated blood mass for a time sufficient to exert a therapeutic effect. Specifically, Kushnir III discloses: “permitting an amount of whole blood to clot on said matrix to form a sheet of clotted whole blood thereon; and (c) applying the clotted blood-containing dressing on a skin injury.” (Kushnir III ¶ [0094].) To the extent Kushnir III does not expressly disclose an elongated shape or placement within the vaginal lumen, Harrison fills this gap by disclosing elongated intravaginal devices. Specifically, Harrison discloses: “a medicated tampon, tampon-like device, pessary, ring, sponge, or cup comprising a bisphosphonate” and placement within the vagina for a therapeutic period. (Harrison, col. 3, lines 60-62) The concept of an elongated device maintained within the vaginal lumen for a therapeutic period was thus well known in the art.
said mass being prepared from the subject’s whole blood and being either (i) a priori coagulated and introduced into said vaginal lumen after coagulation or (ii) introduced into the vaginal lumen after mixing with a coagulating agent and permit to coagulate in situ.
Kushnir III discloses preparing a coagulated blood mass from the subject’s whole blood. Specifically, Kushnir III discloses: “The blood includes autologous blood from the subject.” (Kushnir III ¶ [0095].) Kushnir III further discloses both ex vivo (a priori) coagulation and in situ coagulation with a coagulating agent. Specifically, Kushnir III discloses: “Coagulation influencing additives include, but are not limited to anticoagulants, anti-anticoagulants and/or coagulation accelerators (such as negatively-charged phospholipids (PL) and surface contact agents as Kaoline).” (Kushnir III ¶ [0030].) Kushnir III further discloses: “Optionally, the method comprises adding a coagulation initiator prior to the spreading.” (Kushnir III ¶ [0087].)
Motivation to combine.
It would have been obvious to combine Kushnir III with Harrison because both references are directed to the delivery of therapeutic materials to body cavities of a subject. A person of ordinary skill in the art would have been motivated to apply Kushnir III’s method of preparing a coagulated blood mass for therapeutic use to the vaginal delivery context disclosed by Harrison, recognizing that the vaginal lumen is an internal body cavity amenable to treatment with a coagulated blood mass. The combination would yield a predictable result: a coagulated blood mass maintained within the vaginal lumen for a therapeutic effect.
In relation to claim 13, this claim depends from claim 1 and further recites: the method of claim 1, comprising: introducing an anchoring element into the vagina configured for maintaining the coagulated blood mass in position.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
comprising: introducing an anchoring element into the vagina configured for maintaining the coagulated blood mass in position.
Harrison discloses introducing an anchoring element into the vagina to maintain a therapeutic material in position. Specifically, Harrison discloses: “a medicated tampon, tampon-like device, pessary, ring, sponge, or cup comprising a bisphosphonate” and the use of such devices to maintain therapeutic materials within the vagina. (Harrison, col. 3, lines 59-62.) Harrison further discloses: “Another aspect of this invention is a method for preparation of an intravaginal medicated device comprising incorporating a composition comprising a bisphosphonate agent selected from the group alendronate, clodronate, etidronate, pamidronate, tiludronate, ibandronate, zoledronate, olpadronate, residronate and neridronate with a device for intravaginal delivery of said agent, wherein said device is a vaginal tampon, a strip, capsule or container comprising tampon or a tampon-like device, vaginal strip, vaginal cup, vaginal ring, vaginal pessary, vaginal tablet, vaginal suppository, vaginal sponge, bioadhesive tablet, microparticle, or bioadhesive microparticle.” (Harrison, col. 4, lines 31-42.) The concept of using an anchoring element (tampon, pessary, etc.) to maintain a therapeutic material in position within the vagina was well known in the art.
Motivation to combine.
The motivation to combine is the same as for claim 1. A person of ordinary skill in the art would have been motivated to incorporate Harrison’s teaching of an anchoring element into the base method to prevent premature expulsion of the coagulated blood mass from the vaginal lumen, ensuring that the mass remains at the target site for the required therapeutic duration.
In relation to claim 17, this claim depends from claim 13 and further recites: the method of claim 13, wherein the anchoring element comprises a retrieving thread extending from the proximal end for facilitating retrieval of the anchoring element, and wherein the method further comprises retrieving said anchoring element following a sufficient period of time from its anchoring within the vagina.
Base rejection incorporated.
The rejection of claim 13 is incorporated herein.
wherein the anchoring element comprises a retrieving thread extending from the proximal end for facilitating retrieval of the anchoring element, and wherein the method further comprises retrieving said anchoring element following a sufficient period of time from its anchoring within the vagina.
Harrison discloses a vaginal tampon with a retrieval string. Specifically, Harrison discloses: “the system, for example the tampon, should be easily removable, for example, attached to a string or tape.” (Harrison, col. 18, lines 4-6.) The concept of a retrieval thread/string attached to a vaginal device for facilitating removal after a therapeutic period was well known in the art.
Motivation to combine.
The motivation to combine is the same as for claim 13. A person of ordinary skill in the art would have been motivated to incorporate a retrieval thread into the anchoring element to provide a simple and safe means for removing the anchoring element from the vagina after the coagulated blood mass has exerted its therapeutic effect.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Kushnir et al. (US 2015/0044272A1; hereinafter “Kushnir III”) in view of Harrison et al. (US 6,572,874B1; hereinafter “Harrison”), as discussed above, an in further view of Kushnir et al. (US 2020/0281775A1; hereinafter “Kushnir II”).
In relation to claim 2, this claim depends from claim 1 and further recites: the method of claim 1, wherein the whole blood is permitted to coagulate in a cylindrical vessel before being introduced into said lumen.
Base rejection incorporated. The rejection of claim 1 is incorporated herein.
wherein the whole blood is permitted to coagulate in a cylindrical vessel before being introduced into said lumen.
Kushnir III discloses that blood is permitted to coagulate within a shaped enclosure before use. Specifically, Kushnir III discloses: “According to some exemplary embodiments of the invention a device for clotting whole blood ex-vivo is provided, the device comprising: (a) an inlet including a channel of fluid communication to an interior of the device; (b) a sample receptacle adapted to spread a sample provided therein to produce a uniform layer.” (Kushnir III ¶ [0048].) To the extent the base combination does not expressly disclose a cylindrical vessel specifically, Kushnir II fills this gap by disclosing a blood-clotting mold device with a shaped enclosure that configures the shape of the blood clot. Specifically, Kushnir II discloses: “the enclosure has a shape and dimension that configures the eventual overall shape of the clotted blood mass formed within the enclosure and hence the shape and dimension of the blood clot subsequently applied onto the wound.” (Kushnir II ¶ [0018].) Kushnir II further discloses: “the mold device may have different shape and sizes to match different shapes and sizes of wounds.” (Kushnir II ¶ [0017].) A cylindrical vessel is a well-known shape for a mold device, particularly for producing a blood mass suitable for introduction into the cylindrical vaginal lumen.
Motivation to combine.
It would have been obvious to combine the base combination of Kushnir III and Harrison with Kushnir II because all three references relate to the preparation and use of blood clots for medical treatment. A person of ordinary skill in the art would have been motivated to use Kushnir II’s shaped mold device in the base method to produce a coagulated blood mass having a desired cylindrical shape suitable for introduction into the vaginal lumen, as the cylindrical shape would conform to the cylindrical geometry of the vagina.
In relation to claim 3, this claim depends from claim 1 and further recites: the method of claim 1, comprising, prior to said maintaining, withdrawing whole blood from the subject; wherein the withdrawn whole blood is mixed with an anti-coagulant.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
comprising, prior to said maintaining, withdrawing whole blood from the subject; wherein the withdrawn whole blood is mixed with an anti-coagulant.
Kushnir II discloses withdrawing whole blood from the subject. Specifically, Kushnir II discloses: “The blood is typically whole blood withdrawn from the subject in any manner acceptable in medical practice for blood withdrawal.” (Kushnir II ¶ [0005].) Kushnir III discloses mixing the withdrawn blood with an anti-coagulant. Specifically, Kushnir III discloses: “In order to avoid uncontrolled blood clotting, one or more anticoagulants (e.g. EDTA) may be added to the blood immediately upon withdrawal from an individual.” (Kushnir III ¶ [0030].)
Motivation to combine.
The motivation to combine is the same as for claim 1. The addition of an anti-coagulant to the withdrawn whole blood is expressly disclosed by Kushnir III and would be used in the combined method to prevent premature coagulation of the blood during handling and transport prior to introduction into the vaginal lumen.
Claims 5, 8, 9, 10, 14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kushnir et al. (US 2015/0044272A1; hereinafter “Kushnir III”) in view of Harrison et al. (US 6,572,874B1; hereinafter “Harrison”), as discussed above, an in further view of McNamara (US 6,524,269B2) and Kushnir et al. (US 2020/0281775A1; hereinafter “Kushnir II”).
In relation to claim 5, this claim recites: the method claim 1, comprising: introducing the subject’s whole blood into a lumen of an elongated guiding tube defined between first, blood-introducing end and second, sealed end; either before or after said introducing, mixing said whole blood with one or more coagulating agents and/or anti-anti-coagulating agents and allowing said whole blood to coagulate within the elongated guiding tube to form a coagulated blood mass having a shape imparted by the elongated guiding tube; and inserting said guiding tube into the vagina and discharging the coagulated blood mass at a desired position within the vagina.
The method claim 1, comprising: introducing the subject’s whole blood into a lumen of an elongated guiding tube defined between first, blood-introducing end and second, sealed end;
Kushnir III discloses introducing whole blood into a shaped enclosure. Specifically, Kushnir III discloses: “an inlet including a channel of fluid communication to an interior of the device” and “a sample receptacle adapted to spread a sample provided therein.” (Kushnir III ¶ [0048].) To the extent Kushnir III does not expressly disclose an elongated guiding tube with a first blood-introducing end and a second sealed end, McNamara fills this gap by disclosing a tubular applicator with a front end and a rear end. Specifically, McNamara discloses: “Tampon system 10 features tampon applicator case 12 including tampon insertion cylindrical case 14 having cylindrical case front end 16, insertion plunger 18 being partially inserted into cylindrical case 14 at cylindrical case rear end 20.” (McNamara, col. 5, lines 60-64.) The concept of an elongated tubular body with a first end and a second end was well known in the art of vaginal applicators.
either before or after said introducing, mixing said whole blood with one or more coagulating agents and/or anti-anti-coagulating agents and allowing said whole blood to coagulate within the elongated guiding tube to form a coagulated blood mass having a shape imparted by the elongated guiding tube;
Kushnir III discloses mixing whole blood with coagulating agents and allowing it to coagulate within a shaped enclosure to form a mass having a shape imparted by the enclosure. Specifically, Kushnir III discloses: “Optionally, the method comprises adding a coagulation initiator prior to the spreading.” (Kushnir III ¶ [0087].) Kushnir II further discloses: “the enclosure has a shape and dimension that configures the eventual overall shape of the clotted blood mass formed within the enclosure.” (Kushnir II ¶ [0018].) Kushnir III further discloses: “In order to avoid uncontrolled blood clotting, one or more anticoagulants (e.g. EDTA) may be added to the blood immediately upon withdrawal from an individual.” (Kushnir III ¶ [0030].)
and inserting said guiding tube into the vagina and discharging the coagulated blood mass at a desired position within the vagina.
Harrison discloses inserting an elongated device into the vagina and delivering its contents. Specifically, Harrison discloses: “a medicated tampon, tampon-like device, pessary, ring, sponge, or cup comprising a bisphosphonate” and the method of “intravaginal administration” by introducing the device into the vagina. (Harrison, col. 3, lines 60-62.) McNamara further discloses the mechanism of discharging contents from a tubular applicator. Specifically, McNamara discloses: “tampon 22 is deployed by inserting lubrication cell 30 and insertion cylinder 14 into the vagina. As seen in FIG. 3, plunger 18 is pressed forward against tampon rear end 28 and into insertion cylinder 14 from its location near cylindrical case rear end 20, driving tampon 22 forward.” (McNamara, col. 6, lines 38-43.)
Motivation to combine.
It would have been obvious to combine Kushnir III with Harrison and McNamara because all three references relate to the delivery of therapeutic materials to the vaginal lumen. A person of ordinary skill in the art would have been motivated to use McNamara’s tubular applicator structure to deliver Kushnir III’s coagulated blood mass to the vaginal lumen as taught by Harrison. The combination would yield a predictable result: a coagulated blood mass formed within a tubular applicator and discharged at a desired position within the vagina.
In relation to claim 8, this claim depends from claim 5 and further recites: The method of claim 5, wherein said discharging comprises forcing the coagulated blood mass out of said first end by a piston element inserted through said second end.
Base rejection incorporated.
The rejection of claim 5 is incorporated herein.
wherein said discharging comprises forcing the coagulated blood mass out of said first end by a piston element inserted through said second end.
McNamara discloses forcing a tampon out of a tubular applicator by a plunger/piston element inserted through the rear end. Specifically, McNamara discloses: “tampon 22 is deployed by inserting lubrication cell 30 and insertion cylinder 14 into the vagina. As seen in FIG. 3, plunger 18 is pressed forward against tampon rear end 28 and into insertion cylinder 14 from its location near cylindrical case rear end 20, driving tampon 22 forward.” (McNamara, col. 6, lines 38-43.) The piston element (plunger) is inserted through the rear end (second end) and forces the contents out of the front end (first end).
Motivation to combine.
The motivation to combine is the same as for claim 5. A person of ordinary skill in the art would have been motivated to use McNamara’s plunger/piston mechanism to discharge the coagulated blood mass from the tubular applicator, as this is the standard mechanism for expelling contents from a tubular vaginal applicator.
In relation to claim 9, this claim depends from claim 5 and further recites: the method of claim 5, comprising adjusting the size of the lumen of the tube to define a desired coagulated blood mass.
Base rejection incorporated.
The rejection of claim 5 is incorporated herein.
comprising adjusting the size of the lumen of the tube to define a desired coagulated blood mass.
Kushnir II discloses adjusting the size of the enclosure to define a desired coagulated blood mass. Specifically, Kushnir II discloses: “[t]he mold device may have different shape and sizes to match different shapes and sizes of wounds” and “the enclosure has a shape and dimension that configures the eventual overall shape of the clotted blood mass.” (Kushnir II ¶ [0017], ¶ [0018].) McNamara discloses a tubular applicator in which the plunger can be positioned at different locations within the tube to define different volumes. Specifically, McNamara discloses: “insertion plunger 18 being partially inserted into cylindrical case 14 at cylindrical case rear end 20.” (McNamara, col. 5, lines 63-64.) The concept of adjusting the lumen size of a tubular applicator by repositioning the plunger was well known in the art.
Motivation to combine.
The motivation to combine is the same as for claim 5. A person of ordinary skill in the art would have been motivated to adjust the lumen size of the tubular applicator to control the volume and size of the coagulated blood mass, allowing customization to the patient’s anatomy and treatment needs.
In relation to claim 10, this claim depends from claim 9 and further recites: the method of claim 9, wherein said adjustment is performed only along a longitudinal axis defined between the first and second ends; wherein said adjustment is performed by an axially displaceable piston element defining a blood coagulating space between it and one end of the tube wherein the piston element is at end of a plunger defining a coagulating space between it and one an end of the tube, and wherein said discharging comprises opening the blood-introducing end and axially displacing the plunger toward the opened end.
Base rejection incorporated.
The rejection of claim 9 is incorporated herein.
wherein said adjustment is performed only along a longitudinal axis defined between the first and second ends; wherein said adjustment is performed by an axially displaceable piston element defining a blood coagulating space between it and one end of the tube wherein the piston element is at end of a plunger defining a coagulating space between it and one end of the tube, and wherein said discharging comprises opening the blood-introducing end and axially displacing the plunger toward the opened end.
McNamara discloses an axially displaceable plunger/piston element that adjusts the space within the tube and discharges contents by axial displacement toward the front end. Specifically, McNamara discloses: “Tampon system 10 features tampon applicator case 12 including tampon insertion cylindrical case 14 having cylindrical case front end 16, insertion plunger 18 being partially inserted into cylindrical case 14 at cylindrical case rear end 20.” (McNamara, col. 5, lines 60-64.) McNamara further discloses: “tampon 22 is deployed by inserting lubrication cell 30 and insertion cylinder 14 into the vagina. As seen in FIG. 3, plunger 18 is pressed forward against tampon rear end 28 and into insertion cylinder 14 from its location near cylindrical case rear end 20, driving tampon 22 forward.” (McNamara, col. 6, lines 38-43.) The plunger is axially displaceable along the longitudinal axis of the tube, defining a space between the piston and the front end, and discharging contents by axial displacement toward the opened front end.
Motivation to combine.
The motivation to combine is the same as for claim 9. A person of ordinary skill in the art would have been motivated to use McNamara’s axially displaceable plunger to both define the coagulation space and discharge the coagulated blood mass, as this provides a simple, reliable, and precise mechanism for both operations.
In relation to claim 14, this claim depends from claim 13 and further recites: the method of claim 13, wherein prior to introduction of said anchoring element into the vagina, said anchoring element is disposed in a lumen of an elongated guiding tube defined between first, blood-introducing end and second, sealed end, said anchoring element is defined between distal and proximal ends, said distal end is sealingly fitted in the lumen to block liquid flow from a blood-coagulating space of the lumen, distally therefrom, towards the sealed end of the tube; and wherein the method comprises discharging the coagulated blood mass into the vagina from the tube followed by the anchoring element; wherein the anchoring element comprises an expandable member configured to expand upon being discharged from the guiding tube.
Base rejection incorporated.
The rejection of claim 13 is incorporated herein.
wherein prior to introduction of said anchoring element into the vagina, said anchoring element is disposed in a lumen of an elongated guiding tube defined between first, blood-introducing end and second, sealed end, said anchoring element is defined between distal and proximal ends, said distal end is sealingly fitted in the lumen to block liquid flow from a blood-coagulating space of the lumen, distally therefrom, towards the sealed end of the tube;
McNamara discloses a tampon disposed in a lumen of a tubular applicator, with the tampon acting as a seal within the tube. Specifically, McNamara discloses: “Tampon 22 is stored within cylindrical case 14 and features tampon hemispherically shaped front end 24 and tampon retrieval string 26 attached to tampon 22 at tampon rear end 28.” (McNamara, col. 5, lines 65-67.) McNamara further discloses: “Tampon 62 has a preferred shape wherein tampon front end 64, the leading surface, is rounded and of much less diameter than that of the remainder. This configuration facilitates the leading portion of the tampon sealing with the elastic membrane 74 and trapping lubricant within the lubricant cell 70.” (McNamara, col. 7, lines 42-47.) The concept of a tampon/anchoring element disposed within a tubular applicator and sealingly fitted to block fluid flow was thus disclosed.
and wherein the method comprises discharging the coagulated blood mass into the vagina from the tube followed by the anchoring element;
McNamara discloses discharging contents from the tube by pressing the plunger forward. Specifically, McNamara discloses: “tampon 22 is deployed by inserting lubrication cell 30 and insertion cylinder 14 into the vagina. As seen in FIG. 3, plunger 18 is pressed forward against tampon rear end 28 and into insertion cylinder 14 from its location near cylindrical case rear end 20, driving tampon 22 forward.” (McNamara, col. 6, lines 38-43.) The sequential discharge of contents followed by the anchoring element is a straightforward extension of this mechanism.
wherein the anchoring element comprises an expandable member configured to expand upon being discharged from the guiding tube.
Harrison discloses expandable tampon-like devices for vaginal use. Specifically, Harrison discloses: “Contact with vaginal fluids or menstrual flow causes the tampon to swell, forcing the skirt to open like an umbrella and to press tightly against the vaginal wall, putting the drug in contact with the vaginal mucosa while effectively preventing the drug from being absorbed into the tampon.” (Harrison, col. 20, lines 54-59.) An expandable member that expands upon being discharged from the guiding tube was well known in the art of vaginal applicators.
Motivation to combine.
It would have been obvious to combine the base combination of Kushnir III, Harrison, and McNamara because all references relate to the delivery and retention of therapeutic materials within body cavities. A person of ordinary skill in the art would have been motivated to use McNamara’s tubular applicator structure with Harrison’s expandable tampon-like anchoring element to deliver Kushnir III’s coagulated blood mass and retain it at the target site within the vaginal lumen.
In relation to claim 19, this claim depends from claim 5 and further recites: The method of claim 5, wherein the lumen of the guiding tube comprises said one or more coagulating agents and/or anti-coagulating agents, and said mixing is performed by the introduction of the whole blood into the lumen of the guiding tube.
Base rejection incorporated.
The rejection of claim 5 is incorporated herein.
wherein the lumen of the guiding tube comprises said one or more coagulating agents and/or anti-coagulating agents, and said mixing is performed by the introduction of the whole blood into the lumen of the guiding tube.
Kushnir II discloses that the enclosure comprises coagulating agents, and mixing is performed by introducing blood into the enclosure. Specifically, Kushnir II discloses: “the enclosure comprises a coagulation initiator in an amount sufficient to facilitate coagulation of blood introduced into the enclosure.” (Kushnir II ¶ [0010].) Kushnir III further discloses: “Optionally, the method comprises adding a coagulation initiator prior to the spreading.” (Kushnir III ¶ [0087].) The concept of pre-loading coagulating agents within the lumen/enclosure so that mixing occurs upon introduction of blood was thus disclosed.
Motivation to combine.
The motivation to combine is the same as for claim 5. A person of ordinary skill in the art would have been motivated to pre-load the coagulating agents within the lumen of the guiding tube to simplify the procedure and ensure proper mixing simply by introducing the blood into the tube.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kushnir et al. (US 2015/0044272A1; hereinafter “Kushnir III”) in view of Harrison et al. (US 6,572,874B1; hereinafter “Harrison”) and McNamara (US 6,524,269B2), as discussed above, and in further view of Kushnir et al. (US 2020/0281775A1; hereinafter “Kushnir II”) and Kushnir et al. (US 2020/0306094A1; hereinafter “Kushnir IV”).
In relation to claim 6, this claim depends from claim 1 and further recites: The method of claim 1, wherein the blood-introducing end comprises a closure allowing introduction of blood therethrough into the tube, the method further comprising, prior to said inserting, removing said closure for allowing discharge of the coagulated blood mass through the first, blood-introducing end; wherein said closure is formed with a unidirectional valving element for allowing unidirectional flow of blood therethrough into the tube.
Base rejection incorporated.
The rejection of claim 5 is incorporated herein.
wherein the blood-introducing end comprises a closure allowing introduction of blood therethrough into the tube, the method further comprising, prior to said inserting, removing said closure for allowing discharge of the coagulated blood mass through the first, blood-introducing end;
Kushnir II discloses a blood-clotting mold device with a removable closure. Specifically, Kushnir II discloses: “By a first of its aspects, the present disclosure provides a wound dressing assembly comprising a blood-clotting mold device having an enclosure, defined between walls of a main body and a removable closure (e.g. in the form of a film) that seals an opening of the enclosure (to maintain sterility of the enclosure), the enclosure being configured for introduction of blood thereinto, typically without removal of the closure or portion thereof.” (Kushnir II ¶ [0006].) Kushnir II further discloses: “removing said the closure to open the enclosure; and extracting the blood clot from the enclosure.” (Kushnir II, Abstract.)
wherein said closure is formed with a unidirectional valving element for allowing unidirectional flow of blood therethrough into the tube.
Kushnir II discloses a closure that allows introduction of blood into the enclosure while maintaining sterility. Specifically, Kushnir II discloses: “at least one of the walls or closure of the device is pierceable by a needle and through the pierce formed therewith, blood is introduced into the sealed enclosure.” (Kushnir II ¶ [0007].) To the extent the base combination does not expressly disclose a unidirectional valving element, Kushnir IV discloses a venting valve for controlling fluid flow. Specifically, Kushnir IV discloses: “the walls may comprise a venting valve which, a priori, is sealed and opened before the blood introduction and/or a port for introducing the blood into the mold space.” (Kushnir IV ¶ [0017].) The concept of a unidirectional valve for controlling fluid flow in a medical device was well known in the art.
Motivation to combine.
It would have been obvious to combine the base combination of Kushnir III, Harrison, and McNamara with Kushnir II because all references relate to blood handling and delivery devices. A person of ordinary skill in the art would have been motivated to incorporate Kushnir II’s removable closure into the base method to maintain sterility of the coagulated blood mass within the tube prior to delivery, and to use a unidirectional valve to allow blood introduction while preventing backflow.
Claims 20, 24, 25, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over McNamara (US 6,524,269B2) in view of Kushnir et al. (US 2015/0044272A1; hereinafter “Kushnir III”) and Harrison et al. (US 6,572,874B1; hereinafter “Harrison”).
In relation to claim 20, this claim recites: a device for treating vaginal lesions in a subject, comprising: an elongated guiding tube defined between first, blood-introducing end and second, sealed end and having a lumen for receiving whole blood; a plunger having a displaceable piston element at one of it ends, said piston element is fitted within the lumen of the guiding tube defining a blood coagulating space between it and the blood introducing end; wherein said guiding tube is configured for being introduced into the vagina and to discharge a coagulating blood mass formed within the lumen, in result of displacement of the displaceable piston element.
A device for treating vaginal lesions in a subject, comprising: an elongated guiding tube defined between first, blood-introducing end and second, sealed end and having a lumen for receiving whole blood;
McNamara discloses an elongated tubular applicator with a lumen. Specifically, McNamara discloses: “Tampon system 10 features tampon applicator case 12 including tampon insertion cylindrical case 14 having cylindrical case front end 16, insertion plunger 18 being partially inserted into cylindrical case 14 at cylindrical case rear end 20.” (McNamara, col. 5, lines 60-64.) To the extent McNamara does not expressly disclose the lumen receiving whole blood for coagulation, Kushnir III fills this gap by disclosing a shaped enclosure that receives whole blood for coagulation. Specifically, Kushnir III discloses: “According to some exemplary embodiments of the invention a device for clotting whole blood ex-vivo is provided, the device comprising: (a) an inlet including a channel of fluid communication to an interior of the device; (b) a sample receptacle adapted to spread a sample provided therein to produce a uniform layer.” (Kushnir III ¶ [0048].)
a plunger having a displaceable piston element at one of it ends, said piston element is fitted within the lumen of the guiding tube defining a blood coagulating space between it and the blood introducing end;
McNamara discloses a plunger with a piston element fitted within the lumen. Specifically, McNamara discloses: “insertion plunger 18 being partially inserted into cylindrical case 14 at cylindrical case rear end 20.” (McNamara, col. 5, lines 63-64.) The piston element (plunger) is fitted within the lumen and defines a space between it and the front end of the tube.
wherein said guiding tube is configured for being introduced into the vagina and to discharge a coagulating blood mass formed within the lumen, in result of displacement of the displaceable piston element.
McNamara discloses a tubular applicator configured for insertion into the vagina and discharge of its contents by displacement of the plunger. Specifically, McNamara discloses: “tampon 22 is deployed by inserting lubrication cell 30 and insertion cylinder 14 into the vagina. As seen in FIG. 3, plunger 18 is pressed forward against tampon rear end 28 and into insertion cylinder 14 from its location near cylindrical case rear end 20, driving tampon 22 forward.” (McNamara, col. 6, lines 38-43.) To the extent McNamara does not expressly disclose the tube being configured to receive and discharge a coagulating blood mass (as opposed to a tampon), Kushnir III fills this gap by disclosing the preparation of a coagulated blood mass within a shaped enclosure for therapeutic use.
Motivation to combine.
It would have been obvious to combine McNamara with Kushnir III and Harrison because all three references relate to devices for delivering therapeutic materials to the vaginal lumen. A person of ordinary skill in the art would have been motivated to use McNamara’s tubular applicator structure to deliver Kushnir III’s coagulated blood mass to the vaginal lumen as taught by Harrison. The combination would yield a predictable result: a device comprising a tubular applicator with a plunger that forms a coagulated blood mass within its lumen and discharges it into the vagina.
In relation to claim 24, this claim depends from claim 20 and further recites: the device of claim 20, comprising an anchoring element disposed in said lumen between the first, blood-introducing end and the second, sealed end, said anchoring element is defined between distal and proximal ends, said distal end is sealingly fitted in the lumen to block liquid flow from a blood-coagulating space of the lumen, distally therefrom, towards the sealed end of the tube.
Base rejection incorporated.
The rejection of claim 20 is incorporated herein.
comprising an anchoring element disposed in said lumen between the first, blood-introducing end and the second, sealed end, said anchoring element is defined between distal and proximal ends, said distal end is sealingly fitted in the lumen to block liquid flow from a blood-coagulating space of the lumen, distally therefrom, towards the sealed end of the tube.
McNamara discloses a tampon disposed within the lumen of a tubular applicator, with the tampon acting as a seal. Specifically, McNamara discloses: “Tampon 22 is stored within cylindrical case 14 and features tampon hemispherically shaped front end 24 and tampon retrieval string 26 attached to tampon 22 at tampon rear end 28.” (McNamara, col. 5, lines 65-67.) McNamara further discloses: “Tampon 62 has a preferred shape wherein tampon front end 64, the leading surface, is rounded and of much less diameter than that of the remainder. This configuration facilitates the leading portion of the tampon sealing with the elastic membrane 74 and trapping lubricant within the lubricant cell 70.” (McNamara, col. 7, lines 42-47.) The concept of a tampon/anchoring element disposed within a tubular applicator and sealingly fitted to block fluid flow was thus disclosed.
Motivation to combine.
The motivation to combine is the same as for claim 20. A person of ordinary skill in the art would have been motivated to incorporate an anchoring element within the lumen of the guiding tube to provide a dual-function component that facilitates blood coagulation within the tube and provides effective retention once delivered into the vagina.
In relation to claim 25, this claim depends from claim 24 and further recites: The device of claim 24, wherein the anchoring element comprises an expandable member configured to expand upon being discharged from the guiding tube.
Base rejection incorporated.
The rejection of claim 24 is incorporated herein.
wherein the anchoring element comprises an expandable member configured to expand upon being discharged from the guiding tube.
Harrison discloses expandable tampon-like devices for vaginal use. Specifically, Harrison discloses: “Contact with vaginal fluids or menstrual flow causes the tampon to swell, forcing the skirt to open like an umbrella and to press tightly against the vaginal wall, putting the drug in contact with the vaginal mucosa while effectively preventing the drug from being absorbed into the tampon.” (Harrison, col. 20, lines 54-59.) McNamara further discloses: “The tampon has a lesser circumference about the leading portion than the trailing portion, thereof.” (McNamara, Abstract.) The concept of an expandable tampon/anchoring element that expands upon being discharged from a tubular applicator was well known in the art.
Motivation to combine.
The motivation to combine is the same as for claim 24. A person of ordinary skill in the art would have been motivated to incorporate an expandable member into the anchoring element to ensure that it securely retains the coagulated blood mass in position within the vaginal lumen after discharge from the guiding tube.
In relation to claim 26, this claim depends from claim 25 and further recites: The device of claim 25, wherein the expandable member comprises absorbing material for allowing absorption of vaginal fluids while anchored in the vagina.
Base rejection incorporated.
The rejection of claim 25 is incorporated herein.
wherein the expandable member comprises absorbing material for allowing absorption of vaginal fluids while anchored in the vagina.
Harrison discloses a vaginal tampon comprising absorbing material. Specifically, Harrison discloses: “wherein said device is a ring, strip, vaginal tampon, absorbent vaginal tampon, strip, capsule or suppository comprising tampon or tampon-like device.” (Harrison, col. 4, lines 8-11.) Harrison further discloses: “a retrieval string or tape connected to the tampon device is also included. The absorbent vaginal tampon may contain any of the above-mentioned drugs and be used as a medicated tampon for individual drug or drug combination delivery.” (Harrison, col. 20, lines 25-29.) The concept of an absorbent member for absorbing vaginal fluids while anchored in the vagina was well known in the art.
Motivation to combine.
The motivation to combine is the same as for claim 25. A person of ordinary skill in the art would have been motivated to incorporate absorbing material into the expandable member to provide additional functionality, allowing the anchoring element to manage vaginal fluids during the treatment period and thereby maintain a clean and dry environment around the coagulated blood mass.
Claims 21, 23, 27 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over McNamara (US 6,524,269B2) in view of Kushnir et al. (US 2015/0044272A1; hereinafter “Kushnir III”) and Harrison et al. (US 6,572,874B1; hereinafter “Harrison”), as discussed above, and in further view of Kushnir et al. (US 2020/0281775A1; hereinafter “Kushnir II”), Kushnir et al. (US 2020/0306094A1; hereinafter “Kushnir IV”), and Kushnir et al. (US 2021/0038874A1; hereinafter “Kushnir V”).
In relation to claim 21, this claim depends from claim 20 and further recites: The device of claim 20, wherein the blood-introducing end comprises a removable closure allowing introduction of blood therethrough into the tube; wherein said closure is formed with a unidirectional valving element for allowing unidirectional flow of blood therethrough into the tube.
Base rejection incorporated.
The rejection of claim 20 is incorporated herein.
wherein the blood-introducing end comprises a removable closure allowing introduction of blood therethrough into the tube; wherein said closure is formed with a unidirectional valving element for allowing unidirectional flow of blood therethrough into the tube.
Kushnir II discloses a blood-clotting mold device with a removable closure that allows introduction of blood. Specifically, Kushnir II discloses: “By a first of its aspects, the present disclosure provides a wound dressing assembly comprising a blood-clotting mold device having an enclosure, defined between walls of a main body and a removable closure (e.g. in the form of a film) that seals an opening of the enclosure (to maintain sterility of the enclosure), the enclosure being configured for introduction of blood thereinto, typically without removal of the closure or portion thereof.” (Kushnir II ¶ [0006].) Kushnir II further discloses: “at least one of the walls or closure of the device is pierceable by a needle and through the pierce formed therewith, blood is introduced into the sealed enclosure.” (Kushnir II ¶ [0007].) To the extent the base combination does not expressly disclose a unidirectional valving element, Kushnir IV discloses a venting valve for controlling fluid flow. Specifically, Kushnir IV discloses: “the walls may comprise a venting valve which, a priori, is sealed and opened before the blood introduction and/or a port for introducing the blood into the mold space.” (Kushnir IV ¶ [0017].)
Motivation to combine.
It would have been obvious to combine the base combination of McNamara, Kushnir III, and Harrison with Kushnir II and Kushnir IV because all references relate to blood handling and delivery devices. A person of ordinary skill in the art would have been motivated to incorporate Kushnir II’s removable closure into the base device to maintain sterility of the blood within the tube prior to coagulation, and to use a unidirectional valve to allow blood introduction while preventing backflow.
In relation to claim 23, this claim depends from claim 20 and further recites: The device of claim 20, wherein said guiding tube comprises one or more coagulating agents and/or anti-anti-coagulating agents for initiating a coagulation process upon receiving whole blood into its lumen.
Base rejection incorporated.
The rejection of claim 20 is incorporated herein.
wherein said guiding tube comprises one or more coagulating agents and/or anti-anti-coagulating agents for initiating a coagulation process upon receiving whole blood into its lumen.
Kushnir II discloses a shaped enclosure comprising coagulating agents. Specifically, Kushnir II discloses: “the enclosure comprises a coagulation initiator in an amount sufficient to facilitate coagulation of blood introduced into the enclosure.” (Kushnir II ¶ [0010].) Kushnir III further discloses: “Optionally, the method comprises adding a coagulation initiator prior to the spreading.” (Kushnir III ¶ [0087].) The concept of pre-loading coagulating agents within the lumen/enclosure so that coagulation is initiated upon introduction of blood was thus disclosed.
Motivation to combine.
The motivation to combine is the same as for claim 20. A person of ordinary skill in the art would have been motivated to pre-load the coagulating agents within the lumen of the guiding tube to simplify the procedure and ensure proper coagulation simply by introducing the blood into the tube.
In relation to claim 27, this claim depends from claim 16 (cancelled; treated as depending from claim 20 for analysis purposes) and further recites: the device of claim 16, wherein the anchoring element comprises a retrieving thread extending from the proximal end for facilitating retrieval of the anchoring element; wherein the distal end is made of or coated by a material that does not adhere to blood: wherein the plunger comprises a plunger flange to allow placing the device on a surface.
Base rejection incorporated.
The rejection of claim 20 is incorporated herein.
wherein the anchoring element comprises a retrieving thread extending from the proximal end for facilitating retrieval of the anchoring element;
McNamara discloses a tampon with a retrieval string. Specifically, McNamara discloses: “tampon retrieval string 26 attached to tampon 22 at tampon rear end 28.” (McNamara, col. 5, lines 66-67.) Harrison also discloses: “the system, for example the tampon, should be easily removable, for example, attached to a string or tape.” (Harrison, col. 18, lines 4-6.)
wherein the distal end is made of or coated by a material that does not adhere to blood:
Kushnir V discloses materials that do not adhere to blood in blood-handling devices. Specifically, Kushnir V discloses: “The first and second chambers in the applicator may be of the same or different sizes, and are typically made of or internally coated with a material to which the whole blood and/or coagulation initiator do not adhere.” (Kushnir V ¶ [0055].) The concept of using non-adhering materials in blood-handling devices was thus well known in the art.
wherein the plunger comprises a plunger flange to allow placing the device on a surface.
McNamara discloses a flange-like structure on the applicator. Specifically, McNamara discloses: “Tampon system 10 features tampon applicator case 12 including tampon insertion cylindrical case 14 having cylindrical case front end 16, insertion plunger 18 being partially inserted into cylindrical case 14 at cylindrical case rear end 20.” (McNamara, col. 5, lines 60-64.) The concept of a flange on a tubular applicator to allow stable placement on a surface was well known in the art of medical applicators.
Motivation to combine.
It would have been obvious to combine the base combination of McNamara, Kushnir III, and Harrison with Kushnir V because all references relate to blood-handling and delivery devices. A person of ordinary skill in the art would have been motivated to use non-adhering materials for the distal end of the anchoring element, as taught by Kushnir V, to prevent the anchoring element from adhering to the coagulated blood mass, facilitating clean separation and retrieval. The plunger flange would be incorporated to provide a stable base for the device during preparation and handling.
In relation to claim 30, this claim recites: a kit comprising: the device of claim 20; blood withdrawing tools for withdrawing whole blood from the subject; and one or more coagulating agents and/or anti-anti-coagulating agents for coagulating a blood mass from the withdrawn whole blood from the subject.
Base rejection incorporated.
The rejection of claim 20 is incorporated herein.
A kit comprising: the device of claim 20;
The device of claim 20 is disclosed by McNamara in view of Kushnir III and Harrison, as discussed above.
blood withdrawing tools for withdrawing whole blood from the subject;
Kushnir III discloses a kit comprising tools for withdrawing whole blood. Specifically, Kushnir III discloses: “Provided by the invention is also a kit or assembly comprising one or more of the components needed in order to prepare a blood clot-based dressing in accordance with the invention. Such components comprise one or more of the following: one or more blood withdrawal devices; one or more blood collection receptacles.” (Kushnir III ¶ [0068].)
and one or more coagulating agents and/or anti-anti-coagulating agents for coagulating a blood mass from the withdrawn whole blood from the subject.
Kushnir III discloses a kit comprising coagulating agents and anti-anticoagulants. Specifically, Kushnir III discloses: “an anticoagulant optionally already included in the in the blood withdrawal or blood collection devices; an anticoagulant inhibitor (also referred to in this specification as anti-anticoagulant) for inducing clot formation.” (Kushnir III ¶ [0068].) Kushnir II further discloses: “the assembly may include elements such as those used for blood withdrawal, a blood collection vial, a blood coagulant to prevent premature coagulation of the blood (e.g. before introducing into the enclosure), blood removal and transfer tool, etc.” (Kushnir II ¶ [0029].)
Motivation to combine.
It would have been obvious to combine the base combination of McNamara, Kushnir III, and Harrison with Kushnir II because all references relate to the preparation and delivery of blood-based therapeutic materials. A person of ordinary skill in the art would have been motivated to assemble a kit comprising the device of claim 20, blood withdrawing tools, and coagulating agents to provide a complete, convenient, and self-contained system for preparing and delivering the coagulated blood mass to the vaginal lumen.
Conclusion
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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