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 .
Claims 89 and 100 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 89, the recitation “a sidewall portion of the grip is configured to be urged toward the reservoir to transition the reservoir from a closed condition to an open condition” is indefinite in that it is unclear to the examiner if Applicants are claiming the sidewall portion as an additional structural limitation that transitions the reservoir from a closed condition to an open condition or the same feature as the release mechanism coupled to the reservoir and configured to transition from a closed condition to an open condition to allow medication to flow from the reservoir. If the later Applicants are advised to claim to “a sidewall portion” as such. For example, --the system of claim 78, wherein the release mechanism is a sidewall portion of the grip is configured to be urged toward the reservoir to transition the reservoir from the closed condition to the open condition--.
Regarding claim 100, “the first portion” in lines 5-6 lacks proper antecedent basis.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a release mechanism” in claim 1 and “a set of release mechanisms” in claim 96.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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.
Claim(s) 91, 93, 99 and 101 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated U.S. Patent No. 8,858,593 (“Kerber”).
Regarding claim 91, Kerber discloses an emergency wound treatment device and method that anticipates Applicants’ claimed invention. More specifically, Kerber discloses a system (wound treatment system 20), comprising: an applicator pad (compressible and expandable open cell sponge 21); a grip (tube 11 and rod element 14) releasably couplable to the applicator pad and configured to dispose the applicator pad against a wound of a subject (see Figs. 2, 4, 5 and 6) such that pressure can be transferred to the wound via the applicator pad to enhance hemostasis (pressure from the pad, due to expanding assists with hemostasis, see col. 3, lines 57-64 and col. 4, lines 8-34); a first reservoir included in the applicator pad (the open-cell foam is absorbent and creates a first reservoir in device 100) and configured to contain medication to be released to the wound via the applicator pad (the reservoir in the absorbent pad is configured to release medication to the wound, see col. 4, lines 57-62); a second reservoir (the center of ampoule 24); and a fluid coupling (the outer shell of the ampoule 24) configured such that liquid (polymerizable liquid composition 25, see col. 4, lines 46-51) can flow from the second reservoir to the applicator pad via the fluid coupling.
Regarding claim 93, Kerber discloses the system of claim 91, wherein the medication includes at least one of an antifibrinolytic, a vasoconstrictor, an antibiotic, an anti-infectant, or a steroid (see col. 4, lines 57-62, which discloses the sponge-like material may comprise antimicrobial materials).
Regarding claim 99, Kerber discloses an emergency wound treatment device and method that anticipates Applicants’ claimed invention. More specifically, Kerber discloses a system (wound treatment system 20), comprising: an applicator pad (compressible and expandable open cell sponge 21); a grip (tube 11 and rod element 14) releasably couplable to the applicator pad and configured to dispose the applicator pad against a wound of a subject (see Figs. 2, 4, 5 and 6) such that pressure can be transferred to the wound via the applicator pad to enhance hemostasis (pressure from the pad, due to expanding assists with hemostasis, see col. 3, lines 57-64 and col. 4, lines 8-34); the grip including a housing (tube 11 and rod element 14) defining an interior (the interior of the tube which houses elements in Fig. 2); and a reservoir (ampoule 24) disposed within the interior (see Fig. 2) and configured to contain medication to be released to the wound via the applicator pad (see Figs. 5 and 6 and col. 24-30, the medication when released from the ampoule is diffused throughout the sponge-like material 21; it is inherent that the outer surface of material 21 touches the wound and exchanges some of the medication released and when in contact with the wound the some of the medication will transfer to the wound), a portion (rod element 14) of the housing configured to be urged toward the reservoir to transition the reservoir from a closed condition to an open condition to allow medication to flow from the reservoir to the applicator pad (see col. 4, lines 24-28).
Regarding claim 101, Kerber discloses the system of claim 99, wherein the portion of the housing is a sidewall portion (see Figs. 4-6, wherein a portion of the sidewall is urged towards the applicator pad, specially shown in Fig. 4).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 78, 79 and 88 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2018/0193874 (hereinafter Pozanc) in view of WO 2020/046769 (hereinafter Uzzo).
As regards claim 78, Pozanc discloses a fluid applicator device with fluid control mechanism that substantially discloses Applicant’s presently claimed invention. More specifically, Pozanc discloses a system (constituted by fluid applicator device 100, see Figs. 1, 5 and 6), comprising: an applicator pad (constituted by applicator pad 136); a grip (constituted by handle 102 and reservoir assembly 104, see para. [0019], a user can grip handle 102 and/or reservoir assembly 104) releasably couplable to the applicator pad (see para. [0038] and Fig. 6) and configured to dispose the applicator pad against a surface such that pressure can be transferred to the wound via the applicator pad to enhance hemostasis; a reservoir (reservoir 108) configured to contain fluid to be released to the surface via the applicator pad; and a release mechanism (constituted by a valve mechanism) coupled to the reservoir and configured to transition from a closed condition to an open condition to allow medication to flow from the reservoir and to the applicator pad via the fluid coupling (see para. [0020], lines 1-10) in response to a pressure above a threshold pressure within the reservoir (in order for the fluid to flow, a certain pressure threshold must be met).
It must be noted the recitation that the grip configured to dispose the applicator pad against a wound of a subject such that pressure can be transferred to the wound via the applicator pad to enhance hemostasis is an intended use recitation and that the applicator device is fully capable of being positioned against a wound and while the grip is pressed against the wound, the applicator pad can be removed from the lip (154).
Pozanc fails to teach the fluid in the reservoir is a medication. However, Uzzo, in an analogous fluid applicator device (1) teaches it is known to provide a medicament such as a hemostatic agent in liquid form in delivery component (3) pre-loaded therein (see page 9, lines 20-21) for the purpose of treating a wound (see page 13, lines 14-24).
In view of Uzzo, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the fluid in Pozanc to have included a medicament in order to apply a fluid medicament to a wound for treatment thereof.
Regarding claim 79, modified Pozanc discloses the system of claim 78, wherein the reservoir is a first reservoir, and further comprising a second reservoir included in the applicator pad.
As regards claim 88, modified Pozanc discloses the system of claim 78, wherein the grip includes a plate (applicator base 128 and dispersion interface 132) disposed on a distal end of the grip (see Fig. 6) and configured to apply a distributed, uniform force to the applicator pad when pressed toward the wound with a force orthogonal to the skin (when the handle 120 and reservoir assembly pressed toward the wound applicator base 128 and dispersion interface 132 will inherently apply a uniform force to the applicator pad orthogonal of the skin).
Claim(s) 78, 79, 80, 82 and 83 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/046769 A1 (hereinafter “Uzzo”) in view Pozanc
Regarding claim 78, Uzzo discloses a hematostick/hemotodart that substantially discloses Applicant’s presently claimed invention. More specifically, Uzzo discloses a system (constituted by a kit comprising one or more hemostatic agent applicator 1, see Fig. 1 and page 12, lines 29-30), comprising: an applicator pad (constituted by delivery component 3 comprising one or more hemostatic mesh 8, see page 13, lines 16-20); a grip (constituted by handle 2, see page 4, lines 27-28 which discloses the handle may be in the form of a handhold grip) releasably couplable to the applicator pad (see page 12 which discloses the first actuator is configured to, upon engagement, release the delivery component 3 from the distal end of the handle 2) and configured to dispose the applicator pad against a wound of a subject such that pressure can be transferred to the wound via the applicator pad to enhance hemostasis (the handle upon activation releases the delivery component, see page 4, lines 7-10 and page 13, lines 16-24); a reservoir (positioned in the interior region of the delivery component 3, see page 12, lines 18-22) configured to contain medication to be released to the wound via the applicator pad (see page 12, lines 18-22 which discloses the applicator 1 is configured to release or extrude the hemostatic agent from the interior region of the delivery component 3); and a release mechanism (second actuator 14) coupled to the reservoir and configured to allow medication to flow from the reservoir and the applicator pad (see page 12, lines 18-23).
Uzzo fails to disclose the release mechanism, coupled to the reservoir, is configured to transition from a closed condition to an open condition to allow the medication to flow from the reservoir and to the applicator pad via a fluid coupling in response to a pressure above a threshold pressure applied to the reservoir.
However, Pozanc in it analogous disclosure of a fluid applicator device (100), teaches it is known to provide a reservoir (reservoir 108) configured to contain fluid to be released to the surface via an applicator pad (107); and a release mechanism (constituted by a valve mechanism) coupled to the reservoir and configured to transition from a closed condition to an open condition to allow medication to flow from the reservoir and to the applicator pad via the fluid coupling (see para. [0020], lines 1-10) in response to a pressure above a threshold pressure within the reservoir (in order for the fluid to flow, a certain pressure threshold must be met).
In view of Pozanc, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the reservoir within the interior of the delivery component with a release mechanism in the form of a valve, coupled to the reservoir and configured to transition from a closed condition to an open condition to selectively allow medication to flow from the reservoir and to the delivery component via a fluid coupling in response to a pressure above a threshold pressure within the reservoir and to selectively close the valve to when pressure below the threshold is reached in order provide the delivery component with a certain amount of the medicament.
As regards claim 79, modified Pozanc discloses the system of claim 78, wherein
the reservoir is a second reservoir included in the applicator pad (the applicator pad acts as a second reservoir in that the reservoir releases fluid to, and accumulated by, applicator assembly 106 which includes the applicator pad), further comprising a first reservoir (constituted by reservoir 108) and a fluid coupling (valve mechanism) configured such that liquid can flow from the first reservoir to the applicator pad via the fluid coupling (valve mechanism permits the flow of fluid from reservoir 108 to applicator assembly, see para. [0020], lines 6-10).
Regarding claim 80, modified Uzzo discloses the system of claim 78, wherein the applicator pad includes a pad retainer (constituted by attachment members 15) configured to maintain the applicator pad in contact with the wound after the grip is decoupled from the applicator pad (see page 11, lines 1-3 and see page 13, lines 10-13 which discloses the attachment members attaches the delivery component to the target area).
Regarding claim 82, modified Uzzo discloses the system of claim 78, wherein the medication includes an antifibrinolytic (note the disclosure of fibrinogen which may be used as a hemostatic agent at page 10, lines 6-14).
Regarding claim 83, modified Uzzo discloses the system of claim 78, wherein the medication includes at least one of an antifibrinolytic, a vasoconstrictor, an antibiotic, an anti-infectant, or a steroid (note the disclosure of fibrinogen which may be used as a hemostatic agent at page 10, lines 6-14).
Claim(s) 81 is/are rejected under 35 U.S.C. 103 as being unpatentable Uzzo in view of Pozanc as applied to claim 78, and further as evidenced by Recothrom Package Insert.
As regards claim 81, modified Uzzo discloses the system of claim 78, wherein the grip includes a first portion (handle) and a second portion (second actuator), the second portion configured to be moved relative to the first portion to cause liquid to be released from the reservoir to the applicator pad (see page 4, lines 10-13 which discloses that upon engagement, contents of the delivery component are released, it must be noted Recothrom is a solution as evidenced by the Recothrom Package Insert).
Claims 84, 85 and 87 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/046769 (hereinafter “Uzzo”) in view of Ponzanc as applied to claim 78 above, and further in view of U.S. Patent Application Publication 2019/0184052 (hereinafter “Ilan”), as evidenced by Tranexamic acid in trauma: how we should use it? (hereinafter Roberts).
Regarding claim 84, modified Uzzo discloses the system of claim 78, except wherein the medication is tranexamic acid. However, Ilan in its analogous disclosure of a hemostatic device for treating wounds (see para. [0001]) teaches that it is known to use tranexamic acid as an antifibrinolytic agent (see para. [0150]).
It has been known that the selection of a known material based upon its suitability for the intended use is obvious. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960). Thus, in view of Ilan, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted tranexamic acid as an antifibrinolytic agent in the device of modified Uzzo in order to achieve hemostasis at the wound site because of its known use in inhibiting enzymatic breakdown of fibrin blood clots (see Roberts, lines 1-2 under the section Molecular mechanism of action of tranexamic acid).
Regarding claim 85, modified Uzzo discloses the system of claim 84, wherein the applicator pad includes a material that is non-reactive with TXA (for example polyester or nylon, see page 9, lines 9-15).
Regarding claim 87, modified Uzzo discloses the system of claim 85, wherein the applicator pad includes a natural fiber (see page 9, lines 27-30 which discloses meshes described in U.S. Patent No. 9,821,022; 9,821,022 discloses meshes of natural polymer fibers, col. 1, lines 52-56, constructed by electrospinning fibers see col. 35, lines 16-20).
Claims 84-86 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pozanc in view of Uzzo as applied to claim 78, above and in further view of U.S. Patent No. 10,195,088 (hereinafter Clayborne), as evidenced by Roberts.
Regarding claim 84, modified Pozanc discloses the system of claim 84, except wherein the medication is tranexamic acid. However, Clayborne in an analogous hemostatic medicine applicator (constituted by device 100, see Fig. 1) teaches it is known to place medication such as tranexamic acid in polymer foam sponges for application to a user for treatment (see col. 5, line 67-col. 6, line).
It has been known that the selection of a known material based upon its suitability for the intended use is obvious. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960). Thus, in view of Clayborne, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the medicine disclosed in Pozanc for tranexamic acid for application to a user in order to achieve hemostasis at a wound site because of its known use in inhibiting enzymatic breakdown of fibrin blood clots (see Roberts, lines 1-2 under the section Molecular mechanism of action of tranexamic acid).
Regarding claims 85 and 86, modified Pozanc discloses the system of claim 84, wherein the applicator pad is constructed from a sponge (see para. [0039]). Modified Pozanc fails to disclose the applicator pad includes a material that is non-reactive with TXA (claim 85) and that the non-reactive material is a foamed polymer (claim 86).
However, Clayborne in an analogous hemostatic medicine applicator (constituted by device 100, see Fig. 1) teaches it is known to place medication such as tranexamic acid in polymer foam sponges for application to a user for treatment (see col. 5, line 67-col. 6, line). While Clayborne does not explicitly recite the polymer foam sponges are non-reactive to TXA, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added the TXA to a polymer foam sponge that is non-reactive to TXA in order to maintain the efficacy of the TXA and the polymer foam sponge.
Claim 90 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uzzo in Pozanc, as applied to claim 78 and further in view of JP 2001017461 (“Seki”) and U.S. Patent No. 5,507,721 (“Shippert”).
As regards claim 90, modified Uzzo discloses the system of claim 78, except that the system further comprises a bandage couplable to a proximal surface of the applicator pad, the bandage having a convex distal surface configured to contact a proximal surface of the applicator pad and urge at least a portion of the applicator pad toward the wound.
However, Seki discloses an analogous bandage (10) comprising a base material (1) coated with an adhesive layer (2). The adhesive layer is fixed with a convex-shaped hemostatic pad (3) that is designed to press against the blood or skin vessel puncture holes (see the English Abstract and Fig. 5).
It would have been obvious to one of ordinary skill in the art before the effective time of filing the instant invention to have added the bandage of Seki on top of the hemostatic mesh of modified Uzzo in order to maintain pressure on the hemostatic mesh so as to ensure hemostasis.
It must be noted that Seki fails to disclose the backing layer is more rigid than hemostatic pad (3). However, Shippert in and analogous pressure applicator device (medical device 4) teaches it known to provide a rigid backing layer (baking member 8, constructed from rigid plastic see col. 5, lines 16-18 and col. 6, lines 39-41) and a pad constructed from less rigid material, for example, polyvinyl foam (see col. 4 , lines 54-60) to assist in increasing pressure applied to the body part (claim 1) so as to decrease the time for hemostasis to occur.
In view of Shippert, it would have been obvious to one having ordinary skill in the art to have constructed the backing of modified Uzzo from a material that is more rigid than the pad in order to decrease the time for hemostasis to occur.
Claim(s) 92 and 94 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kerber in view Clayborne, as evidenced by Roberts.
Regarding claim 92, modified Kerber discloses the system of claim 91, except wherein the medication includes an antifibrinolytic. However, Clayborne in an analogous hemostatic medicine applicator (constituted by device 100, see Fig. 1) teaches it is known to place medication such as tranexamic acid in polymer foam sponges for application to a user for treatment (see col. 5, line 67-col. 6, line).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to added tranexamic acid to the compressible and expandable open-cell sponge material device (21) of Kerber in order to quickly achieve hemostasis at the wound site because of its known use in inhibiting enzymatic breakdown of fibrin blood clots (see Roberts, lines 1-2 under the section Molecular mechanism of action of tranexamic acid).
Regarding claim 94, Kerber discloses system of claim 91, except wherein the medication is tranexamic acid. However, Clayborne in an analogous hemostatic medicine applicator (constituted by device 100, see Fig. 1) teaches it is known to place medication such as tranexamic acid in polymer foam sponges for application to a user for treatment (see col. 5, line 67-col. 6, line).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added tranexamic acid to the compressible and expandable open-cell sponge material device (21) of Kerber in order to quickly achieve hemostasis at the wound site because of its known use in inhibiting enzymatic breakdown of fibrin blood clots (see Roberts, lines 1-2 under the section Molecular mechanism of action of tranexamic acid).
Claim(s) 102-104 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kerber in view of Clayborne, as evidenced by Roberts.
Regarding claim 102, Kerber discloses the system of claim 99, wherein except the medication includes an antifibrinolytic. However, Clayborne in an analogous hemostatic medicine applicator (constituted by device 100, see Fig. 1) teaches it is known to place medication, such as the antifibrinolytic medication tranexamic acid, in polymer foam sponges for application to a user for treatment (see col. 5, line 67-col. 6, line).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added the antifibrinolytic medicine tranexamic acid to the compressible and expandable open-cell sponge material device (21) of Kerber in order to quickly achieve hemostasis at the wound site because of its known use in inhibiting enzymatic breakdown of fibrin blood clots (see Roberts, lines 1-2 under the section Molecular mechanism of action of tranexamic acid).
Regarding claim 103, Kerber discloses the system of claim 99, except wherein the medication includes at least one of an antifibrinolytic, a vasoconstrictor, an antibiotic, an anti-infectant, or a steroid. However, Clayborne in an analogous hemostatic medicine applicator (constituted by device 100, see Fig. 1) teaches it is known to place medication, such as the antifibrinolytic medication tranexamic acid, in polymer foam sponges for application to a user for treatment (see col. 5, line 67-col. 6, line).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added the antifibrinolytic medicine, tranexamic acid, to the compressible and expandable open-cell sponge material (21) of Kerber in order to quickly achieve hemostasis at the wound site because of its known use in inhibiting enzymatic breakdown of fibrin blood clots (see Roberts, lines 1-2 under the section Molecular mechanism of action of tranexamic acid).
Regarding claim 104, Kerber discloses the system of claim 99, wherein the medication is tranexamic acid (TXA). However, Clayborne in an analogous hemostatic medicine applicator (constituted by device 100, see Fig. 1) teaches it is known to place medication, such as the antifibrinolytic medication tranexamic acid, in polymer foam sponges for application to a user for treatment (see col. 5, line 67-col. 6, line).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added the antifibrinolytic medicine tranexamic acid to the compressible and expandable open-cell sponge material device (21) of Kerber in order to quickly achieve hemostasis at the wound site because of its known use in inhibiting enzymatic breakdown of fibrin blood clots (see Roberts, lines 1-2 under the section Molecular mechanism of action of tranexamic acid).
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.
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Claims 78, 80-85 and 88-91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,654,057 (“the 057 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are broader in scope.
With respect to claim 78, the ’057 patent discloses a system, comprising: an applicator pad; a grip releasably couplable to the applicator pad and configured to dispose the applicator pad against a wound of a subject such that pressure can be transferred to the wound via the applicator pad to enhance hemostasis; a reservoir configured to contain medication to be released to the wound via the applicator pad; and a release mechanism coupled to the reservoir and configured to transition from a closed condition to an open condition to allow medication to flow from the reservoir and to the applicator pad via a fluid coupling in response to a pressure above a threshold pressure applied to the reservoir (see claim 1, lines 1-7 and 11-18).
Regarding claim 80, the ‘057 patent discloses the system of claim 78, wherein the applicator pad includes a pad retainer configured to maintain the applicator pad in contact with the wound after the grip is decoupled from the applicator pad (see claim 3).
Regarding claim 81, the ‘057 patent discloses the system of claim 78, wherein the grip includes a first portion and a second portion, the second portion configured to be moved relative to the first portion to cause liquid to be released from the reservoir to the applicator pad (see claim 4).
Regarding claim 82, the ‘057 patent discloses the system of claim 78 wherein the medication includes an antifibrinolytic (see claim 11).
Regarding claim 83, the ‘057 patent discloses the system of claim 78, wherein the medication includes at least one of an antifibrinolytic, a vasoconstrictor, an antibiotic, an anti-infectant, or a steroid (see claim 5 and 6).
Regarding claim 84, the ‘057 patent discloses system of claim 78, wherein the medication is tranexamic acid (see claims 5 and 7).
Regarding claim 85, the ‘057 patent discloses the system of claim 84, wherein the applicator pad includes a material that is non-reactive with TXA (see claims 5, 7 and 8).
Regarding claim 88, claim 1 of the ‘057 patent discloses the system of claim 78, wherein the grip includes a plate disposed on a distal end of the grip and configured to apply a distributed, uniform force to the applicator pad when pressed toward the wound with a force orthogonal to the skin (see claim 12).
Regarding claim 89, claim 1 of the ‘057 discloses the system of claim 78, wherein a sidewall portion of the grip is configured to be urged toward the reservoir to transition the reservoir from a closed condition to an open condition (see claim 15).
Regarding claim 90, claim 27 of the ‘057 patent discloses the system of claim 78, wherein the applicator pad includes a backing having a convex distal surface such that the applicator pad has a convex distal surface, the backing being more rigid than a distal portion of the applicator pad coupled to the backing (see claim 17).
Regarding claim 91, claim 27 of the ‘057 patent discloses a system, comprising: an applicator pad; a grip releasably couplable to the applicator pad and configured to dispose the applicator pad against a wound of a subject such that pressure can be transferred to the wound via the applicator pad to enhance hemostasis (claim 1, lines 1-7); a first reservoir included in the applicator pad and configured to contain medication to be released to the wound via the applicator pad (claim 27, lines 11-13); a second reservoir (claim 27, line 14); and a fluid coupling configured such that liquid can flow from the second reservoir to the applicator pad via the fluid coupling (claim 27, lines 15-17).
Claim 86 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7 and 8 of the ‘057 patent in view of Clayborne.
Regarding claim 86, claims 1, 5, 7 and 8 discloses the system of claim 85, except wherein the applicator pad includes a foamed polymer. However, Clayborne in an analogous hemostatic medicine applicator (constituted by device 100, see Fig. 1) teaches it is known to place medication such as tranexamic acid in polymer foam sponges for application to a user for treatment (see col. 5, line 67-col. 6, line).
In view of Clayborne, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have constructed the pad of the ‘057 patent from a polymer foam sponge that is non-reactive to TXA in order to maintain the efficacy of the TXA and the polymer foam sponge.
Claim 87 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 85 of claims 1, 5, 7 and 8 of the ‘057 patent in view of Uzzo.
Regarding claim 87, claims 1, 5, 7 and 8 of the ‘057 patent discloses the system of claim 85, except wherein the applicator pad includes a natural fiber. However, Uzzo discloses an analogous system, wherein the system comprises an applicator pad constructed from natural fiber, for example, silk (see page 9, lines 27-30 which discloses meshes described in U.S. Patent No. 9,821,022; 9,821,022 discloses meshes of natural polymer fibers, col. 1, lines 52-56, constructed by electrospinning fibers see col. 35, lines 16-20, see also 9,821,022 col. 33, lines 49-58).
It has been held that the selection of a known material based upon its suitability for the intended use supports a prima facie case of obviousness. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) and In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have constructed the pad from natural fibers, such as silk, because they are breathable.
Claims 92 and 93 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 27 of the ‘057 patent in view of Uzzo.
Regarding claim 92, claim 27 of the ‘057 patent discloses the system of claim 91, except wherein the medication includes an antifibrinolytic. However, Uzzo in its analogous disclosure of a system teaches it is known to provide a system comprising a medication, wherein the medication is fibrinogen, in order to provide the user with a hemostatic agent that can be used to stop bleeding (see page 10, lines 6-14).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected the antifibrinolytic, fibrinogen, as the medication in the system of the ‘057 patent, in order to provide the user with a hemostatic agent that can be used to stop bleeding at a wound site.
Regarding claim 93, claim 27 of the ‘057 patent discloses the system of claim 91, except wherein the medication includes at least one of an antifibrinolytic, a vasoconstrictor, an antibiotic, an anti-infectant, or a steroid. However, Uzzo in its analogous disclosure of a system teaches it is known to provide a system comprising a medication, wherein the medication is fibrinogen, in order to provide the user with a hemostatic agent that can be used to stop bleeding (see page 10, lines 6-14).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected the antifibrinolytic, fibrinogen, as the medication in the system of the ‘057 patent, in order to provide the user with a hemostatic agent that can be used to stop bleeding at a wound site.
Claim 94 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 27 of the ‘057 patent in view of Ilan, as evidenced by Roberts.
Regarding claim 94, claim 27 of the 0.57 patent discloses the system of claim 91, except wherein the medication is tranexamic acid (TXA). However, Ilan in its analogous disclosure of a hemostatic device for treating wounds (see para. [0001]) teaches that it is known to use tranexamic acid as an antifibrinolytic agent (see para. [0150]).
It has been known that the selection of a known material based upon its suitability for the intended use is obvious. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960). Thus, in view of Ilan, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted tranexamic acid as an antifibrinolytic agent in the system of the ‘057 patent in order to achieve hemostasis at the wound site because of its known use in inhibiting enzymatic breakdown of fibrin blood clots (see Roberts, lines 1-2 under the section Molecular mechanism of action of tranexamic acid).
Claims 95 and 96 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of the ‘057 patent in view of Clayborne, as evidenced by Roberts.
Regarding claim 95, claim 19 of the ‘057 discloses a system, comprising: an applicator pad (claim 19, lines 1-2); a backing coupled to the applicator pad, the backing being more rigid than the applicator pad (claim 19, lines 3-6); a grip releasably couplable to the applicator pad and configured to dispose the applicator pad against a wound of a subject such that pressure can be transferred to the wound via the applicator pad to enhance hemostasis (claim 19, lines 7-11); and a reservoir configured to contain a medicament to be released to the wound via the applicator pad (claim 19, lines 12-13).
Claim 19 of the ‘057 patent fails to teach pad is a foamed polymer and the medication is tranexamic acid (TXA). However, Clayborne in an analogous hemostatic medicine applicator (constituted by device 100, see Fig. 1) teaches it is known to place medication such as tranexamic acid in polymer foam sponges for application to a user for treatment (see col. 5, line 67-col. 6, line).
In view of Clayborne, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have both constructed the pad of the ‘057 patent from a polymer foam sponge and to have used TXA as the medicament since TXA so to maintain the efficacy of the TXA since TXA does not react to the polymer foam sponge, use of TXA because of its known use in inhibiting enzymatic breakdown of fibrin blood clots (see Roberts, lines 1-2 under the section Molecular mechanism of action of tranexamic acid).
Regarding claim 96, modified claim 19 discloses the system of claim 95, wherein the backing has a convex distal surface (see claim 13, line 3).
Claims 95 and 97 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of the ‘057 patent in view of Clayborne, as evidenced by Roberts.
Regarding claim 95, claim 1 of the ‘057 discloses a system, comprising: an applicator pad (claim 1, lines 1-2); a backing coupled to the applicator pad, the backing being more rigid than the applicator pad (claim 17); a grip releasably couplable to the applicator pad and configured to dispose the applicator pad against a wound of a subject such that pressure can be transferred to the wound via the applicator pad to enhance hemostasis (claim 1, lines 7-11); and a reservoir configured to contain a medicament to be released to the wound via the applicator pad (claim 19, lines 12-13).
Claim 19 of the ‘057 patent fails to teach pad is a foamed polymer and the medication is tranexamic acid (TXA). However, Clayborne in an analogous hemostatic medicine applicator (constituted by device 100, see Fig. 1) teaches it is known to place medication such as tranexamic acid in polymer foam sponges for application to a user for treatment (see col. 5, line 67-col. 6, line).
In view of Clayborne, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have both constructed the pad of the ‘057 patent from a polymer foam sponge and to have used TXA as the medicament since TXA so to maintain the efficacy of the TXA since TXA does not react to the polymer foam sponge, use of TXA because of its known use in inhibiting enzymatic breakdown of fibrin blood clots (see Roberts, lines 1-2 under the section Molecular mechanism of action of tranexamic acid).
Regards claim 97, claim 1 of the ‘057 patent discloses the system of claim 95, wherein the grip includes a first portion and a second portion, the second portion configured to be moved relative to the first portion to cause liquid to be released from the reservoir to the applicator pad (see claim 4).
Allowable Subject Matter
Claims 98 and 100 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 98, the prior art fails to teach, show or make obvious the claimed combination of elements as recited in claim 98. Accordingly, an anticipation rejection or a prima facie case of obviousness cannot be established with respect to the claimed subject matter as set forth in claim 98.
With respect to claim 100, the prior art fails to teach, show or make obvious the claimed combination of elements as recited in claim 10098. Accordingly, an anticipation rejection or a prima facie case of obviousness cannot be established with respect to the claimed subject matter as set forth in claim 100.
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