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 .
Status of Claims
Examined Herein: 1-3, 5-17
Priority
Priority to DE102019105111.8 filed on 2/28/2019 and PCT/EP2020/0525723 filed on 2/3/2020 is
acknowledged. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/13/2021 is in
compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Rejections
The objection of claim 16 is hereby withdrawn in view of Applicant’s amendments to claim 16, which now recites the limitation "the paste of claim 16," thereby mooting the objection. [Reply 11/25/2025, Page 5]
The rejection of claim 5 under 35 USC § 112(b) is hereby withdrawn in view of Applicant’s amendments to claim 5, which now recites the limitation "particles of the halloysite," thereby providing sufficient antecedent basis. [Reply 11/25/2025, Page 5]
The rejection of claim 15 under 35 USC § 112(b) is hereby withdrawn in view of Applicant’s amendments to claim 15, which removes the limitation “…applying a sterile wound dressing,” thereby mooting the rejection. [Reply 11/25/2025, Page 5]
The rejection of claim 15 under 35 USC § 112(b) is hereby withdrawn in view of Applicant’s amendments to claim 15, which removes the limitation “a use of the wound dressing as claimed in claim 8 for the treatment of wound lesions,” thereby mooting the rejection. [Reply 11/25/2025, Page 5]
The rejection of claim 15 under 35 USC § 112(b) is hereby withdrawn in view of Applicant’s amendments to claim 15, which removes the limitation “strongly bleeding wounds" thereby mooting the rejection. [Reply 11/25/2025, Page 5]
The rejection of claim 16 under 35 USC § 112(b) is hereby withdrawn in view of Applicant’s amendments to claim 16, which is now dependent upon claim 2 and thereby provides sufficient antecedent basis. [Reply 11/25/2025, Page 5]
The rejection of claims 1-3 and 5-17 under 35 U.S.C. 103 over Schomburg, Dubey, Papp, and Fukuoka are hereby withdrawn in view of Applicant’s amendments to claim 1, which now recites the limitation “the printable paste comprises 80% by volume barite in relation to the total volume of the mineral material.” [Reply 11/25/2025, Page 6]
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation is "which is applied by means of plasma technology and includes atomic copper" in claim 5.
Because this claim limitation is not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 5, 6, 8, and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Schomburg (WO 2019/016367 A1, Filed 7/20/2018; US equivalent - US 2020/0215220 A1 - cited below), in view of Dubey (US 2017/0151365 A1, Published 6/1/2017) and Felder (US 4,588,574, Published 5/13/1986).
With respect to claim 1, Schomburg discloses a composition comprising halloysite and a binding agent. [Schomburg, 0164]
In a specific embodiment, Schomburg discloses the composition comprises 260 g of halloysite powder, 950 g of water, and 50 g of a binding agent. Schomburg further discloses the composition is a printable paste useful for marking wound dressings. [Schomburg, 0164]
The limitation “wherein the printable paste is configured to be printed on the wound dressing” is a non-limiting description. Claim scope is not limited by claim language that does not limit a claim to a particular structure. This limitation does not impose a condition on the composition that is material to patentability. As a result, the limitation is not given weight. MPEP 2111.04
With respect to claim 2, Schomburg discloses the composition comprises a water component and a binder component. [Schomburg, 0164]
With respect to claim 3, Schomburg discloses the composition may further comprise colorants. [Schomburg, 0045] Colorants include pigments.
With respect to claim 5, Schomburg discloses the halloysite particles include a coating, which is applied by means of plasma technology and includes atomic copper. [Schomburg, 0108]
With respect to claim 6, Schomburg discloses the binder includes an acrylate. [Schomburg, 0054, 0164]
With respect to claim 8, Schomburg discloses a wound dressing comprising composite fibers and the halloysite composition. [Schomburg, 0009, 0164]
With respect to claim 10 and 14, Schomburg discloses a method for applying the composition to a wound dressing, characterized in that the composition is applied by a printing method and drying the composition is executed at a drying temperature of about 120°C. [Schomburg, 0112-0142, 0164]
With respect to claim 11, Schomburg discloses the printing method is screen printing. [Schomburg, 0112-0142, 0164]
Claim 12 recites a non-limiting description. The ability to select a printing motif has no effect on the application of the composition to a wound dressing. Therefore, this claim does not distinguish the claimed invention from the prior art.
With respect to claim 13, Schomburg discloses after the printing of the composition, a temperature-controlled drying is carried out. [Schomburg, 0164]
Schomburg does not disclose the composition or the mineral materials therein comprise barite (BaSO4) or the barite and halloysite are in a ratio of four volume parts barite to one volume part halloysite or the composition comprises 80% by volume barite in relation to the total volume of the mineral material or the primary particle size of barite is less than 5 μm. (Claim 1) Schomburg does not disclose the composition comprises 20% by volume barite in relation to the total volume of the mineral material. (Claim 9) Schomburg does not disclose the drying is executed at a drying temperature of less than 100°C or less than 90°C. (Claim 10 and 14)
However, with respect to claim 1 and 9, Dubey discloses a composition useful for marking a wound dressing comprising a hemostatic material and a binder. [Dubey, 0009, 0090] Dubey discloses the hemostatic material is halloysite in one embodiment. [Dubey, 0039-0041] Dubey further discloses a radiopaque agent, barium sulfate (BaSO4), may be incorporated into the composition to impart radiopaque characteristics. [Dubey, 0081]
Moreover, Felder discloses an aqueous composition comprising BaSO4, wherein the primary particle size is preferably 1-5 µm. Felder discloses the aqueous composition is suitable for use as a radiographic contrast agent and should contain at least 200 g of sintered barium sulfate per 100 ml to achieve outstanding contrast visualization. [Felder, Abstract and Col. 2, Line 26-34]
Furthermore, with respect to claim 10 and 14, differences in temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. When the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable by routine experimentation. The general conditions of claim 10 and 14 are disclosed by the combination of Schomburg, Dubey, Felder, as described herein. Therefore, it is not inventive to discover the optimum or workable temperature for executing drying of the composition by routine experimentation.
Modifying the composition disclosed by Schomburg by adding 200 g of barium sulfate having a primary particle size 1-4.9 µm per 100 mL of aqueous solution results in the composition of claim 1 and 9.
Recall, the composition disclosed by Schomburg comprises 950 g (or 950 mL) of water. Thus, 1900 g of BaSO4 to the composition should be added to the composition to maintain the 200 g BaSO4/100 mL water concentration disclosed by Felder. In which case, the modified composition disclosed by Schomburg, Dubey, and Felder comprises 265 g of halloysite, 1900 g of BaSO4, 950 g of water, and 50 g of a binding agent. Therefore, the composition comprises mineral materials comprising BaSO4 and halloysite in a ratio of about 4:1, BaSO4 constitutes 80 vol.% total volume of the mineral material and halloysite constitutes 20 vol.% of the mineral material.
The volume ratio of BaSO4 to halloysite and vol. % of barite and halloysite per total volume of mineral materials was calculated as follows:
Volume = mass (g) /density (g/cm3)
Density of halloysite = 2.6 g/cm3
Density of barium sulfate = 4.5 g/cm3
Volume of BaSO4 in modified composition = 1900 g BaSO4/4.5 (g/cm3) = 422 cm3
Volume of halloysite in modified composition = 275 g halloysite/2.6 (g/cm3) = 106 cm3
Volume ratio of BaSO4 to halloysite = 422 cm3 : 106 cm3 = 4:1
Total volume of mineral materials = 422 cm3 of BaSO4 + 106 cm3 of halloysite = 528 cm3
Volume % of barite/Total volume of mineral materials = 422 cm3/528 cm3 = 80%
Volume % of halloysite/Total volume of mineral materials = 106 cm3/528 cm3 = 20%
Modifying the method disclosed by Schomburg by (1) adding 200g of BaSO4 having a primary particle size 1-4.9 µm per 100 mL of aqueous solution, and (2) through routine experimentation, selecting a drying temperature of less than 100° or 90°C and carrying out drying at said temperature, results in the composition of claim 10 and 14.
It would be obvious to one of ordinary skill in the art to modify the composition disclosed by Schomburg by adding 200 g of BaSO4 having a primary particle size 1-4.9 µm per 100mL of aqueous solution and have a reasonable expectation of success. Schomburg discloses a composition useful for marking wound dressings comprising halloysite, a binding agent, and water. Dubey discloses a composition useful for marking wound dressings comprising a hemostatic agent, a binding agent, and water, wherein in one embodiment the hemostatic agent is halloysite. Dubey further discloses the composition may comprise a radiopaque agent, BaSO4. Felder discloses a radiographic contrast agent comprising BaSO4 having a particle size of 1-5 µm. Felder further discloses the contrast agent should contain 200 g of BaSO4 per 100 mL of aqueous solution to outstanding achieve contrast visualization Dubey and Felder establish that a composition comprising a hemostatic agent, a binding agent, and water may further comprise a radiopaque agent, BaSO4, such as the radiopaque agent containing 200 g of BaSO4 (particle size = 1-5 µm) per 100 mL of aqueous solution disclosed by Felder. Thus, the combined teachings of Schomburg, Dubey, and Felder suggest the composition disclosed by Schomburg may further comprise a radiopaque agent comprising 200 g of BaSO4 (particle size = 1-5 µm) per 100 mL of aqueous solution. Therefore, it is reasonable to expect the composition disclosed by Schomburg may be modified by adding 200 g of BaSO4 having a primary particle size 1-4.9 µm per 100mL of aqueous solution. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II) In the instant case, Dubey discloses BaSO4 is a radiopaque agent that imparts radiopaque characteristics to the hemostatic composition. [Dubey, 0081] Felder discloses a radiopaque agent containing 200 g of BaSO4 (particle size of 1-5 µm) per 100 ml of aqueous solution, achieves outstanding double contrast visualization. [Felder, Abstract] Therefore, one would have been motivated by the expectation that the aforementioned modification could enable BaSO4 to impart radiopacity to the composition disclosed by Schomburg and achieve outstanding contrast visualization.
It would have been a matter of routine optimization to select the claimed drying temperature. Dubey discloses a method for applying the aforementioned composition to a wound dressing, characterized in that the composition is applied and drying the composition is executed at a drying temperature of approximately greater than or equal to 93 °C (200° F). Furthermore, Dubey discloses the temperature at which the drying is executed is a result-effective variable that can be adjusted and or monitored to produce a substantially dry hemostatic device with very low, if any, water content. [Dubey, 0064] Therefore, one of ordinary skill in the art would recognize that the drying temperature in the method disclosed by Schomburg may be selected to achieve a hemostatic device with a desired water content. Accordingly, a person of ordinary skill in the art would have had a reasonable expectation of success in selecting the claimed temperature because Dubey discloses executing drying at a temperature of approximately greater than or equal to 93 °C. Accordingly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Therefore, a POSITA would be motivated to explore values close to 93°C, including less than 90°C.
Claims 1-3, 5, 6, 8, 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Schomburg, Dubey, and Felder, as applied to claim 1-3, 5, 6, 8, 10-14 above, and further in view of Vladimirovich (RU 178466U1, Published 4/4/2018).
With respect to claim 1 and 8, Schomburg, Dubey, and Felder disclose the teachings above.
With respect to claim 8, Schomburg further disclose the wound dressing is hemostatic device used for wound care. [Schomburg, 0015]
Schomburg, Dubey, and Felder do not disclose a method for treating wound lesions.
However, with respect to claim 15, Vladimirovich discloses a method for treating wound lesions comprising the steps of: cleaning a bleeding wound lesion, after the cleaning step, applying a hemostatic device (wound dressing) to the cleaned wound, and applying a pressure bandage over the hemostatic device to avoid a greater blood loss. [Vladimirovich (Translation), Page 4, Paragraph 8]
Combining the wound dressing disclosed by Schomburg, Dubey, and Felder with the method for treating wound lesions disclosed by Vladimirovich results in the method of claim 15, wherein said wound dressing is applied to the cleaned wound in accordance with said method.
It would be obvious to one of ordinary skill in the art to combine the wound dressing disclosed by Schomburg, Dubey, and Felder with the method for treating wound lesions disclosed by Vladimirovich and have a reasonable expectation of success. Schomburg, Dubey, and Felder disclose a hemostatic device (wound dressing) useable for wound care. Vladimirovich discloses a method for treating wound lesions comprising the step of applying a hemostatic device (wound dressing) to a cleaned wound. Thus, the combined teachings of Schomburg/Dubey/Felder and Vladimirovich suggest the hemostatic device (wound dressing) disclosed by Schomburg/Dubey/Felder may be applied to the cleaned wound according to the method disclosed by Vladimirovich. Therefore, it is reasonable to expect the wound dressing disclosed by Schomburg, Dubey, and Felder may be combined with the method for treating wound lesions disclosed by Vladimirovich. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. In the instant case, Schomburg/Dubey/Felder disclose the wound dressing is used for wound care and Vladimirovich discloses a method for treating wound lesions using a wound dressing. Therefore, one would have been motivated by the expectation that the wound dressing disclosed by Schomburg/Dubey/Felder could be employed according to the method disclosed by Vladimirovich to provide wound care as intended.
Claims 1, 2, 6-9, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Dubey, in view of Ruddy (WO 1995/028969 A1, Published 11/2/1995).
With respect to claim 1, Dubey discloses a hemostat/water/binder composition useful for marking a wound dressing comprising a hemostatic material, a binder, and water. [Dubey, 0009, 0090] Dubey discloses the hemostatic material is halloysite in one embodiment. [Dubey 0039-0041] Furthermore, Dubey discloses a radiopaque agent, barium sulfate (BaSO4), may be incorporated into the composition to impart radiopaque characteristics. [Dubey, 0081]
Dubey also discloses the concentration of crosslinkable binder constitutes about 2% of the composition. [Dubey, 0117]
With respect to claim 2, Dubey discloses the composition comprises a water component and a binder component. [Dubey, 0062, 0100]
With respect to claim 6, Dubey discloses the binder may include a cellulose-saccharide mixture consisting essentially of carboxymethylcellulose and calcium alginate. [0074]
With respect to claim 8, Dubey discloses a wound dressing comprising composite fibers and the aforementioned composition. [Dubey, 0051, 0052, 0079]
Dubey does not disclose the barite and halloysite are in a ratio of four volume parts barite to one volume part halloysite or the composition comprises 80% by volume barite in relation to the total volume of the mineral material or the primary particle size of barite is less than 5 μm. (Claim 1) Dubey does not disclose the composition comprises 20% by volume barite in relation to the total volume of the mineral material. (Claim 9) Dubey does not disclose the binder component is present in the composition in amount of between 5% to 10% by weight. (Claim 16 and 17)
However, with respect to claim 1, 7, and 9 Ruddy discloses a composition comprising 15-25% w/v of an X-ray contrast agent, 1-2% w/v of clay, 4-7% of surfactants and excipients, and 66-80% w/v water (q.s.). Accordingly, Ruddy discloses the x-ray contrast agent and clay are present in a ratio of 15:2 – 25:1 % w/v [Page 23 - see table] Ruddy discloses the x-ray contrast agent may be in particulate form and should have a particle size of from 0.05 µm to 5 µm. [Ruddy, Page 9, Paragraph 6, Page 10, Paragraph 1, Page 20, Paragraph 4] Ruddy further discloses the clay is an aluminum silicate. [Ruddy, Page 21, Paragraph 2]
Moreover, with respect to claim 16 and 17, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. The general conditions of the instant claims are disclosed by the combination of Dubey and Ruddy, as described herein. Therefore, it is not inventive to discover the optimum or workable ratio of the binder component.
Modifying the composition disclosed by Dubey so that BaSO4 (the x-ray contrast agent) and halloysite (aluminosilicate clay) are present in a ratio of 15:2 % w/v (or approx. 15:2 % w/w assuming density of aqueous solution = 1 g/mL), and so that BaSO4 has a particle size of 0.05 µm to 4.9 µm, results in the composition of claim 1, 7, and 9.
In which case, the modified composition disclosed by Dubey and Ruddy comprises 2 g of a binder, 15 g BaSO4, 2 g halloysite per 100 mL (or any proportionate amount that maintains the same weight/volume ratio), and water in an amount sufficient to yield the described % w/v and % /ww. Therefore, BaSO4 and halloysite are in a ratio of about 4:1, BaSO4 constitutes 80 vol.%/total volume of the mineral material, and halloysite constitutes 20 vol.%/total volume of the mineral material.
The volume ratio of BaSO4 to halloysite and vol. % of barite and halloysite per total volume of mineral materials was calculated as follows:
Volume = mass (g) /density (g/cm3)
Density of halloysite = 2.6 g/cm3
Density of barium sulfate = 4.5 g/cm3
Volume of BaSO4 in modified composition = 15 g BaSO4/4.5 (g/cm3) = 3.3 cm3
Volume of halloysite in modified composition = 2 g halloysite/2.6 (g/cm3) = 0.8 cm3
Volume ratio of BaSO4 to halloysite = 3.3 cm3 : 0.8 cm3 = 4:1
Total volume of mineral materials = 3.3 cm3 of BaSO4 + 0.8 cm3 of halloysite = 4.1 cm3
Volume % of barite/Total volume of mineral materials = 3.3 cm3/4.1 cm3 = 80%
Volume % of halloysite/Total volume of mineral materials = 0.8 cm3/4.1 cm3 = 20%
Thus, with respect to claim 7, the modified composition disclosed by Dubey and Ruddy comprises approximately 81% by weight of water, 17% by weight of a mineral component, 2% by weight of a binder component (See Dubey 0017), 0% a color pigment component.
Further modifying the composition disclosed by Dubey and Ruddy by, through routine experimentation, selecting a mineral component concentration of 5 to 10 % by weight, results in the composition of claim 16 and 17.
It would be obvious to one of ordinary skill in the art to modify the composition disclosed by Dubey so that BaSO4 and halloysite are present in a ratio of 15:2 % w/v (which corresponds to 4:1 volume part of total mineral material, 80 vol. % barite & 20 vol. % halloysite/total volume of the mineral material) and have a reasonable expectation of success. Dubey discloses a composition comprising halloysite (a hemostatic material, clay, and aluminosilicate), a binder, water, and BaSO4 (a radiopaque agent). Ruddy discloses a composition comprising an aluminosilicate clay, water, and a radiopaque agent, wherein the radiopaque agent and aluminosilicate clay are present in a ratio of 15:2 % w/v. Ruddy establishes that a composition comprising a radiopaque agent and aluminosilicate clay may be present in a ratio of 15:2 % w/v. Thus, the combined teachings of Dubey and Ruddy suggest that the BaSO4 and halloysite in the composition disclosed by Dubey may be present in a ratio of 15:2 % w/v. Therefore, it is reasonable to expect the composition disclosed by Dubey may be modified so that BaSO4 and halloysite are present in a ratio of 15:2 % w/v. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. In the instant case, Ruddy discloses the disclosed composition functions as a contrast agent. [Ruddy, Abstract] In the instant case, Dubey discloses a composition comprising a radiopaque agent (BaSO4) and an aluminosilicate clay (halloysite) in an undefined ratio, wherein the BaSO4 imparts a radiopaque characteristic to the composition. Ruddy discloses a composition comprising a radiopaque agent and aluminosilicate clay in the above defined ratio that enables BaSO4 to impart radiopaque characteristics to the composition. Therefore, one would have been motivated by the expectation that the aforementioned modification could enable the composition disclosed by Dubey to comprise BaSO4 and halloysite in a ratio sufficient to impart sufficient radiopaque characteristics.
It would be obvious to one of ordinary skill in the art to modify the composition disclosed by Dubey so that the BaSO4 has a particle size of 0.05 µm to 4.9 µm and have a reasonable expectation of success. Dubey discloses a composition comprising halloysite (a hemostatic material, clay, and aluminosilicate), a binder, water, BaSO4 (a radiopaque agent). Ruddy discloses a composition comprising an aluminosilicate clay, water, and a radiopaque agent, wherein the radiopaque agent is in particulate form and has a particle size of 0.05 µm to 4.9 µm. Ruddy establishes that a radiopaque agent in particulate form, when included in a composition comprising aluminosilicate clay and water may have a particle size of 0.05 µm to 4.9 µm. Thus, the combined teachings of Dubey and Ruddy suggest that the BaSO4 in the composition disclosed by Dubey may have a particle size of 0.05 µm to 4.9 µm. Therefore, it is reasonable to expect the composition disclosed by Dubey may be modified so that BaSO4 has a particle size of 0.05 µm to 4.9 µm. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. In the instant case, Ruddy discloses BaSO4 having a particle size of 0.05 µm to 4.9 µm allows for sufficient particle distribution in a biological site (GI tract). [Ruddy, Page 21, Paragraph 1] Therefore, one would have been motivated by the expectation that the aforementioned modification could enable the composition disclosed by Dubey to be used to visualize a biological site, like a wound, by providing sufficient particle distribution.
It would have been a matter of routine optimization to select the claimed binder component concentration. Dubey discloses a composition comprising a hemostatic agent and a crosslinkable binder, wherein some embodiments, the concentration of the crosslinkable binder is dependent on the concentration of the hemostatic agent. Dubey discloses the ratio of binder to hemostatic agent may range from about 2:1 to about 1:10. [0118] Moreover, Dubey demonstrates that the crosslinkable binder concentration is a result-effective variable, as modifying it affects the composition’s turbidity and clot time. [0174-0176] Therefore, one of ordinary skill in the art would recognize that the crosslinkable binder component concentration may be selected to achieve a desired turbidity and clot time. Accordingly, a person of ordinary skill in the art would have had a reasonable expectation of success in formulating the claimed range because Dubey discloses the ratio of binder to hemostatic agent may range from about 2:1 to about 1:10. Therefore, a POSITA would explore values within and around this range, including 3:1 or 4:1. Since the modified composition disclosed by Dubey and Ruddy comprises 2% by weight halloysite, a POSITA exploring values like 3:1 or 4:1 would arrive at a binder component concentration of 6% or 8% by weight.
Claims 1, 2, 6-13, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Dubey and Ruddy, as applied to claim 1, 2, 6-9, 16-17 above, and further in view of Schomburg.
With respect to claim 1, Dubey and Ruddy disclose the teachings above.
With respect to claim 10, Dubey discloses a method for applying the composition to a wound dressing, characterized in that the composition is applied to a wound dressing and drying of the composition is executed at a drying temperature of 93°C. [0051, 0052, 0063, 0079]
Claim 12 recites a non-limiting description of the instant method. The ability to select a printing motif has no effect on the application of the composition to a wound dressing. Therefore, this claim is not distinguishable from the prior art.
With respect to claim 13, Schomburg discloses after the composition is applied, a temperature-controlled drying is carried out. [Schomburg, 0164]
Dubey does not disclose the composition is applied to the wound dressing by a printing method.
However, with respect to claim 10, Schomburg discloses a method for applying a hemostatic composition comprising halloysite, water, and a binder to a wound dressing, characterized in that the composition is applied to the wound dressing by a printing method. [Schomburg, 0112-0142, 0164]
With respect to claim 11, Schomburg discloses the printing method is screen printing. [Schomburg, 0112-0142, 0164]
With respect to claim 13, Schomburg discloses after the printing of the composition, a temperature-controlled drying is carried out. [Schomburg, 0164]
Modifying the method disclosed by Dubey by applying the composition to the wound dressing by a screen-printing method, results in a method of claim 10-13.
It would be obvious to one of ordinary skill in the art to modify the method disclosed by Dubey by applying the composition to the wound dressing via a screen-printing method and have a reasonable expectation of success. Dubey discloses a method for applying a hemostatic composition comprising halloysite, water, and a binder to a wound dressing, characterized in that the composition is applied to a wound dressing and drying of the composition is executed at a drying temperature of 93°C. Schomburg discloses a method for applying a hemostatic composition comprising halloysite, water, and a binder to a wound dressing, characterized in that the composition is applied to the wound dressing by a printing method and drying of the composition is executed. Schomburg establishes a hemostatic composition comprising halloysite, water, and a binder to a wound dressing may be applied to a wound dressing via a screen-printing method before executing drying. Thus, the combined teachings of Dubey/Ruddy and Schomburg suggest the hemostatic composition disclosed by Dubey/Ruddy may be applied to a wound dressing via a screen-printing method. Therefore, it is reasonable to expect the method disclosed by Dubey may be modified by applying the composition to the wound dressing via a screen-printing method. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. In the instant case, Schomburg discloses a printing process (screen printing, flat printing) is preferred for applying a composition onto textile under lay which contains halloysite because it provides the possibility to control the ratio of impregnated to non-impregnated textile surface in wide surface areas, which is important with regard to blood absorption and adhesion to the wound which is to be treated. [Schomburg, 0175] Therefore, one would have been motivated by the expectation that the aforementioned modification could provide the possibility to control the ratio of impregnated to non-impregnated textile surface in wide surface areas.
Response to Arguments
Applicant’s arguments with respect to all pending claims under 35 U.S.C 103 over Schomburg, Dubey, Papp, and Fukuoka have been considered but are moot because the new ground of rejection necessitated by Applicant’s amendments to claim 1, does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Affidavit/Declaration
The declaration under 37 CFR 1.132 filed 11/25/2025 is insufficient to overcome the rejection of all pending claims claim based upon 35 U.S.C. 103 as set forth in the last Office action because to establish unexpected results that are effective in rebutting a prima facie case of obviousness, the claimed subject matter must be compared with the closest prior art. Applicant attempts to establish unexpected results by comparing the instant invention to a paste comprising 100% barite as the mineral component. However, a paste comprising 100% barite as the mineral component has never been cited as prior art and raises the question of whether such a composition can reasonably be considered the closest prior art. While the Examiner acknowledges Applicant’s assertions regarding pure barite (e.g. “is highly instable and might disintegrate, contaminate the wound and would hence constitute a health hazard for the patient” and a wound dressing having a 100% barite marking printed thereon would have an inferior hemostatic effect over the dressing comprising a paste according to claim 1”), the declaration fails to undermine the instant rejections, as no reference cited is drawn to pure barite.
Moreover, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. In the instant case, Applicant’s results are expected. Schomburg discloses a paste comprising 100% halloysite as the mineral component, and states halloysite material binds or fixes particularly well to a wound dressing substrate. [0054] Schomburg further discloses halloysite can be distributed well and homogeneously on the wound dressings and the composite fibers of the wound dressings are particularly well suited to absorb halloysites evenly or to be coated with halloysites. [0011, 0015] Schomburg declares the use of [halloysite] nanotubes results in particularly efficient, utilizable wound dressings which enables hemostasis to be achieved particularly quickly and without subsequent or postoperative bleeding. [0024] Thus, the teachings of Schomburg demonstrate that a paste comprising halloysite adheres stably to a wound dressing. Therefore, the ability of the instant invention to achieve a stable connection between the paste and the wound dressing appears to be due to the presence of halloysite. Combining a mineral material (barite) that is unable to adhere to a dressing with a mineral material (halloysite) that is able to adhere to a wound dressing, would reasonably result in a composition that is able to adhere to a wound dressing due to the presence of halloysite. One of ordinary skill in the art would expect a paste comprising a material that is known to adhere to a wound dressing (halloysite), to adhere to a wound dressing. Furthermore, Applicant states that the wound dressing comprising 100% barite as the mineral component does not provide a blood coagulating effect, while the instant invention does. However, barite is not typically considered a coagulant, so one of ordinary skill in the art would not expect barite to achieve such an effect. On the contrary, halloysite is a known hemostatic agent. Schomburg discloses a paste comprising halloysite as the mineral component achieves coagulation. [0053, 0157] So, it is expected that a composition comprising halloysite would achieve a blood coagulating effect. One of ordinary skill in the art would expect a paste comprising a material that is known to achieve coagulation (halloysite), to achieve a blood coagulating effect.
Further, the claims made in the declaration do not appear to be commensurate in scope with the instant claims. First, it is unclear what all is included in the test composition that is within the scope of claim 1, other than the barite and halloysite. However, the claims may include various other components, such as, water and binder (see claims 2 and 6), pigments (see claim 3) coatings (see claim 5), etc. Only a single data point has been shown for the composition in claim 1 in the declaration. There is no evidence or reasoning provided that the alleged unexpected result provided in the declaration would hold true over the scope of claim 1, given that various other and broadly recited components (e.g., binder) may be included and would be expected to have some effect on the properties of the claimed composition.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.A.C./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618