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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/26/2026 has been entered.
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.
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) because the claim limitation recites 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 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 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, and 8-14 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 that the composition comprises 275 g of halloysite powder, 950 g of water, and 50 g of a binding agent. Schomburg further discloses that 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 that the composition comprises a water component and a binder component. [Schomburg, 0164]
With respect to claim 3, Schomburg discloses that the composition may further comprise colorants. [Schomburg, 0045] Colorants include pigments.
With respect to claim 5, Schomburg discloses that the halloysite particles include a coating, which is applied by plasma technology and includes atomic copper. [Schomburg, 0108]
With respect to claim 6, Schomburg discloses that 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 claims 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 dried at a drying temperature of about 120°C. [Schomburg, 0112-0142, 0164]
With respect to claim 11, Schomburg discloses that the printing method is screen printing. [Schomburg, 0112-0142, 0164]
Claim 12 recites a non-limiting description. The ability to select a printing motif does not affect 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 that, after printing the composition, temperature-controlled drying is carried out. [Schomburg, 0164]
Schomburg does not disclose that the composition or the mineral materials therein comprise barite (BaSO4), or that the barite and halloysite are in a ratio of four volume parts barite to one volume part halloysite, or that the composition comprises 80% by volume barite in relation to the total volume of the mineral material, or that the primary particle size of barite is less than 5 μm. (Claim 1) Schomburg does not disclose that the composition comprises 20% by volume barite in relation to the total volume of the mineral material. (Claim 9) Schomburg does not disclose that 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 that, in one embodiment, the hemostatic material is halloysite. [Dubey, 0039-0041] Dubey further discloses that a radiopaque agent, 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 that 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. 4, Line 26-34]
Furthermore, with respect to claims 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 conditions by routine experimentation. The general conditions of claims 10 and 14 are disclosed by the combination of Schomburg, Dubey, and 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 of 1-4.9 µm per 100 mL of aqueous solution results in the composition of claims 1 and 9.
Recall that the composition disclosed by Schomburg comprises 950 g (or 950 mL) of water. Thus, 1900 g of BaSO4 should be added to the composition to maintain the 200 g BaSO4 per 100 mL water concentration disclosed by Felder. Accordingly, the modified composition disclosed by Schomburg, Dubey, and Felder comprises 275 g of halloysite, 1900 g of BaSO4, 950 g of water, and 50 g of a binding agent. Therefore, the modified composition comprises mineral materials comprising BaSO4 and halloysite in a ratio of about 4:1; BaSO4 constitutes 80 vol.% of the 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 were calculated as follows:
Volume = mass (g) ÷ density (g/cm3)
True density of halloysite = 2.6 g/cm3
True density of BaSO4 = 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 BaSO4/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 200 g of BaSO4 having a primary particle size of 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 of 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 that 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 that the contrast agent should contain 200 g of BaSO4 per 100 mL of aqueous solution to achieve outstanding contrast visualization. Thus, Dubey establishes that a composition comprising a hemostatic agent, a binding agent, and water may further comprise a radiopaque agent, BaSO4, and Felder establishes that a radiopaque agent containing 200 g of BaSO4 (particle size = 1-5 µm) per 100 mL of aqueous solution is effective to achieve contrast visualization. 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 = 1-4.9 µm) per 100 mL of aqueous solution, as this concentration and particle size are effective to achieve contrast visualization. Therefore, it is reasonable to expect that the composition disclosed by Schomburg may be modified by adding 200 g of BaSO4 with a primary particle size of 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 present case, Dubey discloses that 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, achieving 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 dried at a drying temperature of approximately greater than or equal to 93°C (200°F). The term “approximately” suggests that greater than or equal to 93°C represents a range of temperatures close to 93°C rather than a precise cutoff. Furthermore, Dubey discloses that the drying temperature 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, and 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over Schomburg, Dubey, and Felder, as applied to claims 1-3, 5, 6, and 8-14 above, and further in view of Vladimirovich (RU 178466U1, Published 4/4/2018).
With respect to claims 1 and 8, Schomburg, Dubey, and Felder disclose the teachings above.
With respect to claim 8, Schomburg further discloses that the wound dressing is a 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 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. MPEP 2144(II). In the present case, Schomburg/Dubey/Felder disclose that 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 to provide wound care as intended according to the method disclosed by Vladimirovich.
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 that the hemostatic material is halloysite in one embodiment. [Dubey 0039-0041] Furthermore, Dubey discloses that a radiopaque agent, BaSO4, may be incorporated into the composition to impart radiopaque characteristics. [Dubey, 0081]
Dubey also discloses that 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. [Dubey, 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 that BaSO4 and halloysite are in a ratio of four volume parts barite to one volume part halloysite, that the composition comprises 80% by volume BaSO4 in relation to the total volume of the mineral material, or that the primary particle size of barite is less than 5 μm. (Claim 1) Dubey does not disclose that the composition comprises 20% by volume halloysite in relation to the total volume of the mineral material. (Claim 9) Dubey does not disclose that the binder component is present in the composition in an amount between 5% and 10% by weight. (Claim 16 and 17)
However, with respect to claims 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 that the X-ray contrast agent and clay are present in a ratio of 15:2 to 25:1 % w/v. [Ruddy, Page 23 - see table] Ruddy discloses that the X-ray contrast agent may be in particulate form and should have a particle size of 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 claims 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 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 (1) BaSO4 (the X-ray contrast agent) and halloysite (aluminosilicate clay) are present in a ratio of 15:2 % w/v (which is equivalent to 15:2 % w/w assuming density of aqueous solution = 1 g/mL), and so that (2) BaSO4 has a particle size of 0.05 µm to 4.9 µm, results in the composition of claims 1, 7, and 9.
Accordingly, 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 % w/w. Therefore, BaSO4 and halloysite are in a ratio of about 4:1; BaSO4 constitutes 80 vol.% of the total volume of the mineral material, and halloysite constitutes 20 vol.% of the 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 were calculated as follows:
Volume = mass (g) ÷ density (g/cm3)
True density of halloysite = 2.6 g/cm3
True density of BaSO4 = 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), and 0% of 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 claims 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/w (which corresponds to 4:1 volume parts of total mineral material, 80 vol. % BaSO4 & 20 vol. % halloysite of the 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 (which is equivalent to 15:2 % w/w). Ruddy establishes that a composition comprising a radiopaque agent and aluminosilicate clay may be present in a ratio of 15:2 % w/w. 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/w. 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/w. 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 present 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 ratio defined above, enabling 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. MPEP 2144(II). In the present case, Ruddy discloses BaSO4 with a particle size of 0.05 µm to 4.9 µm, which 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, in some embodiments, the concentration of the crosslinkable binder is dependent on the concentration of the hemostatic agent. Dubey discloses that the binder to hemostatic agent ratio may range from about 2:1 to about 1:10. [Dubey, 0118]. Moreover, Dubey demonstrates that the binder to crosslinkable binder concentration is a result-effective variable, as modifying it affects the composition’s turbidity and clot time. [Dubey, 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 claims 1, 2, 6-9, and 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. [Dubey, 0051, 0052, 0063, 0079]
Claim 12 recites a non-limiting description of the instant method. The ability to select a printing motif does not affect applying the composition to a wound dressing. Therefore, this claim is not distinguishable from the prior art.
Dubey and Ruddy do not disclose that 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 that the printing method is screen printing. [Schomburg, 0112-0142, 0164]
With respect to claim 13, Schomburg discloses that, after printing the composition, temperature-controlled drying is carried out. [Schomburg, 0164]
Modifying the method disclosed by Dubey by applying the composition to the wound dressing via 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 dried at a drying temperature of 93°C. Schomburg discloses that 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 then dried. Schomburg establishes that a hemostatic composition comprising halloysite, water, and a binder to a wound dressing may be applied to a wound dressing via screen-printing before drying. Thus, the combined teachings of Dubey/Ruddy and Schomburg suggest that 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. MPEP 2144(II). In the present case, Schomburg discloses that 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 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 would allow control of the ratio of impregnated to non-impregnated textile surface in wide surface areas.
Response to Arguments
Applicant's arguments filed 5/26/2026 have been fully considered but they are not persuasive.
Applicant asserts the following:
“Specifically, the Examiner's calculation uses a density of 4.5 g/cm3 for the BaSO4 disclosed in Felder. While this value may represent the theoretical density of pure, crystalline barite found in a handbook, it is not the density of the material actually described in the Felder reference. Applicant respectfully submits that Felder does not teach the use of pure, crystalline barite. Instead, Felder expressly describes a sintered barium sulfate powder having a bulk density of 2.5 to 3.0
g/cm3. [Felder, Abstract and Col. 3, Line 1-6].” [Remarks 5/26/2026, Page 1, Paragraph 3]
“A person of ordinary skill in the art (POSITA) at the time of the invention, when presented
with Dubey and Ruddy, would have had no reason or motivation to select a density of precisely
4.5 g/cm3 to perform such a conversion.” [Remarks 5/26/2026, Page 4, Paragraph 5]
Applicant's arguments are not persuasive because the instant rejection does not physically import the sintered BaSO4 powder disclosed by Felder into Schomburg's composition or the BaSO4 disclosed by Ruddy into Dubey’s composition. "It is well-established that a determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements." MPEP § 2145(III). Felder is relied upon to establish that that BaSO4 at a concentration of 200 g per 100 mL of aqueous solution and having a particle size of 1-5 µm achieves contrast visualization. Ruddy is relied upon to establish that a composition comprising BaSO4 (particle size of 0.05-5 µm) and an aluminosilicate (e.g., halloysite) in a ratio of 15:2% w/v achieves sufficient contrast visualization. The instant rejection does not hinge on the BaSO4 disclosed by Felder and Ruddy being physically extracted from these references and placed into the composition disclosed by Schomburg or Dubey.
Moreover, bulk density is immaterial to the present claims. True density is the value that properly applies to the instant rejection. True density is the ratio of a particle's mass to its volume, excluding the interparticle void space. Bulk density is the ratio of a particle’s total mass to total volume, including the interparticle void space. The instant claim states that the volume of barite and halloysite is relative only to the total volume of mineral materials, not the volume of mineral materials and additionally interparticle void space (e.g., space occupied by air and water). Therefore, using Felder's bulk density value would not determine the volume of BaSO4 and halloysite relative to the total volume of mineral materials in the composition disclosed by Schomburg. Rather, Felder’s bulk density value would determine the volume of BaSO4 and halloysite relative to the total volume of mineral materials, as well as the interparticle void space.
Furthermore, Felder’s bulk density value is inconsistent with the density described in the present claims. True density is the value that would allow a POSITA to determine the volume of BaSO4 and halloysite in the composition disclosed by Schomburg and Dubey, by excluding interparticle void spaces to properly account for the mineral materials only, as required by the present claims.
Applicant asserts, “A person of ordinary skill in the art (POSITA), when attempting to combine the teachings of multiple references, would be guided by the explicit disclosures within those references. A POSITA would have no reason to disregard the specific bulk density for the sintered powder taught by Felder and instead search for a different, theoretical density for a different form of barite. The Examiner's selection of 4.5 g/cm3 constitutes hindsight, chosen because it allows for a post-hoc reconstruction of the Applicant's claimed invention. An obviousness analysis must be based on what the references would have fairly suggested to a POSITA before the invention was made, not on a roadmap constructed with the blueprint of the claims in hand.” [Remarks 5/26/2026, Page 1, Paragraph 4]
Applicant’s argument is not persuasive because a POSITA does not need to be guided by the explicit disclosure of a reference, and using the true density of BaSO4 does not constitute impermissible hindsight. The Applicant's own acknowledgment that this value represents the theoretical density of pure crystalline barite and may be found in a handbook confirms that the value is a recognized property of BaSO4, not gleaned from the Applicant's own disclosure. Applicant's allegations of impermissible hindsight amount to an assertion that a POSITA would not have known that the true density of BaSO4 is 4.5 g/cm3 if the Applicant’s disclosure did not provide this information. However, the Applicant’s disclosure does not provide the true density of BaSO4, specify the type of density required to arrive at the claimed volume, or provide the density value used to arrive at the claimed volume. The specifications' few references to density are unrelated to the claimed volume ratio. Accordingly, A POSITA could not have gleaned any information about the density value from the Applicant’s disclosure.
The MPEP explicitly disproves Applicant’s assertion that POSITA needs to be guided by the explicit disclosure of a reference:
The focus when making a determination of obviousness should be on what a person of ordinary skill in the pertinent art would have known at the relevant time… This is so regardless of whether the source of that knowledge and ability was documentary prior art, general knowledge in the art, or common sense. MPEP 2141(II).
"[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." MPEP 2144.01.
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. MPEP 2144(I).
Applicants may also argue that the combination of two or more references is "hindsight" because "express" motivation to combine the references is lacking. However, there is no requirement that an "express, written motivation to combine must appear in prior art references before a finding of obviousness." MPEP 2145(X)(A).
The true density of BaSO4 is a fixed, inherent property of the mineral itself, readily available in any standard reference source, and would have been known to a POSITA independent of any teaching in Felder or Ruddy. A chemical composition and its properties are inseparable. It is not necessary that the compound explicitly disclose that the true density of BaSO4 is 4.5 g/cm3.
Applicant asserts the following:
“Corrected Calculation: Volume of BaSO4 = 1900 g/2.5 g/cm3 = 760 cm3
Volume of Halloysite = 265 g / 2.6 g/cm3 = 102 cm3
Total Mineral Volume= 760 cm3 + 102 cm3 = 862 cm3
Resulting Composition:
Volume Ratio (Barite:Halloysite) = 760: 102 = 7.5: 1
Volume % of Barite = (760 / 862) * 100% = 88.2 vol.-%
These results are not a near miss; they are a clear teaching away from the claimed invention. A
volume ratio of approximately 7.5: 1 and a barite content of 88.2 vol.-% do not teach, suggest, or motivate the claimed ratio of 4:1 and content of 80 vol.-%.” [Remarks 5/26/2026, Page 2]
Applicant's calculation is internally inconsistent and should be accorded no weight because Applicant does not apply the same type of density to determine the halloysite and BaSO4. Applicant uses the true (mineral) density to determine the volume of halloysite but uses Felder’s bulk density to determine the volume of BaSO4. The value obtained by the Applicant mixes Schomburg’s true density with Felder’s bulk density. This methodology does not yield a meaningful volume ratio or a volume consistent with the requirements of the present claims. Moreover, Applicant's recalculation does not reflect the actual volume ratio of the mineral materials in the composition disclosed by Schomburg because Felder’s bulk density necessarily accounts for the volume of BaSO4, interparticle void space (e.g., space occupied by air and water). True density is the value that should be used to determine the volume occupied by each mineral component in the composition disclosed by Schomburg because it excludes interparticle void spaces and properly accounts for the mineral materials only, as required by the present claims.
Moreover, the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed. MPEP 2145(X)(D)(1). The prior art does not criticize, discredit, or otherwise discourage obtaining the volume of BaSO4 using true density. Therefore, Applicant’s own recalculation using another density value cannot constitute teaching away by the prior art.
Applicant asserts “Applicant’s claims are defined by volume ratios (e.g., "four volume parts barite to one volume part halloysite" and "80% by volume barite"). In contrast, Ruddy teaches compositions defined by weight per volume (% w/v), such as "1-2 %" clay and "15-25%" contrast agent (Office Action, p. 12, citing Ruddy).” [Remarks 5/26/2026, Page 5]
To convert % w/v to % w/w in an aqueous solution, divide the % w/v value by the total density of the solution (in g/mL). The solution in Ruddy is water, and water has a density of about 1 g/mL. Therefore, the % w/v values disclosed by Ruddy are equal to the % w/w values.
Applicant asserts, “A thorough review of Ruddy, however, confirms that Ruddy provides no disclosure or suggestion of the density of its BaSO4 material.” [Remarks 5/26/2026, Page 5]
The true density of BaSO4 (4.5 g/cm3) is a fixed, inherent property of the compound itself. A chemical composition and its properties are inseparable. It is not necessary that Ruddy explicitly disclose that the true density of BaSO4 is 4.5 g/cm3.
Applicant asserts, “…. would have had no reason or motivation to select a density of precisely 4.5 g/cm³ to perform such a conversion.” [Remarks 5/26/2026, Page 5]
A POSITA need not “select” a density of 4.5 g/cm3. The true density of BaSO4 (4.5 g/cm3) is a fixed, inherent property of the mineral itself. A chemical composition and its properties are inseparable. If BaSO4 is selected, its true density is also necessarily selected.
Applicant asserts “The possible BaSO4 materials include various forms (e.g., precipitated, ground, sintered) with a wide range of bulk densities.” [Remarks 5/26/2026, Page 5]
As explained above, bulk density is immaterial to the present claims. Moreover, every form of BaSO4 would read on the claimed limitations because, regardless of physical form, each form of BaSO4 has the same true density, which is the density relevant to the present rejection.
Applicant asserts, “The POSITA would be required to guess the correct density from a multitude of possibilities to achieve the specific claimed result.” [Remarks 5/26/2026, Page 5]
True density does not need to be guessed, as it is a fixed value.
Conclusion
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/K.A.C./Examiner, Art Unit 1618 /Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
