FINAL 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 .
Priority
This application is a CIP of 16460533 filed 07/02/2019 (PAT 11510820).
16460533 is a CIP of 16131300 filed 09/14/2018 (PAT 11304853).
16131300 is a CIP of 15842170 filed 12/14/2017 (ABN).
15842170 has PRO of 62555264 filed 09/07/2017 and PRO of 62533887 filed 07/18/2017.
15842170 is also a CIP of 14989186 filed 01/06/2016 (ABN).
14989186 is a CIP of 14190220 filed 02/26/2014 (ABN).
However, at least the following subject matters are not present or supported in parent application of 16460533:
“non-zero silver concentration,” “operable to contact a wound site of a wearer,” “backing sheet portion configured to be separated from the wound site by the absorbent pad,” and “the backing sheet portion is operable to provide a reservoir of silver particles that propagate outwardly from the bandage over time to release silver ions to the skin around the wound site and provide antimicrobial properties to the skin” of claim 21
subject matter of claim 22
subject matter of claim 23
subject matter of claim 24,
subject matter of claim 25
subject matters of claims 32-34
subject matters of claims 38-40.
At least the following subject matters are not present or supported in parent application of 16131300:
“non-zero silver concentration,” “operable to contact a wound site of a wearer,” “backing sheet portion configured to be separated from the wound site by the absorbent pad,” and “the backing sheet portion is operable to provide a reservoir of silver particles that propagate outwardly from the bandage over time to release silver ions to the skin around the wound site and provide antimicrobial properties to the skin” of claim 21
subject matters of claims 22-28
subject matters of claims 35, 39, and 40
At least the following subject matters are not present or supported in parent application of 15842170:
subject matters of claims 21-40
At least the following subject matters are not present or supported in parent application of 14989186:
subject matters of claims 21-40
At least the following subject matters are not present or supported in parent application of 14190220:
subject matters of claims 21-40
At least the following subject matters are not present or supported in provisional applications of 62555264 and 62533887:
subject matters of claims 21-40
Thus, claims 21-40 will not receive priority filing date benefits of parent applications 16460533, 16131300, 15842170, 14989186, and 14190220, as well as, provisional applications 62555264 and 62533887.
Accordingly, claims 21-40 are afforded the effective filing date of 11/10/2022 (actual filing date).
Status of the Claims
This action is in response to papers filed 12/01/2025 in which claims 1-20 were canceled; and claims 21-40 were newly added. All the amendments have been thoroughly reviewed and entered.
Claims 21-40 are under examination.
Terminal Disclaimer
The terminal disclaimer filed on 12/01/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No(s) 11510820 and 11304853 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Objections/Rejections
The Examiner has re-weighted all the evidence of record. Any rejection and/or objection not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
New Objection
Claim Objections
Claim 36 is objected to because of the following informalities: “the layer of the silver material includes one of an electroless plating layer, a sputtering deposit layer, a dip coating layer, and a nano-coating layer” is an improper Markush language. When materials recited in a claim are so related as to constitute a proper Markush groups, they may be recited in the conventional manner, or alternatively. For example, if “wherein R is a material selected from the group consisting of A, B, C and D” is a proper limitation, then “wherein R is A, B, C or D” shall also be considered proper. Appropriate correction is required.
New Rejections
Necessitated by Applicant’s Claim Amendments
Claim Rejections - 35 USC § 112 – NEW MATTER
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 21-23 introduces new matter as the claim recites the limitation: “non-zero silver concentration.” There is no support in the specification for this limitation. While the specification discloses “the second oligodynamic concentration may be less than 2% by weight” (Specification: [0012]) and that “either or both of absorbent material 722 and net layer 724 can include a silver treatment resulting in exemplary 1%-2% silver concentration” (Specification: [0095]), these are not support for the negative limitation of “non-zero silver concentration,” as the disclosure of “less than 2% by weight” include 0%, and [t]he mere absence of a positive recitation is not basis for an exclusion, as any negative limitation or exclusionary proviso must have basis in the original disclosure. See MPEP §2173.05(i).
Claims 32-34 introduce new matter as the claims recite the limitations: “the second silver treatment comprises a layer of silver having a thickness of between 1 micron and 15 microns,” “the second silver treatment comprises a layer of silver having a thickness of between 15 microns and 30 microns,” and “the second silver treatment comprises a layer of silver having a thickness of between 30 microns and 45 microns,” respectively. There are not support for the above limitations as the pertain to the ranges of the thickness for the layer of silver. The specification discloses:
“[s]chemes can include the second silver concentration in the pad having a thickness of 100 nanometers (nm) or less, the second silver concentration in the pad having a thickness of between 100 nm and 500 nm. the second silver concentration in the pad having a thickness of between 500 nm and 1 micron, the second silver concentration in the pad having a thickness of between 1 micron and 5 microns, and the second silver concentration in the pad having a thickness of greater than 5 microns” (see Specification, paragraph [0096]).
However, nowhere in paragraph [0096] does it provide support for or discloses the particular thickness ranges of “between 1 micron and 15 microns,” “between 15 microns and 30 microns,” and “between 30 microns and 45 microns,” respectively of claims 32-34.
Claim 38 introduces new matter as the claims recites the limitation: “a layer of silver material upon the net layer material.” There is no support in the specification for this limitation. Paragraph [0094] of the specification discloses:
“FIG. 20 illustrates in cross section an exemplary bandage with multiple layers with different concentrations of silver treatment upon different portions of the bandage. Bandage 700 is illustrated including a cloth portion 710 and an absorbent pad portion 720. Cloth portion 710 includes two side tab portions 712 and one central portion 714. Central portion 714 can be indented or recessed to permit the addition of adhesive pad portion 720 thereto, while permitting a bottom of each side tab portion 712 and a bottom of the absorbent pad portion 720 being nearly co-planar and easy to install to skin of a patient. Absorbent pad portion 720 can include an absorbent material 722 and a thin net layer 724 retaining absorbent material 722 in place. Adhesive layers 730 are illustrated provided upon a bottom of each side tab portions 712.”
Also, paragraph [0095] of the specification discloses:
“[v]arious portions of bandage700 can include silver of different percentages or concentrations. For example, either or both of absorbent material 722 and net layer 724 can include a silver treatment resulting in exemplary 1%-2% silver concentration. Additionally, cloth portion 710 can include threads with a silver treatment, a silver coating upon top surface 715 of cloth portion 710. or any other silver treatment described herein, with a resulting silver concentration of between 5-15%.”
However, nowhere in paragraphs [0094]-[0095] do they disclose a layer of sliver material upon the net layer material, as recited in claim 38.
Claim 39 introduces new matter as the claims recites the limitations: all limitations pertaining to “metal treatment,” as well as, “non-zero metal concentration.” There is no support for the genus of “metal” and the negative limitation of “non-zero metal concentration.” While paragraph [00112] of the specification discloses: “cloth layers and threads including metallic content can include oligodynamic materials” and “[o]ligodynamic materials can include but are not limited to silver, gold, copper, brass, and platinum,” this is not support for the broad breadth of the genus of metal which includes hundreds of metals including nickel, manganese, chromium, potassium, magnesium, zinc, and strontium – to name a few--, which are not supported by Applicant’s specification. With respect to the limitation of “non-zero metal concentration,” it is noted that while the specification discloses “the second oligodynamic concentration may be less than 2% by weight” (Specification: [0012]) and that “either or both of absorbent material 722 and net layer 724 can include a silver treatment resulting in exemplary 1%-2% silver concentration” (Specification: [0095]), these are not support for the negative limitation of ““non-zero silver concentration,” as the disclosure of “less than 2% by weight” include 0%, and [t]he mere absence of a positive recitation is not basis for an exclusion, as any negative limitation or exclusionary proviso must have basis in the original disclosure. See MPEP §2173.05(i).
Claim 40 introduces new matter as the claims recites the limitation: “non-zero silver concentration.” There is no support in the specification for this limitation. While the specification discloses “the second oligodynamic concentration may be less than 2% by weight” (Specification: [0012]) and that “either or both of absorbent material 722 and net layer 724 can include a silver treatment resulting in exemplary 1%-2% silver concentration” (Specification: [0095]), these are not support for the negative limitation of ““non-zero silver concentration,” as the disclosure of “less than 2% by weight” include 0%, and [t]he mere absence of a positive recitation is not basis for an exclusion, as any negative limitation or exclusionary proviso must have basis in the original disclosure. See MPEP §2173.05(i).
MPEP §2163.06 states: “Applicant should therefore specifically point out the support for any amendments made to the disclosure.” Applicant has not directed the Examiner to the support in the specification for the amendments.
Claims 24-31 and 35-37 are also rejected as they are dependent from rejected base claim 21, thereby also contains the conflicting new matter materials.
As such, it is the Examiner’s position that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendments at the time of filing of the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-40 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 claims 21, 39, and 40, the recitation of "configured" in claims 21, 39, and 40 render said claim indefinite. It is unclear how the backing sheet portion or the adhesive layer is "configured" to “be separated from the wound site by the absorbent pad portion” or “adhere the bandage to the skin around the wound site without contacting the wound site,” respectively of claims 21, 39, and 40, as the specification does not define what is meant by “configured.” It is noted that the term "configured" is typically used in the electronics art (i.e., to design, arrange, set up or shape something on a computer or other electronic devices), and thus, nothing in said claims relate to the electronics art. It is suggested that “configured” languages be removed from said claims. Claims 22-38 are also rejected as they depend directly or indirectly from indefinite claim 21.
As a result, claims 21-40 do not clearly set forth the metes and bounds of patent protection desired.
Claim Rejections - 35 USC § 102
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) 21-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stojanovski (US 2019/0008688 A1; cited in IDS filed 11/14/2024).
Regarding claims 21, 39, and 40, Stojanovski teaches a bandage includes multiple portions with different concentrations of silver treatment upon the portions of the bandage, wherein the bandage include (i) a cloth layer portion (backing sheet) including a first silver treatment including a first silver concentration; and an adhesive layer upon a bottom surface of the cloth layer portion configured to adhere the bandage to skin of a wearer; and (ii) an absorbent pad portion comprising a second silver treatment including a second silver concentration lower than the first silver concentration (Abstract; [0011]-[0048] and [0040]-[0095]; claims 1-20). Stojanovski teaches the cloth portion includes two side tab portions and one central portion provided therebetween the first silver treatment containing the first silver concentration ([0082]). Stojanovski teaches the absorbent pad portion is provided on a bottom surface of the central portion of the cloth layer portion ([0011]-[0039] and [0082]). Stojanovski further teaches absorbent pad portion comprising a second silver treatment including a second silver concentration lower than the first silver concentration (Abstract; [0010], [0081]; claim 1). Stojanovski further the absorbent pad provides silver ions directly to the wound site on the skin of the user, while the cloth layer provides a reservoir of silver that can propagate outwardly from the bandage over time ([0080]-[0081]). Stojanovski further teaches the first silver concentration is between 15% and 25% by weight, and the second silver concentration is 1%-2% by weight ([0070]-[0080], [0084]; claims 5-9). Stojanovski teaches the second silver concentration can be less than 2% by weight or less than 1% by weight ([0070]-[0080], [0084]; claims 5-9).
Regarding claims 22-26, Stojanovski further teaches the first silver concentration is between 15% and 25% by weight, and the second silver concentration is 1%-2% by weight ([0070]-[0080], [0084]; claims 5-9). Stojanovski teaches the second silver concentration can be less than 2% by weight or less than 1% by weight ([0070]-[0080], [0084]; claims 5-9).
Regarding claim 27, Stojanovski teaches the bandage contains a planar gauze pad that includes first planar side and a second planar side, and the first planar side is covered in an entirety with the backing sheet portion and the second planar side is covered in an entirety with the absorbent pad portion ([0078]-[0087[; Figs. 6-30).
Regarding claim 28, Stojanovski teaches that in place of the cloth layer, a non-fabric material like polymers, rubber, latex, or non-latex substitutes can be used ([0061], [0067], [0091]).
Regarding claim 29, Stojanovski teaches the second silver treatment comprises a layer of silver having a thickness of less than 100 nanometers.
Regarding claim 30, Stojanovski teaches the second silver treatment comprises a layer of silver having a thickness of between 100 nanometers and 500 nanometers.
Regarding claim 31, Stojanovski teaches the second silver treatment comprises a layer of silver having a thickness of between 500 nanometers and 1 micron.
Regarding claim 32, Stojanovski teaches the second silver treatment comprises a layer of silver having a thickness of between 1 micron and 15 microns.
Regarding claim 33, Stojanovski teaches the second silver treatment comprises a layer of silver having a thickness of between 15 micron and 30 microns.
Regarding claim 34, Stojanovski teaches the second silver treatment comprises a layer of silver having a thickness of between 30 micron and 45 microns.
Regarding claims 35-36, Stojanovski teaches a silver coating can be additionally added upon top surface of the cloth layer portion ([0027], [0083], [0085]-[0086], [0093]). Stojanovski teaches the silver coating on the cloth layer of the bandage threads that make the bandage cloth layer can be coated with common textile coating techniques such as electroless plating, sputtering, dip coating, and nano-coating ([0085]-[0087], [0094]; claim 4).
Regarding claim 37, Stojanovski teaches the silver can be distributed only around a perimeter of the bandage ([0093]).
Regarding claim 38, Stojanovski teaches the absorbent pad contains an absorbent material and a thin net layer retaining the absorbent material in place, wherein the net layer can include a silver treatment ([0039], [0082], and [0095]).
As a result, the aforementioned teachings from Stojanovski are anticipatory to claims 21-40 of the instant invention.
Response to Arguments
Applicant's arguments filed 12/01/2025 have been fully considered but they are not persuasive.
Below is the Examiner’s response to Applicant’s arguments as they pertain to the pending 102 rejection.
Applicant argues:
“In light of the claims reciting "oligodynamic treatments" or "oligodynamic concentrations" being cancelled, the Applicant respectfully submits that the priority claim of claims 21-40 in the present application to U.S. Application No. 16/131,300 is valid. As a result, the publication of U.S. Application No. 16/131,300 as US 2019/0008688 is not valid prior art against new claims 21-40.” (Remarks, page 7, last paragraph).
In response, the Examiner disagrees. As discussed above in the Priority section, new claims 21-40 did not receive priority filing date benefits of parent applications 16460533, 16131300, 15842170, 14989186, and 14190220, as well as, provisional applications 62555264 and 62533887. See Priority section, pages 2-4 of this office action. Thus, claims 21-40 were afforded the effective filing date of 11/10/2022 (actual filing date). As such, Stojanovski remained valid as prior art under 102(a)(1).
As a result, the teachings from Stojanovski remained anticipatory to claims 21-40 of the instant invention.
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.
Claim(s) 21-28 and 35-40 is/are rejected under 35 U.S.C. 103 as being unpatentable Case-Gustafson et al (WO 2013/177124 A2) in view of Patel (US 2014/0107555 A1) and Flach et al (WO 2016/038111 A1).
Regarding claims 21, 39, and 40, Case-Gustafson teaches an adhesive bandage adhere to skin of a user comprising a carrier (a backing sheet portion) containing an inner face, an outer face, and an adhesive arranged along the inner face, and an absorbent pad arranged along at least a central portion of the inner face and arranged to contact a wound of the user (Abstract; [0017]-[0064] and [0071]-[0088]; claims 1-29; Figs. 1-9). Case-Gustafson teaches carrier contains an electrically conductive material, as well as, the absorbent pad also contains an electrically conductive material (Abstract; [0017]-[0064] and [0071]-[0088]; claims 1-29). Case-Gustafson teaches the electrically conductive material is selected from aluminum, chromium, copper, silver, gold, titanium, tin or tungsten, wherein silver is preferred for having anti-bacterial properties ([0051]).
While Case-Gustafson does not expressly teach the bandage containing different concentrations of the electrically conductive material in which the electrically conductive material present in the absorbent pad is of a lower concentration than the electrically conductive material in the carrier (backing sheet portion), it would have been obvious to formulate the bandage of Case-Gustafson to contain containing different concentrations of the electrically conductive material (oligodynamic material) in which the electrically conductive material present in the absorbent pad is of a lower concentration than the electrically conductive material in the carrier (backing sheet portion), in view of the guidance from Patel and Flach.
Patel teaches a multi-layer wound dressing having layers with different concentrations of antimicrobial agent such as silver, wherein the dressing can be constructed with at least one interior layer (backing sheet portion) and at least one exterior layer having an absorbent material, and wherein the interior layer and exterior layer contain the antimicrobial agent in different amounts, particularly the at least one interior layer contains a relatively higher concentration of the antimicrobial agent than the exterior layer ([0048]-[0122]; claims 1-14). Patel teaches the concentration of the antimicrobial agent in the interior layer can be at least 30,000 ppm (3%) and the exterior layer is contains the antimicrobial agent in an amount less than the amount contained in the interior layer ([0053]-[0100]). Patel teaches the construction of the wound dressing to contain different concentrations of the antimicrobial agent provides controlled release of the antimicrobial agent over an extended period of time ([0053]-[0054]).
Flach teaches the concept of constructing a wound dressing in which two chemical compounds, preferably silver, is present in the wound dressing at different concentration, wherein the skin-facing surface has a lower concentration of silver than the backing layer (adhesive layer) (Abstract; pages 1-14; claims 1-15). Flach teaches a first concentration of silver is present in the adhesive layer and a second concentration of silver is present in the skin-facing surface of the adhesive layer, wherein the ratio between the second and first concentration is in the range of 1:5 to 1:100, and particularly 1:10 to 1:50 (pages 3, 6-7, 9, and 13-14). Flach teaches that by varying the concentration of the first and second chemical compounds, release profile of the dressing can be tailor made for different application and would allow for a more controlled release of the first and second chemical compounds by maintaining the release of the compounds (silver) over a desired period of time (pages 7, 9, and 13-14).
It would have been obvious to one of ordinary skill in the art to construct the bandage of Case-Gustafson to contain different concentrations of the electrically conductive material (silver) in which the electrically conductive material present in the absorbent pad is of a lower concentration than the electrically conductive material in the carrier (backing sheet portion), and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Patel and Flach established that such a construction of different concentrations of silver allows for a more controlled release of silver over an extended period of time. Thus, an ordinary artisan seeking to provide a bandage which provides sustained release of the electrically conductive material (silver) over an extended period of time would have looked to constructing the bandage of Case-Gustafson to contain different concentrations of the electrically conductive material (silver) in which the electrically conductive material present in the absorbent pad is of a lower concentration than the electrically conductive material in the carrier (backing sheet portion), and achieve Applicant’s claimed invention with reasonable expectation of success.
It would also have been obvious to optimize the concentration of the electrically conductive material in the absorbent pad to a lower concentration as claimed in claims 21, 39, and 40, and produce the claimed invention. One of ordinary skill in the art would have been motivate do so because as discussed above, to provide wound dressing (bandage) that allows for a more controlled release of the antimicrobial agent (silver) over an extended period of time, the concentration of antimicrobial agent (silver) in an interior layer (backing sheet portion) can be at least 30,000 ppm (3%) (first concentration) and the exterior layer (an absorbent containing layer/portion) contains the antimicrobial agent in an amount (second concentration) less than the amount contained in the interior layer per Patel, where Flach established that the ratio between the second and first concentration is in the range of 1: to 1:100, and particularly 1:10 to 1:50, which are concentration amounts/ratios that overlaps the claimed 1%-2% for the absorbent pad portion (second concentration). Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the backing sheet portion and the absorbent pad portion such that the concentration of the concentration of the electrically conductive material (silver) in the absorbent pad portion is lower than the concentration in the backing sheet portion would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claims 22-26, as discussed above, to provide wound dressing (bandage) that allows for a more controlled release of the antimicrobial agent (silver) over an extended period of time, the concentration of antimicrobial agent (silver) in an interior layer (backing sheet portion) can be at least 30,000 ppm (3%) (first concentration) and the exterior layer (an absorbent containing layer/portion) contains the antimicrobial agent in an amount (second concentration) less than the amount contained in the interior layer per Patel, where Flach established that the ratio between the second and first concentration is in the range of 1: to 1:100, and particularly 1:10 to 1:50, which are concentration amounts/ratios that overlaps the claimed of ranges as recited in claims 22-26. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the backing sheet portion and the absorbent pad portion such that the concentration of the concentration of the electrically conductive material (silver) in the absorbent pad portion is lower than the concentration in the backing sheet portion would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim 27, Case-Gustafson teaches the absorbent pad portion contains a planar gauze material ([0009], [0023]-[0041]; Figs. 1-9).
Regarding claim 28, Case-Gustafson teaches the carrier can be a non-fabric material such as polymeric sheets, paper or foil ([0053]).
Regarding claims 35 and 36, Case-Gustafson teaches the carrier contains a coating layer of the electrically conductive material ([0013], [0051]). Patel provides the guidance for producing the coating layer by known technique of dip coating ([0107]).
Regarding claim 37, Case-Gustafson teaches the electrically conductive material is spread over a perimeter of the carrier ([0058]; claim 9).
Regarding claim 38, Case-Gustafson teaches the electrically conductive material is woven into, stitched into, or coated on the absorbent pad ([0051], [0058], [0060]; claim 5).
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 29 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable Case-Gustafson et al (WO 2013/177124 A2) in view of Patel (US 2014/0107555 A1) and Flach et al (WO 2016/038111 A1), as applied to claim 21 above, and further in view of Burrell et al (US 6,333,093 B1).
The bandage of claims 21 is discussed above, said discussion being incorporated herein in its entirety.
Regarding claims 29 and 30, Burrell teaches a multilayer antimicrobial wound dressing comprising a first layer (top layer - wound facing layer), a second layer (absorbent layer), and a third layer (outer layer), wherein the wound facing layer contains an antimicrobial coating layer (silver layer) and having a thickness of less than 400 nm, and wherein the outer layer also contains an antimicrobial coating layer (Abstract; columns 2-15; claims 1-44).
It would have been obvious to one of ordinary skill in the art to optimize the thickness of the electrically conductive material (silver) that is coated on the absorbent pad of Case-Gustafson to a thickness as recited in claims 29 and 30, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Burrell provided the guidance to do so by teaching that the thickness of the wound facing layer that contains an antimicrobial coating layer (the electrically conductive material (silver) that is coated on the absorbent pad) can be optimize to have a thickness of less than 400 nm, which is a thickness that overlaps the claimed thickness as recited in claims 29-30. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of thickness of the silver layer would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable Case-Gustafson et al (WO 2013/177124 A2) in view of Patel (US 2014/0107555 A1) and Flach et al (WO 2016/038111 A1), as applied to claim 21 above, and further in view of Flick (US 2004/0030276 A1).
The bandage of claims 21 is discussed above, said discussion being incorporated herein in its entirety.
Regarding claims 31 and 32, Flick teaches a wound dressing comprising at least one conductive layer (silver layer) coating on at least one absorbent layer (absorbent pad), wherein the conductive layer coated on the absorbent layer is wound facing, and having a thickness of varying from about 0.1 micrometers to about 2.0 microns and provide antibacterial environment that promotes wound healing (Abstract; [0064]-[0077], [0112], and [0132]).
It would have been obvious to one of ordinary skill in the art to optimize the thickness of the electrically conductive material (silver) that is coated on the absorbent pad of Case-Gustafson to a thickness as recited in claims 31 and 32, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Flick provided the guidance to do so by teaching that the thickness of the wound facing layer that contains an antimicrobial coating layer (the conductive layer (silver layer) that is coated on the absorbent layer) can be optimize to have a thickness of from about 0.1 micrometers to about 2.0 microns, which is a thickness that overlaps the claimed thickness as recited in claims 31-32. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of thickness of the silver layer would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 32-34 is/are rejected under 35 U.S.C. 103 as being unpatentable Case-Gustafson et al (WO 2013/177124 A2) in view of Patel (US 2014/0107555 A1) and Flach et al (WO 2016/038111 A1), as applied to claim 21 above, and further in view of Eckstein (US 2009/0216168 A1).
The bandage of claims 21 is discussed above, said discussion being incorporated herein in its entirety.
Regarding claims 32-34, Eckstein teaches a multilayer absorbent wound dressing containing a hydrophilic wound contact layer coated on (connected to) absorbent layer, wherein the hydrophilic wound contact layer contains silver and have a thickness of 10 µm to 250 µm, wherein the hydrophilic wound contact layer containing silver provide an antimicrobial effect that supports wound healing (Abstract; [0010]-[0011], [0038]-[0040] and [0055]-[0069]).
It would have been obvious to one of ordinary skill in the art to optimize the thickness of the electrically conductive material (silver) that is coated on the absorbent pad of Case-Gustafson to a thickness as recited in claims 32-34, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Eckstein provided the guidance to do so by teaching that the thickness of hydrophilic wound contact layer that contains silver (the conductive layer (silver layer) that is coated on the absorbent layer) can be optimize to have a thickness of 10 µm to 250 µm, which is a thickness that overlaps the claimed thickness as recited in claims 32-34. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of thickness of the silver layer would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 12/01/2025 have been fully considered but they are not persuasive.
Below is the Examiner’s response to Applicant’s arguments as they pertain to the pending 103 rejections
Applicant argues:
“The Patel reference apparently has a hydrophobic layer and a hydrophilic layer, similar to the present bandage, with the difference that Patel then disposes a second hydrophobic layer between the absorbent portion of the bandage and the skin of the patient. The Patel disclosure goes on to describe in paragraphs [0056] and [0057] that the absorbent, hydrophilic interior layer has a higher concentration of antimicrobial agent than the outer hydrophobic layers. The portion of the Patel bandage that is likely to be inundated with water-based substances has a higher concentration of antimicrobial. This is the opposite of the claimed bandage of the present application. Blood from a patient's wound reaching the inner layer of the Patel bandage would dissolve a large amount of the antimicrobial, which would then quickly leech out and come into contact with the wound of the patient. The Patel reference fails to teach a bandage with the fundamental properties or function of the disclosed bandage, operating in the reverse of the claimed bandage.” (Remarks, pages 9-10).
In response, the Examiner disagrees. The broader disclosure of not only paragraphs [0056] and [0057], but also paragraphs [0100]-[0102] of Patel do teach an interior layer (backing sheet portion) having a higher concentration of antimicrobial agent (i.e., 30,000 ppm = 3% by weight) than the exterior (outer) layer(s) (absorbent material) (i.e., 10,000 ppm = 1% by weight). Thus, the broader disclosures of Patel do contemplate and guide an ordinary artisan for optimizing the concentration of the absorbent pad to have a lower concentration as claimed.
Applicant is noted that [d]isclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). Furthermore, "[t]he 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…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Applicant argues:
“The Flach dressing includes an adhesive layer that contains the higher concentration of the antimicrobial agent that contacts the skin of the patient. This would be as if the absorbent layer of the presently claimed bandage included high concentration of silver (the opposite of the claimed device). The existence of a thin, soluble coating layer on the adhesive layer, which still permits contact of the adhesive layer to the skin of the patient, is irrelevant. The Flach dressing causes an absorbent adhesive layer with high concentration of antimicrobial agent to contact the wound site of the patient.” (Remarks, pages 10-12).
In response, the Examiner disagrees. Flach do teach the concept of constructing a wound dressing in which two chemical compounds, preferably silver, is present in the wound dress at different concentration, wherein the skin-facing surface has a lower concentration of silver than the backing layer (adhesive layer). Page 8 of Flach teaches the adhesive layer (a backing layer) contains a first chemical compound and a coating layer (a skin-surface layer) on the adhesive layer, wherein the coating layer contains a second chemical compound. Page 13 of Flach teaches the first and second compounds are both silver compounds. Pages 14 of Flach teaches the concentration of the first compound in the adhesive layer is a larger amount, and the concentration of the second compound in the surface coating (the skin-surface layer) is a smaller amount, particularly the ratio between the second and the first concentration is in the range of 1:5 to 1:100. Thus, contrary to Applicant’s allegation, Flach does not teach the opposite of the claimed invention, but rather the combined teachings of Patel and Flach teach toward Applicant’s claimed invention by providing guidance for construct the bandage of Case-Gustafson to contain different concentrations of the electrically conductive material (silver) in which the electrically conductive material present in the absorbent pad is of a lower concentration than the electrically conductive material in the carrier (backing sheet portion), as well as, the guidance for optimizing the concentration of the electrically conductive material in the absorbent pad to a lower concentration as claimed in claims 21, 39, and 40.
As a result, for at least the reasons discussed above, claims 21-40 remain rejected as being obvious and unpatentable over the teachings of the cited prior arts in the pending 103 rejections as set forth in this office action.
Conclusion
No claim is allowed.
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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/DOAN T PHAN/ Primary Examiner, Art Unit 1613