DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 2, 12 objected to because of the following informalities:
Claim 2 recites the limitation "such that sheet of absorbent material" in line 5 should be - such that the sheet of absorbent material-.
Claim 12 recites the limitation "such that sheet of absorbent material" in lines 3-4 should be - such that the sheet of absorbent material-.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 11-14 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hilfenhaus (US 20040259445 A1).
Regarding claim 11, Hilfenhaus discloses a bandage (Fig. 3-4) comprising:
a sheet of absorbent material having a first face and a second face (liquid-absorbing layer 1 having upper/first face and lower/second face, [0104] and Fig. 3; noted as being the “second layer” in claim 21) and defining a plurality of pores exposed at the first face for absorbing liquid from a wound ([0053] liquid-absorbing layer has a hole/mesh structure being a plurality of pores for absorbing liquid at the upper/first face facing towards the wound); and
a layer of metal bonded to the first face of the sheet of absorbent material (claim 46, second layer being the absorbent material 1 has a silver coating 3 on the surface facing the “first layer” 2 which is the first face therein as seen in Fig. 3 and [0103-0108]), wherein the layer of metal maintains openings to the plurality of pores at the first face, such that the sheet of absorbent material can absorb liquid from a wound through the first face ([0104, 0053, 0068, 0028] the second absorbent layer is capable of absorbing fluids and wound exudate therein thus the pores are implicitly maintained even with the metal bonded layer present).
Regarding claim 12, Hilfenhaus discloses the bandage of claim 11.
Hilfenhaus discloses a sheet of base material bonded to the second face of the sheet of absorbent material (Fig. 3 and [0108], backing layer 5 is a sheet of base material having a first/upper face and a second/lower face) (Fig. 3 and [0103-0108], absorbent material 1 lower/second face is bonded to the upper/first face of the backing layer),
the sheet of base material extending outward from the sheet of absorbent material such that sheet of absorbent material forms an absorbent pad on the sheet of base material and defines at least a first portion of the sheet of base material that extends outward from the absorbent pad (Fig. 6-7, the backing layer 5/base material extends outward from the sheet of absorbent material 1/A thus forming an absorbent pad A on the sheet of backing layer and the first portion of the backing layer 5 being the portion extending from the absorbent pad A);
adhesive disposed on a portion of at least a first portion of the first face of the sheet of base material, wherein the adhesive is configured to adhere the bandage to human skin (Fig. 3-4 and [0108], adhesive 6 disposed on the area of the backing layer around the absorbent pad A).
Regarding claim 13, Hilfenhaus discloses the bandage of claim 12.
Hilfenhaus discloses a perforated contact layer ([0023, 0068, 0105] and Fig. 3, first layer/liquid-permeable layer 2 being a perforated contact layer) disposed over the first face of the sheet of absorbent material including over the metal bonded to the sheet of absorbent material (Fig. 3, perforated contact layer 2 disposed over the silver metal bonded layer 3 and the absorbent material 1), such that the perforated contact layer is disposed between the sheet of absorbent material and the wound when the bandage is applied to human skin (Fig. 3 and [0046], perforated contact layer/first layer 2 contacts the wound and is thus between the wound and the absorbent material 1).
Regarding claim 14, Hilfenhaus discloses the bandage of claim 11.
Hilfenhaus discloses the metal includes one or more of silver, zinc, and copper (Hilfenhaus metal layer 3 on the absorbent layer 1 is silver [0107], Fig 3).
Regarding claim 18, Hilfenhaus discloses the bandage of claim 11.
Hilfenhaus discloses a layer of metal on a first face of the perforated contact layer (Fig. 3 and [0103-0108], aluminum 4 disposed on the first/lower face of the perforated contact layer 2),
wherein the first face of the perforated contact layer faces the first face of the sheet of absorbent material (Fig 3, first/lower face of contact layer 2 faces the first/upper layer of the absorbent material 1),
wherein the layer of metal bonded to the first face of the sheet of absorbent material includes a first metal and not a second metal (Fig. 3 and [0103-0108], silver layer 3 to the absorbent material 1 upper/first face is only silver being the first metal),
wherein the layer of metal on the first face of the perforated contact layer includes a second metal and not a first metal (Fig. 3 and [0103-0108], aluminum layer 4 to the contact layer 2 lower/first face is only aluminum being the second metal).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-6, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hilfenhaus (US 20040259445 A1) in view of Swisher (US 20220306888 A1).
Regarding claim 1, Hilfenhaus discloses a method for creating a bandage (Fig. 3-4, [0093-0094] bandage), the method comprising:
providing a sheet of absorbent material having a first face and a second face (liquid-absorbing layer 1 having upper/first face and lower/second face, [0104] and Fig. 3; noted as being the “second layer” in claim 21) and defining a plurality of pores exposed at the first face for absorbing liquid from a wound ([0053] liquid-absorbing layer has a hole/mesh structure being a plurality of pores for absorbing liquid at the upper/first face facing towards the wound);
the sheet of absorbent material having metal bonded to the sheet of absorbent material at the first face (claim 46, second layer being the absorbent material 1 has a silver coating 3 on the surface facing the “first layer” 2 which is the first face therein as seen in Fig. 3 and [0103-0108]).
Hilfenhaus does not disclose the method of disposing particle-free metal ink on the first face of the sheet of absorbent material; and curing the particle-free metal ink on the first face of the sheet of absorbent material to form metal bonded to the sheet of absorbent material at the first face.
However, Swisher provides a method of manufacturing metal layers ([0127-0129] metal complex layers) on flexible substrates such as bandages ([0237, 0150]) comprising the method steps of disposing particle-free metal ink on a face of a substrate; and curing the particle-free metal ink on the disposed face therein to form metal bonded to the substrate at the face therein (see [0161, 0016], molecular ink being particle-free metal ink (Abstract, “The molecular inks generally include a particle-fee metal-complex”, and [0009]) is disposed on a substrate surface and then cured to form a metal layer being a metallic structure).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the method of forming the metal bonded to the sheet of absorbent material of Swisher to be formed by the method steps as taught by Swisher, thus providing “the method of disposing particle-free metal ink on the first face of the sheet of absorbent material; and curing the particle-free metal ink on the first face of the sheet of absorbent material to form metal bonded to the sheet of absorbent material at the first face” in order to provide an improve end result as the particle-free ink method would provide an improved metal coated substrate therein that is resistant to degradation (Swisher [0087]).
Regarding claim 2, Hilfenhaus in view of Swisher discloses the method of claim 1.
Hilfenhaus further discloses providing a sheet of base material having a first face and a second face (Fig. 3 and [0108], backing layer 5 is a sheet of base material having a first/upper face and a second/lower face);
bonding the second face of the sheet of absorbent material to the first face of the sheet of base material (Fig. 3 and [0103-0108], absorbent material 1 lower/second face is bonded to the upper/first face of the backing layer),
the sheet of base material extending outward from the sheet of absorbent material such that sheet of absorbent material forms an absorbent pad on the sheet of base material and defines at least a first portion of the sheet of base material that extends outward from the absorbent pad (Fig. 6-7, the backing layer 5/base material extends outward from the sheet of absorbent material 1/A thus forming an absorbent pad A on the sheet of backing layer and the first portion of the backing layer 5 being the portion extending from the absorbent pad A); and
disposing adhesive on a portion of at least a first portion of the first face of the sheet of base material, wherein the adhesive is configured to adhere the bandage to human skin (Fig. 3-4 and [0108], adhesive 6 disposed on the area of the backing layer around the absorbent pad A).
Regarding claim 3, Hilfenhaus in view of Swisher discloses the method of claim 2.
Hilfenhaus further discloses disposing a perforated contact layer ([0023, 0068, 0105] and Fig. 3, first layer/liquid-permeable layer 2 being a perforated contact layer), over the first face of the sheet of absorbent material including over the metal bonded to the sheet of absorbent material (Fig. 3, perforated contact layer 2 disposed over the silver metal bonded layer 3 and the absorbent material 1), such that the perforated contact layer is disposed between the sheet of absorbent material and the wound when the bandage is applied to human skin (Fig. 3 and [0046], perforated contact layer/first layer 2 contacts the wound and is thus between the wound and the absorbent material 1).
Regarding claim 4, Hilfenhaus in view of Swisher discloses the method of claim 1.
Hilfenhaus/Swisher further discloses wherein disposing particle-free metal ink on the first face of the sheet of absorbent material includes one or more of printing, spraying, and contacting with an ink pad (as modified in claim 1 the silver metal layer 3 of Hilfenhaus is disposed as particle-free ink and then cured as taught by Swisher) (Swisher teaches ink deposition methods of printing, spraying, and contacting with an ink pad [0020]).
Regarding claim 5, Hilfenhaus in view of Swisher discloses the method of claim 1.
Hilfenhaus/Swisher further discloses the particle-free metal ink includes one or more of silver, zinc, and copper (as modified in claim 1 the silver metal layer 3 of Hilfenhaus is disposed as particle-free ink and then cured as taught by Swisher) (Hilfenhaus metal layer 3 on the absorbent layer 1 is silver [0107], Fig 3).
Regarding claim 6, Hilfenhaus in view of Swisher discloses the method of claim 1.
Swisher further teaches providing a plasma atmosphere proximate the particle-free ink during the curing ([0151, 0168, 0171] the particle-free ink is plasma atmosphere treated as part of the curing process).
Regarding claim 10, Hilfenhaus in view of Swisher discloses the method of claim 1.
Hilfenhaus/Swisher further discloses wherein disposing particle-free metal ink on the first face of the sheet of absorbent material includes depositing a first particle-free metal ink on the first face of the sheet of absorbent material (Hilfenhaus claim 46 the second layer being the liquid-absorbent material has a silver coating thereon as seen in Fig. 3, as modified by Swisher to be a particle-free metal ink being thus the first metal ink therein);
disposing a second particle-free metal ink on a first face of the perforated contact layer (Fig. 3 and claim 49, the first layer being the perforated contact layer/liquid-permeable layer has an aluminum layer disposed thereon, as modified by Swisher to be a particle-free metal ink being thus the second metal ink therein);
curing the second particle-free metal ink on the first face of the perforated contact layer (as modified by Swisher in claim 1, the metals of Hilfenhaus are disposed as particle-free metal ink and then cured, the aluminum layer being a second metal ink thus as combined therein),
wherein disposing the perforated contact layer over the first face of the sheet of absorbent material includes disposing the first face of the second particle-free metal ink facing the first face of the sheet of absorbent material (Fig. 3, the perforated contact layer first face having the aluminum layer 4 thereon is facing towards the absorbent material 1 first face with silver layer 3 thereon),
wherein the second particle-free metal ink includes at least one metal that is not in the first particle-free metal ink and the first particle-free metal ink includes at least one metal that is not in the second particle-free metal ink (Fig. 3, [0103-0108] aluminum layer 4 being the second metal ink as modified and the silver metal layer 4 being the first metal ink as modified are different metals).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hilfenhaus (US 20040259445 A1) in view of Swisher (US 20220306888 A1), in further view of Crisp (US 20100069813 A1).
Regarding claim 7, Hilfenhaus in view of Swisher discloses the method of claim 1.
Hilfenhaus/Swisher fails to disclose disposing a saline solution on the first face of the sheet of absorbent material after curing the particle-free metal ink on the first face; and drying the saline solution on the first face of the sheet of absorbent material to form a saline deposit at the first face of the sheet of absorbent material.
However, Crisp teaches an analogous wound dressing (10) (title) (Fig. 1-2) comprising analogous silver metal for improving wound care ([0020, 0026]) wherein saline solution is disposed on the silver for activating the silver antimicrobial effects therein ([0030]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method of Hilfenhaus/Swisher to have the step of disposing saline solution on the first face of the sheet of absorbent material after curing the particle-free metal ink on the first face (being the solid silver metal layer therein); and drying the saline solution on the first face of the sheet of absorbent material to form a saline deposit at the first face of the sheet of absorbent material (saline solution added would implicitly dry over time and form a saline deposit on the first face of the absorbent material having the silver therein) as taught by Crisp in order to activate/improve the effects of the silver metal therein and its antimicrobial effects (Crisp [0030]).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hilfenhaus (US 20040259445 A1) in view of Swisher (US 20220306888 A1), in further view of Skiba (US 7457667 B2).
Regarding claim 8, Hilfenhaus in view of Swisher discloses the method of claim 1.
Hilfenhaus/Swisher fails to disclose wherein disposing particle-free metal ink on the first face of the sheet of absorbent material includes: disposing a first particle-free metal ink on one or more first portions of the first face of the sheet of absorbent material; and disposing a second particle-free metal ink on one or more second portions of the first face of the sheet of absorbent material, wherein the second particle-free metal ink includes at least one metal that is not in the first particle-free metal ink and the first particle-free metal ink includes at least one metal that is not in the second particle-free metal ink.
However, Skiba teaches an analogous wound dressing (title) (Fig. 1-4) having an analogous absorbent material 22 with a first/upper surface (Fig. 4 and Col. 5 lines 4-12) comprising an analogous silver metal layer disposed thereon formed from an analogous silver ink therein (Col. 3 lines 34-67, silver ink electrodes being a metal layer formed on top of the absorbent material 22 as shown in Fig. 1-4),
wherein silver ink is a first metal ink disposed on the face of the sheet of absorbent material being on one or more first portions of the first face of the sheet of absorbent material (Fig. 1-2 and Col. 4 lines 30-52, silver ink spots forming a dot pattern);
wherein there is also a further a second metal ink on one or more second portions of the first face of the sheet of absorbent material (Fig. 1-2 and Col. 4 lines 30-52, masses of metal zinc ink interspersed on second other portions thereof),
wherein the second particle-free metal ink includes at least one metal that is not in the first particle-free metal ink and the first particle-free metal ink includes at least one metal that is not in the second particle-free metal ink (Fig. 1-2 and Col. 4 lines 30-52, first metal ink being silver and second metal ink being zinc).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method steps of Hilfenhaus/Swisher such that the disposed particle-free metal ink silver layer (of Hilfenhaus/Swisher) is instead the zinc and silver ink pattern layer as taught by Skiba (Fig. 1-2 and Col. 4 lines 30-52) such that the invention as combined provides wherein disposing particle-free metal ink on the first face of the sheet of absorbent material includes: disposing a first particle-free metal ink on one or more first portions of the first face of the sheet of absorbent material; and disposing a second particle-free metal ink on one or more second portions of the first face of the sheet of absorbent material, wherein the second particle-free metal ink includes at least one metal that is not in the first particle-free metal ink and the first particle-free metal ink includes at least one metal that is not in the second particle-free metal ink. This would provide an improved antimicrobial system by enabling the metal layer being the interspersed silver and zinc to provide voltage at the wound that would kill microbes and also provide other improved therapeutic effects (Skiba Col. 6 lines 52-66).
Regarding claim 9, Hilfenhaus in view of Swisher and Skiba discloses the method of claim 8.
Skiba further teaches wherein the one or more first portions of the first face of the sheet of absorbent material are interspersed amongst the one or more second portions of the first face of the sheet of absorbent material (Fig. 1-2 and Col. 4 lines 30-52, the first portions being the silver ink and the second portions being the zinc ink are interspersed amongst one another in the pattern shown in top of the absorbent material 22).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hilfenhaus (US 20040259445 A1), in further view of Crisp (US 20100069813 A1).
Regarding claim 15, Hilfenhaus discloses the bandage of claim 11.
Hilfenhaus fails to disclose a saline deposit at the first face of the sheet of absorbent material.
However, Crisp teaches an analogous wound dressing (10) (title) (Fig. 1-2) comprising analogous silver metal for improving wound care ([0020, 0026]) wherein saline solution is disposed on the silver for activating the silver antimicrobial effects therein which would form a saline deposit therein ([0030]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified bandage of Hilfenhaus to comprise a saline deposit at the first face of the sheet of absorbent material (being the solid silver metal layer therein) as taught by Crisp in order to activate/improve the effects of the silver metal therein and its antimicrobial effects (Crisp [0030]).
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hilfenhaus (US 20040259445 A1) in further view of Skiba (US 7457667 B2).
Regarding claim 16, Hilfenhaus discloses the bandage of claim 11.
Hilfenhaus fails to disclose wherein the layer of metal bonded to the first face of the sheet of absorbent material includes: one or more first portions including a first metal and one or more second portions including a second metal, wherein the one or more first portions do not include the second metal and the one or more second portions do not include the first metal.
However, Skiba teaches an analogous wound dressing (title) (Fig. 1-4) having an analogous absorbent material 22 with a first/upper surface (Fig. 4 and Col. 5 lines 4-12) comprising an analogous silver metal layer disposed (Col. 3 lines 34-67, silver ink electrodes being a metal layer formed on top of the absorbent material 22 as shown in Fig. 1-4),
wherein silver ink is a first metal ink disposed on the face of the sheet of absorbent material being on one or more first portions of the first face of the sheet of absorbent material (Fig. 1-2 and Col. 4 lines 30-52, silver ink spots forming a dot pattern);
wherein there is also a further a second metal ink on one or more second portions of the first face of the sheet of absorbent material (Fig. 1-2 and Col. 4 lines 30-52, masses of metal zinc ink interspersed on second other portions thereof),
wherein the one or more first portions do not include the second metal and the one or more second portions do not include the first metal (Fig. 1-2 and Col. 4 lines 30-52, first metal ink being silver and second metal ink being zinc).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified bandage of Hilfenhaus such that the silver metal layer (of Hilfenhaus) is instead the zinc and silver ink pattern layer as taught by Skiba (Fig. 1-2 and Col. 4 lines 30-52) such that the invention as combined wherein the layer of metal bonded to the first face of the sheet of absorbent material includes: one or more first portions including a first metal and one or more second portions including a second metal, wherein the one or more first portions do not include the second metal and the one or more second portions do not include the first metal. This would provide an improved antimicrobial system by enabling the metal layer being the interspersed silver and zinc to provide voltage at the wound that would kill microbes and also provide other improved therapeutic effects (Skiba Col. 6 lines 52-66).
Regarding claim 17, Hilfenhaus in view of Skiba discloses the bandage of claim 16.
Skiba further teaches wherein the one or more first portions are interspersed amongst the one or more second portions (Fig. 1-2 and Col. 4 lines 30-52, the first portions being the silver ink and the second portions being the zinc ink are interspersed amongst one another in the pattern shown in top of the absorbent material 22).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN S ALBERS whose telephone number is (571)272-0139. The examiner can normally be reached Monday-Friday 7:30 am to 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached at (571) 270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
Prosecution Insights