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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 1, 2, and 6-7 are objected to because of the following informalities:
Claim 1 recites the limitation “a wound dressing for placement on a wound”. This limitation should be amended to include “configured for” to avoid positive recitation of a human organism.
Claim 1 recites the limitation “wherein the fluid absorption layer comprises or a super-absorber”. This limitation should be amended to remove “or”.
Claim 2 recites the limitation “absorption of fluid”. This limitation while not unclear, should be amended to recite “the fluid” to maintain consistency and clarity in the claims.
Claim 6 recites the limitation “an opposite rear-side outer layer that faces away in relation to a skin surface”. This limitation should be amended to include “configured to” to avoid positive recitation of a human organism.
Claim 7 recites the limitation “a high ac voltage”. This limitation while not unclear, should be amended to recite “the high ac voltage” as this limitation was recited in claim 1 from which claim 7 indirectly depends.
Appropriate correction is required.
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 5, 9, and 14 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.
Claim 5 recites the limitation “the area of the passage openings” in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “an area of the passage openings”.
Claim 9 recites the limitation "the super-absorber’s own weight" in line 4. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a weight of the super-absorber”.
Regarding claim 14, the phrase "pocket-like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10 recites “wherein the electrode arrangement is configured to form a dielectric barrier plasma discharge”. This claim fails to limit claim 1 as claim 1 recites “an electrode arrangement for forming a dielectric barrier plasma discharge”. Thus, claim 10 does not recite any additional limitations or limiting structures to further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 6-12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hahnl et al. (DE 102017100192 A1) (hereinafter Hahnl; Examiner relies on a machine translation of the reference provided by Espacenet.com) in view of Cotton (WO 2015/173547 A1).
In regards to claim 1, Hahnl discloses a wound dressing (wound dressing; see [0008]; see figure 1) for placement on a wound located on a skin surface (see [0001]), comprising:
an electrode arrangement (arrangement of 6; see figures 8 and 10) for forming a dielectric barrier plasma discharge by way of at least one electrode (6; see [0020]; see figure 10) supplied with a high AC voltage (see [0015] in reference to “high-voltage signals, with which the dielectrically hindered plasma discharge; see [0017] in reference to said voltage being formed by converting DC voltage to AC voltage; and see [0020] that the dielectric layer acts as a shield or “barrier”; thus 6 is configured as claimed);
wherein the electrode arrangement (arrangement of 6) is completely embedded in a flat dielectric (5; see [0020]; see figure 8 and 11 that 6 is completely embedded within 5) comprising a wound application side (lower side of 5 facing 7; see figure 8);
wherein the at least one electrode (6) has intermediate spaces (through holes in 6; see [0027]) dispersed across a surface of the at least one electrode (6) that are aligned with passage openings (32; see [0026]; see figure 9) of the flat dielectric (5; see [0027]);
wherein the passage openings (32) have smaller dimensions than the intermediate spaces (through holes in 6) of the at least one electrode (6; see [0027]);
wherein the flat dielectric (5) completely covers the at least one electrode (6) in an area of the flat dielectric comprising the passage openings (area of 5 which comprises 32) and extends from the wound-side application side (lower side of 5 facing 7) to a rear side (upper side of 5 facing 8; see figure 8) of the flat dielectric (5; see [0020] in reference to 6 being embedded (i.e. completely covered) within 5; see [0026-0027] in reference to the continuous layer of 5 shielding 6 such that no liquid comes into contact with 6; see figures 8 and 11 that 5 continuously extends from the wound-side application side to a rear side of the flat dielectric as claimed);
wherein the rear side of the flat dielectric (upper side of 5 facing 8) is opposite the wound-side application side (lower side of 5 facing 7; see figure 8) and is permeable to fluid (see [0026] in reference to 5 comprising 32 from 31 on the lower side of 5, to 33 bounded to the upper side of 5; see figure 8);
a fluid absorption layer (33; see [0026] in reference to 33 being filled with absorbent material; see figure 8) for absorbing a fluid conducted through the passage openings (32; see [0037]) of the flat dielectric (5) from the wound-side application side (lower side of 5 facing 7) to the rear side (upper side of 5 facing 8), wherein the fluid absorption layer (33) rests against the rear side of the dielectric (upper side of 5 facing 8; see [0026] in reference to 33 being bounded by 5 (i.e. resting against 5).
Hahnl does not disclose wherein the fluid absorption layer comprises or a super absorber.
However, Cotton teaches an analogous wound dressing (601; see [pg 35 para 3]; see figure 6) for the analogous purpose of healing a user’s wounds (see [abstract]), comprising an analogous fluid absorption layer (612; see [pg 35 para 3]; see figure 7); wherein the fluid absorption layer (612) comprises or a super absorber (614; see [pg 35 para 3]; see figure 7; 614 is sodium polyacrylate which is a super-absorber) for the purpose of providing a liquid absorption layer that is capable of absorbing many times its own mass of fluids (see [pg 17 para 3]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid absorption layer as disclosed by Hahnl and to have included the sodium polyacrylate super absorber material as taught by Cotton in order to have provided an improved fluid absorption layer that would add the benefit of providing a liquid absorption layer that is capable of absorbing many times its own mass of fluids (see [pg 17 para 3]).
In regards to claim 2, Hahnl as now modified by Cotton discloses the invention as discussed above.
Hahnl as now modified by Cotton does not explicitly disclose wherein a cross-sectional size of the passage openings are designed such that absorption of fluid by the fluid absorption layer is supported by a capillary effect in the passage openings.
However, Cotton further teaches wherein a cross-sectional size (diameter) of the passage openings (first set of perforations; see [pg 9 para 1]) are designed such that absorption of fluid by the fluid absorption layer is supported by a capillary effect in the passage openings (see [pg 8 para 6]; the perforations of Cotton have a diameter of 50µm to 10 mm which is encompasses Applicant’s range of diameters disclosed to exhibit the claimed capillary action (see Applicant’s specification [pg 7]) and thus would have the same properties of exhibiting a capillary effect for removal of wound exudate (see MPEP 2112.01)) for the purpose of permitting fluid to pass through the film into the absorbent body (See [pg 8 para 6]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cross-sectional size of the passage openings as disclosed by Hahnl as now modified by Cotton and to have formed the passage openings with a diameter such that absorption of fluid by the fluid absorption layer is supported by a capillary effect in the passage openings as further taught by Cotton in order to have provided improved passage openings that would add the benefit of permitting fluid to pass through the film into the absorbent body (See [pg 8 para 6]) which would add the benefit of allowing the dressing of Hahnl to absorb fluid without the requirement for a suction device to facilitate removal of wound exudate.
In regards to claim 3, Hahnl as now modified by Cotton discloses the invention as discussed above.
Hahnl as now modified by Cotton does not disclose further comprising a wound contact layer that rests against the wound-side application side of the flat dielectric, wherein the wound contact layer is designed to be permeable to fluid to be absorbed by the fluid absorption layer in a direction of the electrode arrangement.
However, Cotton further teaches a wound contact layer, wherein the wound contact layer (615; see [pg 35 para 4]; see figure 7) is designed to be permeable to fluid to be absorbed by the fluid absorption layer (614) in a direction of the fluid absorption layer (614; see [pg 35 para 4]) for the purpose of providing a wound contact layer that is soft, tactile, conformable, and exhibiting good adhesion to dry skin but low adherence to the wound (see [pg 22 para 1]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wound-side application side of the flat dielectric as disclosed by Hahnl as now modified by Cotton and to have included the perforated wound contact layer that is designed to be permeable to fluid to be absorbed by the fluid absorption layer in a direction of the fluid absorption layer (and therefore in a direction of the electrode arrangement in the dressing of Hahnl) as further taught by Cotton in order to have provided an improved wound dressing that would add the benefit of providing a wound contact layer that is soft, tactile, conformable, and exhibiting good adhesion to dry skin but low adherence to the wound (see [pg 22 para 1]).
In regards to claim 4, Hahnl as now modified by Cotton discloses the invention as discussed above.
Hahnl as now modified by Cotton does not disclose wherein the passage openings of the flat dielectric have a diameter of between .5mm and 7mm.
However, Cotton further teaches he passage openings (first set of perforations; see [pg 9 para 1]) have a diameter of between .5mm and 7mm (see [pg 8 para 6]) for the purpose of permitting fluid to pass through the film into the absorbent body (See [pg 8 para 6]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the diameter of the passage openings of the flat dielectric as disclosed by Hahnl as now modified by Cotton and to have formed the passage openings with a diameter of 50µm to 10 mm as further taught by Cotton in order to have provided improved passage openings that would add the benefit of permitting fluid to pass through the dielectric into the absorbent body (See [pg 8 para 6]) which would add the benefit of allowing the dressing of Hahnl to absorb fluid without the requirement for a suction device to facilitate removal of wound exudate.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the diameter of the passage openings as disclosed by Hahnl as now modified by Cotton from 50µm to 10 mm to .5mm to 7mm as applicant appears to have placed no criticality on the claimed range (see Specification [pg 7] in reference to “according to one embodiment, it is provided for that the passage openings of the dielectric have a diameter of between 0.5mm and 7mm, preferably a diameter of between 0.75mm and 5mm” thereby disclosing there can be other embodiments with other diameters and the claimed diameter is a preferential design choice obvious to one of ordinary skill in the art) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. 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).
In regards to claim 6, Hahnl as now modified by Cotton discloses the invention as discussed above.
Hahnl further discloses further comprising a wound-side outer layer (7; see [0020]; see figure 8) and an opposite rear-side outer layer (8; see [0020]; see figure 8) that faces away in relation to a skin surface (See figure 8),
wherein the fluid absorption layer (33) is arranged between the wound-side outer layer (7) and the rear-side outer layer (8; see figure 8),
wherein an accommodation space is formed between the wound-side outer layer (7) and the fluid absorption layer (33; see figure 8), wherein the accommodation space is configured for having the electrode arrangement (arrangement of 6) arranged therein (See figure 8),
wherein the wound-side outer layer (7) is permeable to fluid to be absorbed by the fluid absorption layer (33) in a direction of the electrode arrangement (arrangement of 6; see [0026]).
In regards to claim 7, Hahnl as now modified by Cotton discloses the invention as discussed above.
Hahnl further discloses further comprising a connecting piece (11; see [0029]; see figure 7) of the electrode arrangement (arrangement of 6) that protrudes from the accommodation space (see figure 7) of the wound dressing configured for connecting the at least one electrode (6) to a high-voltage generator (2; see [0022]; see figure 3) for supplying a high AC voltage (see [0022]).
In regards to claim 8, Hahnl as now modified by Cotton discloses the invention as discussed above.
Hahnl further discloses wherein the passage openings (32) of the flat dielectric (5) comprise more than 20 passage openings (See figure that there is a 10x10 grid of passage openings or 100 total passage openings in 5).
In regards to claim 9, Hahnl as now modified by Cotton discloses the invention as discussed above.
Hahnl as now modified by Cotton further discloses wherein a water absorption capacity of the super-absorber (614 of Cotton) corresponds to the super-absorber’s own weight many times over (See Cotton [pg 17 para 3]).
In regards to claim 10, Hahnl as now modified by Cotton discloses the invention as discussed above.
Hahnl further discloses wherein the electrode arrangement (arrangement of 6) is configured to form a dielectric barrier plasma discharge (see discussion of claim 1 above).
In regards to claim 11, Hahnl as now modified by Cotton discloses the invention as discussed above.
Hahnl further discloses wherein the electrode arrangement (arrangement of 6) is designed to be flexible (See [0001]).
In regards to claim 12, Hahnl as now modified by Cotton discloses the invention as discussed above.
Hahnl further discloses wherein the at least one electrode (6) of the electrode arrangement (arrangement of 6) comprises at least two partial electrodes (6 and 6’; see [0034]; see figure 12) that are arranged next to each other (See figure 12) and insulated against each other by the flat dielectric (5; insulated by 37; see [0034]; see figure 12), wherein the at least two partial electrodes (6 and 6’) comprises neighboring partial electrodes (see figure 12) that are supplied by a control device (2; see [0022]; see figure 3) with compensating partial alternating voltages of opposite waveforms and voltage levels (see [0035] opposite polarity of high-voltage pulses are opposite waveforms and voltage levels).
In regards to claim 14, Hahnl as now modified by Cotton discloses the invention as discussed above.
Hahnl further discloses wherein the wound-side outer layer (7) and the rear-side outer layer (8) are connected to each other on three sides, thereby forming a pocket-like accommodation space (See figure 7 and 8 that 8 and 7 are connected to each other except where 11 extends outward from, thereby forming a pocket as claimed).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hahnl in view of Cotton as applied to claim 1 above, and further in view of Polak et al. (US 2021/0022234 A1) (hereinafter Polak).
In regards to claim 5, Hahnl as now modified by Cotton discloses the invention as discussed above.
Hahnl as now modified by Cotton discloses an area of the passage openings (32 of Hahnl as now modified by Cotton to have a diameter of 50µm to 10mm, thereby having an area of .0019635mm2 to 78.5mm2). Hahnl as now modified by Cotton does not explicitly disclose wherein the area of the passage openings of the flat dielectric corresponds to an area of .1% to 60% of an electrode area enclosed by an outer edge of the at least one electrode as Hahnl does not disclose the dimensions of the at least one electrode to determine the area of the electrode.
However, Polak teaches an analogous wound dressing (100; see [0399]; see figure 1) comprising an analogous electrode arrangement (10 and 12; see [0400]; see figure 1) for applying an analogous plasma treatment to a user (See [abstract]); wherein the electrode arrangement (10 and 12) has at least one electrode (10) wherein the at least one electrode has an electrode area enclosed by an outer edge of the at least one electrode (see [0148] in reference to the electrode structure being a square and [0155] in reference to the electrode having a width of 5mm, or 10mm; thereby disclosing an area of 25mm2 or 100mm2) for the purpose of providing an advantageous dimension (see [0155]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one electrode as disclosed by Hahnl as now modified by Cotton and to have formed the electrode with an area of 25mm2 or 100mm2 as taught by Polak as Polak teaches that such dimensions for electrodes applying plasma treatment is an advantageous dimension.
Thus, as now combined Hahnl as now modified by Cotton and Polak discloses a range of areas for the passage openings which are from 0.0019635% to 78.5% of the larger electrode area of the at least one electrode, which fully encompasses Applicant’s claimed range of .1% to 60%. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the areas of the passage openings with respect to the area of the at least one electrode as disclosed by Hahnl as now modified by Cotton and Polak from 0.0019635% to 78.5% to .1% to 60% as applicant appears to have placed no criticality on the claimed range (see Specification [pg 7] According to one embodiment, it is provided that the area of all passage openings of the dielectric corresponds to an area of 0.1% to 60% of the electrode area enclosed by the outer edge of the electrode. Preferably, the area corresponds to 1% to 35% of the enclosed electrode surface, thereby evidencing that there can be other embodiments which do not have the claimed dimensions and the claimed dimensions are design choice preferences obvious to one of ordinary skill in the art) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. 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).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hahnl in view of Cotton as applied to claim 1 above, and further in view of Wandke et al. (US 2019/0223280 A1) (hereinafter Wandke).
In regards to claim 13, Hahnl as now modified by Cotton discloses the invention as discussed above.
Hahnl as now modified by Cotton does not explicitly disclose wherein the partial electrodes are the same size.
However, Wandke teaches an analogous wound dressing (device as seen in figure 1 and 2) for applying plasma treatment to a user (see [abstract]) comprising two partial electrodes (2 and 3; see [0025]; see figure 1) that are arranged next to each other and insulated against each other by a flat dielectric (8; see [0028]; see figures 1 and 2) which are supplied by a control device (20; see [0035]; see figure 2) with compensating partial alternative voltages of opposite waveforms and voltage levels (see figure 3); wherein the partial electrodes (2 and 3) are the same size (see [0019]; See figures 1-3) for the purpose of uniformly distributing the plasma over the partial electrodes (see [0019]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the two partial electrodes as disclosed by Hahnl as now modified by Cotton and to have formed the two partial electrodes as the same size as taught by Wandke in order to have provided an improved electrode arrangement that would add the benefit of providing two partial electrodes with an identical size, so that the area that is effective for the formation of the plasma is distributed uniformly over the number of partial electrodes (see [0019]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL MILLER whose telephone number is (571)270-5445. The examiner can normally be reached Mon-Fri 8am-4pm.
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, Alireza Nia can be reached at 571-270-3076. 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.
/DANIEL A MILLER/Primary Examiner, Art Unit 3786