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
1. Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on 06/01/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this submission of the information disclosure statement is being considered by the examiner.
Response to Amendment
3. The amendment filed 10/02/2025 has been entered. Currently, claims 18-34 remain pending in the application. Claims 18-34 were amended to overcome previous claim objections and 35 USC 101 rejections in the Non-Final Office Action mailed 07/02/2025.
Response to Arguments
4. Applicant's arguments filed 10/02/2025 have been fully considered but they are not persuasive.
Therefore, the rejection is maintained with the current prior art of the record: Ludwig et al. (WO 2017109209), Hoffstetter et al. (U.S. Patent Pub. No. 20110313383), and Ring et al. (U.S. Patent Pub. No. 20080255531).
5. Applicant makes the argument that “firstly, it should be noted that Ludwig and Hoffstetter are directed to different types of medical devices having different functions and that are used for different purposes. Ludwig is directed to compression bandages, which are made from an elastic material and which are able to apply compressive pressure to an injured (i.e., a sprained) or swollen body part (see, for example, the Abstract and pages 1-2 of Ludwig). Hofstetter does not describe a compression bandage, but instead describes a wound dressing used to protect and cover a wound, such as a cut, scrape, or burn, that releases an exudate and which may become infected (see, for example, the Abstract and page 1 of Hofstetter). Wound exudates are problematic in that they may carry germs and can prevent proper healing of the wound (see page 3 of the English translation of the present specification). However, it is difficult to remove fluids away from a wound where a compression bandage is used because the compression can trap the fluid in the area of the wound. If an absorbent pad or wound contact layer is placed under the compression bandage, there is a risk that the pad or wound contact layer will slip relative to the compression bandage during use (see page 3 of the English translation of the present specification). The presently claimed invention seeks to address this problem by incorporating superabsorbent fibers within the first nonwoven layer of the compression bandage itself (see independent claim 18). Because the first and second layers are interconnected by means of a stitch-bonding process using an elastic sewing thread, the compression bandage is able to retain a degree of stretchability while also being able to absorb fluid from the wound without the need of an additional absorption pad. Ludwig does not teach or suggest any need to incorporate an absorbent layer, such as described in Hoffstetter. Ludwig also does not disclose that their compression bandage would benefit by increasing its fluid absorption capacity. Likewise, Hoffstetter does not teach or suggest combining their wound dressing with a compression bandage, or that the superabsorbent fibers used in their absorbent layer could be incorporated into a compression bandage and still allow the compression bandage to retain its stretchability and provide compression to the injured area.
Accordingly, the cited references themselves do not provide any reason or motivation to modify Ludwig with the superabsorbent fibers of Hoffstetter as suggested by the Office Action, much less allow one skilled in the art to predict that such a modification would be successful” (Remarks, Page 7, Paragraphs 3-5 and Page 8, Paragraphs 1-2).
In response to applicant's argument (Remarks, Page 7, Paragraphs 3-5 and Page 8, Paragraphs 1-2) that the secondary reference, Hofstetter, is nonanalogous art to the primary reference, Ludwig, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Ludwig already discloses the nonwoven layers 1,2. Hofsetter then also teaches a nonwoven layer 24,28 having superabsorbent integrated therein. Albeit that Ludwig and Hofsetter may not be in the same field of endeavor of compression bandages, even though they are both related to bandages, nonetheless Hofsetter still solves a problem faced by the inventor of a nonwoven layer with superabsorbent therein, and thereby Hofsetter is analogous art applicable to Ludwig and Applicant’s claimed invention; see MPEP 2144.04(iv). Additionally, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986); see MPEP 2145(IV). In this case, Hofsetter even suggests the non-woven layers 24,28 formed of polyester, thereby with the elastic sewing thread stitch-bonding of Ludwig continued to be maintained, provides an inherently compressive and stretchable nonwoven layer in the combination of Ludwig in view of Hofsetter as a whole. Furthermore, an absorbent pad isn’t being added as an additional layer to potentially cause slip, rather the superabsorbent is provided directly in the non-woven layer of the compression bandage of Ludwig, such that the combination of Ludwig in view of Hofstetter as a whole forms the same structure and material as claimed to result in a slip likelihood in as much as that of Applicant’s invention. Similarly, the combination of Ludwig in view of Hofstetter as a whole forms the same structure and material of the compression bandage as claimed as well maintains the external compressive wrapping force around the body part of Ludwig to result in a stretchability and compression profile in as much as that of Applicant’s invention. Therefore, non-slip, stretchability, and compression are maintained in the combination Ludwig in view of Hofstetter as a whole, such that combination is advantageously contemplated for the benefit of desirable sanitary and healing condition properties at the skin site by absorbing wound exudate via the superabsorbent fibers (Hofstetter, Paragraphs 24, 42, 47), without teaching away or jeopardizing the operability/functionality of Ludwig.
Accordingly, the 35 USC 103 rejection from the Non-Final Office Action mailed 07/02/2025 is maintained below.
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.
Claims 18-32 are rejected under 35 U.S.C. 103 as being unpatentable over Ludwig et al. (WO 2017109209) in view Hoffstetter et al. (U.S. Patent Pub. No. 20110313383).
Regarding claim 18, Ludwig discloses a compression bandage 1,2 (Page 3/32, Paragraph 17, Page 4/32, Paragraphs 16-18, Page 5/32, Paragraphs 6-10, Page 7/32, Paragraph 7, and Figure 1, compression bandage formed of a first skin facing cushion nonwoven layer 1 and a second support nonwoven layer 2 to the first nonwoven layer 1) comprising a first nonwoven layer 1 (Page 3/32, Paragraph 17, Page 4/32, Paragraphs 16-18, Page 5/32, Paragraphs 6-10, Page 7/32, Paragraph 7, and Figure 1) and at least a second nonwoven layer 2 (Page 3/32, Paragraph 17, Page 4/32, Paragraphs 16-18, Page 5/32, Paragraphs 6-10, Page 7/32, Paragraph 7, and Figure 1) which is connected to the first nonwoven layer in a planar manner (Page 3/32, Paragraph 17, Page 4/32, Paragraphs 1-2, 9-12, 16-18, Page 5/32, Paragraphs 6-10, Page 7/32, Paragraph 7, and Figure 1, stitch-bonding layers 1,2 along stitch lines in the same plane thereby providing a planner interconnection with elastic sewing thread), the two nonwoven layers 1,2 being interconnected by means of a stitch-bonding process via an elastic sewing thread (Page 3/32, Paragraph 17, Page 4/32, Paragraphs 1-2, 16-18, Page 5/32, Paragraphs 6-10, Page 7/32, Paragraph 7, and Figure 1), wherein the first nonwoven layer 1 is configured to be positioned adjacent a wound of a wearer.
How
However, Ludwig fails to explicitly disclose wherein superabsorbent fibers are provided in the first nonwoven layer; wherein the super absorbent fibers of the first nonwoven layer are configured to absorb wound exudate from the wound to promote healing thereof.
Hofstetter teaches an analogous bandage 20 (Paragraphs 24, 42, 47 and Figure 2, bandage 20 with skin contact non-woven layer 28 against wound and more superior second non-woven layer 24 formed of polyester and each having superabsorbent polyacrylate fibers) wherein superabsorbent fibers are provided in the analogous first nonwoven layer 28; wherein the super absorbent fibers of the analogous first nonwoven layer 28 are configured to absorb wound exudate from the wound to promote healing thereof.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the first nonwoven layer of Ludwig, so that superabsorbent fibers are provided in the first nonwoven layer; wherein the super absorbent fibers of the first nonwoven layer are configured to absorb wound exudate from the wound to promote healing thereof, as taught by Hofstetter (maintaining the stitch bonding interconnecting the first and second nonwoven layer of Ludwig, while modifying the first nonwoven layer of Ludwig to have the superabsorbent fibers of Hofstetter), in order to provide an improved compression bandage with an enhanced first nonwoven layer having superabsorbent material for maintaining desirable sanitary and healing condition properties at the skin site by absorbing wound exudate via the superabsorbent fibers (Hofstetter, Paragraphs 24, 42, 47).
Regarding claim 19, the combination of Ludwig in view of Hofstetter, as applied to claim 18, discloses the invention as described above. Ludwig further discloses that the first nonwoven layer 1 is configured to be directed towards a wearer of the compression bandage 1,2 in an applied state and is designed as a padding layer 1 (Page 3/32, Paragraph 17, Page 4/32, Paragraphs 16-18, Page 5/32, Paragraphs 6-10, Page 7/32, Paragraph 7, and Figure 1, user contacting layer 1, thereby providing skin padding).
Regarding claim 20, the combination of Ludwig in view of Hofstetter, as applied to claim 18, discloses the invention as described above. Ludwig further discloses wherein the first nonwoven layer 1 (Page 5/32, Paragraph 1 and claim 5, thermofused nonwoven first layer 1) is a thermofused nonwoven.
Regarding claim 21, the combination of Ludwig in view of Hofstetter, as applied to claim 18, discloses the invention as described above. Ludwig further discloses wherein the second nonwoven layer 2 (Page 5/32, Paragraph 6 and claim 6, thermobonded nonwoven second layer 2) is a thermobonded nonwoven.
Regarding claim 22, the combination of Ludwig in view of Hofstetter, as applied to claim 18, discloses the invention as described above. Ludwig further discloses wherein material of one or both of the layers 1,2 is inelastic (Page 4/32, Paragraphs 11 and 15, one or both non-woven layers 1,2 are inelastic).
Regarding claim 23, the combination of Ludwig in view of Hofstetter, as applied to claim 18, discloses the invention as described above. Ludwig further discloses wherein a thickness of the first nonwoven layer 1 is 0.6 - 1.2mm (Page 5/32, Paragraph 18 and claim 2, nonwoven layer 1 has thickness of 0.6 to 1.2 mm; this is prima facie obviousness as the claimed range is the same as the prior art range, see MPEP 2144.05(I)).
Regarding claim 24, the combination of Ludwig in view of Hofstetter, as applied to claim 18, discloses the invention as described above but fails to explicitly disclose wherein the nonwoven material of the first nonwoven layer and/or second nonwoven layer comprises polyester.
Hofstetter further teaches wherein the analogous nonwoven material (Paragraphs 24, 42, 47, and Figure 2, bandage 20 with skin contact non-woven layer 28 against wound and more superior second non-woven layer 24 formed of polyester) of the analogous first 28 and/or second 24 nonwoven layer comprises polyester.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the nonwoven material of the first and/or second nonwoven layer of Ludwig in view of Hofstetter, so that the nonwoven material of the first nonwoven layer and/or second nonwoven layer comprises polyester, as taught by Hofstetter, in order to provide an improved compression bandage with an enhanced nonwoven layer formed from polyester for desirable material properties in compression, cushioning, and support (Hofstetter, Paragraphs 24, 42, 47).
Regarding claim 25, the combination of Ludwig in view of Hofstetter, as applied to claim 18, discloses the invention as described above and further discloses that the superabsorbent fibers (Hofstetter, Paragraphs 25, superabsorbent fibers formed only of polyacrylate) consist of polyacrylate.
Regarding claim 26, the combination of Ludwig in view of Hofstetter, as applied to claim 22, discloses the invention as described above. Ludwig further discloses wherein the elastic stitching thread (Page 5/32, Paragraphs 8-11, elastic stitching thread composed of any of the following materials listed) is selected from a group composed of cotton spun crepe threads, cotton twisted crepe threads, textured polyamide yarns, textured polyester yarns, rubber threads or polyurethane elastane threads, and combinations thereof.
Regarding claim 27, the combination of Ludwig in view of Hofstetter, as applied to claim 18, discloses the invention as described above. Ludwig further discloses wherein the compression bandage 1,2 has a stretching threshold which indicates a maximum stretchability (Page 5/32, Paragraphs 13-15, maximum extensibility threshold).
Regarding claim 28, the combination of Ludwig in view of Hofstetter, as applied to claim 18, discloses the invention as described above. Ludwig further discloses wherein a maximum stretchability (Page 5/32, Paragraphs 13-15, maximum extensibility threshold for optimal therapeutic pressure) corresponds to a therapeutically mandated application pressure of the compression bandage 1,2 configured on a limb of a wearer.
Regarding claim 29, the combination of Ludwig in view of Hofstetter, as applied to claim 18, discloses the invention as described above. Ludwig further discloses wherein a side of the compression bandage 1,2 configured to point away from the wearer has a cohesive coating (Page 6/32, Paragraph 11, cohesive coating adhesive applied to a surface facing away from wearer).
Regarding claim 30, the combination of Ludwig in view of Hofstetter, as applied to claim 18, discloses the invention as described above. Ludwig further discloses a compression bandage combination comprising a first compression bandage 1,2 which is the compression bandage of claim 18, and also a second compression bandage (Page 2/32, Paragraph 10 and claims 12-13, second compression bandage applied over first compression bandage 1,2 to apply resting pressure while first compression bandage 1,2 exerts working pressure) which in particular may be applied over the first compression bandage 1,2.
Regarding claim 31, the combination of Ludwig in view of Hofstetter, as applied to claim 30, discloses the invention as described above. Ludwig further discloses the first compression bandage 1,2 is configured to apply a working pressure and the second compression bandage (Page 2/32, Paragraph 10 and claims 12-13, second compression bandage applied over first compression bandage 1,2 to apply resting pressure while first compression bandage 1,2 exerts working pressure) is configured to apply a resting pressure to a limb in an applied state.
Regarding claim 32, the combination of Ludwig in view of Hofstetter, as applied to claim 30, discloses the invention as described above but fails to explicitly disclose wherein the second first nonwoven layer includes superabsorbent fibers..
Hofstetter teaches an analogous bandage 20 (Paragraphs 24, 42, 47 and Figure 2, bandage 20 with skin contact non-woven layer 28 against wound and more superior second non-woven layer 24 formed of polyester and each having superabsorbent polyacrylate fibers) wherein the analogous second nonwoven layer 24 includes superabsorbent fibers.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the second nonwoven layer of Ludwig in view of Hofstetter, so that superabsorbent fibers are provided in the second nonwoven layer, as taught by Hofstetter (maintaining the stitch bonding interconnecting the first and second nonwoven layer of Ludwig, while modifying the second nonwoven layer of Ludwig to have the superabsorbent fibers of Hofstetter), in order to provide an improved compression bandage with an enhanced second nonwoven layer having superabsorbent material for maintaining desirable uniform absorption distribution from the skin site and through the first nonwoven layer by absorbing wound exudate via the superabsorbent fibers in both the respective layers (Hofstetter, Paragraphs 24, 42, 47).
Claims 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Ludwig et al. (WO 2017109209) in view Hoffstetter et al. (U.S. Patent Pub. No. 20110313383), as applied to claim 32, and in further view of Ring et al. (U.S. Patent Pub. No. 20080255531).
Regarding claim 33, the combination of Ludwig in view of Hofstetter, as applied to claim 32, discloses the invention as described above but fails to explicitly disclose wherein the first nonwoven layer comprises a fiber mixture of at least 20 wt % of the superabsorbent fibers.
Ring teaches an analogous bandage (Paragraphs 21 and 23, wound dressing with a non-woven layer comprises 85 wt. % superabsorbent material; see MPEP 2144.05(I) prima facie obviousness of overlapping ranges as the prior art range of 80% is narrower and within the claimed range of greater than 20%) wherein the analogous nonwoven layer (Paragraphs 21 and 23) comprises a fiber mixture of at least 20 wt % of the analogous superabsorbent material.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a wt. % of the superabsorbent fibers in the first nonwoven layer of Ludwig in view of Hofstetter, so that the first nonwoven layer comprises a fiber mixture of at least 20 wt % of the superabsorbent, as taught by Ring, in order to provide an improved compression bandage with an enhanced first nonwoven layer that has a high amount of superabsorbent for quickly removing exudate from the wound yielding rapid uptake, distribution, and filling within the layer (Ring, Paragraphs 21, 23, and 49).
Regarding claim 34, the combination of Ludwig in view of Hofstetter in view of Ring, as applied to claim 33, discloses the invention as described above and further discloses wherein the second nonwoven layer 2 (Ludwig, Page 3/32, Paragraph 17, Page 4/32, Paragraphs 16-18, Page 5/32, Paragraphs 6-10, Page 7/32, Paragraph 7, and Figure 1) comprises a fiber mixture of at least 40 wt % of the superabsorbent fibers (Hofstetter, Paragraphs 24 and 26, second non-woven layer 24 has at least 40% by weight superabsorbent fibers; see MPEP 2144.05(I) prima facie obviousness of overlapping ranges as the prior art range of at least 40% is the exact same as the claimed range of at least 40%).
Conclusion
Applicant's amendment did not necessitate a new grounds of rejection based on new references. THIS ACTION IS MADE FINAL. 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Milo whose telephone number is (571)272-6476. The examiner can normally be reached on Mon-Fri 7:00-5:00.
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 on +1(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 an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL MILO/
Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786