DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement filed January 13, 2025 has been received and made of record. Note the acknowledged PTO-1449 enclosed herewith.
Response to Amendment
The Preliminary Amendment field December 30, 2024 has been received and made of record. The specification has been amended and claims 1-37 have been cancelled. Claims 38-56 have been added and are the only claims pending in the 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.
Each of claims 41-54 recites the limitation "The negative pressure treatment apparatus" in line 1. There is insufficient antecedent basis for this limitation in the claim. Applicant should note that claim 38 from which claims 41-54 depend, either directly or indirectly, is directed to a wound dressing and not a negative pressure treatment apparatus. The claim language will be interpreted as --The wound dressing--.
The term “substantially” in claim 51 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore the recitation of “substantially collapse” in claim 51 is indefinite since.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 38-57 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Application Publication No. 2001/0043943 (“Coffey”) in view of U.S. Patent No. 6,794,554 (“Sessions et al.”).
Regarding claim 38, Coffey discloses a combination and sis and vacuum bandage that substantially discloses Applicant’s claimed invention. More specifically, Coffey discloses a wound dressing (constituted by bandage 10, see Fig.1 and para. [0027]), comprising: a body of porous material (porous filler or pad 20, see para. [0032], lines 4-7); and a cover layer (cover 18, see para.[0027]) positioned over the body of porous material (see Fig. 1), the cover layer comprising an opening (see Fig. 1, and para. [0036], lines 7-9 which discloses an aperture in the cover) configured to communicate negative pressure, further the opening is configured to connect to a source of negative pressure (see Fig. 1, lines 3-10; a vacuum source 26 is connected to a vacuum tube coupled to the aperture via collar 34).
Coffey fails to teach the body comprises an array of continuous partial pre-cuts configured to increase extensibility of the body, individual partial pre-cuts extending from a first outer edge to a second outer edge, the array of partial pre-cuts comprising a plurality of first cuts extending in a first direction and a plurality of second cuts extending in a second direction.
Sessions et al. in its analogous disclosure of a wound packing material teaches it is known to provide a porous body (porous foam 1, col. 2, lines 49-20; constructed from polymers of urethane, col. 2, lines 61-66) comprising an array of continuous partial pre-cuts (see col. 3, lines 9-11, which discloses the slits may partially extend in the foam), the array of partial pre-cuts comprising a plurality of first cuts extending in a first direction (see 4a,4b,5a,5b). Applicant’s attention is directed to the figure which shows an array of parallel slits extending in one direction. See also col. 3, lines 35-38 which discloses the plurality of lines formed by the slits may be oriented with respect to one another in any desirable manner, e.g., crossing one another at right angles, thereby disclosing an array second slits/cuts, wherein the plurality of second cuts extend a second direction such that individual first cuts intersect with individual second cuts. The slits both permit the foam to be folded to allow it to more easily be configured to match the dimension of a wound (see col. 2, lines 9-11) and allows for an increase in extensibility of the foam by allowing it to stretch further due to the openings in the foam formed by the slits.
In view of Sessions et al., it would have been obvious to one having ordinary skill in the art to have modified the porous filler or pad (20) of Coffey with an array of continuous partial pre-cuts, wherein individual partial pre-cuts extend from a first outer edge to a second outer edge, the array of partial pre-cuts comprising a plurality of first cuts extending in a first direction and a plurality of second cuts extending in a second direction in order to both allow the foam dressing to more easily be configured to match the dimension of a wound and to allow for an increase in extensibility of the foam by allowing it to stretch further due to the openings in the foam formed by the slits.
Regarding claim 39, modified Coffey discloses the wound dressing of claim 38, wherein the cover layer comprises an opening configured to communicate negative pressure (note the rejection of claim 38 above).
Regarding claim 40, modified Coffey discloses the wound dressing of claim 39, wherein the opening is configured to connect to a source of negative pressure (note the rejection of claim 38 above).
Regarding claim 41, modified Coffey discloses the wound dressing of claim 38, wherein individual first cuts are perpendicular to individual second cuts (note the disclosure of the plurality of lines formed by the slits may be oriented with respect to one another in any desirable manner, e.g., crossing one another at right angles, as discussed above in the rejection of claim 38).
Regarding claim 42, modified Coffey discloses the wound dressing of claim 38, wherein the porous material (20) is preferably rather flexible to conform to any complex wound or wound surface (see para. [0032]). Modified Coffey fails to disclose the porous material comprises foam. However, Sessions et al. in its disclosure of an analogous wound packing material teaches it is known to pack a wound with a porous material such as monomers or polymers of urethane foam because it is resilient (see col. 2, lines 53-66).
Applicant is remined that the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have constructed the porous pad of modified Coffey from urethane foam because it is resilient.
Regarding claim 43, modified Coffey discloses the wound dressing of claim 42, wherein the foam comprises polyurethane (note the rejection of claim 42 above).
Regarding claim 44, modified Coffey discloses the wound dressing of claim 38, except wherein individual first cuts extend from a first outer edge to a second outer edge. However, Sessions et al. in its disclosure of an analogous wound packing material teaches it is known to provide an array of partial cut slits in parallel lines that extend from a first outer edge to a second outer edge (see the figure in Sessions et al.).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide individual first cuts that extend from a first outer edge to a second outer edge in order to allow the entire length to fold and occupy a smaller volume when positioned in a wound.
Regarding claim 45, modified Coffey discloses the wound dressing of claim 44, except wherein individual first cuts extend across the entire length of the body of porous material from a first outer edge to a second outer edge. However, Sessions et al. in its disclosure of an analogous wound packing material teaches it is known to provide an individual first slits in parallel lines that extend across the entire length of the body of porous material (see the figure in Sessions et al.).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide individual first cuts that extend across the entire length of the body of porous material in order to allow the entire length to fold and occupy a smaller volume when positioned in a wound to further increase the conformability of the porous pad to match the shape of a wound.
Regarding claim 46, modified Coffey discloses the wound dressing of claim 38, except wherein individual second cuts extend from a third outer edge to a fourth outer edge. However, Sessions et al. in its disclosure of an analogous wound packing material teaches a plurality of lines formed by the first oriented parallel to one another. Sessions et al. also teaches a plurality of lines formed by slits be oriented with respect to one another in any desirable manner, e.g., crossing one another at right angles (see col. 2, lines 35-37), thereby teaching lines formed by second slits oriented perpendicular to the first slits and the third and fourth edges (see annotated Figure below).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of claimed invention to have modified the porous pad (20) of modified Coffey such that individual second slits form a plurality of lines that cross parallel lines formed by first slits at right angles and extend perpendicular to third and fourth edges of modified Coffey.
While Sessions et al. does not teach the plurality of second slits extend from the third edge to the second edge, it would have been obvious to one having ordinary skill in the art before the effective filing date of claimed invention to have modified the porous pad (20) of modified Coffey such that individual second slits form a plurality of lines that extend from the third edge to the second edge, i.e., along the width of the porous material, in order to permit the porous pad to be folded in various directions to allow it to more easily be configured to match the dimensions of a wound (see col. 2, lines 9-11).
Regarding claim 47, modified Coffey discloses the wound dressing of claim 46, except wherein individual second cuts extend across the entire width of the body of porous material. However, as discussed in the rejection of claim 46 above, it would have been obvious to one having ordinary skill in the art before the effective filing date of claimed invention to have modified the porous pad (20) of modified Coffey such that individual second slits form a plurality of lines that extend from the third edge to the second edge, i.e., along the width of the porous material, in order to permit the porous pad to be folded in various directions to allow it to more easily be configured to match the dimensions of a wound (see col. 2, lines 9-11). It would have been further obvious to have provided the porous pad of modified Coffey with individual slits extending along entire width of the porous pad in order to further increase the conformability of the porous pad to match the shape of a wound.
Regarding claim 48, modified Coffey discloses the wound dressing of claim 40, further comprising a connector (see collar 34 and tube 32 and para. [0036] of Coffey) configured to connect to a source of negative pressure (vacuum source 26, see para. [0036]).
Regarding claim 49, modified Coffey discloses the wound dressing of claim 48, further comprising a source of negative pressure (vacuum source 26, see para. [0036]).
Regarding claim 50, modified Coffey discloses the wound dressing of claim 38, wherein the porous material is formed from a wound packing material suitable for use in negative pressure wound therapy (porous pad 20 in Coffey is a wound packing material and suitable for use in negative wound pressure therapy, see paras. [0020], [0037-0038] and Fig. 1 of Coffey which shows the structure packed in a wound).
Regarding claim 51, modified Coffey discloses the wound dressing of claim 38, wherein the porous material is configured such that it does not substantially collapse when negative pressure is applied (in use, the foam will fill the wound and will perform the same function of the instant invention, allowing a vacuum to be applied to promote inflow of blood from the wound, further see para. [0040] which discloses vacuum may be applied at 0.1 atmospheres to promote inflow of blood from a wound, thus it will not substantially collapse polyurethane foam since it is strong material).
Regarding claim 52, modified Coffey discloses the wound dressing of claim 49, except wherein the negative pressure is in the range of 80 to 125 mm Hg below ambient atmospheric pressure. However, Coffey discloses negative pressure may be applied up to 125 mm Hg (see para. [0038] and in the range of 0.1 to 0.99 atmospheres (see para [0040]; 76 mm Hg to 752 mm Hg), which overlaps Applicants’ claimed range. Applicant is reminded that in 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).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art before the filing date of the claimed invention to have provided the negative pressure in the range of 50 to 125 in order to promote the inflow of blood from the wound in order to allow healing to take place (see Coffey para. [0040]).
Regarding claim 53, modified Coffey fails to disclose the wound dressing of claim 38, wherein the partial pre-cuts are formed during initial production of the body of porous material.
However, Sessions et al. in its disclosure of an analogous wound packing material teaches slits in the packing permits (see col. 2, lines 9-17); thus, the slits are formed during initial manufacturing).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the slits in porous pad (20) of modified Coffey in order to allow a healthcare worker to readily customize the porous pad to fit a variety of wounds.
Regarding claim 54, modified Coffey discloses the wound dressing of claim 38, wherein individual partial precuts are generally planar (the slits form parallel lines and are therefore planar since they intersect at right angles, see the rejection of claim 38 above).
Regarding claim 55, Coffey discloses a method of treating a wound (see the abstract which discloses a wound care bandage for treating a wound is provided), comprising: positioning a wound dressing over a wound (see Fig. 1), the wound dressing comprising a body of porous material (porous foam 1, col. 2, lines 49-20; constructed from polymers of urethane, col. 2, lines 61-66) and a cover layer (cover 18, see Fig. 1 and para. [0027]) positioned over the body of porous material (see Fig. 1); connecting the wound dressing to a source of negative pressure (see para. (0036], a second end 42 of a tube 32 is coupled to vacuum source 26); and applying negative pressure to the wound (see para. [0036]-[0040], negative pressure is applied in order to encourage blow flow to the wound).
Coffey fails to disclose an array of continuous partial pre-cuts configured to increase extensibility of the body, individual partial pre-cuts extending from a first outer edge to a second outer edge, the array of partial pre-cuts comprising a plurality of first cuts extending in a first direction and a plurality of second cuts extending in a second direction.
Sessions et al. in its analogous disclosure of a wound packing material teaches it is known to provide a porous body (porous foam 1, col. 2, lines 49-20; constructed from polymers of urethane, col. 2, lines 61-66) comprising an array of continuous partial pre-cuts (see col. 3, lines 9-11, which discloses the slits may partially extend in the foam), the array of partial pre-cuts comprising a plurality of first cuts extending in a first direction (see 4a,4b,5a,5b). Applicant’s attention is directed to the figure which shows an array of parallel slits extending in one direction. See also col. 3, lines 35-38 which discloses the plurality of lines formed by the slits may be oriented with respect to one another in any desirable manner, e.g., crossing one another at right angles, thereby disclosing an array second slits/cuts, wherein the plurality of second cuts extend a second direction such that individual first cuts intersect with individual second cuts. The slits both permit the foam to be folded to allow it to more easily be configured to match the dimension of a wound (see col. 2, lines 9-11) and allows for an increase in extensibility of the foam by allowing it to stretch further due to the openings in the foam formed by the slits.
In view of Sessions et al., it would have been obvious to one having ordinary skill in the art to have modified the porous filler or pad (20) of Coffey with an array of continuous partial pre-cuts, wherein individual partial pre-cuts extend from a first outer edge to a second outer edge, the array of partial pre-cuts comprising a plurality of first cuts extending in a first direction and a plurality of second cuts extending in a second direction in order to both allow the foam dressing to more easily be configured to match the dimension of a wound and to allow for an increase in extensibility of the foam by allowing it to stretch further due to the openings in the foam formed by the slits.
Regarding claim 56, modified Coffey et al. discloses the method of claim 55, wherein individual first cuts are perpendicular to individual second cuts (note the rejection of claim 55 above, which discloses that a plurality of lines formed by the slits may be oriented with respect to one another in any desirable manner, e.g. crossing one another at right angles).
Regarding claim 57, modified Coffey discloses the method of claim 55, except wherein individual first cuts extend from a first outer edge to a second outer edge. However, Sessions et al. in its disclosure of an analogous wound packing material teaches it is known to provide an array of partial cut slits in parallel lines that extend from a first outer edge to a second outer edge (see the figure in Sessions et al.).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide individual first cuts that extend from a first outer edge to a second outer edge in order to allow the entire length to fold and occupy a smaller volume when positioned in a wound so as to assist with the lessening of resistance to folding at the edges of the foam (see Sessions col. 1, lines 61-64).
PNG
media_image1.png
830
975
media_image1.png
Greyscale
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 38-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,121,417 (the ‘417 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader in scope.
Regarding claim 38, claim 1 of the ‘417 patent discloses a wound dressing (note the disclosure of a wound treatment apparatus in line 1, which covers a wound and is a wound dressing), comprising: a body of porous material (line 3) comprising an array of continuous partial pre-cuts, individual partial pre-cuts extending from a first outer edge to a second outer edge (lines 7-8), the array of partial pre-cuts comprising a plurality of first cuts extending in a first direction and a plurality of second cuts extending in a second direction (lines 10-12); and a cover layer positioned over the body of porous material (line 15).
Claim 1 of the ‘417 patent fails to recite an array of partial pre-cuts configured to increase extensibility of the body; however, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that cutting the body of porous material would allow for greater extensibility of the body since the cuts decrease restriction to extension of the body.
Regarding claim 39, claim 1 of the ‘417 patent recites the wound dressing of claim 38, wherein the cover layer comprises an opening configured to communicate negative pressure (see claim 1, lines 16-17).
Regarding claim 40, claim 1 of the ‘417 patent recites the wound dressing of claim 39, wherein the opening is configured to connect to a source of negative pressure (claim 1, lines 17-18).
Regarding claim 41, ‘the 417 patent recites negative pressure treatment apparatus (interpreted as the wound dressing) of claim 38, wherein individual first cuts are perpendicular to individual second cuts (see claim 2).
Regarding claim 42, the ‘417 patent recites the negative pressure treatment apparatus (interpreted as the wound dressing) of claim 38, wherein the porous material comprises foam (claim 3).
Regarding claim 43, the ‘417 patent recites negative pressure treatment apparatus of claim 42, wherein the foam comprises polyurethane (claim 4).
Regarding 44, the ‘417 patent recites negative pressure treatment apparatus of claim 38, wherein individual first cuts extend from a first outer edge to a second outer edge (claim 5).
Regarding claim 45 negative pressure treatment apparatus of claim 44, wherein individual first cuts extend across the entire length of the body of porous material (claim 6).
Regarding claim 46, the ‘417 patent recites the negative pressure treatment apparatus (interpreted as the wound dressing) of claim 38, wherein individual second cuts extend from a third outer edge to a fourth outer edge (claim 7).
Regarding claim 47, the ‘417 patent recites the negative pressure treatment apparatus (interpreted as the wound dressing) of claim 46, wherein individual second cuts extend across the entire width of the body of porous material (claim 8).
Regarding claim 48, the ‘417 patent recites the negative pressure treatment apparatus (interpreted as the wound dressing) of claim 40, further comprising a connector configured to connect to a source of negative pressure (claim 9).
Regarding claim 49, the ‘417 patent recites the negative pressure treatment apparatus (interpreted as the wound dressing) of claim 48, further comprising a source of negative pressure (claim 10).
Regarding claim 50, the ‘417 patent recites the negative pressure treatment apparatus (interpreted as the wound dressing) of claim 38, wherein the porous material is formed from a wound packing material suitable for use in negative pressure wound therapy (claim 11).
Regarding claim 51, the ‘417 patent recites the negative pressure treatment apparatus (interpreted as the wound dressing) of claim 38, wherein the porous material is configured such that it does not substantially collapse when negative pressure is applied (claim 12).
Regarding claim 52, the ‘417 patent recites the negative pressure treatment apparatus (interpreted as the wound dressing (of claim 49, wherein the negative pressure is in the range of 80 to 125 mm Hg below ambient atmospheric pressure (claim 13).
Regarding claim 53, the ‘417 patent recites the negative pressure treatment apparatus (interpreted as the wound dressing) of claim 38, wherein the partial pre- cuts are formed during initial production of the body of porous material (claim 14).
Regarding claim 54, the ‘417 patent recites the negative pressure treatment apparatus (interpreted as the wound dressing) of claim 38, wherein individual partial pre-cuts are generally planar (claim 15).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIM M LEWIS whose telephone number is (571)272-4796. The examiner can normally be reached Monday -Friday 5:30 am -11:30 am.
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.
/KIM M LEWIS/Primary Examiner, Art Unit 3786