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 .
Status of Claims
Claims 1-20 are pending and examined on the merits.
Claims 4, 8, 11, 14-17, and 20 are currently pending.
Information Disclosure Statement
The two information disclosure statements (IDS’s) submitted on 03/01/2024 were filed before the mailing date of the First Office Action on the Merits. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 11-16 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.
Claims 11-16 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: in claim 11 lines 7-12, Applicant discloses that a non-zero difference between the second characteristic and first characteristic causes the dressing to collapse perpendicular to the longitudinal direction to a greater extent than a zero difference between the second characteristic and first characteristic. It is unclear what Applicant intends. Furthermore, the Specification does not explain such intention (see para. [0005-0006]). For the purposes of this Office Action, and in the interest in compact prosecution, Examiner will treat this claim to mean that the dressing collapses more when the foam section is experiencing the first characteristic as compared to the second characteristic.
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.
Claims 1-3 and 5-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Robinson (U.S. Pre Grant Pub. No. 2022/0111138 A1).
Regarding claim 1, Robinson teaches: A negative pressure dressing (see Abstract, Fig. 2, and at least para. [0046]) comprising:
a first foam section (see lower left quadrant in Fig. 3; para. [0063] teaches that manifold sections 215 comprise foam);
a second foam section (see lower right quadrant in Fig. 3; para. [0063] teaches that manifold sections 215 comprise foam); and
a longitudinal seam (see seam 210) joining the first foam section to the second foam section (see at least Fig. 3), wherein the longitudinal seam has a higher rigidity than the first foam section and the second foam section (para. [0070] teaches that the seams 210 are formed by one or more bonds between a first and second layer; therefore, the seams 210 will have a higher rigidity than the first and second foam sections).
Regarding claim 2, Robinson teaches the invention as discussed above in claim 1. Additionally, Robinson teaches wherein the longitudinal seam is configured to cause the first foam section and the second foam section to collapse more in a medial direction of the dressing perpendicular to the longitudinal seam than in a longitudinal direction parallel with the longitudinal seam when subjected to a negative pressure (para. [0070] teaches that the seams 210 are formed by one or more bonds between a first and second layer; therefore, the seams 210 are configured to cause a greater collapse in a medial direction than in a longitudinal direction at least because para. [0063] teaches that manifold sections 215 comprise foam which would collapse more readily than seams 210).
Regarding claim 3, Robinson teaches the invention as discussed above in claim 1. Additionally, Robinson teaches wherein the longitudinal seam is configured to cause the first foam section and the second foam section to exert, when subjected to a negative pressure, a medial force in a direction perpendicular to the longitudinal seam which exceeds a longitudinal force exerted by the first foam section and the second foam section in a direction parallel with the longitudinal seam (para. [0070] teaches that the seams 210 are formed by one or more bonds between a first and second layer; therefore, the seams 210 are configured to cause the first and second foam sections to exert a medial force greater than a longitudinal force at least because para. [0063] teaches that manifold sections 215 comprise foam which would collapse more readily than seams 210).
Regarding claim 5, Robinson teaches the invention as discussed above in claim 1. Additionally, Robinson teaches wherein the longitudinal seam comprises glue (see para. [0081]).
Regarding claim 6, Robinson teaches the invention as discussed above in claim 1. Additionally, Robinson teaches wherein the longitudinal seam comprises a panel of a non-foam material (para. [0070] teaches that seams 210 are formed between the first layer 405 and second layer 410, which are non-foam; see also para. [0071]).
Regarding claim 7, Robinson teaches the invention as discussed above in claim 1. Additionally, Robinson teaches further comprising:
a third foam section (see top right quadrant in Fig. 3; para. [0063] teaches that manifold sections 215 comprise foam); and
an additional longitudinal seam (see seam 210), wherein the third foam section is separated from the second foam section by the additional longitudinal seam (see Fig. 3), the additional longitudinal seam having a higher rigidity than the third foam section and the second foam section (para. [0070] teaches that the seams 210 are formed by one or more bonds between a first and second layer; therefore, the seams 210 will have a higher rigidity than the third and second foam sections).
Regarding claim 8, Robinson teaches the invention as discussed above in claim 1. Additionally, Robinson teaches wherein the longitudinal seam and the additional longitudinal seam are positioned symmetrically across an imaginary longitudinal center line of the second foam section (as shown in Fig. 3, seams 210 are positioned symmetrically across an imaginary longitudinal center line of the lower left quadrant at least because if one draws an imaginary longitudinal center line of the lower left quadrant the seams 210 will be located symmetrically across the imaginary longitudinal line).
Regarding claim 9, Robinson teaches the invention as discussed above in claim 1. Additionally, Robinson teaches further comprising a fenestrated visceral protective layer (see tissue interface 114 having fluid restrictions 220) configured to be placed over an open abdominal wound (see para. [0055]) to separate the first foam section and the second foam section from the open abdominal wound (as shown in Fig. 2, tissue interface 114 separates the wound site, at release line 245, from interface sections 205).
Regarding claim 10, Robinson teaches the invention as discussed above in claim 1. Additionally, Robinson teaches further comprising a drape (see cover 116 in Fig. 2) sealable over a wound (see para. [0056]) to define an airtight volume containing the first foam section, the second foam section, and the longitudinal seam (as shown in Fig. 2, cover 116 is adapted to be placed over tissue interface 114).
Regarding claim 11, Robinson teaches: A negative pressure dressing (see Abstract, Fig. 2, and at least para. [0046]), comprising:
a first foam section (see lower left quadrant in Fig. 3; para. [0063] teaches that manifold sections 215 comprise foam) having a first characteristic (at least inherent);
a second foam (see lower right quadrant in Fig. 3; para. [0063] teaches that manifold sections 215 comprise foam) section having the first characteristic (since para. [0063] teaches that the manifold sections 215 may comprise foam, it is assumed that the manifold sections 215 are of the same material and therefore have the same characteristics); and
a third foam section (see seam 210) having a second characteristic different than the first characteristic (para. [0070] teaches that the seams 210 are formed by one or more bonds between a first and second layer; therefore, the seams 210 will have different characteristics from the first characteristic), the third foam section separating the first foam section from the second foam section along a longitudinal direction of the dressing (see Fig. 3; see also para. [0062]);
wherein, when the dressing is subjected to a negative pressure, a non-zero difference between the second characteristic and the first characteristic causes the dressing to collapse in a medial direction perpendicular to the longitudinal direction to a greater extent than a zero difference between the second characteristic and the first characteristic (at least inherent; since manifold sections 215 are made of foam, they experience more of a collapse in a direction perpendicular to the longitudinal direction as opposed to the seams 210 which are formed by bonds between layers).
Regarding claim 12, Robinson teaches the invention as discussed above in claim 11. Additionally, Robinson teaches wherein the first characteristic is a first thickness and the second characteristic is a second thickness, the second thickness greater than the first thickness (para. [0070] teaches that the seams 210 are formed by one or more bonds between a first and second layer; therefore, the seams 210 will inherently have a greater thickness than the manifold sections 215).
Regarding claim 13, Robinson teaches the invention as discussed above in claim 11. Additionally, Robinson teaches wherein the first characteristic is a first density and the second characteristic is a second density, the second density greater than the first density (para. [0070] teaches that the seams 210 are formed by one or more bonds between a first and second layer; therefore, the seams 210 will inherently have a greater density than the manifold sections 215).
Regarding claims 14-15, Robinson teaches the invention as discussed above in claim 11. Additionally, Robinson teaches wherein the collapse of the dressing to the greater intent includes a greater force (as applied to claim 14; at least inherent since a greater force applied to the dressing will necessarily result in a greater collapse) and/or includes a greater distance of compression (as applied to claim 15; at least inherent since a greater collapse would necessarily mean a greater distance of compression).
Regarding claim 16, Robinson teaches the invention as discussed above in claim 11. Additionally, Robinson teaches wherein the non-zero difference between the second characteristic and the first characteristic causes the dressing to collapse to a lesser extent in the longitudinal direction compared to the zero difference between the second characteristic and the first characteristic (due to the presence of seams 210, as seen in Fig. 2, and due to the foam structure of the manifold sections 215, as taught by para. [0063], the manifold sections 215 are expected to collapse less in the longitudinal direction compared to the seams 210).
Regarding claim 17, Robinson teaches A negative pressure therapy system (see Abstract), comprising:
a negative pressure source (102 in Fig. 1);
a dressing fluidly communicable with the negative pressure source (see dressing 104 in Fig. 1 and para. [0046] which comprises tissue interface 114 in Fig. 2), the dressing comprising:
a wound contact layer (see tissue interface 114 in Fig. 2) configured to contact an open wound of a patient (see para. [0055]),
a manifold layer (see manifold sections 215 in Fig. 2),
and a drape layer coupled to the wound contact layer (see cover 116 in Fig. 2) such that the manifold layer is between the wound contact layer and the drape layer (as shown in Fig. 2, the manifold sections 215 are in between tissue interface 114 and cover 116);
wherein the manifold layer comprises:
a first foam section (see lower left quadrant in Fig. 3; para. [0063] teaches that manifold sections 215 comprise foam),
a second foam section (see lower right quadrant in Fig. 3; para. [0063] teaches that manifold sections 215 comprise foam), and
a longitudinal seam (see seam 210) joining the first foam section to the second foam section (see at least Fig. 3), wherein the longitudinal seam has a higher rigidity than the first foam section and the second foam section (para. [0070] teaches that the seams 210 are formed by one or more bonds between a first and second layer; therefore, the seams 210 will have a higher rigidity than the first and second foam sections).
Regarding claim 18, Robinson teaches the invention as discussed above in claim 17. Additionally, Robinson teaches wherein:
the negative pressure source is operable to establish a negative pressure in the manifold layer (as shown in Fig. 1, negative pressure source 102 and tissue interface 114 are fluidically connected; therefore, when the source is operable, negative pressure will be exerted on the tissue interface 114 and the manifold sections 215); and
the longitudinal seam is configured to cause the first foam section and the second foam section to collapse more in a medial direction of the dressing perpendicular to the longitudinal seam than in a longitudinal direction parallel with the longitudinal seam when the negative pressure is established in the manifold layer (para. [0070] teaches that the seams 210 are formed by one or more bonds between a first and second layer; therefore, the seams 210 are configured to cause a greater collapse in a medial direction than in a longitudinal direction at least because para. [0063] teaches that manifold sections 215 comprise foam which would collapse more readily than seams 210).
Regarding claim 19, Robinson teaches the invention as discussed above in claim 17. Additionally, Robinson teaches wherein the longitudinal seam is configured to allow communication of negative pressure across the longitudinal seam from the first foam section to the second foam section (para. [0056] teaches that the cover 116 provides for a fluid seal across the dressing 104, the negative-pressure source 102 will exert negative pressure across all of the dressing, including the seams 210).
Regarding claim 20, Robinson teaches the invention as discussed above in claim 18. Additionally, Robinson teaches wherein the longitudinal seam comprises a panel of a non-foam material (para. [0070] teaches that seams 210 are formed between the first layer 405 and second layer 410, which are non-foam; see also para. [0071]).
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Robinson (U.S. Pre Grant Pub. No. 2022/0111138 A1) in view of Mitchell (U.S. Pre Grant Pub. No. 2004/0054340 A1).
Regarding claim 4, Robinson teaches the invention as discussed above in claim 1. However, Robinson fails to explicitly teach that the longitudinal seam is porous, as required by the claim.
Mitchell teaches an analogous medical device in the form of a wearable article (see Abstract) comprising cloth that is vapor permeable and seams that are air permeable (see Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Robinson to incorporate the teachings of Mitchell by making the longitudinal seam is porous by replacing the first layer 405 and second layer 410 with a vapor permeable cloth at least for the seam to exhibit cooling effects, as taught by Mitchell (see Abstract), which may improve comfort for the wearer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Carroll (U.S. Pre Grant Pub. No. 2021/0077302 A1) - Peel And Place Dressing For Thick Exudate And Instillation
Shuler (U.S. Pre Grant Pub. No. 2021/0220530 A1) - NEGATIVE PRESSURE WOUND THERAPY BARRIER
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781