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 .
Response to Amendment
The amendment filed 06/12/2026 has been entered. Claims 1-7, 10, 17-24 are cancelled. Claims 8-9, 11-16 remain pending in this application.
Response to Arguments
Applicant's arguments filed 06/12/2026 have been fully considered but they are not persuasive.
Applicant argues that the specification provides sufficient written description support for the features of claim 8, namely, “a plurality of removable portions formed by both the cut portions and perforated portions of the second plurality of scores”. Applicant points to figure 6 and ¶ 0044 which recites “the second portion 192 of scores, which is indicated by the dashed lines in fig. 6, include a cut portion and a perforated portion. The perforations of the perforated portion penetrate through to the second surface 152’. The perforations facilitate removal of at least one piece 196 of the second portion 192 of the manifold layer 124”. However, such passage and figure fail to describe that the plurality of removable portions are formed by both the cut portions and perforated portions. Rather, such passage and figure only support the plurality of removable portions formed by the perforated portion/perforations. Further, the specification describes an embodiment of fig. 7 comprising a scoring pattern 208 that can facilitate removal of a portion of the manifold layer, such scoring pattern does not extend completely through form the first surface through to the second surface (¶ 0046). Such feature of a removable portion formed by both the cut portions and the perforated portions of the second plurality of scores is not described in a single embodiment.
Thus, the rejection is maintained and claim 8 and its dependents remain rejected under 35 USC §112(a).
Applicant argues that the prior art does not disclose, teach or suggest “a plurality of removable portions formed by both the cut portions and the perforated portions of the second plurality of scores”. Applicant argues that Corley does not teach both cut portions and perforated portions defining discrete separable components. However, the rejection below does not rely on Corley teaching cut portions and perforated portions in a single embodiment. Rather, the rejection below relies on Corley’s teaching that both cut portions that do not penetrate the second surface and perforated portions that penetrate the second surface can define the discrete separable components (¶ 0038), both types of scores suitable for providing discrete separable components. Thus, such feature of removable portions formed by both cut portions and perforated portions is obvious.
Applicant argues that neither Robinson nor Corley teach any structural distinction between a first plurality of scores and a second plurality of scores and their relative position on the manifold layer as recited in claim 8. However, to further expand on the rejection below, Corley teaches (fig. 3) second scores that define a closed shape around the plurality of removable portions, the plurality of removable portions configured to be removed to provide an opening through the manifold (¶ 0038). Thus, Corley teaches a structural distinction between a first plurality of scores and a second plurality of scores and their relative position on the manifold layer, as required by claim 8, the second plurality of scores configuring the removable portion to provide an opening through the manifold.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Accordingly, claim 8 remains obvious over Robinson in view of Corley.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8-9, 11-16 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 8 recites “a plurality of removable portions formed by both the cut portions and the perforated portions of the second plurality of scores”. The specification fails to describe such limitation. Rather, the specification discloses that “the perforations permit selective removal of one or more pieces of the manifold” (¶ 0023) and “the perforations facilitate removal of at least one piece 196 of the second portion 192 of the manifold layer 124” (¶ 0044). The specification further describes that the “scoring pattern 208 can facilitate removal of at least some of a center portion of the manifold 204 as described with respect to fig. 6” (¶ 0046).
Claims 9 and 11-16 are rejected due to dependency on claim 8.
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.
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.
Claims 8-9, 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (Pub. No.: US 2012/0330253 A1) in view of Corley (Pub. No.: US 2014/0094761 A1).
Regarding claim 8, Robinson discloses (fig. 1-2, 11) a wound dressing (distribution manifold 116) for negative pressure wound therapy treatment of breast incisions (¶ 0024, ¶ 0048) including a manifold layer (porous member 118) and a drape layer (sealing member 132), the manifold layer comprising:
A first surface (first side 120);
A second surface (second side 122) opposite the first surface and configured to face toward a wound (tissue site 102) (¶ 0025); and
A first plurality of scores and a plurality of second scores (notches or cuts 156) formed in the first surface and extending towards the second surface (¶ 0050, fig. 11), the manifold layer being bendable about the first and second plurality of scores (¶ 0050), wherein the first plurality of scores are positioned proximate a perimeter of the manifold layer and do not penetrate the second surface (fig. 11, ¶ 0050); and wherein the second plurality of scores are positioned proximate a center of the manifold layer and include cut portions that do not penetrate the second surface (fig. 11, ¶ 0050).
While Robinson does not explicitly disclose that the drape layer is substantially impermeable to liquid and substantially permeable to vapor, Robinson discloses that the drape may be formed from silicone (¶ 0038) which is the same material as the claimed invention. Thus, the property of the drape being “substantially impermeable to liquid and substantially permeable to vapor” is inherent to the drape of Robinson.
It is further noted: “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775,227 USPQ 773 (Fed. Cir. 1985)”.
Robinson fails to disclose the second plurality of scores include perforations that penetrate the second surface; and a plurality of removable portions formed by both the cut portions and the perforated portions of the second plurality of scores being connected in a continuous pattern defining a closed shape around each of the plurality of removable portions in a single plane, and wherein each of the plurality of removable portions are configured to be removed to provide an opening through both the first surface and the second surface of the manifold layer.
Corley teaches (fig. 2-3), as best understood, a wound dressing (12) for negative pressure wound therapy treatment (abstract) including a manifold layer (packing member 20) and a drape layer (cover layer 24) and thus in the same field of endeavor, the manifold layer comprising:
A first surface; a second surface opposite the first surface and configured to face toward a wound (fig. 2, ¶ 0037);
A second plurality of scores (seams 56, 60), wherein the second plurality of scores include perforated portions that penetrate the second surface (the seams may extend partially, ¶ 0038); and a plurality of removable portions (discrete separable components 62) (fig. 3, ¶ 0038), and wherein each of the plurality of removable portions are configured to be removed to provide an opening through both the first surface and the second surface of the manifold (¶ 0038), the perforated portions and the plurality of removable portions configured to conform the manifold to the size of the wound (¶ 0038).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the manifold layer of Robinson such that the second plurality of scores include perforations that penetrate the second surface; and a plurality of removable, and wherein each of the plurality of removable portions are configured to be removed to provide an opening through both the first surface and the second surface of the manifold layer, as taught by Corley, in order to conform the manifold to the size of the wound (Corley, ¶ 0038).
Corley further teaches that both cut portions that do not penetrate the second surface and perforated portions that penetrate the second surface can define the discrete separable components (¶ 0038).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the manifold of Robinson in view of Corley such that the second plurality of scores include cut portions that do not penetrate the second surface and perforated portions that penetrate the second surface; and the plurality of removable portions formed by both the cut portions and the perforated portions of the second plurality of scores being connected in a continuous pattern defining a closed shape around each of the plurality of removable portions in a single plane, as such cut portions and perforated portions are suitable for providing discrete separable components that can conform the manifold to the size of the wound (Corley, fig. 3, ¶ 0038).
Regarding claim 9, Robinson discloses wherein the first and the second plurality of scores define a geometric pattern that includes at least one of hexagons (fig. 12), quadrilaterals (fig. 11) or concentric curves.
Regarding claim 11, Robinson in view of Corley disclose wherein each of the plurality of removable portions is selectively removable to provide a window through the manifold (Corley, ¶ 0038).
Regarding claim 12, Robinson discloses wherein the manifold layer is configured to conform to a surface defined by a breast (¶ 0048).
While Robinson in view of Corley do not explicitly disclose wherein the window of the manifold layer proximate the perforations is configured to be positioned proximate a nipple of the breast, such limitations of claim 12 relate to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. The window taught by Robinson in view of Corley is capable of being positioned proximate a nipple of the breast and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the window of the manifold layer proximate the perforations configured to be positioned proximate a nipple of the breast in order to enhance the comfort of the wearer.
Regarding claim 13, while Robinson does not explicitly disclose wherein the manifold layer is positionable in at least one of a first position in which the manifold layer conforms to a substantively two-dimensional shape with the scores substantially closed and a second position in which the manifold layer conforms to a substantively three-dimensional shape with at least some of the scores splayed apart, such limitations relate to the function of the system. Since the device of Robinson comprising the plurality of scores is identical to the device as claimed, it must necessarily function in the identical manner. Furthermore, the manifold of Robinson is fully capable of being positionable in at least one of a first position in which the manifold layer conforms to a substantively two-dimensional shape with the scores substantially closed and a second position in which the manifold layer conforms to a substantively three-dimensional shape with at least some of the scores splayed apart.
Features of an apparatus may be recited either structurally or functionally. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997). See also MPEP § 2173.05(g). If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of Corley, as applied to claim 8 above, in view of Askem et al. (Pub. No.: US 2019/0290499 A1).
Regarding claim 14, Robinson in view of Corley fail to disclose the wound dressing further comprising a first curved side surface defining a first lobe, a second curved surface defining a second lobe, and a connecting portion between the first lobe and the second lobe, wherein the first lobe and the second lobe are convex or the connecting portion is concave.
Askem teaches (annotated fig. 3B) a wound dressing (300) for negative pressure wound therapy treatment of breast incisions (abstract) and thus in the same field of endeavor, wherein the wound dressing comprises a first curved side surface defining a first lobe, a second curved surface defining a second lobe, and a connecting portion between the first lobe and the second lobe, wherein the first lobe and the second lobe are convex (annotated fig. 3B), wherein the wound dressing is configured to conform to an area of the body that is tailored to the particular type of wound or specific surgical incision to be treated (¶ 0072).
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Annotated Fig. 3B
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wound dressing of Robinson in view of Corley such that it comprises a first curved side surface defining a first lobe, a second curved surface defining a second lobe, and a connecting portion between the first lobe and the second lobe, wherein the first lobe and the second lobe are convex or the connecting portion is concave, as taught by Askem, in order to provide a wound dressing of a specific shape to conform to an area of the body that is tailored to the particular type of wound or specific surgical incision to be treated (Askem ¶ 0072).
Regarding claim 15, Robinson in view of Corley and further in view of Askem disclose wherein the first lobe is configured to conform to a shape of an upper portion of the breast and the second lobe is configured to conform to a shape of a lower portion of the breast (Askem, fig. 3B).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of Corley, as applied to claim 8 above, in view of Gilmartin (Pub. No.: US 2013/0102983 A1).
Regarding claim 16, Robinson in view of Corley fail to disclose wherein the manifold layer comprises a single lobe including a first curved comer having first radius of curvature, a second curved comer having a second radius of curvature, and a third curved comer having a third radius of curvature, and wherein the third radius of curvature is smaller than the first radius of curvature and the second radius of curvature.
Gilmartin teaches (fig. 1, 3) a dressing for a breast (fluid-absorbing member 100, ¶ 0018) and thus in the same field of endeavor comprising a manifold layer (second layer 102b, ¶ 0026) comprising a single lobe including a first curved corner (first lobe 110), having a first radius of curvature (fig. 1), a second curved corner (second lobe 112) having a second radius of curvature (fig. 1), and a third curved corner (second vertex 116) having a third radius of curvature (fig. 1), and wherein the third radius of curvature is smaller than the first radius of curvature and the second radius of curvature (fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the manifold layer of Robinson in view of Corley such that it comprises a single lobe including a first curved comer having first radius of curvature, a second curved comer having a second radius of curvature, and a third curved comer having a third radius of curvature, and wherein the third radius of curvature is smaller than the first radius of curvature and the second radius of curvature, as taught by Gilmartin, in order to allow the manifold to contour itself to the body of the user (Gilmartin ¶ 0018).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Krasikoff et al. (Pub. No.: US 2013/0331808 A1) discloses a dressing for a breast incision having an opening. Houser (Pat. No.: US 6,241,715 B1) discloses a breast pad having an opening.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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, Sarah Al-Hashimi can be reached on (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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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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