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
An amendment was filed on 07/30/2026. Claims 1, 5, 16-18, and 20-21 have been amended. Currently, claims 1-12, 14-18, and 20-22 are pending and are being examined on the merits.
Response to Arguments
Applicant’s arguments with respect to claims 16-18, and 20 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Notably, newly cited Tsuk (US 3972995) teaches the new limitations of claims 16-18 and 20.
Response to Arguments
Applicant's arguments filed 07/30/2026 with respect to claim 1 have been fully considered but they are not persuasive.
In response to the applicant’s traversal to the rejections with the amendments constituting a narrowing of the claims, the examiner respectfully disagrees.
Upon review of the amended limitations and of the prior art, examiner determined, as described further below, that the previously cited Clark reads over the amendment in claim 1 in conjunction with the amendment in claim 5.
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.
Claim 21 is 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 21 recites the senate deport being flush with the lower side and extending along the upper side. However, this appears to involve a combination of embodiments that is not demonstrated. For instance, fig. 8 shows the sensate extending along the upper side, fig. 9 shows the sensate being flush with the lower side, and fig. 11 shows the sensate extending along both sides but not being flush with the upper or lower surfaces. Fig. 19A appears to show blisters (374) that appear flush with the lower side and extend along the upper side, but it is not immediately clear if this embodiment also has the pressure sensitive adhesive contacting a lower end of the sensate depot.
More generally, however, there does not appear to be an embodiment that has the sensate being flush with the lower surface as understood by the embodiment shown in fig. 9, and also having the adhesive on the underside of the sensate depot as demonstrated in an embodiment shown in fig. 17A.
It is noted that while there is not a prior art rejection on the record for claim 21, claim 21 is still rejected under 35 U.S.C. 112(a).
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.
Claims 1-10, 12, 14-15, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Clark (US 5259835) in view of Broom (US 20110189270), and further in view of Robinson (US 20120330253)
Regarding claim 1, Clark discloses a skin closure system (abstract) comprising:
(a) a surgical mesh (fig. 1, mesh interpreted to include both the carrier member 32 and the bonding pad 36) comprising:
(i) an upper side (fig. 1, upper side with apertures 36)
(ii) a lower side defining a lower surface defining a recess, the lower surface including a central area, (fig. 3, lower side with contact adhesive 40, also including lower surface of bonding pad 36 in the central area. There is also a recess that holds the bonding pad 36 and surrounds the bonding pad as the recess is larger than the bonding pad.),
a peripheral area surrounding the central area and the recess, the recess extending at least partially around the central area (fig. 2, recess is partially around central area of bonding pad 36 as being bigger than the bonding pad), wherein the lower side, the lower surface, the central area, and the peripheral area are positioned and configured to directly contact a section of skin of a patient that surrounds a wound such that the central area is positioned over the wound and the peripheral area is positioned around the wound yet not over the wound (fig. 2, peripheral region defined by contact adhesive areas 40, lower surface and central area also directly contact section of skin. NOTE: contact adhesive on the bonding pad 36, while appearing to space away the bonding pad 36 from the skin, is part of the bonding pad 36 directly contacting the skin)
(b) a topical skin adhesive configured to be applied to the upper side of the surgical mesh (fig. 1, tube 146 filled with adhesive to be applied to the openings 36), wherein the topical skin adhesive is configured to cure within the surgical mesh to thereby form a protective layer over the wound (abstract, flowable adhesive for adhering the bonding member to the skin of the patient to create the protective layer)
Clark discloses an adhesive located on the lower side of the surgical mesh (fig. 3, contact adhesive 40 to make a seal on the skin), but does not teach (c) a sensate located on the peripheral area of the surgical mesh such that the sensate is spaced a distance from the wound, wherein the adhesive on the lower side is a pressure sensitive adhesive, and wherein the pressure sensitive adhesive is configured to dissolve after the protective layer is formed.
However, Broom teaches a mesh or patch (paragraph 0026) that utilizes a sensate (72) that comprises a sensate located on the peripheral area of the surgical mesh such that the sensate is spaced a distance from the wound (fig. 7, bioactive agent 72 at the periphery, paragraph 0030 describes them being anesthetics, analgesics, capsaicin, which, as defined in the instant specification, are sensates. The bioactive agent 72 is also capable of being spaced away from the wound).
Therefore, 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 device disclosed in Clark such that it comprises a sensate located on the peripheral area of the surgical mesh such that the sensate is spaced a distance from the wound, as taught by Broom, for the purpose of providing a suitable structure that grants immediate therapeutic relief upon attachment (see Broom, paragraph 0058).
Clark, as modified by Broom, does not teach wherein the adhesive on the lower side is a pressure sensitive adhesive, and wherein the pressure sensitive adhesive is configured to dissolve after the protective layer is formed.
However, Robinson teaches wherein a pressure sensitive adhesive one a lower side of the dressing can be dissolved after a given period of time (fig. 8, tissue-fixation element 126 meant to be dissolvable within up to 3 hours in contact with a liquid, paragraph 0034).
Moreover, Clark notes that the flowable adhesive bonds and cures to the patient after one minute (col. 5, lines 58-61). As such, the adhesive in Robinson would be capable of dissolving after the flowable adhesive of Clark cures.
Therefore, 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 device disclosed in Clark such that the pressure sensitive adhesive is configured to dissolve after the protective layer is formed, as taught by Robinson, for the purpose of providing a suitable structure that allows the device to be more easily replaced when needed.
Regarding claim 2, Clark, as modified by Broom, discloses wherein the sensate is configured to contact a portion of skin directly under the peripheral area of the surgical mesh (see Broom, fig. 7, bioactive agent 72 configured to contact skin around the peripheral area).
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 device disclosed in Clark such that the sensate is configured to contact a portion of skin directly under the peripheral area of the surgical mesh, as taught by Broom, for the purpose of providing a suitable structure that grants immediate therapeutic relief upon attachment (see Broom, paragraph 0058).
Regarding claim 3, Clark, as modified by Broom, discloses wherein the sensate is configured to be isolated from the wound after the protective layer is formed over the wound (see Broom, fig. 7, bioactive agent 72 configured to be isolated from the wound depending on wound size, especially after the protective layer of Clark is applied, and if Clark had the bioactive agent at the periphery which is isolated from the wound as taught by Broom)
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 device disclosed in Clark such that the sensate is configured to be isolated from the wound after the protective layer is formed over the wound, as taught by Broom, for the purpose of providing a suitable structure that grants immediate therapeutic relief for the surrounding area upon attachment (see Broom, paragraph 0058).
Regarding claim 4, Clark, as modified by Broom, appears to disclose wherein the topical skin adhesive, after curing, is configured to form an isolated area around the wound (fig. 1, isolated area around the wound defined by bonding pad with cured adhesive) thereby preventing migration of the sensate into the wound (fig. 1, the curing of the adhesive forms a seal that at least partially prevents migration of the senate taught in Broom).
However, if this is not clearly envisioned by the applicant, it has been held that 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 Spada
Regarding claim 5, Clark, as modified by Broom, discloses the recess extending between the sensate and the central area, wherein the recess is configured to receive the topical skin adhesive that forms the isolated area (fig. 2, recess holding bonding pad 36 extends between the central area and the peripheral area that contains the sensate taught in Broom, recess configured to receive adhesive from tube 146 shown in fig. 1)
Regarding claim 6, Clark, as modified by Broom, discloses wherein the surgical mesh further comprises an absorbent strip (36) extending at least partially around the central area between the sensate (see teachings of Broom for sensate) and the central area, wherein the absorbent strip is configured to receive the topical skin adhesive that forms the isolated area (fig. 3, bonding pad 36 to absorb the topical skin adhesive, which extends around the central area between periphery and central area).
Regarding claim 7, Clark does not teach the device further comprising a sensate depot associated with the peripheral area of the surgical mesh, wherein the sensate is incorporated into the sensate depot.
However, Broom teaches a sensate depot associated with the peripheral area of the surgical mesh, wherein the sensate is incorporated into the sensate depot (fig. 7, polymeric capsules 79 containing bioactive agent 72).
Therefore, 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 device disclosed in Clark such that it further comprises a sensate depot associated with the peripheral area of the surgical mesh, wherein the sensate is incorporated into the sensate depot, as taught by Broom, for the purpose of providing a suitable structure that grants immediate therapeutic relief upon attachment and that allows for dealing with post attachment infection (see Broom, paragraph 0058).
Regarding claim 8, Clark does not teach wherein the sensate depot comprises a material configured to inhibit the topical skin adhesive from penetrating into and underneath the sensate depot.
However, Broom teaches wherein the sensate depots comprise polymeric capsules composed of bioerodible polymer (paragraph 0057), which inhibits topical skin adhesive from penetrating into the depot (paragraph 0057, polymeric material creates an at least temporary barrier that prevents adhesive from entering).
Therefore, 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 device disclosed in Clark such that the sensate depot comprises a material configured to inhibit the topical skin adhesive from penetrating into and underneath the sensate depot, as taught by Broom, for the purpose of providing a suitable structure that grants immediate therapeutic relief upon attachment (see Broom, paragraph 0058)
Regarding claim 9, Clark does not teach the device further comprising a mask positioned over the sensate depot, wherein the mask is configured to inhibit the topical skin adhesive from penetrating underneath the sensate depot.
However, Broom teaches wherein the sensate depots comprise polymeric capsules composed of bioerodible polymer (paragraph 0057), which inhibits topical skin adhesive from penetrating into the depot. The capsule prior to breaking serves as a “mask positioned over the senate depot” as claimed
Therefore, 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 device disclosed in Clark such that the device further comprising a mask positioned over the sensate depot, wherein the mask is configured to inhibit the topical skin adhesive from penetrating underneath the sensate depot, as taught by Broom, for the purpose of providing a suitable structure that grants immediate therapeutic relief upon attachment (see Broom, paragraph 0058).
Regarding claim 10, Clark, as modified by Broom and Robinson, discloses wherein the pressure-sensitive adhesive (as taught by Robinson) is configured to prevent the topic skin adhesive from curing between the sensate and a portion of the skin directly underneath the sensate (fig. 3, contact adhesive 40 to make a seal on the skin, and thus prevent adhesive from curing outside the designated area).
Regarding claim 12, Clark, as modified by Broom, discloses wherein the sensate is incorporated into a sensate depot associated with the peripheral area of the surgical mesh (see Broom, fig. 7, areas at the periphery with active agent 72 constitute as depots), but does not teach wherein the pressures sensitive adhesive is located underneath the sensate depot.
However, Robinson teaches wherein the pressure sensitive adhesive (126) is located underneath the senate depot (fig. 8, tissue fixation element 126 underneath substrate member 124 with lidocaine, paragraph 0030)
Therefore, 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 device disclosed in Clark in view of Broom such that the pressure sensitive adhesive is located underneath the sensate depot, as taught by Robinson, for the purpose of providing a suitable structure that allows the sensate depot to stay in contact with the patient (see Robinson, paragraph 0030).
Regarding claim 14, Clark does not teach wherein the sensate comprises at least one of the following therapeutic agents: capsaicin, capsicum, lidocaine, menthol, methyl salicylate, glycol salicylate, topical nonsteroidal anti-inflammatory agents, or camphor.
However, Broom teaches wherein the sensate comprises lidocaine (paragraph 0033).
Therefore, 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 device disclosed in Clark such that the sensate comprises lidocaine, as taught by Broom, for the purpose of providing a suitable structure that grants immediate therapeutic relief upon attachment (see Broom, paragraph 0058)
Regarding claim 15, Clark does not teach wherein the sensate is housed in a rupturable capsule associated with the surgical mesh.
However, Broom teaches wherein the sensate is housed in a rupturable capsule associated with the surgical mesh (paragraph 0057, “The polymeric pocket or patch may be composed of a rapidly bioerodible polymer for quick degradation and release of the bioactive agent, or may be breakable via an external force for release of the bioactive agent.”).
Therefore, 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 device disclosed in Clark such that the sensate comprises lidocaine, as taught by Broom, for the purpose of providing a suitable structure that grants immediate therapeutic relief upon attachment (see Broom, paragraph 0058).
Regarding claim 22, Clark, as modified by Broom and Rule, does not teach wherein the pressure sensitive adhesive is positioned such that after the pressure sensitive adhesive dissolves, the sensate is in flowable communication with the section of the skin.
However, Robinson teaches wherein the pressure sensitive adhesive is positioned such that after the pressure sensitive adhesive dissolves, the sensate is in flowable communication with the section of the skin (fig. 8, after the tissue-fixation element 126 dissolves, the fluid-permeable substrate member 124 would be in contact with the skin, paragraph 0029, “The fluid-permeable substate member 124 is operational to prevent or inhibit irritation of the tissue site 102 by the porous member 118”. Thus, the lidocaine within the substrate member 124 would be in flowable communication with the section of the skin).
Therefore, 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 device disclosed in Clark in view of Broom and Rule such that the pressure sensitive adhesive is positioned such that after the pressure sensitive adhesive dissolves, the sensate is in flowable communication with the section of the skin, as taught by Robinson, for the purpose of providing a suitable means of administering medicament to a target area after the adhesive dissolves.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Clark in view of Broom and Robinson, and further in view of Rule (US 20140363564).
Regarding claim 11, Clark, as modified by Broom, does not teach wherein the sensate is incorporated into the pressure sensitive adhesive.
However, Rule teaches that incorporating medicament into a pressure-sensitive adhesive is a well-known practice in the art (fig. 1, active deposits 124 on the pressure sensitive adhesive layer 140).
Therefore, 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 device disclosed in Clark in view of Broom such that the sensate is incorporated into the pressure-sensitive adhesive, as taught by Rule, for the purpose of providing a suitable structure that grants a further reservoir for sensate to be applied to the patient if desired.
Claims 16-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Clark in view of Broom and Robinson, and further in view of Tsuk (US 3972995)
Regarding claim 16, Clark discloses a skin closure system, comprising:
(a) a surgical mesh including an upper side (fig. 1, upper side with apertures 36), a lower side (fig. 3, lower side with contact adhesive 40), a central portion (fig. 1, central area defined by area with apertures 36 and bonding pad 36), and a peripheral portion surrounding the central portion (fig. 2, peripheral region defined by contact adhesive areas 40), wherein the lower side is configured to associate to a section of skin of a patient surrounding a wound such that the central portion is above the wound and the peripheral portion is spaced away from the wound (fig. 1, central area spaced away from wound from bonding pad 36);
(b) a topical skin adhesive configured to be applied to the upper side of the surgical mesh (fig. 1, tube 146 filled with adhesive to be applied to the openings 36), wherein the topical skin adhesive is configured to cure within the surgical mesh to thereby form a protective layer over the wound (abstract, flowable adhesive for adhering the bonding member to the skin of the patient to create the protective layer); and
Clark discloses an adhesive located on the lower side of the surgical mesh (fig. 3, contact adhesive 40 to make a seal on the skin), but does not teach (c) a sensate material associated with the peripheral portion of the surgical mesh, wherein a portion of the topical skin adhesive is configured to cure within the surgical mesh to isolate the sensate material from the wound, wherein the adhesive on the lower side is a pressure sensitive adhesive, and wherein the pressure sensitive adhesive is configured to dissolve after the protective layer is formed.
However, Broom teaches a mesh or patch (paragraph 0026) that utilizes a sensate (72) that comprises a sensate located on the peripheral area of the surgical mesh such that the sensate is spaced a distance from the wound (fig. 7, bioactive agent 72 at the periphery, paragraph 0030 describes theme being anesthetics, analgesics, capsaicin, which, as defined in the instant specification, are sensates. The bioactive agent 72 is also capable of being spaced away from the wound).
Therefore, 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 device disclosed in Clark such that it comprises a sensate material associated with the peripheral portion of the surgical mesh, as taught by Broom, for the purpose of providing a suitable structure that grants immediate therapeutic relief upon attachment (see Broom, paragraph 0058).
Moreover, the topical skin adhesive taught in Clark would cure to isolate the sensate taught in Broom from the wound (abstract, flowable adhesive for adhering the bonding member to the skin of the patient to create the protective layer and seals the wound from other materials).
Clark, as modified by Broom, does not teach wherein the adhesive on the lower side is a pressure sensitive adhesive, and wherein the pressure sensitive adhesive is configured to dissolve after the protective layer is formed.
However, Robinson teaches wherein a pressure sensitive adhesive one a lower side of the dressing can be dissolved after a given period of time (fig. 8, tissue-fixation element 126 meant to be dissolvable within up to 3 hours in contact with a liquid, paragraph 0034).
Moreover, Clark notes that the flowable adhesive bonds and cures to the patient after one minute (col. 5, lines 58-61). As such, the adhesive in Robinson would be capable of dissolving after the flowable adhesive of Clark cures.
Therefore, 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 device disclosed in Clark such that the pressure sensitive adhesive is configured to dissolve after the protective layer is formed, as taught by Robinson, for the purpose of providing a suitable structure that allows the device to be more easily replaced when needed.
Clark, as modified by Broom, does not teach the surgical mesh defining a first thickness and a second thickness that is different from the first thickness, the second thickness being positioned between sections of the surgical mesh having the first thickness
However, Tsuk teaches wherein a medicament within a surgical mesh is within a thickness that is different from a main thickness (fig. 1, medicament 20 within a recess 14, which defines a second thickness), the second thickness being positioned between sections of the surgical mesh having the first thickness (see annotated fig. 1 below). Moreover, because Broom teaches the sensate in the peripheral area, Broom as modified by Tsuk teaches this second thickness near a peripheral area and not in the central area.
PNG
media_image1.png
240
549
media_image1.png
Greyscale
Therefore, 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 device disclosed in Clark in view of Broom such that the surgical mesh defines a first thickness and a second thickness that is different from the first thickness, the second thickness being positioned between sections of the surgical mesh having the first thickness, as taught by Tsuk, for the purpose of providing a suitable means of supporting the medicament in the article (see Tsuk, col. 3, lines 3-13).
Regarding claim 17, Clark does not teach the device further comprising a sensate depot at the second thickness and attached to the peripheral portion of the surgical mesh, wherein the sensate material is incorporated into the sensate depot.
However, Broom teaches a sensate depot attached to the peripheral area of the surgical mesh, wherein the sensate is incorporated into the sensate depot (fig. 7, polymeric capsules 79 containing bioactive agent 72). Moreover, Tsuk as described above has the sensate depot defining the second thickness.
Therefore, 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 device disclosed in Clark such that it further comprises a sensate depot at the second thickness and attached to the peripheral area of the surgical mesh, wherein the sensate is incorporated into the sensate depot, as taught by Broom and Tsuk, for the purpose of providing a suitable structure that grants immediate therapeutic relief upon attachment and that allows for dealing with post attachment infection (see Broom, paragraph 0058), and for the purpose of providing a suitable means of supporting the medicament in the article (see Tsuk, col. 3, lines 3-13)..
Regarding claim 18, Clark, as modified by Broom, discloses wherein the sensate material is configured to diffuse away from the sensate depot (see Broom, fig. 7, active agent 72 in capsules 79 configured to diffuse to provide relief).
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 device disclosed in Clark such that the sensate is configured to diffuse away from the sensate depot, as taught by Broom, for the purpose of providing a suitable structure that grants immediate therapeutic relief upon attachment (see Broom, paragraph 0058).
Regarding claim 20, Clark discloses a skin closure system (abstract), comprising:
(a) a surgical mesh including an upper side (fig. 1, upper side with apertures 36), a lower side (fig. 3, lower side with contact adhesive 40), a central portion (fig. 1, central area defined by area with apertures 36 and bonding pad 36), and a peripheral portion surrounding the central portion (fig. 2, peripheral region defined by contact adhesive areas 40), wherein the lower side comprises an adhesive, wherein the lower side is configured to self-adhere to a section of skin of a patient surrounding a wound such that the central portion is above the wound and the peripheral portion is spaced away from the wound (fig. 3, contact adhesive 40 to adhere to skin, and said portion spaced away from the wound);
(b) a topical skin adhesive configured to be applied to the upper side of the surgical mesh (fig. 1, tube 146 filled with adhesive to be applied to the openings 36), wherein the topical skin adhesive is configured to cure within the surgical mesh to thereby form a protective layer over the wound (abstract, flowable adhesive for adhering the bonding member to the skin of the patient to create the protective layer).
Clark is silent to wherein the lower side comprises a pressure sensitive adhesive, the surgical mesh including a peripheral portion having a recess, and a sensate depot housing a diffusible sensate material, wherein the sensate depot is incorporated within the recess of the peripheral portion of the surgical mesh such that the diffusible sensate material is configured to transfer onto a portion of skin within the protective layer and spaced away from the wound, and wherein the pressure sensitive adhesive is configured to dissolve after the protective layer is formed.
However, Broom teaches a mesh or patch (paragraph 0026) that utilizes a sensate (72) that comprises a sensate located on the peripheral area of the surgical mesh such that the sensate is spaced a distance from the wound (fig. 7, bioactive agent 72 at the periphery, paragraph 0030 describes theme being anesthetics, analgesics, capsaicin, which, as defined in the instant specification, are sensates. The bioactive agent 72 is also capable of being spaced away from the wound). Moreover, the sensate would be diffusible to transfer onto a portion of the skin within the protective layer and to be spaced away from the wound (fig. 7, the entire mesh as the protective layer over the skin, where the active agent 72 at the periphery).
Therefore, 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 device disclosed in Clark such that it comprises a sensate depot housing a diffusible sensate material, wherein the sensate depot is attached to the peripheral portion of the surgical mesh such that the diffusible sensate material is configured to transfer onto a portion of skin within the protective layer and spaced away from the wound, as taught by Broom, for the purpose of providing a suitable structure that grants immediate therapeutic relief upon attachment (see Broom, paragraph 0058).
Clark, as modified by Broom, does not teach wherein the adhesive is a pressure sensitive adhesive, wherein the pressure sensitive adhesive is configured to dissolve after the protective layer is formed.
However, Robinson teaches wherein a pressure sensitive adhesive one a lower side of the dressing can be dissolved after a given period of time (fig. 8, tissue-fixation element 126 meant to be dissolvable within up to 3 hours in contact with a liquid, paragraph 0034).
Moreover, Clark notes that the flowable adhesive bonds and cures to the patient after one minute (col. 5, lines 58-61). As such, the adhesive in Robinson would be capable of dissolving after the flowable adhesive cures.
Therefore, 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 device disclosed in Clark such that the pressure sensitive adhesive is configured to dissolve after the protective layer is formed, as taught by Robinson, for the purpose of providing a suitable structure that allows the device to be more easily replaced when needed.
Clark, as modified by Broom, does not teach the peripheral portion having a recess, wherein the senate depot is incorporated within the recess of the peripheral portion.
However, Tsuk teaches a dosage form (abstract) that places a medicament in a recess (fig. 1, medicament 20 supported in recess 14). Moreover, because Broom teaches wherein the peripheral portion has the sensate depot as described above, Broom as modified by Tsuk would have the recess within the peripheral portion for the sensate deport.
Therefore, 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 device disclosed in Clark in view of Broom such that the peripheral portion has a recess, wherein the senate depot is incorporated within the recess of the peripheral portion, as taught by Tsuk, for the purpose of providing a suitable means of supporting the medicament in the article (see Tsuk, col. 3, lines 3-13).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
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, Rebecca Eisenberg can be reached at 5712705879. 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.
/Brandon W. Levy/Examiner, Art Unit 3781
Prosecution Insights