DETAILED ACTION
The receipt is acknowledged of applicant’s amendment filed 03/17/2026; and IDS filed 01/07/2026.
Claims 1, 2, 5-16, 20-22 previously presented. Claims 23-25 are currently added. Claims 1, 2, 5-16, 20-25 are pending and subject of this office 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 .
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.
Claims 1, 2, 5-7, 11-13 and 20-25 are rejected under 35 U.S.C. 103 as being unpatentable over Cassel (US 6,383,511, of record) in view of De Visscher et al. (US 2016/0199343, of record), and Haack (US 5,377,695, previously cited on PTO 892).
Applicant Claims
Claim 1 is directed to a dermal patch for treating a wound in a patient’s skin, the dermal patch comprising:
a support layer having a top side and a bottom side opposite the top side, the bottom side of the support layer being configured to face a skin of a patient and the bottom side of the support layer extends between an inner portion and an outer portion, and the inner portion of the bottom side configured to cover a wound and the outer portion of the bottom side is configured to cover the skin surrounding the wound; a first polymeric medicament depot attached to the support layer, the first medicament depo including a therapeutically effective amount of at least one pain reliever for managing pain associated with the wound in the skin of the patient, and
a second polymeric medicament depot attached to the support layer, the second polymeric medicament depot including a therapeutically effective amount of at least one medicament for treating the wound in the skin of the patient, wherein the first polymeric medicament depot and the second polymeric medicament depot are separate from each other positioned along the outer portion of the bottom side of the support layer and configured to straddle the wound on separate first and second opposing parts of the skin surrounding the wound without covering and sealing the wound.
Claim 22 is directed to a dermal patch for treating a wound in a patient’s skin, the dermal patch comprising:
a support layer having a top side and a bottom side opposite the top side, the bottom side of the support layer being configured to face a skin of a patient and the bottom side of the support layer extends between an inner portion and an outer portion, and the inner portion of the bottom side configured to cover and contact a wound and the outer portion of the bottom side is configured to cover and contact the skin surrounding the wound, wherein the support layer is a porous surgical tape or a porous surgical knit mesh;
a first polymeric medicament depot attached to the support layer, the first polymeric medicament depot including a therapeutically effective amount of at least one pain reliever for managing pain associated with the wound in the skin of the patient;
a first non-porous barrier layer positioned between a top side of the first polymeric medicament depot and the bottom side of the support layer;
a second polymeric medicament depot attached to the support layer, the second
medicament depot including a therapeutically effective amount of at least one medicament for treating the wound in the skin of the patient;
a second non-porous barrier layer positioned between a top side of the second
polymeric medicament depot and the bottom side of the support layer; wherein the first medicament depot and the second medicament depot are separated
from each other and extend parallel to each other along opposing first and second parts of the skin surrounding the wound without covering and sealing the wound.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Cassel teaches topical delivery device to topically deliver therapeutically effective amount of local anesthetic formulation to exterior surface around a closed wound to ameliorate pain (abstract; col.3, lines 34-47; col.5, lines 1-5; col.5, lines 50-55). The local anesthetic include bupivacaine HCl (col.3, line 55-57; col.4, lines 33, 40-41). The topical composition can be in the form of adhesive matrix (col.4, lines 64-67). The formulation is covered by porous or nonporous dressing that reads on the claimed support layer and comprises nonabsorbable material (col.5, lines 42-45; col.6, lines 50-53). The patch comprising impermeable layer to minimize the migration of drug to the backing layer (col.6, lines 12-25) that reads on the barrier layer. The patch deliver the contained anesthetic at a constant rate for 1-7 days (col.5, lines 57-64). Acrylic adhesive is taught as suitable adhesive for the dermal patch (col.6, lines 54-65). The amount of the local anesthetic in the topical formulation is from 0.5-40%, in a concentration of 0.5-5 g/cm2 administered around the wound (col.7, lines 40-60).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Cassel teaches closed wound wherein the active agent is administered to the exterior surrounding area of the wound, the reference however does exemplify the delivery from exterior of the wound, and does not explicitly teach administering the active agent to the skin surrounding the wound from two separate portions as claimed by claim 1.
De Visscher teaches treating closed wound by applying active agent to area around the closed wound so the wound does not get disturbed. The active agent includes bupivacaine included in reservoir of adhesive or non-adhesive materials (abstract; ¶¶ 0021, 0045, 0047, 0100, 0143).
Haack teaches a wound closure strip that is safe, easy to use and cheap to manufacture. The strip has a pair of edges has a pair of parallel tapes each formed by a U-shaped one-piece textile outer strip having a longitudinally extending outside flap and, parallel thereto, an inside flap joined at a longitudinal fold, and a filler strip extending longitudinally between and spacing the flaps apart. Each tape has an inner edge turned toward the other tape and carrying one of a pair of longitudinal rows of interleavable teeth (fasteners) on the outside flaps. Stitches or the like engaged through the flaps and filler strip of each tape hold them together. A skin-compatible adhesive adhered to inside faces of the inside flaps allows the inside flaps to be adhered to skin to each side of the wound. A slider clasp fastener displaceable longitudinally along the rows of teeth can interleave and couple them together so that, when the tapes are adhered to skin to each side of the wound, coupling the rows of teeth with the slider pulls the edges of the wound together (see the entire document, and in particular: abstract; col.1, lines 45-67; col.2, lines 10-45; figures; claims).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide dermal patch to treat closed wound that comprises cover layer comprising polymer matrix at the wound facing area and containing local anesthetic wherein the anesthetic containing layer surrounds the wound as taught by Cassel, and make sure to keep the drug containing layer around the perimeter of the wound as taught by De Visscher. One would have been motivated to do so because De Visscher teaches that the wound does not get disturbed by applying active agent to area around the closed wound. One would reasonably expect treating closed wound by applying a dermal patch comprising active agent polymer layer at the perimeter of the wound wherein the wound healing is not disturbed.
Further, one having ordinary skill in the art would have divided the polymeric active agent layer of the dermal patch surrounding the wound taught by the combination of Cassel with De Visscher into a two parallel strips on each side of the edge of the wound as taught by Haack because Haack teaches such parallel strips are safe, easy to use and cheap to manufacture, and also allow fastening the wound.
Regarding claims 1 and 22 that more than one drug depot layer surrounding the wound, this is taught by combination of the cited references.
Regarding the limitation that first and second drug depos are separate and straddle the wound as claimed by claims 1 and 22, the combination of the cited references teaches two separate parallel adhesive strips drug depots. In any event, changing the shape of the depos is obvious. MPEP §2144.04 (IV)(B) similarly states that simply changing the shape of a device was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed invention was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). It is expressly evident in prior art teachings that the shape of the adhesive can be chosen and decided by a versed artisan. Further, it has been held by the court that aesthetic changes that have no mechanical function cannot be relied upon to patentability distinguish the claimed invention from the prior art. See In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947).
Regarding claim 2 that the support layer is porous, this is taught by Cassel.
Regarding claim 5 that the depot layers are parallel to each other, this is taught by Haack teaches two parallel adhesive strips.
Regarding semicircular shape of the depot layers as claimed by claim 6, applicants failed to show unexpected results obtained from semicircular shape versus circular or parallel strips taught by Haack.
Regarding barrier claimed by claims 7 and 22, Cassel teaches impermeable layer to minimize the migration of active agent from the drug surrounding the wound to the backing layer that reads on the barrier.
Regarding anesthetic claimed by claims 11 and 21, and bupivacaine HCl claimed by claim 12, this is taught by Cassel.
Regarding delivery of anesthetic for 3 days as claimed by claim 13, Cassel teaches delivery for 3-7 days.
Regarding closed wound by fastener as claimed by claim 20, Haack teaches using fastener attached to the two parallel strips to close the wound, and the fasteners do not bring the strips together, only the edge of the wound.
Regarding claim 23 that the patch is configured to be centered on the wound and the wound fastener is a suture, this is taught by Haack that teaches stiches to fasten the wound.
Regarding non-adhesive depot is not adhesive to the skin as claimed by claim 24, De Visscher teaches drug reservoir (depot) can be non-adhesive to the skin.
Regarding porous nonabsorbable support claimed by claim 25, this is taught by Cassel.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Cassel, De Visscher and Haack as applied to claims 1, 3, 5-7, 11-13, and 20-25 above, and further in view of Zawoy et al. (US 2022/0192888, of record).
Applicant Claims
Claims 8 and 9 recite transparent support layer and claim 10 recited colored layer but the wound remains visible, i.e. claim 10 also requires transparent support.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The combined teachings of Cassel, De Visscher and Haack are previously discussed in this office action.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
The combination of the cited references do not teach transparent support layer as claimed by claims 8-10.
Zawoy teaches method of treating closed wound using a bandage creating a seal
around the wound perimeter and provide non-contact protected wound treatment
method. The bandage is transparent to visualize the healing wound (abstract; ¢f 0010-0011, 0013, 0028-0030, 0032-0035, 0045-0047, 0065, 0068, 0072, figures 9-12).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide the wound dressing comprising two adhesive strips comprising active agent surrounding the wound and support layer covering the wound as taught by the combination of Cassel, De Visscher and Haack, and make the support layer covering the wound a transparent as taught by Zawoy. One would have been motivated to do so because Zawoy teaches transparent layer permits visualizing the wound. One would reasonably expect formulating wound dressing comprising two adhesive polymer strips and transparent support covering he wound so the wound is visible to the care giver without hurting the wound and exposing it to the environment and without disturbing the patient.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Cassel combined with De Visscher and Haack as applied to claims 1-2, 5-7, 11-13 and 20-25 above, and further in view of Yum et al. (US 2009/0060986, of record).
Applicant Claims
Claim 14 recites that the medicament depot is configured to release the anesthetic at a rate of about 1ug/cm2/h to 100 ug/cm2/h. Claim 15 recite that the medicament depot includes about 0.1 mg/cm2 to 20 mg/cm2 of an anesthetic.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The combined teachings of Cassel with De Visscher, and Haack are previously discussed in this office action.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
The combined teachings of the references however does not teach the release rate of local anesthetic as claimed by claim 14. While Cassel teaches the claimed 0.5-5 mg/cm2 of local anesthetic in topical formulation, the reference does not teach the claimed amount in dermal patch as claimed by claim 15.
Yum teaches transdermal delivery patch comprising bupivacaine in adhesive matrix. Yum teaches that bupivacaine is useful in treatment of variety of localized pain. The adhesive comprises acrylate and vinyl acetate adhesive, and the acrylate is hexyl methacrylate. The bupivacaine transdermal patch in Yum is present in amount of 0.29 mg/cm2, and is designed to provide a net flux of the drug through the skin at about 0.01 ug/cm2/hr to about 15ug/cm2/hr for the first three-day period (abstract; ¶¶ 0004, 0082, 0108, 0124).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to deliver bupivacaine to closed wound using adhesive matrix as taught by the combination of Cassel with either De Visscher, and Haack, and use the amount of the bupivacaine that is designed to deliver bupivacaine in the rate taught Yum. One would have been motivated to do so because Yum teaches such amount and delivery rate treat different varieties of pain. One would reasonably expect formulating pain relief dermal patch comprising and delivering the claimed amount of bupivacaine.
Regarding the claimed amounts bupivacaine and its delivery rate, Yum teaches amounts and delivery rates overlapping with the claimed values. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Cassel combined with De Visscher, and Haack as applied to claims 1-2, 5-7, 11-13 and 20-25 above, and further in view of Yum et al. (US 2009/0060986) and Udipi et al. (US 2005/0084515), both references are of record
Applicant Claims
Claim 16 recites the medicament depot is made of an acrylate copolymer, wherein the acrylate copolymer includes or is derived from a combination of hexyl methacrylate, vinylpyrrolidone, and vinyl acetate.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The combined teachings of Cassel, De Visscher, and Haack are previously discussed in this office action.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While the combination of Cassel with De Visscher, and Haack suggest acrylate polymer, the references however do not explicitly teach the claimed combination of hexyl methacrylate, vinylpyrrolidone, and vinyl acetate as claimed by claim 16.
Yum teaching are previously discussed in this office action. Yum teaches adhesive comprises hexyl methacrylate and vinyl acetate.
Udipi teaches highly biocompatible adhesive for controlled release of active agent comprising hexyl methacrylate, vinylpyrrolidone and vinyl acetate (abstract; ¶¶ 0009, 0029-0030).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide dermal patch comprising depot containing medicament as taught by the combination of Cassel, De Visscher, and Haack, and use the combination of hexyl methacrylate acrylate and vinyl acetate adhesive taught by Yum and further add polyvinyl pyrrolidone taught by Udipi. One would have been motivated to do so because Yum teaches that combination of hexyl methacrylate and vinyl acetate is suitable to deliver bupivacaine and because Udipi further teaches the combination hexyl methacrylate, vinylpyrrolidone and vinyl acetate is highly biocompatible and provides controlled release of active agent. One would reasonably expect delivering bupivacaine from a formulation comprising the claimed polymer combination wherein the combination is biocompatible and provides controlled release of bupivacaine.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 03/17/2026 have been fully considered but they are not persuasive.
35 USC § 103 Rejections
Applicants argue that the present rejection fails to provide a prima facie case of obviousness because the rejection does not identify every element of independent claims 1 and 22 that each require a patch that includes two separate polymeric medicament depots-a first depot and a second depot-positioned on opposing sides of the wound.
The examiner respectfully disagrees because every limitation of claims 1 and 22 is taught either explicitly or implicitly by the cited references, and every limitation is addressed by the office action as set forth supra.
Applicants argue that Cassel indisputably fails to disclose the claimed configuration of first and second medicament depots positioned on opposing sides of a wound. De Visscher allegedly teaches to "make sure to keep the drug containing layer around the perimeter of the wound," and Haack allegedly teaches "two parallel strips on each side of the edge of the wound." However, neither citation expressly or inherently cures the acknowledged deficiency in Cassel. First, the cited portion of De Visscher merely refers to maintaining a drug-containing layer around a wound perimeter. The Office Action does not identify any disclosure in De Visscher of two separate portions configured to administer an active agent from opposing sides of the wound, nor does it identify any disclosure of separate polymeric medicament depots as required by the claims. This interpretation of De Visscher is further supported by the Office requiring the addition of Haack. Second, Haack likewise fails to disclose the missing claim elements. While Haack is cited for "two parallel strips on each side of the edge of the wound," the Office Action does not identify any disclosure in Haack of a medicament, a medicament depot, and/or a polymeric medicament depot. Haack is not even cited for allegedly teaching polymeric medicament depots of any kind, let alone separate medicament depots positioned on opposing sides of a wound. Thus, even if Haack discloses two non-medicated parallel strips, Haack does not cure the deficiency expressly noted by the Office in Cassel (i.e., administering the active agent to the skin surrounding the wound from two separate portions) rendering the present rejection improper and failing to provide a prima facie case of obviousness. An obviousness rejection must identify where each and every element of the claimed invention is taught or suggested in the prior art. Here, the Office Action acknowledges that Cassel lacks the claimed two opposing medicament depots and does not identify any teaching in De Visscher or Haack that supplies the missing elements. Thus, the present rejection fails to establish the required prima facie case.
In response to this argument, it is argued that Cassel clearly teaches topical delivery device to topically deliver local anesthetic formulation to the surface around a closed wound. Cassel further teaches the delivery of the local anesthetic to the exterior of wound and to the skin surrounding the wound that would suggest delivery of the local anesthetic to area hugging or straddle the wound. Cassel differs from the present invention in that he does not teach two separate portions to deliver the medicaments as claimed by claims 1 and 22. The missing element from Cassel are taught by the secondary references as set forth in this office action. First, De Visscher is relied upon to emphasize that closed wound can be treated by applying active agent to area around the closed wound so the wound does not get disturbed. De Visscher supports the teachings of Cassel to apply active agent around the periphery of the closed wound and not on the closed wound itself. If any of Cassel or De Visscher was to teach first and second medicament depots, such a reference would have been considered for anticipation. Second, Haack teaches two adhesive strips parallel to each other applied to either side of the wound. In view of Haack, one having ordinary skill in the art would have selected to use the medicament depot surrounding the wound in the form of two parallel strip because it is easier to manufacture and also can be used to attach means for fastening the wound as applicants desired to achieve. Regardless if Haack teach medicated two compartment or not, combination of Haack with the other references teaches medicated compartments. Further, replacing a continuous depot surround the wound as taught by Cassel or De Visscher by two separate depots surrounding the wound as taught by Haack is not more than a change in the aesthetic appearance, absent evidence to the contrary. It has been held by the court that aesthetic changes that have no mechanical function cannot be relied upon to patentability distinguish the claimed invention from the prior art. See In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947).
Combination of the cites references teaches the claimed invention, and motivation to combine the references exists, as well as reasonable expectation to achieve the present invention was presented and prima facie case of obviousness was established. One cannot attack the references individually wherein obviousness is based on combination of references.
Applicants disagree with the examiner that dividing an alleged continuous medicament layer into two separate medicament strips, and particularly two separate parallel medicament strips, would merely present a change in shape or aesthetic appearance. This characterization is improper because none of the cited references teach or suggest to divide a continuous medicament layer. The only reference relied upon by the Office that allegedly teaches using two pieces is Haack and neither piece of Haack includes a medicament.
In response to this argument, it is argued that, as applicants themselves noted, Haack teaches two separate strips. Haack is not used in vacuum, it is used in combination with other references that teaches medicated strips surrounding the wound, therefore, combination of the cited references would have achieved the present invention of two separate medicated strips surrounding the wound, as set forth in this office action. Combination of the cited references made the present invention obvious. The rationale to modify the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art and the reason to modify the reference may often suggest what the applicant has done.
Applicants argue that the two separate polymeric medicament depots located on opposite sides of a wound (claim 1), and particularly parallel to each other (claim 22) and/or separate by a distance sufficient to not overlap both the closed wound and the wound fastener closing the wound (claim 20), is not merely a change in shape or aesthetics from a continuous layer because the claimed structural arrangement provides: a) spatial separation of the medicament(s) from each other and the wound, while limiting direct exposure of the medicament to only specific or necessary portions of the healthy skin as opposed to an entirety of the healthy skin covered by an alleged continuous layer; and b) targeted delivery from opposite sides of the wound increases the likelihood that the zone of efficacy of each of the opposing depots will reach and/or overlap the wound, particularly when the depots are parallel and/or the patch is centered on the wound.
In response to this argument, applicant’s attention is directed to the scope of the present claims that are directed to a product, and all the elements of the claimed product are taught by combination of the cited references. The function applicants achieved from having two separate depots are expected from the patch achieved by combination of the cited references. Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results.
Applicants argue that, even assuming, arguendo, that the Office maintains that the cited art render the claims obvious, the present rejection is still improper because Cassel and Haack teach away from each other, Haack teaches away from the present claims, and/or the proposed combination of Cassel and Haack would modify the principle operation of Cassel. The proposed combination of Cassel and Haack is also improper because the references address fundamentally different wound conditions and therefore teach away from one another. The Office Action relies on Cassel for teaching the application of a patch to a closed wound (page 6). In contrast, Haack teaches a wound closure device used on an open wound, where the device mechanically draws the wound edges together to achieve closure. Thus, Cassel is used after a wound is already closed, while Haack is used to close an open wound. These teachings are incompatible. Applying Haack's wound-closing strip system to Cassel's closed-wound patch would defeat Cassel's intended purpose. A person of ordinary skill in the art would have had no reason to modify a patch intended for use on a closed wound by incorporating a closure device designed for open wounds.
In response to this argument, applicant’s attention is directed to the scope of the present claims that are directed to a product, and all the elements of the claimed product are taught by combination of the cited references. Motivation to combine the references exists, and reasonable expectation to achieve the present invention. It has been decided by the Courts that even in a case where the reference does not teach the same use of the composition (product), the two different intended uses are not distinguishable in terms of the composition/product, see In re Thuau, 57 USPQ 324; Ex parte Douros, 163 USPQ 667; and In re Craige, 89 USPQ 393.
Further, the references do not have to combined for the same reasons as applicants. It should be noted that the motivation to combine references can be different from the ones set forth by Applicant. That is, as long as motivation exists to combine the elements, the problem to be solved does not have to involve the same reason. As such, the examiner respectfully submits that there is motivation to combine the cited references as set forth in this office action. The rationale to modify the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art and the reason to modify the reference may often suggest what the applicant has done.
The teachings of the references are compatible because the cited references are analogous art and are in the field of the inventor’s endeavor, and are reasonably pertinent to the particular problem with which the inventor was concerned that is wound treatment. Therefore, it is proper to rely on and combine these references as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992).
Applicants argue that Haack teaches away from the patch of claims 1 and 22. Claims 1 and 22 recite a support layer including an inner portion configured to cover the wound (see at least Figs. 3A- 3D). In contrast, as shown in every Figure of Haack, Haack teaches a two-piece closure strip wherein the strips 1 do not cover the wound, rather the row of teeth 2 cover the wound to create a wound-clearing area 9. These teachings are incompatible. In addition, the proposed modification of Cassel with Haack would also fundamentally alter the principle of operation of Cassel. Cassel's patch operates by delivering anesthetic to a closed wound. Introducing the wound-closure structure of Haack would convert the patch of Cassel into a system intended to close an open wound, thereby changing the fundamental function of the Cassel patch. Such a modification would destroy Cassel's intended operation and therefore would not have been obvious to a person of ordinary skill in the art.
In response to this argument, it is argued that Haack does not teach away from the claimed patch because the reference teaches wound closure strips placed on opposite sides surrounding the wound. Note that the present claims do not require the strips to cover the wound, rather surrounding the wound. The presence of teeth that cover the wound reads on the claimed fastening mechanism. Further the claims’ language permits the presence of such teeth. The combination of the references would not alter the fundamental principle of operation of the Cassel because the wound will be surrounded by two medicated strips and provided by fastening mechanism. Therefore, Haack does not teach away from Cassel. "A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant. The degree of teaching away will of course depend on the particular facts; in general, a reference will teach away if it suggests that the line of development flowing from the reference's disclosure is unlikely to be productive of the result sought by the applicant." In re Gurley, 27 F.3d 551,553 (Fed. Cir. 1994). It has been held by the court that a prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed invention. W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984).
Applicants argue that, the Office Action asserts that the cited combination would make the device "safe, easy to use and cheap to manufacture." However, these statements merely repeat benefits attributed to Haack's non-medicated wound closure strips and do not provide a reason why a skilled artisan would modify Cassel's closed-wound anesthetic patch to incorporate Haack's open-wound closure structure. The Office has not provided why a skilled artisan would find it safe, easy or cheap to modify a patch designed to be applied to a closed wound to be used on an open wound. Haack addresses a problem-closing an open wound-that is already solved in Cassel because Cassel is applied after the wound has been closed. Accordingly, there would have been no motivation to incorporate Haack's closure strips into Cassel.
In response to this argument, it is argued that motivation to combine the reference does not have to be the same as what applicant had done or to achieve the same results. It is reiterated that, it should be noted that the motivation to combine references can be different from the ones set forth by Applicant. That is, as long as motivation exists to combine the elements, the problem to be solved does not have to involve the same reason. Obviousness does not require absolute predictability of success all that is required is a reasonable expectation of success. See In re Kubin, 561 F.3d at 1360. The Court has held that "the test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them." See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965). "There is no requirement (under 35 USC 103(a)) that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art." Motorola, Inc. V. Interdigital Tech. Corp., 43 USPQ2d 1481, 1489 (Fed. Cir. 1997). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR Int'l Co. V. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.").
Applicants argue that the deficiencies of Cassel, De Visscher, and Haack regarding claim 1 are provided in detail hereinabove. The addition of Zawoy, Yum and/or Udipi fails to cure the deficiencies of Cassel, De Visscher, and Haack. Zawoy is cited for creating a seal around a wound. Yum is cited for allegedly teaching a transdermal delivery patch comprising bupivacaine in adhesive. Udipi is cited for allegedly teaching a biocompatible adhesive comprising hexyl methacrylate, vinylpyrrolidone and vinyl acetate matrix. Even assuming the characterization of Zawoy, Yum and/or Udipi is accurate and the combination of Cassel, De Visscher, Haack, Zawoy, Yum and/or Udipi is proper, neither of which is conceded by Applicant, the cited portions of Zawoy, Yum and/or Udipi do not cure the deficiencies of Cassel, De Visscher, and Haack.
In response to this argument, it is argued that combination of Cassel, De Visscher, and Haack suggests all the limitations of claims 1 and 22. As applicants noted, Yum and Udipi are applied to teach the limitations of claims 14-16, and the references satisfy the purposes for which they were applied.
Conclusion
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.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./
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