DETAILED ACTION
This is an Office action based on application number 16/693,273 filed 23 November 2019, which is a divisional of application number 15/400,885 (now US Patent No. 10,524,956) filed 6 January 2017, which claims priority to US Provisional Application No. 62/276,131 filed 7 January 2016. Claims 28-93 are pending. Claims 32-34, 36, 50-67, 71-76, and 78-81 are withdrawn from consideration due to Applicant’s election.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 28-31, 35, 37-42, 46-49, 68-70, 77, and 82-86 are rejected under 35 U.S.C. 103 as being unpatentable over Kitahata et al. (US Patent Application Publication No. US 2007/0166438 A1) (Kitahata) in view of Maegli (US Patent No. 5,298,268) (Maegli) and Jorgensen et al. (WIPO International Publication No. WO 98/22114) (Jorgensen).
Regarding instant claims 28-31, 37-42, 68-70, 85-93:
Kitahata discloses a covering material for a wound comprising a porous silica imparting agent and a film forming material, wherein said covering material has excellent water breathability wherein moisture is quickly absorbed under high humidity conditions and quickly desorbed under low humidity conditions (paragraphs [0215-0221]) (i.e., the wound covering material is absorbent).
Kitahata further discloses that the wound covering material comprises an adhesive material that prevents detachment from the surface of the wound and has safety against a human body (paragraph [0227]). Kitahata discloses that the adhesive is inclusive of glycerols, fructose, and combinations thereof (paragraphs [0228-0229]).
Kitahata teaches that wound curing is advantageously influenced by the dryness of the wound surface (paragraph [0243]).
Kitahata is silent with regard to an adhesive having the specific physical and chemical properties recited by the claims.
However, Maegli discloses an adhesive having low water activity and low moisture content (col. 3, lines 43-50).
Maegli discloses that said adhesive comprises a mixture of at least one monosaccharide and at least one polyhydric, aliphatic saturated alcohol having 3 to 6 carbon atoms (col. 4, lines 33-37).
Maegli teaches that the monosaccharide is inclusive of fructose (col. 6, lines 25-28).
Maegli teaches that the polyhydric alcohol is inclusive of glycerol (col. 6, lines 29-35).
Maegli teaches that the weight ratio of monosaccharide to alcohol is between 0.5:1 and 8:1, which is inclusive of those amounts recited by claims 69-70; however, “in the case where claimed ranges ‘overlap or lie inside ranges disclosed by prior art’ a prima facie case of obviousness exists.” See MPEP § 2144.05.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art, having the teachings of the prior art references before him or her, to use the fructose-glycerol adhesive mixture of Maegli in the wound covering material of Kitahata. The motivation for doing so would have been that the adhesive of Maegli has a low moisture content, which is advantageous to wound curing. Furthermore, the adhesive of Maegli meets the desired adhesive comprising compounds inclusive of glycols and fructose desired by Kitahata. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007). See MPEP §2143(B).
Kitahata does not explicitly disclose the adhesive is in the form of a gel.
However, Jorgensen discloses compositions for gels, bandages, and dressings (page 20, lines 27-31). Jorgensen further discloses that gel bases for these compositions are capable of taking up exudate from a wound/ulcer are inclusive of glycerol (page 23, lines 21-25).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art, having the teachings of the prior art before him or her, to form the adhesive comprising a glycerol of Kitahata into a gel as described by Jorgensen. The motivation for doing so would have been that those gels used in bandage/dressing applications are capable of taking up exudates from wounds/ulcers.
Kitahata in view Maegli and Jorgensen does not explicitly recite those physical and chemical properties recited by claims 28-29, 38-42, and 85-93.
However, one of ordinary skill in the art would readily conclude that the scope of Maegli encompasses an embodiment that is substantially identical to that of Applicant’s invention, and that said substantially identical embodiment must have the same properties as those claimed. 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). See MPEP §2112.01(I).
In the instant case, Applicant discloses an exemplary adhesive formulation in their original disclosure, wherein said exemplary adhesive includes 43%w/w fructose and 57%w/w glycerol (pages 36-39, paragraphs [00120-00127]). One of ordinary skill in the art would readily conclude, given the extensive testing in the original disclosure, that the adhesive comprising 43%w/w fructose and 57%w/w glycerol is well within the scope of the claimed invention and must exhibit the claimed properties.
As discussed above, the scope of Maegli encompasses an adhesive comprising fructose and glycerol in amounts inclusive of 43%w/w fructose and 57%w/w glycerol. Therefore, Maegli must encompass an embodiment having all of the claimed properties.
Kitahata in view of Maegli and Jorgensen does not explicitly disclose the intended use limitation of a composite structure of use with an applicator and the adhesive is formed for positioning between the applicator and human skin with a specific tensile adhesion; however, “if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention' s limitations, then the preamble is not considered a limitation and is of no significance to the claim construction”. See MPEP § 2111.02.
Therefore, it would have been obvious to combine Maegli and Jorgensen with Kitahata to obtain the invention as specified by the instant claims.
Regarding instant claim 35:
As cited and discussed above, Kitahata teaches the importance of a dry wound surface in wound healing, and Maegli discloses an adhesive preferably having a low moisture content.
Since the instant specification is silent to unexpected results, the specific moisture content of the adhesive is not considered to confer patentability to the claims. As the sufficient healing of a wound is a variable that can be modified, among others, by adjusting the moisture content of the wound covering structure, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the moisture content of the prior art combination’s adhesive to obtain the desired stability (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding instant claims 46-47:’
Kitahata teaches that in addition to fructose and glycols, the adhesive material can further comprise those materials used in the film forming material (paragraph [0229]). Kitahata teaches that said film forming materials are inclusive of polysaccharides and proteins (paragraph [0222]).
While Kitahata does not explicitly disclose that said polysaccharides and proteins are gelling agents, their use as “gelling agents” is an intended use limitation, and one of ordinary skill in the art would readily conclude that the substances of the claims and those of the prior art are capable of the same intended use.
Regarding instant claims 48-49:
Kitahata further discloses that the wound covering material can be formulated with pigments inclusive of iron oxides (paragraph [0237]).
The disclosure of the wound covering material formulated with said pigments is construed to include both the film forming material and the adhesive of the wound covering.
As to the claimed average effective diameter of the fillers, one of ordinary skill in the art would readily conclude that the broad range recited by the claims (i.e., greater than 100 nanometers) would necessarily include those particles typically used in the art as filler material.
As to the claimed limitation “wherein the particles are configured to be magnetically shifted in situ to increase a thermal conductivity of the adhesive”, Kithara in view of Maegli encompasses an embodiment wherein iron oxide pigments are included in an adhesive. One of ordinary skill in the art would readily understand that “iron oxides” are inclusive of magnetic iron oxide particles. Furthermore, it is not clear what is required to be “configured to be magnetically shifted in situ to increase a thermal conductivity” other than combining magnetic particles with an adhesive. Therefore, structure of the prior art is construed to meet the limitation.
As to the claimed limitation “wherein the adhesive is a suspension at room temperature”, the prior art combination encompasses an embodiment that is substantially identical to the claimed composition (i.e., a fructose-glycol adhesive comprising magnetic particles), and one of ordinary skill in the art would readily conclude that the encompassed embodiment must have the same properties as the claimed composition (i.e., is a suspension at room temperature). 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). See MPEP §2112.01(I).
Regarding instant claims 77 and 82-84:
Kitahata discloses a covering material for a wound comprising a porous silica imparting agent and a film forming material, wherein said covering material has excellent water breathability wherein moisture is quickly absorbed under high humidity conditions and quickly desorbed under low humidity conditions (paragraphs [0215-0221]) (i.e., the wound covering material is absorbent).
Kitahata further discloses that the wound covering material comprises an adhesive material that prevents detachment from the surface of the wound and has safety against a human body (paragraph [0227]). Kitahata discloses that the adhesive is inclusive of glycerols, fructose, and combinations thereof (paragraphs [0228-0229]).
Kitahata teaches that wound curing is advantageously influenced by the dryness of the wound surface (paragraph [0243]).
Kitahata is silent with regard to an adhesive having the specific physical and chemical properties recited by the claims.
However, Maegli discloses an adhesive having low water activity and low moisture content (col. 3, lines 43-50).
monosaccharide and at least one polyhydric, aliphatic saturated alcohol having 3 to 6 carbon atoms (col. 4, lines 33-37).
Maegli teaches that the monosaccharide is inclusive of fructose (col. 6, lines 25-28).
Maegli teaches that the polyhydric alcohol is inclusive of glycerol (col. 6, lines 29-35).
Maegli teaches that the weight ratio of monosaccharide to alcohol is between 0.5:1 and 8:1, which is inclusive of those amounts recited by the claim; however, “in the case where claimed ranges ‘overlap or lie inside ranges disclosed by prior art’ a prima facie case of obviousness exists.” See MPEP § 2144.05.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art, having the teachings of the prior art references before him or her, to use the fructose-glycol adhesive of Maegli in the wound covering material of Kitahata. The motivation for doing so would have been that the adhesive of Maegli has a low moisture content, which is advantageous to wound curing. Furthermore, the adhesive of Maegli meets the desired adhesive comprising compounds inclusive of glycols and fructose desired by Kitahata. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007). See MPEP §2143(B).
Kitahata does not explicitly disclose the adhesive is in the form of a gel.
However, Jorgensen discloses compositions for gels, bandages, and dressings (page 20, lines 27-31). Jorgensen further discloses that gel bases for these compositions are capable of taking up exudate from a wound/ulcer are inclusive of glycerol (page 23, lines 21-25).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art, having the teachings of the prior art before him or her, to form the adhesive comprising a glycerol of Kitahata into a gel as described by Jorgensen. The motivation for doing so would have been that those gels used in bandage/dressing applications are capable of taking up exudates from wounds/ulcers.
Kitahata in view Maegli and Jorgensen does not explicitly recite those physical and chemical properties recited by claims 77 and 82-84.
However, one of ordinary skill in the art would readily conclude that the scope of Maegli encompasses an embodiment that is substantially identical to that of Applicant’s invention, and that said substantially identical embodiment must have the same properties as those claimed. 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). See MPEP §2112.01(I).
In the instant case, Applicant discloses an exemplary adhesive formulation in their original disclosure, wherein said exemplary adhesive includes 43%w/w fructose and 57%w/w glycerol (pages 36-39, paragraphs [00120-00127]). One of ordinary skill in the art would readily conclude, given the extensive testing in the original disclosure, that the adhesive comprising 43%w/w fructose and 57%w/w glycerol is well within the scope of the claimed invention and must exhibit the claimed properties.
As discussed above, the scope of Maegli encompasses an adhesive comprising fructose and glycerol in amounts inclusive of 43%w/w fructose and 57%w/w glycerol. Therefore, Maegli must encompass an embodiment having all of the claimed properties.
Kitahata in view of Maegli and Jorgensen does not explicitly disclose the intended use limitation of a composite structure of use with an applicator and the adhesive is formed for positioning between the applicator and human skin with a specific tensile adhesion; however, “if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention' s limitations, then the preamble is not considered a limitation and is of no significance to the claim construction”. See MPEP § 2111.02.
Therefore, it would have been obvious to combine Maegli and Jorgensen with Kitahata to obtain the invention as specified by the instant claims.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Kitahata in view of Maegli and Jorgensen as applied to claim 28 above, and further in view of Capik et al. (US Patent No. 5,354,597).
Regarding instant claim 43:
Kitahata in view of Maegli and Jorgensen discloses the wound covering material comprising a fructose-glycol-based adhesive, as cited above.
Kitahata further discloses that the wound covering material may comprise a film forming material composed of synthetic polymer substances (paragraph [0222]).
Kitahata in view of Maegli and Jorgensen does not explicitly disclose that the substrate is a stretchable fabric including metal fibers or carbon fibers.
However, Capik teaches that elastomeric tapes are used as stretchable backings for bandages; furthermore, Capik teaches that woven structures comprising elastomeric yarns are readily known in the art (col. 6, lines 16-21).
Capik further discloses that short fibers or microfibers can be used to reinforce elastomers, and that said fibers include carbon fibers (col. 5, lines 11-15).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art, having the teachings of the prior art before him or her, to use the art recognized woven elastomeric backings taught by Capik as a stretchable backing for the wound covering material of Kitahata. The motivation for doing so would have been that such elastomeric backings meet the synthetic polymer film forming materials desired by Kitahata. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007). See MPEP §2143(B).
Furthermore, it would have been obvious to one of ordinary skill in the art to include the carbon fibers of Capik in the backing of Kitahata. The motivation for doing so would have been to provide structural reinforcement.
Therefore, it would have been obvious to combine Capik with Kitahata in view of Maegli and Jorgensen to obtain the invention as specified by the instant claims.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Kitahata view of Maegli and Jorgensen, as applied to claim 28 above, and further in view of Capik and Robinson et al. (US Patent Application Publication No. US 2009/0163984 A1).
Regarding instant claim 44:
Kitahata in view of Maegli and Jorgensen discloses the wound covering material comprising a fructose-glycol-based adhesive, as cited above.
Kitahata further discloses that the wound covering material may comprise a film forming material composed of synthetic polymer substances (paragraph [0222]).
Kitahata in view of Maegli and Jorgensen does not explicitly disclose that the substrate is a stretchable fabric including fibers having a thermally conductive coating.
However, Capik teaches that elastomeric tapes are used as stretchable backings for bandages; furthermore, Capik teaches that woven structures comprising elastomeric yarns are readily known in the art (col. 6, lines 16-21).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art, having the teachings of the prior art before him or her, to use the art recognized woven elastomeric backings taught by Capik as a stretchable backing for the wound covering material of Kitahata. The motivation for doing so would have been that such elastomeric backings meet the synthetic polymer film forming materials desired by Kitahata. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007). See MPEP §2143(B).
Furthermore, Robinson discloses a therapeutic device comprising a conductive fabrics (Claims 1 and 5), wherein said fabrics include metal coated yarns (paragraph [0026]). Robinson teaches that the application of heat to the skin is used for pain relief and treatment of inflammatory conditions (paragraph [0002]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art, having the teachings of the prior art before him or her, to include the conductive fabric composed of metal coated yarn of Robinson into the would covering Kitahata. The motivation for doing so would have been to configure the would covering so as to allow pain relieving and anti-inflammatory heat treatment.
Therefore, it would have been obvious to combine Capik and Robinson with Kitahata in view of Maegli and Jorgensen to obtain the invention as specified by the instant claim.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Kitahata in view of Maegli and Jorgensen as applied to claim 28 above, and further in view of Bunyan (US Patent No. 4,035,483).
Regarding instant claim 45:
Kitahata in view of Maegli and Jorgensen discloses the wound covering material comprising a fructose-glycol-based adhesive, as cited above.
Kitahata in view of Maegli and Jorgensen does not explicitly a moisture impermeable package containing the adhesive and the substrate.
However, Bunyan teaches that biological dressings are normally packaged in sterile moisture-impermeable package in conventional manners (col. 10, lines 7-9).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art, having the teachings of the prior art before him or her, to package the wound covering material of Kitahata in a sterile moisture-impermeable package as taught by Bunyan. The motivation for doing so would have been that such packages are convention in the packaging of dressing materials. The use of a known technique to improve similar products in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007). See MPEP § 2143(C).
Therefore, it would have been obvious to combine Bunyan with Kitahata in view of Maegli and Jorgensen to obtain the invention as specified by the instant claims.
Answers to Applicant’s Arguments
Applicant’s arguments regarding the prior art rejections of record are fully considered, but are unpersuasive.
Applicant broadly disagrees with the Examiner’s position that the prior art combination of record obviates the invention of the claims. Applicant first argues that there is no motivation to combine the teachings of Maegli and Kitahara. Specifically, Applicant argues that (a) the adhesive of Maegli is applied at high temperature and low viscosity. Applicant alleges that the such a temperature would not be preferable for a wound covering since the high temperature would cause additional irritation and disruption of the wound healing process. Further, (b) Applicant alleges that the skilled artisan would appreciate that the adhesive of Maegli has a very low viscosity during application such that it can be applied using a spray gun. In contrast, Applicant argues that the adhesive of their invention has a higher viscosity to conform readily to irregularities while maintaining its shape. Applicant further argues that the adhesive of Maegli has decreased tackiness at low temperatures, whereas the adhesive of their invention has a low tack when applied but a substantially increased tack when cooled. Applicant further argues that (c) Maegli teaches that their adhesive forms an irreversible bond after prolonged contact with the snack food and seasoning when moisture will migrate from the adhesive and drive crystallization of the monosaccharide to form an irreversible bond. In contrast, Applicant contends that their adhesive has a reversible adhesion based on the temperature of the adhesive.
Applicant’s argument is unpersuasive. As to Applicant’s arguments regarding (a) Maegli’s teaching of the temperature and viscosity at which the adhesive is applied is not relied upon in the instant rejection. As set forth above, the rejection merely relies upon the disclosure of the weight ratio of fructose to glycerol in the formation of an adhesive. The rejection does not rely upon the disclosure of Maegli to teach the temperature and viscosity at which an adhesive must be applied to form the structure of Kitahata or the temperature and viscosity at which the adhesive must be in order for Kitahata to perform its intended use.
As to Applicant’s arguments regarding (b), said arguments are unpersuasive because it is not immediately clear if the decreased tack is inherent to the mixture of glycerol and fructose alone (i.e., the teaching of Maegli relied upon in the prior art rejection), or if the decreased tackiness at low temperature is due to the entire disclosure of Maegli (e.g., application on to a snack food via application at a temperature above the melting point of the monosaccharaide and alcohol, wherein the method of application is not relied upon by the rejection of record). As set forth in the rejections of record, Applicant discloses an exemplary adhesive formulation in their original disclosure, wherein said exemplary adhesive includes 43%w/w fructose and 57%w/w glycerol (pages 36-39, paragraphs [00120-00127]). One of ordinary skill in the art would readily conclude, given the extensive testing in the original disclosure, that the adhesive comprising 43%w/w fructose and 57%w/w glycerol is well within the scope of the claimed invention and must exhibit the alleged properties; furthermore, the scope of the prior art encompasses an adhesive comprising fructose and glycerol in amounts inclusive of 43%w/w fructose and 57%w/w glycerol. Therefore, the prior art must encompass an embodiment having all of the properties of the claimed composition absent evidence to the contrary.
As to Applicant’s arguments regarding (c), said arguments are unpersuasive because it is unclear if the irreversible bond is inherent to the mixture of glycerol and fructose alone (i.e., the teaching of Maegli relied upon in the prior art rejection), or if the irreversible bond is due to the entire disclosure of Maegli (e.g., application on to a snack food via application at a temperature above the melting point of the monosaccharaide and alcohol, wherein the method of application is not relied upon by the rejection of record, and/or the application to snack food and seasoning for a prolonged period of time causing a migration of moisture). Again, as set forth in the rejections of record, Applicant discloses an exemplary adhesive formulation in their original disclosure, wherein said exemplary adhesive includes 43%w/w fructose and 57%w/w glycerol (pages 36-39, paragraphs [00120-00127]). One of ordinary skill in the art would readily conclude, given the extensive testing in the original disclosure, that the adhesive comprising 43%w/w fructose and 57%w/w glycerol is well within the scope of the claimed invention and must exhibit the alleged properties; furthermore, the scope of the prior art encompasses an adhesive comprising fructose and glycerol in amounts inclusive of 43%w/w fructose and 57%w/w glycerol. Therefore, the prior art must encompass an embodiment having all of the properties of the claimed composition absent evidence to the contrary.
Applicant further argues that the Office has failed to provide evidence that the inherent characteristic flows from the teachings of Maegli.
Applicant’s argument is unpersuasive. As set forth in the prior art rejection of record, while the prior art combination does not explicitly disclose that those physical and chemical properties recited by the claims, one of ordinary skill in the art would readily conclude that the scope of Maegli encompasses an embodiment that is substantially identical to that of Applicant’s invention, and that said substantially identical embodiment must have the same properties as those claimed. 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). See MPEP §2112.01(I).
In the instant case, Applicant discloses an exemplary adhesive formulation in their original disclosure, wherein said exemplary adhesive includes 43%w/w fructose and 57%w/w glycerol (pages 36-39, paragraphs [00120-00127]). One of ordinary skill in the art would readily conclude, given the extensive testing in the original disclosure, that the adhesive comprising 43%w/w fructose and 57%w/w glycerol is well within the scope of the claimed invention and must exhibit the claimed properties.
As discussed above, the scope of Maegli encompasses an adhesive comprising fructose and glycerol in amounts inclusive of 43%w/w fructose and 57%w/w glycerol. Therefore, Maegli must encompass an embodiment having all of the claimed properties. If Applicant has reason to believe that additional factors not present in the prior art contribute to the claimed properties, Applicant should provide persuasive evidence commensurate in scope with the claims to support such a position.
Applicant further argues that the suggested combination is not a simple substitution. Applicant contends that while Kitahata teaches a wound covering with “excellent water breathability wherein moisture is quickly absorbed under high humidity condition, and moisture is quickly desorbed under low humidity conditions”, Kitahata does not teach that the adhesive needs to be low-moisture, but instead teaches that the adhesive merely prevents the wound covering from detaching from the surface of the wound.
Applicant’s argument is unpersuasive. As cited above, the Kitahata reference desires an adhesive inclusive of those comprising a combination of at least a glycerol and fructose. Maegli provides an art recognized adhesive comprising a discrete amount of glycerol and fructose that includes the range recited by the claims, which also provides the benefits above. Therefore, one of ordinary skill in the art would be readily motivated, having the teachings of Kitahata, to look to the prior art to find a specific fructose and glycerol-containing adhesive such as the one disclosed by Maegli.
Applicant further argues that the instant claims recite that the adhesive is in gel form, and the skilled artisan would appreciate that gels are well known for having high moisture content. Applicant contends that this contradicts the central premise of the Office’s suggested combination.
Applicant’s argument is unpersuasive. As cited in the rejections of record, Jorgensen discloses compositions for gels, bandages, and dressings. Jorgensen further discloses that gel bases for these compositions are capable of taking up exudate from a wound/ulcer are inclusive of glycerol. Therefore, one of ordinary skill in the art would be readily motivated to form a gel from at least the adhesive of the wound covering such that exudate from the wound is easily taken up. It is not readily clear that the amount of moisture provided by a gel-based adhesive would render the wound covering inoperable or less-effective in performing its intended use. Applicant’s argument that a gel having a substantially high moisture content such that it would destroy any obvious combination of the prior art references in merely conclusory and not supported by evidence.
Applicant further argues that there is no reasonable expectation of success in combining the cited references suggested by the Office.
Applicant’s argument is unpersuasive. Again, as cited above, the Kitahata reference desires an adhesive inclusive of those comprising a combination of at least a glycerol and fructose. Maegli provides an art recognized adhesive comprising a discrete amount of glycerol and fructose that includes the range recited by the claims, which also provides the benefits above. Therefore, one of ordinary skill in the art would be readily motivated, having the teachings of Kitahata, to look to the prior art to find a specific fructose and glycerol-containing adhesive such as the one disclosed by Maegli. Therefore, since both references desire the same combination of fructose and glycerol in the formation of an adhesives, one of ordinary skill in the art would assume a reasonable expectation of success in using the discrete combination of Maegli to form the adhesive of Kitahata.
Applicant further argues that none of the remaining prior art references remedy the defects of Kitahata and Maegli.
Applicant’s arguments are unpersuasive as the alleged defects of Kitahata and Maegli are addressed in the comments above.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thomas A Mangohig whose telephone number is (571)270-7664. The examiner can normally be reached M-F 9-5 Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alicia Chevalier can be reached at (571)272-1490. 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.
/TAM/Examiner, Art Unit 1788 01/30/2026
/Alicia Chevalier/Supervisory Patent Examiner, Art Unit 1788