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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first layer possessing a plurality of slits and a second layer described in claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: in claim 2, the limitation “where there is an additional component of salinomycin, native high molecular weight collagen, and Mafenide Acetate in the biological coating” is not found to have proper antecedent basis for this claimed subject matter in the original filed disclosure.
Claim Objections
Claim 1 is objected to because of the following informalities: the use of the pronoun “its” should be replaced with the structure to which applicant is seeking patent protection. Appropriate correction is required.
Claim Interpretation
As to claim 1, the limitation, “the preferred combination method is heating” is drawn to an article of manufacture, and therefore the limitation is considered to be a product-by-process limitation that is given patentable weight only for the structural limitations imparted to the final product by the process. When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps (emphasis added). Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the first layer" in line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the second layer" in lines 3-4 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the porosity" in line 13 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "said skin substitute" in line 13 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the mode" in line 14 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the amount of stretching" in line 16 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the direction" in line 16 of the claim. There is insufficient antecedent basis for this limitation in the claim.
As to claim 1, the limitation, preferred range of thickness of 15/1 denier knitted nylon of an average of 0.0080" with STDEV of 0.0008" renders the claimed indefinite as the term “preferred” is not required or definite and therefore the resulting claim does not clearly set forth the metes and bounds of the patent protection desired.
Claim 2 recites the limitation "the biological coating" in line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Furthermore, as to claim 2, since “the biological coating” lacks antecedent basis for the claimed subject matter, it is unclear what Applicant meant by “where is an additional component of salinomycin, native high molecular weight collagen, and Mafenide Acetate” since there were no “components” claimed in independent claim 1 to which claim 2 depends.
Claim 4 recites the limitation "said coating" in lines 1-2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter since claim 3 depend directly on rejected base claim 1 and therefore, contain the same deficiency.
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.
Claim(s) 1 is rejected under 35 U.S.C. 103 as being unpatentable over Woodroof (WO2014/138309 A1) in view of woodroof U.S. Publication No. (2014/0343676 A1).
With respect to claim 1, Woodroof substantially discloses a bilaminate cured silicone/nylon material (abstract; [page 6, para 2]; [page 7, para 1]; and [page 11; an improved skin substitute is presented comprised of a silicone layer backed up with a woven nylon fabric layer. Further, the two layers combined together with a combination means such that the two layers form a single structure, the preferred combination method is heating; and the openings are made after the silicone component has been cured), the silicone/nylon material comprised of two layers of material ([page 6, para 1; a thin silicone component and an underlying thin knitted nylon component)]; the first layer of material comprised of a silicone membrane, the second layer comprised of a woven fabric (page 11; [page 7, para 2; the first layer of material comprised of a silicone membrane, the second layer comprised of a woven fabric)], the two layers combined together with a combination means such that the two layers form a single structure, the preferred combination method is heating (page 11; abstract; the two layers combined together with a combination means such that the two layers form a single structure, the preferred combination method is heating), the first layer possessing a plurality of slits in its surface, said slits made after the two layers are combined, said slits in a regular pattern (page 11; page 6, para 2; page 7, para 1; figure 1; the first layer possessing a plurality of slits in its surface, said slits made after the two layers are combined, said slits in a regular pattern), said first layer and said second layer treated with a coating comprised of one or more medicinal or therapeutic substances (page 3, para 2 and page 11; said first layer and said second layer treated with a one or more medicinal or therapeutic substances), the porosity of said skin substitute minimized to essentially zero porosity in the mode where no stretching tension is exerted on the skin substitute, the porosity of said skin substitute variable proportional to the amount of stretching tension and the direction in which said stretching tension is placed on the skin substitute (page 11; page 6, para 1; page 7, para 2; the porosity of said skin substitute minimized in the mode where no stretching tension is exerted on the skin substitute, the porosity of said skin substitute variable proportional to the amount of stretching tension and the direction in which said stretching tension is placed on the skin substitute), said second layer of material with a 15/1 denier knitted nylon (page 9, para 3; the knitted nylon component would be the thinnest commercially-available mesh, the preferred material nylon. Either 12/1 or 15/1 denier filament would be used to knit the mesh).
Woodroof substantially discloses the invention as claimed except the second layer of material with a preferred range of thickness of an average of 0.0080" with STDEV of 0.0008".
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to optimize the thickness of the second layer of material with a preferred range of thickness of an average of 0.0080" with STDEV of 0.0008" as applicant appears to have placed no criticality on the claimed range (see 112(b) rejection above as regard the use of the term “preferred” which is not required or definite and therefore the resulting claim does not clearly set forth the metes and bounds of the patent protection desired) with routine experimentation; such as for example; the second layer of material with a preferred range of thickness of an average of 0.0080" with STDEV of 0.0008"; in order to provide a skin substitute which possesses all the characteristics and attributes known to be important for optimal wound healing, as well as containing certain advances that result in minimization of wound (abstract; page 2, para 1); depending on the wound site, type of wound, and size of wound (page 2, para 2). For instance, in order to provide support and therapy for hernias, a restricted set of requirements are needed. In particular, the mesh/silicone structure has to be thin enough to be inserted with laparoscopic surgical techniques (page 9, para 2), since it has been held that where the general conditions of a 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 233.
In addition, Woodroof fails to disclose that the regular pattern comprising a parallel vertical orientation.
Woodroof (‘676) however, teaches that the regular pattern comprising a parallel vertical orientation (para [0015]-[0016]; figure 1A; In the embodiment that is shown in figure 1A, the pattern of the slits are in parallel vertical orientation).
In view of the teachings of Woodroof (‘676), it would have been obvious to one ordinary skilled in the art before the effective filing date of the invention to provide the slits in a parallel vertical orientation, with the bilaminate cured silicone/nylon material because of the orientation of the slits, stretch along the axis of the slits is minimal and stretch perpendicular to the slit axes is maximized (Woodroof, para [0016]; figure 1A). In this configuration (see figure 1A), with no stretch, the wound is protected by an essentially continuous thin silicone membrane which minimizes wound desiccation and punctate scarring. This configuration (see figure 1A) enables the clinician to stretch the dressing parallel to the direction of the slits with minimal opening of the slits. This is parallel to the wale direction of the underlying fabric. Fluids from the wound can still escape through the closed slits and be absorbed into a secondary dressing, which can be removed and replaced without interfering with the healing process or causing pain to the patient (para [0018]; figure 1A).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claim 1 rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of U.S. Patent No. (9,585,793 B2). Although the conflicting claims are not identical, they are not patentably distinct from each other because the application claims are a broader recitation of the invention than that of the patented application.
Claim 1 of the instant application recites a bilaminate cured silicone/nylon material, the silicone/nylon material comprised of two layers of material, the first layer of material comprised of a silicone membrane, the second layer comprised of a woven fabric, the two layers combined together with a combination means such that the two layers form a single structure, the preferred combination method is heating, the first layer possessing a plurality of slits in its surface, said slits made after the two layers are combined, said slits in a regular pattern, the regular pattern comprising a parallel vertical orientation, said first layer and said second layer treated with a coating comprised of one or more medicinal or therapeutic substances, the porosity of said skin substitute minimized to essentially zero porosity in the mode where no stretching tension is exerted on the skin substitute, the porosity of said skin substitute variable proportional to the amount of stretching tension and the direction in which said stretching tension is placed on the skin substitute, said second layer of material with a preferred range of thickness of 15/1 denier knitted nylon of an average of 0.0080" with STDEV of 0.0008".
Claim 1 of U.S. Patent No. (9,585,793 B2) recites a skin substitute, the skin substitute comprised of two layers of material, the first layer of material, an upper layer, comprised of a silicone membrane, the second layer, a lower layer, comprised of a woven nylon fabric, the silicone membrane selected in a thickness from 0.001″ to 0.005″, the upper layer possessing a plurality of slits in its surface, said slits made after the two layers are joined together, said slits in a regular pattern, the regular pattern comprising alternating perpendicular orientation, both horizontal and vertical, the lower layer woven in a regular pattern with a perpendicular wale and course orientation, the slits on the surface either following the wale direction of the lower layer or crossing the wale direction of the lower layer perpendicularly, said upper layer and said lower layer treated with a plurality of layers of medicinal or therapeutic substances applied to the two layers of the skin substitute, said lower layer also treated with a water soluble or water insoluble anti-scar compound, said slits placed in said upper layer such that the skin substitute has essentially zero porosity with no stretching tension placed on it, the porosity of said skin substitute variable proportional to the amount of stretching tension and the direction in which said stretching tension is placed on the skin substitute, the direction of stretching tension dependent on the orientation of said slits with the wale and course orientation of the woven nylon fabric, the skin substitute designed to place the woven nylon fabric side down on top of a wound when in use, the skin substitute selected to be used in combination with an absorptive dressing placed above said skin substitute over the wound.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 1 of the current application and claim 1 of patent U.S. Patent No. (9,585,793 B2) lies in the fact that the patented claims includes many more elements and is thus much more specific. Thus the invention of claim 1 of U.S. Patent No. (9,585,793 B2) is in effect a “species” of the “generic” invention of current application claim 1. It has been held that the generic invention is “anticipated” by the “species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the current application is anticipated by claim 1 of U.S. Patent No. (9,585,793 B2), it is not patentably distinct from claim 1 of U.S. Patent No. (9,585,793 B2).
Claim 1 rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of U.S. Patent No. (9,017,405 B2). Although the conflicting claims are not identical, they are not patentably distinct from each other because the application claims are a broader recitation of the invention than that of the patented application.
Claim 1 of the instant application recites a bilaminate cured silicone/nylon material, the silicone/nylon material comprised of two layers of material, the first layer of material comprised of a silicone membrane, the second layer comprised of a woven fabric, the two layers combined together with a combination means such that the two layers form a single structure, the preferred combination method is heating, the first layer possessing a plurality of slits in its surface, said slits made after the two layers are combined, said slits in a regular pattern, the regular pattern comprising a parallel vertical orientation, said first layer and said second layer treated with a coating comprised of one or more medicinal or therapeutic substances, the porosity of said skin substitute minimized to essentially zero porosity in the mode where no stretching tension is exerted on the skin substitute, the porosity of said skin substitute variable proportional to the amount of stretching tension and the direction in which said stretching tension is placed on the skin substitute, said second layer of material with a preferred range of thickness of 15/1 denier knitted nylon of an average of 0.0080" with STDEV of 0.0008".
Claim 1 of U.S. Patent No. (9,017,405 B2) recites: a skin substitute, the skin substitute comprised of two layers of material, the first layer of material, an upper layer, comprised of a silicone membrane, the second layer, a lower layer, comprised of a woven nylon fabric, the silicone membrane selected in a thickness from 0.001'' to 0.005'', the upper layer possessing a plurality of slits in its surface, said slits made after the two layers are joined together, said slits in a pattern comprised of multiple rows of parallel slits, the lower layer woven in a regular pattern with a perpendicular wale and course orientation, the slits on the surface either following the wale direction of the lower layer or crossing the wale direction of the lower layer perpendicularly, said upper layer and said lower layer treated with a plurality of layers of medicinal or therapeutic substances applied to the two layers of the skin substitute, said slits placed in said upper layer such that the skin substitute has essentially zero porosity with no stretching tension placed on it, the porosity of said skin substitute variable proportional to the amount of stretching tension and the direction in which said stretching tension is placed on the skin substitute, the direction of stretching tension dependent on the orientation of said slits with the wale and course orientation of the woven nylon fabric, the skin substitute designed to place the woven nylon fabric side down on top of a wound when in use, the skin substitute selected to be used in combination with an absorptive dressing placed above said skin substitute over the wound.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 1 of the current application and claim 1 of patent U.S. Patent No. (9,017,405 B2) lies in the fact that the patented claims includes many more elements and is thus much more specific. Thus the invention of claim 1 of U.S. Patent No. (9,017,405 B2) is in effect a “species” of the “generic” invention of current application claim 1. It has been held that the generic invention is “anticipated” by the “species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the current application is anticipated by claim 1 of U.S. Patent No. (9,017,405 B2), it is not patentably distinct from claim 1 of U.S. Patent No. (9,017,405 B2).
Claim 1 rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of U.S. Patent No. (9,439,808 B2). Although the conflicting claims are not identical, they are not patentably distinct from each other because the application claims are a broader recitation of the invention than that of the patented application.
Claim 1 of the instant application recites a bilaminate cured silicone/nylon material, the silicone/nylon material comprised of two layers of material, the first layer of material comprised of a silicone membrane, the second layer comprised of a woven fabric, the two layers combined together with a combination means such that the two layers form a single structure, the preferred combination method is heating, the first layer possessing a plurality of slits in its surface, said slits made after the two layers are combined, said slits in a regular pattern, the regular pattern comprising a parallel vertical orientation, said first layer and said second layer treated with a coating comprised of one or more medicinal or therapeutic substances, the porosity of said skin substitute minimized to essentially zero porosity in the mode where no stretching tension is exerted on the skin substitute, the porosity of said skin substitute variable proportional to the amount of stretching tension and the direction in which said stretching tension is placed on the skin substitute, said second layer of material with a preferred range of thickness of 15/1 denier knitted nylon of an average of 0.0080" with STDEV of 0.0008".
Claim 1 of U.S. Patent No. (9,439,808 B2) recites: a skin substitute, the skin substitute comprised of two layers of material, the first layer of material, an upper layer, comprised of a silicone membrane, the second layer, a lower layer, comprised of a woven nylon fabric, the silicone membrane selected in a thickness from 0.001″ to 0.005″, the upper layer possessing a plurality of slits in its surface, said slits made after the two layers are joined together, said slits in a pattern comprised of multiple rows of parallel slits, the lower layer woven in a regular pattern with a perpendicular wale and course orientation, the slits on the surface either following the wale direction of the lower layer or crossing the wale direction of the lower layer perpendicularly, said upper layer and said lower layer treated with a plurality of layers of medicinal or therapeutic substances applied to the two layers of the skin substitute, said lower layer also treated with a water soluble or water insoluble anti-scar compound, said slits placed in said upper layer such that the skin substitute has essentially zero porosity with no stretching tension placed on it, the porosity of said skin substitute variable proportional to the amount of stretching tension and the direction in which said stretching tension is placed on the skin substitute, the direction of stretching tension dependent on the orientation of said slits with the wale and course orientation of the woven nylon fabric, the skin substitute designed to place the woven nylon fabric side down on top of a wound when in use, the skin substitute selected to be used in combination with an absorptive dressing placed above said skin substitute over the wound.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 1 of the current application and claim 1 of patent U.S. Patent No. (9,439,808 B2) lies in the fact that the patented claim include many more elements and is thus much more specific. Thus, the invention of claim 1 of U.S. Patent No. (9,439,808 B2) is in effect a “species” of the “generic” invention of current application claim 1. It has been held that the generic invention is “anticipated” by the “species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the current application is anticipated by claim 1 of U.S. Patent No. (99,439,808 B2), it is not patentably distinct from claim 1 of U.S. Patent No. (9,439,808 B2).
Conclusion
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786
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