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 . 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.
Claim Objections
Claims 4-6 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, the claims 4-6 not been further treated on the merits.
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 1-6 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 mutual dissolution” in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Houze (U.S PG pub 20040018241A1), Glenn Jr (U.S PG Pub 20120053108A1), Singh (U.S Patent 8658201B2), Weber (U.S PG Pub 20040029764A1), and as evidenced by Tips for Removing Stubborn Medical Adhesive (see NPL attached - referred to herein as Tips).
Regarding claim 1, Houze drawn also to the art of a bioadhesive and methods for topical administration of such adhesives (Title; Abstract), discloses a composition containing betaine [0325] & [0360], and containing a volatile (evaporable) solvent [0429] in a weight range of 45 wt.%. Houze also discloses the adhesive containing collagen [0062]. Houze has not explicitly disclosed the weight range for betaine, while also not explicitly disclosing the weight range for the monosaccharide, as well as the collagen, however, the above weight ranges are known from Glenn Jr, and Singh.
Glenn Jr, drawn also to the art of a method for delivering an active agent through a film/filament (i.e. analogous to delivering an adhesive through film in Houze) (Abstract; [0002], discloses that betaine can be a part of the composition, and that betaine is responsible for sudsing or is a suds booster and that if high sudsing is needed, then the betaine amount can be appropriately added [0254]. Thus, the teaching of Glenn Jr establishes the weight range of betaine to be added as a result effective variable, with the result being the degree of sudsing. Thus, it is within the purview of an ordinarily skilled artisan to routinely optimize the weight range of betaine, in order to achieve the needed degree of sudsing (MPEP 2144.05(II)).
Regarding the weight ranges of the monosaccharide and the collagen, these weight ranges are disclosed by Singh.
Singh drawn also to the art of film-forming binder and delivery of an active agent to a surface (Abstract), discloses the film-forming composition to contain a monosaccharide (Column 7, lines 21-42) and collagen (Column 14, lines 17-25). Singh further discloses in Table 1, a maltodextrin (monosaccharide analog) to be in the weight range of 10% by weight, which forms an overlapping range with the instantly claimed range (Table 1). Further, Singh discloses the composition to contain HPC (one of the listed alternatives along with collagen in the list of thickeners) in the weight range of 40 wt.% (Table 1), which forms an overlapping range with the instantly claimed range in instant claim 2. The courts have held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (MPEP 2144.05(I)).
It would have been obvious to an ordinarily skilled artisan to have modified the composition of Houze, with the weight ranges of collagen and monosaccharides, as disclosed by Singh, to arrive at the instant invention, in order to have a rapidly dissolving film for delivery of an active agent and to provide a sustained and controlled release of a variety of active agents (Column 2, lines 24-29).
Regarding the limitation of the molecular weight of the collagen, it is known from Weber, to have collagen in the claimed weight range of 1 to 30 kilodaltons in order to have an outstanding film material [0185]. The courts have held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (MPEP 2144.05(I)).
It would have been obvious to an ordinarily skilled artisan to have modified the collagen of Houze, with the molecular weight as claimed, in order to obtain outstanding film material [0185].
Finally, regarding the limitations in instant claims 1, as pertaining to the solvent system and adhesive composition ‘having the potential to…’ and further as pertaining to the limitations after the wherein clause, it is noted that these limitations add up to intended use recitations and product-by process recitations, and as such the intended use or the method of making a product are not patentably distinguishing over the prior art given the presence of the product. The product in the instant claims, is merely an composition of betaine, monosaccharides, and collagen, in the claimed weight range (MPEP 2114 & 2115 & 2113).
Further, the combination of Houze, Glenn Jr, Weber, and Singh, discloses a composition that is the same or very similar to the instantly claimed composition (i.e. betaine, monosaccharide, and collagen, and solvent, in the weight ranges as claimed, thus the instant properties recited would naturally be present given that the same or similar solvent is present. The examiner notes that the quorum solvent as disclosed by the combination of Houze, Glenn Jr, Weber, Singh has a similar composition as claimed by applicant, which would result in the claimed property (a quorum solvent that has betaine and monosaccharides, and an evaporable solvent, wherein the betaine and monosaccharides synergistically facilitate mutual dissolution into ethanol, and wherein the betaine and monosaccharides alter the properties of the solvent such that solubility of hydrophilic compounds is improved into alcohol solvents, and wherein the solvent is evaporable and leaves a film residue behind). The burden is upon the Applicant to prove otherwise. In re Fitzgerald 205 USPQ 594. In addition, the presently claimed properties would obviously have been present once the same or similar product is provided. Note In re Best, 195 USPQ at 433, footnote 4 (CCPA 1977).
Regarding claim 2, Houze drawn also to the art of a bioadhesive and methods for topical administration of such adhesives (Title; Abstract), discloses a composition containing betaine [0325] & [0360], and containing a volatile (evaporable) solvent [0429] in a weight range of 45 wt.%. Houze also discloses the adhesive containing collagen [0062]. Houze has not explicitly disclosed the weight range for betaine, while also not explicitly disclosing the weight range for the monosaccharide, as well as the collagen, however, the above weight ranges are known from Glenn Jr, and Singh.
Glenn Jr, drawn also to the art of a method for delivering an active agent through a film/filament (i.e. analogous to delivering an adhesive through film in Houze) (Abstract; [0002], discloses that betaine can be a part of the composition, and that betaine is responsible for sudsing or is a suds booster and that if high sudsing is needed, then the betaine amount can be appropriately added [0254]. Thus, the teaching of Glenn Jr establishes the weight range of betaine to be added as a result effective variable, with the result being the degree of sudsing. Thus, it is within the purview of an ordinarily skilled artisan to routinely optimize the weight range of betaine, in order to achieve the needed degree of sudsing (MPEP 2144.05(II)).
Regarding the weight ranges of the monosaccharide and the collagen, these weight ranges are disclosed by Singh.
Singh drawn also to the art of film-forming binder and delivery of an active agent to a surface (Abstract), discloses the film-forming composition to contain a monosaccharide (Column 7, lines 21-42) and collagen (Column 14, lines 17-25). Singh further discloses in Table 1, a maltodextrin (monosaccharide analog) to be in the weight range of 10% by weight, which forms an overlapping range with the instantly claimed range (Table 1). Further, Singh discloses the composition to contain HPC (one of the listed alternatives along with collagen in the list of thickeners) in the weight range of 40 wt.% (Table 1), which forms an overlapping range with the instantly claimed range in instant claim 2. The courts have held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (MPEP 2144.05(I)).
It would have been obvious to an ordinarily skilled artisan to have modified the composition of Houze, with the weight ranges of collagen and monosaccharides, as disclosed by Singh, to arrive at the instant invention, in order to have a rapidly dissolving film for delivery of an active agent and to provide a sustained and controlled release of a variety of active agents (Column 2, lines 24-29).
Regarding the limitation of the molecular weight of the collagen, it is known from Weber, to have collagen in the claimed weight range of 1 to 30 kilodaltons in order to have an outstanding film material [0185]. The courts have held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (MPEP 2144.05(I)).
It would have been obvious to an ordinarily skilled artisan to have modified the collagen of Houze, with the molecular weight as claimed, in order to obtain outstanding film material [0185].
Finally, regarding the limitations in instant claim 2, as pertaining to the quorum solvent system having the potential to dissolve or stabilize peptide components and the potential to evaporate and leave behind a film residue, it is noted that these limitations add up to intended use recitations and product-by process recitations, and as such the intended use or the method of making a product are not patentably distinguishing over the prior art given the presence of the product. The product in the instant claims, is merely an composition of betaine, monosaccharides, and collagen, in the claimed weight range (MPEP 2114 & 2115 & 2113).
Further, the combination of Houze, Glenn Jr, Weber, and Singh, discloses a composition that is the same or very similar to the instantly claimed composition (i.e. betaine, monosaccharide, and collagen, and solvent, in the weight ranges as claimed, thus the instant properties recited would naturally be present given that the same or similar solvent is present. The examiner notes that the quorum solvent and adhesive composition as disclosed by the combination of Houze, Glenn Jr, Weber, Singh has a similar composition as claimed by applicant, which would result in the claimed property (a quorum solvent that has potential to dissolve or stabilize peptide components and the potential to evaporate and leave behind a film residue). The burden is upon the Applicant to prove otherwise. In re Fitzgerald 205 USPQ 594. In addition, the presently claimed properties would obviously have been present once the same or similar product is provided. Note In re Best, 195 USPQ at 433, footnote 4 (CCPA 1977).
Regarding claim 3, Houze has disclosed fillers to be present in the weight range as claimed (clay) [0428]. The courts have held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (MPEP 2144.05(I)). The instant claim language is interpreted as the filler comprising the listed components but not being limited to it, and further then, given that Houze discloses a clay filler being used, it meets the instant limitations, since one of the recited fillers is a part of the composition.
Regarding claim 6, the combination of Houze, Glenn Jr, Weber, and Singh, disclose a hotmelt adhesive that has an evaporable solvent (as disclosed by Houze), and that can be applied onto a surface during heating and solidify upon cooling to the temperature of its intended use. Further, the limitations of the evaporable solvent being removed and the application of adhesive onto a surface during heating and solidifying upon cooling, are intended use recitations and product by process limitations, and as such the intended use or the method of using the product are not patentably distinguishing over the prior art. The product in the instant claims, is merely an composition of betaine, monosaccharides, and collagen, in the claimed weight range, and such a product is capable of performing the intended use as recited (MPEP 2114 & 2115 & 2113).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Houze (U.S PG pub 20040018241A1), Glenn Jr (U.S PG Pub 20120053108A1), Singh (U.S Patent 8658201B2), Weber (U.S PG Pub 20040029764A1), Hauru (U.S PG Pub 20230383144A1), and as evidenced by Tips for Removing Stubborn Medical Adhesive (see NPL attached - referred to herein as Tips).
Regarding claim 4, the use of an adhesive to bond two materials (objects, films etc.) by applying the adhesive between the said materials, is well-known in the art, and further Weber has disclosed such a process (weber is relied upon for the molecular weight of collagen and thus necessitates another obviousness type statement unless the adhesive bonding flows from the collagen MW), as well as disclosing a water-soluble hotmelt adhesive that can be detached with the use of water or cooling [0354 & 0365-0366 & 0368]. Further, as evidenced by ‘Tips for Removing Stubborn Medical Adhesive’, a warm water bath, i.e. applying water and heat, is a known method of removing an adhesive (see page 4).
It would have been obvious to an ordinarily skilled artisan to have modified the product of Houze, with the method of using it as claimed, as disclosed by Weber, and as evidenced by ‘Tips for Removing Stubborn Medical Adhesive’, to arrive at the instant invention, in order to obtain outstanding film material [0185].
In the event the applicant does not agree with the above rationale, it is further disclosed by Hauru, to bond objects/films together with an adhesive.
Hauru, drawn also to the art of joining biomaterials with an adhesive (Abstract), discloses a method of applying adhesive to objects (can be films, given recycled textiles can be in film or sheet form ([0112]; claim 16; [0090])), and wherein once the adhesive and films/objects forms a laminate stack, they are pressed together (i.e. pressure activation) (claim 1; [0088]) and wherein after joining heating causes evaporation of ionic liquid (analogous to solvent) (Claims 6-7).
It would have been obvious to an ordinarily skilled artisan to have modified the product of Houze, with the method of joining two films together, as disclosed by Hauru, to arrive at the instant invention, in order to achieve bonding of wood directly in situ, and bypass issues with smell [0011].
Regarding claim 5, the use of an adhesive to bond two materials (objects, films etc.) by applying the adhesive between the said materials, is well-known in the art, and further Weber has disclosed such a process (weber is relied upon for the molecular weight of collagen and thus necessitates another obviousness type statement unless the adhesive bonding flows from the collagen MW), as well as disclosing a water-soluble hotmelt adhesive that can be detached with the use of water or cooling [0354 & 0365-0366 & 0368]. Further, as evidenced by ‘Tips for Removing Stubborn Medical Adhesive’, a warm water bath, i.e. applying water and heat, is a known method of removing an adhesive (see page 4).
It would have been obvious to an ordinarily skilled artisan to have modified the product of Houze, with the method of using it as claimed, as disclosed by Weber, and as evidenced by ‘Tips for Removing Stubborn Medical Adhesive’, to arrive at the instant invention, in order to obtain outstanding film material [0185].
In the event the applicant does not agree with the above rationale, it is further disclosed by Hauru, to bond objects/films together with an adhesive.
Hauru, drawn also to the art of joining biomaterials with an adhesive (Abstract), discloses a method of applying adhesive to objects (can be films, given recycled textiles can be in film or sheet form ([0112]; claim 16; [0090])), and wherein once the adhesive and films/objects forms a laminate stack, they are pressed together (i.e. pressure activation) (claim 1; [0088]) and wherein after joining heating causes evaporation of ionic liquid (analogous to solvent) (Claims 6-7). Hauru further discloses joining wooden materials together (Claim 18).
It would have been obvious to an ordinarily skilled artisan to have modified the product of Houze, with the method of joining two wooden materials together, as disclosed by Hauru, to arrive at the instant invention, in order to achieve bonding of wood directly in situ, and bypass issues with smell [0011].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABHISHEK A PATWARDHAN whose telephone number is (571)272-8431. The examiner can normally be reached Monday to Friday 7:30am-5pm.
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/ABHISHEK A PATWARDHAN/Examiner, Art Unit 1746
/MICHAEL N ORLANDO/Supervisory Patent Examiner, Art Unit 1746