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 .
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1, 2, 5-10-27, 29 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 8-27 of U.S. Patent No. 12,239,759. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding the application claims 1, 8 and 9, the patent claim 1 recites all the limitations as claimed except it recites a narrower range of viscocity and additionally recites a cross-linking agent comprising an acrylate function (patent claim 1, lines 8-11). Regarding the application claim 30, the patent claim 27 recites all the limitations as claimed except the monomer is not polymerizable under near-visible radiation and the viscosity is less than 10 mPa.s. Therefore, the patent claim 1 is in essence a “species” of the generic invention of the application claims 1, 8 and 9 and the patent claim 27 is in essence a “species” of the generic invention of the application claim 30. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims 1, 8 and 9 are anticipated by the patent claim 1, they are not patentably distinct from the patent claim 1.
Regarding the application claims 2, 5-7, 10-27, and 29, the patent claims 2, 3-5 and 8-26 recite all the limitations as claimed, respectively (and/or recite a narrower range - patent claims 16, 18 and 21).
Claims 3, 4 and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,239,759 in view of Watanabe et al. (US 2016/0121018).
Regarding the Application claims 3, 4 and 28, the patent claim 1 recites all the limitations as claimed but fails to recite the claimed wavelengths.
Watanabe et al. disclose UV or near-visible wavelengths within the claimed range as being suitable for polymerization of biological adhesives (¶[0125]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the wavelengths of Watanabe et al. to polymerize the composition of Boyden et al. since the prior art demonstrates that they are suitable for the intended purpose of Boyden et al. (MPEP 2144.03).
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.
Claim 20 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 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 20 recites the limitation "said cross-linking agent" in line 1. 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 non-obviousness.
Claims 1, 5-18, 21, 24, 25 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Boyden et al. (US 2010/0152880) in view of Bonfanti et al. (US 2005/0032952) and Broadley et al. (US 2010/0104349).
Regarding claims 1, 8 and 9, Boyden et al. disclose a composition, intended to be used in a method for at least one of adhesion of biological tissues to one another, for adhesion of a material to a biological tissue, for adhesion of an adhesive or of a substance to a surface of a biological tissue, for blocking an orifice in a biological tissue, for reinforcing a biological tissue and/or for fixing and stabilizing biological tissue (¶[0444]-[0475]).
Boyden et al. disclose that the composition can comprise a polymerizable monomer (¶[0444], Table II; ¶[0467]); that the composition can comprise a component polymerizable under the effect of photoinitiation with UV light (¶[0474]); and, that the composition can comprise a monomer polymerizable upon photoinitiation (Table II). Note that the above referenced portions of the specification are given under the heading “Adhesive Agents” (between paragraphs [0443] and [0444]). However, Boyden et al. fail to explicitly disclose that composition can comprise a monomer polymerizable under the effect of UV radiation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the composition with a monomer polymerizable under the effect of UV radiation since this would merely require using a disclosed wavelength for photoinitiation of polymerization with a monomer disclosed as requiring photoinitiation for polymerization.
Boyden et al. fail to explicitly state that the composition is not a hydrogel. Boyden et al. disclose that some embodiments of the adhesive may contain or be a hydrogel (¶[0450], [0456]) and thereby imply that other embodiments may not. Boyden et al. further disclose that the composition can be used on moist wounds (¶[0461]).
Bonfanti et al. teach that using hydrogels as medical adhesives has the disadvantage in that they tend to lose their adhesiveness over time when exposed to excessive moisture (¶[0002], [0017]-[0024]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Bonfanti et al. to not have formulated the composition of Boyden et al. as a hydrogel in order to prevent loss of adhesion over time; particularly when exposure to excessive moisture is required.
Boyden et al. fail to disclose that the composition has a viscosity of less than 10 or 6 or 3 mPa.s at 20°C as claimed. Boyden et al. disclose that the viscosity of the adhesive should be adjusted to suit the particular application (¶[0461]).
Broadley et al. teach that the viscosity of a medical adhesive should be between 1-1000 mPa.s at 25°C and most preferably 3-100 mPa.s in order to allow it to be spread evenly across a tissue surface (¶[0027], [0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Broadley et al. to have made the composition with a viscosity of less than 30 mPa.s at 20°C in order to allow the composition to be more easily spread over tissue. Alternatively, since Boyden et al. disclose that the viscosity of the adhesive should be adjusted to suit the particular application, Boyden et al. have effectively disclosed that the composition viscosity is a result effective variable. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the composition with a viscosity anywhere within the range of 3-100 mPA.s at 20°C since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable range by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 5, since as described above, it would be obvious to deliberately make the composition polymerizable by UV radiation, it would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have only used UV radiation to polymerize the monomer since that would be the sole intent for making the monomer polymerizable by UV radiation. Furthermore, the claim is being treated as reciting an intended use limitation - “only initiated”; not --only polymerizable-- (i.e. --only able to be polymerized by/with--). Therefore, whether one skilled in the art chooses to polymerize the above composition via UV radiation or not is irrelevant. Polymerization of the composition as described above could be only initiated by exposure to UV radiation.
Regarding claim 6, since as described above in regard to claims 1 and 5, it would have been obvious to one of ordinary skill in the art to have only used UV radiation to polymerize the monomer, it would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have not made the composition such that the monomer is polymerized by contact with water because that would negate the intent of Boyden et al. and tissue wounds have significant amounts of aqueous fluid present. Further still, some of the Boyden et al. compositions which are polymerizable via photoinitiation are also in an aqueous solution (Table II).
Regarding claim 7, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the composition of Boyden et al. to not have polymerizable monomers of the cyanoacrylate family sine those are not disclosed as being present in the compositions which are photoinitiated (Table II).
Regarding claim 10, the monomer of Boyden et al. is one of an acrylate monomer or a methacrylate monomer or an acrylate oligomer or a methacrylate oligomer (Table II of Boyden et al.).
Regarding claims 11 and 12, said monomer comprises a polar function chosen from the group comprising hydroxyl, amide, carboxyl, amino, carbonate, carbamate, sulphonamide, sulphonic, phosphonic, methoxyethyl, methoxyethoxyethyl, hydroxyethyl and hydroxyethoxyethyl functions (Table II of Boyden et al.).
Regarding claim 13, said monomer is chosen in the group comprising the mono-, di-, tri-, tetra- and penta-acrylate or methacrylate, and their mixtures (Table II of Boyden et al.).
Regarding claim 14, said acrylate monomer is chosen in the group comprising acrylic acid, methyl methacrylate; dimethylaminoethyl methacrylate; ethyl acrylate; cyclohexyl methacrylate; 2-hydroxyethyl methacrylate; 3-hydroxypropyl acrylate; alpha-bromoethyl acrylate; alpha-chloroethyl acrylate; chloromethyl methacrylate; 2-bromoethyl methacrylate; 2-naphtyl methacrylate; paratolyl acrylate; parachlorophenyl methacrylate; metabromophenyl acrylate; 2,4,6-tribromophenyl acrylate; paracholorobenzyl methacrylate; metamethoxybenzyl methacrylate; paraethylbenzyl acrylate; 1,6-hexanediol dimethacrylate; neopentylglycol diacrylate; thiodiethylene-glycol dimethacrylate; bisphenol A ethoxyl diacrylate; bisphenol A ethoxyl dimethacrylate; pentaerythritol triacrylate; glyceryl triacrylate; dipentaerythritol pentaacrylate; trimethylolpropane triacrylate; tris isocyanurate trimethacrylate (2-hydroxyethyl); trimethylolpropane polyoxyethylene triacrylate; a urethane acrylate; a urethane methacrylate; bis sulphur (4- methacryloylthiophenyl); tert-butyl acrylate; an ethyleneglycol or a polyethyleneglycol chosen in the group composed of acrylate, methacrylate; diacrylate, dimethacrylate and their mixtures (Table II of Boyden et al.).
Regarding claim 15, said acrylate monomer is chosen in the group comprising hydroxy(ethyl)methacrylate, acrylic acid, hydroxy(propyl)methacrylate, tert-butyl acrylate, dimethylaminoethyl methacrylate and their mixtures (Table II of Boyden et al.).
Regarding claim 16, said monomer has a molar mass of between 50 and 300g.mol-1 (Table II of Boyden et al.).
Regarding claim 17, since the composition of Boyden et al. is intended to be solid in final form in some embodiments (¶[0445]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formulated the composition such that no solvent is present in its final form (e.g. after curing).
Regarding claim 18, since the composition of Boyden et al. is intended to be solid in final form in some embodiments (¶[0445]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the composition such that the monomer has a concentration of between 90 and 100% in mass in relation to the total mass of the composition in its final form.
Regarding claim 21, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the composition with a photoinitiator since Boyden et al. disclose that polymerization occurs via photoinitiation (Table II).
Regarding claim 24, Boyden et al. disclose the composition as described above and further disclose a non-invasive method for at least one of adhesion of biological tissues to one another, for adhesion of a material to a biological tissue, for adhesion of an adhesive or a substance to a surface of a biological tissue, for blocking an orifice in a biological tissue, for reinforcing a biological tissue and/or for fixing and stabilizing a biological tissue (¶[0444]-[0475]) comprising: (i) coating the tissue to treat with a composition according to claim 29 (¶[0456]) and (iii) inducing, by UV radiation, polymerization of said composition (made obvious as described above in regard to claim 29).
Boyden et al. fail to explicitly disclose: (ii) letting the composition penetrate into said biological tissue.
However, Boyden et al. disclose that the composition can be a film (¶[0456]) and can be used to treat a puncture or penetration wound (¶[0517]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have allowed the composition to penetrate into biological tissue in order to allow the composition to be used as a film for treating tissue within a puncture or penetration wound.
Regarding claim 25, since Boyden et al. disclose that the adhesive can be formed into a artificial skin (¶[0456]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made an additional composition as (or allowed the above composition to cure into) an artificial skin to be brought into apposition to the surface of the wound for large wounds requiring an artificial skin for complete healing or cosmetic reasons.
Regarding claim 29, Boyden et al. disclose that the various components of their invention can be made into a kit (¶[1583]) but fail to explicitly disclose that the kit would include the composition and UV radiation source. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included these components into the kit since a kit is generally known as something having all necessary components for a procedure and the composition of claim 29 and UV radiation source are necessary for the above procedure.
Claims 2-4 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Boyden et al. (US 2010/0152880) in view of Bonfanti et al. (US 2005/0032952) and Broadley et al. (US 2010/0104349), as applied to claim 1 above, and further in view of Watanabe et al. (US 2016/0121018),
Regarding claims 2-4 and 26-28, Boyden et al. fail to disclose the claimed wavelengths and power of
the UV radiation.
Watanabe et al. disclose UV or near-visible wavelengths and power within the claimed range as being suitable for polymerization of biological adhesives (¶[0125]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to have used the wavelengths of Watanabe et al. to polymerize the composition
of Boyden et al. since the prior art demonstrates that they are suitable for the intended purpose of Boyden et al. (MPEP 2144.03).
Allowable Subject Matter
Claim 19 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
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