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 . Claims included in the prosecution are claims 1-15.
Claim Objections
Claim 15 is objected to because of the following informalities: “100 kPa of 60 MPa” should be recited as --- 100 kPa to 60 MPa ---. Appropriate correction is required.
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 1-15 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.
The term “low-endotoxin” in claims 1, 5 and 9- 12 is a relative term which renders the claim indefinite. The term “low- endotoxin” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although the specification discloses in paragraph [0068] wherein the endotoxin content is preferably 500 endotoxin unit (EU)/g or less, it is not clear whether the term “low-endotoxin” is bound to this range or whether the endotoxin unit (EU)/g may be higher.
Claims 1, 3-8 and 13-15 recite the term “sponge-like.” The claims are indefinite since it is unclear how the term “like” modifies the otherwise definite term “sponge.” Since the term is not necessary to an understanding of the claimed subject matter, the examiner recommends deleting it.
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.
1. Claims 1, 2, 4-6 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Taichi et al. (WO 2016/114355 A1, Jul. 21, 2016) (hereinafter Taichi) in view of Totakura et al. (US 5,795,584, Aug. 18, 1998) (hereinafter Totakura), Pines et al. (EP 0109197A2, May, 23, 1984) (hereinafter Pines), Schmidt et al. (US 2015/0320915, Nov. 12, 2015) (hereinafter Schmidt), and Spinnler et al. (US 2009/0192532, Jul. 30, 2009) (hereinafter Spinnler).
Taichi discloses an adhesion-preventing method, characterized in that a composition is applied to a subject in need of prevention of adhesion, said composition comprising a monovalent metal salt of low endotoxin alginic acid (claim 14). The endotoxin content of the monovalent metal salt of alginic acid is equal to or less than 500 EU/g (claim 3). The monovalent metal salt of alginic acid may be crosslinked with a hardening agent (i.e. curing a low-endotoxin monovalent metal salt of alginic acid) to immobilize a solution of the monovalent metal salt of alginic acid. Suitable hardening agents (i.e., curing agents) include CaCl2, CaSO4, SrCl2, and BaCl2. The content of the hardening agent is adjusted according to the viscosity of the composition (¶ [0047]). The monovalent metal salt of alginic acid is a high-molecular weight polysaccharide. In the case where the molecular weight is determined by the GPS-MALS method, the weight-average molecular weight is preferably in a range of 1,000 to 300,000 (¶ [0032]). The content of the monovalent metal salt of alginic acid in the composition is in a range of 0.1 wt. % to 99.9 wt. % (¶ [0026]). The monovalent salt of alginic acid is either sodium alginate or potassium alginate (claim 4). The composition may be in the form of a sponge or a gel (¶ [0029]).
Tachi differs from the instant claims insofar as not disclosing another layer of the monovalent metal salt of low endotoxin alginic acid.
However, Totakura discloses wherein a multilayer surgical structure having one or more bioabsorbable layers superimposed on a non-absorbable layer is useful for minimizing or preventing formation of fibrous adhesions between a healing trauma site and adjacent surrounding tissue (abstract). Each bioabsorbable layer bioabsorb at different rates (col. 3, lines 1-3). Rates of bioabsorption can be engineered to fit particular needs. In this way, an outermost bioabsorbable layer can be constructed to slowly biodegrade and, when it does, adhesions which have formed between the outer layer and surrounding tissue fall away. Any slower forming adhesions which may have adhered through the outermost layer to an inner layer would then be disconnected by the absorption of a rapidly biodegrading inner layer. Alternatively, a rapidly bioabsorbed outer layer would act as the first line of defense against rapidly forming adhesions and a slower bioabsorbed inner layer would prevent the attachment of late forming adhesions (col. 9, lines 53-64). Suitable bioabsorbable materials include alginic acid (col. 6, lines 44-46).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have modified the composition of Tachi to have another layer of the monovalent metal salt of low endotoxin alginic acid motivated by the desire to have different bioabsorption rates to treat adhesion formation that arrive at different rates as taught by Totakura.
The combined teachings of Tachi and Totakura do not teach wherein each layer comprise a different molecular weight of monovalent metal salt of low endotoxin alginic acid.
However, Pines discloses wherein the rate of absorption of lactide and glycolide polymers depend primarily upon the composition of the polymer and the molecular weight. High molecular weight polymers have longer absorption times than low molecular weight polymers (page 4, lines 12-21).
As discussed above, it would have been obvious to have different bioabsorption rates to treat adhesion formation. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated each layer with a different molecular weight of monovalent metal salt of low endotoxin alginic acid in order to have each layer with a different bioabsorption rate since molecular weight affects rate of absorption as taught by Pines.
The combined teachings of Tachi, Totakura and Pines do not teach how to apply the second layer.
However, Schmidt discloses preparing membranes of alginate and a photo-reactive derivative of hyaluronic acid (GMHA). After preparation of a first membrane layer, the sample was dried under sterile condition and a second layer of collagen and GMHA was cast on top. The two layers were chemically crosslinked and fused by treatment with 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide (EDC). Bilayer formation was then confirmed. In vitro cell morphology and characterization indicate that the collagen layer effectively provides an adhesive, proliferative substrate. The anti-adhesive layer effectively prevents cell proliferation and attachment (¶ [0046]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have casted the second monovalent metal salt of low endotoxin alginic acid onto the first monovalent metal salt of low endotoxin alginic acid and then crosslinked the composition with a hardening agent (i.e., curing) since this is a known and effective method of forming a multilayer composition as taught by Schmidt.
The combined teachings of Tachi, Totakura, Pines, and Schmidt do not disclose wherein the composition is lyophilized.
However, Spinnler discloses wherein a sponge can be obtained by lyophilization of a gel (¶ [0015]).
Tachi discloses wherein the composition may be a sponge or a gel. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have lyophilized the composition motivated by the desire to obtain a sponge as taught by Spinnler.
In regards to instant claim 1 reciting wherein the weight-average molecular weight of the monovalent metal salt of alginic acid in the first layer is 30,000-300,000 and the weight-average molecular weight of the monovalent metal salt of alginic acid in the second layer is 1,000-200,000, and the weight-average molecular weight of the monovalent metal salt of alginic acid in the first layer is higher than the weight-average molecular weight of the monovalent metal salt of alginic acid in the second layer, Tachi discloses wherein the weight-average molecular weight of the monovalent metal salt of alginic acid is preferably in a range of 1,000 to 300,000. Therefore, it would have been obvious to one of ordinary skill in the art to have selected a weight-average molecular weight of the monovalent metal salt of alginic acid for each layer from this range. Since molecular weight affects absorption rates as taught by Pines and it would have been obvious to one of ordinary skill in the art to have each sponge layer with a different molecular weight, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed weight-average molecular weight of the monovalent metal salt of alginic acid for each layer based on the rate of absorption desired for each layer.
In regards to instant claim 5 reciting wherein the total amount of the low-endotoxin monovalent metal salts of alginic acid used in the first layer and the second layer is in a range of 0.1 mg/cm2-3 mg/cm2, Tachi discloses wherein the content of the monovalent metal salt of alginic acid in the composition is in a range of 0.1 wt. % to 99.9 wt. %. Therefore, the claimed amount would have been obvious depending on the size of the sponge laminate. Also, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
In regards to instant claim 8 reciting wherein the first layer faces a surface of a wound, such configuration would have been obvious depending on the rate of bioabsorption desired. Totakura disclose wherein rates of bioaborption can be engineered to fit particular needs. In one embodiment, a rapidly bioabsorbed outer layer would act as the first line of defense against rapidly forming adhesions and a slower bioabsorbed inner layer would prevent the attachment of late forming adhesions. Pines discloses wherein higher molecular weight polymers have longer absorption times. Therefore, if a person desires this rate of bioabsorption disclosed by Totakura, it would have been obvious to one of ordinary skill in the art to apply the layer with a higher molecular weight to the surface of a wound.
In regards to instant claims 9-12 reciting an amount of curing agent in the first layer of 0.5 µmol/cm2 to 2 µmol/cm2 and an amount of curing agent in the second layer of 0.6 µmol/cm2 to 2.4 µmol/cm2, Tachi discloses wherein the content of the hardening agent (i.e., curing agent) is adjusted according to the viscosity of the composition. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount of curing agent in each layer based on the viscosity of each layer desired.
2. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Taichi et al. (WO 2016/114355 A1, Jul. 21, 2016) (hereinafter Taichi) in view of Totakura et al. (US 5,795,584, Aug. 18, 1998) (hereinafter Totakura), Pines et al. (EP 0109197A2, May, 23, 1984) (hereinafter Pines), Schmidt et al. (US 2015/0320915, Nov. 12, 2015) (hereinafter Schmidt), Spinnler et al. (US 2009/0192532, Jul. 30, 2009) (hereinafter Spinnler), and further in view of Ashby et al. (US 2002/0190226, Dec. 19, 2002) (hereinafter Ashby).
The teachings of Taichi, Totakura, Pines, Schmidt, and Spinnler are discussed above. Taichi, Totakura, Pines, Schmidt, and Spinnler do not teach wherein the composition is electron-beam sterilized.
However, Ashby discloses employing E-beam sterilization for sterilizing cross-linked gelatin (abstract). The cross-linked gelatin must be sterilized before use because it is placed on or in the body (¶ [0020]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have E-beam sterilized the composition of Taichi since compositions placed on or in the body needs to be sterilized and E-beam sterilization is a known and effective sterilization method as taught by Ashby.
3. Claims 7 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Taichi et al. (WO 2016/114355 A1, Jul. 21, 2016) (hereinafter Taichi) in view of Totakura et al. (US 5,795,584, Aug. 18, 1998) (hereinafter Totakura), Pines et al. (EP 0109197A2, May, 23, 1984) (hereinafter Pines), Schmidt et al. (US 2015/0320915, Nov. 12, 2015) (hereinafter Schmidt), Spinnler et al. (US 2009/0192532, Jul. 30, 2009) (hereinafter Spinnler), and further in view of Matsuda et al. (US 2004/0137179, Jul. 15, 2004) (hereinafter Matsuda).
The teachings of Taichi, Totakura, Pines, Schmidt, and Spinnler are discussed above. Taichi, Totakura, Pines, Schmidt, and Spinnler do not teach wherein the composition is pressed at a pressure in a range of 100 kPa to 60 MPa..
However, Matsuda discloses an antiadhesive material comprising a reinforcing material (abstract). Where the reinforcing material is a two or more layer laminate composed of two or more fabric bodies, hot pressing may be applied after the fabric bodies are laminated so that the fabric bodies are integrated (¶ [0075]). Hot pressing is carried out under a pressure in a range of 0.01 MPa to 5 MPa (¶ [0072]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have hot pressed the composition of the prior art comprising more than one layer at a pressure of 0.01 MPa to 5 MPa since this is a known and effective method to integrate two or more layers as taught by Matsuda.
4. Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Taichi et al. (WO 2016/114355 A1, Jul. 21, 2016) (hereinafter Taichi) in view of Totakura et al. (US 5,795,584, Aug. 18, 1998) (hereinafter Totakura), and Pines et al. (EP 0109197A2, May, 23, 1984) (hereinafter Pines).
Taichi discloses an adhesion-preventing method, characterized in that a composition is applied to a subject in need of prevention of adhesion, said composition comprising a monovalent metal salt of low endotoxin alginic acid (claim 14). The endotoxin content of the monovalent metal salt of alginic acid is equal to or less than 500 EU/g (claim 3). The monovalent metal salt of alginic acid may be crosslinked with a hardening agent (i.e. curing a low-endotoxin monovalent metal salt of alginic acid) to immobilize a solution of the monovalent metal salt of alginic acid. Suitable hardening agents (i.e., curing agents) include CaCl2, CaSO4, SrCl2, and BaCl2. The content of the hardening agent is adjusted according to the viscosity of the composition (¶ [0047]). The monovalent metal salt of alginic acid is a high-molecular weight polysaccharide. In the case where the molecular weight is determined by the GPS-MALS method, the weight-average molecular weight is preferably in a range of 1,000 to 300,000 (¶ [0032]). The content of the monovalent metal salt of alginic acid in the composition is in a range of 0.1 wt. % to 99.9 wt. % (¶ [0026]). The monovalent salt of alginic acid is either sodium alginate or potassium alginate (claim 4). The composition may be in the form of a sponge or a gel (¶ [0029]).
Tachi differs from the instant claims insofar as not disclosing another layer of the monovalent metal salt of low endotoxin alginic acid.
However, Totakura discloses wherein a multilayer surgical structure having one or more bioabsorbable layers superimposed on a non-absorbable layer is useful for minimizing or preventing formation of fibrous adhesions between a healing trauma site and adjacent surrounding tissue (abstract). Each bioabsorbable layer bioabsorb at different rates (col. 3, lines 1-3). Rates of bioabsorption can be engineered to fit particular needs. In this way, an outermost bioabsorbable layer can be constructed to slowly biodegrade and, when it does, adhesions which have formed between the outer layer and surrounding tissue fall away. Any slower forming adhesions which may have adhered through the outermost layer to an inner layer would then be disconnected by the absorption of a rapidly biodegrading inner layer. Alternatively, a rapidly bioabsorbed outer layer would act as the first line of defense against rapidly forming adhesions and a slower bioabsorbed inner layer would prevent the attachment of late forming adhesions (col. 9, lines 53-64). Suitable bioabsorbable materials include alginic acid (col. 6, lines 44-46).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have modified the composition of Tachi to have another layer of the monovalent metal salt of low endotoxin alginic acid motivated by the desire to have different bioabsorption rates to treat adhesion formation that arrive at different rates as taught by Totakura.
The combined teachings of Tachi and Totakura do not teach wherein each layer comprise a different molecular weight of monovalent metal salt of low endotoxin alginic acid.
However, Pines discloses wherein the rate of absorption of lactide and glycolide polymers depend primarily upon the composition of the polymer and the molecular weight. High molecular weight polymers have longer absorption times than low molecular weight polymers (page 4, lines 12-21).
As discussed above, it would have been obvious to have different bioabsorption rates to treat adhesion formation. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated each layer with a different molecular weight of monovalent metal salt of low endotoxin alginic acid in order to have each layer with a different bioabsorption rate since molecular weight affects rate of absorption as taught by Pines.
In regards to instant claim 1 reciting wherein the weight-average molecular weight of the monovalent metal salt of alginic acid in the first layer is 30,000-300,000 and the weight-average molecular weight of the monovalent metal salt of alginic acid in the second layer is 1,000-200,000, and the weight-average molecular weight of the monovalent metal salt of alginic acid in the first layer is higher than the weight-average molecular weight of the monovalent metal salt of alginic acid in the second layer, Tachi discloses wherein the weight-average molecular weight of the monovalent metal salt of alginic acid is preferably in a range of 1,000 to 300,000. Therefore, it would have been obvious to one of ordinary skill in the art to have selected a weight-average molecular weight of the monovalent metal salt of alginic acid for each layer from this range. Since molecular weight affects absorption rates as taught by Pines and it would have been obvious to one of ordinary skill in the art to have each sponge layer with a different molecular weight, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed weight-average molecular weight of the monovalent metal salt of alginic acid for each layer based on the rate of absorption desired for each layer.
In regards to instant claim 4 reciting wherein the laminate is obtained by performing the method according to claim 1, the claim is a product-by-process claim. 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. See MPEP 2113. Therefore, since a sponge laminate comprising a different molecular weight of low-endotoxin monovalent metal salt of alginic acid in each layer is obvious as discussed above, the claim is unpatentable even though the prior art does not disclose the process steps as claimed.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 and 17 of U.S. Patent No. 11,464,597. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite additional method steps such as freezing) and thus read on the instant claims.
Conclusion
Claims 1-15 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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