DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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: the polymer composition is non-crystalline was not found in the written description to define its meaning.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 46 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for crystallinity (mentioned word twice in specification, but with no details), does not reasonably provide enablement for non-crystalline. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims. It must be noted without the details of a “non-crystalline” polymer composition, there is lack of sufficient details on what amounts of specific materials are capable of providing the chains or even any details of amorphous regions to establish that what amount of crosslinking results in a polymer that is considered “non-crystalline”.
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 50,52,53-55 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 50 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the description of structure to define a first portion and second portion since the claim just recites they abut one another. how can a central portion be considered “central” just by being adjacent to another portion as recited in the claim? When something is central to another element, it often means one portion can possibly surround in some way the other element, however, the claim fails to detail this and is not implied by use of arbitrary clauses “first portion” and “second portion” which define no structure whatsoever.
Regarding claims 52,54,55 it is not understood what the scaffold is increasing relative to because it recites properties that are said to increase, but defines no baseline or what possesses some standard value for the tensile strength and bending strength or elasticity or fracture resistance.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 38,39,43,45,47-57 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Arinzeh et al. (2010/0233234) in view of Rowlands et al. (polyurethane/poly(lactic-co-glycolic) acid composite scaffolds fabricated by thermally induced phase separation) and Venkatraman et al. (2007/0299510). Arinzeh et al. disclose (paragraph 14) a biodegradable medical implant for implantation in the human body, the implant comprising a polymer composition comprising a mixture (paragraphs 13,14,43) of: a first polymer backbone having a first rate of biodegradation, the first polymer backbone comprising a polyurethane; a second polymer backbone cross-linked (paragraph 13) to the first polymer backbone and having a second rate of biodegradation faster than the first rate of biodegradation, wherein the second polymer comprises polyglycolic acid (PGA) or polyglycolic lactic acid (PGLA), since the same materials as claimed are disclosed in the prior art, they inherently possess the biodegradation rates as recited. Material properties cannot be separated from a material. It is noted that Arinzeh discloses (paragraph 70) the amount of a degradable polymer can be about 20 to 30, but did not explicitly state a weight ratio of polyurethane to PGLA or PGA in the composition ranges from about 20:80 to 80:20, wherein the degradation rates of the first and second polymer backbone are configured such that the first polymer backbone provides a scaffold for the implant that is maintained while the second polymer backbone degrades. Rowland et al. teach (abstract, Fig. 3, page 2120) a polyurethane/PGLA mixture that a ratio of the polymers are used within the claimed range of about 20:80 to 80:20. It would have been obvious to one of ordinary skill in the art to select a ratio for the polymers selected to prepare the medical implant with the range of about 20:80 to 80:20 for the polyurethane composition mixture with PGLA as taught by Rowland et al. in the medical implant of Arinzeh et al. in order to enhance the mechanical and cell adhesion properties of the material compared to PGLA and polyurethane alone. It is noted that Arinzeh et al. does disclose (paragraphs 8, 81) cell adhesion molecules can be used with the composition. However, Arinzeh did not disclose the adhesion compound is a cell adhesion and migration promoting polypeptide (CAMPP) cross-linked to the first polymer backbone wherein the cell adhesion and migration promoting polypeptide is configured to promote the adhesion and migration of a confluent layer of cells on a surface of the implant. Venkatraman et al. teach (paragraphs 50-52) a cell adhesion and migration promoting polypeptide (CAMPP) cross-linked to a polymer backbone to enhance the tissue composition. It would have been obvious to select an alternative cell adhesion vehicle such as a cell adhesion and migration promoting polypeptide (CAMPP) cross-linked to the first polymer backbone as taught by Venkatraman et al. with the medical implant scaffold of Arinzeh et al. as modified with Rowlands et al. in order to promote the adhesion and migration of a confluent layer of endothelial cells on a surface of the implant, as taught by Venkatraman et al. (paragraph 47). Regarding claim 39, Venkatraman et al. teach (paragraph 47) the cell adhesion and migration promoting polypeptide is configured to promote the adhesion and migration of a confluent layer of cells on a surface of the implant the confluent layer of cells comprising endothelial cells. Regarding claim 43, since Arinzeh discloses the same materials as claimed it follows that the biodegradation for the second rate is at least ten times faster than the rate of biodegradation for the first rate, the rate of biodegradation of the materials such as polyurethane and PGA or PGLA are properties and they cannot be separated from the material. Regarding claim 45, Arinzeh discloses (paragraphs 14,18) the first polymer can be polyurethane and is non-degradable to thus remain within the human body during a life of the implant. Additionally per the modification with Rowlands and the possible 20,30 % PGA one can modify and provide at least 80% of a structure of the first polymer backbone with the polyurethane. With respect to claim 47, Arinzeh discloses (paragraphs 14,18) there can be a nondegradable polymer and a degradable polymer such that it can be construed the implant comprises a first portion including the first polymer backbone and a second portion including the second polymer backbone since this is just arbitrary locations, positions or configuration. Regarding claims 48,49 Arinzeh et al. did not disclose the different polymers are within first and second layers and the second over the first. Venkatraman et al. teach that in using different polymers, one can use the properties advantageously by applying them in layers and arranging one on the other to provide a vascular implant, see Fig. 3. It would have been obvious to one of ordinary skill in the art to use a first polymer in a first layer and a second polymer in a second layer with the second layer over the first layer as taught by Venkatraman with the implant materials of Arinzeh as modified with Rowlands such that a controlled delivery or biodegradation rate is established using the configuration to control endothelialization of a body fluid contacting surface of the implant, see abstract of Venkatraman. Regarding claim 50 as best understood, Fig. 3 of Venkatraman shows one layer surrounding another layer, thus it could be construed the first portion defines a central portion and the second portion lying thereon abuts the first portion. With respect to claim 51, it is inherent the amount of crosslinking controls the second rate of biodegradation as evidenced by Zhong cited in IDS. Zhong states (col. 12, lines 24-36) varied biodegradation rates are controlled by the crosslinking. Regarding claims 52,53,54,55 since the implant material of Arinzeh as modified with Rowlands and Venkatraman is the same as claimed, it possesses the bending strength and tensile strength as recited. Further it can be said the implant material will provide a tensile strength within the claimed range of 0.7 to 3.8 lbs since a material composition’s properties cannot be separated from its general conditions. Additionally since the material as claimed has the same composition with that disclosed in the prior art in view of Arinzeh as modified with Rowlands and Venkatraman it inherently possesses an ability to increase the elasticity and the fracture resistance. With respect to claim 56, Arinzeh did not disclose the implant is a stent. However, Venkatraman teaches (paragraphs 28,31,32) that the use of polyurethanes, PGA or PGLA materials can be used for stents. It would have been obvious to one of ordinary skill in the art to select a use for biocompatible materials known in the art to provide a stent as taught by Venkatraman with the polyurethane and PGA or PGLA composition for an implant by Arinzeh as modified with Rowlands such that it provides the necessary support when used in a vascular or liquid conveying vessel repair. Regarding claim 57, Arinzeh discloses (paragraph 13) the implantable scaffold can be a graft such as for tissue regeneration.
Claim 40 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Arinzeh et al. (2010/0233234) in view of Rowlands et al. (polyurethane/poly(lactic-co-glycolic) acid composite scaffolds fabricated by thermally induced phase separation) and Venkatraman et al. (2007/0299510) as applied to claim 38 above, and further in view of Li et al. (2005/0063937). Arinzeh et al. in view of Rowlands et al. and Venkatraman et al. is explained supra. However, Arinzeh et al. in view of Rowlands et al. did not explicitly disclose the cell adhesion and migration promoting polypeptide is a multi-armed polypeptide or P-15 polypeptide. Li et al. teach (paragraph 56) the use of cell adhesion and migration promoting polypeptides such a multiple arm type polypeptides or a P-15 polypeptide, see paragraphs 35,62. It would have been obvious to one of ordinary skill in the art to select a cell adhesion polypeptide such as a multiple arm type or a P-15 polypeptide and use with the implant composition of Arinzeh et al. in view of Rowlands et al. and Venkatraman et al. such that it enhances the cell adhesion, attachment, proliferation and improve healing at the tissue site, see abstract Li et al.
Claims 41,42 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Arinzeh et al. (2010/0233234) in view of Rowlands et al. (polyurethane/poly(lactic-co-glycolic) acid composite scaffolds fabricated by thermally induced phase separation) and Venkatraman et al. (2007/0299510) as applied to claim 38 above, and further in view of Conley et al. (2006/0094017). Arinzeh et al. in view of Rowlands et al. and Venkatraman et al. is explained supra. However, Arinzeh et al. in view of Rowlands et al. did not explicitly disclose the cell adhesion and migration promoting polypeptide is cross-linked via an amino acid residue to a side chain of the first polymer backbone. Conley et al. teach (paragraph 44) the use of crosslinking via isocyanates and is a non-specific crosslinking reaction, in the field of biochemistry, for the purpose of creating permanent bonds between different components. In addition Conley et al. teach (paragraph 44) that these side chain off amino acids are resulting from such a coupling, via tyrosine. It would have been obvious to one of ordinary skill in the art to provide the cell adhesion and migration promoting polypeptide which is cross-linked via an amino acid such as a tyrosine residue to a side chain of the first polymer backbone as taught by Conley et al. and use with the implant composition of Arinzeh et al. in view of Rowlands et al. and Venkatraman et al. such that it enhances the cellular attachment.
Claim 44 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Arinzeh et al. (2010/0233234) in view of Rowlands et al. (polyurethane/poly(lactic-co-glycolic) acid composite scaffolds fabricated by thermally induced phase separation) and Venkatraman et al. (2007/0299510) as applied to claim 38 above, and further in view of Leong (5176907). Arinzeh et al. in view of Rowlands et al. and Venkatraman et al. is explained supra. However, Arinzeh et al. in view of Rowlands et al. did not explicitly disclose the first polymer backbone and the second polymer backbone are cross-linked by a urethane linkage between an isocyanate side group on the first polymer backbone and a methylene side group on the second polymer backbone. Leong teaches (col. 10, lines 1-11) that polyurethane compositions can be crosslinked to provide a urethane linkage and a methylene side group on the second polymer backbone. It would have been obvious to one of ordinary skill in the art to use a urethane linkage between an isocyanate side group on the first polymer backbone and a methylene side group on the second polymer backbone when crosslinked as taught by Leong in the implant material composition of Arinzeh as modified with Rowlands and Venkatraman such that the appropriate time of scaffold presence is supplied by the material.
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 38-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,6-10 of U.S. Patent No. 10046085. Although the claims at issue are not identical, they are not patentably distinct from each other because the narrower claim anticipates the broader, see In re Goodman. Dependent claim 6 of US ‘085 (also includes features of independent claim 1) has all the claim features recited in pending claim 1. Regarding claim 39, see claim 7 of US ‘085. Regarding claim 40, see claim 8 of US ‘085. Regarding claim 41, see claim 9 of US ‘085. Regarding claim 42, see claim 10 of US ‘085.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799