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 .
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 39-41 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 39 recites the limitation "the matrix" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 40-41 are indefinite by virtue of their dependency on indefinite base claim 39.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 30-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0214149 A1 to Hunt et al. (hereinafter “Hunt”) in view of US 2005/0228442 A1 to Wheatley et al. (hereinafter “Wheatley”).
Regarding claim 30, Hunt discloses (see abstract; Figs. 10-12B; and [0035]-[0080]) a system (120) for forming an anastomosis between two adjacent walls of a digestive tract (see [0076] and [0035]-[0041]), the system comprising: first (122) and second (124) magnetic (see [0078]) implants configured to magnetically couple to each other through the two adjacent walls of the digestive tract to compress a portion of the two adjacent walls therebetween and form a necrotic area that becomes surrounded by a scarred edge following a healing time period (see [0076] & [0035]-[0041]); at least one of the first and second magnetic implants comprising: a magnet (134); and a housing (148, or alternatively the housing defined by device half 122/124) configured to house the magnet therein (see Fig. 11 and [0078]-[0079]); and a retention member (structures for keeping device halves 122/124 together, including 136/126 or 138/146/128) extending outwardly from a corresponding one of the first and second magnetic implants, the retention member being configured to retain the first and second magnetic implants in position and prevent passage thereof through the necrotic area during the healing time period (see [0079] & [0038]-[0041]).
Regarding claim 30, Hunt fails to specifically disclose wherein at least one of the housing and the retention member is configured to release a drug therefrom once implanted in the digestive tract.
Wheatley discloses (see abstract, Fig. 1, and [0017]-[0049]), in the same field of endeavor of anastomosis devices (see at least [0017]), a device comprising first and second magnetic implants (see [0019]/[0020]/[0030]) contained within a housing (shown in Fig. 1), wherein the housing is configured to release a drug therefrom one implanted in the digestive tract (see [0017]/[0020]) for the purpose of delivering bioactive agents to an anastomosis site to provide a therapeutic treatment, such as antibiotics, anti-inflammatory agents, chemotherapeutic agents, radioactive agents, and anti-thrombosis treatments (see [0017]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hunt's anastomosis system with the drug releasing mechanism taught by Wheatley in order to deliver bioactive agents to an anastomosis site to provide a therapeutic treatment, such as antibiotics, anti-inflammatory agents, chemotherapeutic agents, radioactive agents, and anti-thrombosis treatments.
Regarding claims 31-32, the combination of Hunt and Wheatley discloses the invention substantially as claimed as discussed above, however, Hunt is silent as to whether the retention member and the housing are made of a same material or a different material. Hunt is silent as to the material. Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art, as a matter of being obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see KSR International Co. v. Teleflex Inc., 550 U.S. 398,82 USPQ2d 1385,1395-97 (2007)), to obtain the predictable result of the retention member and housing being made of the same material or different materials, as these are the only two options in terms of relative materials between the retention member and housing - they can either be the same material or different material and merely being the same material or a different material doesn't provide an unexpected result. Moreover, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
The combination of Hunt and Wheatley, as set forth above for the reasons set forth above, would further disclose (as per Wheatley): (claim 33) wherein the material from which is made the at least one of the housing and the retention member comprises a matrix that is configured to include the drug therein up to a given timepoint once implanted in the digestive tract (see [0026]-[0027]); (claim 34) wherein the matrix is configured to progressively release the drug therefrom once the at least one of the housing and the retention member is implanted in the digestive tract (see [0026]-[0027]); (claim 35) wherein the matrix comprises a bioerodible material that is configured to undergo degradation once implanted in the digestive tract (see [0017] & [0025]-[0026]); (claim 36) wherein the drug has at least one of pro-thrombosis properties, antifibrinolytic properties and wound-healing properties (see [0017], [0020], [0025]-[0027]); (claim 37) wherein the drug comprises a peptide (see [0027]); (claim 38) wherein the drug comprises a plurality of drugs (see [0020]); (claim 39) wherein the matrix is configured such that at least two drugs of the plurality of drugs are released therefrom sequentially (see [0020] and [0025]-[0027]); (claim 40) wherein the plurality of drugs comprises an antifibrinolytic drug and a wound-healing promoting drug, and the antifibrinolytic drug is released first and the wound-healing promoting drug is released second (see [0020] and [0025]-[0027]); and (claim 41) wherein the matrix is configured such that at least two drugs of the plurality of drugs are released therefrom substantially simultaneously (see [0020] and [0025]-[0027]).
Claim(s) 42-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunt in view of US 2012/0197061 A1 to Requarth (hereinafter “Requarth”).
Regarding claim 42, Hunt discloses (see abstract; Figs. 10-12B; and [0035]-[0080]) a system (120 )for forming an anastomosis between two adjacent walls of a digestive tract (see [0076] and [0035]-[0041]), the system comprising: first (122) and second (124) magnetic (see [0078]) implants configured to magnetically couple to each other through the two adjacent walls of the digestive tract to compress a portion of the two adjacent walls therebetween and form a necrotic area that becomes surrounded by a scarred edge following a healing time period (see [0076] & [0035]-[0041]); at least one of the first and second magnetic implants comprising: a magnet (134); and a housing (148, or alternatively the housing defined by device half 122/124) configured to house the magnet therein (see Fig. 11 and [0078]-[0079]); and a retention member (structures for keeping device halves 122/124 together, including 136/126 or 138/146/128) extending outwardly from a corresponding one of the first and second magnetic implants, the retention member being configured to retain the first and second magnetic implants in position and prevent passage thereof through the necrotic area during the healing time period (see [0079] & [0038]-[0041]).
Regarding claim 42, Hunt fails to specifically disclose wherein at least one of the housing and the retention member is configured to contain a biologically active component therein. Requarth discloses (see abstract; Figs. 1-6; and [0049]-[0078]), in the same field of endeavor, an anastomosis system for the digestive tract (see [0049]/[0074]), the system comprising magnetic implants (15m) configured to magnetically couple to each other through adjacent tissue walls (see [0048]-[0049]), the magnetic implants comprising a magnet (magnetic component of 15m) and a housing configured to house the magnet therein (exterior of 15m housing magnetic component and material 50 as per [0060]-[0062]), wherein the housing is configured to contain a biologically active component therein (50, such as stem cells, see [0060]-[0062]) for the purpose of applying therapy via a therapeutic agent to treat a disease like cancer during anastomosis (see [0060]-[0062]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hunt's system with the biologically active component taught by Requarth in order to apply therapy via a therapeutic agent to treat a disease like cancer during anastomosis.
The combination of Hunt and Requarth, as set forth above for the reasons set forth above, would further disclose (as per Requarth): (claim 43) wherein the biologically active component comprises viable cells (see [0061]); (claim 44) wherein the biologically active component comprises stem cells (see [0061]); (claim 45) wherein the housing is configured to progressively release the biologically active component therefrom once implanted in the digestive tract (see [0060]-[0062], [0066], & [0074]); (claim 46) wherein the housing comprises a bioresorbable material (see [0066]); (claim 47) wherein the housing comprises a semi-permeable membrane (film, see [0066]); (claim 48) wherein the semi-permeable membrane is configured to enable diffusion of oxygen and cell nutrients (see [0066], the film disclosed is fully capable of enabling diffusion of oxygen and cell nutrients); (claim 49) wherein the biologically active component comprises a plurality of biologically active components (see [0061] & [0066], stem cells and mucosal cells); (claim 50) wherein the housing is configured such that at least two biologically active components of the plurality of biologically active components are released therefrom sequentially (see [0060]-[0062] & [0066], depending on the dissolving rate of the film); and (claim 51) wherein the housing is configured such that at least two biologically active components of the plurality of biologically active components are released therefrom substantially simultaneously (see [0060]-[0062] & [0066], depending on the dissolving rate of the film).
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 30-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 6-7 of U.S. Patent No. 11,576,676 in view of Wheatley.
Claim 42 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 11,576,676 in view of Requarth.
Regarding claims 30/42, ‘676 claim 2 discloses (with reference to Col/Line numbers of the issued patent) a system for forming an anastomosis between two adjacent walls of a digestive tract (C55L56-57), the system comprising: first and second magnetic implants (C55L58) configured to magnetically couple to each other through the two adjacent walls of the digestive tract to compress a portion of the two adjacent walls therebetween and form a necrotic area that becomes surrounded by a scarred edge following a healing time period (C55L62-C56L57), at least one of the first and second magnetic implants comprising: a magnet; and a housing configured to house the magnet therein (C57L4-6); and a retention member extending outwardly from a corresponding one of the first and second magnetic implants (C56L58-60), the retention member being configured to retain the first and second magnetic implants in position and prevent passage thereof through the necrotic area during the healing time period (C56L67-C57L3).
Regarding claim 30, ‘676 claim 2 fails to specifically disclose wherein at least one of the housing and the retention member is configured to release a drug therefrom once implanted in the digestive tract. Wheatley discloses (see abstract, Fig. 1, and [0017]-[0049]), in the same field of endeavor of anastomosis devices (see at least [0017]), a device comprising first and second magnetic implants (see [0019]/[0020]/[0030]) contained within a housing (shown in Fig. 1), wherein the housing is configured to release a drug therefrom one implanted in the digestive tract (see [0017]/[0020]) for the purpose of delivering bioactive agents to an anastomosis site to provide a therapeutic treatment, such as antibiotics, anti-inflammatory agents, chemotherapeutic agents, radioactive agents, and anti-thrombosis treatments (see [0017]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘676’s claimed anastomosis system with the drug releasing mechanism taught by Wheatley in order to deliver bioactive agents to an anastomosis site to provide a therapeutic treatment, such as antibiotics, anti-inflammatory agents, chemotherapeutic agents, radioactive agents, and anti-thrombosis treatments.
Regarding claim 42, '676 claim 2 fails to specifically disclose wherein at least one of the housing and the retention member is configured to contain a biologically active component therein. Requarth discloses (see abstract; Figs. 1-6; and [0049]-[0078]), in the same field of endeavor, an anastomosis system for the digestive tract (see [0049]/[0074]), the system comprising magnetic implants (15m) configured to magnetically couple to each other through adjacent tissue walls (see [0048]-[0049]), the magnetic implants comprising a magnet (magnetic component of 15m) and a housing configured to house the magnet therein (exterior of 15m housing magnetic component and material 50 as per [0060]-[0062]), wherein the housing is configured to contain a biologically active component therein (50, such as stem cells, see [0060]-[0062]) for the purpose of applying therapy via a therapeutic agent to treat a disease like cancer during anastomosis (see [0060]-[0062]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘676’s claimed system with the biologically active component taught by Requarth in order to apply therapy via a therapeutic agent to treat a disease like cancer during anastomosis.
Further, there is correspondence between dependent claims 31-32 and claims 6-7 of ‘676.
Claims 30-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 11-12 of U.S. Patent No. 12,349,914 in view of Wheatley.
Claim 42 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 12,349,914 in view of Requarth.
Regarding claims 30/42, ‘914 claim 2 discloses (with reference to Col/Line numbers of the issued patent) a system for forming an anastomosis between two adjacent walls of a digestive tract (C45L46-47), the system comprising: first and second magnetic implants (C45L48) configured to magnetically couple to each other through the two adjacent walls of the digestive tract to compress a portion of the two adjacent walls therebetween and form a necrotic area that becomes surrounded by a scarred edge following a healing time period (C45L54-59), at least one of the first and second magnetic implants comprising: a magnet; and a housing configured to house the magnet therein (C46L45-47); and a retention member extending outwardly from a corresponding one of the first and second magnetic implants (C45L60-62), the retention member being configured to retain the first and second magnetic implants in position and prevent passage thereof through the necrotic area during the healing time period (C45L64-67),
Regarding claim 30, ‘914 claim 2 fails to specifically disclose wherein at least one of the housing and the retention member is configured to release a drug therefrom once implanted in the digestive tract. Wheatley discloses (see abstract, Fig. 1, and [0017]-[0049]), in the same field of endeavor of anastomosis devices (see at least [0017]), a device comprising first and second magnetic implants (see [0019]/[0020]/[0030]) contained within a housing (shown in Fig. 1), wherein the housing is configured to release a drug therefrom one implanted in the digestive tract (see [0017]/[0020]) for the purpose of delivering bioactive agents to an anastomosis site to provide a therapeutic treatment, such as antibiotics, anti-inflammatory agents, chemotherapeutic agents, radioactive agents, and anti-thrombosis treatments (see [0017]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘914’s claimed anastomosis system with the drug releasing mechanism taught by Wheatley in order to deliver bioactive agents to an anastomosis site to provide a therapeutic treatment, such as antibiotics, anti-inflammatory agents, chemotherapeutic agents, radioactive agents, and anti-thrombosis treatments.
Regarding claim 42, '914 claim 2 fails to specifically disclose wherein at least one of the housing and the retention member is configured to contain a biologically active component therein. Requarth discloses (see abstract; Figs. 1-6; and [0049]-[0078]), in the same field of endeavor, an anastomosis system for the digestive tract (see [0049]/[0074]), the system comprising magnetic implants (15m) configured to magnetically couple to each other through adjacent tissue walls (see [0048]-[0049]), the magnetic implants comprising a magnet (magnetic component of 15m) and a housing configured to house the magnet therein (exterior of 15m housing magnetic component and material 50 as per [0060]-[0062]), wherein the housing is configured to contain a biologically active component therein (50, such as stem cells, see [0060]-[0062]) for the purpose of applying therapy via a therapeutic agent to treat a disease like cancer during anastomosis (see [0060]-[0062]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘914’s claimed system with the biologically active component taught by Requarth in order to apply therapy via a therapeutic agent to treat a disease like cancer during anastomosis.
Further, there is correspondence between dependent claims 31-32 and claims 6-7 of ‘914.
Claims 30 and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6 and 9 of U.S. Patent No. 11,583,280 in view of Wheatley.
Claim 42 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 11,583,280 in view of Requarth.
Regarding claims 30/42, ‘280 claim 6 discloses (with reference to Col/Line numbers of the issued patent) a system for forming an anastomosis between two adjacent walls of a digestive tract (C39L50-51), the system comprising: first and second magnetic implants (C50L52) configured to magnetically couple to each other through the two adjacent walls of the digestive tract to compress a portion of the two adjacent walls therebetween and form a necrotic area that becomes surrounded by a scarred edge following a healing time period (C51L52-57), at least one of the first and second magnetic implants comprising: a magnet; and a housing configured to house the magnet therein (C41L30-32); and a retention member extending outwardly from a corresponding one of the first and second magnetic implants (C40L65-67), the retention member being configured to retain the first and second magnetic implants in position and prevent passage thereof through the necrotic area during the healing time period (C41L2-6).
Regarding claim 30, ‘280 claim 2 fails to specifically disclose wherein at least one of the housing and the retention member is configured to release a drug therefrom once implanted in the digestive tract. Wheatley discloses (see abstract, Fig. 1, and [0017]-[0049]), in the same field of endeavor of anastomosis devices (see at least [0017]), a device comprising first and second magnetic implants (see [0019]/[0020]/[0030]) contained within a housing (shown in Fig. 1), wherein the housing is configured to release a drug therefrom one implanted in the digestive tract (see [0017]/[0020]) for the purpose of delivering bioactive agents to an anastomosis site to provide a therapeutic treatment, such as antibiotics, anti-inflammatory agents, chemotherapeutic agents, radioactive agents, and anti-thrombosis treatments (see [0017]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘280’s claimed anastomosis system with the drug releasing mechanism taught by Wheatley in order to deliver bioactive agents to an anastomosis site to provide a therapeutic treatment, such as antibiotics, anti-inflammatory agents, chemotherapeutic agents, radioactive agents, and anti-thrombosis treatments.
Regarding claim 42, '280 claim 2 fails to specifically disclose wherein at least one of the housing and the retention member is configured to contain a biologically active component therein. Requarth discloses (see abstract; Figs. 1-6; and [0049]-[0078]), in the same field of endeavor, an anastomosis system for the digestive tract (see [0049]/[0074]), the system comprising magnetic implants (15m) configured to magnetically couple to each other through adjacent tissue walls (see [0048]-[0049]), the magnetic implants comprising a magnet (magnetic component of 15m) and a housing configured to house the magnet therein (exterior of 15m housing magnetic component and material 50 as per [0060]-[0062]), wherein the housing is configured to contain a biologically active component therein (50, such as stem cells, see [0060]-[0062]) for the purpose of applying therapy via a therapeutic agent to treat a disease like cancer during anastomosis (see [0060]-[0062]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘280’s claimed system with the biologically active component taught by Requarth in order to apply therapy via a therapeutic agent to treat a disease like cancer during anastomosis.
Further, there is correspondence between dependent claim 32 and claim 9 of ‘280.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see the attached PTO-892 Notice of References cited for additional relevant prior art disclosing magnetic anastomosis systems, or anastomosis systems configured for applying a drug or a biological agent to the anastomosis site.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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