DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Interpretation
Of note, claim 101 use terminology “closely fit”. The term may have a general non-defined scope, but there seems to be support for the limitations with respect to there will be a similar size within a potential range that can allow the two devices to engage with each other. The examiner will interrupt the limitations accordingly.
Claim Objections
Claim 107 is objected to because of the following informalities: In order to avoid any potential 101 issues with respect to positively claiming human tissue, the claim should be amended to use functional language with respect to the radial pressure is “adapted to be” minimal such that the blood circulation is not prohibited. Appropriate correction is required.
Claim 112 is objected to because of the following informalities: In order to avoid any antecedent issues, the claim should be amended to read “…tapers toward an edge of said free end portion”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 101, 102, 105, 106, 110, 111, 114, 115 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by U.S. Patent Publication 2004/0153104 to Buckman.
As to claim 101, Buckman discloses an implantable tissue connector adapted so as to be connectable to a tubular part of living tissue within a patient's body (paragraph 7), comprising: a conduit (12, figure 4a-d) having at least a first end (end closer to 20) and a second end (end with 16) and further having an outer surface (figure 4a-d), and at least one flexible sleeve (80) adapted to axially extend and closely fit around at least part of said outer surface of the conduit (paragraph 66, figure 4a-c, the elastic characteristic of the clamp allows the device to closely fit around the outer surface), characterized in that the flexible sleeve is mounted on said outer surface either folded or rolled upon itself so that it can be unfolded or unrolled, or said flexible sleeve is mounted on the outer surface so as to be foldable upon itself (figure 4b-d, paragraph 66-68).
As to claim 102, Buckman discloses the flexible sleeve is made from a biocompatible material (paragraph 66, the polyurethane, silicone, latex rubber, polyisoprene or the like can read on the biocompatible materials).
As to claim 105, Buckman discloses where the flexible sleeve is mounted on said outer surface either folded or rolled upon itself, the flexible sleeve, when unfolded or unrolled, will exert radial pressure (figure 4a-d, paragraph 66-68).
As to claim 106, Buckman discloses when implanted in a patient's body with the sleeve unfolded or unrolled, the tissue connector is adapted to exert said radial pressure on any living tubular tissue placed intermediate the sleeve and the outer surface of the conduit (figure 4a-d, paragraph 66-68).
As to claim 110, Buckman discloses the conduit and the flexible sleeve are fixedly connected to each other along an axially extending portion of the sleeve (figure 4b, paragraph 66). Where the clamp is attached to the tube 12, the sleeve is fixedly connected along an axially extending portion along the sleeve.
As to claim 111, Buckman discloses the fat least one flexible sleeve is located proximately to the first end of the conduit (figure 4b,d). In an interpretation, the rolled up clamp 80 can be proximally spaced from the end where 20 is located if 20 is located at the distal end of the device.
As to claim 114, Buckman discloses the second end of the conduit is adapted for connecting the tissue connector to at least one of the following items: an implantable reservoir, an implantable pump, an implantable motor, and implantable medical device, a biological transplant (figure 4b-d). The flange 16 can be connected to the sleeve 14 which is an implantable medical device.
As to claim 115, Buckman discloses between the first and second ends of the conduit or connected to the second end of the conduit, there is provided at least one of the following items: a reservoir, a pump, a motor, and medical device, a flow restrictor (figure 4b-d). The flange 16 can be connected to the sleeve 14 which is an implantable medical device.
Claims 101-107, 112-115 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by U.S. Patent Publication 2005/0070933 to Leiboff.
As to claim 101, Leiboff discloses an implantable tissue connector adapted so as to be connectable to a tubular part of living tissue within a patient's body (paragraph 32), comprising: a conduit (10, figure ) having at least a first end (18) and a second end (20) and further having an outer surface (figure 1), and at least one flexible sleeve (44/36, paragraph 35, 36, 44, 45, figure 1, 5) adapted to axially extend and closely fit around at least part of said outer surface of the conduit (paragraph 35, 36, 44, 45, figure 1, 5, how the sleeve is attached, and the elastic characteristics, allows the sleeve to closely fit around the outer surface), characterized in that the flexible sleeve is mounted on said outer surface either folded or rolled upon itself so that it can be unfolded or unrolled, or said flexible sleeve is mounted on the outer surface so as to be foldable upon itself (figure 1, 5, paragraph 51).
As to claim 102, Leiboff discloses the flexible sheath is made from a biocompatible material (paragraph 36). The latex, silicone, and elastomer can read on the biocompatible material.
As to claim 103, Leiboff discloses the flexible sleeve is mounted on said outer surface either folded or rolled upon itself or so as to be foldable upon itself, wherein, where the flexible sleeve is mounted on the outer surface of the conduit so as to be foldable upon itself, the flexible sleeve, when folded upon itself, will exert radial pressure (figure 4-5, paragraph 35, 45, 50, 51, 54). The elastic nature and the clamping effect of the flexible sleeve, will allow the device to exert a radial pressure.
As to claim 104, Leiboff discloses when implanted in a patient's body with the sleeve folded upon itself, the tissue connector is adapted to exert said radial pressure on any living tubular tissue placed intermediate the sleeve and the outer surface of the conduit (figure 4-5, paragraph 35, 45, 50, 51, 54).
As to claim 105, Leiboff discloses where the flexible sleeve is mounted on said outer surface either folded or rolled upon itself, the flexible sleeve, when unfolded or unrolled, will exert radial pressure (figure 4-5, paragraph 35, 45, 50, 51, 54).
As to claim 106, Leiboff discloses when implanted in a patient's body with the sleeve unfolded or unrolled, the tissue connector is adapted to exert said radial pressure on any living tubular tissue placed intermediate the sleeve and the outer surface of the conduit (figure 4-5, paragraph 35, 45, 50, 51, 54).
As to claim 107, Leiboff discloses the radial pressure is minimal such that blood circulation in living tissue is not prohibited (paragraph 48-50). The radial pressure of the device can be minimal, such that there is circulation in the bowel 90 since the device can be sized for the appropriate bowel.
As to claim 112, Leiboff discloses the first end of the free conduit has a free end (42) portion and tapers toward the edge of the said free end portion (figure 1, paragraph 41).
As to claim 113, Leiboff discloses at least one bulge (42) extending outwardly from the conduit’s outer surface in a circumferential direction of the conduit about at least a part of the conduit’s circumference (figure 1, paragraph 41), at least one blocking ring (60, figure 5, paragraph 46, 51) loose fitting over the outer surface of the conduit with a clearance between the outer surface and the blocking ring for mounting tubular living tissue or a hole within the clearance, said blocking ring having an inner cross sectional diameter which is smaller than or substantially identical to an outer cross sectional diameter of the at least one bulge so as to prevent the blocking ring from slipping over the bulge when living tissue or a hose is mounted within the clearance (figure 5). The ties can be placed with respect to the bulges 42 where there is space between the ties and the conduit, which can read on the clearance, the loose fitting, and the inner cross sectional dimeter.
As to claim 114, Leiboff discloses the second end of the conduit is adapted for connecting the tissue connector to at least one of the following items: an implantable reservoir, an implantable pump, an implantable motor, and implantable medical device, a biological transplant (figure 5). The second end can be attached to the closure member 50.
As to claim 115, Leiboff discloses between the first and second ends of the conduit or connected to the second end of the conduit, there is provided at least at least one of the following items: a reservoir, a pump, a motor, and medical device, a flow restrictor (figure 5). The flange 16 can be connected to the sleeve 14 which is an implantable medical device. Between the ends, an outer flow tube 22 is connected to the device.
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 of this title, 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 negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 112 is rejected under pre-AIA 35 U.S.C. 102 (a)(1) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over U.S. Patent Publication 2004/0153104 to Buckman.
As to claim 112, Buckman discloses the first end of the conduit has a free end portion and tapers towards the edge of the free end portion (figure 3a, 4b). Buckman discloses the obturator 20 can taper. If it would not be known that the obturator 20 can read on the free end portion, Buckman discloses an embodiment where the obturator (60, figure 3a, paragraph 60) for the purpose of facilitating wedging of the end of the tube into the blood vessel. It would have been obvious to one of ordinary skill in the art at the time of the invention for the first end of the conduit in figure 3a to have the tapered free end portion in order for facilitating wedging of the end of the tube into the blood vessel.
Claim 108 is rejected under pre-AIA 35 U.S.C. 103(a) as obvious over U.S. Patent Publication 2004/000153104 to Buckman in view of U.S. Patent Publication 2005/0137614 to Porter.
As to claim 108, Buckman discloses the device above but is silent about the flexible sleeve comprises a porous ingrowth layer allowing ingrowth of living tissue.
Porter teaches a similar device (connecting conduits, abstract) having a sleeve with a porous ingrowth layer allowing ingrowth of living tissue (paragraph 52) to facilitating tissue growth as desired. It would have been obvious to one of ordinary skill in the art at the time of the invention to have the flexible sleeve of Buckman comprise a porous ingrowth layer in order for facilitating tissue growth as desired.
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 101-112, 114, 115 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,389,288. Although the claims at issue are not identical, they are not patentably distinct from each other because with respect to claim 101, the reference patent claims an implantable tissue connector adapted so as to be connectable to a tubular part of living tissue within a patient's body (claim 1), comprising: a conduit (claim 1) having at least a first end (claim 1) and a second end (claim 1) and further having an outer surface (claim 1), and at least one flexible sleeve (claim 1) adapted to axially extend and closely fit around at least part of said outer surface of the conduit (claim 1), characterized in that the flexible sleeve is mounted on said outer surface either folded or rolled upon itself so that it can be unfolded or unrolled, or said flexible sleeve is mounted on the outer surface so as to be foldable upon itself (claim 1).
As to the instant application’s claim 102, see reference patent claim 2.
As to the instant application’s claim 103, 105, see reference patent claim 5.
As to the instant application’s claim 104, 106, see reference patent claim 6.
As to the instant application’s claim 107, see reference patent claim 7.
As to the instant application’s claim 108, see reference patent claim 1.
As to the instant application’s claim 109, see reference patent claim 1.
As to the instant application’s claim 110, see reference patent claim 12.
As to the instant application’s claim 111, see reference patent claim 13.
As to the instant application’s claim 112, see reference patent claim 14.
As to the instant application’s claim 114, see reference patent claim 15.
As to the instant application’s claim 115, see reference patent claim 16.
Claims 101, 103-109, 113 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 9,480,551. Although the claims at issue are not identical, they are not patentably distinct from each other because with respect to claim 101, the reference patent claims an implantable tissue connector adapted so as to be connectable to a tubular part of living tissue within a patient's body (claim 1), comprising: a conduit (claim 1) having at least a first end (claim 1) and a second end (claim 1) and further having an outer surface (claim 1), and at least one flexible sleeve (claim 11) adapted to axially extend and closely fit around at least part of said outer surface of the conduit (claim 11), characterized in that the flexible sleeve is mounted on said outer surface either folded or rolled upon itself so that it can be unfolded or unrolled, or said flexible sleeve is mounted on the outer surface so as to be foldable upon itself (claim 15).
As to the instant application’s claim 103, 105, see reference patent claim 16.
As to the instant application’s claim 104, 106, see reference patent claim 17.
As to the instant application’s claim 107, see reference patent claim 18.
As to the instant application’s claim 108, see reference patent claim 21.
As to the instant application’s claim 109, see reference patent claim 22.
As to the instant application’s claim 113, see reference patent claim 1.
Claims 102, 111, 112 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 9,480,551 in view of U.S. Patent Publication 2005/0070933 to Leiboff.
As to instant applications claim 102, the reference patent claims the device above but is silent about the material of the conduit.
Leiboff teaches a similar device having a conduit is made from a biocompatible material (paragraph 42) for the purpose of using a known material based on the intended use of the device. It would have been obvious to one of ordinary skill in the art at the time of the invention to have material of the conduit of the claimed reference patent be the material as taught by Leiboff in order for using a known material based on the intended use of the device.
As to the instant application claim 111, the reference patent claims the device above but is silent about the flexible sleeve is located proximately the first end of the conduit.
Leiboff teaches a similar having where the flexible sleeve is mounted proximately the first end of the conduit (figure 4-5, paragraph 35, 45, 50, 51, 54) for the purpose of helping to secure the tubular tissue to the conduit coupled to the first end. It would have been obvious to one of ordinary skill in the art at the time of the invention to have the flexible sleeve of the claimed reference patent be mounted proximately the first end of the conduit in order for helping to secure the tubular tissue to the conduit at the first end.
As to the instant application claim 112, the reference patent claims the device above but is silent about the first end of the conduit has a free end portion and tapers towards the edge of the free end portion.
Leiboff teaches a similar device where a first end of the conduit has a free end portion and tapers towards the edge of the free end portion (paragraph 41) for the purpose of facilitating insertion of the sleeve into tissue. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to for the reference patent to have the first end of the conduit has a free end portion and tapers towards the edge of the free end portion in order for facilitating insertion of the sleeve into tissue.
Claim 110 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 9,480,551 in view of U.S. Patent 5,865,723 to Love.
As to the instant application claim 110, the reference patent claims the device above but is silent about the flexible sleeve and conduit are fixedly connected to each other along an axially extended portion.
Love teaches a similar device (tubular prosthesis, abstract) having a layers bonded to each other axially along extending portion of the sleeve (col. 7 ll. 10-24) for the purpose of a using a known mechanism to enhance bonding of different layers. The bonding technique of Love can be applied to the connection between the conduit and sleeve of reference patent which will allow the conduit and flexible sleeve to be bonded at least a part of the axially extended portion. It would have been obvious at the time of the invention to have the flexible sleeve and conduit of the claimed reference patent be bonded along the axially extended portion as taught by Love in order for using a known mechanism to enhance bonding of different layers.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 2,453,056 to Zack, U.S. Patent 5,352,198 to Goldenberg, U.S. Patent 5,769,862 to Kammerer, and U.S. Patent 6,197,050 to Eno all disclose similar devices capable of disclosing, rendering obvious, and/or providing evidence on the claims of record.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached on Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771