DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
1. Claims 30-49 are pending and currently under consideration for patentability.
Claims 1-29 are canceled as of the May 17, 2023 preliminary claim amendment.
Priority
2. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on May 17, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
4. Claims 30, 32-36, 38, 39, 42, and 45-49 are objected to because of the following informalities:
Claims 30, 32, 33, 35, 39 and 42 recite “the electromagnetic member” and “the electromagnetic members”; however, while the limitations are clear, antecedent basis is only provided for “at least one electromagnetic member” in claim 30. Therefore, each instance should be amended to --- the at least one electromagnetic member---.
Claims 33, 35, 36, 38 and 39 recite “the wire accommodating portions” and “the wire accommodating portion”; however, while the limitations are clear, antecedent basis is only provided for “a plurality of wire accommodating portions” in claim 33. Therefore, each instance should be amended to --- the plurality of wire accommodating portions---.
Claims 33, 34, 36 and 38 recite “the wire connecting portions”, “the wire connection portions” and “the wire connecting portion”; however, while the limitations are clear, antecedent basis is only provided for “a plurality of wire connecting portions” in claim 33. Therefore, each instance should be amended to --- the plurality of wire connecting portions---.
Claims 45 and 47-49 recite “the pressure sensor” and “the pressure sensors”; however, while the limitations are clear, antecedent basis is only provided for “at least one pressure sensor” in claim 44. Therefore, each instance should be amended to --- the at least one pressure sensor ---.
Claims 46 and 47 recite “the pressure sensors”; however, while the limitations are clear, antecedent basis is only provided for “a plurality of pressure sensors” in claims 46 and 47, respectively. Therefore, each instance should be amended to --- the plurality of pressure sensors ---.
Claim 34 recites “out of human body” in line 3, which appears to be a typographical error and should read as ---out of a human body---.
Claim 47 recites “a plurality of pressure sensors” in lines 6-7; however, claim 47 already provides antecedent basis for “a plurality of pressure sensors” in lines 4-5. Accordingly, the second instance should be amended to ---[[the plurality of pressure sensors ---.
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.
5. Claims 33-39 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 33 recites the limitation "the power supply wire" in line 1. There is insufficient antecedent basis for this limitation in the claim. The “power supply wire " is provided antecedent basis in claim 32; however, claim 33 depends from claim 31. For the purpose of examination, claim 33 will be treated as depending from claim 32.
Claims 34-38 are rejected for depending from claim 33.
Claim 39 recites the limitation "the wire accommodating portions" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. The “wire accommodating portions" are provided antecedent basis in claim 33; however, claim 39 depends from claim 32. For the purpose of examination, claim 39 will be treated as depending from claim 33.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
6. Claims 30-49 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 30 recites “a protective sleeve located inside a tubular tissue and positioned correspondingly to an anastomotic stoma” in lines 2-3, which positively recites “a tubular tissue” and somewhat positively recites “an anastomotic stoma” and therefore is interpreted to read on a human organism. Examiner suggests the inclusion of ---configured to--- or ---configured for--- language within the claims in order to overcome this issue. For example, this limitation should be amended to ---a protective sleeve configured to be located inside a tubular tissue and positioned correspondingly to an anastomotic stoma---.
Claim 31 recites “the plurality of electromagnetic members are arranged sequentially in a circumferential direction of the tubular tissue” in lines 2-3, which positively recites “the tubular tissue” and therefore is interpreted to read on a human organism. Examiner suggests the inclusion of ---configured to--- or ---configured for--- language within the claims in order to overcome this issue. For example, this limitation should be amended to --- the plurality of electromagnetic members are configured to be arranged sequentially in a circumferential direction of the tubular tissue---.
Claim 32 recites “a power supply wire, which surrounds the outer wall of the tubular tissue” in lines 1-2, which positively recites “the tubular tissue” therefore is interpreted to read on a human organism. Examiner suggests the inclusion of ---configured to--- or ---configured for--- language within the claims in order to overcome this issue. For example, this limitation should be amended to ---a power supply wire, which is configured to surround the outer wall of the tubular tissue ---.
Claim 34 recites “the other end of the extension portion extends out of human body” in lines 1-2, which positively recites the “human body” therefore is interpreted to read on a human organism. Examiner suggests the inclusion of ---configured to--- or ---configured for--- language within the claims in order to overcome this issue. For example, this limitation should be amended to ---the other end of the extension portion is configured to extend out of a human body ---.
Claim 39 recites “a first connector surrounding the outer wall of the tubular tissue” in lines 1-2, which positively recites “the tubular tissue” therefore is interpreted to read on a human organism. Examiner suggests the inclusion of ---configured to--- or ---configured for--- language within the claims in order to overcome this issue. For example, this limitation should be amended to ---a first connector configured to surround the outer wall of the tubular tissue---.
Claim 40 recites “a state of being connected at the first connecting structure to surround the outer wall of the tubular tissue, and another state of being disconnected at the first connecting structure to be separated from the outer wall of the tubular tissue” in lines 2-4, which positively recites “the tubular tissue” therefore is interpreted to read on a human organism. Examiner suggests the inclusion of ---configured to--- or ---configured for--- language within the claims in order to overcome this issue. For example, this limitation should be amended to ---a state of being connected at the first connecting structure configured to surround the outer wall of the tubular tissue, and another state of being disconnected at the first connecting structure configured to be separated from the outer wall of the tubular tissue---.
Claim 44 recites “a side of the first fixing assembly facing the tubular tissue” in lines 1-2, which positively recites “the tubular tissue” therefore is interpreted to read on a human organism. Examiner suggests the inclusion of ---configured to--- or ---configured for--- language within the claims in order to overcome this issue. For example, this limitation should be amended to --- a side of the first fixing assembly configured to face the tubular tissue---.
Claims 33, 35-38, 41-43 and 45-49 are rejected due to their dependency.
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.
7. Claim(s) 30, 31 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Belhe et al. (US PGPUB 2011/0106273 A1) in view of Sharkawy et al. (US PGPUB 2004/0034377 A1) in view of Heltai (US PGPUB 2011/0264184 A1).
8. With regard to claim 30, Belhe discloses gastrointestinal prostheses devices having partial bypass configurations (abstract; Fig. 1) comprising: a protective sleeve (tubular implant, e.g. sleeve, 111) located inside a tubular tissue (inside esophagus; [0034]); a first fixing assembly (external anchoring element or band, 110) provided on an outer wall of the tubular tissue (“secured or positioned around the outside of the esophagus”; [0034]), wherein the first fixing assembly (110) comprises at least one magnetic member (magnets, 135; Fig. 1; [0034]); and a second fixing assembly (self-expanding stent, 500 with magnets, 136) provided on an inner surface of the protective sleeve (111), wherein the second fixing assembly (500, 136) and the magnetic member (135) of the first fixing assembly (110) are relatively fixed by means of magnetic attraction ([0007]; [0034]; [0036]).
However, while Belhe discloses use of the device in the field of anastomosis (“Rouen-Y gastric bypass (RYGB), and the biliopancreatic diversion (BPD)”; [0003]), Belhe fails to explicitly disclose an anastomosis protection device, wherein the protective sleeve positioned correspondingly to an anastomotic stoma.
Within the same field of endeavor, magnetic coupling of implanted tubular body sleeves, Sharkawy discloses an anastomosis protection device (components, systems and methods for forming anastomoses using magnetism or other coupling means, 370; abstract; Figs. 29A, 29B; [0003]; [0014]; [0018]) comprising: a protective sleeve (tubular body, 372) positioned correspondingly to an anastomotic stoma; a first exterior magnetic fixing assembly (attachment structure, 376) and a second interior magnetic fixing assembly (adjacent magnets, 378; [0101-0102]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the gastrointestinal prostheses protective sleeve disclosed by Belhe to be an anastomosis protection device positioned correspondingly to an anastomotic stoma, similar to that disclosed by Sharkawy, in order to protect and treat a formed port in a body lumen, or repaired diseased body lumen through known and conventional means, as suggested by Sharkawy in the abstract and paragraph [0016], as well as to utilize the protective sleeve in surgical procedures that utilize anastomosis, like RYGB and/or BPD, as suggested by Belhe in paragraph [0003].
Furthermore, while Belhe discloses the first fixing assembly (110) comprises at least one magnetic member (135; [0034]), Belhe is silent in regard to the first fixing assembly comprising at least one electromagnetic member; and a power supply assembly electrically connected to the electromagnetic member, used for supplying power to the electromagnetic member, wherein the electromagnetic member is configured to become magnetic when powered on.
However, within the same field of endeavor, Heltai discloses a sleeve and tubing device for restricting and constricting aneurysms and a system and method for using such a device (abstract; Fig. 37) comprising a protective sleeve (double-walled sleeve, 610) positioned inside a body lumen (aorta, 600); and a fixing assembly comprising at least one electromagnetic member (magnets, 619); and a power supply assembly (pacemaker, 6210) electrically connected to the electromagnetic member (612), used for supplying power to the electromagnetic member (612), wherein the electromagnetic member is configured to become magnetic when powered on ([0129-0130]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the first fixing assembly disclosed by Belhe in view of Sharkawy to comprise at least one electromagnetic member electrically connected to a power supply, similar to that disclosed by Sharkawy, in order to selectively secure the protective sleeve via a generated electromagnetic field, as suggested by Heltai in paragraph [0130].
9. With regard to claim 31, Belhe, as modified by Sharkawy and Heltai above, further discloses that the first fixing assembly (110) comprises a plurality of electromagnetic members (magnets, 135; claim 15) arranged sequentially along a circumference of the tubular tissue (see expanded view of 500 in bottom left of Fig. 1); and that the second fixing assembly (500, 136) comprises a plurality of internal fixing members (magnets, 136) arranged at intervals (see expanded view of 500 in bottom left of Fig. 1), and the internal fixing members (136) are magnetic members or attractable by magnets ([0034-0036]).
However, Belhe and Heltai are silent in regard to the first fixing assembly comprising a plurality of electromagnetic members arranged at intervals, and the plurality of electromagnetic members are arranged sequentially in a circumferential direction of the tubular tissue.
Sharkawy discloses a first fixing assembly (376) comprising a plurality of electromagnetic members (378) arranged at intervals, and the plurality of electromagnetic members (378) are arranged sequentially in a circumferential direction of the tubular tissue (Figs. 29A, 29B; [0102]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the plurality of electromagnetic members disclosed by Belhe in view of Sharkawy in view of Heltai to be arranged at intervals, sequentially, in a circumferential direction of the tubular tissue, similar to that disclosed by Sharkawy, in order to allow for easy of collapse of the protective sleeve during delivery, as suggested by Sharkawy in paragraph [0102].
10. With regard to claim 41, Belhe, as modified by Sharkawy and Heltai above, discloses the power supply assembly of claim 30 (see modification via teachings of Heltai in [0129-0130]), and Heltai further discloses that an output current of the power supply assembly (6210) is regulable ([0130]).
11. Claim(s) 32, 33, 40, 42 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Belhe in view of Sharkawy in view of Heltai, as applied to claim 30 above, and further in view of Sandhu et al. (US PGPUB 2009/0118817 A1).
12. With regard to claims 32 and 40, Belhe as modified by Sharkawy in view of Heltai above, discloses the device of claim 31. While Belhe and Sharkawy each disclose the magnetic/electromagnetic members surrounding the outer wall of the tubular tissue (135 and Fig. 1 of Belhe; 376, 378 and Fig. 29A of Sharkawy), Belhe, Sharkawy and Heltai fail to explicitly disclose that the power supply assembly comprises a power supply wire, which surrounds the outer wall of the tubular tissue and is electrically connected to the electromagnetic members; wherein the power supply wire comprises a first connecting structure, the power supply wire has a state of being connected at the first connecting structure to surround the outer wall of the tubular tissue, and another state of being disconnected at the first connecting structure to be separated from the outer wall of the tubular tissue.
However, within the same field of endeavor of magnetic medical sleeve implants, Sandhu discloses a magnetic medical apparatus, kits and methods (abstract; Figs. 13, 14) comprising a protective sleeve (medical device, 1010, 1110) deployed within a body lumen (vessel, 1000) including magnetizable materials ([0148]); and a magnetic field generator (1040, 1160) connected to a power supply assembly (power source, 1046, 1164) comprising a power supply wire (electrical lead, 1044, 1162) electrically connected to the magnetic field generator (1040, 1160) and capable of surrounding the outer wall of the tubular tissue (1000; [1047-0160]); wherein the power supply wire (1044, 1162) comprises a first connecting structure (connection point to 1040, 1160), the power supply wire (1044, 1162) has a state of being connected at the first connecting structure (of 1040, 1160) capable of surrounding the outer wall of the tubular tissue (1000), and another state of being disconnected at the first connecting structure (of 1040, 1160) to be separated from the outer wall of the tubular tissue (1000; [1047-0160]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the power supply assembly disclosed by Belhe in view of Sharkawy and Heltai to include a power supply wire, similar to that disclosed by Sandhu, in order to provide electrical energy to the magnetic field generator capable of inducing magnetization to magnetizable materials of the medical implant, as suggested by Sanhu in paragraph [0152].
13. With regard to claim 33, Belhe as modified by Sharkawy in view of Heltai above, discloses the power supply wire connected to the electromagnetic members of claim 32; wherein the electromagnetic members (135) of the first fixing assembly (110) disclosed by Belhe form a circular structure surrounding the outer wall of the tubular tissue (Fig. 1; [0034]).
Belhe further discloses that the second fixing assembly (500; see expanded view in bottom left of Fig. 1) comprises a plurality of wire accommodating portions (wire portions of stent, 500 accommodating magnets, 136) and a plurality of wire connecting portions (wire portions of stent, 500 connecting adjacent accommodating portions), the wire accommodating portions surround outer sides of the magnetic members (136; Fig. 1), and the wire connecting portion is connected between two adjacent wire accommodating portions (Fig. 1), the wire accommodating portions and the wire connecting portions together form a circular structure anchoring against the inner wall of the tubular tissue (Fig. 1; [0034]).
Additionally, Belhe suggests that the first fixing assembly (110) may be in the form of stents, rings, fabric, or elastomeric cuffs ([0005]; [0007]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the first fixing assembly disclosed by Belhe in view of Sharkawy, Heltai and Sandu to take the form of a stent with a plurality of wire accommodating portions and a plurality of wire connecting portions, similar to the second fixing member disclosed by Belhe, in order to provide the first fixing assembly as a self-expanding external anchoring element that allows for attachment of electromagnets, as suggested by Belhe in paragraph [0007].
14. With regard to claims 42 and 43, Belhe as modified by Sharkawy in view of Heltai above, discloses the device of claim 41 and the power supply assembly of claim 30 (see modification via teachings of Heltai in [0129-0130] above), and Heltai further discloses that the power supply assembly (6210; Fig. 37) comprises an input power source (inherent internal batteries of pacemaker), a current regulating circuit (inherent regulating circuit of pacemaker), and a control element (inherent control element of pacemaker), the input power source (battery) fully capable of supplying power to the electromagnetic member (619) sequentially through the current regulating circuit, and the control element is fully capapble of being used for adjusting a value of an output current of the current regulating circuit ([0129-0130]); wherein the current regulating circuit comprises a transformer (‘electromagnetic field generator’), and the current regulating circuit comprises a variable resistor (inherent to pacemakers; [0129-0130]).
However, Belhe, Sharkawy and Helati are silent in regard to a power supply wire; and the current regulating circuit comprising a voltage dividing circuit or a current dividing circuit, and at least one current dividing branch in the voltage dividing circuit or the current dividing circuit comprises a variable resistor.
Sandhu discloses a magnetic medical apparatus, kits and methods (abstract; Figs. 13, 14) comprising a protective sleeve (medical device, 1010, 1110) deployed within a body lumen (vessel, 1000) including magnetizable materials ([0148]); and a magnetic field generator (1040, 1160) connected to a power supply assembly (power source, 1046, 1164) comprising a power supply wire (electrical lead, 1044, 1162) electrically connected to the magnetic field generator (1040, 1160); a current regulating circuit of the power supply assembly (power source, 1046, 1164) comprising a voltage dividing circuit or a current dividing circuit (inherent to traditional power sources), and at least one current dividing branch in the voltage dividing circuit or the current dividing circuit comprises a variable resistor (inherent to traditional power sources; [1047-0160]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the power supply assembly disclosed by Belhe in view of Sharkawy and Heltai to include a power supply wire and traditional power source components, similar to that disclosed by Sandhu, in order to provide wired electrical energy to the magnetic field generator capable of inducing magnetization to magnetizable materials of the medical implant, as suggested by Sandhu in paragraph [0152].
15. Claim(s) 34-39 are rejected under 35 U.S.C. 103 as being unpatentable over Belhe in view of Sharkawy in view of Heltai in view of Sandhu, as applied to claim 33 above, and further in view of Hernandez et al. (CN 103930049 A).
16. With regard to claim 34, Belhe as modified by Sharkawy in view of Heltai and Sandhu above, discloses the device and power supply wire of claim 33; wherein Sandhu clearly discloses one end of the power supply wire connecting to the magnetic field generator, and one end extending out of a human body (Figs. 13, 14; [0152]).
However, Belhe, Sharkawy, Heltai and Sandhu are silent in regard to the power supply wire further comprises an extension portion, one end of the extension portion is connected to the wire connection portions.
Within the same field of endeavor, Hernandez discloses a modular magnetic anastomosis device (abstract; Figs. 1-10 and 21-25) comprising a chain of magnets (3), a flexible neck (2) an elastic housing (1; [0061]), and a wire guide (4), extending out of a human body ([0063]); wherein the wire guide (4) comprises an extension portion (wire guide, 5), one end of the extension portion (5) is connected to a plurality of wire connection portions (wire guide, 6; [0065]; Fig. 23).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the power supply wire disclosed by Belhe in view of Sharkawy, Heltai and Sandhu, to include an extension portion connected to the wire connection portions, similar to that disclosed by Hernandez, in order to more readily deliver and deploy the first fixing assembly around the tubular tissue, as suggested by Hernandez in paragraph [0063], and to provide a direct electrical connection between the power supply wire and each of the electromagnetic members, as suggested by Sandhu in paragraph [0152].
17. With regard to claims 35 and 37, Belhe as modified by Sharkawy in view of Heltai and Sandhu above, discloses the device and power supply wire of claim 33; wherein Belhe discloses a plurality of wire accommodating portions and a plurality of wire connecting portions (see rejection to claim 33 above).
However, Belhe, Sharkawy, Heltai and Sandhu fail to explicitly disclose that an outer side of the magnetic member is provided with a first mounting groove in a circumferential direction of the electromagnetic member, and the wire accommodating portion of the power supply wire is embedded in the first mounting groove; or, an inner side of the wire accommodating portion of the power supply wire is provided with a first mounting groove in a circumferential direction of the wire accommodating portion, and the electromagnetic member is embedded in the first mounting groove; wherein the power supply wire is elastic.
Hernandez discloses that an inner side of the wire accommodating portion (formed between 2) of the wire guide (4, 5) is provided with a first mounting groove (within 2) in a circumferential direction of the wire accommodating portion (2), and the magnetic member (3) is embedded in the first mounting groove (within 2; Figs. 1-3, 10, 11, 21, 23, 25; [0077]; [0014]; [0065]; [0068]); wherein elastic wire materials are suggested ([0049]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the wire accommodating portion disclosed by Belhe in view of Sharkawy, Heltai and Sandhu, to include a first mounting groove, similar to that disclosed by Hernandez, in order to provide the electromagnetic members with an elastic and biocompatible jacket having a low coefficient of friction, which allows the device to be easily moved during operation, as suggested by Hernandez in paragraph [0061].
Additionally, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the power supply wire disclosed by Belhe in view of Sharkawy, Heltai and Sandhu, to be elastic, similar to that disclosed by Hernandez, in order to utilize suitable elastic biocompatible materials that may employ shape memory properties as is well-known to those having ordinary skill in the art, as suggested by Hernandez in paragraph [0049].
18. With regard to claim 36, Belhe as modified by Sharkawy in view of Heltai, Sandhu and Hernandez above, discloses the device and power supply wire of claim 35; wherein Belhe discloses a plurality of wire accommodating portions and a plurality of wire connecting portions (see rejection to claim 33 above).
However, Belhe, Sharkawy, Heltai, Sandhu and Hernandez are silent in regard to a width of the wire accommodating portion is greater than a width of the wire connecting portion, and/or a thickness of the wire accommodating portion is greater than a thickness of the wire connecting portion.
Nevertheless, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the width of the wire accommodating and wire connecting portions disclosed by Belhe in view of Sharkawy, Heltai, Sandhu and Hernandez, so that a width of the wire accommodating portion is greater than a width of the wire connecting portion, and/or a thickness of the wire accommodating portion is greater than a thickness of the wire connecting portion, in order to provide additional support to the portions holding the magnets, while maintaining thin enough wire connecting portions to readily allow for expansion/contraction of the first fixing assembly, with a reasonable expectation of success. Additionally, it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04(IV)(A).
19. With regard to claim 38, Belhe as modified by Sharkawy in view of Heltai, Sandhu and Hernandez above, discloses the device and power supply wire of claim 37; wherein Belhe discloses a plurality of wire accommodating portions and a plurality of wire connecting portions (see rejection to claim 33 above), and Hernandez discloses the housing (1) and wire accommodating portions (2) as being elastic ([0049]; [0061]; [0065]).
However, Belhe, Sharkawy, Heltai, Sandhu and Hernandez are silent in regard to an elasticity of the wire connecting portion is greater than an elasticity of the wire accommodating portion.
Nevertheless, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the elasticity of the wire accommodating and wire connecting portions disclosed by Belhe in view of Sharkawy, Heltai, Sandhu and Hernandez, so that the elasticity of the wire connecting portion is greater than an elasticity of the wire accommodating portion, in order to provide additional support to the portions holding the magnets, while maintaining elastic enough wire connecting portions to readily allow for expansion/contraction of the first fixing assembly, with a reasonable expectation of success; and to utilize suitable elastic biocompatible materials that may employ shape memory properties as is well-known to those having ordinary skill in the art, as suggested by Hernandez in paragraph [0049].
20. With regard to claim 39, Belhe as modified by Sharkawy in view of Heltai and Sandhu above, discloses the device and power supply wire of claim 33; wherein Belhe discloses a plurality of wire accommodating portions and a plurality of wire connecting portions (see rejection to claim 33 above).
However, Belhe, Sharkawy, Heltai and Sandhu fail to explicitly disclose that the first fixing assembly further comprises a first connector surrounding the outer wall of the tubular tissue, the first connector comprises a plurality of first accommodating portions being configured to accommodate the electromagnetic members and a plurality of first connecting portions, the first connecting portion is connected between two adjacent first accommodating portions, the first accommodating portions surround outer sides of the wire accommodating portions.
Hernandez discloses a first connector (biodegradable elastic material, 1; Figs. 21, 24) surrounding the outer wall of the tubular tissue, the first connector (1) comprises a plurality of first accommodating portions being (2) configured to accommodate the magnetic members (3) and a plurality of first connecting portions (spring or biocompatible material connectors, 4; see Figs. 19-25), the first connecting portion (4) is connected between two adjacent first accommodating portions (2), the first accommodating portions (2) surround outer sides of the wire accommodating portions (2; Figs. 1-3, 10, 11, 19, 20, 21, 23, 25; [0077]; [0014]; [0065]; [0068]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the plurality of wire accommodating portions disclosed by Belhe in view of Sharkawy, Heltai and Sandhu, to include a plurality of first connecting portions, similar to that disclosed by Hernandez, in order to provide the electromagnetic members with an elastic and biocompatible jacket having a low coefficient of friction, which allows the device to be easily moved during operation, as suggested by Hernandez in paragraph [0061].
21. Claim(s) 44-47 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Belhe in view of Sharkawy in view of Heltai in view of Sandhu, as applied to claim 42 above, and further in view of Kassab et al. (US PGPUB 2008/0300672 A1).
22. With regard to claims 44 and 45, Belhe as modified by Sharkawy in view of Heltai and Sandhu above, discloses the device of claim 42; and Sharkawy and Sandhu each suggesting the supplying of a power supply current, a signal processing assembly used for determining a power supply current value, and that the power supply assembly is configured to be used for sending a driving signal comprising the power supply current value to the power supply assembly and to control a value of an output current based on the power supply current value (see above equated power supply assemblies, above).
However, Belhe, Sharkawy, Heltai and Sandhu fail to explicitly disclose a signal acquisition assembly, wherein the signal acquisition assembly comprises at least one pressure sensor arranged on a side of the first fixing assembly facing the tubular tissue and/or a side of the second fixing assembly facing the protective sleeve; wherein the device further comprises a signal processing assembly used for determining a power supply current value based on a predetermined power supply current change period, and/or determining the power supply current value based on detection data of the pressure sensor.
Within the same field of endeavor, Kassab discloses devices and methods for magnetic tissue support (abstract; Figs. 1, 3B, 5) comprising a graft assembly (500; Fig. 5), which includes a protective sleeve (aneurysmic sack, 521), a first fixing assembly comprising magnetic bodies (510), a second fixing assembly comprising a magnetic polymer graft (511), and a signal acquisition assembly (pressure sensor, 518 and “wireless communication system”, not shown), wherein the signal acquisition assembly comprises at least one pressure sensor (518) arranged on a side of the second fixing assembly (511) facing the protective sleeve (521; [0061]); wherein the device further comprises a signal processing assembly (“external telemetry monitoring system”, not shown) used for determining whether or not a successful deployment of the implant has been achieved based on detection data of the pressure sensor (518; [0062]); the signal processing assembly (“external telemetry monitoring system”, not shown) is further used for sending a signal (“indication”; [0062]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device disclosed by Belhe in view of Sharkawy, Heltai and Sandhu, to include a pressure sensor to be in communication with a signal processing assembly, similar to that disclosed by Kassab, in order to monitor deployment of the device and indicate whether or not a successful deployment of the implant has been achieved based on detection data of the pressure sensor, as suggested by Kassab in paragraph [0062].
23. With regard to claim 46, Belhe as modified by Sharkawy in view of Heltai, Sandhu and Kassab above, discloses the device, the power supply assembly, the pressure sensor and the signal processing assembly of claim 45 (see rejection above).
However, Belhe, Sharkawy, Heltai, Sandhu and Kassab fail to explicitly disclose a plurality of pressure sensors, the power supply assembly comprises a plurality of electromagnetic driving modules provided correspondingly to the pressure sensors, and the signal processing assembly is configured to determine a power supply current value of the electromagnetic driving module based on the detection data of the corresponding pressure sensor, and send a driving signal comprising the power supply current value to the corresponding electromagnetic driving module.
Nonetheless, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device disclosed by Belhe in view of Sharkawy, Heltai, Sandhu and Kassab to include a plurality of pressure sensors and electromagnetic driving modules corresponding to each pressure sensor, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Additionally, one having ordinary skill in the art would have recognized that the addition of more pressure sensors and associated electromagnetic driving modules would allow for more localized indications as to where the improper deployment of magnetized coupling is located.
24. With regard to claim 47, Belhe as modified by Sharkawy in view of Heltai, Sandhu and Kassab above, discloses the device, the power supply assembly, the pressure sensor and the signal processing assembly of claim 45 (see rejection above). Further, Kassab discloses that the signal processing assembly (not shown) is further used for comparing the detection data of the pressure sensors (518; Fig. 5) with a preset reference value, and determining whether to provide an indication based on comparison results ([0062]).
However, Belhe, Sharkawy, Heltai, Sandhu and Kassab fail to explicitly disclose the act of alarming based on comparison results.
Nonetheless, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the signal processing assembly disclosed by Belhe in view of Sharkawy, Heltai, Sandhu and Kassab to provide an alarm based on comparison results, similar to the indication disclosed by Kassab, in order to utilize visual or audible indications to a surgeon as to whether or not a successful deployment of the implant has been achieved, as suggested by Kassab in paragraph [0062]. Additionally, one having ordinary skill in the art would recognize the benefits of alarm indicators for alerting to undesirable or possibly dangerous situations.
25. With regard to claim 49, Belhe as modified by Sharkawy in view of Heltai, Sandhu and Kassab above, discloses the device, the power supply assembly, the pressure sensor and the signal processing assembly of claim 45 (see rejection above). Heltai and Sandhu disclose that the signal processing assembly (620 of Heltai) transmits data with the power supply assembly (620 of Heltai; 1046, 1164 of Sandhu) through wireless communications and signal wire connections, respectively. Further, Kassab discloses that the signal processing assembly (not shown) transmits data with the pressure sensor (518; Fig. 5) through wireless communication ([0062]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the signal processing assembly disclosed by Belhe in view of Sharkawy, Heltai, Sandhu and Kassab to transmit data with both the power supply assembly and the pressure sensor, similar to the indication disclosed by Heltai and Kassab, in order to monitor deployment of the device and indicate whether or not a successful deployment of the implant has been achieved based on detection data of the pressure sensor, as suggested by Kassab in paragraph [0062]; and to selectively control strength of electromagnetic field delivered to the first fixing assembly, as suggested by Heltai in paragraph [0131].
26. Claim(s) 48 is rejected under 35 U.S.C. 103 as being unpatentable over Belhe in view of Sharkawy in view of Heltai in view of Sandhu in view of Kassab, as applied to claim 45 above, and further in view of Boyden et al. (US PGPUB 2009/0104250 A1).
27. With regard to claim 48, Belhe as modified by Sharkawy in view of Heltai, Sandhu and Kassab above, discloses the device of claim 45 (see rejection above).
However, Belhe, Sharkawy, Heltai, Sandhu and Kassab are silent in regard to a display module for displaying the detection data of the pressure sensor and/or a value of the output current of the power supply assembly.
Within the same field of endeavor, Boyden discloses medical digestive tract utilization systems and methods (abstract; Figs. 1, 4, 10, 21, 24) comprising a display module (one or more user interfaces, 2110 including “video display”; [0093]; [0129]) for displaying detection data of a pressure sensor (2487; [0102]; [0118]) and/or a value of the output current of the power supply assembly ([0024]; [0028]; [0107-0108]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device disclosed by Belhe in view of Sharkawy, Heltai, Sandhu and Kassab to further include a display module, similar to that disclosed by Boyden, in order to visually convey monitoring data and information to an external module to be interacted with by a surgeon, as suggested by Boyden in paragraph [0020].
Conclusion
28. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chun (US PGPUB 2009/0143793) discloses a connector for surgical anastomosis.
Connor (US PGPUB 2014/0275747) discloses an adjustable GI bifurcation.
29. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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/ANDREW J MENSH/ Primary Examiner, Art Unit 3781