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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/30/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4, 6-11, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Shohat et al (US 2013/0116794 A1).
Regarding claim 1, Shohat discloses a method for treating rotator cuff injuries (see Shohat, paragraph 0099) comprising the steps of
providing a trilobe inflatable implant (see Shohat, Figures 8B-C depict a trilobe inflatable implant, where a lobe is defined as “a curved or rounded projection or division”, Figure 8C depicts three curved divisions of the inflatable implant; paragraph 0177))
providing an implant placement tool (see Shohat, Figures 10A-D, item 1000; paragraph 0191);
attaching said trilobe inflatable implant to said implant placement tool (Figures 10A-D shows trilobe inflatable implant (1002, 1004, and 1010) attached to said implant placement tool 1000, through sheath 1030 and inflation tube 1032);
Inflating the implant [0194];
inserting said trilobe inflatable implant into a shoulder area of a patient with said implant placement tool (Figures 10A-D, paragraph 0191);
removing said implant placement tool from said sealed inflated trilobe implant (Figures 8A-B, item 826 depicts a port for inflation and paragraph 0194 discloses inflating trilobes; paragraph 0045 and 0102 discloses sealing means for the inflated trilobe implant); and
removing said implant placement tool from said shoulder area of said patient (Figures 10A-D, implant placement tool is removed after inflation is completed).
The embodiment of Figures 8B-C of Shohat does not specifically disclose wherein the trilobe implant is rolled.
However, the Figures of 9B-C of Shohat discloses wherein the trilobe implant is rolled for placement within a delivery sheath (see Shohat, paragraph 0180).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the trilobe implant of Figures 8B-C wherein the trilobe implant is rolled, as taught by the embodiment of Figures 9B-C, because rolling up the inflatable trilobe implant allows it to be delivered in a compressed manner through a sheath. This allows for minimally invasive delivery.
Regarding claim 4, Shohat discloses further comprising a step of holding said Inflated trilobe implant in place with a shoulder area chosen from acromion, deltoid, coracoacromial ligament, coracoid, glenoid, humerus, and any combination thereof (Figures 10A-D, paragraph 0191 discloses that part of the inflated trilobe implant is held in the subacromial space, between the acromion and humerus).
Regarding claim 6, Shohat discloses wherein said step of inflating said rolled trilobe inflatable implant to create said inflated trilobe implant comprises a step of inflating said rolled trilobe inflatable implant with a predetermined amount of a filler located in said implant placement tool (Figure 10D, paragraph 0194 discloses inflating rolled trilobe inflatable implant with a predetermined amount of filler located in implant placement tool, through inflation tubes 1032 and 1034).
Regarding claim 7, Shohat discloses wherein said filler comprises a substance chosen from saline, biologics, antibiotics, inflatable liquid, paste, gas, and any combination thereof (see Shohat, paragraph 0059).
Regarding claim 8, Shohat discloses further comprising a step of deflating said inflated trilobe implant (paragraphs 0193 discloses that the inflation tube allows for inflation and deflation of trilobe inflatable implant).
Regarding claim 9, Shohat discloses further comprising a step of providing a sheath (see Shohat, paragraph 0130 and 0180 disclose the rolled implant in a sheath) over said rolled trilobe inflatable implant prior to being inserted in said shoulder area of said patient (Figure 9B and paragraph 0180 discloses wherein the rolled implant is provided in a sheath prior to insertion in the shoulder area).
Regarding claim 10, Shohat discloses further comprising a step of removing said sheath from said rolled trilobe inflatable implant with said implant placement tool after said step of inserting said rolled trilobe inflatable implant into said shoulder area of said patient (Figures 10A-D, item 1030 “sheath” depicts removing the sheath from the rolled trilobe inflatable implant (when the rolled implant taught in Figures 9A-I are residing in combination with the trilobe inflatable implant of steps of Figures 10A-D), after inserting the trilobe inflatable implant into the shoulder area of the patient).
Regarding claim 11, The embodiment of Figures 10A-D of Shohat does not specifically discloses further comprising a step of repositioning said sealed inflated trilobe implant.
The embodiment of Figures 3A-D discloses further comprising a step of repositioning said sealed inflated trilobe implant (see Shohat, paragraph 0135 discloses the step of imaging and repositioning the sealed inflated trilobe implant).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the method of Figures 10A-D by further comprising a step of repositioning said sealed inflated trilobe implant as taught by the method of Figures 3A-D because imaging and repositioning the sealed inflated trilobe implant fine-tunes the implant such that the implant characteristics are matched to the particular patient's need (see Shohat, paragraph 0135).
Regarding claim 15, the embodiment of Figures 8A-C of Shohat does not disclose wherein said rolled trilobe inflatable implant is made of a material chosen from bioabsorbable material and a non-absorbable material.
Figure 7 of Shohat discloses wherein said rolled trilobe inflatable implant is made of a material chosen from bioabsorbable material and a non-absorbable material (see Shohat, Figure 7, paragraph 0114 discloses bioabsorbable and non-absorbable materials for the implant; paragraph 0168 states “The mechanical properties of the two sections may be different, for example, being different wall thicknesses, different inflation properties, different biodegradability and/or permanency properties and/or different adherence properties”, differing the biodegradability and permanency of the two sections would result in the trilobe inflatable implant being made of a material from bioabsorbable and non-bioabsorbable materials).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claim invention to modify the embodiment of Figures 8A-C of Shohat by providing wherein said rolled trilobe inflatable implant is made of a material chosen from bioabsorbable material and a non-absorbable material, as taught by the embodiment of Figure 7, of Shohat because this allows for two sections of an implant with different properties treating two separate deficiencies, such as a synovium simulating portion (or for otherwise treating a glenohumeral joint) and a bursa simulating portion (or for otherwise protecting a tendon from contact with bone), located and allowing frictionless movement between a hard tissue and a soft tissue (such as between the acromion and the biceps tendon) and/or between two hard tissues (such as between the acromion and the humerus) (see Shohat, paragraph 0168).
Regarding claim 16, Shohat discloses further comprising a step of sizing said shoulder area of said patient and determining an amount of said filler to be inserted into said rolled trilobe inflatable implant (see Shohat, paragraph 0120).
Regarding claim 17, Shohat discloses a rotator cuff injury treatment apparatus (see Shohat, paragraph 0099) comprising:
a trilobe inflatable implant (see Shohat, Figures 8B-C depict a trilobe inflatable implant, where a lobe is defined as “a curved or rounded projection or division”, Figure 8C depicts three curved divisions of the inflatable implant; paragraph 0177));
an implant placement tool configured (see Shohat, Figures 10A-D, item 1000; paragraph 0191) to insert said trilobe inflatable implant into a shoulder area of a patient (Figures 10A-D, paragraph 0191) and configured to inflate said trilobe inflatable implant (Figure 10D, paragraph 0194 discloses inflating rolled trilobe inflatable implant with a predetermined amount of filler located in implant placement tool, through inflation tubes 1032 and 1034);
and a seal for said rollable trilobe inflatable implant (paragraph 0045 and 0102 discloses sealing means for the inflated trilobe implant).
The embodiment of Figures 8B-C of Shohat does not specifically disclose wherein the trilobe implant is rolled.
However, the Figures of 9B-C of Shohat discloses wherein the trilobe implant is rolled (see Shohat, paragraph 0180).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the trilobe implant of Figures 8B-C wherein the trilobe implant is rolled as taught by the embodiment of Figures 9B-C because rolling up the inflatable trilobe implant allows it to be delivered in a compressed manner through a sheath. This allows for minimally invasive delivery.
Claims 2-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Shohat et al (US 2013/0116794 A1) as applied to claims 1 and 4, and further in view of Morris et al (US 2016/0256286 A1).
Regarding claim 2, Shohat discloses the rolled trilobe inflatable implant (see Shohat, Figures 3A-C) and tabs and anchors for securement in the shoulder (see Shohat, Figure 5B; paragraph 0149).
However, Shohat does not specifically disclose further comprising a step of securing part of said rolled trilobe inflatable implant to an acromion and a coracoid process of said shoulder area with a securement.
Morris discloses an inflatable implant (Figures 7A-B, 9; paragraphs 0041 and 0051) further comprising a step of securing part of said inflatable implant(when the rolled trilobe inflatable implant of Shohat is residing in combination with the inflatable implant of Morris) to an acromion and a coracoid process of said shoulder area with a securement (see Morris, Figure 9 depicts tabs 50 which a suture 50 may be threaded for securing the inflatable implant 52 to the acromion and coracoid process (claims 13-14)
Morris does not specifically state that the suture is secured to the acromion and coracoid process, however, it discloses a method of securing and that the method of securing is proximal to the acromion and coracoid process, therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to comprise a step of securing part of said rolled trilobe inflatable implant to an acromion and a coracoid process of said shoulder area with a securement, as taught by Morris, because this will maintain the implant in a desired spatial location (see Morris, paragraph 0013).
Regarding claim 3, as set forth supra, the combination discloses wherein said securement is chosen from adjustable loop tensioning sutures, tapes, bands, and any combination thereof (see Morris, Figure 9, item 50 “sutures”; paragraph 0045).
Regarding claim 5, Shohat discloses the rolled trilobe inflatable implant (see Shohat, Figures 3A-C) and tabs and anchors for securement in the shoulder (see Shohat, Figure 5B; paragraph 0149).
However, Shohat does not specifically disclose further comprising a step of securing each of three lobes of said inflated trilobe implant with different parts of said shoulder area chosen from acromion, deltoid, coracoacromial ligament, glenoid, humerus, and coracoid.
Morris discloses an inflatable implant (Figures 7A-B, 9; paragraphs 0041 and 0051) further comprising a step of securing part inflatable implant (when the three lobes of inflated trilobe implant of Shohat is residing in combination with the inflatable implant of Morris) with different parts of said shoulder area chosen from acromion, deltoid, coracoacromial ligament, glenoid, humerus, and coracoid (see Morris, Figure 9 depicts tabs 50 which a suture 50 may be threaded for securing the inflatable implant 52 to different parts of said shoulder area chosen from acromion, deltoid, coracoacromial ligament, glenoid, humerus, and coracoid (claims 13-18).
Morris does not specifically state that the suture is secured to the with different parts of said shoulder area chosen from acromion, deltoid, coracoacromial ligament, glenoid, humerus, and coracoid, however, it discloses a method of securing and that the method of securing is proximal to the different parts of said shoulder area chosen from acromion, deltoid, coracoacromial ligament, glenoid, humerus, and coracoid, therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to comprise a step of securing each of three lobes of said inflated trilobe implant with different parts of said shoulder area chosen from acromion, deltoid, coracoacromial ligament, glenoid, humerus, and coracoid, as taught by Morris, because this will maintain the implant in a desired spatial location (see Morris, paragraph 0013).
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Shohat et al (US 2013/0116794 A1) in view of Tytgadt et al (EP 1820473).
Regarding claim 12, Shohat discloses the step of sealing said inflated trilobe implant.
However, Shohat does not disclose wherein said step of sealing said inflated comprises a step of sealing said inflated implant with a cork.
Tytgadt discloses an inflatable implant (Figure 4a depicts an inflatable implant; paragraph 0006 discloses an implant, paragraph 0008 discloses inflating the implant with fluid) said step of sealing said inflated implant comprises a step of sealing said inflated implant with a cork (Figures 2 and 4a depicts a cork (i.e. plug) for sealing the inflated implant (paragraph 0003, column 2, lines 10-19, paragraph 0016, wherein the definition of a cork is “A bottle stopper made of other material, such as plastic” (American Heritage Dictionary)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the sealing means of the inflated trilobe implant of Shohat by providing wherein said step of sealing said inflated comprises a step of sealing said inflated implant with a cork as taught by Tytgadt because this allows the sealing means to be open and closed multiple times to adjust inflation levels (see Tytgadt, column 9, lines 1-10).
Regarding claim 13, as set forth supra, the combination discloses further comprising a step of final locking said sealed trilobe implant by securing distal threads of said cork into an aperture of said trilobe implant (see Tytgadt, Figures 2 and 4a depicts a plug secured into an aperture of the implant, the cork (i.e. plug) would be threaded into the trilobe implant, when the trilobe implant of Shohat is residing in combination with the inflatable implant of Tytgadt, paragraphs 0003, column 2, lines 10-19, and paragraph 0016 “screw system” discloses distal threads on the cork).
Regarding claim 14, as set forth supra, the combination discloses wherein said step of removing said implant placement tool from said sealed inflated trilobe implant comprises a step of rotating said implant placement tool until a tip unthreads from said cork (when the sealed inflated trilobe implant of Shohat is residing in combination with the inflated implant of Tytgadt, the handle disclosed in Figures 2 and 4a of Tytgadt (i.e. implant placement tool) would be removed by rotating until a tip unthreads from said cork (i.e. plug) (see Tytgadt, Figure 2, paragraph 0017)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA LYNEE ZIMMERMAN whose telephone number is (313)446-4864. The examiner can normally be reached Mon. 8:30 AM-6:30 PM, Tues. - Fri. 8:30-4:00 PM.
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/REBECCA LYNEE ZIMMERMAN/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774