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 § 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.
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.
Claim(s) 1, 4-5, 7-8, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over in view of Dlugos (US 2011/0040313) in view of Wiley (US 2007/0250086) further in view of Andrade (US 2018/0161138).
Regarding claim 1, Dlugos teaches a band-shaped medical device (as seen in Fig. 8) for
narrowing a body channel of a patient, the device being placeable around body tissue surrounding the body channel the device (paragraph [0002] "the invention relates to the protection of both the implantable restriction device and internal tissue or lumen, such as, stomach tissue,") comprising:
a first section (Fig 9, highlighted red section)
a second section having a lower Shore A hardness compared to the first silicone composition (Figs. 9, highlighted yellow section, element 542. paragraph [0055] “ The standoffs 542 as disclosed in accordance with this embodiment would be of a different durometer (higher or lower) “;
a connecting section which integrally bonds the first section to the second section (figure 9, highlighted green section. paragraph [0055] “These features may be overmolded onto the balloon 520 so that no extra connection points or attachments would be needed” The examiner notes that if the element 542 is overmolded onto element 520, there is a connecting section between the two sections as no extra attachment or connection points would be needed.);
and the first section and the second section having a first locking part and a second locking part, respectively, by which the device is closable to form a ring which encircles a passage opening for the body tissue surrounding the body channel (figure 9, first section has a male locking part, second section has a female locking part.)
wherein the first section. the connecting section. and the second section are arranged successively in a longitudinal direction of the band-shaped device (figure 9, element 520 and 542 are arranged along the length of the gastric belt, thus making the first, connecting, and second section arranged successively in the longitudinal direction. The examiner notes that all three sections have a section made of one material (520), second material (542) and a connecting portion between the two.):
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However, Dlugos fails to teach that each section is made of a silicone composition.
Wiley teaches a gastric belt with a balloon that is made of a silicone composition. (paragraph [0057] “The balloon 414 is composed of a biocompatible material, preferably silicone, and has a durometer of between approximately 45 and approximately 55, preferably approximately 50. The use of a softer material for the balloon 414 allows more compliance of the system and improves the reliability of the balloon 414 as it is cycled,” The examiner is modifying elements 520 and 542 to be made of a silicone composition, as taught by Wiley. This would create a first section with a silicone composition, second section with a silicone composition having a lower durometer (hardness), and connecting section made of the first and second silicone composition.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify Dlugos in view of Wiley. One of ordinary skill in the art would have been able to recognize that silicone is a biocompatible material that would allow for safe implantation of the belt in patient.
However, both Dlugos and Wiley fail to teach that the connecting section has a length of at least 1mm measured in the longitudinal direction of the band-shaped device.
Andrade teaches an implantable restrictive band with connecting sections 1 inch long (Fig. 2, element 120. paragraph [0024] “Where the fastener section is 1 inch in length, the middle section 110 is 8 inches in length. The ribbed section 108 is 5 inches in length and the engagement member 128 is 1 inch in length.”)
It would be prima facie obvious to modify the connecting section taught by Dlugos and Wiley in view of Andrade. One of ordinary skill would have been able to recognize that even though where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Please see MPEP 2144, section II, A; in re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); and in re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997).
Regarding claim 4, Dlugos and Wiley teach the device of claim 1, and Dlugos further teaches wherein the first locking part has an insertion opening. (Fig. 2, elements 22, 24. paragraph [0044] “The first and second ends 22, 24 of the belt 18 respectively act as both male and female members depending on the direction of motion and intent to lock or unlock the latching mechanism of the present gastric band 10.” The examiner notes element 24 having an insertion opening.)Regarding claim 5, Dlugos and Wiley teach the device of claim 4, wherein the second locking part is insertable (Fig. 2, elements 22, 24. paragraph [0044] “The first and second ends 22, 24 of the belt 18 respectively act as both male and female members depending on the direction of motion and intent to lock or unlock the latching mechanism of the present gastric band 10.” The examiner notes element 26 as insertable) into the insertion opening and is latchable with respect to the first locking part in a closed state (The examiner notes that the art states the intention is to lock the latching mechanism, therefore putting the belt in closed state).
Regarding claim 7, Dlugos teaches the device of claim 1, but fails to teach further comprising a third section formed of a third silicone composition and an additional connecting section which integrally bonds the third section to the second section, the additional connecting section consisting of a mixture of the second silicone composition and the third silicone composition.
However, Wiley teaches a silicone gastric band of variable hardness with an extender (Fig 2, element 100) made of silicone (paragraph [0092] “the flexible silicone extender”) that connects to the gastric band (as shown in fig. 1, paragraph [0082] “The tether strap 108 is shaped and dimensioned for passage through the aperture 38 formed in the tab 24 and ultimate attachment within a coupling indent 110 formed in the outer surface of the first end 102 of the extender 100. In this way, the tether strap 108 extending from the extender 100 loops through the tab 24 readily coupling the first end 102 of the extender 100 to the first latching member 22 for selective attachment and detachment.” And paragraph [0039] “The extender 100 is removable with one cut through the tether strap 108 on the extender 100 and incorporates a recess or an open recess, for example, a cuplike feature, 106 for coupling the first end 14 of gastric band 10 and extender 100 close together so as to move as an integral unit.”) The examiner is interpreting this extender to be a third section formed of a third silicone composition section and the connecting section to be where the gastric belt and extender are bonded to each other (element 106). Since the gastric belt and the extender are made of two different silicone compositions, the connecting section is being interpreted to be made of a second and third silicone composition. The examiner is interpreting being able to “move as integral unit” as the extender (third section) and the belt (second section) being integrally bonded to each other.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the gastric band taught in Dlugos to have this third section taught in Wiley. One of ordinary skill in the art would have been able to recognize that adding a third section to the gastric band that is removable in some capacity by the surgeon after implantation is a known technique in the art of gastric bands. The claimed device is applying this known technique and would have yielded the predictable results of having a gastric band that would allow for a temporary locking mechanism while the surgeon determines the final size prior to tearing off the extra third section.
Regarding claim 8, Dlugos and Wiley teach the device of claim 8, and Wiley further teaches wherein the first locking part has an insertion opening, and the third section forms a band-shaped manipulation section for passing the second locking part through the insertion opening. (fig. 3 shows the band with the extender in a closed or locked position. Paragraph [0038] “In practice, and with reference to FIG. 3, the present suture tab extender 100 is secured to the first end 14 of the gastric band 10 adjacent the first latching member 22 to form a single band/extender functional unit. Thereafter, the gastric band 10, with the extender 100 secured thereto, is inserted behind the stomach. The first latching member 22 of the latching mechanism 20, as well as the extender 100, are then pushed or pulled through the second latching member 26 of the latching mechanism 20.”)
It would be prima facie obvious to modify the device taught by Dlugos and Wiley to have the extender manipulate the band as taught by Wiley. One of ordinary skill in the art would have been able to recognize that the addition of the present suture tab extender 100 provides a longer region for grasping and manipulation of the first latching member 22 as it is passed about the stomach and through the second latching member 26. See paragraph [0038] of Wiley.
Regarding claim 10, Dlugos and Wiley teach the device of claim 1 and Dlugos to teach wherein the device is formed as a single piece. (The examiner notes that the band is made of one piece in that no parts are disconnectable from the band.)
Claim(s) 2, is/are rejected under 35 U.S.C. 103 as being unpatentable over Dlugos in view of Wiley further in view of Andrade further in view of Benchetrit (US 2005/0119672), as cited in the applicant’s IDS.
Regarding claim 2, Dlugos and Wiley teach the device of claim 1 but fail to teach wherein the second silicone composition has a Shore A hardness lower at least by a value of 15 compared to the first silicone composition.
However, Benchetrit teach a gastric band wherein the second silicone composition has a Shore A hardness lower at least by a value of 15 compared to the first silicone composition. (Paragraph [0056] “Advantageously, the value of d1 lies in the range 65 to 85 on the Shore A scale, with the value of d2 lying in the range 25 to 45 on the Shore A scale. In particularly advantageously manner, the value of d1 is about 80 on the Shore A scale and the value d2 is about 30 on the Shore A scale.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the device taught by Dlugos and WIley in view of Benchetrit. One of ordinary skill in the art would have been able to recognize that the feet or ribs provide a stronger material and/or a separation of the staple line from the fluid filled balloon 520 and reduce the potential for reduction of slippage and maintain effective restriction of current bands. See paragraph [0055] of Dlugos.
Claim 3, 9 is rejected under 35 U.S.C. 103 as being unpatentable over Dlugos in view of Wiley further in view of Andrade further in view of Bertolote (US 2010/0087843).
Regarding claim 3, Dlugos and Wiley teach the device as claimed in claim 1, but fails to teach wherein the first silicone composition has a Shore A hardness in a range from 30 to 70, and the second silicone composition has a Shore A hardness in a range from 2 to 15.
However, Bertolote teaches a molded silicone gastric band with two different sections of varying stiffness. (Paragraph [0130] “In a specific embodiment, cushions 1016 are made of silicone elastomer having a hardness of 10 Shore A and membrane 1014 is made of silicone elastomer having a hardness of 30 Shore A”) The examiner is interpreting the gastric band taught in Benchetrit would be modified to have the inner surface/second silicone modified to have a shore A hardness of 10 (like the cushions taught in Bertolote) and the outer surface/first silicone to have a shore A hardness of 30 (like the membrane taught in Bertolote).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the gastric band taught in Dlugos and Wiley to have the shore A hardness of Bertolote. One of ordinary skill in the art would have been able to recognize that a gastric band with sections of lower hardness would provide less inflammation / irritability when implanted in the patient.
Regarding claim 9, Dlugos and Wiley teach the device of claim 7 but fails to teach wherein the third silicone composition has a Shore A hardness in a range from 30 to 70.
However, Bertolote teaches a molded silicone gastric band of varying stiffness with one range within the claimed Shore A hardness range. (Paragraph [0130] “In a specific embodiment….membrane 1014 is made of silicone elastomer having a hardness of 30 Shore A.”) The examiner is modifying the third section taught in Benchetrit and Wiley to have a shore A hardness of 30 as taught in Bertolote.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the gastric band taught in Dlugos and Wiley to have the shore A hardness of Bertolote. One of ordinary skill in the art would have been able to recognize that a gastric band with sections of lower hardness would provide less inflammation / irritability when implanted in the patient.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Dlugos in view of Wiley further in view of Andrade further in view of Benchetrit further in view of Jarsaillon (US 7753841).
Regarding claim 6, Dlugos, Wiley, and Benchetrit teaches the device of claim 5 but fails to teach wherein the second locking part has at least two latching lugs which are latchable with the first locking part as desired to adjust a size of the passage opening.
However, Jarsaillon teaches an adjustable silicone gastric ring with latching lugs (Figure 2B, element 6. Column 4, line 4: “At its other end 2b, it has a tapered shape facilitating its insertion into the eyelet 4 and comprises a snap-fit catch 6 intended to be snap-fitted into the eyelet 4 and to cooperate with the shoulder 5 in order to maintain the band 2 in the form of a ring.” And Column 4, line 8: “As shown in FIG. 2B, end 2b can comprise several successive catches 6, making it possible to close the band 2 at several diameters adapted to the specific circumstances of the patient to be treated.”) The examiner is interpreting that the gastric band taught in Dlugos and Wiley would be modified at the second locking section, (Dlugos, fig. 2, element 22) to have two or more latching lugs as taught in Jarsaillon.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the gastric band taught in Dlugos and Wiley to have the latching lugs taught in Jarsaillon. One of ordinary skill in the art would have been able to recognize that this is a known technique in the art of gastric bands and that modifying the band taught in Dlugos and Wiley to have the latching lugs taught in Jarsaillon would have produced a gastric band that is secure and adjustable.
Response to Arguments
Specification
Applicant’s arguments, with respect to the specification have been fully considered and are persuasive. No new matter has been introduced.
35 U.S.C. 102
Applicant’s arguments with respect to claim(s) 1-2, 4-5, 10 have been considered but are moot because the new ground of rejection relies on a different combination of references than the ones in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Dlugos teaches a gastric band with a soft balloon and a harder ribbed element arranged successively in the longitudinal direction and has been modified in view of Wiley who teaches the use of silicone compositions in a gastric band. Dlugos further teaches using the process of overmolding to create the different sections of the gastric band to have no additional connecting or attachment parts. Inherently, the process of overmolding would create a transitional area between the first and second section because the two sections would be bonded together. The combination of the new references cited in claim 1 discloses the amended limitations. Therefore, claim 1 is not in condition for allowance.
35 U.S.C. 103
Dependent claims 2-10 have been updated with respect to the new grounds of rejection. Since, claims 2-10 depend on claim 1, these claims are not in condition for allowance.
Withdrawn Claim
Claim 11 was not elected as part of the restricted invention group I and the claims are not in condition for allowance, and therefore is still considered withdrawn. Claim 11 will not be rejoined to this application at this time.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA JOY LACAY DECASTRO whose telephone number is (571)272-8316. The examiner can normally be reached Monday - Friday 9:00 AM - 5:30.
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/A.L.D./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights