DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed 2/26/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As detailed in the rejection, the prior art taken as a whole renders the claimed invention obvious. Each reference provides motivation that would have led of ordinary skill in the art to modify Hastings to include the claimed tacky coating.
Applicant argues on page 9 that Sambasivam explicitly limits medical device applications to external applications/devices. In response to applicant's argument that Sambasivam is non-analogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Sambasivam discloses that silicone pressure sensitive adhesives are widely used in a variety of healthcare applications, such as transdermal drug delivery, wound dressings, scar dressings, etc. [0001] and goes on to describe the use of the pressure sensitive adhesive for ostomy devices, incontinence care and infusion [0026]. Although Sambasivam does not explicitly disclose the use of the pressure sensitive adhesive for internal applications, Weber and Goldberg are relied upon for this teaching. Sambasivam is relied upon for teaching a specific composition of a tacky silicone material comprising polydimethylsiloxane. Since Sambasivam is in the field of medical devices, one of ordinary skill in the art would have found it obvious to combine polydimethylsiloxane taught by Sambasivam with the adhesive layer of modified Hastings (as modified by Goldberg and Weber).
Applicant argues on page 10 that that Goldberg is non-analogous art, as it is not a stent and is instead a female incontinence device. It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). Although Goldberg does not disclose the use of the adhesive coating for a stent, Weber is relied upon for teaching the concept of a sticky coating on the outer surface of the stent to enable sticking of its outer surface to a body lumen wall (for example, see [0006]). Weber discloses the coating may comprise silicone [0045-0046] but fails to explicitly disclose a tacky silicone gel. Goldberg is relied upon for teaching that a sticky coating for adhering an implantable medical device to tissue may be a biocompatible tacky silicone gel (see column 6, lines 53-63 and column 7, lines 22-31). Goldberg is considered to be analogous to Hastings and Weber, as they are all tubular implantable devices placed within a body lumen. One of ordinary skill in the art looking to provide a sticky silicone coating on the outer surface of a stent taught by Weber would have found it obvious to try the tacky silicone gel taught by Goldberg, as its purpose is to adhere a medical device to tissue.
Applicant argues on pages 10-11 that the prior art does not address exposure to moisture, since the tacky silicone gel coating taught by Goldberg is placed externally to the body lumen and not in continuous contact with moisture. Weber is relied upon for teaching the concept a silicone coating for increasing the grip of the outer surface of the stent with a body lumen [0045-0046] but fails to explicitly disclose a tacky silicone gel. Goldberg is relied upon for teaching that a sticky coating for adhering an implantable medical device to tissue may be a biocompatible tacky silicone gel (see column 6, lines 53-63 and column 7, lines 22-31). Although not explicitly stated by the prior art, it is understood that the silicone coatings have a degree of stability in an environment having a level of moisture, as it is well known in the art of medical devices that human skin and body lumens have a degree of moisture and/or exposure to external moisture on the skin due to bathing, sweat, humidity, etc. One of ordinary skill in the art looking to provide a sticky silicone coating on the outer surface of a stent taught by Weber would have found it obvious to try the tacky silicone gel taught by Goldberg, as its purpose is to adhere a medical device to tissue.
Applicant argues on pages 10-11 that the cited art does not address moisture resistance, but the ability of the device to withstand a certain level of moisture exposure is not recited in the claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Although the resultant product may have drawbacks/ side effects realized after production, this is not considered to be a factor when determining obviousness of a claimed invention. The prior art provides proper motivation for combining the teachings of Weber, Goldberg and Sambasivam with Hastings, and therefore would have led one of ordinary skill in the art to arrive at the claimed invention. Since the prior art meets all the structural requirements of a tacky silicone material with a peel adhesion range recited in claim 1, the tacky layer of modified Hastings is considered to be capable of achieving the recited function of providing adhesion to human tissue.
In response to Applicant’s argument that Weber’s disclosure is primarily focused on a method of spray coating, this is considered to be irrelevant to the issue of patentability of the claimed invention. The passage of Weber describing a sticky coating at [0006] provides a reason for applying a silicone coating [0045-0046] an outer surface of a stent described elsewhere in the disclosure.
In response to Applicant’s argument on pages 14-15 that Hastings teaches away from removable applications, the mere absence of a disclosure of removing the stent from the body lumen by a particular method (not recited in the claims) to prevent migration is not considered to be “teaching away.” The claims have not recited a particular manner in which the tacky silicone material must be removed. “The prior art's mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). (As recited in MPEP §2145(X)(D)(1)). The claims only require the tacky silicone material to provide adhesion, wherein a tacky silicone coating taught by Weber and Goldberg achieves this function. The manner is which the stent may be “removable” is irrelevant to the tacky coating, since the function of being removable is not necessarily tied to the properties of the coating. The capability of the stent to be removed from the body by some known procedure meets the broad requirement. Additionally, a tacky coating that provides a degree of adhesion to tissue would aid in achieving the goal of Hastings to maintain a stent at a desired location.
In response to Applicant’s argument that the cited art does not teach the “embedded” limitation, the claim language only requires the stent frame to be “at least partially embedded within” the silicone covering. Firstly, the term “embed” means "to enclose closely in" (see Merriam Webster dictionary1). The term “embedded” is not construed to require a stent completely encapsulated in a silicone covering. The phrase ”at least partially embedded within” makes the limitation is broader, wherein any partial covering would meet the broadest reasonable interpretation of this limitation. The structure of Hastings meets the broad limitation ”at least partially embedded within” as the body (12) is at least partially covered by coating (14a and 14b) in Fig 5A-B.
In response to applicant's argument on page 17 that the examiner has combined an excessive number of references, reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991). The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the Examiner has pointed to motivation in each of the references for modifying Hastings and/or describing how the references are analogous to one another and would have led one of ordinary skill in the art to the claimed invention.
In response to applicant's argument that the adhesive material of Sambasivam is too thick, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, Sambasivam is only relied upon for teaching a particular composition of a tacky silicone layer so the thickness described in the reference is irrelevant to the rejection.
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, 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 negated by the manner in which the invention was made.
Claims 1-6, 8-9, 12-13, 15, and 17-18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hastings (US 20110190870 A1) in view of Weber (US 20050149177 A1), Goldberg (US 5234409 A), Sambasivam (US 20120108749 A1) and Alden (US 6743249 B1).
Regarding claim 1, Hastings teaches a removable stent device ([0010], Fig 1a, the structure is capable of being removed, for example with a stent removal surgery), the stent device having an inner surface and an outer surface (see surfaces of Fig 1a), the stent device comprising a stent body (see element 12 of Fig
1a); a silicone covering ([0049], [0051]) disposed on at least one surface of the stent body (element 14a and b, fig 5a/b), wherein the stent body is at least partially embedded within the silicone covering; (note the word embed means "to enclose closely in" (see Merriam Webster dictionary1) wherein the body 12 covered by coating 14a and 14b in Fig5a/b meets this broad requirement), and a biocompatible coating (element 36 of Fig 5b, [0053]) disposed over the silicone covering and defining an entirety of the outer surface of the stent device prior to implantation of the removal stent device (for example, see [0053] and Figure 5B and Figure 1A).
Hastings fails to teach the biocompatible coating is a tacky silicone material over the silicone covering that is selected so as to provide adhesion to human tissue. Weber discloses another stent device (see entire document) and teaches it is desirable to provide a relatively soft or sticky coating on the outer surface of the stent to enable sticking of its outer surface to another surface, such a body lumen wall (for example, see [0006]). Weber discloses the coating may comprise silicone [0045-0046] but fails to explicitly disclose a tacky silicone gel. Goldberg discloses an implantable medical device (see entire document) having a tubular conduit (92) inserted within a body lumen (Figure 6). Goldberg teaches that a sticky coating for adhering a medical device to tissue may be a biocompatible tacky silicone gel (see column 6, lines 53-63 and column 7, lines 22-31).
Given the teachings of Weber and Goldberg, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Hastings to include a tacky silicone gel coating over the silicone covering, in order to impart a degree of adhesiveness to the outer surface of the stent device that comes into contact with the lumen wall, thus enhancing securement of the stent in its deployed position.
Hastings in view of Weber and Goldberg does not disclose the biocompatible coating comprising polydimethylsiloxane. Sambasivam also discloses biocompatible tacky silicone material (see entire document) and teaches a tacky silicone material comprising polydimethylsiloxane (for example, [0042]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize a tacky silicone gel comprising polydimethylsiloxane, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of design choice.
Hastings in view of Weber, Goldberg, and Sambasivam does not disclose wherein the tacky silicone material has a peel adhesion of about 20 grams per inch to about 1000 grams per inch. Alden also discloses a biocompatible tacky polymer, or silicone, material for attaching a device to a patient's skin or tissue (for example, see column 1, lines 8-13 and column 5, lines 22-24). Alden teaches a peel adhesion strength of 0.5 pounds per inch or less (or about 227 grams per inch or less, which overlaps the claimed ranges; for example, see column 5, lines 24-31) enables the device to easily peel from the skin (for example, see column 5, lines 24-31). Alden further teaches the degree of adhesion or tackiness, or adhesion peel strengths, exhibited by the tacky polymer, or silicone, gel may be adjusted depending on the intended application, particularly when applied to fragile wound tissue or internal tissues and organs (for example, see column 5, lines 43-57). It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the tacky polymer, or silicone, gel having a peel adhesion of about 20 grams per inch to about 1000 grams per inch, per inch as taught by Alden, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, doing so would provide the stent with a desired adhesion peel strength that would enable it to be easily pulled away from the body lumen wall if it were desired to remove the stent from the patient after a certain period of time.
Regarding claim 2, further, the tackiness of the tacky silicone gel of Hastings as modified by Weber and Goldberg is considered not compromised by the presence of moisture in that it sticks or adheres to tissue which has moisture.
Regarding claim 3, further the tacky silicone gel of Hastings as modified by Weber and Goldberg is disposed over the silicone covering and defining an entirety of the outer surface of the stent device prior to implantation of the removal stent device (for example, see Hastings [0053] and Figure 5B and Figure 1A).
Regarding claim 4, further, the tacky silicone gel of Hastings as modified by Weber and Goldberg is considered pressure sensitive in that it sticks or adheres to that with which it applies pressure to through contact (for example, see Goldberg's column 6, lines 53-63 and column 7, lines 22-31).
Regarding claim 5, Hastings in view of Weber, Goldberg, and Sambasivam does not disclose wherein the tacky silicone material has a peel adhesion of about 20 grams per inch to about 100 grams per inch. Alden also discloses a biocompatible tacky polymer, or silicone, material for attaching a device to a patient's skin or tissue (for example, see column 1, lines 8-13 and column 5, lines 22-24). Alden teaches a peel adhesion strength of 0.5 pounds per inch or less (or about 227 grams per inch or less, which overlaps the claimed ranges; for example, see column 5, lines 24-31) enables the device to easily peel from the skin (for example, see column 5, lines 24-31). Alden further teaches the degree of adhesion or tackiness, or adhesion peel strengths, exhibited by the tacky polymer, or silicone, gel may be adjusted depending on the intended application, particularly when applied to fragile wound tissue or internal tissues and organs (for example, see column 5, lines 43-57). It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the tacky polymer, or silicone, gel having a peel adhesion of about 20 grams per inch to about 100 grams per inch, per inch as taught by Alden, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, doing so would provide the stent with a desired adhesion peel strength that would enable it to be easily pulled away from the body lumen wall if it were desired to remove the stent from the patient after a certain period of time.
Regarding claim 6, Hastings in view of Weber, Goldberg, and Sambasivam does not disclose wherein the tacky silicone material has a peel adhesion of about 20 grams per inch to about 50 grams per inch. Alden also discloses a biocompatible tacky polymer, or silicone, material for attaching a device to a patient's skin or tissue (for example, see column 1, lines 8-13 and column 5, lines 22-24). Alden
teaches a peel adhesion strength of 0.5 pounds per inch or less (or about 227 grams per inch or less, which overlaps the claimed ranges; for example, see column 5, lines 24-31) enables the device to easily peel from the skin (for example, see column 5, lines 24-31). Alden further teaches the degree of adhesion or tackiness, or adhesion peel strengths, exhibited by the tacky polymer, or silicone, gel may be adjusted depending on the intended application, particularly when applied to fragile wound tissue or internal tissues and organs (for example, see column 5, lines 43-57). It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the tacky polymer, or silicone, gel having a peel adhesion of about 20 grams per inch to about 50 grams per inch, per inch as taught by Alden, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, doing so would provide the stent with a desired adhesion peel strength that would enable it to be easily pulled away from the body lumen wall if it were desired to remove the stent from the patient after a certain period of time.
Regarding claim 8, Hastings further teaches, wherein the silicone covering comprises a partial or full covering of the stent body (see element 14a and 14b of Fig 5b, fig 1a).
Regarding claims 9 and 18, Hastings further teaches, wherein the stent comprises a member selected from the group consisting of esophageal stents, pancreatic stents, duodenal stents, colonic stents, biliary stents and airway stents (this instant case is being interpreted as an intended use claim, the structure is fully capable of being used in this way).
Regarding claim 12, Hastings as modified teaches a removable stent device ([0010], Fig 1a, the structure is capable of being removed, for example with a stent removal surgery), the stent device having an inner surface and an outer surface (see surfaces of Fig 1a), the stent device comprising a stent body (see element 12
of Fig 1a); a silicone covering ([0049], [0051]) disposed on at least one surface of the stent body (element 14a and b, fig 5a/b), wherein the stent body is at least partially embedded within the silicone covering; (see body 12 embedded within 14a and 14b in Fig5a/b, note the word embed means "to enclose closely in" (see Merriam Webster dictionary1)), and a biocompatible coating (element 36 of Fig 5b, [0053]) disposed over the silicone covering and defining an entirety of the outer surface of the stent device prior to implantation of the removal stent device (for example, see [0053] and Figure 5B and Figure 1A).
Hastings fails to teach the biocompatible coating is a tacky silicone material over the silicone covering that is selected so as to provide adhesion to human tissue. Weber discloses another stent device (see entire document) and teaches it is desirable to provide a relatively soft or sticky coating on the outer surface of the stent to enable sticking of its outer surface to another surface, such a body lumen wall (for example, see [0006]). Weber discloses the coating may comprise silicone [0045-0046] but fails to explicitly disclose a tacky silicone gel. Goldberg discloses an implantable medical device (see entire document) having a tubular conduit (92) inserted within a body lumen (Figure 6). Goldberg teaches that a sticky coating for adhering a medical device to tissue may be a biocompatible tacky silicone gel (see column 6, lines 53-63 and column 7, lines 22-31).
Given the teachings of Weber and Goldberg, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Hastings to include a tacky silicone gel coating over the silicone covering, in order to impart a degree of adhesiveness to the outer surface of the stent device that comes into contact with the lumen wall, thus enhancing securement of the stent in its deployed position. Further, the tackiness of the tacky silicone gel of Hastings as modified by Weber and Goldberg is considered not compromised by the presence of moisture in that it sticks or adheres to tissue (wherein it is well known in the art that human tissue comprises moisture and/or is exposed to moisture due to bathing, sweat, humidity, etc). Further, the tacky silicone gel of Hastings as modified by Weber and Goldberg is considered pressure sensitive, in that it sticks or adheres to that with which it applies pressure to through contact (for example, see Goldberg's column 6, lines 53-63 and column 7, lines 22-31).
Hastings in view of Weber and Goldberg does not disclose the biocompatible coating comprising polydimethylsiloxane. Sambasivam also discloses biocompatible tacky silicone material (see entire document) and teaches a tacky silicone material comprising polydimethylsiloxane (for example, [0042]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize a tacky silicone gel comprising polydimethylsiloxane, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of design choice.
Hastings in view of Weber, Goldberg, and Sambasivam does not disclose wherein the tacky silicone material has a peel adhesion of about 20 grams per inch to about 50 grams per inch. Alden also discloses a biocompatible tacky polymer, or silicone, material for attaching a device to a patient's skin or tissue (for example, see column 1, lines 8-13 and column 5, lines 22-24). Alden teaches a peel adhesion strength of 0.5 pounds per inch or less (or about 227 grams per inch or less, which overlaps the claimed ranges; for example, see column 5, lines 24-31) enables the device to easily peel from the skin (for example, see column 5, lines 24-31). Alden further teaches the degree of adhesion or tackiness, or adhesion peel strengths, exhibited by the tacky polymer, or silicone, gel may be adjusted depending on the intended application, particularly when applied to fragile wound tissue or internal tissues and organs (for example, see column 5, lines 43-57). It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the tacky polymer, or silicone, gel having a peel adhesion of about 20 grams per inch to about 50 grams per inch, per inch as taught by Alden, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, doing so would provide the stent with a desired adhesion peel strength that would enable it to be easily pulled away from the body lumen wall if it were desired to remove the stent from the patient after a certain period of time.
Regarding claim 13, modified Hastings comprises a tacky silicone material that is selected so as to provide adhesion to human tissue, as taught by Weber and Goldberg.
Regarding claim 15, Hastings further teaches wherein the biocompatible coating includes a therapeutic agent ([0054]).
Regarding claim 17, Hastings further teaches wherein the silicone covering extends radially inward of the stent body (element 14a of Fig 5a extends radially inwards of the stent body 12).
Claims 11, 19, and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable Hastings (US 20110190870 A1) in view of Weber (US 20050149177 A1), Goldberg (US 5234409 A), Sambasivam (US 20120108749 A1) and Alden (US 6743249 B1) and in further view of Cheng (US 20040215313 A1).
Regarding claim 11 and 19, Hastings in view of the above combination does not disclose a hydrophilic biodegradable coating. Cheng teaches an adhesive stent device (abstract) comprising a hydrophilic biodegradable coating ([0040]) surrounding and disposed on an outer surface of the top of the underlying silicone coating ([0040]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the stent device of modified Hastings to include a hydrophilic biodegradable coating, as taught by Cheng, in order to protect the underlying coating from damage ([0040]).
Regarding claim 20, Hastings teaches a removable stent device ([0010], Fig 1a, the structure is capable of being removed, for example with a stent removal surgery), the stent device having an inner surface and an outer surface (see surfaces of Fig 1a), the stent device comprising a stent body (see element 12 of Fig 1a); a silicone covering ([0049], [0051]) disposed on at least one surface of the stent body (element 14a and b, fig 5a/b), wherein the stent body is at least partially embedded within the silicone covering; (see body 12 embedded within 14a and 14b in Fig5a/b, note the word embed means "to enclose closely in" (see Merriam Webster dictionary1)), a biocompatible coating disposed over the silicone covering (element 36 of Fig 5b, [0053]) and a biocompatible coating (element 36 of Fig 5b, [0053]) disposed over the silicone covering and defining an entirety of the outer surface of the stent device prior to implantation of the removal stent device (for example, see [0053] and Figure 5B and Figure 1A).
The limitation “being configured for endoscopic placement in a body lumen selected from a group consisting of esophogeal lumens, etc…” is a functional limitation that is not given full patentable weight. The prior art is not required to disclose the recited body lumens, but merely have the capability of being placed in one of the recited lumens in order to meet the claim requirements. It is well known in the art of implants that body lumens vary widely in size due to patient age, health, race, height, injuries, illnesses, birth defects, etc. Therefore, the Hastings stent is considered to be capable of placement in at least one of the recited body lumens in at least some existing patient.
Hastings fails to teach the biocompatible coating is a tacky silicone material over the silicone covering that is selected so as to provide adhesion to human tissue. Weber discloses another stent device (see entire document) and teaches it is desirable to provide a relatively soft or sticky coating on the outer surface of the stent to enable sticking of its outer surface to another surface, such a body lumen wall (for example, see [0006]). Weber discloses the coating may comprise silicone [0045-0046] but fails to explicitly disclose a tacky silicone gel. Goldberg discloses an implantable medical device (see entire document) having a tubular conduit (92) inserted within a body lumen (Figure 6). Goldberg teaches that a sticky coating for adhering a medical device to tissue may be a biocompatible tacky silicone gel (see column 6, lines 53-63 and column 7, lines 22-31).
Given the teachings of Weber and Goldberg, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Hastings to include a tacky silicone gel coating over the silicone covering, in order to impart a degree of adhesiveness to the outer surface of the stent device that comes into contact with the lumen wall, thus enhancing securement of the stent in its deployed position, which prevents migration at least to some degree.
Further, the tackiness of the tacky silicone gel of Hastings as modified by Weber and Goldberg is considered not compromised by the presence of moisture in that it sticks or adheres to tissue which has moisture. Hastings in view of Weber and Goldberg does not disclose the biocompatible coating comprising polydimethylsiloxane. Sambasivam also discloses biocompatible tacky silicone material (see entire document) and teaches a tacky silicone material comprising polydimethylsiloxane (for example, [0042]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize a tacky silicone gel comprising polydimethylsiloxane, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of design choice.
Hastings in view of Weber, Goldberg, and Sambasivam does not disclose wherein the tacky silicone material has a peel adhesion of about 20 grams per inch to about 500 grams per inch. Alden also discloses a biocompatible tacky polymer, or silicone, material for attaching a device to a patient's skin or tissue (for example, see column 1, lines 8-13 and column 5, lines 22-24). Alden teaches a peel adhesion strength of 0.5 pounds per inch or less (or about 227 grams per inch or less, which overlaps the claimed ranges; for example, see column 5, lines 24-31) enables the device to easily peel from the skin (for example, see column 5, lines 24-31). Alden further teaches the degree of adhesion or tackiness, or adhesion peel strengths, exhibited by the tacky polymer, or silicone, gel may be adjusted depending on the intended application, particularly when applied to fragile wound tissue or internal tissues and organs (for example, see column 5, lines 43-57). It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the tacky polymer, or silicone, gel having a peel adhesion of about 20 grams per inch to about 500 grams per inch, per inch as taught by Alden, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, doing so would provide the stent with a desired adhesion peel strength that would enable it to be easily pulled away from the body lumen wall if it were desired to remove the stent from the patient after a certain period of time.
Hastings in view of the above combination does not disclose a hydrophilic biodegradable coating. Cheng teaches an adhesive stent device (abstract) comprising a hydrophilic biodegradable coating ([0040]) surrounding and disposed on an outer surface of the top of the underlying silicone coating ([0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the stent device of Hastings to include a hydrophilic biodegradable coating, as taught by Cheng, in order to protect the underlying coating from damage ([0040]).
Claims 7 and 16 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable Hastings (US 20110190870 A1) in view of Weber (US 20050149177 A1), Goldberg (US 5234409 A), Sambasivam (US 20120108749 A1), Alden (US 6743249 B1), and Cheng (US 20040215313 A1), and further in view of Yang (US 7052512 B2).
Regarding claims 7 and 16, Hasting in view of in view of the above combination fails to teach the silicone material of the stent device including a biocompatible dye. Yang teaches a coating for medical devices (see entire document) comprising a tacky silicone material including a biocompatible dye (col 7 lines 5-20). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the silicone material of the stent device of Hastings in view of the above combination by including the biocompatible dye as taught by Yang, in order to view the consistency of the tacky coating coverage on the silicone cover (col 11, lines 16-25).
Claims 21 and 22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable Hastings (US 20110190870 A1) in view of Weber (US 20050149177 A1), Goldberg (US 5234409 A), Sambasivam (US 20120108749 A1), Alden (US 6743249 B1), and Cheng (US 20040215313 A1), and further in view of Parbhoo (Fundamental aspects of adhesion technology in silicones).
Regarding claims 21 and 22, Hasting in view of the above combination fails to exactly disclose moisture curing. However, Parbhoo teaches moisture curing is a common process for curing polydimethylsiloxane (see section 3.1-3.1.1.1 of Parbhoo). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the moisture curing teachings in Parbhoo to the silicone material of the stent device taught by Hastings in view of the above combination. Parbhoo provides evidential support of know curing techniques. It would be obvious to try various known methods in the art MPEP 2143(I)(E). The know curing methods of the material represent a finite number of solutions, there would be reasonable success to try different curing methods.
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 SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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