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 .
Reopening of Prosecution After Appeal Brief
In view of the appeal brief filed on 27 June 2025, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783
Response to Arguments
Applicant's arguments filed in the Appeal Brief received 27 June 2025 have been fully considered but they are not persuasive. However, because new rejections are being made, this office action is Non-Final. New alternative rejections of the independent claims and new 112(b) rejections are made.
Applicant argues the devices of Hietanen and Hoffman do not teach the intended use language in the preamble by being fully capable of use as claimed. The examiner respectfully disagrees. The device of Hietanen is specifically made for moving skin and the device of Hoffman is made for applying a tension force to the handle and it can be adhered to any surface. The references do not need to mention the devices are intended to elevate abdominal tissue of a patient in laparoscopic surgery to meet the claim limitation. Such use is not contraindicated by Hietanen and Hoffman and use of the devices of Hietanen and Hoffman would not risk injury if used as claimed either. As such, the devices of Hietanen and Hoffman are both adapted for use as claimed. However, because the interpretation of the claims is in dispute, the examiner has included alternative rejections for the independent claims as outlined below.
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.
Claims 1 and 3-30 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.
Claims 1, 14, and 30 recite an adhesive "being configured to sufficiently (jointly) tent the abdomen under a tensile force for insertion of an instrument through said elevated skin". It is unclear what is considered sufficient tenting as an instrument can be inserted through non- elevated skin so it is unclear how an adhesive can be configured to provide sufficient tenting. For the purpose of examination, to determine how an adhesive can sufficiently tent the abdomen as claimed, the examiner is using paragraph [045] from the instant specification which discusses an adhesive configured to provide sufficient tenting: "Adhesive 26 in certain instances is selected to be capable of lifting a load of at least 10 pounds and to hold such load for a period of at least 30 seconds. Otherwise, adhesive 26 is selected to be sufficiently capable of tenting the abdomen for insertion by a Veress needle, trocar or other instruments. As such, adhesive 26 may be comprised of biocompatible materials including synthetic rubber, silicone, or acrylic based adhesives, or other suitable commercially available adhesive." Using this text from the specification, an adhesive that is sufficiently capable, may be "comprised of biocompatible materials including synthetic rubber, silicone, or acrylic based adhesives, or other suitable commercially available adhesive." The examiner notes removing the word “sufficiently” as proposed in the response after final action received 27 March 2025, but not entered, would overcome this rejection.
Claims 1, 14 and 30 recite the limitation “said elevated skin” in lines 5-6 of claim 1, line 8 of claim 14, and line 8 of claim 30. There is insufficient antecedent basis for this limitation in the claims.
Claims 3-13, 15-22, and 24-28 are rejected as being dependent on, and failing to cure the deficiencies of, rejected independent claims 1 and 14.
Claim 29 is rejected because it is unclear if a device or a process of making the device is being claimed. The preamble in independent claim 29 recites a hand held tissue lifting device, but the body of the claim further recites it is formed by a process and recites a list of steps in the body of the claim.
Claims 23 and 30 are rejected as being dependent on, and failing to cure the deficiencies of, rejected independent claim 29.
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.
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.
Claims 1, 3, 7-9, and 12 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Hietanen et al. (US 2018/0104087 A1) or, in the alternative, under 35 U.S.C. 103 as obvious over Hietanen et al. (US 2018/0104087 A1) in view of Liu et al. (CN 201542695 U).
Regarding claim 1, Hietanen et al. discloses a hand held tissue lifting device ([0004] “the adhesive material is configured to maintain adherence with the backing layer and the patient's skin while the handles are pulled normal to the patient's skin.”) configured to elevate abdominal tissue of a patient in laparoscopic surgery (the device of Hietanen et al. is fully capable of being adhered to abdominal tissue and this can be performed during a laparoscopic surgery, the device of Hietanen et al. is made to elevate tissue, the tissue can be abdominal and can be during a laparoscopic procedure, [0020] “For example, the handles may enable the healthcare professional and/or the patient to pull, stretch, twist, extend, elongate, and/or the like the underlying skin, tissue, fascia, and/or the like as a part of a medical treatment (e.g., a medical treatment including stretching, pulling, pushing, twisting, and/or the like the underlying skin, tissue and/or fascia of a patient)”, [0036] “the adhesive layer may provide sufficient tensile strength between the therapy tape and the patient's skin that manipulating the therapy tape (e.g., via handles) may cause relative manipulation of the patient's skin, and the therapy tape may remain secured to the patient's skin”), comprising: an anchor ([0004] backing layer) including an upper surface and a lower surface ([0004] “the flexible backing layer defines a top side and a bottom side opposite the top side”), and a layer of adhesive on the lower surface ([0004] “(ii) an adhesive material secured relative to the bottom side of the flexible backing layer”) for attachment to abdominal skin of a patient ([0004] “wherein the adhesive material is configured to adhere the backing layer against a patient's skin”) said adhesive being configured to sufficiently tent the abdomen under a tensile force for insertion of an instrument through said elevated skin in laparoscopic surgery (using paragraph [045] from the instant application specification, an adhesive sufficiently capable is described as “may be comprised of biocompatible materials including synthetic rubber, silicone, or acrylic based adhesives, or other suitable commercially available adhesive”, [0036] “the adhesive may comprise an acrylic polymer.”); and a handle ([0004] “(iii) one or more handles”) that is sized and configured to be hand held by a user (a grippable handle is sized and configured to be handheld), the handle being movably attached to the upper surface of the anchor ([0004] “secured relative to the top side of the flexible backing layer”, [0040] “the handle 4 to pivot and/or otherwise flex relative to the backing layer 2.”).
Regarding claim 1, Hietanen et al. discloses a hand held tissue lifting device ([0004] “the adhesive material is configured to maintain adherence with the backing layer and the patient's skin while the handles are pulled normal to the patient's skin.”) configured to elevate abdominal tissue of a patient (the device of Hietanen et al. is made to elevate tissue, the tissue can be abdominal, [0020] “For example, the handles may enable the healthcare professional and/or the patient to pull, stretch, twist, extend, elongate, and/or the like the underlying skin, tissue, fascia, and/or the like as a part of a medical treatment (e.g., a medical treatment including stretching, pulling, pushing, twisting, and/or the like the underlying skin, tissue and/or fascia of a patient)”, [0036] “the adhesive layer may provide sufficient tensile strength between the therapy tape and the patient's skin that manipulating the therapy tape (e.g., via handles) may cause relative manipulation of the patient's skin, and the therapy tape may remain secured to the patient's skin”), comprising: an anchor ([0004] backing layer) including an upper surface and a lower surface ([0004] “the flexible backing layer defines a top side and a bottom side opposite the top side”), and a layer of adhesive on the lower surface ([0004] “(ii) an adhesive material secured relative to the bottom side of the flexible backing layer”) for attachment to abdominal skin of a patient ([0004] “wherein the adhesive material is configured to adhere the backing layer against a patient's skin”) said adhesive being configured to sufficiently tent the abdomen under a tensile force for insertion of an instrument through said elevated skin in laparoscopic surgery (using paragraph [045] from the instant application specification, an adhesive sufficiently capable is described as “may be comprised of biocompatible materials including synthetic rubber, silicone, or acrylic based adhesives, or other suitable commercially available adhesive”, [0036] “the adhesive may comprise an acrylic polymer.”); and a handle ([0004] “(iii) one or more handles”) that is sized and configured to be hand held by a user (a grippable handle is sized and configured to be handheld), the handle being movably attached to the upper surface of the anchor ([0004] “secured relative to the top side of the flexible backing layer”, [0040] “the handle 4 to pivot and/or otherwise flex relative to the backing layer 2.”).
However, Hietanen et al. fails to explicitly teach the hand held tissue lifting device is configured for use in a laparoscopic surgery.
Liu et al. teaches a hand held tissue lifting device (Fig 1) configured to elevate abdominal tissue of a patient in laparoscopic surgery ([0001] “laparoscopic skin lifting forceps”, “effectively lift the umbilical skin.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of Hietanen et al. to be configured for use in a laparoscopic surgery as taught by Liu et al. to “to increase the abdominal space and prevent the pneumoperitoneum puncture needle from damaging the intestine and other abdominal organs.” [0002]
Regarding claim 3, Hietanen et al. discloses the hand held tissue lifting device of claim 1. Hietanen et al. further discloses wherein the anchor and the handle are separate components ([0040] “the handle 4 may be a separate component from the backing layer 2”) attachable to each other ([0040] “secured relative to the backing layer 2”).
Regarding claim 7, Hietanen et al. discloses the hand held tissue lifting device of claim 3. Hietanen et al. further teaches wherein the handle is formed of a material that is more rigid than the material of the anchor ([0028] “a first portion of the backing layer may comprise a flexible, inelastic material and a second portion of the backing layer may comprise a flexible, elastic material.”, [0040] “the handle 4 may comprise a material different from the backing layer 2”, “the handle may comprise a rigid material”).
Regarding claim 8, Hietanen et al. discloses the hand held tissue lifting device of claim 7. Hietanen et al. further teaches wherein the anchor comprises a sheet of flexible polymer material (the backing layer having the adhesive [0026], the adhesive being an “acrylic polymer.” [0036]).
Regarding claim 9, Hietanen et al. discloses the hand held tissue lifting device of claim 8. Hietanen et al. further teaches wherein the sheet of flexible polymer material has a thickness that allows the anchor to follow contours of a patient’s skin ([0004] “(i) a backing layer configured to conform to a portion of a patient's body” the backing must necessarily have a thickness to allow it to conform as described).
Regarding claim 12, Hietanen et al. discloses the hand held tissue lifting device of claim 1. Hietanen et al. further discloses wherein the layer of adhesive on the lower surface of the anchor is configured to provide tenting by having the capability of lifting a load of at least 10 pounds applied to said abdominal skin and to hold such load for a period of at least 30 seconds (while the device of Hietanen et al. is silent to this function, using paragraph [045] from the instant application specification, this capability is attributed to an adhesive that “may be comprised of biocompatible materials including synthetic rubber, silicone, or acrylic based adhesives, or other suitable commercially available adhesive”, since the device of Hietanen et al. has such an adhesive on its bottom surface to adhere to skin, it would also function as claimed, [0036] “the adhesive may comprise an acrylic polymer.”, [0036] “the adhesive layer may provide sufficient tensile strength between the therapy tape and the patient's skin that manipulating the therapy tape (e.g., via handles) may cause relative manipulation of the patient's skin, and the therapy tape may remain secured to the patient's skin”).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Hietanen et al. (US 2018/0104087 A1) and in the alternative in view of Liu et al. (CN 201542695 U) as applied to claim 3 above, and further in view of Carriere (US 6,769,541 B1).
Regarding claim 4, Hietanen et al. discloses the hand held tissue lifting device of claim 3. Hietanen et al. further discloses wherein the handle defines an opening ([0039] the handle is a D-ring, a D-ring has an opening) such that the tissue lifting device may be hand held (D-rings may be handheld).
However, Hietanen et al. fails to teach the opening is sized and configured for insertion of a user’s fingers.
Carriere teaches a handle defines an opening (10a, 10b Fig 2c) that is sized and configured for insertion of a user’s fingers (As shown in Fig 2C). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the opening of Hietanen et al. to be sized and configured with the limitations as taught by Carriere to permit the handle to be gripped by the fingers of a user (Col 7 lines 38-53).
Regarding claim 5, modified Hietanen et al. discloses the hand held tissue lifting device of claim 4. Modified Hietanen et al. further teaches wherein the opening is fully enclosed (The D-ring of Hietanen et al. is fully enclosed, further the opening of Carriere is fully enclosed in Fig 2c).
Regarding claim 6, modified Hietanen et al. discloses the hand held tissue lifting device of claim 4. Hietanen et al. further teaches a handle has a fully enclosed opening defined by a semicircular ring or loop ([0039] the handle is a D-ring, A D-ring is a fully enclosed semicircular ring).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hietanen et al. (US 2018/0104087 A1) and in the alternative in view of Liu et al. (CN 201542695 U) as applied to claim 9 above, and further in view of Hagy et al. (US 2016/0339186 A1).
Regarding claim 10, Hietanen et al. discloses the hand held tissue lifting device of claim 9. However, Hietanen et al. fails to teach wherein the sheet of flexible polymer material has a thickness of 0.003 to 0.100 inches.
Hagy et al. teaches a sheet of flexible polymer material ([0041] “suitable elastomers”, “(b) diisocyanates and polyalkylene polyester glycols; Hycar* brand butadiene-acrylonitrile modified with carboxyl groups; Hydrin™ brand copolymer of epichlorohydrin with ethylene oxide; styrene-butadiene-styrene block copolymers available under the Kraton™ brand; Hytrel™ brand copolyester, and the like, which are essentially liquid-impervious, do not absorb a significant amount of moisture, and can be formed into thin smooth surfaced sheets”) has a thickness of 0.003 to 0.100 inches ([0041] “5 mil”, 5 mil is 0.005 inches). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the sheet of flexible polymer material of Hietanen et al. to have the thickness as taught by Hagy et al. since such a thickness forms a flexible skin contact sheet. [0041]
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hietanen et al. (US
2018/0104087 A1) and in the alternative in view of Liu et al. (CN 201542695 U) as applied to claim 3 above, and further in view of Pratl (US 2002/0166212 A1).
Regarding claim 11, Hietanen et al. discloses the hand held tissue lifting device of claim 3. However, Hietanen et al. fails to teach wherein the handle is attached to the anchor at a hinge that allows free rotation of the handle relative to the anchor.
Pratl teaches a handle (22 Fig 2) is attached to the anchor (20 Fig 2) at a hinge (50 Fig 8a) that allows free rotation of the handle relative to the anchor (See the rotation from Figs 2-4, [0028] “The first portion 70 of the ring 22 preferably fits within the recess 50 with a loose interference fit […]the ring is captured within the recess and is pivotally movable between its first and second positions with light finger pressure, but is held in place by friction between the ring and the base panel in the absence of external force.”, the handle freely rotates between positions relative to the anchor with light finger pressure). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of Hietanen et al. to include the hinge with the limitations as taught by Pratl to allow the user to easily orient the handle relative to the anchor to accommodate the user’s preferences or needs. Accordingly, Hietanen et al. teaches embodiments where the handle may have a different orientation relative to the anchor ([0043] “therapy tape 11 may have a different handle orientation relative to the length of the therapy tape 11”).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hietanen et al. (US 2018/0104087 A1) and in the alternative in view of Liu et al. (CN 201542695 U) as applied to claim 1 above, and further in view of Hoffman et al. (US 2019/0038051 A1).
Regarding claim 13, Hietanen et al. discloses the hand held tissue lifting device of claim 1. However, Hietanen et al. fails to teach wherein a non-adhesive dead zone is formed on a least a portion of a periphery of the anchor to assist a user in removal of the hand held tissue lifting device from the patient.
Hoffman et al. teaches wherein a non-adhesive dead zone (39 Fig 3, [0041] “adhesive layer 34 can also extend only as far as end line 38, thereby leaving a portion of panel 26B uncoated by adhesive layer 34. Thus, a portion of panel 26B can form pull tab 39 that can be grasped to peel panel 26B away from surface 40.”) is formed on a least a portion of a periphery of the anchor (39 Fig 3 is formed on the edge of the anchor as shown in Fig 3) to assist a user in removal of the device from the attachment surface ([0041] “Thus, a portion of panel 26B can form pull tab 39 that can be grasped to peel panel 26B away from surface 40. Pull tab 39 can aid with removal of hanger device 10, such as by allowing panel 26B to be pulled up from an edge. Thus, because panel 26B is flexible, panel 26B can be pulled away from surface 40 along a peel front so that only a small amount of adhesive layer 34 needs to be overcome at a time.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of Hietanen et al. to include the non-adhesive dead zone with the limitations as taught by Hoffman et al. to aid with removal of the device from the attachment surface [0041].
Claims 14-15, 19, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Hietanen et al. (US 2018/0104087 A1) and in the alternative in view of Liu et al. (CN 201542695 U), and further in view of and Hoffman et al. (US 2019/0038051 A1).
Regarding claim 14, Hietanen et al. discloses a hand held tissue lifting device ([0004] “the adhesive material is configured to maintain adherence with the backing layer and the patient's skin while the handles are pulled normal to the patient's skin.”) configured to elevate abdominal tissue of a patient in laparoscopic surgery (the device of Hietanen et al. is fully capable of being adhered to abdominal tissue and this can be performed during a laparoscopic surgery, the device of Hietanen et al. is made to elevate tissue, the tissue can be abdominal and can be during a laparoscopic procedure, [0020] “For example, the handles may enable the healthcare professional and/or the patient to pull, stretch, twist, extend, elongate, and/or the like the underlying skin, tissue, fascia, and/or the like as a part of a medical treatment (e.g., a medical treatment including stretching, pulling, pushing, twisting, and/or the like the underlying skin, tissue and/or fascia of a patient)”, [0036] “the adhesive layer may provide sufficient tensile strength between the therapy tape and the patient's skin that manipulating the therapy tape (e.g., via handles) may cause relative manipulation of the patient's skin, and the therapy tape may remain secured to the patient's skin”), comprising: a flexible anchor ([0004] flexible backing layer) comprising a first anchor portion and a second anchor portion (the portions of the backing layer 2 on either side of the handles 4 as shown in Figs 1A and 1C), a first layer of adhesive on a lower surface of the first anchor portion for attachment to abdominal skin of a patient and a second layer of adhesive on a lower portion of the second anchor portion for attachment to said abdominal skin of said patient ([0004] “wherein the adhesive material is configured to adhere the backing layer against a patient's skin”, the layer on the portion of the backing layer on the side above the handle as shown in Fig 1A and on the side below the handle as shown in Fig 1A, [0004] “(ii) an adhesive material secured relative to the bottom side of the flexible backing layer”) said first layer of adhesive and said second layer of adhesive each being configured to sufficiently jointly tent the abdomen under a tensile force for insertion of an instrument through said elevated skin (using paragraph [045] from the instant application specification, an adhesive sufficiently capable is described as “may be comprised of biocompatible materials including synthetic rubber, silicone, or acrylic based adhesives, or other suitable commercially available adhesive”, [0036] “the adhesive may comprise an acrylic polymer.”); and a handle ([0004] “(iii) one or more handles”, [0039] the handle is a D-ring) sized and configured to be hand held (a grippable handle is sized and configured to be handheld).
However, Hietanen et al. fails to teach a handle support connecting the first anchor portion and the second anchor portion; a first fold line adjacent the handle support, the first anchor portion being foldable about the first fold line; a second fold line adjacent to the handle support, the second anchor portion being foldable about the second fold line, the handle being attachable to the handle support for movement relative to the first anchor portion and the second anchor portion.
Hoffman et al. teaches a handle support (12 Fig 1A) connecting the first anchor portion (14A Fig 1A) and the second anchor portion (14B Fig 1A) ([0037] “Backing 16 is folded over hook element 18 at crease 20 to form central flap zone 12, while adhesion zones 14A and 14B extend out from central flap zone 12 at creases 22A and 22B.”); a first fold line (22A Fig 1A) adjacent the handle support (see the flap 12 adjacent crease 22A Fig 1A), the first anchor portion being foldable about the first fold line (shown folded in Fig 1A); a second fold line (22B Fig 1A) adjacent to the handle support (see the flap 12 adjacent crease 22B Fig 1A), the second anchor portion being foldable about the second fold line (shown folded in Fig 1A), the handle (18 Fig 1A) being attached to the handle support for movement relative to the first anchor portion and the second anchor portion ([0037] “central flap zone 12 is flexible such that hook element 18 can be used to hang items in all such angles and orientations.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of Hietanen et al. to include the limitations as taught by Hoffman et al. to form the device such that it promotes adhesion to a surface under a variety of loading orientations [0037].
Regarding claim 14, Hietanen et al. discloses a hand held tissue lifting device ([0004] “the adhesive material is configured to maintain adherence with the backing layer and the patient's skin while the handles are pulled normal to the patient's skin.”) configured to elevate abdominal tissue of a patient (the device of Hietanen et al. is made to elevate tissue, the tissue can be abdominal, [0020] “For example, the handles may enable the healthcare professional and/or the patient to pull, stretch, twist, extend, elongate, and/or the like the underlying skin, tissue, fascia, and/or the like as a part of a medical treatment (e.g., a medical treatment including stretching, pulling, pushing, twisting, and/or the like the underlying skin, tissue and/or fascia of a patient)”, [0036] “the adhesive layer may provide sufficient tensile strength between the therapy tape and the patient's skin that manipulating the therapy tape (e.g., via handles) may cause relative manipulation of the patient's skin, and the therapy tape may remain secured to the patient's skin”), comprising: a flexible anchor ([0004] flexible backing layer) comprising a first anchor portion and a second anchor portion (the portions of the backing layer 2 on either side of the handles 4 as shown in Figs 1A and 1C), a first layer of adhesive on a lower surface of the first anchor portion for attachment to abdominal skin of a patient and a second layer of adhesive on a lower portion of the second anchor portion for attachment to said abdominal skin of said patient ([0004] “wherein the adhesive material is configured to adhere the backing layer against a patient's skin”, the layer on the portion of the backing layer on the side above the handle as shown in Fig 1A and on the side below the handle as shown in Fig 1A, [0004] “(ii) an adhesive material secured relative to the bottom side of the flexible backing layer”) said first layer of adhesive and said second layer of adhesive each being configured to sufficiently jointly tent the abdomen under a tensile force for insertion of an instrument through said elevated skin (using paragraph [045] from the instant application specification, an adhesive sufficiently capable is described as “may be comprised of biocompatible materials including synthetic rubber, silicone, or acrylic based adhesives, or other suitable commercially available adhesive”, [0036] “the adhesive may comprise an acrylic polymer.”); and a handle ([0004] “(iii) one or more handles”, [0039] the handle is a D-ring) sized and configured to be hand held (a grippable handle is sized and configured to be handheld).
However, Hietanen et al. fails to explicitly teach the hand held tissue lifting device is configured for use in a laparoscopic surgery and a handle support connecting the first anchor portion and the second anchor portion; a first fold line adjacent the handle support, the first anchor portion being foldable about the first fold line; a second fold line adjacent to the handle support, the second anchor portion being foldable about the second fold line, the handle being attachable to the handle support for movement relative to the first anchor portion and the second anchor portion.
Liu et al. teaches a hand held tissue lifting device (Fig 1) configured to elevate abdominal tissue of a patient in laparoscopic surgery ([0001] “laparoscopic skin lifting forceps”, “effectively lift the umbilical skin.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of Hietanen et al. to be configured for use in a laparoscopic surgery as taught by Liu et al. to “to increase the abdominal space and prevent the pneumoperitoneum puncture needle from damaging the intestine and other abdominal organs.” [0002]
Hoffman et al. teaches a handle support (12 Fig 1A) connecting the first anchor portion (14A Fig 1A) and the second anchor portion (14B Fig 1A) ([0037] “Backing 16 is folded over hook element 18 at crease 20 to form central flap zone 12, while adhesion zones 14A and 14B extend out from central flap zone 12 at creases 22A and 22B.”); a first fold line (22A Fig 1A) adjacent the handle support (see the flap 12 adjacent crease 22A Fig 1A), the first anchor portion being foldable about the first fold line (shown folded in Fig 1A); a second fold line (22B Fig 1A) adjacent to the handle support (see the flap 12 adjacent crease 22B Fig 1A), the second anchor portion being foldable about the second fold line (shown folded in Fig 1A), the handle (18 Fig 1A) being attached to the handle support for movement relative to the first anchor portion and the second anchor portion ([0037] “central flap zone 12 is flexible such that hook element 18 can be used to hang items in all such angles and orientations.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of modified Hietanen et al. to include the limitations as taught by Hoffman et al. to form the device such that it promotes adhesion to a surface under a variety of loading orientations [0037].
Regarding claim 15, modified Hietanen et al. teaches the hand held tissue lifting device of claim 14. Modified Hietanen et al. further teaches wherein the first anchor portion and the second anchor portion are folded about the respective fold lines such that the first anchor portion and the second anchor portion are substantially parallel to and face each other and are substantially parallel to the handle support (the modification in view of Hoffman et al. would result in the claimed configuration, because of the flexibility of the elongate body, the device would be folded as claimed during normal use, for example, before attachment to a surface, where only the crease to form the hinge for the hook is folded, the first and second anchor portions would be parallel and facing each other, and would be parallel with the handle support/central flap as they start as one planar sheet as shown in Fig 1B).
Regarding claim 19, modified Hietanen et al. teaches the hand held tissue lifting device of claim 14. Modified Hietanen et al. further teaches wherein the first anchor portion and the second anchor portion are folded about the respective fold lines such that the first anchor portion and the second anchor portion are substantially parallel to each other and substantially perpendicular the handle support, the first anchor portion and the second anchor portion lying in a common plane (See the configuration as shown in Figs 2 and 4a of Hoffman et al. the central flap 12 is substantially perpendicular to the anchor portions 14A and 14B which are lying in a common plane).
Regarding claim 26, modified Hietanen et al. teaches the hand held tissue lifting device of claim 14. However, modified Hietanen et al. fails to teach wherein a non-adhesive dead zone is formed on a portion of a periphery of one of the first anchor portion or the second anchor portion to assist a user in removal of the hand held tissue lifting device from the patient.
Hoffman et al. teaches wherein a non-adhesive dead zone (39 Fig 3, [0041] “adhesive layer 34 can also extend only as far as end line 38, thereby leaving a portion of panel 26B uncoated by adhesive layer 34. Thus, a portion of panel 26B can form pull tab 39 that can be grasped to peel panel 26B away from surface 40.”) is formed on a least a portion of a periphery of the second anchor (39 Fig 3 is formed on the edge of the second anchor 26B as shown in Fig 3) to assist a user in removal of the device from the attachment surface ([0041] “Thus, a portion of panel 26B can form pull tab 39 that can be grasped to peel panel 26B away from surface 40. Pull tab 39 can aid with removal of hanger device 10, such as by allowing panel 26B to be pulled up from an edge. Thus, because panel 26B is flexible, panel 26B can be pulled away from surface 40 along a peel front so that only a small amount of adhesive layer 34 needs to be overcome at a time.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of Hietanen et al. to include the non-adhesive dead zone with the limitations as taught by Hoffman et al. to aid with removal of the device from the attachment surface [0041].
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hietanen et al. (US
2018/0104087 A1), and in the alternative in view of Liu et al. (CN 201542695 U), and in view of Hoffman et al. (US 2019/0038051 A1) as applied to claim 14 above, and further in view of Pratl (US 2002/0166212 A1).
Regarding claim 16, modified Hietanen et al. teaches the hand held tissue lifting device of claim 14. the handle support includes a hinge (the modification in view of Hoffman et al. includes the hinge loop formed at crease 20 as shown in Fig 1).
However, modified Hietanen et al. fails to teach wherein said hinge is disposed fully interiorly of the periphery of said hand held tissue lifting device for applying a tensile force to said first anchor portion and to said second anchor portion only at a central portion of said hand held tissue device, and wherein said handle is rotatably attached to said handle support within said hinge.
Hoffman et al. teaches an alternate embodiment (Fig 9A) wherein said hinge (the loop in Fig 9A) is disposed fully interiorly of the periphery of said hand held tissue lifting device (as shown in Fig 9A, the loop is at the end of the 24A which is completely surrounded by the panels 26A and 26B) for applying a tensile force to said first anchor portion and to said second anchor portion only at a central portion of said hand held tissue device (The force transmitted through 24A Fig 9A would apply force as claimed). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the hinge to be disposed as taught by the alternate embodiment of Hoffman et al. to allow structure for tabs to “distribute loading of hook element 18 throughout both of panels 26A and 26B to minimize edge loading effects that can propagate peeling and separation of panels 26A and 26B from surface 40.” [0069].
Pratl teaches a handle (22 Fig 2) is rotatably attached within a hinge (50 Fig 8a) (See the rotation from Figs 2-4, [0028] “The first portion 70 of the ring 22 preferably fits within the recess 50 with a loose interference fit […]the ring is captured within the recess and is pivotally movable between its first and second positions with light finger pressure, but is held in place by friction between the ring and the base panel in the absence of external force.”, the handle freely rotates between positions relative to the anchor with light finger pressure). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of Hietanen et al. to include the hinge with the limitations as taught by Pratl to allow the user to easily orient the handle relative to the anchor to accommodate the user’s preferences or needs. Accordingly, Hietanen et al. teaches embodiments where the handle may have a different orientation relative to the anchor ([0043] “therapy tape 11 may have a different handle orientation relative to the length of the therapy tape 11”).
Regarding claim 17, modified Hietanen et al. teaches the hand held tissue lifting device of claim 16. Modified Hietanen et al. further teaches wherein the handle is rotatable within the hinge relative to the first and second anchor portions about an arc of approximately 360 degrees (where the handle of Hoffman et al. is not adhered to the central flap as taught by Pratl, the handle would be rotatable within the hinge around the central flap about an arc of approximately 360 degrees as claimed, only not being able to rotate beyond when the handle contacts the flap at 0 and 360 degree positions ).
Regarding claim 18, modified Hietanen et al. teaches the hand held tissue lifting device of claim 17. Modified Hietanen et al. further teaches wherein the handle lies substantially parallel to and in closely spaced facing relation to the first anchor portion or the second anchor portion (See the configuration as shown in Figs 5A and 5B of Hoffman et al. the central flap 12 is substantially parallel to and in closely spaced facing relation to the anchor portion 26B).
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Hietanen et al. (US
2018/0104087 A1), and in the alternative in view of Liu et al. (CN 201542695 U), and in view of Hoffman et al. (US 2019/0038051 A1) as applied to claim 14 above, and further in view of Carriere (US 6,769,541 B1).
Regarding claim 20, modified Hietanen et al. teaches the hand held tissue lifting device of claim 14. However, modified Hietanen et al. fails to teach wherein the handle defines an opening that is sized and configured for insertion of a user’s fingers such that the handle may be hand held.
Carriere teaches a handle defines an opening (10a, 10b Fig 2c) that is sized and configured for insertion of a user’s fingers (As shown in Fig 2C) such that the handle may be handheld. It would have been obvious to one of ordinary skill in the art at the time of effective filing for the opening of Hietanen et al. to be sized and configured with the limitations as taught by Carriere to permit the handle to be gripped by the fingers of a user (Col 7 lines 38-53).
Regarding claim 21, modified Hietanen et al. discloses the hand held tissue lifting device of claim 20. Modified Hietanen et al. further teaches wherein the opening is fully enclosed (The D-ring of Hietanen et al. is fully enclosed, further the opening of Carriere is fully enclosed in Fig 2c).
Regarding claim 22, modified Hietanen et al. discloses the hand held tissue lifting device of claim 21. Hietanen et al. further teaches wherein the fully enclosed opening is defined by a semicircular ring or loop ([0039] the handle is a D-ring, A D-ring is a fully enclosed semicircular ring).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Hietanen et al. (US
2018/0104087 A1), and in the alternative in view of Liu et al. (CN 201542695 U), and in view of Hoffman et al. (US 2019/0038051 A1) as applied to claim 14 above, and further in view of Geist (US 4,333,468 A).
Regarding claim 24, modified Hietanen et al. teaches the hand held tissue lifting device of claim 14. Modified Hietanen et al. further teaches wherein said handle support (Hoffman et al.- 12 Fig 1A) comprises a first attachment zone (24A Fig 1B) and a second attachment zone (24B Fig 1B) that are connected to each other by a connecting adhesive ([0041] “a first side of panels 24A, 24B, 26A and 26B is exposed, while a second side is substantially covered with adhesive layer 34. As shown in FIG. 3”) to form said handle support.
However Modified Hietanen et al. fails to teach said connecting adhesive having a stronger adhesive strength than an adhesive strength of the first layer of adhesive on said lower surface of said first anchor portion and an adhesive strength of said second layer of adhesive on said lower surface of said second anchor portion.
Geist teaches a connecting adhesive (33 Fig 4) having a stronger adhesive strength than an adhesive strength of the first layer of adhesive (36 Fig 4) on said lower surface of said first anchor portion (the left side of 30b Fig 4) and an adhesive strength of said second layer of adhesive (36 Fig 4) on said lower surface of said second anchor portion (the right side of 30b Fig 4) (the adhesive strength of a permanent adhesive 33 is stronger than that of a skin safe pressure sensitive adhesive 36, Col 4 lines 4-6 “upwardly extending intermediate portions 31b, 32b likewise joined by the permanent adhesive 33.”, Col 4 lines 22-25 “the peel-off strip, if any, is separated from adhesive layer 36 and then the adhesive layer 36 adhered to the patient's skin in the desired position.“). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the adhesives of modified Hietanen et al. to include the limitations as taught by Geist to strengthen the structure of the device with an adhesive that will not result in unintentional disassembly.
Accordingly, Hoffman et al. teaches that it is known to more securely attach the handle support layers to eliminate a peel from ([0055] “panels 24A and 24B can be welded or otherwise fixed together to eliminate a peel front.”).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Hietanen et al. (US
2018/0104087 A1), and in the alternative in view of Liu et al. (CN 201542695 U), and in view of Hoffman et al. (US 2019/0038051 A1) as applied to claim 14 above, and further in view of Hagy et al. (US 2016/0339186 A1).
Regarding claim 25, modified Hietanen et al. teaches the hand held tissue lifting device of claim 14. However, modified Hietanen et al. fails to teach wherein a cutout is formed into a periphery of at least one of the first anchor portion or the second anchor portion.
Hagy et al. teaches a cutout is formed into a periphery of at least one of the first anchor portion or the second anchor portion (24 Fig 1B). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of modified Hietanen et al. to include the cutout with the limitations as taught by Hagy et al. to allow “access through the skin contacting member 14 to reach the skin beneath, for instance for placement of a catheter, a needle, an IV line, a dialysis port (e.g., to access a fistula), or the like.” [0051]
Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Hietanen et al. (US
2018/0104087 A1), and in the alternative in view of Liu et al. (CN 201542695 U), and in view of Hoffman et al. (US 2019/0038051 A1) as applied to claim 14 above, and further in view of Leung et al. (US 2021/0251628 A1).
Regarding claim 27, modified Hietanen et al. discloses the hand held tissue lifting device of claim 14. However, modified Hietanen et al. fails to teach a container, comprising: one or more hand held tissue lifting devices of claim 14; and a tray within which the one or more hand held tissue lifting devices are contained.
Leung et al. teaches a tray ([0035] “a procedure kit tray”) within which the one or more devices are contained ([0035] “The combined unit may then be disposed in a sterile package such as a Tyvek pouch, blister packaging, a procedure kit tray”). It would have been obvious to one of ordinary skill in the art at the time of effective filing to include the tray with the limitations as taught by Leung et al. to provide for a sterile package for the device which would prevent incidence of infection where it is used in a surgical procedure.
Regarding claim 28, modified Hietanen et al. discloses the container of claim 27. Modified Hietanen et al. further teaches where the tray and one or more of the hand held tissue lifting devices are sterilized (Leung et al.- [0035] “then terminally sterilized with ethylene oxide, gamma or e-beam irradiation, plasma, or other sterilization methods known in the art.”, where the contents of the tray are sterilized this includes the one or more of the hand held tissue lifting devices).
Claims 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman et al. (US
2019/0038051 A1) and Pratl (US 2002/0166212 A1) and in the alternative in view of Liu et al. (CN 201542695 U).
Regarding claim 29, Hoffman et al. discloses a hand held tissue lifting device (while the device of Hoffman et al. does not contemplate the use of tissue lifting, it is fully capable of performing the
claimed intended use, the adhesive would attach to skin and would lift tissue upon applying a force to the hook) configured to elevate abdominal tissue of a patient in laparoscopic surgery, said device being (the device of Hoffman et al. is fully capable of being adhered to abdominal tissue and this can be performed during a laparoscopic surgery, [0003] “the ability of the adhesive to remain adhered to a surface under load”) formed by a process comprising the steps of: providing an elongate base (Fig 1B, [0006] “an elongate sheet of pliable backing,”) having a first end and an opposing second end (the bottom and top ends as shown in Fig 1B, [0006] “The elongate sheet of pliable backing comprises a first end, a second end”), an upper surface (the surface shown in Fig 1A), a lower surface (the surface with the adhesive layer, [0006] “The adhesive layer is disposed on one side of the sheet of pliable backing.”), a first anchor portion adjacent the first end ([0006] “a first zone positioned adjacent the first end”, [0038] “adhesion zones 14A and 14B”, 14A Fig 1B) and a second anchor portion adjacent the second end ([0006] “a second zone positioned adjacent the second end”, 14B Fig 1B), a connecting portion (the loop formed by crease 20 in Fig 1A) disposed between and joining the first anchor portion and the second anchor portion (As shown in Figs 1A and 1B, the loop at the crease 20 is in the center of the elongate sheet, joining the ends together), a first attachment zone (24A Fig 1B) between the first anchor portion and the connecting portion, a first fold line (See the dashed line 22A in Fig 1B, and 22A folded in Fig 1A) between the first anchor portion and the first attachment zone, a second attachment zone (24B Fig 1B) between the second anchor portion and the connecting portion, a second fold line (See the bottom dashed line in Fig 1B, opposite 22A, and labeled 22B in Fig 1A) between the second anchor portion and the second anchor portion, a first layer of adhesive on a lower surface of the first attachment zone, a second layer of adhesive on a lower surface of the second attachment zone ([0041] “a first side of panels 24A, 24B, 26A and 26B is exposed, while a second side is substantially covered with adhesive layer 34”, [0055] “central flap zone 12 comprises two panels of backing 16 joined by two portions of adhesive layer 34”, the adhesive layer on 24A is a first layer of adhesive, the adhesive layer on 24B is a second layer of adhesive); providing a handle (18 Fig 1A) sized and configured to be hand held by a user (a hanger hook 18 can be hand held by a user), the handle having a section defining a hinge pin (30A, 30B Fig 1A define hinge pins); placing the handle in juxtaposition to the elongate base; and folding the connecting portion over the hinge pin to move the first and second anchor portions toward each other to place the first attachment zone and the second attachment zone in alignment, and then joining the first layer of adhesive of the first attachment zone to the second layer of adhesive of the second attachment zone to thereby form a hinge about the hinge pin (the product formed is shown in Fig 1A with the first and second attachment zones joined and the hinge at crease 20 formed around the hinge pins 30A and 30B, [0037] “Backing 16 is folded over hook element 18 at crease 20 to form central flap zone 12, while adhesion zones 14A and 14B extend out from central flap zone 12 at creases 22A and 22B.”).
However, Hoffman et al. fails to disclose a non-adhesive surface on a lower surface of the connecting portion, the hinge pin in alignment with the non-adhesive surface of the connecting portion, and a hinge about the hinge pin within which the handle may freely rotate.
Pratl teaches a non-adhesive surface on a lower surface of the connecting portion (50 Fig 8A, the surface 60 in Fig 5 is formed of a foam [0027]), the hinge pin (70 Fig 8b) in alignment with the non-adhesive surface of the connecting portion (See the arrow showing the assembly in Fig 8b and the assembled device in Fig 9), and a hinge about the hinge pin (the gap 50 forms the hinge) within which the handle may freely rotate (See the rotation from Figs 2-4, [0028] “The first portion 70 of the ring 22 preferably fits within the recess 50 with a loose interference fit […]the ring is captured within the recess and is pivotally movable between its first and second positions with light finger pressure, but is held in place by friction between the ring and the base panel in the absence of external force.”, the handle freely rotates between positions relative to the anchor with light finger pressure). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the connecting portion of Hoffman et al. to include the non-adhesive surface with the limitations as taught by Pratl to allow the user to easily orient the hook relative to the flap to accommodate the user’s preferences or needs.
Regarding claim 29, Hoffman et al. discloses a device formed by a process comprising the steps of: providing an elongate base (Fig 1B, [0006] “an elongate sheet of pliable backing,”) having a first end and an opposing second end (the bottom and top ends as shown in Fig 1B, [0006] “The elongate sheet of pliable backing comprises a first end, a second end”), an upper surface (the surface shown in Fig 1A), a lower surface (the surface with the adhesive layer, [0006] “The adhesive layer is disposed on one side of the sheet of pliable backing.”), a first anchor portion adjacent the first end ([0006] “a first zone positioned adjacent the first end”, [0038] “adhesion zones 14A and 14B”, 14A Fig 1B) and a second anchor portion adjacent the second end ([0006] “a second zone positioned adjacent the second end”, 14B Fig 1B), a connecting portion (the loop formed by crease 20 in Fig 1A) disposed between and joining the first anchor portion and the second anchor portion (As shown in Figs 1A and 1B, the loop at the crease 20 is in the center of the elongate sheet, joining the ends together), a first attachment zone (24A Fig 1B) between the first anchor portion and the connecting portion, a first fold line (See the dashed line 22A in Fig 1B, and 22A folded in Fig 1A) between the first anchor portion and the first attachment zone, a second attachment zone (24B Fig 1B) between the second anchor portion and the connecting portion, a second fold line (See the bottom dashed line in Fig 1B, opposite 22A, and labeled 22B in Fig 1A) between the second anchor portion and the second anchor portion, a first layer of adhesive on a lower surface of the first attachment zone, a second layer of adhesive on a lower surface of the second attachment zone ([0041] “a first side of panels 24A, 24B, 26A and 26B is exposed, while a second side is substantially covered with adhesive layer 34”, [0055] “central flap zone 12 comprises two panels of backing 16 joined by two portions of adhesive layer 34”, the adhesive layer on 24A is a first layer of adhesive, the adhesive layer on 24B is a second layer of adhesive); providing a handle (18 Fig 1A) sized and configured to be hand held by a user (a hanger hook 18 can be hand held by a user), the handle having a section defining a hinge pin (30A, 30B Fig 1A define hinge pins); placing the handle in juxtaposition to the elongate base; and folding the connecting portion over the hinge pin to move the first and second anchor portions toward each other to place the first attachment zone and the second attachment zone in alignment, and then joining the first layer of adhesive of the first attachment zone to the second layer of adhesive of the second attachment zone to thereby form a hinge about the hinge pin (the product formed is shown in Fig 1A with the first and second attachment zones joined and the hinge at crease 20 formed around the hinge pins 30A and 30B, [0037] “Backing 16 is folded over hook element 18 at crease 20 to form central flap zone 12, while adhesion zones 14A and 14B extend out from central flap zone 12 at creases 22A and 22B.”).
However, Hoffman et al. fails to explicitly disclose the device is a hand held tissue lifting device configured to elevate abdominal tissue of a patient in laparoscopic surgery, said device being a non-adhesive surface on a lower surface of the connecting portion, the hinge pin in alignment with the non-adhesive surface of the connecting portion, and a hinge about the hinge pin within which the handle may freely rotate.
Pratl teaches a non-adhesive surface on a lower surface of the connecting portion (50 Fig 8A, the surface 60 in Fig 5 is formed of a foam [0027]), the hinge pin (70 Fig 8b) in alignment with the non-adhesive surface of the connecting portion (See the arrow showing the assembly in Fig 8b and the assembled device in Fig 9), and a hinge about the hinge pin (the gap 50 forms the hinge) within which the handle may freely rotate (See the rotation from Figs 2-4, [0028] “The first portion 70 of the ring 22 preferably fits within the recess 50 with a loose interference fit […]the ring is captured within the recess and is pivotally movable between its first and second positions with light finger pressure, but is held in place by friction between the ring and the base panel in the absence of external force.”, the handle freely rotates between positions relative to the anchor with light finger pressure). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the connecting portion of Hoffman et al. to include the non-adhesive surface with the limitations as taught by Pratl to allow the user to easily orient the hook relative to the flap to accommodate the user’s preferences or needs.
Liu et al. teaches a hand held tissue lifting device (Fig 1) configured to elevate abdominal tissue of a patient in laparoscopic surgery ([0001] “laparoscopic skin lifting forceps”, “effectively lift the umbilical skin.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of modified Hoffman et al. to be configured for use in a laparoscopic surgery as taught by Liu et al. to “to increase the abdominal space and prevent the pneumoperitoneum puncture needle from damaging the intestine and other abdominal organs.” [0002]
Regarding claim 30, modified Hoffman et al. teaches the hand held tissue lifting device of claim 29. Modified Hoffman et al. further teaches wherein the first anchor portion comprises a first adhesive on a lower surface and the second anchor portion comprises a second adhesive on a lower surface (first and second anchor portions 14A and 14B, also shown as 26A and 26B Fig 1B each include a layer of an adhesive 34, [0041] “a first side of panels 24A, 24B, 26A and 26B is exposed, while a second side is substantially covered with adhesive layer 34”), said first adhesive and said second adhesive each being configured to sufficiently jointly tent the abdomen under a tensile force for insertion of an instrument through said elevated skin (using paragraph [045] from the instant application specification, an adhesive sufficiently capable is described as “may be comprised of biocompatible materials including synthetic rubber, silicone, or acrylic based adhesives, or other suitable commercially available adhesive”, [0046] “In some embodiments, the peelable adhesive layer can include at least one of rubber, silicone, or acrylic based adhesives”), and wherein each of the first adhesive and the second adhesive is covered by a removable liner (liners 36A and 36B Fig 3, [0041] “panels 26A and 26B are provided with protective sheets 36A and 36B, respectively, to cover adhesive layer 34.”, [0054] “In FIG. 2, protective sheets 36A and 36B (see FIG. 3) are removed so that folding flap hanger device 10 can be adhered to surface 40.”).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Hoffman et al. (US
2019/0038051 A1), and Pratl (US 2002/0166212 A1), and in the alternative in view of Liu et al. (CN 201542695 U) as applied to claim 29 above, and further in view of Buttaravoli (US 4,324,237 A).
Regarding claim 23, modified Hoffman et al. teaches the hand held tissue lifting device of claim 29. Modified Hoffman et al. further teaches wherein each of said first anchor portion and said second anchor portion comprises a sheet of polymer material ([0046] “copolymers of isooctylacrylate and acrylic acid, which can be polymerized by radiation, solution, suspension, or emulsion techniques”).
However, modified Hietanen et al. fails to teach and wherein a third layer of adhesive is disposed on said lower surface of said connecting portion, and wherein said non-adhesive surface is defined by a covering disposed on said third layer of adhesive.
Buttaravoli teaches a non-adhesive surface is defined by a layer of adhesive covering (narrow liner 13 Figs 2 and 9) disposed on a layer of adhesive (liner 13 is disposed on adhesive layer 11 as shown in the expanded view in Fig 2, Col 5 lines 48-50 “narrow liner 13 may be permanently adhered to the endmost portion 9c of cover strip 9”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the non-adhesive surface of modified Hietanen et al. to be defined by a covering with the limitations as taught by Buttaravoli as this is taught as a known alternative to an adhesive layer stopping short of the non-adhesive surface (Col 5 lines 50-51).
Conclusion
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/A.E.V./Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783