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 .
Election/Restrictions
Applicant’s election without traverse of Invention II, claims 25-40, drawn to a method of applying an insert at a patient in connection with an endoscopy procedure, in the reply filed on April 10, 2026 is acknowledged.
Claims 1-24 have been cancelled. Claims 25-57 are currently pending.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 25, 28-29, 33, 36-39, 41, 45, 48-53, and 55 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arber (US 2011/0087263, hereinafter “Arber”).
Regarding claim 25, Arber discloses a method of applying an insert at a patient in connection with an endoscopy procedure (para [0011-0013]), the method comprising:
placing the insert (bladders 6, 7, 8, 9) between the patient and at least a portion of an elastic compression device (elastic abdominal binder 1; para [0034]), wherein the insert includes:
an outer housing (bladders 6, 7, 8, 9) having at least a portion comprising a flexible, pliable material (para [0037]); and
an inner material within the outer housing (filler material of bladders – air or liquid; para [0037]), wherein the inner material has at least one property related to adipose tissue (filler material allows insert to be moldable or provide cushioning, similar or related to adipose tissue);
maintaining or applying at least the portion of the elastic compression device over the insert (para [0042-0043]; Figs 6-8); and
maintaining the insert at an abdomen of the patient during one or more of endoscope insertion, imaging, endoscope withdrawal, or a post endoscopy time period (para [0042-0043]).
Regarding claim 28, wherein the insert (bladders 6, 7, 8, 9) is positioned between the abdomen of the patient and a primary wrap (1) of the elastic compression device (para [0042-0043]; Figs 6-8).
Regarding claim 29, further comprising: adjusting compression delivered to the abdomen via the insert based on one or more of: adjustment of a primary band (1) of the elastic compression device (through fastening means 2; para [0034]), adjustment of at least one secondary strap of the elastic compression device, adjustment of insert placement (para [0042]), or adjustment of a moveable component of the insert (inflation adjustment para [0039]).
Regarding claim 33, wherein the outer housing includes a first side including a first material (hard, supportive plate 3 made out of metal, cardboard, or preferably plastic – para [0035]), and a second side including a second material (flexible bladder material - para [0037]) and configured for placement toward the abdomen of the patient (Figs 6-8), wherein the first material is different than the second material, and wherein the second material has a lower hardness than the first material.
Regarding claim 36, further comprising: inserting a fluid (air or liquid) into an interior of the outer housing to generate the inner material as a viscous material or change a property of the insert (change property of insert by controlling inflation pressure – para [0039]).
Regarding claim 37, further comprising: manipulating one or more moveable components within the outer housing to adjust compression to the abdomen of the patient (move walls of bladder by adjusting inflation pressure to adjust compression to the abdomen – para [0039]).
Regarding claim 38, further comprising: manipulating the inner material of the insert to form a moldable structure to assist in targeted compression at the abdomen (by adjusting inflation pressure of bladders – para [0039]).
Regarding claim 39, wherein the outer housing includes multiple compartments (bladder sleeve pockets 5), each compartment filled with one or more inner materials (bladders 6, 7, 8, 9) (para [0038-0039]).
Regarding claim 41, further comprising: inserting a gas (air) into an interior of the outer housing to generate the inner material as a viscous material or change a property of the insert (inflate bladder to change a pressure of the insert – para [0039]).
Regarding claim 45, wherein inserting the fluid into the interior of the outer housing includes inserting the fluid via: a self-healing material, a spout, or a port (10b) (Fig 6; para [0033, 0039]).
Regarding claim 48, further comprising a gas (air) within the outer housing (para [0039]).
Regarding claim 49, wherein the insert further includes an inflatable bladder (bladders 6, 7, 8, 9; para [0037, 0039]).
Regarding claim 50, wherein the inner material forms a moldable structure within the outer housing (moldable depending on inflation pressure of inner material – para [0039]).
Regarding claim 51, wherein a shape of the moldable structure is maintained based on a relationship between a volume of the inner material relative to an interstitial space enclosed by the outer housing (para [0039]).
Regarding claim 52, wherein one or more of the outer housing or the inner material includes a pressure reactive material (para [0039]).
Regarding claim 53, wherein the multiple compartments are fully enclosed and separate (para [0038-0039]).
Regarding claim 55, wherein each of the multiple compartments includes a same filler materials (para [0037, 0039]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 26-27, 30-32, 40, 43, 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arber (US 2011/0087263), as applied to claim 25 above, in view of Hathorn (US 2020/0206058, hereinafter “Hathorn”).
Regarding claims 26-27, Arber discloses the invention substantially as claimed, as shown above, including wrapping a primary wrap (1) of the elastic compression device around the abdomen of the patient. However, Arber fails to disclose the claimed secondary strap and the step of wrapping the primary wrap (10) of the elastic compression device around the abdomen of the patient before placing the insert on an exterior side of the primary wrap, wherein the insert is placed between the primary wrap and at least one secondary strap of the elastic compression device. Hathorn discloses a similar method of applying an insert at a patient in connection with an endoscopy procedure (Figs 25-26) and teaches wrapping the primary wrap (10) of the elastic compression device around the abdomen of the patient (para [0044]; step 2602 of Fig 26) before placing the insert on an exterior side of the primary wrap (step 2610), wherein the insert is placed between the primary wrap and at least one secondary strap (44) of the elastic compression device and compression applied to the abdomen is adjusted by fastening the secondary strap of the elastic compression device over the insert (para [0062]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Arber such that the elastic compression device comprised both a primary wrap and a secondary strap, as taught by Hathorn, and such that the method comprised wrapping the primary wrap of the elastic compression device around the abdomen of the patient before placing the insert on an exterior side of the primary wrap, wherein the insert is placed between the primary wrap and at least one secondary strap of the elastic compression device and compression applied to the abdomen is adjusted by fastening the secondary strap of the elastic compression device over the insert, since substitution of one known element (Arber’s method of wrapping with a single primary wrap) for another element (Hathorn’s method of wrapping with a primary wrap and secondary strap) providing the same function (applying compression during an endoscopy procedure) to yield predictable results would have been obvious to one of ordinary skill in the art at the time of the invention. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 at 416, 82 USPQ2d 1385 at 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Regarding claim 30, Arber teaches adjusting the insert (bladders 6,7,8,9) to different inflation pressures depending on the patient (para [0039]). Furthermore, Hathorn teaches adjusting an insert multiple times during an endoscopic procedure as needed (para [0062-0065]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Arber to include the step of further comprising: iterative application and removal of the insert multiple times during an endoscopic procedure to optimize the externally applied pressure for an improved colonoscopy and since a person with ordinary skill has good reason to pursue the known options within his or her technical grasp and since it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success
Regarding claim 31, Arber fails to disclose the claimed pressure sensor. Hathorn discloses a similar method of applying an insert at a patient in connection with an endoscopy procedure (Figs 25-26) and teaches placing a pressure sensor between the abdomen of the patient and the elastic compression device (para [0079]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Arber to include the step of placing a pressure sensor between the abdomen of the patient and the elastic compression device, as taught by Hathorn, for the purpose of monitoring the applied pressure to ensure an optimal pressure is applied.
Regarding claim 32, Arber teaches the outer housing of the insert (bladder) may have any shape (para [0017]). Furthermore, Hathorn teaches the insert may comprise a variety of shapes wherein “the insert shape may be configured to provide firm pressure to the sigmoid colon without pinching the colon or compressing the lumen in a way that impedes the advancement of the colonoscope” (para [0050]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Arber such that the outer housing includes a wider portion configured for placement at the abdomen of the patient between iliac crests of hips of the patient, wherein the wider portion includes a first edge and a second edge, and wherein the first edge and the second edge of the wider portion taper to a narrower portion configured for the placement at a lower abdominal region below the iliac crests to optimize the shape such that “the insert shape may be configured to provide firm pressure to the sigmoid colon without pinching the colon or compressing the lumen in a way that impedes the advancement of the colonoscope” (para [0050]), as taught by Hathorn.
Regarding claims 40 and 57, Arber fails to teach rupturing a container within the outer housing to cause a reaction that warms the insert. Hathorn teaches the benefit of applying heat with the wrap to relax the patient and assist in the procedure. The Examiner is taking Official Notice that it is old and well known in the art to provide heating pads that are activated by rupturing a container to cause a warming reaction. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Arber to provide a known heating pad, as taught by Hathorn, and include the step of rupturing a container within the outer housing to cause a reaction that warms the insert.
Regarding claim 43, Arber fails to disclose the insert is attached as claimed. Hathorn teaches “the insert may be attached to the primary wrap by an adhesive, Velcro, or magnets while the primary wrap is fastened” (para [0047]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Arber to further include one or more protrusions extending from the first side, a hook material at the first side, or an adhesive positioned at the first side, as taught by Hathorn, to securely attach to the wrap.
Claim(s) 34, 42, 44, 54, and 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arber (US 2011/0087263), as applied to claim 25 above.
Regarding claims 34 and 44, Arber discloses the invention substantially as claimed, as shown above, including the inflatable bladders being inflated generically by air or fluid. However, Arber fails to disclose the specific material or material properties of the inflation fluid. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Arber such that the inflation fluid comprised a material having at least one property including a density within a range of 0.75-1.5 g/cm3 or 0.85-0.95 g/cm3 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 obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 42, Arber discloses the invention substantially as claimed, as shown above, including the inflatable bladders being inflated generically by air or fluid. However, Arber fails to disclose the combination of a fluid and a gas to generate the inner material as a viscous material or change a property of the insert. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Arber such that the material of the inflation fluid comprised a liquid and a gas as claimed 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 obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 54, Arber discloses the invention substantially as claimed, as shown above, but fails to disclose the multiple compartments are connected via one or more channels. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying Arber such that the multiple compartments are connected via one or more channels in an attempt to provide an improved method allowing for a single inflation mechanism for the multiple compartments, as a person with ordinary skill has good reason to pursue the known options within his or her technical grasp and since it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success. Futhermore, it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Regarding claim 56, Arber discloses the invention substantially as claimed, as shown above, but fails to disclose different filler material for different compartments. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Arber such that different filler material was used for different compartments since Arber teaches any generic air or fluid may be used as filler material and 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 obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arber (US 2011/0087263), as applied to claim 25 above, in view of Choi et al. (US 2013/0180530, hereinafter “Choi”).
Regarding claim 35, Arber discloses the invention substantially as claimed, as shown above, including the inflatable bladders being inflated generically by air or fluid. However, Arber fails to disclose the specific material or material properties of the inflation fluid. Choi teaches a similar adjustable support system with a plurality of bladders or pods that “may be filled with an incompressible fluid such as water, viscous oil, or some other biocompatible fluid” (para [0017]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Arber such that the bladders were filled with a material including one or more of a viscous material, a gel, or a fluidized material, as taught by Choi, 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 obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 46-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arber (US 2011/0087263), as applied to claim 25 above, in view of Emslander et al. (US 2019/0388263, hereinafter “Emslander”). Arber discloses the invention substantially as claimed, as shown above, but fails to teach the movable component of the inflatable bladder comprises a plurality of spherical components or a porous foam as claimed. Emslander discloses a similar compression device and teaches reinforcing portion of the compression device may include foam layers with microspheres or expandable microspheres (para [0094]). Emslander teaches “the microspheres may be compressible and retain their spherical shape and integrity after compression, resulting in the reinforcing portion being very resilient and having a high restoration force. During use/wear of the support article, the reinforcing portion(s) readily conform to user movement but continue to provide support because the expanded spheres are resilient and provide strength and support before, during, and after compression” (para [0095]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Arber such that the bladders were filled with a plurality of spherical components or a porous foam as claimed, as taught by Emslander, to improve the resilience and strength of the bladder and 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 obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771
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