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 .
Detailed Action
This is in response to non-provisional application filed 10/16/2024.
Claim Interpretation - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 5 recites wherein the closure element is a filter, the filter including one or more hooks extending from the saddle region.
The Office agrees the art for record fails to teach or suggest these features.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 14, 15 19 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claims 14, 19 recite the flanges anchored against the duodenum which would encompass a device in combination with a human organism.
The Office suggests the following amendment to withdraw the rejection:
14. (currently amended) The pyloric occlusion device according to claim 1, wherein the pyloric occlusion is deployable across a pylorus with the saddle region bridging the pylorus, the first flange configured to be anchored against a duodenum side of the pylorus, the second flange configured to be anchored against a gastric side of the pylorus, and the closure element operable to occlude the flow of material through a pylorus.
19. (currently amended) The system according to claim 16, wherein the pyloric occlusion is deployable across a pylorus with the saddle region bridging the pylorus, one of the first flange or the second flange configured to be .
Claim Rejections - 35 USC § 102
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) 1, 2, 9, 14, 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticapted by U.S. Patent Publication Number 2003/0153935 (Miahle)
Regarding claim 1, 2, 9, 14, 15 Miahle discloses as shown in Figures 1-5 a pyloric occlusion device capable of deployment across a pylorus, the device comprising: a first flange (member 3, see paragraph [0073]); a second flange (member 4, see paragraph [0073]) connected to the first flange by a saddle region (middle region of intermediate portion 5, see paragraph [0083]) defining a lumen, the second flange being proximal to the first flange; and a closure element (constriction region 6, see paragraph [0083]), wherein the closure element is capable of occluding a flow of material through the lumen upon deployment of the device, and to continue to occlude flow of material after deployment of the device, wherein the closure element is a closure of the lumen by rotation of one of the first or second flange relative to the other of the first or second flange, or by rotation of the first and second flange opposite of each other, wherein a first diameter of the first flange is equal to a second diameter of the second flange, wherein the pyloric occlusion is deployable across a pylorus with the saddle region bridging the pylorus, the first flange anchored against a duodenum side of the pylorus, the second flange anchored against a gastric side of the pylorus, and the closure element operable to occlude the flow of material through a pylorus, wherein the pyloric occlusion device is removable to allow flow of material through the pylorus. See paragraphs [0083]-[0085].
Claim(s) 1, 3, is/are rejected under 35 U.S.C. 102(a)(1) as being anticapted by U.S. Patent Publication Number 2009/0093837 (Dillion)
Regarding claims 1, 3 Dillion discloses as shown in Figure 3 a pyloric occlusion device capable of deployment across a pylorus, the device comprising: a first flange (anchor 32, see paragraph [0019]); a second flange (anchor 34, see paragraph [0019]) connected to the first flange by a saddle region (middle region of tube 22, see paragraph [0020]) defining a lumen, the second flange being proximal to the first flange; and a closure element (elastic band 52, see paragraph [0023]), wherein the closure element is capable of occluding a flow of material through the lumen upon deployment of the device, and to continue to occlude flow of material after deployment of the device, wherein the closure element is a fastener. See paragraphs [0083]-[0085].
Claim(s) 1, 4, is/are rejected under 35 U.S.C. 102(a)(1) as being anticapted by U.S. Patent Publication Number 2005/0273060 (Levy et al.)
Regarding claims 1, 4 Levy et al. discloses as shown in Figure 19 a pyloric occlusion device capable of deployment across a pylorus, the device comprising: a first flange (chamber 430, see paragraph [0142]); a second flange (chamber 440, see paragraph [0142]) connected to the first flange by a saddle region (middle region of passageway 420, see paragraph [00142]) defining a lumen, the second flange being proximal to the first flange; and a closure element (valve 480, see paragraph [0143]), wherein the closure element is capable of occluding a flow of material through the lumen upon deployment of the device, wherein the closure element is a plug to fill the lumen. See paragraphs [0083]-[0085].
Claim(s) 1, 6-8, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticapted by U.S. Patent Publication Number 2013/0030351 (Belhe et al.)
Regarding claims 1, 6, 7 Belhe et al. discloses as shown in Figure 28 a pyloric occlusion device capable of deployment across a pylorus, the device comprising: a first flange (one of anchors 394, see paragraph [0139]); a second flange (the other one of anchors 394, see paragraph [0139]) connected to the first flange by a saddle region (middle region of central cylinder 396 and 397, see paragraph [00139]) defining a lumen, the second flange being proximal to the first flange; and a closure element (valve 401, see paragraph [0139]), wherein the closure element is capable of occluding a flow of material through the lumen upon deployment of the device, wherein the first flange includes a bulb and the second flange includes a duodenal extension; wherein the pyloric occlusion device is formed of a braided self-expanding material, wherein the braided material is concentrated at the closure element. see paragraphs [0091], [0098].
Regarding claim 20 Belhe et al. discloses as shown in Figures 16, 22, 30, 48A-51 a method for delivering an occlusion device to a pylorus in an endoscopic procedure, comprising: deploying a first flange (one of anchors 394, see paragraph [0139]) of a pyloric occlusion device against a duodenum side of the pylorus; extending an occluded saddle region (middle region of central cylinder 396 and 397, see paragraph [00139]) of the pyloric device across the pylorus to occlude the pylorus upon deployment; and deploying a second flange (the other one of anchors 394, see paragraph [0139]) of a pyloric occlusion device against a gastric side of the pylorus.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2005/0273060 (Levy et al.).
Regarding claim 10, Levy fails to disclose in the embodiment in Figure 21, a first diameter of the first flange is different from a second diameter of the second flange.
Levy discloses in another embodiment shown in Figures 17, 18 a similar device with similar first and second flanges (230, 240) for the purpose of isolating stomach content from the grinding and propelling action of the antrum A thereby further enhancing the mal-digestive nature of the invention, and reducing the stomach volume and has a potential for creating a bigger satiety effect.
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 device disclosed by Levy by increasing the size of first expandable chamber 30 such that a first diameter of the first flange is different from a second diameter of the second flange in order to isolate stomach content from the grinding and propelling action of the antrum A thereby further enhancing the mal-digestive nature of the invention, and reducing the stomach volume and has a potential for creating a bigger satiety effect.
Claim 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2005/0273060 (Levy et al.) in view of U.S. Patent Publication Number 2009/0082644 (Li)
Regarding claim 11, Levy fails to disclose one or more mechanical fasteners disposed around the second flange for anchoring the second flange to tissue.
Li, from the same field of endeavor teaches a similar occlusion device as show in Figure 4a the device includes one or more mechanical fasteners (distal projections 308, 308', 308'', see paragraph [0060]) for the purpose of keeping that part of the device in place and not entering the intestine.
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 device disclosed by Levy to include the projections 308, 308', 308'' around first expandable chamber 30 in order to keeping that part of the device in place and not entering the intestine.
Claims 12, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2005/0273060 (Levy et al.) in view of U.S. Patent Publication Number 2012/0184980 (Anderson)
Regarding claims 12, 13 Levy fails to disclose wherein a covering is disposed on a least a portion of the first flange, second flange, or lumen, or combinations thereof, for preventing tissue ingrowth, a membrane, sleeve, or coating, or combinations thereof.
Anderson, from the same field of endeavor teaches a similar system as shown in Figure 1, where the device includes a covering (coating of sheath, see paragraph [0052]) for the purpose of preventing tissue ingrowth. See paragraph [0052].
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 device disclosed by Levy to include the coating disclosed by Anderson disposed on at least a portion of the first flange or second flange in order to prevent tissue ingrowth.
Claims 16, 17, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2013/0030351 (Belhe et al.) in view of U.S. Patent Publication Number 2015/0374383 (Bodewadt et al.)
Regarding claims 16, 17, 19 Belhe et al. discloses as shown in Figure 5, 6, 30, 36 a system for delivering an occlusion device to a pylorus in an endoscopic procedure, the system comprising: a delivery device including an inner member (pusher catheter 642, see paragraph [0145]) having a guidewire (guidewire 702) and a retractable outer sheath (outer capsule 706, see paragraph [0177]), the inner member and the outer sheath being operable to constrain the occlusion device therebetween prior to deployment; wherein the occlusion device includes: a first flange (cylindrical portion 359, see paragraph [0098]); a second flange (disk 360, see paragraph [0098]) connected to the first flange by a saddle region (cylindrical portion 363, see paragraph [0098]) having a lumen, the second flange being proximal to the first flange, wherein the pyloric occlusion is deployable across a pylorus with the saddle region bridging the pylorus, one of the first flange or the second flange being anchored against a duodenum side of the pylorus, the other of the first flange or the second flange anchored against a gastric side of the pylorus, and the closure element operable to occlude the flow of material through the pylorus.
Belhe fails to disclose a closure element, wherein the closure element is configured to occlude a flow of material through the lumen upon deployment of the device, and to continue to occlude the flow of material after deployment of the device.
Bodewadt, from a related field of endeavor teaches a similar system as shown in Figure 2, were the occlusion device includes a closure element (twist 50, see paragraph [0042]) , the closure element is configured to occlude a flow of material through the lumen upon deployment of the device, and to continue to occlude the flow of material after deployment of the device, wherein the closure element is configured to occlude a flow of material through the lumen through a saddle region, for the purpose of further narrowing the saddle region, wherein the closure element is a closure of the lumen by rotation of one of the first or second flange relative to the other of the first or second flange, or by rotation of the first and second flange opposite of each other.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to include the closure element disclosed by to include the closure element disclosed by Bodewadt in the saddle region disclosed by Belhe in order to further narrow the saddle region.
Regarding the closure element, the applicant describes the first and second flanges 705, 710 may both rotate relative to each other in opposite directions to create the closure element 730 in the saddle 715.
Bodewadt discloses first and second flanges 16, 18 may both rotate relative to each other in opposite directions to create the closure element 50.
It is the position of the Office that Bodewadt teaches an equivalent structure to the claimed closure element because twist performs the same function (capable of occlude a flow of material through the lumen) as specified in the claim in substantially the same manner (reducing the size of the lumen), and produces substantially the same result as the corresponding element disclosed in the specification, is not excluded by any explicit definition provided in the specification for an equivalent of the means plus-function limitation. See Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 54 USPQ2d 1308 (Fed. Cir. 2000)
Claims 16, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2013/0030351 (Belhe et al.) in view of U.S. Patent Publication Number 2009/0093837 (Dillon)
Regarding claims 16, 18 Belhe et al. discloses as shown in Figure 5, 6, 30, 36 a system for delivering an occlusion device to a pylorus in an endoscopic procedure, the system comprising: a delivery device including an inner member (pusher catheter 642, see paragraph [0145]) having a guidewire (guidewire 702) and a retractable outer sheath (outer capsule 706, see paragraph [0177]), the inner member and the outer sheath being operable to constrain the occlusion device therebetween prior to deployment; wherein the occlusion device includes: a first flange (cylindrical portion 359, see paragraph [0098]); a second flange (disk 360, see paragraph [0098]) connected to the first flange by a saddle region (cylindrical portion 363, see paragraph [0098]) having a lumen, the second flange being proximal to the first flange.
Belhe fails to disclose a closure element, the closure element is configured to occlude a flow of material through the lumen upon deployment of the device, and to continue to occlude the flow of material after deployment of the device.
Dillon discloses elastic band 52 which is a fastener, configured to create a closure, hold the saddle in place, or make it so the saddle will not expand, the closure element is configured to occlude a flow of material through the lumen upon deployment of the device, and to continue to occlude the flow of material after deployment of the device. See paragraph [0023].
It is the position of the Office that Dillion teaches an equivalent structure to the claimed closure element because elastic band 52 performs the same function (capable of occlude a flow of material through the lumen) as specified in the claim in substantially the same manner (creating a closure, holding the saddle in place, or making it so the saddle will not expand), and produces substantially the same result as the corresponding element disclosed in the specification, is not excluded by any explicit definition provided in the specification for an equivalent of the means plus-function limitation. See Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 54 USPQ2d 1308 (Fed. Cir. 2000).
Claims 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2013/0030351 (Belhe et al.) in U.S. Patent Publication Number 2009/0093837 (Dillon)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771