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 .
Drawings
The drawings were received on 01/02/2026. These drawings are acceptable.
Specification
The amendment to the specification filed 01/02/2026 has been entered because it does not add any new matter and corrects discrepancies.
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication (Restreppo et al.) is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
Response to Arguments
Applicant's arguments filed 01/02/2026 have been fully considered but they are not persuasive. Applicant argues the claims are not invoking the 112 (f) interpretation and that the specification sufficiently describes the phrase “phase transforming cellular materials” and references paragraph 132, but specifically to an article attempted to be incorporated by reference. However, the examiner would like to note that MPEP CFR 1.57 states "Essential material" may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference. "Essential material" is material that is necessary to:
(1) Provide a written description of the claimed invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and set forth the best mode contemplated by the inventor of carrying out the invention as required by 35 U.S.C. 112(a);
(2) Describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b); or
(3) Describe the structure, material, or acts that correspond to a claimed means or step for performing a specified function as required by 35 U.S.C. 112(f).
Thus, in this instance it appears that any reliance on the article would be improper. Further the applicant failed to indicate how the claimed “phase transforming cellular material” is capable of performing the function to “move the outlet between an open configuration and a closed configuration” in response to a change in one or more of an energy imbalance in the PXCM, a change in pressure through an interior of the second region, and a change in a local concentration of cholecystokinin (CCK) because the Applicant argues the phrase “phase transforming cellular material” means a structural architected material composed of repeating unit cells and not a biological type cell. The examiner notes that phase transforming materials are well known in the art and Applicant even acknowledges this in discussing shape memory materials. Thus in giving the ordinary definition of the phrase, it is not understood how the recited terminology defines anything more different other than adding “cellular” in the phrase which Applicant stated was meant to be structural and not chemical or biological. Thus, if that is the case, then the use of cellular was meant to be something like a mesh, it does not necessarily mean any special functioning structure different than any prior art shape memory alloy mesh stent made of a material that inherently has phase transformation that is imparted therein that changes from a martensitic state to an austenitic. No special definition was set forth in the specification. Claims are given their broadest reasonable interpretation and the examiner is entitled to give terms in a claim its plain meaning as interpreted by one of ordinary skill in the art. It is noted that the specification must clearly set forth the definition explicitly and with reasonable clarity, deliberateness, and precision. Exemplification is not an explicit definition. Even explicit definitions can be subject to varying interpretations. See Teleflex, Inc. v. Ficosa North America Corp., 63 USPQ2d 1374, 1381 (Fed. Cir. 2002), Rexnord Corp. v. Laitram Corp., 60 USPQ2d 1851,1854 (Fed. Cir. 2001) and MPEP 2111.01. Claims fail to define any specific material, thus the only distinction Applicant has made is that different terminology is being used in naming parts/materials of a stent.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., stent structure shown in figures 15A-15D that are structures of PXCM) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). However, most importantly the examiner raised a point, issue of scope that the Applicant has failed to address of which how this claimed material detects change to then perform the ability to move. If the claimed material is not cellular type, it is not understood how a mechanical or architected design enables such detection of change cause a movement to reduce diameter configuration, especially when the claims (1,12) just recite arbitrary regions with no specific structure whatsoever to provide any discernable “means” that would enable this function to occur. Claims 1 and 12 recite regions which define or implies not structure, but just sections.
Now in addressing Applicant’s request to remove the 112 6th paragraph rejection, the examiner does acknowledge it could be withdrawn. However, the examiner disagrees that there is not another 112 (b) issue since it seems Applicant is asserting the phrase at issue has some special meaning. However, it is not evident where this is required such that the examiner does maintain a 112 (b) since Applicant fails to define how the material is functioning.
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 1-12,19,20 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.
In claims 1, 12, the recitation of “phase transforming cellular materials (PXCM) configured to move the outlet between an open configuration and a closed configuration in response to a change in one or more of an energy imbalance in the PXCM, a change in pressure through an interior of the second region, and a change in a local concentration of cholecystokinin (CCK)” which all relate to some physical or chemical condition. However, the claim (s) fail to indicate how this recited material is able to detect and cause some change.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nath (WO 2018/022862). Fig. 4 shows a stent 6 comprising: a first region comprising an upstream end, a downstream end, and a lumen extending a length between the upstream end and the downstream end, the first region having an elongated tubular configuration where each of the downstream end and the upstream end are expanded radially (paragraph 4) and the first region defines a first diameter along the length of the lumen; and a second region coupled with the downstream end of the first region, defining an outlet 4 that is in fluid communication with the lumen of the first region. Nath discloses ( paragraph 28) the second region 12 is comprised of one or more phase transforming cellular materials (PXCM) configured to move the outlet between an open configuration and a closed configuration (biasing) in response to a change in pressure through an interior of the second region. Claims are given their broadest reasonable interpretation and the examiner is entitled to give terms in a claim its plain meaning as interpreted by one of ordinary skill in the art. It is noted that the specification must clearly set forth the definition explicitly and with reasonable clarity, deliberateness, and precision. Exemplification is not an explicit definition. Even explicit definitions can be subject to varying interpretations. See Teleflex, Inc. v. Ficosa North America Corp., 63 USPQ2d 1374, 1381 (Fed. Cir. 2002), Rexnord Corp. v. Laitram Corp., 60 USPQ2d 1851,1854 (Fed. Cir. 2001) and MPEP 2111.01. Nath discloses (paragraph 30) cellular polymers that provide phase transformation due to heat as a stimulus to expand the foam. Regarding claim 2, Nath discloses (paragraph 29) the stent is placed in a bile duct, and thus when moving between the open configuration and a closed configuration can be construed to emulate the mechanics and associated geometric changes of an ampulla of Vater contraction and relaxation of a Sphincter of Oddi. Regarding claim 3, it is inherent the first region of the stent comprises a reduced configuration (paragraph 28 states the stent is expandable, thus it has a reduced configuration) where each of the downstream end and the upstream end are collapsed relative to each other in the tubular configuration and the first region defines a second diameter along the length of the lumen, wherein the second diameter is less than the first diameter of the elongated tubular configuration.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Nath (WO 2018/022862) in view of Howard et al. (2015/0250579). Nath is explained supra. However, Nath did not explicitly state the first region is configured for self- expansion from the reduced configuration to the tubular configuration. Howard et al. did state (paragraph 2) the stent is used for a bile duct. Howard et al. further teach (paragraph 17) that stents for use in treating a duct can be provided as self-expanding. It would have been obvious to one of ordinary skill in the art to utilize self-expanding material for a stent as taught by Howard et al. for the first region of the stent of Nath to allow to expand from a reduced configuration to the tubular configuration which enables a surgeon to deliver such a structure in a minimally invasive procedure.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Nath (WO 2018/022862) in view of Parsons et al. (2017/0007810). Nath is explained supra. However, Nath did not explicitly state the first region is configured to stiffen and be subjected to circumferential load or a concentric radial force. Parsons et al. teach (paragraph 153) that a material used to form a tubular configuration is delivered to a lumen and hardens or stiffens, such that it can maintain or be responsive to circumferential loads or a concentric radial force applied thereabout from the site. Parsons et al. further teach (paragraph 30) that the material used that provides a stiffening effect can be used in a biliary tract. It would have been obvious to one of ordinary skill in the art to provide a material that stiffens as taught by Parsons et al. such
that a stent of Nath used in a bile duct would be able to maintain patency by providing a hardened structure to withstand compressive forces.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Nath (WO 2018/022862) in view of Pellkofer et al. (EP 800800). Nath is explained supra. However, Nath did not explicitly state the first region comprises one or more PXCM or architected material analog for shape memory alloy (ASMA) unit cells. Pellkofer et al. teach (Figs. 7,8) a stent 1 can be provided or architected with a plurality of unit cells 5 defined with openings 19. Pellkofer et al. teach (page 2 of translation) material analog for shape memory alloy (ASMA). It would have been obvious to one of ordinary skill in the art to use a material analog for shape memory alloy (ASMA) for the unit cells of the stent as taught by Pellkofer et al. with the stent of Nath as it provides a controllable responsive implantable device.
Claim(s) 7-9, 12 are rejected under 35 U.S.C. 103 as being unpatentable over Nath (WO 2018/022862) in view of Hingston et al. (2018/0289462). Nath is explained supra. However, Nath did not explicitly state the first region comprises a one-way valve. Hingston et al. teach (Fig. 10) a stent 20 with a one-way valve 30. Hingston et al. also teach (paragraph 45) the stent can be used in biliary duct. It would have been obvious to one of ordinary skill in the art to incorporate a one-way valve as taught by Hingston et al. in the stent of Nath such that it aids in prevention of bile reflux, see paragraph 62 of Hingston et al. Regarding claim 8, it can be seen (Fig. 10) that the one-way valve comprises an interior surface defining the lumen and extending between the upstream end and the downstream end, the interior surface comprising one or more interior walls of a fixed-geometry passive check valve configuration to permit free passage of fluid
through the lumen in a first direction but deter or prevent back flow of the fluid in a direction opposite the first direction. With respect to claim 9, Nath discloses (paragraph 30) the first region (arbitrary space of device) further comprises at least one PXCM covering positioned around a circumference of the first region, each of the PXCM coverings configured to compress or decompress the underlying first region in response to a change in local concentration of CCK to restrict or allow, respectively, fluid flow through the first region. Regarding claim 12, it is noted the limitations are the same and detailed as mentioned above for claim 1 and further include limitations as detailed here as the same for claims 7- 9, thus the claim is obvious over Nath and Hingston.
Claim(s) 10,11 are rejected under 35 U.S.C. 103 as being unpatentable over Nath (WO 2018/022862) in view of Ben Muvhar (WO 2010/109467). Nath is explained supra. However, Nath did not explicitly state the first and second region are biodegradable and the first region comprises a drug eluting stent. Ben Muvhar teaches (page 6, lines 3,4) a gastrointestinal implantable device can be biodegradable. It would have been obvious to one of ordinary skill in the art to utilize biodegradable material for an implantable structure used in the gastrointestinal tract as taught by Ben Muvhar and provide the stent of Nath the ability to degrade over time but provide the necessary functional capabilities to assist the malfunctioning duct or region structural support. Ben Muvhar additionally teach (page 16, lines 15,16) a drug can be provided with an implantable mesh structure. It would have been obvious to one of ordinary skill in the art to utilize a drug with an implantable mesh as taught by Ben Muvhar and provide the stent of Nath the ability to treat with a pharmaceutical and provide a therapeutic effect.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799