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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/16/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The applicant has stated the replacement drawings filed October 7, 2025 have removed element 252 from Fig. 2A. However, annotated Fig. 2A below, clearly shows element 252 is present.
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Claim Status
The drawing objection a and the claim objection b have been overcome.
Claims 1-20 are examined below.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 252. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 6-8, 10-11 and 16-17 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.
Claim 6 recites, “wherein at least one of” in line one. This is understood to mean one of the following limitations is required. However, the second limitation further limits the first limitation. They are not two separate and distinct limitation options. The second limitation is dependent on the first limitation. It is unclear what the options of “at least one” are. Dependent claims 7-8 are likewise rejected.
Claim 6 recites “facilitating opening of at least a part of the obstructive portion” in line 2. It is unclear if this is the same “at least a part of the obstructive portion in claim 1 line 7-8 or a separate and additional at least a part of the obstructive portion. If it is the same “at least a part of the obstructive portion”, the Examiner recommends amending the language to “facilitating opening of the at least a part of the obstructive portion”. Dependent claims 7-8 are likewise rejected.
Claim 10 recites, “is at a least part of the obstructive portion” in line 3. It is unclear what a least part of the obstructive portion. The specification does not define “a least part” nor is it language commonly used in the art. Examiner understands this to be “the at least a part of the obstructive portion”. Dependent claim 11 is likewise rejected.
Claim 16 recites “facilitating opening of at least a part of the obstructive portion” in line 3. It is unclear if this is the same “at least a part of the obstructive portion in claim 1 line 7-8 or a separate and additional at least a part of the obstructive portion. If it is the same “at least a part of the obstructive portion”, the Examiner recommends amending the language to “facilitating opening of the at least a part of the obstructive portion”. Dependent claim 17 is likewise rejected.
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.
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.
Claim(s) 1-10 and 12-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller (US 10,183,442 B1) in view of Eubanks (US 2019/0328556 A1).
Regarding claim 1, Miller teaches a bronchial stent (200, stent, fig. 2A) comprising:
a first branch configured to at least one of widen, open, and mechanically support a first airway (col 7, lines 40-53);
an obstructive portion that, when the stent is deployed in the first airway, obstructs a second airway (prior to making the cutouts the airways the stent covers would be obstructed), the second airway forming a branching connection with the first airway (col 7, lines 54-64).
Miller fails to teach a feature proximal to the obstructive potion configured to facilitate opening of at least a part of the obstructive portion and serves as guide defining a boundary for removal of the at least part of the obstructive portion. However, Eubanks teaches a stent for a branched system of the body that includes a feature proximal to the obstructive portion (340, reinforcement/marking patch, and 365, hole, fig. 4), the feature configured to facilitate opening of at least a part of the obstructive portion (¶ [0060]), wherein the feature serves as a guide defining a boundary for removal of the at least part of the obstructive portion (¶ [0059-0060]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Miller to include a feature proximal to the obstructive potion configured to facilitate opening of at least a part of the obstructive portion and serves as guide defining a boundary for removal of the at least part of the obstructive portion as taught by Eubanks in order to strengthen the material in the area of the intended cuts (¶ [0060], Eubanks).
Regarding claim 2, Miller fails to teach the features form an outline of the at least a part of the obstructive portion. However, Eubanks further teaches the feature forms one of a circumference of and an outline of the at least a part of the obstructive portion (fig. 4). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Miller to include forming an outline of the at least a part of the obstructive portion as taught by Eubanks in order to strengthen the material in the area of the intended cuts (¶ [0060], Eubanks).
Regarding claim 3, Miller and Eubanks fails to explicitly teach the thickness proportions. However, it would have been an obvious matter of design choice to make the different portions of the stent and the feature of whatever relative sizes were desired, since such a modification would have involved a mere change in the proportions of components. A change in proportion is generally recognized as being within the level of ordinary skill in the art. (MPEP2144.IV)
Regarding claim 4, Miller fails to teach the features is a raised portion of the stent. However, Eubanks further teaches the feature comprises at least one of a raised portion of the stent (the patch is raised, fig. 4), a marked portion of the stent (the sent is marked by the patch, fig. 4), and a perforation (365, hole, fig. 4). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Miller to include the feature is a raised portion of the stent as taught by Eubanks in order to strengthen the material in the area of the intended cuts (¶ [0060], Eubanks).
Regarding claim 5, Miller fails to teach the perforation substantially outlines the at least a part of the obstructive portion. However, Eubanks further teaches the perforation substantially outlines the at least a part of the obstructive portion (¶ [0042]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Miller to include the perforation substantially outlines the at least a part of the obstructive portion as taught by Eubanks in order to strengthen the material in the area of the intended cuts (¶ [0060], Eubanks).
Claim 6 is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being a stent with the feature removed. Manufacturing steps such as mechanical removal of the feature from the stent are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113).”
Claim 7 is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a stent with a feature removed. Manufacturing steps such as using forceps for mechanical remove of the feature are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113).”
Claim 8 is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a stent with the feature removed. Manufacturing steps such as the removal is performed prior to deployment are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113).” The stent of Miller and Eubanks is capable of mechanical removal of the feature of the stent prior to deploying the stent in the first airway.
Regarding claim 9, Miller further teaches the stent is made from a material (col 8 lines 55-67).
Miller fails to teach the feature comprises a hole in the stent. However, Eubanks further teaches the feature comprises a hole in the stent (365, hole, fig. 4). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Miller to include the feature comprises a hole as taught by Eubanks in order to strengthen the material in the area of the intended cuts (¶ [0060], Eubanks).
Regarding claim 10, Miller fails to teach the hole at least overlaps, encompasses or is part of the obstructive portion. However, Eubanks further teaches the hole at least one of: substantially overlaps the obstructive portion; is at a least part of the obstructive portion; and substantially encompasses the obstructive portion (¶ [0042]). . Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Miller to include the hole at least overlaps, encompasses or is part of the obstructive portion as taught by Eubanks in order to strengthen the material in the area of the intended cuts (¶ [0060], Eubanks).
Claim 12 is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a stent with a feature. Manufacturing steps such as 3D printing the stent are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113).”
Regarding claim 13, Miller further teaches the first and second airway belong to a patient (col 5 lines 26-38); and the first branch, the obstructive portion, and the feature proximal to the obstructive portion are configured to substantially fit at least the first airway (col 3, lines 62-64).
Claim 14 is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a stent with a feature. Manufacturing steps such as designing the stent using computer aided design are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113).”
Claim 15 is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a stent with a feature. Manufacturing steps such as usings computed tomography or magnetic resonance imaging to design the stent are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113).”
Regarding claim 16, Miller further teaches the feature is proximal to an edge of the stent (206, top surface, fig. 2A); and configuring the feature to facilitate opening of at least a part of the obstructive portion comprises designing the feature to avoid creating bridge-like portions in the stent (fig. 2A).
Regarding claim 17, Miller further teaches the designing the feature to avoid creating bridge-like portions comprises creating a notch at the edge of the stent (204, notch, fig. 2A).
Regarding claim 18, Miller fails to teach a reinforcing feature. However, Eubanks further teaches a reinforcing feature (340, reinforcement patch, fig. 4). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Miller to include a reinforcing feature as taught by Eubanks in order to strengthen the material in the area of the intended cuts (¶ [0060], Eubanks).
Regarding claim 19, Miller fails to teach the reinforcing feature has a thickness greater than a n average overall stent thickness. However, Eubanks further teaches the reinforcing feature has a thickness greater than an average overall stent thickness. The patch is an additional layer of material over the stent material. The addition of a layer would make the reinforcing feature (the area of the patch and the stent) thicker than the average stent thickness. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Miller to include the reinforcing feature has a thickness greater than an average overall stent thickness as taught by Eubanks in order to strengthen the material in the area of the intended cuts (¶ [0060], Eubanks).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Eubanks as applied to claim 10 above, and further in view of Boyden (US 2009/0024152 A1).
Regarding claim 11, Miller and Eubanks fails to teach the material consists essentially of silicone. However, Boyden discloses a custom implant for a branched system that includes the material consists essentially of silicone (¶ [0054-0055]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the material of Miller and Eubanks to include silicone as taught by Boyden since it has been held to be within 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.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Eubanks as applied to claim 1 above, and further in view of Ganesan (US 2006/0247760 A1).
Regarding claim 20, Miller and Eubanks fail to teach a fitting portion configured to accommodate another stent. However, Ganesan discloses a technique for combing two stents to accommodate adjacent branches that includes the stent further comprises a fitting portion (125", insertion site, fig. 8A), the fitting portion configured to accommodate another stent (figs 8A and 8B). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Miller and Eubanks to include a fitting portion configured to accommodate another stent as taught by Ganesan in order to enable stent grafting adjacent to branch vessels (¶ [0006], Ganesan).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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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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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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