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 with traverse of invention I (claims 1-13) in the reply filed on 04/23/26 is acknowledged. The traversal is on the ground(s) that the Examiner has no burden to examine both inventions. This is not found persuasive because the Examiner presented reasons for the burden on page 3 of the Restriction Requirement mailed 02/19/26). Namely, that the two inventions have distinct scopes that require distinct searches, including searching for an adapter for one invention, or searching for a deployment device with removeable coupling and other method steps, for the other invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/23/26.
Claim Objections
Claims 1, 6-7, 9 are objected to because of the following informalities:
Claim 1 is objected to for claiming “an airway stent positioned at a first end” but it is unclear what has the first end (e.g. the airway, the deployment device, something else).
Further, the claim is unclear for referring to “the first end of the deployment device” and “the position” with improper antecedent basis.
Claim 6 is objected to for referring to “the braided metallic scaffold” with improper antecedent basis.
Claims 7 and 9 are objected to for referring to “two airway passages” when it is unclear how, if at all, these relate to the previously claimed “airway passage”.
Appropriate correction is required.
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 6-7 and 9 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 pre-AIA the applicant regards as the invention.
Claim 6 is indefinite for claiming the aperture is disposed at an opening of the stent, when the disclosure and figures make it appear that the opening is the aperture. Specification [0048] for example, indicates that the opening/aperture (item 508) is actually the same item. The aperture is not disposed at an opening. Figures (e.g. figure 5) also make this unclear, since the item 508 is simply an opening/aperture, not an aperture disposed AT an opening. Only one hole appears to be present, making this claim unclear. For the purposes of examination, this claim will be understood to claim that the aperture is an opening (which is already understood to be inherent).
Claims 7 and 9 are indefinite for claiming the airway stent is inserted “precisely” at or beyond a branch between two passages, when it is unclear exactly how precise the insertion has to be to be considered to be “precisely” inserted. For example, it is unclear whether or not 1cm beyond the branch would be considered to be “precisely at” the two passage, “precisely beyond” the branch, both, or neither. The specification does not appear to give any guidance on what would fall into either category.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 3-4, 9-11 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wondka et al. (US 20060162731 A1) hereinafter known as Wondka, or in the alternative, over 35 U.S.C. 103 as being unpatentable over Wondka in view of Krimsky et al. (US 20130103163 A1) hereinafter known as Krimsky.
Regarding claim 1 Wondka discloses a method of treating an airway ([0011] lung passageway) comprising:
obtaining a deployment device ([0011] delivery catheter) which contains an airway stent at a first end, and the device having a second end with a release handle ([0022]),
introducing the first end of the device into a working channel of a bronchoscope ([0049], Figures 1, 8a),
removably coupling the device to the working channel of the bronchoscope ([0023]),
introducing the first end of the device into an airway passage of a patient by adjusting a position of the device with respect to the bronchoscope while the device is coupled thereto ([0019]),
actuating the release handle of the device to release the stent into the patient’s passage ([0019], [0022]) such that the stent is positioned to hold open the passage ([0028] while the disclosure of Wondka discusses the stent being for occlusion of the airway passage, it states also that the stent can be for a non-occlusion type stent, which would hold the airway passage open. Alternatively, Krimsky teaches that non-occlusive stents are able to hold open passages (Abstract). Wondka and Krimsky are involved in the same field of endeavor, namely airway stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of Wondka so that the non-occlusive airway stent maintained patency of the passage as is taught by Krimsky in order to treat a patient who needs a passage’s patency to be maintained, thus increasing the amount of patients the method can help.).
Regarding claim 3 Wondka discloses, or the Wondka Krimsky Combination teaches the method of claim 1 substantially as is claimed,
wherein Wondka further discloses the stent is braided ([0065]) and covered ([0068]),
and wherein Krimsky further teaches that non-occlusive stents can also be braided ([0046] woven) and covered ([0046]).
Regarding claim 4 Wondka discloses, or the Wondka Krimsky Combination teaches the method of claim 3 substantially as is claimed,
wherein Wondka further discloses the stent has a nitinol scaffold portion ([0065]) covered by a flexible covering ([0068]), and
wherein Krimsky further teaches the stent has a nitinol scaffold portion ([0046]) covered by a flexible covering ([0047]).
Regarding claim 9 Wondka discloses, or the Wondka Krimsky Combination teaches the method of claim 1 substantially as is claimed,
wherein Wondka further discloses inserting the stent beyond a branch between two airway passages within the patient ([0020]; Figure 14c shows a stent being inserted beyond at least a branch between two air passages).
Regarding claim 10 Wondka discloses, or the Wondka Krimsky Combination teaches the method of claim 1 substantially as is claimed,
wherein Wondka further discloses removably coupling the device to the bronchoscope comprises coupling an adapter interface to the bronchoscope such that the adapter is removably connected to the bronchoscope ([0012], [0023]).
Regarding claim 11 Wondka discloses, or the Wondka Krimsky Combination teaches the method of claim 1 substantially as is claimed,
wherein Wondka further discloses removably coupling the device to the bronchoscope comprises coupling the device directly to an integral component of the bronchoscope ([0012], [0023] the connector can be an integral part of the delivery device, indicating the device connects directly to the integral bronchoscope).
Claim 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wondka, or over Wondka in view of Krimsky as is applied above in view of Delaloye et al. (US 20170224486 A1) hereinafter known as Delaloye.
Regarding claim 2 Wondka discloses, or the Wondka Krimsky Combination teaches the method of claim 1 substantially as is claimed,
but is silent with regards to the release handle comprising an indicator that correlates to the orientation of the stent.
However, regarding claim 2 Delaloye teaches that a catheter handle can comprises an indicator that correlates to the orientation of the stent which it carries ([0120]). Wondka and Delaloye are involved in the same field of endeavor, namely airway stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of Wondka to have an indicator on the handle as is taught by Delaloye in order to ensure the physician implanting the stent understands where features of the stent are and can accordingly orient the stent properly during delivery, thus easing delivery for the physician and increasing safety for the patient.
Claims 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wondka, or over Wondka in view of Krimsky as is applied above in view of Vardi et al. (US 20030028233 A1) hereinafter known as Vardi.
Regarding claim 5 Wondka discloses, or the Wondka Krimsky Combination teaches the method of claim 3 substantially as is claimed,
but is silent with regards to the stent comprising an aperture in a sidewall portion that allows fluid communication between the internal and exterior surfaces of the stent.
However, regarding claim 5 Vardi teaches that a stent can comprise an aperture in a sidewall portion (Figure 2a item 27) which provides fluid communication between an internal channel of the stent and an exterior surface of the stent (Figure 2a). Wondka and Vardi are involved in the same field of endeavor, namely airway stents ([0003]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of Wondka to have the stent comprise an aperture as is taught by Vardi as a known configuration which allows the stent to be useful at a branch bifurcation, which are very common within the airways. Notably, any configuration of a stent useful within the airways would have been obvious to the person of ordinary skill to try within the context of this invention.
Regarding claim 6 the Wondka Vardi Combination, or the Wondka Krimsky Vardi Combination teaches the method of claim 5 substantially as is claimed,
Wondka further discloses the stent is braided ([0065]) metallic scaffold ([0065]),
and wherein Krimsky further teaches the stent is a braided ([0046] woven) metallic scaffold ([0046] nitinol).
Regarding claim 7 Wondka discloses, or the Wondka Krimsky Combination teaches the method of claim 5 substantially as is claimed,
wherein Wondka further discloses inserting the stent at a branch location between at least two airway passages ([0020]) Figure 14c shows a stent 46 positioned at a branch location),
and wherein Vardi further teaches inserting the stent at a branch location between two passageways such that the aperture is positioned adjacent one of the two passages (Figures 6b-8).
Claim 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wondka in view of Delaloye, further in view of Vardi, or over Wondka in view of Krimsky and Delaloye, further in view of Vardi as is applied above.
Regarding claim 8 Wondka discloses, or the Wondka Krimsky Combination teaches the method of claim 5 substantially as is claimed,
but is silent with regards to the release handle comprising an indicator that correlates to the orientation of the aperture.
However, regarding claim 8 Vardi teaches a catheter can comprise an indicator that correslates to the orientation of an aperture of a stent which it carries (Abstract, Figures 6a-b), and wherein Delaloye teaches that a catheter handle can comprises an indicator that correlates to the orientation of the stent which it carries ([0120]). Wondka, Delaloye, and Vardi are involved in the same field of endeavor, namely the positioning of stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of Wondka to have an indicator on the handle as is taught by Delaloy, and to have the indicator correlate to the orientation of a stent aperture as is taught by Vardi in order to ensure the physician implanting the stent understands where features of the stent are and can accordingly orient the stent properly during delivery, thus easing delivery for the physician and increasing safety for the patient.
Claims 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wondka, or over Wondka in view of Krimsky as is applied above in view of Hillis et al. (US 20060069425 A1) hereinafter known as Hillis.
Regarding claim 12 Wondka discloses, or the Wondka Krimsky Combination teaches the method of claim 1 substantially as is claimed,
wherein Wondka further discloses the stent comprises a covering ([0068]), and wherein Krimsky further teaches the stent comprises a covering ([0047[),
but is silent with regards to the covering including microprinting on a surface thereof.
However, regarding claim 12 Hillis teaches a stent coating ([0029] the system can be coated with polymers) which includes microprinting on an inside surface (Figure 3 item 311; [0032]-[0034] and [0037] the inner surface 311 includes cilia on the scale of 10 microns (e.g. a microscale). As regards the limitation of being microprinted, the Examiner notes that printing is recited as a product-by-process limitation. Even 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”. See MPEP 2113. In this case, the cited limitations failed to distinguish the claimed structure from Hillis, since all the structural limitations of the claim appear to be met (something on a microscale present on the inside surface).). Wondka and Hillis are involved in the same field of endeavor, namely airway stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of Wondka or the Wondka Krimsky Combination so that the covering includes microprinting as is taught by Hillis in order to provide a textured surface which can aid in promoting the flow of air, fluid, debris, particles, mucus, debris, etc. ([0032]) when implanted, thus maintaining a clear airway and so increasing safety for the patient.
Regarding claim 13 Wondka discloses, or the Wondka Krimsky Combination teaches the method of claim 1 substantially as is claimed,
wherein Wondka further discloses the stent comprises a covering ([0068]), and wherein Krimsky further teaches the stent comprises a covering ([0047]),
but is silent with regards to the covering including microprinting on a surface thereof.
However, regarding claim 13 Hillis teaches a stent can include a covering ([0032]) which includes microprinting on an outside surface (Figure 1 item 101; [0032]-[0034], [0037] the cilia can be on both the inner and outer surfaces; As regards the limitation of being microprinted, the Examiner notes that printing is recited as a product-by-process limitation. See the explanation in the rejection to claim 12 above regarding product-by-process limitations. In this case, the cited limitations failed to distinguish the claimed structure from Hillis, since all the structural limitations of the claim appear to be met (something on a microscale present on the outside surface).). Wondka and Hillis are involved in the same field of endeavor, namely airway stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of Wondka or the Wondka Krimsky Combination so that the covering includes microprinting as is taught by Hillis in order to provide a textured surface which can aid in securement of the stent ([0032]), and thus prevent movement after implantation, thus increasing safety for the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 05/06/26
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