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 .
Response to Arguments
Applicant's arguments filed 09/11/26 have been fully considered but they are not persuasive.
On pages 6-7 regarding claim objections and 112 rejections, Applicant argues amendments overcome the objections of record.
The Examiner respectfully agrees and withdraws claim objections and 112 rejections.
On pages 8-9 regarding prior art rejections Applicant argues amendments overcome the rejection of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “adjustable coupling”, and “adapter interface” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 Objections
Claims 5-6, 9 are objected to because of the following informalities:
Claims 5 and 9 are objected to for referring to ‘the airway stent” when it is unclear how, if at all, this relates back to the previously claimed “braided covered airway stent”.
Claim 6 is objected to for referring to “the aperture” with improper antecedent basis.
The claim is further objected to for referring to “the metallic scaffold” when it is unclear how, if at all, this relates to the previously claimed “metallic scaffold portion”.
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.
Claim 10-11 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 10 is indefinite for claiming coupling an “adapter interface” to the bronchoscope. Claim 1 has identified an “adjustable coupling” already that appears to be located in the same location as the “adapter interface” based on the claims. Neither of these elements is depicted in the figures or described with a reference number. The Examiner is accordingly unclear on what exactly each of these elements are, and how they might be related to one another. It appears from the specification that these might actually be the same element, but without an understanding with explanation from the specification and figures describing either, the claim cannot be understood.
Claim 11 is indefinite for claiming that the coupling between the bronchoscope and deployment device is direct, and apparently appears to prevent the presence of an additional or intervening coupling element. However, claim 1, from which this claim depends, has identified an “adjustable coupling between the deployment device and the bronchoscope” making it unclear how both of these limitations can be met at the same time. It appears they cannot both be met at the same time, and the Examiner is accordingly unsure on how to interpret this claim.
Claim Interpretation
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “adjustable coupling” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. In this case, the “adjustable coupling” is understood to be a “slide assembly” that allows adjustment.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 1, 3-4, 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wondka et al. (US 20060162731 A1) hereinafter known as Wondka in view of Lee et al.( US 20160331468 A1) hereinafter known as Lee or in the alternative, over Wondka in view of Krimsky et al. (US 20130103163 A1) hereinafter known as Krimsky, further in view of Lee .
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 of the deployment device, 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 ([0019]) by adjusting an adjustable coupling (Figure 1 item 60) between the deployment device and the bronchoscope ([0057]) to position of the device with respect to the bronchoscope while the device is coupled thereto ([0019], [0057]),
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.),
but is silent with regards to the adjustable coupling being adjustable in length.
However, regarding claim 1 Lee teaches that delivery systems can have length-adjustable portions (Figures 3a-c item 36; [0050]). Wondka and Lee are involved in the same field of endeavor, namely delivery devices. 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 or the Wondka Krimsky Combination so that the adjustable coupling mechanism of Wondka includes a length-adjustable portion as is taught by Lee as a mechanism to allow length adjustment while the catheter and bronchoscope are fixedly coupled to one another, thus ensuring the devices maintain a coupling while positioned somewhat near one another, and still ensuring that adjustment of the catheter’s position can be adjusted relative to the bronchoscope for fine tuning of the position for delivery.
Regarding claim 3 the Wondka Lee Combination, or the Wondka Krimsky Lee 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 the Wondka Lee Combination, or the Wondka Krimsky Lee 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 the Wondka Lee Combination, or the Wondka Krimsky Lee Combination teaches the method of claim 1 substantially as is claimed,
wherein Wondka further discloses inserting the stent beyond a branch between the airway passage and a second airway passage within the patient ([0020]; Figure 14c shows a stent being inserted beyond at least a branch between two air passages).
Regarding claim 10 the Wondka Lee Combination, or the Wondka Krimsky Lee 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 the Wondka Lee Combination, or the Wondka Krimsky Lee 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 and Lee, or over Wondka in view of Krimsky and Lee as is applied above in view of Delaloye et al. (US 20170224486 A1) hereinafter known as Delaloye.
Regarding claim 2 the Wondka Lee Combination, or the Wondka Krimsky Lee 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 the Wondka Lee Combination, or the Wondka Krimsky Lee Combination 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 and Lee, or over Wondka in view of Krimsky and Lee as is applied above in view of Vardi et al. (US 20030028233 A1) hereinafter known as Vardi.
Regarding claim 5 the Wondka Lee Combination, or the Wondka Krimsky Lee 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 the Wondka Lee Combination, or the Wondka Kriminsky Lee Combination 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 Lee Combination, or the Wondka Krimsky Lee Combination teaches the method of claim 4 substantially as is claimed,
wherein Wondka further discloses the stent is braided ([0065]) metallic scaffold ([0065]), and Krimsky further teaches the stent is a braided ([0046] woven) metallic scaffold ([0046] nitinol),
but is silent with regards to an aperture extending through the metallic scaffold of the braided covered airway stent.
However, regarding claim 6 Vardi teaches that a stent can comprise an aperture (Figure 2a item 27). 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 the Wondka Lee Combination, or the Wondka Kriminsky Lee Combination 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 7 the Wondka Lee Combination, or the Wondka Krimsky Lee 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 the airway passage and a second airway passage ([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). It would have been obvious to one of ordinary skill to have the aperture positioned near one of the passageways in order to ensure the goal of the invention, to stent at a branch, is able to be met.
Claim 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wondka in view of Lee, Vardi, and Delaloye, or over Wondka, Krimsky, Lee, Vardi, and Delaloye, as is applied above.
Regarding claim 8 the Wondka Lee Vardi Combination, or the Wondka Krimsky Lee Vardi 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 correlates 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 the Wondka Lee Vardi Combination, or the Wondka Krimsky Lee Vardi Combination 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 and Lee, or over Wondka, Lee, and Krimsky as is applied above, further in view of Hillis et al. (US 20060069425 A1) hereinafter known as Hillis.
Regarding claim 12 the Wondka Lee Combination, or the Wondka Krimsky Lee 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 the Wondka Lee Combination or the Wondka Krimsky Lee 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 the Wondka Lee Combination, or the Wondka Krimsky Lee 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 the Wondka Lee Combinatoin or the Wondka Krimsky Lee 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
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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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, 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
