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 . Claims 1-15 are pending and examined below.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-7, drawn to a stent delivery device, classified in A61M 25/01.
II. Claims 8-12, drawn to an endoscope system, classified in A61B 1/00.
III. Claims 13-15, drawn to method of using an endoscope and stent delivery device, classified in A61B 1/00002.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the subcombination requires an intermediate portion, while the combination does not . The subcombination has separate utility such as delivery a medical device, without the need of an endoscope.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Inventions I and III are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the method of using an endoscopic device can be performed with a delivery device that does not include protrusion on the outer surface of the second tube as described in the invention I.
Inventions II and III are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the method of using an endoscope and a delivery device to visualize an anatomical location, rather than delivery a stent.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Invention I and II are classified in different classes (see above). Additionally, they require specific and distinct text searching. For example, invention II requires searching for an endoscope, while invention I does not.
Invention I and III are classified in different classes (see above). Additionally, they require specific and distinct text searching. For example, invention III requires searching for an endoscope, while invention I does not.
Invention II and III are classified in different classes (see above). Additionally, they require specific and distinct text searching. For example, invention III requires searching for a method of using an endoscope along with a delivery device, while invention II does not.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with attorney Thomas Spinelli on 06/09/2025 a provisional election was made without traverse to prosecute the invention of Group I, claim1-7. Affirmation of this election must be made by applicant in replying to this Office action. Claims 8-15 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “45” has been used to designate both “an opening; seen in fig. 10” and “the outer peripheral surface; seen in fig. 18”. 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. 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.
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 flared shape at the distal end of the second outer tube, as recited in claim 7 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 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.
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Matsuoka et al (US 2006/0259124 A1), in view of Corwin et al (US 2017/0304097 A1).
Regarding claim 1, Matsuoka et al discloses a stent delivery system (abstract) comprising: a first outer tube (Fig. 3: stent accommodation cylindrical member (5), paragraph 0090); a second outer tube disposed at a proximal side from the first outer tube (Fig. 3: proximal-side tube (4), paragraph 0090); an inner tube connected to a distal end part of the second outer tube and configured to be inserted into the first outer tube (Fig. 3: distal-side tube (2), paragraph 0090; also see MPEP 2114(II)); a traction member connected to a proximal end part of the first outer tube and configured to be inserted into the second outer tube (Fig. 3: pulling member (3), paragraph 0090; also see MPEP 2114(II)); and a stent housed between the inner tube and the first outer tube (Fig. 3: stent (3), paragraph 0090), however doesn’t specifically disclose wherein a surface roughness of an outer surface of the second outer tube is higher than a surface roughness of an outer surface of the first outer tube.
Corwin et al discloses a catheter for delivery a self-expanding stent that includes an inner shaft and an outer shaft (abstract). Corwin et al further discloses wherein a surface roughness of an outer surface of the second outer tube is higher than a surface roughness of an outer surface of the first outer tube (Fig. 3: the surface of tube (124) has multiple protrusions (132) on the outer surface, whereas the surface of tube (115) does not have any protrusion, which would inherently be less rough compared to the surface with the protrusions, paragraphs 0026-0029).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the surface of the second tube taught buy Matsuoka et al to include the protrusions on the outer surface as taught by Corwin et al in order to have a tube that can provide sufficient friction to secure a tube or stent (paragraph 0028).
Regarding claim 2, Matsuoka et al discloses the stent delivery system according to claim 1, wherein the inner tube and the traction member are parallel to each other in an intermediate portion between the first outer tube and the second outer tube (Fig. 3: the inner tube and traction member are parallel and within the intermediate tube (7), paragraph 0124).
Regarding claim 3, Matsuoka et al discloses the stent delivery system according to claim 2, wherein a length of the intermediate portion in a longitudinal direction is longer than a length of the stent in the longitudinal direction (Fig. 7: the intermediate portion (7) extends over a greater portion the delivery device compared to the stent, which is located at the distal end the delivery device, paragraphs 0110 and 0118).
Regarding claim 4, Matsuoka et al discloses the stent delivery system according to claim 1, wherein the inner tube has a guide wire lumen through which a guide wire is insertable(Fig. 3: guide wire lumen (21), paragraphs 0091 and 0109), and an opening communicating with the guide wire lumen is formed in the inner tube (Fig. 3: paragraphs 0091, 0095, and 0109).
Regarding claim 5, Matsuoka et al discloses the stent delivery system according to claim 2, wherein the inner tube has a guide wire lumen through which a guide wire is insertable (Fig. 3: guide wire lumen (21), paragraphs 0091 and 0109), and an opening communicating with the guide wire lumen is formed in the inner tube at a position of the intermediate portion (Fig. 3: paragraphs 0091, 0095, and 0109).
Regarding claim 6, Matsuoka et al discloses the stent delivery system according to claim 1, wherein the inner tube has a guide wire lumen through which a guide wire is insertable (Fig. 3: guide wire lumen (21), paragraph 0091), and an opening communicating with the guide wire lumen is formed in the second outer tube (Fig. 3: paragraphs 0091 and 0095).
Regarding claim 7, Matsuoka et al discloses the stent delivery system according to claim 6, wherein a distal end opening of the second outer tube is formed in a flare shape (Fig. 3: distal end of tube (4), paragraphs 0090-0091 and 0095)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSE H TREVINO III whose telephone number is (703)756-4678. The examiner can normally be reached Monday - Friday: 9-6 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 at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.H.T./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774