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 of species a in the reply filed on 08/21/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Status of Claims
Claims 1-20 are pending and currently under consideration for patentability under 37 CFR 1.104
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/16/2024, 02/10/2026, and 08/06/2026 have been considered by the examiner.
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 cap assembly having a plurality of perforations and also first and second reservoir, the second reservoir is aligned with the imaging device such that the imaging device is able to capture images distally of the cap through a distal face of the cap, and wherein the first reservoir is misaligned from the imaging device, such that the imaging device is isolated from the material stored in the first reservoir (claim 9, 14) 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.
Claim(s) 1, 2, 5-8, 10-12 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piskun (US 2016/0374658).
With respect to claim 1, Piskun teaches a medical device, comprising:
a shaft (1055) having a distal end, wherein the distal end includes an opening and an imaging device (315 for example);
a cap assembly (1098,1099) at the distal end of the shaft, wherein the cap assembly defines a reservoir (FIG. 10B for example) for storing a material (1051,1052,1053,1054),
wherein, in a first configuration, the cap assembly includes a plurality of perforations formed in an outer body of the cap assembly (para [0198]), the plurality of perforations being sized such that the material is retained within the reservoir (FIG. 10B for example),
wherein, in transitioning from the first configuration of the cap assembly to a second configuration of the cap assembly, the plurality of perforations form at least one opening that is sized such that the material is ejected through the at least one opening (FIG. 10E for example).
That is, Piskun et al. teaches multiple embodiments and further teaches the systems taught herein can include any combination of components (para [0123]).
With respect to claim 2, Piskun teaches the cap assembly includes a deployment mechanism (1070/1075), and wherein movement of the deployment mechanism causes the material to exert a force on the plurality of perforations to form the at least one opening (para [0143],[0150]).
With respect to claim 5, Piskun teaches as the cap assembly transitions from the first configuration to the second configuration, an area of the outer body between adjacent perforations of the plurality of perforations breaks to form the at least one opening (FIG. 10E).
With respect to claim 6, Piskun teaches breaking of the area of the outer body between the adjacent perforations causes the adjacent perforations to combine to form the at least one opening (FIG. 10E).
With respect to claim 7, Piskun teaches the area of the outer body between the adjacent perforations is a weakened portion (para [0198]).
With respect to claim 8, Piskun does not specifically teach the weakened portion includes a biodegradable or a bioabsorbable material. However, it would be obvious to one of ordinary skill in the art to modify material of the perforations since there are a finite number of predictable potential materials such that one of ordinary skill in the art could have pursued a biodegradable or a bioabsorbable material with a reasonable expectation of success.
With respect to claim 10, Piskun teaches a medical device, comprising:
a shaft (1055) having a distal end, wherein the distal end includes an opening and an imaging device (315 for example);
a cap assembly (1098,1099) at the distal end of the shaft, wherein the cap assembly defines a reservoir (FIG. 10B for example) for storing a material (1051,1052,1053,1054) and includes a deployment mechanism (1070/1075) configured to apply force to the material ((para [0143],[0150]));
wherein application of a sufficient force to the material within the reservoir causes adjacent perforations of a plurality of perforations in the cap assembly to combine to form an opening for ejecting the material (para [0198], see also FIG. 10E).
That is, Piskun et al. teaches multiple embodiments and further teaches the systems taught herein can include any combination of components (para [0123]).
With respect to claim 11, Piskun teaches an area between the adjacent perforations is a weakened portion configured to break upon application of the sufficient force (para [0198]).
With respect to claim 12, Piskun does not teach a specific size of the perforations. However, it would be obvious to one of ordinary skill in the art to modify the size of the perforations since there are a finite number of predictable potential perforation sizes such that one of ordinary skill in the art could have pursued a perforation size of 0.001 inches to approximately 0.010 inches with a reasonable expectation of success.
With respect to claim 16, Piskun teaches a medical device, comprising:
a shaft (1055) having a distal end, wherein the distal end includes an opening and an imaging device (315 for example);
a cap assembly (1098,1099) at the distal end of the shaft, wherein the cap assembly defines a reservoir (FIG. 10B for example) for storing a material (1051,1052,1053,1054);
wherein, to eject the material from the cap assembly, a plurality of perforations of the cap assembly combine to form an opening as portions of a body of the cap assembly between adjacent perforations of the plurality of perforations break (para [0198], FIG. 10E).
With respect to claim 17, Piskun teaches the portions of the body of the cap assembly between the adjacent perforations include weakened portions (para [0198]).
With respect to claim 18, Piskun teaches individual perforations of the plurality of perforations are sized so as to retain the material within the reservoir before the plurality of perforations combine to form the opening (FIG. 10A vs 10E).
With respect to claim 19, Piskun teaches the opening is sized so as to allow the material to exit through the opening (FIG. 10E).
With respect to claim 20, Piskun teaches activation of a deployment mechanism exerts a force on the material, causing the material to exert a pressure on the body of the cap assembly to cause the portions of the cap assembly between the adjacent perforations to break (FIG. 10A vs 10E).
Allowable Subject Matter
Claims 3, 4, 9, and 13-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexandra Newton Surgan whose telephone number is (571)270-1618. The examiner can normally be reached Monday-Friday 8am-4pm 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, Michael Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALEXANDRA L. SURGAN
Primary Examiner
Art Unit 3795
/ALEXANDRA L NEWTON/Primary Examiner, Art Unit 3799
