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 group I and species a in the reply filed on 01/16/2026 is acknowledged. The traversal is on the ground(s) that groups I and III share substantial common subject matter and the alleged differences cited by the Examiner represent alternative embodiments of the same inventive concept rather than distinct inventions requiring separate search and examination. This is not found persuasive because, as Applicant acknowledges, there are in fact distinct features of each invention not found in the other, and these distinct features in fact create the search burden.
The requirement is still deemed proper and is therefore made FINAL.
Status of Claims
Claims 1, 3-9, 11, 13, 14, and 43-51 are pending, claims 43-51 have been withdrawn from consideration, and claims 1, 3-9, 11, 13, and 14 are currently under consideration for patentability under 37 CFR 1.104
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/15/2024 has 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 adjustable sheath being configured to accommodate endoscopes of varying lengths (claim 1) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 mechanical foot pedal assembly communicatively connected to the combined suction and irrigation port (claim 1) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 spring loaded pinch valves being color-coded (claim 6) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 sheath including a Luer lock mechanism (claim 3) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 sheath being configured to translate relative to the body portion to accommodate different endoscope models (claim 11) 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 § 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 1, 8, and all dependent claims thereof 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.
The term “soft” in claim 1 is a relative term which renders the claim indefinite. The term “soft” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “soft” in claim 8 is a relative term which renders the claim indefinite. The term “soft” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katballe et al. (U.S. 2019/0282072) in view of Jenkins et al. (U.S. 2014/0261579).
With respect to claim 1, Katballe et al. teaches an apparatus for endoscopic procedures, comprising:
a body portion (1086,1088, 1002) configured to receive and retain an endoscope;
an adjustable sheath (1092,1076) coupled to the body portion, wherein the adjustable sheath is configured to accommodate endoscopes of varying lengths;
a suction port (1006) integrated into the body portion;
an ergonomic hand grip portion (1086) formed on the body portion, the ergonomic hand grip portion including a soft overmolded material (polymer, para [0105]) designed to reduce carpal tunnel pressure and fatigue during use.
However, Katballe et al. does not teach a mechanical foot pedal assembly communicatively connected to the combined suction and irrigation port, the mechanical foot pedal assembly including spring-loaded pinch valves for controlling fluid flow.
With respect to claim 1, Jenkins et al. teaches an apparatus for endoscopic procedures, comprising:
a body portion (FIG. 18);
a combined suction and irrigation port (274) integrated into the body portion; and
a mechanical foot pedal assembly (800) communicatively connected to the combined suction and irrigation port (FIG. 19), the mechanical foot pedal assembly including spring-loaded pinch valves for controlling fluid flow (para [0084]-[0086]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Katballe et al. to have combined suction and irrigation in the manner taught by Jenkins et al. in order to provide a washing system for use with the endoscope to maintain visualization within an anatomical passageway (para [0003] of Jenkins et al.).
With respect to claim 4, Katballe et al. teaches the suction port comprises a single Luer lock or barbed fitting (para [0119]).
With respect to claim 5, Jenkins et al. teaches the mechanical foot pedal assembly is non-electronic (FIG. 19 for example).
With respect to claim 7, Katballe et al. teaches the ergonomic hand grip portion is designed to support the thenar eminence of a user's hand (FIG. 9).
With respect to claim 9, Katballe et al. in view of Jenkins et al. teaches the adjustable sheath is configured to provide a fluid flow path for both irrigation and suction fluids (para [0132] of Katballe et al., para [0058] of Jenkins et al.).
With respect to claim 11, Katballe et al. teaches the adjustable sheath is configured to translate relative to the body portion to accommodate different endoscope models (via 1094,1096,1098).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katballe et al. (U.S. 2019/0282072) in view of Jenkins et al. (U.S. 2014/0261579) as applied to claim 1 above and further in view of Wu et al. (U.S. 2015/0196194).
With respect to claim 3, Katballe et al. teaches the adjustable sheath includes a port (1090) for securing the endoscope.
However, Katballe et al. does not teach the adjustable sheath includes a luer lock mechanism.
With respect to claim 3, Wu et al. teaches a sheath for an endoscope wherein the sheath is fixed to the endoscope via Luer-lock (para [0108]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Katballe et al. to utilize a Luer lock at port 1090 because Wu et al. teaches this is a standard means of attachment (para [0108]).
Claim(s) 6, 13, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katballe et al. (U.S. 2019/0282072) in view of Jenkins et al. (U.S. 2014/0261579) as applied to claim 1 above and further in view of Abouzgheib (U.S. 2018/0344142).
Katballe et al. in view of Jenkins e tal. Teaches an apparatus as set forth above. However, Katballe et al. in view of Jenkins et al. does not teach the spring-loaded pinch valves are color-coded for easy identification of suction and irrigation controls.
With respect to claim 6, Abouzgheib teaches color coded foot pedals (para [0089]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Katballe et al. in view of Jenkins et al. to utilize color coded foot pedals in the manner taught by Abouzgheib in order to provide an easy guide for an operator to determine which state the pedal/valve apparatus is in (para [0089] of Abouzgheib).
With respect to claim 13, Jenkins et al. teaches the mechanical foot pedal assembly is configured to return to a default position that closes the spring-loaded pinch valves when not engaged (para [0084]-[0086]).
With respect to claim 14, Jenkins et al. teaches the combined suction and irrigation port is configured to allow continuous flow of fluids without interruption (intended use, see also para [0084]-[0086]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katballe et al. (U.S. 2019/0282072) in view of Jenkins et al. (U.S. 2014/0261579) as applied to claim 1 above and further in view of Geist et al. (U.S. 2007/0093693).
Katballe et al. in view of Jenkins et al. teaches an apparatus as set forth above. However, Katballe et al. in view of Jenkins et al. does not teach the body portion further comprises a rigid structure with a soft rubber overmold.
With respect to claim 8, Geist et al. teaches a handle for an endoscopic device wherein the body of the handle comprises a rigid structure (22) with a soft rubber overmold (24, para [0033]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the handle of Katballe et al. to utilize a rigid structure with a soft rubber overmold in the manner taught by Geist et al. in order to reduce hand fatigue (para [0034] of Geist et al.).
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.
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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 NEWTON/ Primary Examiner, Art Unit 3799