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
Newly added claim 59 recites inter alia, “a stabilizing system configured to retain the endoscope in a selected rotational orientation within the adjustable sheath, the stabilizing system comprising a wedge element configured to accommodate endoscopes of varying diameters.” This is directed to the non-elected embodiment of FIG. 18 (see para [0086] of the published specification). Therefore claim 59 is withdrawn from consideration.
Status of Claims
Applicant’s amendments filed 05/13/2026 have been entered. Claims 1, 3-9, 11, 13, 14, and 52-60 are pending, claim 59 has been withdrawn from consideration, and claims 1, 3-9, 11, 13, 14, 52-58 and 60 are currently under consideration for patentability under 37 CFR 1.104. Previous rejection under 35 U.S.C. 112(b) has been withdrawn in light of Applicant’s arguments. Response to arguments found below.
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, a combined suction and irrigation port integrated into the body portion wherein the combined suction and irrigation port is configured to simultaneously provide liquid irrigation fluid to and remove liquid suction fluid from an endoscopic procedure site (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 configured for communicative connection with the combined suction and irrigation port via internal flexible tubing and a coupler assembly (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, securement mechanism disposed within the adjustable sheath for securing the endoscope within the sheath with a fluid-tight seal (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 spring loaded pinch valves each include color-coded indicators integrated into a respective valve lever, with distinct colors corresponding to suction and irrigation functions for easy identification of suction and irrigation controls during surgical procedures (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 internal channels integrated with the combined suction and irrigation port (claim 9) 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 accommodate different endoscope models of varying lengths (claim 11) 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 is positioned external to the body portion and connected via tubing that maintains sterile separation between cleaning functions and surgical functions (claim 52) 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 comprise a first valve configured to independently control irrigation fluid flow and a second valve configured to independently control suction fluid flow, such that irrigation and suction are each actuable separately and without activating the other (claim 55) 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 first valve and the second valve are each biased to a normally-closed position and transition to an open position only upon actuation of a corresponding pedal of the mechanical foot pedal assembly (claim 56) 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 soft overmolded grip portion including a thenar rest configured to support the apparatus on a user's thenar eminence to relieve pressure associated with repetitive strain on the carpal tunnel (claim 60) 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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 and all dependent claims thereof is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite inter alia, “a combined suction and irrigation port integrated into the body portion wherein the combined suction and irrigation port is configured to simultaneously provide liquid irrigation fluid to and remove liquid suction fluid from an endoscopic procedure site.” While the specification discloses a fluid control system capable of simultaneous irrigation and suction (para [0069] of the published specification, for example), the specification does not teach or disclose a combined suction and irrigation port that is capable of simultaneous suction and irrigation. Therefore claim1 is rejected for containing new matter.
Claim 1 has been amended to recite inter alia, “a mechanical foot pedal assembly configured for communicative connection with the combined suction and irrigation port via internal flexible tubing and a coupler assembly.” There is no disclosure in the specification of a “coupler assembly.” Therefore claim 1 is rejected for containing new matter.
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, 3, 4, 5, 7, 9, 11, 52-58 and 60 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 during surgical procedures;
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 havng a durometer of less than 80 Shore A (polypropylene, 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 wherein the combined suction and irrigation port is configured to simultaneously provide liquid irrigation fluid and to remove liquid suction fluid from an endoscopic procedure site (intended use); and
a mechanical foot pedal assembly (800) configured for communicative connection with the combined suction and irrigation port via internal flexible tubing and a coupler assembly, (FIG. 19), the mechanical foot pedal assembly including spring-loaded pinch valves for controlling fluid flow during surgical procedures (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 3, Jenkins et al. teaches a securement mechanism (277) disposed within the adjustable sheath for securing the endoscope within the sheath with a fluid-tight seal.
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 through intenral channels integrated with the combined suction and irrigation port (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 accommodate different endoscope models of varying lengths (via 1094,1096,1098).
With respect to claim 52, Jenkins et al. teaches the mechanical foot pedal assembly is positioned external to the body portion and connected via tubing that maintains sterile separation between cleaning functions and surgical functions (FIG. 19).
With respect to claim 53, Katballe et al. teaches the soft overmolded material comprises a medical-grade polymer configured to provide tactile grip during extended surgical procedures (para [0105]).
With respect to claim 54, Jenkins et al. teaches the securement mechanism includes an 0- ring gasket (277) providing the fluid-tight seal around the endoscope within the adjustable sheath.
With respect to claim 55, Jenkins et al. teaches the spring-loaded pinch valves comprise a first valve configured to independently control irrigation fluid flow and a second valve configured to independently control suction fluid flow, such that irrigation and suction are each actuable separately and without activating the other (FIG. 19).
With respect to claim 56, Jenkins et al. teaches the first valve and the second valve are each biased to a normally-closed position and transition to an open position only upon actuation of a corresponding pedal of the mechanical foot pedal assembly (FIG. 19).
With respect to claim 57, Katballe et al. teaches he combined suction and irrigation port is configured to evacuate fluid comprising at least one of blood, saline irrigation fluid, pus, or tissue debris from an operative field during an endoscopic procedure (intended use).
With respect to claim 58, Jenkins et al. teaches the adjustable sheath further comprises a coupler portion including a seal element (277) disposed between the coupler portion and the adjustable sheath, the seal element configured to inhibit fluid leakage into the body portion.
With respect to claim 60, Katballe et al. teaches the ergonomic hand grip comprises a soft overmolded grip portion configured to maintain a neutral wrist position during use, the soft overmolded grip portion including a thenar rest configured to support the apparatus on a user's thenar eminence to relieve pressure associated with repetitive strain on the carpal tunnel (para [0105]).
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 et al. 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.).
Response to Arguments
Applicant's arguments filed 05/13/2026 have been fully considered but they are not persuasive.
Applicant responds to the drawing objections by indicating where in the specification support can be found for the claim limitations. This is not persuasive at least because support in the specification is not germane to a drawing objection. As set forth above, the drawings must show every feature of the invention specified in the claims. Applicant has provided no arguments, persuasive or otherwise, that the claim limitations listed above are found in the drawings. Therefore the drawing objections are maintained.
In response to applicant's argument that the mechanically coupled, single-path arrangement of Jenkins does not teach or suggest a combined suction and irrigation port configured to simultaneously provide liquid irrigation fluid and to remove liquid suction fluid from an endoscopic procedure site, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Specifically, it is noted that Applicant’s elected embodiment is a single path arrangement (see Applicant’s FIG. 7 for example).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a compliant grip layer, or any ergonomic grip feature designed to reduce hand fatigue) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that Jenkins fluid inlet communicates fluid through hub 270 into washing shaft 230 via fluid lumen 240, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Katballe et al. teaches a suction port integrated into the body portion. Jenkins is relied upon to modify the suction port into a combined suction and irrigation port.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., independent control of suction and irrigation) are not recited in claim 1. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to Applicant’s argument that there is no motivation to combine Katballe and Jenkins, Examiner respectfully disagrees. As set forth above, 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.).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 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
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