Prosecution Insights
Last updated: July 17, 2026
Application No. 18/554,957

ENDOSCOPE, IN PARTICULAR A MEDICAL SINGLE-USE ENDOSCOPE

Non-Final OA §103§112
Filed
Oct 11, 2023
Priority
Apr 12, 2021 — DE 10 2021 109 023.7 +1 more
Examiner
WU, PAMELA F
Art Unit
3795
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Karl Storz SE & Co. KG
OA Round
1 (Non-Final)
58%
Grant Probability
Moderate
1-2
OA Rounds
7m
Est. Remaining
80%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allowance Rate
163 granted / 282 resolved
-12.2% vs TC avg
Strong +22% interview lift
Without
With
+21.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
42 currently pending
Career history
337
Total Applications
across all art units

Statute-Specific Performance

§101
0.2%
-39.8% vs TC avg
§103
70.9%
+30.9% vs TC avg
§102
7.8%
-32.2% vs TC avg
§112
6.1%
-33.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 282 resolved cases

Office Action

§103 §112
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 . Status of Claims Claims 1-15 are pending, claims 7-10 have been withdrawn from consideration, and claims 1-6 and 11-15 are currently under consideration for patentability under 37 CFR 1.104. Election/Restrictions Applicant's election with traverse of Species 1 and Subspecies A, readable on claims 1-6 and 11-15, in the reply filed on 04/03/2026 is acknowledged. The traversal is on the ground(s) that “The Office Action has not established that the identified species are patentable distinct” (p. 6 of Remarks) and “the Office Action has not demonstrated that examining the claims together would impose a serious burden” (p. 6 of Remarks). This is not found persuasive because the Requirement for Restriction of 12/03/2025 focuses on a requirement for unity of invention, where the corresponding technical features do not make a contribution over the prior art in view of Adair (US 4,782,819). The requirement is still deemed proper and is therefore made FINAL. 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: “clamping element/s” and “tensioning element” 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. 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 § 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 5 and 13-15 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. Regarding claim 5, the limitation “means of respective structural elements and respective corresponding structural elements” is unclear. It is unclear if the structural elements and corresponding structural elements are the same, a part of, or a different feature from the structuring and the corresponding structuring recited in claims 3 and 5. Regarding claims 13-15, the limitation “connection means” is unclear. It is unclear if this feature is the same or different feature to the connection device recited in claim 1. Regarding claim 14, the limitation “the imaging means” is unclear. It is unclear if this feature is the same or different feature to the image recording means recited in claim 1. Regarding claim 15, the limitation “a transition piece” is unclear. It is unclear if this feature is the same or different feature to the separate transition piece recited in claim 13. Claim limitation “means of respective structural elements and respective corresponding structural elements” (in claim 5) has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it is unclear if the "means of" language is referring to the structure and corresponding structuring OR the structural elements and corresponding structural elements. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may: (a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function; (b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function; (c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or (d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function. 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. Claim(s) 1-6, 11, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Leong (US 2019/0350440), in view of Freitag (US 2023/0157518; foreign priority to DE 202020102272U1 with date of 04/21/2020). Regarding claim 1, Leong discloses an endoscope system (see figure 1) in particular a disposable medical endoscope (disposable endoscope [0023]) comprising: a handle housing (108, figure 1) for gripping and/or operating the endoscope system (see control lever 112, figure 1) and/or for receiving functional components (see figure 2a), a shaft (110, figure 1) and a tip (distal end 118, figure 1), wherein the shaft mechanically connects the handle housing to the tip along a longitudinal axis (see figures 1-2a), and the tip has an image recording means (this element is interpreted under 35 USC 112f as an image recording chip [14] | camera module 316, figure 3b; CCD or CMOS device [0109]) for recording an image of a viewing region; and the handle housing has a connection device (400, figure 4). Leong is silent regarding the connection device with a clamping element or a plurality of clamping elements and a tensioning element, wherein the clamping element or the clamping elements allows or allow the shaft to be inserted into the connection device in a mounting position of the tensioning element, and the tensioning element moves the clamping element or the clamping elements mechanically to the shaft in a fastening position, in such a way that the shaft is received in a mechanically fixed manner on the handle housing by means of a force fit or form fit between the clamping element or clamping elements and the shaft. Freitag teaches an endoscope head (1, figure 1) with a clamping device (5, figure 1). The clamping device has several displaceable clamping bodies (6, figure 1). The individual clamping bodies are connected to a base body (8, figure 1), where the base body has a threaded portion (9, figure 1). The threaded portion is provided for engagement with a threaded portion (10, figure 6) on a clamping sleeve (11, figure 6). Rotating the clamping sleeve relative to the endoscope head or threaded portion on the base body causes the clamping sleeve to be displaced in the longitudinal direction of the endoscope head and as a result to strike the clamping bodies ([0051]). The distal end of the clamping sleeve strike the individual clamping bodies and are actively displaced inward or displaced outward by springing back when the clamping sleeve is rotated back ([0051]). As a result, it is possible to adjust the variable opening width (D1, figure 5) in such a way that endoscope tubes (2, figure 1) of different diameters (D2, figure 1) can be received in the longitudinal channel (4, figure 1) and held by the clamping device ([0051]). It would have been obvious to modify the system of Leong with the clamping device (5, figure 1) and clamping sleeve (11, figure 1) of Freitag. Doing so would allow endoscope tubes of different diameters to be received and held in the clamping device/connection device ([0051]). The modified system would have the connection device with a clamping element or a plurality of clamping elements (this element is interpreted under 35 USC 112f as clamping tabs | 6, figure 1; Freitag) and a tensioning element (this element is interpreted under 35 USC 112f as a tensioning sleeve | 11, figure 6), wherein the clamping element or the clamping elements allows or allow the shaft to be inserted into the connection device in a mounting position of the tensioning element (see figure 1 | figures 2-3), and the tensioning element moves the clamping element or the clamping elements mechanically to the shaft in a fastening position (clamping sleeve 11 strikes the individual clamping bodies 6…actively displaced inwards [0051] | figure 5), in such a way that the shaft is received in a mechanically fixed manner on the handle housing by means of a force fit or form fit (force-fitting manner through clamping [0057]) between the clamping element or clamping elements and the shaft (held by the clamping device 5 [0051]; see figures 1 and 5). Regarding claim 2, Freitag further teaches the clamping element or the clamping elements is or are arranged parallel or substantially parallel to the longitudinal axis (see figures 1-2; Freitag), in particular distributed around the longitudinal axis (see figures 1-2). Regarding claim 3, Freitag further teaches the clamping element or the clamping elements has or have a structuring facing the shaft (see internal surface of 6, figure 5; Freitag), wherein in particular the shaft has a corresponding structuring facing the clamping element or clamping elements (see outer surface of 2, figure 1; which engages with the internal surface of 6; see figure 5). Regarding claim 4, Freitag further teaches the structuring and/or the corresponding structuring acts or act frictionally by means of the force fit between the clamping element or the clamping elements and the shaft (displaced inwards…held by the clamping device [0051]; Freitag), such that a coefficient of friction is increased (displaced inwards…held [0051] | interpreted the coefficient of friction is increased in order to hold the shaft) and the shaft is thus mechanically fixed in the handle housing with a higher load capacity (force-fitting…able to transmit a force to the distal end [0027]). Regarding claim 5, Freitag further teaches the structuring and the corresponding structuring engage on the shaft, by means of respective structural elements and respective corresponding structural elements (see 112b rejection above | see internal surface of 6, figure 5 and see outer surface of 2, figure 1; Freitag), in a form-fitting manner between the clamping element or the clamping elements and the shaft (force-fitting and/or form-fitting [0027]), wherein in particular structural elements and corresponding structural elements are arranged along the longitudinal axis (see length of 6, figure 1) in order to increase a transmissible torque between the shaft and the connection device (torque can be exerted on the endoscope tube 2 via the endoscope head 1 [0057]) and/or structural elements and corresponding structural elements are arranged along a circumference around the longitudinal axis in order to increase transmissible tensile forces (see 6, figures 1-2 | evenly dispersed…[0049]). Regarding claim 6, Freitag further teaches the tensioning element is annular (11, figure 6; Freitag) and partially or completely surrounds the clamping element or clamping elements in the fastening position (clamping sleeve 11 …displaced in longitudinal direction toward the distal end 20 of the endoscope head 1 [0051]; see figure 1). Regarding claim 11, Freitag further teaches the tensioning element, in particular on an accessible outer side facing away from the shaft (see outer surface of 11, figure 6; Freitag), has a structure (broadly interpreted as the outer circular surface of 11, figure 6) for applying forces for transferring the tensioning element into the fastening position (rotating the clamping sleeve…[0051]), such that the forces for transferring the tensioning element into the fastening position can be applied manually by means of the structure and/or by means of a tool (rotating the clamping sleeve [0051] | interpreted the rotation can occur manually). Regarding claim 13, Leong further discloses the connection means is designed as a separate transition piece (400, figure 4; Leong | 126, figure 1) between the handle housing and the shaft and in particular has an attachment (406 and 408, figure 4), wherein the attachment is able to be brought into engagement with a corresponding receptacle (410 and 412, figure 4) on the handle housing. Regarding claim 14, Leong further discloses the connection means (see 112b rejection above | 400, figure 4; Leong) has a passage (408, figure 4) arranged orthogonally or substantially orthogonally to the longitudinal axis (interpreted 408 to have a length/direction that is orthogonal to the longitudinal axis) in order to facilitate mounting of the shaft on the handle housing (engaging…shell 202 [0045]), such that connections (electrical conductors 214 and/or pull wires 208, figure 2a) for the imaging means (this element is interpreted under 35 USC 112f as an image recording chip [14] | camera module 316, figure 3b; CCD or CMOS device [0109]) and/or mechanical control means (this element is interpreted under 5 USC 112f as pull wires | 208, figure 2a) guided within the shaft and protruding beyond one end of the shaft can be reached by means of a finger or several fingers of an operator (during assembly, 208 and 214 can be reached by an operator before 400 is assembled within 200, figure 4). Regarding claim 15, Leong further discloses the handle housing has a first handle shell (200 or 202, figures 2b-c; Leong) and a second handle shell (200 or 202, figures 2b-c), such that, when the first handle shell is joined to the second handle shell (see figure 1), the connection means designed as a transition piece (400, figure 4) is framed in a form-fitting manner between the first handle shell and the second handle shell by means of the attachment (see 406 and 408, figure 4 | positively engage…restrict or prevent rotation…clamped between right and left shells [0045]). Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Leong (US 2019/0350440) and Freitag (US 2023/0157518) as applied to claim 11 above, and further in view of Bacher (US 2014/0336688). Regarding claim 12, Leong and Freitag discloses all of the features in the current invention as shown above in claim 11. They are silent regarding the structure has depressions introduced radially into the tensioning element and/or elevations applied to the tensioning element and/or recesses for fingers of an operator and/or a corresponding tool which are introduced axially into the tensioning element or applied to the tensioning element, in particular surrounding the shaft. Bacher teaches a grip aid sleeve (14, figure 1) with gripping areas (14, figure 1), which can both be gripped by a key and enable comfortable manual rotation ([0059]). It would have been obvious to modify the system, specifically the tensioning element, with gripping areas (14, figure 1) as taught by Bacher. Doing so would allow gripping by a key and enable comfortable manual rotation ([0059]). The modified system would have the structure has depressions (see 14, figure 1; Bacher) introduced radially into the tensioning element and/or elevations applied to the tensioning element and/or recesses for fingers of an operator and/or a corresponding tool which are introduced axially into the tensioning element or applied to the tensioning element, in particular surrounding the shaft (gripped by a key and enable manual rotation [0059]; Bacher | rotating the clamping sleeve [0051]; Freitag). Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Takahashi (US 5,735,793) with a fixing member. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA F WU whose telephone number is (571)272-9851. The examiner can normally be reached M-F: 8-4 PM. 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. 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. PAMELA F. WU Examiner Art Unit 3795 June 12, 2026 /RYAN N HENDERSON/Primary Examiner, Art Unit 3795
Read full office action

Prosecution Timeline

Oct 11, 2023
Application Filed
Jun 17, 2026
Non-Final Rejection mailed — §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
58%
Grant Probability
80%
With Interview (+21.8%)
3y 4m (~7m remaining)
Median Time to Grant
Low
PTA Risk
Based on 282 resolved cases by this examiner. Grant probability derived from career allowance rate.

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