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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 19, 2025 has been entered.
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: a handheld surgical device configured to accommodate an optical unit and at least one further instrument, as claimed in Claim 1, which is depicted as handheld surgical device 10 in FIG. 1 and described in paragraph [0017] of the present specification.
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 § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1, 7, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Muller (US Patent 5,549,541 – “Muller”) in view of Ibe (US Patent 4,132,227 – “Ibe”).
Regarding Claim 1, Muller discloses:
A shaft (Muller FIG. 1, shaft 20) for a handheld surgical device (Muller FIG. 1, instrument 18) configured to accommodate an optical unit (Muller FIG. 4, viewing lens 84 of telescope 80) and at least one further instrument (Muller FIG. 4, laser 92), the shaft comprising a proximal end (Examiner-annotated Muller FIG. 2a shown below, proximal end 24 of shaft 20) and a distal opening (Muller FIG. 2a, distal opening 28),
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wherein the proximal end of the shaft can be coupled to a device body (Muller FIG. 1, connecting means 40) and/or a handle unit, and
the optical unit and the instrument are positionable with their distal ends inside the distal opening of the shaft (Muller FIG. 4, showing viewing lens 84 and laser 92 at opening of distal section 30 of shaft 20),
wherein a peripheral border of the distal opening of the shaft has a thickened portion facing outward at least in sections (Muller FIG. 4, showing thickened/bulbous distal portion of elongated fenestra 32),
wherein the distal opening is formed obliquely with respect to a longitudinal axis of the shaft (Muller FIG. 2a, distal opening 28; Muller col. 8, lines 1-3, “opening 28 is formed at an acute angle relative to the central axis”), and an edge of the distal opening comprises two oblique portions and a horizontal portion oriented at least substantially parallel to the longitudinal axis of the shaft, the horizontal portion being located between the two oblique portions along the longitudinal axis of the shaft (See annotated Muller FIG. 2a above, showing a horizontal portion, parallel to the longitudinal axis of shaft 20, located between a first oblique portion and a second oblique portion of bulbous fenestra 32),
wherein the thickness of the thickened portion of the distal opening varies continuously along the shaft (Muller FIG. 4, showing elongated fenestra 32 getting continuously thicker as it extends to the distal end of shaft 20).
Muller does not explicitly disclose:
wherein an external circumference of the shaft is only enlarged in regions by the thickened portion of the border, and
wherein the external circumference of the shaft is enlarged by the thickened portion of the border only over a distal end length of the shaft of 0.1% to 1.0%.
Ibe teaches wherein an external circumference of the shaft is only enlarged in regions by the thickened portion of the border (Ibe FIG. 5 and Ibe FIG. 6, showing ridge 11 enlarging the external circumference of sheath 1).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Ibe’s ridge with the shaft disclosed by Muller. A person having ordinary skill in the art would be motivated to combine these
prior art elements according to known methods to yield the predictable result of a shaft/sheath having aperture flushing capabilities for the distal end of the shaft/sheath (see Ibe col. 4, lines 21-47).
Muller in view of Ibe does not explicitly teach wherein the external circumference of the shaft is enlarged by the thickened portion of the border only over a distal end length of the shaft of 0.1% to 1.0%.
Ibe teaches a ridge 11 that mates with a beak 5, as shown in Ibe FIGs. 5-6. One of ordinary skill in the art would have had a reasonable expectation of success in modifying Ibe to have a thickening length within the claimed range, as it involves only adjusting the dimension of the component disclosed by Ibe to provide the strength required to support the distal end of Ibe’s shaft 1 when mating with Ibe’s beak 5. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Ibe in the shaft taught by Muller in view of Ibe by making the thickening 0.1% to 1.0% of the shaft as a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. “ In re Aller, 220 F.2d 454, 456, 105 USPG 233,235 (CCPS 1955). See also MPEP 2144.05(II)(A)(B). Specifically, Miller FIG. 4 discloses a thickened/bulbous distal portion of elongated fenestra 32. Ibe FIG. 5 and Ibe FIG. 6 teach ridge 11 enlarging the external circumference of sheath 1. As such, Ibe is cited for modifying (not replacing) Muller’s elongated fenestra 32. As described in Ibe col. 4, lines 21-47, use of Ibe’s ridge 11 would yield the predictable result of a shaft/sheath having aperture flushing capabilities for the distal end of the shaft/sheath.
Furthermore, it appears that Applicant’s specification places no criticality on the range claimed. Paragraph [0007] of Applicant’s disclosure states “These values have proven to be particularly advantageous for their application”, but does not explain what advantage they provide nor what application is improved. As such, there appears to be nothing critical about these ranges. See MPEP 2144.04(IV)(A).
Regarding Claim 7, Muller in view of Ibe teaches the features of Claim 1, as described above.
Ibe further teaches wherein the external circumference of the shaft is enlarged by the thickened portion of the border (Ibe FIG. 6, showing ridge 11 enlarging the external circumference of sheath 1).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Ibe’s ridge with the shaft disclosed by Muller. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a shaft/sheath having aperture flushing capabilities for the distal end of the shaft/sheath (see Ibe col. 4, lines 21-47).
Muller in view of Ibe do not explicitly teach that the thickening is only over a distal end length of the shaft of 0.5 mm to 5mm.
Ibe teaches a ridge 11 that mates with a beak 5, as shown in Ibe FIGs. 5-6. One of ordinary skill in the art would have had a reasonable expectation of success in modifying Ibe to have a thickening length within the claimed range, as it involves only adjusting the dimension of the component disclosed by Ibe to provide the strength required to support the distal end of Ibe’s shaft 1 when mating with Ibe’s beak 5. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Ibe in the shaft taught by Muller in view of Ibe by making the thickening 0.5 mm to 5 mm of the shaft as a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. “ In re Aller, 220 F.2d 454, 456, 105 USPG 233,235 (CCPS 1955). See also MPEP 2144.05(II)(A).
Furthermore, it appears that Applicant’s specification places no criticality on the range claimed. Paragraph [0007] of Applicant’s disclosure states “These values have proven to be particularly advantageous for their application”, but does not explain what advantage they provide nor what application is improved. As such, there appears to be nothing critical about these ranges. See MPEP 2144.04(IV)(A).
Regarding Claim 10, Muller in view of Ibe teaches the features of Claim 1, as described above, including a handheld surgical device (Muller FIG. 1, instrument 18).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Muller (US Patent 5,549,541 – “Muller”) in view of Ibe (US Patent 4,132,227 – “Ibe”) and Charles (US PGPUB 2015/0173947 – “Charles”).
Regarding Claim 2, Muller in view of Ibe teaches the features of Claim 1, as described above.
Muller in view of Ibe does not explicitly teach wherein an entire peripheral border of the distal opening has the outwardly facing thickened portion.
Charles teaches wherein an entire peripheral border (Charles FIG. 9, periphery of distal thickened portion 670 of probe 110) of the distal opening (Charles FIG. 9, distal end of lumen 665) has the outwardly facing thickened portion (Charles FIG. 9, distal thickened portion 670 of probe 110).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Charles’ thickened portion 670 with the shaft taught by Muller in view of Ibe. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a shaft that has “a soft, pliable, annular thickened portion” (see Charles paragraph [0048]).
Response to Arguments
Applicant comments, on page 4 of the December 19, 2025 response, regarding the claim interpretation under 35 U.S.C. 112(f) of a handheld surgical device configured to accommodate an optical unit and at least one further instrument claimed in Claim 1 merely states that “Applicant is not making any amendments to the claims because this is not a rejection”. Examiner agrees that 112(f) is an interpretation, and not a rejection. However, as described above, a handheld surgical device configured to accommodate an optical unit and at least one further instrument, as claimed in Claim 1, which is depicted as handheld surgical device 10 in FIG. 1 and described in paragraph [0017] of the present specification, remains interpreted under 35 U.S.C. 112(f). This interpretation under 35 U.S.C. 112(f) is maintained.
Applicant arguments (citing only Muller US Patent 5,549,541), on pages 4-5 of the December 19, 2025 response, appear to assert that the rejection of Claim 1 under 35 U.S.C. 102(a)(1) is improper. These arguments are moot since the present amendment incorporates features of Claims 6 and 8 into Claim 1, which is now rejected under 35 U.S.C. 103.
Applicant arguments, on page 5 of the December 19, 2025 response, assert that Muller (US Patent 5,549,541) does not teach or suggest that the thickened portion of the end of the shaft is limited to an extremely short range (“external circumference of the shaft is enlarged by the thickened portion of the border only over a distal end length of the shaft of 0.1% to 1.0%”). That is, Applicant asserts that since the cited portion of cited elongated fenestra 32 of Muller is elongated/long, then it cannot be extremely short. First, the thickened portion of elongated fenestra 32 cited is not the entire elongated fenestra 32, but rather is the thickened/bulbous distal portion of elongated fenestra 32 shown in Muller FIG. 4. Second, the term “elongated” has no specific definition (see attached definition of “elongated” from Dictionary.com, which defines the adjective “elongated” simply as extended; lengthened; long and thin. Nothing in the adjective “elongated” describes a specific length.
Applicant arguments, on pages 6-9 of the December 19, 2025 response, assert that Muller in view of Ibe does not teach “wherein the external circumference of the shaft is enlarged by the thickened portion of the border only over a distal end length of the shaft of 0.1% to 1.0%”, as now claimed in Claim 1, and cited in the rejection of Claim 1 under 35 U.S.C. 103, for the following reasons.
On pages 6-7, Applicant asserts that a specific range (i.e., 0.1% to 1.0%) does not constitute “routine optimization” according to the following analysis. First, Applicant agrees that Muller teaches a shaft with an elongated fenestra 32. As shown in Muller FIG. 4, fenestra 32 has a bulbous end, similar to the bulbous distal end 18 of shaft 17 shown in the present patent application’s FIG. 3. Second, Applicant states that the purpose of ridge 11 shown Ibe FIG. 11 is to push away surrounding tissue. This simply bolsters the function of Muller’s fenestra 32.
Applicant then asserts that making the thickened distal end of Muller only 0.1% to 1.0% of the shaft length would make Muller’s invention/structure unsuitable for performing Muller’s intended function of channel formation, and would make Ibe’s invention/structure unsuitable for performing Ibe’s intended function of tissue displacement over a relevant length. Examiner respectfully disagrees. First, Muller does not assert that the bulbous end of fenestra 32 is to form a channel. Rather, Muller col. 9, lines 10-16 states that “elongated fenestra 32 having a shaped tip at the end thereof to facilitate atraumatic insertion of the distal end of the cystoscope into the urethra”. Second, Applicant provide no reason why Ibe’s ridge 11 would not move aside tissue if it were 0.1%-1.0% the length of the shaft. Ibe’s ridge 11 combined with Muller’s bulbous end of fenestra 32 would perform this feature regardless of how long it was. Third, Applicant makes no limitation in the claim regarding how long the shaft itself is. Thus, if the shaft were an insertion portion that is 150 centimeters long (e.g., for use in colonoscopy), then the bulbous end would be 15mm long, which is interpreted as being “long” enough to push aside tissue and to support a bulbous end.
On pages 8-9, Applicant further argues that the present invention has a long flexible insertion portion and a short stiff distal end. This is exactly what Muller and/or Ibe teach. Furthermore, Applicant’s specification places no criticality on the range claimed. Paragraph [0007] of Applicant’s disclosure states “These values have proven to be particularly advantageous for their application”, but does not explain what advantage they provide nor what application is improved. As such, there is nothing critical about these ranges. See MPEP 2144.04(IV)(A).
Finally, in the penultimate paragraph of page 8, Applicant asserts that a combination of Muller and Ibe fails to teach or suggest (a) an oblique opening with a specific edge shape horizontal between two oblique sections (“the horizontal portion being located between the two oblique portions along the longitudinal axis of the shaft”), (b) an enlargement of the circumference only in certain areas (“an external circumference of the shaft is only enlarged in regions by the thickened portion of the border”), and (c) the extremely short length of the thickening (wherein the external circumference of the shaft is enlarged by the thickened portion of the border only over a distal end length of the shaft of 0.1% to 1.0%. ), as claimed in Claim 1. Feature (a) has been rejected above citing Muller FIG. 2a, distal opening 28; Muller col. 8, lines 1-3; feature (b) has been rejected above citing Ibe FIG. 5 and Ibe FIG. 6, showing ridge 11 enlarging the external circumference of sheath 1; and feature (c) has been rejected above by citing Muller and/or Ibe and the MPWP, as discussed extensively in the response to arguments above. Examiner further notes that the section of the Applicant’s arguments present no additional reasoning why the combination of cited art fails to teach these features.
Finally, Applicant is reminded that MPEP 2144(IV) states that a prior art structure that has an equivalent of the claimed invention reads on the claimed invention, even if the prior art solves a different problem. Various passages in Applicant’s arguments allude to a premise that the prior art must solve the same problem as the present invention, which is not the case in the MPEP guidelines. Furthermore, Applicant is reminded that MPEP 2141.01(a)(IV) states that prior art that teaches a similar structure as the claimed invention is relevant analogous art, without being restricted by the purpose of the prior art.
As such, the rejections of Claims 1-2, 7, and 10 under 35 U.S.C. 103 are maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
02/25/26