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 .
This Office Action is in response to the amendments dated June 29, 2026
Claims 1-2, 7, and 10 are pending.
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”. 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),
PNG
media_image1.png
278
620
media_image1.png
Greyscale
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 has an oblique formation 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); and
wherein the external circumference of the shaft decreases toward the distal end due to the oblique formation of the distal opening, notwithstanding the thickened portion of the border (Muller FIG. 2a. showing an external circumference of shaft 20 decreasing toward the distal end due to the shaft 20 reducing from the large diameter outer sheath 22 down to the small diameter distal section 30).
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's arguments filed June 29, 2026 regarding the rejection of Claims 1-2, 7, and 10 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
On pages 4-6 of the June 29, 2026 response, Applicant asserts that there would be no reason for person having ordinary skill in the art of handheld surgical devices to combine Ibe’s ridge 11 shown in Ibe FIG. 6 with the shaft disclosed by Muller. Examiner respectfully disagrees. 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). Applicant responds by stating that Ibe’s enlarged ridge 11 is for displacing tissue by increasing an outer circumference of an instrument, rather than providing an atraumatic, rounded edge. Although Applicant states that the combination of Muller and Ibe “leads away from the subject matter of claim 1”, it appears that Applicant intends to argue that the combination of Muller and Ibe “teaches away from the subject matter of claim 1”. Examiner responds by citing MPEP 2141.02(VI), which states that “A prior art reference must be considered in its entirety…in light of the disclosures in the art that teach away from the invention.” That is, the question posed by Applicant appears to be not whether it would be obvious to combine multiple pieces of prior art (MPEP 2141(III)), but whether the Ibe’s enlarged ridge 11 would render the present invention unsuitable for its intended purpose (MPEP 2141.02(VI)). There is no evidence of this, since Ibe’s enlarged ridge 11, just as thickening 21 shown in Applicant’s FIG. 3, does not render Applicant’s invention unsuitable for its intended purpose.
On page 5 of the June 29, 2026 response, Applicant asserts that the intended purpose of Applicant’s thickening 21 shown in Applicant’s FIG. 3 is to provide an atraumatic tip, while Ibe’s enlarged ridge 11 is to push aside patient tissue. Examiner notes that the claimed feature of “the shaft has a thickened portion” is a structural limitation, not a functional limitation (MPEP 2114(I), “Features of an apparatus may be recited either structurally or functionally. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997)). As such, this argument is moot.
On page 6 of the June 29, 2026 response, Applicant asserts that the feature “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%” claiming the length specification of “0.1% to 1.0%” is essential to creating “an atraumatic yet very slender tip”. The only passage in the present written description in the present patent application that addresses this feature is in paragraph [0007], which states “it is conceivable that the external circumference of the shaft is only enlarged by the thickening of the border over a length of the shaft of 0.1% to 1.0%, in particular 0.5%. These values have proven to be particularly advantageous for their application.” However, this passage fails to describe why these limitations exist, why they are critical, why they are “particularly advantageous”, and/or why they result in an unexpected result. That is, paragraph [0007] of the present specification provides no reason why such “values have proven to be particularly advantageous”, and particularly does not teach how such dimensions would create “an atraumatic yet very slender tip”. As such, under MPEP 2144.04(III)(A) this feature hold no patentable weight, making Applicant’s argument unpersuasive.
For reasons stated herein, the rejection of Claim 1-2, 7, and 10 under 35 U.S.C. 103 are maintained.
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 JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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, 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.
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.
JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
8/5/26
Prosecution Insights