NON-FINAL REJECTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-15) in the reply filed on 2/22/2026 is acknowledged.
Claims 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/22/2026.
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 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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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) 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) 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) 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: “biasing device” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. A coil spring as been identified from the Specification as corresponding structure (see ¶ [0025] of the Spec. as filed). Therefore, the biasing device is being interpreted to cover a coil spring and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (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).
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.
Claims 1-15 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 1: There is a lack of antecedent basis for the term “said housing” in line 3 of the claim. It is unclear what housing this refers to.
Dependent claims thereof inherit the aforementioned deficiency by virtue of their dependencies1 on claim 1, and therefore rejected for the same reason.
In accordance with compact prosecution practice (see MPEP 2173.06), this is being construed for purposes of applying prior art as referring to the handle or a housing thereof.
Allowable Subject Matter
Claims 1-15 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record does not teach or reasonably suggest to the ordinarily skilled artisan a speculum comprising:
a handle comprising a pressurized gas flow lumen and a viewing device;
a vaginal interface element coupled to a distal end of said housing2, said vaginal interface element comprising a flexible cup with folds and an air inlet septum; and
a probe which comprises an imaging lumen and which passes through said vaginal interface element, wherein said imaging lumen comprises an optical window, wherein said viewing device is positioned proximal to said optical window, and a biasing device is configured to urge said viewing device to abut against an inner surface of said optical window.
Shachrur, US 2022/0218192 A1 (hereinafter “Shachrur”) is cited as prior art closest to the claimed invention. Shachrur teaches a speculum comprising:
a handle (handle 16, Figs. 1A and 1B) comprising a pressurized gas flow lumen (tubing 23, Fig. 2A; ¶ [0016]) and a viewing device (viewing device/camera 18, light source 14, and light guides/optical fibers, Fig. 1A and 1B; ¶ [0015]-[0017]); and
a probe which comprises an imaging lumen (third lumen 30), wherein said imaging lumen comprises an optical window (lens 31, Fig. 2A; ¶ [0016]-[0017]), wherein said viewing device is positioned proximal to said optical window.
Shachrur does not teach a vaginal interface element coupled to a distal end of said housing, said vaginal interface element comprising a flexible cup with folds and an air inlet septum, let alone that the probe passes through the vaginal interface element. Further, Shachrur does not teach a biasing device is configured to urge said viewing device to abut against an inner surface of said optical window.
Although a vaginal interface element comprising a flexible cup with folds applied to endoscopic speculums is known in the art (e.g., Sauer3), the prior art does not teach such a vaginal interface element that comprises an air inlet septum as recited in the claim.
Although a vaginal interface element comprising an air inlet septum is known from Tokarz4 (the septum in Tokarz is the portion of 225/225a/225b that separates port 250 and inlet passage 255 from passage/opening 21), the vaginal interface element of Tokarz is not applied to an endoscopic air speculum. Rather, it is applied to a urinary incontinence device for collecting urine. The ordinarily skilled artisan trying to improve upon the endoscopic air speculum of Shachrur would not have looked to the urinary incontinence device of Tokarz short of improper hindsight. It therefore would not have been obvious to combine Shachrur with Tokarz to arrive at the claimed invention.
Additional references are further cited below but are not any more relevant than the references discussed above:
Dieter, US 5,716,329
Meehan et al., US 5,865,729
Luecke, US 8,721,534 B1
Yamashita et al., US 10,792,475 B2
Brecheen et al., US 12,201,322 B2
Ahn, US 2015/0209073 A1
Goldfain et al., US 2015/0223678 A1
Decherf et al., US 2019/0038115 A1
Magno et al., US 2019/0191985 A1
Wu et al., US 2019/0254708 A1
Akbary et al., US 2022/0304565 A1
Ben-Nathan et al., US 2024/0398222 A1
Garner, US 2025/0302292 A1
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN T. SAKAMOTO whose telephone number is (571)272-4958. The examiner can normally be reached Monday - Friday, ~9AM-5PM Pacific.
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, KEITH M. RAYMOND can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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COLIN T. SAKAMOTO
Primary Examiner
Art Unit 3798
/COLIN T. SAKAMOTO/Primary Examiner, Art Unit 3798
2 May 2026
1 in view of the provisions of §112(d) which state that a claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
2 The term “said housing” as recited in claim 1 is being construed for purposes of applying prior art as a housing of the handle; i.e., the handle is being construed as comprising “said housing”.
3 Sauer, US 2012/0330324 A1, US 2015/0127016 A1
4 Tokarz et al., US 4,681,752
Prosecution Insights