DETAILED ACTION
The following Office Action is in response to the Preliminary Amendment filed on June 19, 2025. Claims 16-20 are currently pending.
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 .
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.
Claim Objections
Claims 16 and 20 are objected to because of the following informalities:
Concerning claim 16, line 3 of the claim recites the term “the base porting” wherein the word “porting” appears to be a misspelling of the word “portion”.
Line 10 of the claim recites the “a distal portion ;”, wherein there appears to be a space mistakenly inserted before the semi-colon.
Line 19 of the claim recites the term “energy activate tool”, wherein the word “activate” appears to be a misspelling of the word “activated”.
Concerning claim 20, line 12 of the claim recites the term “a patient receive tissue”, wherein the words “receive tissue” appear to be mistakenly inserted.
Appropriate correction is required.
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 16-19 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.
Concerning claim 16, line 12 of the claim recites the limitation of “the annular space”. There is a lack of antecedent basis for this limitation in the claim, therein making it indefinite as to what this limitation is referring to. For the purposes of compact prosecution, the limitation will be interpreted as “an annular space”.
Concerning claim 17, line 1 of the claim recites the limitation of “the electrode”, wherein it is indefinite as to whether this is referring to the electrode associated with colpotomy cup or the electrode of the energy activated tool. For the purposes of compact prosecution, “the electrode” will be interpreted as referring to “the electrode associated with the colpotomy cup”.
Claims 17-19 are further rejected for being dependent on an indefinite claim.
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) 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ahluwalia et al. (US 9,522,252, hereinafter Ahluwalia) in view of Dycus (US 2009/0182329).
Concerning claim 16, the Ahluwalia et al. prior art reference teaches an apparatus, comprising: a base portion (Figure 12E; 32 | Column 13, Lines 31-51 | See OA Figure 1 below) configured to selectively couple with a robotic arm (See OA Figure 1 below); a shaft assembly (Figure 8D; 31) extending distally from the base portion (Figure 12E; 31), wherein the shaft assembly comprises: an elongated shaft (Figure 2A; 31) terminating into a distal end, and a distal anchoring member coupled to a portion of the elongated shaft (Figure 2A; 70, tip may be interpreted as an anchoring member because it may assist in anchoring the device in the uterus), a colpotomy cup slidably attached along a length of the elongated shaft (Figure 2A; 20), wherein the colpotomy cup is configured to actuate along the elongated shaft between a proximal position and a distal position (Column 8, Lines 2-16), but it does not teach an energy activated assembly configured to apply RF energy to tissue received within an annular space, wherein the energy activated assembly comprises: an electrode associated with the colpotomy cup, an RF generator in communication with the electrode, and an energy activated tool in communication with the RF generator such that the electrode associated with the colpotomy cup is configured to cooperate with a corresponding electrode of the energy activated tool to apply RF energy to tissue positioned between the electrodes.
However, the Dycus reference teaches an apparatus, the apparatus being a uterine manipulation device similar to that of the Dycus reference, wherein the device includes a colpotomy cup (Figure 2; 100), wherein the colpotomy cup includes an energy activated assembly (Figures 1, 2, & 3B; 500) configured to apply RF energy to tissue within an annular space ([¶ 0043]), wherein the energy activated assembly comprises: an electrode associated with the colpotomy cup (Figure 2; 125), an RF generator in communication with the electrode (Figure 2; 500), and an energy activated tool in communication with the RF generator (Figure 1; 10) such that the electrode associated with the colpotomy cup is configured to cooperate with a corresponding electrode of the energy activated tool (Figure 3C) to apply RF energy to tissue positioned between the electrodes ([¶ 0048]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the colpotomy system of the Ahluwalia reference include the energy activated assembly of the Dycus reference to allow the colpotomy system of Aluwalia to seal, resect, and cut uterine tissue to perform a laparoscopic hysterectomy ([¶ 0009]).
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OA Figure 1
Concerning claim 17, the combination of the Ahluwalia and Dycus references as discussed above teaches the apparatus of claim 16, wherein the Dycus reference further teaches the electrode of the colpotomy cup comprising a ring shape (Figure 2; 125).
Concerning claim 18, the combination of the Ahluwalia and Dycus references as discussed above teaches the apparatus of claim 16, wherein the Ahluwalia reference teaches a distally extending annular edge (Figure 4D; 13c) and an obliquely extending annular edge of the colpotomy cup (Figure 4D; 13f), which may define the annular space.
Concerning claim 19, the combination of the Ahluwalia and Dycus references as discussed above teaches the apparatus of claim 16, wherein the energy activated tool comprises a laparoscopic tool ([¶ 0048], tool is introduced through trocar for laparoscopic surgery, defining it as a laparoscopic tool).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ahluwalia et al. (US 9,522,252, hereinafter Ahluwalia) in view of Gleiman et al. (US 2022/0104875, hereinafter Gleiman).
Concerning claim 20, the Ahluwalia et al. prior art reference teaches an apparatus, comprising: a base portion (Figure 12E; 32 | Column 13, Lines 31-51 | See OA Figure 1 above) configured to selectively couple with a robotic arm (See OA Figure 1 above); a shaft assembly (Figure 8D; 31) extending distally from the base portion (Figure 12E; 31), wherein the shaft assembly comprises: an elongated shaft (Figure 2A; 31) terminating into a distal end, and a distal anchoring member coupled to a portion of the elongated shaft (Figure 2A; 70, tip may be interpreted as an anchoring member because it may assist in anchoring the device in the uterus), a colpotomy cup slidably attached along a length of the elongated shaft (Figure 2A; 20), wherein the colpotomy cup is configured to actuate along the elongated shaft between a proximal position and a distal position (Column 8, Lines 2-16), wherein the colpotomy cup defines an interior region dimensioned to house a cervix of a patient (Figure 17; 113), but does not specifically teach a tissue sensing assembly associated with the interior region of the colpotomy cup, wherein the tissue sensing assembly is configured to sense movement of the cervix within the interior region of the colpotomy cup.
However, the Gleiman reference teaches a device similar to that of the Ahluwalia reference, wherein the Gleiman reference teaches a treatment device for treating and accessing a luminal structure such as a uterus ([¶ 0139]), therein defining it as being in the same field of endeavor, wherein the reference teaches that the device may include a tissue sensing assembly in the form of one or more impedance sensors configured to detect movement of tissue relative to the instrument ([¶ 0261]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the device of the Ahluwalia and Dycus combination include the impedance sensors of the Gleiman reference to allow for the approximate mapping of the tissue treatment area, the treatment area being within the interior space of the colpotomy cup (Gleiman; [¶ 0318]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Weihe et al. reference (US 2018/0325552) teaches an apparatus with a colpotomy cup and an energy activated assembly; both the Barakat et al. references (US 2022/0192707 and US 2021/0307850) teach an apparatus configured to couple to a robotic arm with a colpotomy cup and a tissue sensing assembly; and the Brecheen et al. reference (US 2012/0143210) teaches an apparatus with a colpotomy cup and a cutting device including an RF generator.
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/MARTIN T TON/Examiner, Art Unit 3771 9/29/2026
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