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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/2/2024, 3/12/2025, and 6/17/2025 is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 measurement assembly” and “an indicating device” in claims 1 and 5, “a steering mechanism” in claim 18, and “actuation mechanism” in claim 33.
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.
Based on Applicant's specification the terms are being interpreted as follows:
measurement assembly can be anything that enables the determination of distance including light, sound, or electrical sources (page 11),
indicating device is a computing system with a display (figure 11 and page 31),
steering mechanism is made of several rings joined together with at least one cable to
form a structure implemented in a tube wall (see figures 9A-H pages 26-30), and
actuation mechanism are motors (see figure 13H, pages 30 and 41-42).
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 1, 3-6, 8, 10, 12-14, 16-18, 23, 30, 32-35, and 40-43 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.
Claims 1 and 5 are unclear. As currently written, the inner body being recited is not being positively claimed; however, the measurement assembly needs the inner body to perform the measurements. It is not clear if the inner body is supposed to be claimed as part of the device.
Claim 1 recites the limitation "the endometrial epithelium" in line 6 and “the direction” in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claims 3-4, 16-18, 23, 30, 32-35, 40-43 inherit the deficiencies of claim 1 and are likewise rejected.
Claim 3 recites the limitation "the capacitance" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 inherits the deficiencies of claim 3 and is likewise rejected.
Claim 5 recites the limitation "the endometrial epithelium" in line 6 and “the direction” in line 13. There is insufficient antecedent basis for this limitation in the claim.
Claims 6, 8, 10, 12, 13, and 14 inherit the deficiencies of claim 5 and are likewise rejected.
Claim 8 recites the limitation “the predetermined proximity” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the part of the distal portion of the body" in line 2 and “the capacitance” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 inherits the deficiencies of claim 10 and is likewise rejected.
Claim 14 recites the limitation "the capacitance" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “an inner body…endometrial epithelium” in lines 1-2. It is not clear if this is a new instance or refers to the “inner body” mentioned in lines 5-6 of claim 1.
Claim 23 recites the limitation "the steering mechanism" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim 35 recites the limitation “one or more of the lead screws” in line 3. There is insufficient antecedent basis for “the lead screws” limitation in the claim. It is noted that earlier in the claim there is a recitation of “a lead screw”. The plural form lacks antecedent basis
Claim 40 recites the limitation "the measurement portion" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 41 recites the limitation "one or more actuators" in lines 1-2. It is not clear if these are new actuators or include the first and second actuators mentioned in claim 1.
Claim 42 recites the limitation "one or more actuators" in lines 1-2. It is not clear if these are new actuators or include the first and second actuators mentioned in claim 1.
Claim 43 recites the limitation "the program" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 43 recites the limitation "one or more electronically controlled actuators" in lines 1-2. It is not clear if these are new actuators or include the first and second actuators mentioned in claim 1.
Allowable Subject Matter
Claims 1, 3-6, 8, 10, 12, 13, 14, 16-18, 2, 30, 32-35, and 40-43 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:
In regards to claims 1 and 5, the closest prior art found is US 2019/0159662 (Papas et al., hereinafter Papas). Papas teaches the lumen and actuators. However, the prior art does not teach or suggest a device, with a combination of components as claimed by Applicant that includes
a measurement assembly configured to measure whether the apparatus is in a first state indicating that a distance between the distal end of the inner body and the endometrial epithelium is greater than a predetermined distance in the direction that the inner body is advanced from the distal opening, or a second state indicating that a distance between the distal end of the inner body and the endometrial epithelium is equal to or less than a predetermined distance in the direction that the inner body is advanced from the distal opening; and
an indicating device coupled to the measurement assembly and configured to indicate that the apparatus is in the first state or the second state.
Claims 3, 4, 6, 8, 10, 12, 13, 14, 16-18, 2, 30, 32-35, and 40-43 are dependent on allowable matter from claims 1 or 5 and would be allowable once the 112 rejections are overcome.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 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, Charles Marmor can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791