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 .
Response to Preliminary Amendment
Claim 10 has an incorrect status identifier (see 37 C.F.R. 1.121(c)(1) and MPEP § 714(II)(C)(A)). Given that Claim 10 was amended with the claim set filed October, 24, 2024, the status identifier of Claim 10 should read “Currently Amended” rather than “Original”. Appropriate correction is required.
Disposition of Claims
Claims 1-15 are pending and rejected.
Drawings
The drawings are objected to because:
The drawings do not have sheet numbers (see 37 CFR 1.84(t)).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 2 & 13-14 are objected to because of the following informality:
Regarding Claim 2, Claim 1 recites the limitation “at least one arm” on Line 12. Claim 2, however, further recites the limitation “said arm” on Line 3. Examiner kindly requests Applicant amend “said arm” in Claim 2 to read “said at least one arm [emphasis added]” to provide consistent claim language throughout.
Regarding Claim 13, Claim 1 recites the limitation “at least one arm” on Line 12. Claim 13, however, further recites the limitation “said arm” on Line 2. Examiner kindly requests Applicant amend “said arm” in Claim 13 to read “said at least one arm [emphasis added]” to provide consistent claim language throughout.
Regarding Claim 14, Claim 1 recites the limitation “at least one arm” on Line 12. Claim 14, however, further recites the limitation “said arm” on Line 2. Examiner kindly requests Applicant amend “said arm” in Claim 14 to read “said at least one arm [emphasis added]” to provide consistent claim language throughout.
Regarding Claim 14, Claim 1 recites the limitation “a longitudinal axis” on Line 2. Further, Claims 11 & 12 recite the limitation “said longitudinal axis”. Claim 14, however, recites the limitation “said axis” on Line 5. Examiner kindly requests Applicant amend “said axis” of Claim 14 to read “said longitudinal axis [emphasis added]” to provide consistent claim language throughout.
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 limitations 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 limitations are:
“first fixing members… configured to… prevent forward and backward moments of said at least one arm” in Claim 1, as described on Page 6, Lines 21-31 & Page 7, Lines 1-24 of Applicant’s specification.
“second fixing members… configured to prevent the lateral movement of said at least one arm” in Claim 7, as described on Page 7, Lines 30-31 & Page 8, Lines 1-16 of Applicant’s specification.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation recite sufficient structure, materials, or acts to entirely perform the recited function.
Such claim limitations are:
“means of an at least partially spherical hinge” in Claim 10.
“means of at least a first connection portion” in Claim 14.
Because these claim limitations are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitations do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 112(b)
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 1-15 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, Claim 1 recites the limitation “an internal cavity of a patient” on Lines 6-7. It is unclear whether this “internal cavity” and “patient” are the same as “a cavity” and “a patient”, respectively, previously recited on Line 1 of Claim 1, or a separate, different cavity and a separate, different patient. For the purpose of examination, “an internal cavity of a patient” is being interpreted as “the cavity of the patient”.
Regarding Claim 1, Claim 1 recites the limitation “the movement” on Lines 13-14. There is insufficient antecedent basis for this limitation in the claims. For the purpose of examination, “the movement” is being interpreted as “a movement”.
Regarding Claim 3, Claim 3 recites the limitation “to enable the passage of said at least one arm towards said rest position [emphasis added]” on Lines 3-4. There is insufficient antecedent basis for this limitation in the claims. For the purpose of examination, “to enable the passage of said at least one arm towards said rest position” is being interpreted as “to enable a passage of said at least one arm towards said rest position [emphasis added]”.
Regarding Claim 4, Claim 3 recites the limitation “the passage of said at least one arm towards said operative position [emphasis added]” on Lines 6-7. There is insufficient antecedent basis for this limitation in the claims. For the purpose of examination, “the passage of said at least one arm towards said operative position” is being interpreted as “a passage of said at least one arm towards said operative position [emphasis added]”.
Regarding Claim 4, Claim 4 recites the limitation “the initial position” on Line 7. There is insufficient antecedent basis for this limitation in the claims. For the purpose of examination, “the initial position” is being interpreted as “the rest position”.
Regarding Claim 7, Claim 7 recites the limitation “to prevent the lateral movements of said at least one arm [emphasis added]” on Line 4. There is insufficient antecedent basis for this limitation in the claims. For the purpose of examination, “to prevent the lateral movements of said at least one arm” is being interpreted as “to prevent lateral movements of said at least one arm”.
Regarding Claim 8, Claim 8 recites the limitation “the rotation of said at least one arm” on Lines 2-3. There is insufficient antecedent basis for this limitation in the claims. For the purpose of examination, “the rotation of said at least one arm” is being interpreted as “a rotation of said at least one arm”.
Regarding Claim 8, Claim 8 recites the limitation “the inner surface of the channel” on Lines 5-6. There is insufficient antecedent basis for this limitation in the claims. For the purpose of examination, “the inner surface of the channel” is being interpreted as “an inner surface of the channel”.
Regarding Claim 8, Claim 8 recites the limitation “a direction perpendicular to said main direction of movement” on Lines 7-8. It is unclear whether this “[perpendicular] direction” is the same as the “a direction perpendicular to said main direction of movement”, previously recited on Lines 5-6 of Claim 7, or a separate, different perpendicular direction. For the purpose of examination, “a direction perpendicular to said main direction of movement” is being interpreted as “the direction perpendicular to said main direction of movement”.
Regarding Claim 9, Claim 9 recites the limitation “facilitating the entry and exit of the guide” on Line 3. There is insufficient antecedent basis for this limitation in the claims. For the purpose of examination, “facilitating the entry and exit of the guide” is being interpreted as “facilitating an entry and an exit of the guide”.
Regarding Claim 14, Claim 14 recites the limitation “wherein said arm is connected to an adaptor body stably applicable to the proximal portion of the dilator body by means of at least a first connecting portion and comprising a seat for a camera [emphasis added]” on Lines 2-4. It is unclear whether this “seat for a camera” is a portion of the adaptor body or a portion of the at least one arm. For the purpose of examination, “wherein said arm is connected to an adaptor body stably applicable to the proximal portion of the dilator body by means of at least a first connecting portion and comprising a seat for a camera” is being interpreted as “wherein said arm is connected to an adaptor body, the adaptor body stably applicable to the proximal portion of the dilator body by means of at least a first connecting portion and the adaptor body comprising a seat for a camera [emphasis added]” in light of Page 12, Lines 24-26 of Applicant’s specification.
Regarding Claim 15, Claim 15 recites the limitation “comprising a pair of arms, at least one of the pair of arms having a respective rest seat and the arms configured to embrace opposite symmetrical sides of the proximal portion” on Lines 2-4. It is unclear whether this “pair of arms” is the same as the “at least one arm” previously recited on Line 12 of Claim 1, or a separate, different pair of arms. For the purpose of examination, “comprising a pair of arms, at least one of the pair of arms having a respective rest seat and the arms configured to embrace opposite symmetrical sides of the proximal portion” is being interpreted as “said at least one arm further comprising a pair of arms, at least one of the pair of arms having a respective rest seat and each of the pair of arms configured to embrace opposite symmetrical sides of the proximal portion [emphasis added]”.
Regarding Claims 2, 5-6 & 10-13, Claims 2, 5-6 & 10-13 are rejected as being dependent upon claims previously rejected under 35 U.S.C. § 112(b).
Allowable Subject Matter
Claims 1-15 would be allowable if rewritten or amended to overcome the rejections 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:
Regarding Claim 1, Kaji et al. (JP 2001/000447 A), as best understood, discloses a device (Fig. 1a, 1; [0009]) for inspecting a cavity of a patient ([0002]), the device comprising:
a dilator body (Fig. 2a, 2; [0009]) extending along a longitudinal axis (Fig. 2a, L; [0013]) between a distal end (Fig. 2a, 6; [0010]) and a proximal end (Fig. 2a, 8; [0010]);
a handle (Fig. 2c, 29; [0019]) applied or fixed to said dilator body (see Fig. 1a);
wherein the dilator body comprises:
a distal portion (Fig. 2a, 6; [0010]) having a substantially tubular shape (see Fig. 2a) defining a zone of dilation of an internal cavity of a patient ([0022]) and adapted to internally delimit an internal volume (6 is substantially hollow; see Figs. 1a & 2a) comprising a front opening (Fig. 2a, 7; [0010]) to enable access to the patient’s mucosa or tissue from said volume ([0013]);
a proximal portion (Fig. 2a, 8; [0010]), extending from the distal portion in a diverging fashion (see Fig. 2a), comprising a rear access opening made on said proximal portion communicating with said internal volume (8 has a proximal opening to receive 3 therethrough; see Fig. 1a);
at least one arm (Fig. 2c, 21; [0015]) mounted on the proximal portion (Fig. 1a, 21 is attached to 8 via 17 of 4; [0014] & [0015]) and comprising at least one rest seat (Fig. 2c, 24; [0016]) configured to receive, resting upon it, a front surface of a laser head (Fig. 2c, 24 is an instrument channel and thus is capable of receiving a front surface of a laser head; [0016]) and to enable the movement thereof in such a way as to emit a linear laser beam through said front opening (Fig. 1a, 21 pivots such that 24 is positioned in or out of the proximal opening of 8 and therefore would be capable of permitting the laser head to emit a laser beam through the proximal opening and out 7 of 6; [0015] & [0018]); and
wherein said at least one arm is rotatable according to a main direction of movement ([0015]) relative to said proximal portion (see Fig. 1a) and is movable between an operative position (Fig. 1a, 21 is rotated into a holding state (illustrated by solid lines) in which 24 is disposed in the proximal opening of 8; [0018]) and a rest position (Fig. 1a, a retracted state (illustrated by dotted lines); [0015]), in which said at least one arm does not embrace said proximal portion (Fig. 1a, 21 is rotated into a retracted state (illustrated by dotted lines) in which 24 is not disposed in the proximal opening of 8 nor does it circumferentially engage an outer surface of 8; [0015]).
Kaji et al., as best understood, fails to explicitly disclose wherein the operative position is when said at least one arm externally embraces said proximal portion; first fixing members, operatively interposed between said at least one arm and said proximal portion, wherein said first fixing members are configured to be activated when said at least one arm reaches the operative position to prevent forward and backward movements of said at least one arm relative to the proximal portion along said main direction of movement, and wherein said first fixing members are configured to be deactivated to enable the movement of said at least one arm from the operative position to the rest position.
Additionally, all other prior art of record fail to disclose, teach or suggest, alone or in combination, inter alia, at least one arm rotatable between an operative position, in which the at least one arm circumferentially engages an outer surface of a proximal portion of a dilator body, and a rest position, in which the at least one arm does not circumferentially engage the outer surface of the proximal portion of the dilator body; and first fixing members configured to reversibly prevent forward and backward movment of the at least one arm when in the operative position.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kort (US 2021/0315450) teaches a vaginal speculum with an attachable port assembly.
Mantovani et al. (US 2020/0288958) teaches an improved surgical mouth gag.
Gifford et al. (US 2016/0015374) teaches a tissue retraction system with an actuatable clamping mechanism.
Alexander et al. (US 2013/0190558) teaches an expander device with manipulable handles for treatment of pelvic conditions.
Sohn et al. (US 2010/0331620) teaches a transanal endoscopic microsurgery instrument with a tool insertion cover.
Sorensen (US 2008/0058605) teaches a tunnel vision gynecological examination device with an instrument locking system.
McMillin et al. (U.S. 6,416,467) teaches a vaginal speculum and a method of using.
Hoftman et al. (U.S. 6,024,696) teaches a vaginal speculum with hingeable side wall support blades.
Burgin (U.S. 4,638,792) teaches an adjustable speculum with incorporated lighting system.
Fiore (U.S. 3,532,088) teaches a vaginal speculum with a semi-permanent handle light unit.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN FLOYD LONDON whose telephone number is (571)272-4478. The examiner can normally be reached Monday - Friday: 10:00 am ET - 6:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL CAREY can be reached at (571)270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEPHEN FLOYD LONDON/Examiner, Art Unit 3795
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