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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the sliding device and the magnifying device must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 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: the detecting device in claim 1, the locking elements in claims 2, the sliding guide in claim 3, and the magnifying device in claim 6, .
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 Objections
Claim 1 is objected to because of the following informalities: “the outside environment. said device” should be changed to -- the outside environment; said device -- Appropriate correction is required.
Claim 4 is objected to because of the following informalities: “signalling” should be changed to -- signaling --. 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 1-13 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.
Claim 1 recites the limitation "the side opening" in the twentieth line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 1, the terms “prevalently” in the phrase “extending prevalently along a longitudinal axis”, and “substantially” in the phrase “substantially ogival shape” in claim 1 are relative terms which renders the claim indefinite. The terms “prevalently and substantially” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how straight the dilator body must be in order to extend “prevalently” along a longitudinal axis. Additionally, the degree to which the shape must be ogival to be considered “substantially” ogival is unclear. Accordingly, the claim is rendered indefinite.
Claims 3 and 8 recite the claim limitations “a sliding guide” and “a magnifying device”, respectively, and invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is insufficient disclosure of the corresponding structures, materials or acts for performing the claimed function as the disclosure is devoid of any structure that performs the functions in the claims. Therefore, the claims are indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claims so that the claim limitations will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structures, materials, or acts perform the entire claimed functions, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structures, materials, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-7 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bastia (US 2018/0146849 A1).
Regarding claim 1, Bastia discloses a device (Fig. 3) for inspecting a cavity, comprising: a dilator body (2; Fig. 1; par. [0024]), extending prevalently along a longitudinal axis (X), between a proximal end (proximal end of 2b; Fig. 1; par. [0022]) and a distal end (distal end of 2a; Fig. 1; par. [0022]), wherein the proximal end and the distal end are connected by a side wall (side wall of 2; Fig. 1) and define, together with said side wall, an inner volume (V; par. [0021]; Fig. 1); wherein the proximal end identifies a proximal opening (4; Fig. 1; par. [0022]) crossed by said longitudinal axis (X) and is connected to a gripping element (5; Fig. 1; par. [0023]), which is accessible or graspable by an operator, said proximal end being couplable with a detecting device (200; Fig. 6; par. [0024]); wherein the distal end identifies a distal opening (3; Fig. 3; par. [0022]), for accessing the tissues delimiting the orifice from the inner volume (V; par. [0021]; Fig. 1); and wherein the side wall comprises at least one side wall (interpreted as side wall opening; 7; Fig. 1; par. [0026]) connecting the inner volume (V) with the outside environment. said device (Fig. 3) further comprising: an introducing body (300; Fig. 3; par. [0030]), having a gripping portion (proximal-most end of 304; Fig. 3), which is accessible or graspable by the operator, connected to an insertion portion (301; Fig. 3); wherein said insertion portion (301) extends along the longitudinal axis X between an insertion end (302; Fig. 3; par. [0039]), of substantially ogival shape (Fig. 3; par. [0039]), which is distal from the gripping portion (proximal-most end of 304), and an intermediate portion (distal portion of 304; Fig. 3; par. [0040]) that is proximal with respect to the gripping portion (proximal-most end of 304), said inspection device (Fig. 3) being characterized in that: said insertion portion (301) is shaped to be introduced into the inner volume (V) through the side opening (7) of the dilator body (2), following a transverse direction (2; 301 is capable of being introduced through 7 following a transverse direction; see Fig. 3; intended use); and said insertion portion (301) being shaped to be moved inside the inner volume (V) parallel to the longitudinal axis (X) between a stroke start position (Fig. 3 – initial insertion of 301 into 2), in which the insertion end (302) is proximal to the side window (7) and a stroke end position (Fig. 4), in which the insertion end (302) protrudes from the distal opening (3) of the dilator body (2; Fig. 4).
Regarding claim 2, Bastia in view of Bastia-2 disclose the device according to claim 1 comprising locking elements (6; par. [0024] and [0043]; Fig. 3 and 4) for locking the introducing body (300; par. [0043]), said locking elements reversibly constraining the introducing body (300) on the dilator body (2) when the insertion portion (301) of the dilator body (2) reaches the stroke end position (Fig. 4).
Regarding claim 3, Bastia in view of Bastia-2 disclose the device according to claim 1 wherein the side wall of the dilator body (2) is delimited inside by an inner surface (inner surface of 2; Fig. 1) having a sliding guide (surface on which 300 slides on when inserted), and wherein the insertion portion (301) of the introducing body (300) is slidable along said sliding guide until the stroke end position is reached (Figs. 3-4).
Regarding claim 4, Bastia in view of Bastia-2 disclose the device according to claim 1 wherein the introducing body (300) comprises a stop element (distal-most end of 304; Fig. 3), signalling to the operator that the stroke end position has been reached (Fig. 4 – distal-most end of 304 contacts 7 at the end position).
Regarding claim 5, Bastia in view of Bastia-2 disclose the device according to claim 4 wherein the stop element (distal-most end of 304) is located at the intermediate portion (distal portion of 304).
Regarding claim 6, Bastia in view of Bastia-2 disclose the device according to claim 4 wherein the opening (7) of the dilator body is delimited by an edge (edge of 7) and wherein the stop element (distal-most end of 304) comprises at least one abutment surface (portion of the distal-most end of 304 that contacts the edge of 7) configured to come into contact with a portion of said edge when the stroke end position is reached (Fig. 4), preventing the introducing body (300) from being inserted further into the dilator body (2).
Regarding claim 7, Bastia in view of Bastia-2 disclose the device according to claim 1 wherein the intermediate portion defines a viewing opening (at the proximal end of 301) that is coaxial with respect to the longitudinal axis (X).
Regarding claim 13, Bastia in view of Bastia-2 disclose the device according to claim 1 wherein the gripping element (5) has a hooking site (length of 5) that is couplable with a sucking device (capable of such intended use; see, for example, Fig. 7).
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.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bastia, as applied to the claims above, in view of To (US 2011/0098531 A1).
Regarding claim 8, Bastia discloses the device according to claim 7, but does not specifically disclose wherein the introducing body comprises a magnifying device located at the intermediate portion or the insertion end, permitting a magnified view of the tissues delimiting the cavity. To teaches an analogous introducing body (2510; Fig. 25) wherein the introducing body comprises a magnifying device (2520; par. [0146]; Fig. 25) located at the intermediate portion or the insertion end, permitting a magnified view of the tissues delimiting the cavity (Fig. 25; par. [0146]). It would have been obvious to one having ordinary skill in the art to include a magnifying device in the introducing body of Bastia, as taught by To, in order to provide a magnified view of the surgical area to the operator.
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bastia, as applied to claim 1 above, in view of Bastia (US 2012/0016204 A1, hereinafter referred to as “Bastia-2”).
Regarding claim 9, Bastia discloses the device according to claim 1, but does not specifically disclose wherein the gripping portion comprises a gripping end connected to a connecting wall, said gripping end facilitating gripping and moving the introducing body; and said connecting wall being interposed between the gripping end and the insertion portion and being tilted by an angle relative to the longitudinal axis. Bastia-2 teaches an analogous device (Figs. 1 and 4) wherein the introducing body (5, Figs. 1 and 4) terminates with either a gripping portion like that of Bastia (Fig. 1; par. [0091]) or with a gripping portion (26; Fig. 4) comprise a gripping end (Fig. 4) connected to a connecting wall (wall connecting finger rings of 26 to the distal portion of the introducing body; Figs. 1 and 4), said gripping end facilitating gripping and moving the introducing body (5; par. [0091]-[0092]); and said connecting wall (wall connecting finger rings of 26 to the distal portion of the introducing body; Figs. 1 and 4) being interposed between the gripping end (Fig. 4) and the insertion portion (5a; Fig. 2) and being tilted by an angle (Fig. 4) relative to the longitudinal axis (X). It would have been obvious to one having ordinary skill in the art to modify the gripping portion of Bastia with the gripping portion of Basita-2 in order to facilitate the insertion and extraction of the introducer body by virtue of its longer extension along the X-axis, as taught Bastia-2 (par. [0092]).
Regarding claim 10, Bastia in view of Bastia-2 disclose the device according to claim 9 wherein the angle (α) is comprised between 0 and 90° (Bastia-2: Fig. 4).
Regarding claim 11, Bastia in view of Bastia-2 disclose the device according to claim 9 wherein the gripping end (Bastia-2: Fig. 4) comprises a couple of rings (Bastia-2: Fig. 4; rings of 26) into which the fingers of the operator are inserted.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bastia, as applied to claim 1 above, in view of Bastia (US 2009/0306481 A1, hereinafter referred to as “Bastia-3”) in view of To (US 2011/0098531 A1).
Regarding claim 12, Bastia discloses the device according to claim 1, but does not specifically disclose wherein the dilator body and the introducing body are made of transparent polymeric material. Bastia-3 teaches an analogous dilator body and introducing body wherein the dilator body (1; Figs. 1-3) made of transparent polymeric material (par. [0041]). It would have been obvious to one having ordinary skill in the art to make the dilator of transparent polymeric material in order to allow visualization of the surgical site/bodily orifice to the operator. Modified Bastia does not specifically disclose that the introducing body is made of transparent polymeric material. To teaches an analogous introducing body (Figs. 24-25) that is made of transparent polymeric material (par. [0140]). It would have been obvious to one having ordinary skill in the art to make the introducing body of transparent polymeric material in order to allow visualization of the surgical site/bodily orifice to the operator.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYNAE E BOLER whose telephone number is (571)270-3620. The examiner can normally be reached Mon - Fri 9:00-5:00.
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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.
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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
07/26/26
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