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 .
Claims Pending
Claims 11-20 are currently pending.
Election/Restrictions
Applicant's election with traverse of Invention I, drawn to an apparatus of Claims 11-15, in the reply filed on 07/27/2026 is acknowledged. The traversal is on the ground(s) that the examiner could examine all of the claims of Inventions I and II without serious burden.
The applicant’s argument has been fully considered and deemed as not relevant to the restriction analysis (Unity of Invention) required for a national stage application under 371. As indicated in the previous restriction, filed 06/16/2026, “As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.”
As indicated in the previous restriction, filed 06/16/2026, Restriction is required under 35 U.S.C. 121 and 372. This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1. The examiner further indicated that Groups 1 and 2 lacked unity of invention because even though the inventions of these groups require the indicated technical feature (Examiner's Note: technical feature as indicated in the previous restriction, filed 06/16/2026), the technical feature is not a special technical feature as it does not make a contribution over the prior art in view Manca (EP 3310246 B1) hereinafter Manca (Examiner's Note: As indicated in full detail in the restriction, filed 06/16/2026). Therefore, Groups 1 and 2 lack unity of invention a posterori.
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/27/2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims 11-15 are hereby under examination.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “16” has been used to designate both “first alignment marker” and “thread attachment”. 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. 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 11-15 are objected to because of the following informalities:
In claim 11, “first region” (second line), should read - a first region-,
In claim 11, “and that a” (third to last line), should read -and a-,
In claim 11, the claim lacks indentations, semicolons, and additional punctuation marks, which creates confusion.
Appropriate correction is required.
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:
Claim 11: The claim limitation “a second locking element that can be positively connected and fixed to one of the first locking elements” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “element” coupled with functional language “that can be positively connected and fixed to one of the first locking elements” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “element”.
Claim 11: The claim limitation “a further radial fixation arranged so as to snap into the radial fixation disposed on the surgical tube when the obturator is inserted into the surgical tube” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “fixation” coupled with functional language “arranged so as to snap into the radial fixation disposed on the surgical tube when the obturator is inserted into the surgical tube” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “fixation”.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
A latch structure, or equivalents thereof, as described on Page 14 of the disclosure filed on 01/29/2025.
A protrusion, or equivalents thereof, as described on Page 8 of the disclosure filed on 01/29/2025.
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 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 11-15 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.
The term “several” in claim 11 is a relative term which renders the claim indefinite. The term “several” is 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 as to how many “position markers” and “first locking elements” are present. For example, Merriam-Webster defines “several” as “more than one” and “more than two but fewer than many” (Merriam-Webster Dictionary). How many is “fewer than many”? How many is “many”? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this quantity will be interpreted as a plurality.
Claim 11 recites the limitation “wherein the securing ring is composed of a transparent material”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what the applicant considers to be a “transparent material”. How transparent is the material? What type of material being claimed? The sole indication of types of materials within the specification is indicated as “According to the invention, it is further provided that at least the obturator and the surgical tube are made of a material that can be used in medical technology, laboratory technology and in the diagnostic field. Polypropylene homopolymers, such as Purell HP 373, Purell HP 371, PPH 9020 or PPM H250, are known for such areas of application…” (Page 8-9, lines 28-4 of applicant’s spec.). This passage does not explicitly state that the surgical ring is made of these material types as it states “at least the obturator and the surgical tube”. However, as there is no other indication regarding any types of materials within the provided specification, it is unclear as to what material the applicant considers to be a “transparent material”. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this material will be interpreted as any material with any indicated level of transparency.
Claim 11 recites the limitation “a positioning aid in the form of a 12 o’clock mark”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what the applicant considers to be a 12 o’clock mark. The applicant’s spec. states “a positioning aid in the form of a 12 o'clock mark is provided, which points upwards on the human body in the direction of the patient's spine or head” (Page 5, lines 4-7 of applicant’s spec.) and “positioning aid 11, a 12 o'clock mark, is shown in addition to the six position markers 10.” (Page 13, lines 12-14 of applicant’s spec.). However, it is unclear as to what specific form a “12 o’clock mark” would have compared to any standard marking or indicator. Was it the intention to claim a marking at the 12 o’clock position? What does a 12 o’clock marking look like? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as any type of positioning aid or marking (Page 13, lines 12-14 of applicant’s spec.).
Claim 11 recites “the surgical tube having a frustoconical or hemispherical, at least partially closed first end and a surgical window shaped as a rectangular opening arranged essentially along a cylinder wall of the surgical tube”, which fails to effectively define the metes and bounds of the claim as it is unclear as to desired shape and positioning of the surgical window. What does it mean for the opening to be arranged essentially along a cylinder wall? What does the applicant mean by rectangular? As the claims are viewed in light of the specification, the applicant’s spec. states “It is also intended that the essentially rectangular opening of the surgical window partially protrudes into the truncated cone-shaped or hemispherical first end of the…” “… The surgical window is designed to be almost rectangular and is dimensioned in such a way that a surgeon can perform a surgical procedure on the patient's tissue protruding in the surgical window.” (Page 5, lines 8-22), which merely further indicates an “almost rectangular” shape of the surgical window. Additionally, surgical window – 13 in Fig. 3A and 3B of the provided drawings is observably not a standard rectangle, which creates confusion as to what shape the applicant considers to be “rectangular”. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as any shape.
Claim 11 recites the limitation “the obturator having a first conical or hemispherical closed end adapted to the first end of the surgical tube and completely closing the surgical window when inserted and radially fixed in the surgical tube”, which fails to effectively define the metes and bounds of the claim as it is unclear as to the manner in which the claim is intended to be interpreted. How is the obturator adapted to the surgical tube? Is the closed end the part that is adapted to the surgical tube? As the claims are viewed in light of the specification, the applicant’s spec. states “For this purpose, the outer diameter of the obturator 19 is optimally adapted to the inner diameter of the surgical tube 9 and the first end 20 of the obturator 19 is optimally adapted to the first end 12 of the surgical tube 9 having the conical or hemispherical shape.” (Page 15, lines 1-6 of applicant’s spec.), which merely reiterates the claim language. What does it mean for the obturator to be “optimally adapted” to the first end of the surgical tube? Does this merely mean that the obturator fits inside the surgical tube? Does this mean that the two structures have the indicated corresponding shapes? The applicant further makes no indication as to the meaning behind the phrase “optimally adapted”. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, the obturator will be interpreted as having a conical or hemispherical closed end that corresponds to the shape of the indicated surgical tube.
Claim 11 recites the limitation “a second end having at least one first alignment marker with a thread attachment”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what structure the “thread attachment” refers to. What is the thread attachment? The applicant’s spec. states “known solutions do not have a thread attachment by means of which a surgical thread can be attached to a part of the proctoscope” (Page 3, lines 6-10 of applicant’s spec.) and “the first alignment marker 16 or a thread attachment 16 is arranged at this second end 14” (Page 14, lines 11-12 of applicant’s spec.), however, a term cannot be defined by itself. There is no further indication as to the actual structure of the thread attachment, or examples of any other types of thread attachments. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, the claim will be interpreted as without the thread attachment (Examiner's Note: As there is no indication as to any example or type of “thread attachment” the limitation is interpreted as solely the presence of an alignment marker) (Page. 14, lines 11-12 of applicant’s spec.).
Claim 11 recites the limitation “a second end having at least one first alignment marker with a thread attachment and a radial fixation”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what aspect of the limitation is referred to by “at least one…”. Is the intended interpretation a second end having “at least one first alignment marker with a thread attachment”, where there may be more than one alignment marker? Does “at least one…” refer to simply one of “first alignment marker with a thread attachment” and “a radial fixation”, where only a single is required for the claim? The applicant’s spec. states “at least one first alignment marker is arranged at this second end” (Page 5-6, lines 30-2 of applicant’s spec.), which appears to indicate that the at least one refers to the total quantity of alignment markers. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as there being at least one alignment marker (Examiner's Note: The applicant’s spec. also states “This alignment between obturator 19 and surgical tube 9 is achieved when the second alignment marker 23 of the obturator 19 has been aligned with the first alignment marker 16 or the thread attachment 16 of the surgical tube 9, as can be seen in Figure 5” (Page 15, lines 23-26 of applicant’s spec.). Additionally, there are no figures present in which the second end comprises an additional alignment marker. There is a second alignment marker present on the obturator, but not the surgical tube.).
Claim 11 is rejected as failing to define the invention in the manner required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. The claim(s) are narrative in form and replete with indefinite language. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. The claim(s) must be in one sentence form only. Note the format of the claims in the patent(s) cited.
Claim 15 recites the limitation “The proctoscope of claims 11, wherein the obturator has a second alignment marker at its second end and a plurality of holes or dimples arranged along the circumference of the surgical tube”, which fails to effectively define the metes and bounds of the claim as it is unclear as to where the holes or dimples are located. Are they located on the surgical tube itself? Are they located on the obturator? Based on the claim, it appears that they are located on the obturator. However, claim 14 recites “wherein a plurality of holes or dimples are arranged at the second end of the surgical tube along the circumference of the surgical tube”, which appears to indicate that the plurality of holes or dimples are on the surgical tube. For claim 14, “along the circumference of the surgical tube” indicates that the dimples are physically on the surgical tube itself. For claim 15, “along the circumference of the surgical tube” appears to indicate that the dimples are on the obturator. As such, it is unclear what is meant by the phrase “along the circumference of the surgical tube”. Does this mean that the holes are located on the obturator, but configured to be along the circumference of the surgical tube when inserted in the surgical tube? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as a plurality of holes or dimples being located on a second end of the obturator (Examiner's Note: Dimples – 15 as seen in Fig. 4 of applicant’s drawings).
Claims 12-15 are dependent on claim 11, and as such are also rejected.
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.
The claims are generally directed towards a proctoscope made up of three parts. The first part is a securing ring with a plurality of position markers and locking elements. The second part is a surgical tube configured to be disposed in an inner diameter of the securing ring. The third part is an obturator configured to be inserted in the surgical tube.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manca (EP 3310246 B1)(Examiner's Note: Provided in IDS, filed 01/29/2025) hereinafter Manca, and further in view of Chen (US Pub. No. 20100280523) hereinafter Chen.
Regarding claim 11, Manca discloses A proctoscope comprising three parts (Par. 14, Fig. 1 (anoscope -1)) (Par. 14, “anoscope 1, comprising a fixed portion 2, a mobile portion 3 and a dilator 4”), having:
a first part constructed as a securing ring having open opposite sides and first region having an at least partially cylindrical shape or cylindrically conical shape and a flange-shaped second region (Fig. 1, 4, 5, fixed portion – 2) (Par. 16, “The fixed portion 2 (Figure 1; Figure 4; Figure 5) comprises a proximal end 2a and a distal end 2b, the latter being delimited by an edge 2f. The two ends 2a, 2b are open and reciprocally opposite. The proximal end 2a, in use, is the end of the fixed portion 2 - and thus of the anoscope 1 - facing towards an operator that uses the anoscope. Going from the proximal end 2a to the distal end 2b, the fixed portion 2 comprises a proximal segment 2c, which is approximately shaped as a frustum of cone, and a distal segment 2d, which is approximately cylinder-shaped.”), wherein the securing ring is composed of a material (Par. 14, “The fixed portion 2, the mobile portion 3 and the dilator 4 are made of a sterilizable polymeric material, for example polypropylene, or of another material that is suitable for medical use.”), has several position markers (unlabeled position markers as indicated in modified Fig. 4 below), a positioning aid in the form of a 12 o'clock mark (12 o’clock mark as indicated in modified Fig. 4 below) and several first locking elements (Fig. 4,5 (recesses – 6a)) (Par. 26, “The positioning and locking means 9 comprises a plurality of recesses 6a and a stop 11.”) (Par. 27, “The recesses 6a are in number of six (Figure 4) and are made at a shoulder 6 (Figure 5) obtained in an internal portion of the proximal end 2a of the fixed portion 2. Each recess 6a is approximately hemispheric and is shapingly coupled with the stop 11.”),
a second part constructed as a surgical tube configured to be disposed in an inner diameter of the securing ring (Fig. 1, 2, 5, Par. 14, 20, (mobile portion – 3)) (Par. 15, “The fixed portion 2 and the mobile portion 3, which are shapingly coupled, are hollow and open at the opposite ends. In use, namely when the anoscope 1 is assembled (Figure 5), the mobile portion 3 is received inside the fixed portion 2”) and has a second locking element that can be positively connected and fixed to one of the first locking elements (Fig. 4,5 (stop - 11)) (Par. 26, “The positioning and locking means 9 comprises a plurality of recesses 6a and a stop 11.”) (Par. 27, “Each recess 6a is approximately hemispheric and is shapingly coupled with the stop 11.”)(Par. 28, “The stop 11 is approximately hemispheric and is made in the mobile part 3 near the slider 16. More precisely, the stop 11 is made in the zone of the flange portion 12 which the slider 16 is fixed to and which - in the assembled anoscope 1 - faces the proximal end 2a of the fixed portion 2, as shown in Figure 5”), the surgical tube having a frustoconical or hemispherical, at least partially closed first end (Par. 20, “The rotation segment 3a is approximately conical-cylindrical, while the operating segment 3b is distally tapered and approximately shaped as a frustum of cone. The rotation segment 3a corresponds to the proximal part of the mobile portion 3, while the operating segment 3b corresponds to the distal part of the mobile portion 3.”) and a surgical window shaped as a rectangular opening arranged essentially along a cylinder wall of the surgical tube (Par. 21, “At one end of the operating segment 3b that is opposite to the rotation segment 3a, a U-shaped indentation 7 is obtained, the concavity of which faces the direction opposite to the rotation segment 3a. The indentation 7 defines a window 8 that, in use, makes accessible to the operator a portion of rectal mucosa to be surgically treated or to be subjected to diagnosis.”)(Fig. 1, 4, (indentation -7, window – 8)), and a second end having at least one first alignment marker with a thread attachment (Par. 25, “A slider 16 is fixed to the flange portion 12, in a position of the latter that is comprised between two consecutive notches 15….”) and a radial fixation (Fig. 1 (grooves 10, proximal segment – 10a)) (Par. 23, “In the mobile portion 3 a plurality of grooves 10 is obtained. Each groove 10 is obtained in the thickness of the lateral wall of the rotation segment 3a and comprises a proximal segment 10a...”) (Par. 34, “On the external surface of the connecting portion 4d a plurality of jutting elements 17 are obtained that are shapingly coupled with the grooves 10. More precisely, the jutting elements 17 are shapingly coupled with the proximal segments 10a of the grooves 10”), and
a third part constructed as an obturator (Fig. 1, 5, Par. 14, 33, (dilator – 4)) designed to be inserted and radially fixed in the surgical tube (Fig. 1, jutting elements – 17) (Par. 34, “On the external surface of the connecting portion 4d a plurality of jutting elements 17 are obtained that are shapingly coupled with the grooves 10. More precisely, the jutting elements 17 are shapingly coupled with the proximal segments 10a of the grooves 10 and therefore they are provided with an approximately U-shaped profile (having a convexity faced towards the distal portion 4c).”), the obturator having a first conical or hemispherical closed end adapted to the first end of the surgical tube (Par. 33, “the distal portion 4c, which corresponds to the tip of the dilator 4 and it is tapered and/or rounded…”) and completely closing the surgical window when inserted and radially fixed in the surgical tube (Fig. 1, 5, (dilator 4 observably in window - 8)), and that a further radial fixation (Fig. 1, Par. 34, 35 (jutting elements – 17)) arranged so as to snap into the radial fixation disposed on the surgical tube when the obturator is inserted into the surgical tube (Par. 35, “dilator 4 is inserted in the longitudinal cavity 13 along the direction F1, in such a way that each jutting element 17 reaches and fully engages the proximal segment 10a of a corresponding groove 10…”) (Par. 34, “On the external surface of the connecting portion 4d a plurality of jutting elements 17 are obtained that are shapingly coupled with the grooves 10. More precisely, the jutting elements 17 are shapingly coupled with the proximal segments 10a of the grooves 10 and therefore they are provided with an approximately U-shaped profile (having a convexity faced towards the distal portion 4c).”) (Fig. 1 (grooves 10, proximal segment – 10a)) (Par. 23, “In the mobile portion 3 a plurality of grooves 10 is obtained. Each groove 10 is obtained in the thickness of the lateral wall of the rotation segment 3a and comprises a proximal segment 10a...”).
Manca fails to explicitly disclose wherein the securing ring is composed of a transparent material.
However, Chen teaches wherein the securing ring is composed of a transparent material (Par. 58, “Preferably, the main body 1 and the suture junction 2 of the instrument are made transparent for the convenience of the doctor's observing. And the cone-shaped body 31 is made opaque so that the visual field will not be affected by other tissues during the surgical operation.”).
Manca and Chen are considered to be analogous art to the claimed invention as they are involved with devices in body cavities.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Manca with that of Chen to include wherein the securing ring is composed of a transparent material through the combination of references as it would have yielded the predictable result of improving the visibility for doctors during surgical operations (Chen (Par. 58)).
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Manca Modified Fig. 4
Regarding claim 12, modified Manca further discloses wherein the securing ring comprises a handle (Manca (Par. 17, “The fixed portion 2 comprises a handle 5, provided with a shape that is substantially ergonomic and suitable for allowing the operator to easily hold and handle the anoscope 1…”)).
Modified Manca fails to explicitly disclose wherein the securing ring comprises a plurality of fastening holes.
However, Chen further teaches wherein the securing ring comprises a plurality of fastening holes (Chen (Par. 60, “More specifically, three hollowed-out structures 22 are distributed at equal intervals on the broad brim 21 for the convenience of suturing the broad brim 21 with the skin.”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Manca and Chen with that of Chen to include wherein the securing ring comprises a plurality of fastening holes through the combination of references as it would have yielded the predictable result of allowing for the securement of the device to the patient (Chen (Par. 60)).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manca in view of Chen as applied to claim 11 above, and further in view of Clark (US Pub. No. 20190117058) hereinafter Clark.
Manca and Chen teach the device of claim 11 above.
Regarding claim 13, Modified Manca fails to explicitly disclose the limitations of the claim.
However, Manca does disclose wherein the further radial fixation is U-shaped (Manca (Fig. 1, Par. 34-35, jutting element – 17)(Par. 34, “On the external surface of the connecting portion 4d a plurality of jutting elements 17 are obtained that are shapingly coupled with the grooves 10. More precisely, the jutting elements 17 are shapingly coupled with the proximal segments 10a of the grooves 10 and therefore they are provided with an approximately U-shaped profile (having a convexity faced towards the distal portion 4c).”)),
wherein the radial fixation is also U-shaped (Manca (Fig. 1 (grooves 10, proximal segment – 10a)) (Par. 23, “In the mobile portion 3 a plurality of grooves 10 is obtained. Each groove 10 is obtained in the thickness of the lateral wall of the rotation segment 3a and comprises a proximal segment 10a, which is approximately U-shaped…”) (Par. 34, “On the external surface of the connecting portion 4d a plurality of jutting elements 17 are obtained that are shapingly coupled with the grooves 10. More precisely, the jutting elements 17 are shapingly coupled with the proximal segments 10a of the grooves 10”)),
configured to engage with one another when the obturator is inserted in the surgical tube (Manca (Par. 35, “dilator 4 is inserted in the longitudinal cavity 13 along the direction F1, in such a way that each jutting element 17 reaches and fully engages the proximal segment 10a of a corresponding groove 10…”) (Par. 34, “On the external surface of the connecting portion 4d a plurality of jutting elements 17 are obtained that are shapingly coupled with the grooves 10. More precisely, the jutting elements 17 are shapingly coupled with the proximal segments 10a of the grooves 10 and therefore they are provided with an approximately U-shaped profile (having a convexity faced towards the distal portion 4c).”)).
Clark teaches arcuate locking protrusions arranged on opposite parallel outer legs of the U-shaped further radial fixation (Par. 177, “the engagement protrusions 2037a on the inner surface of the rear faceplate 2037…”)(Fig. 28D, protrusions - 2037a) (Par. 166, “As shown in FIGS. 25A-25B, 26A and 27, the rear faceplate 2037 includes a plurality of engagement portions 2037a protruding from an inner surface thereof and configured to engage with corresponding protrusions formed on the inner side of the handle sidewalls”) (Fig. 27, protrusions -2037a),
arcuate locking recesses arranged on opposite parallel inner legs of the U-shaped radial fixation (Par. 177, “the sidewalls of the handle may include channels formed on the inner surfaces thereof for engagement with the engagement protrusions 2037a on the rear faceplate 2037 by sliding the engagement protrusions 2037a into the channels” (Channels)),
and wherein the arcuate locking protrusions and the arcuate locking recesses have corresponding, complementary shapes and are configured to engage with one another (Par. 177, “the sidewalls of the handle may include channels formed on the inner surfaces thereof for engagement with the engagement protrusions 2037a on the rear faceplate 2037 by sliding the engagement protrusions 2037a into the channels”).
Manca, Chen, and Clark are considered to be analogous art to the claimed invention as they are involved with devices in body cavities.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Manca and Chen with that of Clark to include wherein the further radial fixation of Manca is U-shaped and has arcuate locking protrusions arranged on opposite parallel outer legs of the U-shaped further radial fixation of Manca, wherein the radial fixation of Manca is also U-shaped and has arcuate locking recesses arranged on opposite parallel inner legs of the U-shaped radial fixation of Manca, and wherein the arcuate locking protrusions and the arcuate locking recesses have corresponding, complementary shapes and are configured to engage with one another when the obturator of Manca is inserted in the surgical tube of Manca through the combination of references as differing engagement structures are known in the art (Clark (Par. 177)) and it would have yielded the predictable result of securing the structures together.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manca in view of Chen as applied to claim 11 above, and further in view of Longo (US Pat. No. 6102271) hereinafter Longo.
Manca and Chen teach the device of claim 11 above.
Regarding claim 14, Modified Manca fails to explicitly disclose the limitations of the claim.
However, Longo teaches wherein a plurality of holes or dimples (Fig. 2, (concave surfaces – 126 of anoscope – 120)) are arranged at the second end of the surgical tube along the circumference of the surgical tube (Fig. 2, anoscope – 120) (Col. 6-7, lines 66-22).
Manca, Chen, and Longo are considered to be analogous art to the claimed invention as they are involved with devices in body cavities.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Manca and Chen with that of Longo include wherein a plurality of holes or dimples are arranged at the second end of the surgical tube along the circumference of the surgical tube through the combination of references as it would have yielded the predictable result of improving the grip for the user (Longo (Col. 6-7, lines 66-22)).
Regarding claim 15, modified Manca further discloses wherein the obturator has a second alignment marker at its second end (Manca (Fig. 1, jutting elements – 17) (Par. 34, “On the external surface of the connecting portion 4d a plurality of jutting elements 17 are obtained that are shapingly coupled with the grooves 10. More precisely, the jutting elements 17 are shapingly coupled with the proximal segments 10a of the grooves 10 and therefore they are provided with an approximately U-shaped profile (having a convexity faced towards the distal portion 4c).”)).
Modified Manca fails to explicitly disclose wherein the obturator has a plurality of holes or dimples arranged along the circumference of the surgical tube.
However, Longo teaches wherein the obturator has a plurality of holes or dimples arranged along the circumference of the surgical tube (Col. 6, lines 36-48 (ribs – 115 increasing grip)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Manca and Chen with that of Longo include wherein the obturator of Manca has a plurality of holes or dimples arranged along the circumference of the surgical tube of Manca through the combination of references as it would have yielded the predictable result of improving the grip for the user (Longo (Col. 6, lines 36-48)).
Conclusion
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/ARI S PADDA/Examiner, Art Unit 3791 .
/RENE T TOWA/Primary Examiner, Art Unit 3791
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