Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 13 is objected to because of the following informalities: the claim states “comprises (5) comprises” where one of the comprises is redundant. 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:
“support element” in claim 1 (“element is a nonce term; the term is modified by functional language beginning with “configured to” and “so as to support”; and is not modified by sufficient structure to perform the claimed function).
“guide element” in claim 2 (“element” is a nonce term; the term is modified by functional language beginning with “configured to”; and is not modified by sufficient structure to perform the claimed function).
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 3 and 10-12 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 3 states “the guide element (6) preferably being in the form of at least one rail (6a) defined on the gripping element (5)”. Description of examples and preferences is properly set forth in the specification rather than in a single claim. Because the claim includes a preference, it is unclear whether or not the preference is part of the scope of the claim. The Examiner assumes it is not. Appropriate correction is required.
Claim 10 states “The device (1) according to claim 8, when dependent on claim 7” where it is unclear what is meant by “when dependent on claim 7”. Claim 8 depends on claim 1 and never depends on claim 7. The scope of the phrase is unclear. The Examiner assumes that claim 10 depends from claim 8. Appropriate correction is required. Claims 11 and 12 depend on claim 10 and 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.
Claims 1-3, 5, 7-8, and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Bouquet (US 2023/0148856) in view of Balas (US 2009/0076368).
Regarding Claim 1, Bouquet discloses:
An inspection device (1) of a cavity, comprising:
a dilator body (2) (602), having a prevalent extension along a longitudinal axis (X) between a proximal end (21) and a distal end (22) (see Fig. 6A showing the extension of 602 along the longitudinal axis), wherein the proximal end (21) and the distal end (22) are connected by a side wall (23) and define, together with said side wall (23), an inner volume (V) (see Fig. 6A showing the sidewall of 602 extending from the proximal to the distal end), wherein the proximal end (21) identifies a proximal opening (PO) (proximal end of 602 is open; see Fig. 6A), and wherein the distal end (22) identifies a distal opening (DO) for access, from the inner volume (V), to the tissues delimiting the cavity (see Figs. 6A and 6B showing the distal opening of 602);
an introducer body (3) (604), applicable in use in a removable manner to said dilator body (2), in particular the introducer body (3) being slidably insertable into, and disengageable from, the inner volume (V) through the proximal opening (PO) (see Figs. 6A-6B and Paragraphs 0073-0075 discussing how 604 moves in and out of 602);
a gripping element (4) (608) with an elongated shape, applied or applicable to the proximal end (PO) of the dilator body (2), wherein the gripping element (4) is arranged transversely with respect to the longitudinal axis (X) and wherein the gripping element (4) is graspable by an operator (see Fig. 6A, for example, showing the handle),
said device (1) comprises a support element (5) (681) configured to define a connection with an inspection group (1000) (see Figs. 11A and 11B showing the support element connected to imaging system 680; see Paragraph 0109 describing that the imaging system 680 as removable),
wherein the support element (5) is arranged externally with respect to the inner volume (V) defined by the dilator body (2), so as to support the inspection group (1000) externally with respect to said inner volume (V) (see Fig. 11A, for example, showing 681 externally to the inner volume), and
wherein the support element (5) is connected to the gripping element (4) and is movable along said gripping element (4) towards and/or away from the proximal end (PO) (see Figs. 11A-11C showing how the support element 681 moves in and out; see also Paragraph 0109 describing this relationship),
the inspection group (1000) comprising at least one acquisition device (100) (682).
Bouquet does disclose a lighting device (see Paragraph 0085, for example) but that not necessarily as part of the inspection group. Bouquet also discloses that other imaging elements may be part of the system 680 (see Paragraph 0109). Balas teaches using a light source (113) with an imaging system to provide illumination. Including a lighting device to illuminate the body cavity, therefore, would be obvious as one of the other imaging elements. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Bouquet to include a lighting device. Such a modification provides illumination of the body cavity for the camera to acquire images of the target.
Bouquet also does not explicitly disclose wherein the support element defines a reversible connection with the inspection group. Balas teaches a similar speculum device where the imaging module is detachably attached to the body (see Paragraph 0119). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Bouquet’s device to have Balas’s detachable feature. Such a modification allows the imaging module to be swapped out as desired, possibly for different cameras, different lights, or for repair.
Regarding Claim 2, Bouquet further discloses a guide element (6) (684), arranged at the gripping element (4), configured to guide a movement of the support element (5) along a predefined path, extending along the gripping element (4) (see Figs. 11A-11C and Paragraph 0109 discussing how 684 acts to guide 681 on 608).
Regarding Claim 3, Bouquet further discloses wherein the guide element (6) is defined on the gripping element (4) (see Figs. 11A-11C showing 684 on the grip 608), the guide element (6) preferably being in the form of at least one rail (6a) defined on the gripping element (5) (684 is a slot, the preference that this be a rail is not considered a structural limitation of the claim).
Regarding Claim 5, Bouquet further discloses wherein the guide element (6) defines a channel (61) delimiting the predefined path (684 is a slot), and wherein the support element (5) comprises: an interconnection portion (51), inserted into, and sliding along, said channel (61) (body of 681), and a connection portion (52) extending transversely with respect to said channel (61) or with respect to said interconnection portion (51) and configured to support the inspection group (1000) (not shown, but 681 includes one or more protrusions that are received in 686; those protrusions extend transversely relative to the slot to support the inspection group).
Regarding Claim 7, Bouquet further discloses wherein the support element (5) is sliding along the gripping element (4) between: an insertion position, in which the support element (5) is arranged in a distal position with respect to the proximal opening (PO) of the dilator body (2); an acquisition position, in which the support element (5) is arranged in a proximal position with respect to the proximal opening (PO) of the dilator body (2); an observation position, in which the support element (5) is arranged between the insertion position and the acquisition position (see Figs. 11A-11C, the support element is shown in three distinct positions, one in each figure).
Regarding Claim 8, Bouquet further discloses wherein the support element (5) comprises: an acquisition seat (53), configured in use to receive the acquisition device (100) by insertion (see Fig. 11B, for example, showing 682 seated in the distal end of 681). Bouquet does not explicitly disclose a lighting seat (54), configured in use to receive the lighting device (200) by insertion; however, as discussed above, a light is considered obvious. Such a light would need to seated or attached to the support element. Using a seat or groove or any other mechanism for attachment meets the need. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Bouquet’s support element to include a lighting seat. Such a modification provides a means for attaching the light to the support element to yield the predictable result of attaching components to one another in a secure fashion.
Regarding Claim 10, Bouquet further discloses wherein: the acquisition seat (53) extends along a respective acquisition axis (Y) passing through the distal opening (DO) of the dilator body (2) in the acquisition position, the lighting seat (54) extends along a respective lighting axis (Z) passing through at least the proximal opening (PO) of the dilator body (2) in both the acquisition position and in the lighting position, the lighting axis (Z) also passing through the distal opening (DO) of the dilator body (2) (the imaging element and its seat extend in a direction along the longitudinal axis of the body so that images can be taken during use; the lighting element emits light parallel to the imaging element as is known in the art to provide illumination in the same direction of image acquisition; as seen in Figs. 11B and 11C, the lighting axes extend through the proximal and openings in both positions).
Regarding Claim 11, Bouquet further discloses wherein the acquisition seat (53) defines in use an acquisition direction parallel to or coincident with the acquisition axis (Y) and is configured in use to receive by insertion the acquisition device (100) of the inspection group (1000) oriented along the respective acquisition direction; said acquisition direction or said acquisition axis (Y) being: passing through the distal opening (DO) of the dilator body (2) and incident with respect to the longitudinal axis (X) in the acquisition position, and not passing through the distal opening (DO) of the dilator body (2) and not incident with respect to the longitudinal axis (X) in the insertion position (the imaging element and its seat extend in a direction along the longitudinal axis of the body so that images can be taken during use; as seen in Fig. 11A, when in the insertion position, the axis of the imaging element does not extend through the longitudinal axis).
Regarding Claim 12, Bouquet further discloses wherein the lighting seat (54) defines in use a lighting direction parallel to or coincident with the lighting axis (Y) and is configured in use to receive by insertion the lighting device (200) of the inspection group (1000) oriented along the respective lighting direction; said lighting direction or said lighting axis (Z) being: passing through the distal opening (DO) of the dilator body (2) and incident with respect to the longitudinal axis (X) in the acquisition position and in the lighting position, and not passing through the distal opening (DO) of the dilator body (2) and not incident with respect to the longitudinal axis (X) in the insertion position (the lighting element and its seat extend in a direction along the longitudinal axis of the body so that lighting for images can be provided during use; as seen in Fig. 11A, when in the insertion position, the axis of the lighting element does not extend through the longitudinal axis).
Regarding Claim 13, Bouquet does not explicitly disclose wherein the support element (5) comprises (5) comprises an adaptor (55), configured to define a reversible connection with the inspection group (1000), the adaptor (55) being removable from said support element (5). Balas teaches a similar speculum device with an adaptor (202) so that the inspection group can be removably attached to the device. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Bouquet’s device to include Balas’s adaptor. Such a modification provides a means for removing the imaging components when desired for repair, cleaning, disposal, or different components with different parameters.
Regarding Claim 14, Bouquet further discloses:
An inspection kit of a cavity, comprising: a device (1) according to claim 1 (see rejection of claim 1 above); an acquisition device (100) (682) and a lighting device (200) (see rejection of claim 1 discussing obviousness of the lighting device) reversibly connected to the support element (5) of the device (1) (see obviousness rejection of claim 1 above). Bouquet does not explicitly disclose a portable battery (300) connected or connectible to the acquisition device (100) and to the lighting device (200); however, a battery is discussed for providing power to one illumination option (see Paragraph 0083), and battery power is common in the art. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Bouquet’s device to have a battery for the imaging elements. Such a modification provides the necessary power without needing to be plugged in. This makes the device portable as is known in the art.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bouquet (US 2023/0148856) and Balas (US 2009/0076368), as applied to claim 1 above, and further in view of Bar-Or et al. (US 2020/0107714).
Bouquet and Balas disclose the invention substantially as claimed as stated above. However, they do not explicitly disclose wherein the guide element (6) comprises locking members (B) configured to define a respective plurality of predefined positions in which to retain said support element (5) along said gripping element (4), said locking members (B) comprising a plurality of protuberances (62). The Examiner notes that such a locking mechanism is structurally and functionally similar to a ratcheting mechanism. Bar-Or teaches using a locking mechanism with protrusions for controlling the location of the camera relative to the main device (see Fig. 16 and protrusions 1625). Other mechanisms of similar construction are known in the art (see Conclusion). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Bouquet and Balas’s device to include Bar-Or’s locking mechanism. Such a modification provides a well-known means for controlling the location of the camera relative to the body of the device.
Allowable Subject Matter
Claims 4 and 9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The primary reason the claims are allowable over the prior art is that the prior art fails to disclose or render obvious the removable rail features of claim 4 and the configuration of the acquisition and lighting seats of claim 9. As to the removable rail, Bouquet’s guide element 684 is a slot and is not a rail or removable. There is no clear reason on the record to modify the reference to include such a feature. Similarly, the configuration of the seats is not compatible with Bouquet. Bouquet’s connection portion would not be a good place to locate the imaging components as they would not necessarily be directed to the target location. For at least these reasons, the claims in combination with the claims from which they depend overcome the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sanders et al. (US 2008/0108869) discussing using ratchet assemblies to fix the location of the camera relative to the shaft; Richey (US 2016/0278810) including a ratchet-type mechanism for advancing and retracting a component along the length of a tube.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30.
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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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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795
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