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 .
Disposition of Claims
Claims 33-52 are pending and rejected.
Claims 1-32 are canceled.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 48 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding Claim 48, the limitations of Claim 48 are identical to the limitations of Lines 7-9 of Claim 45. As such, Claim 48 fails to further limit the subject matter of Claim 45.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Interpretation
Regarding Claims 33-52, the metes and bounds of Claims 33-52 (i.e., when direct infringement occurs) are interpreted to be a device, an elongated flexible shaft, a structure, an imaging coupler and all further limitations thereof (e.g., an inner wall of the structure, an outer surface of the elongated flexible shaft, a cable adapter of the imaging coupler, etc.). Given Applicant’s use of functional limitations (see MPEP §§ 2114 & 2173.05(g)), the catheter and all further limitations of the catheter thereof (e.g., a main lumen, a plurality of flat surfaces, a first curved surface, etc.) are interpreted to be not within the metes and bounds of the claims and are thus anticipated by and/or obvious over the prior art as long as the prior art is capable of performing the functional limitations of the claims. For the sake of brevity and clarity, all functional limitations relating to the catheter will not be individually addressed in the rejection below as the device(s) of the prior art are capable of performing said functional limitations.
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.
Claims 33-38 & 43-52 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meiri et al. (hereinafter "Meiri") (U.S. 4,207,872).
Regarding Claim 33, Meiri discloses a device (Fig. 3, an endoscopic device comprising 10 and 16; Col. 2, Lines 11-18) comprising:
an elongate flexible shaft (Fig. 3, 16 wherein 16 is flexible; Col. 2, Lines 17-19 & Col. 3, Lines 14-15) configured to be slideably inserted within a main lumen of a catheter; and
a structure (Fig. 1, 10; Col. 2, Lines 11-12) coupled to an outer surface (Fig. 4, 21; Col. 3, Lines 50-60) of the elongate flexible shaft (see Figs. 3 & 4),
wherein the structure is configured to engage with a plurality of flat surfaces comprising a portion of an inner surface of a wall of the main lumen to prevent rotation of the elongate flexible shaft within the main lumen,
wherein the structure includes an inner wall (Fig. 4, 13; Col. 2, Lines 13-16) that engages with a portion of the outer surface of the elongate flexible shaft (see Fig. 4), the inner wall having a shape that makes up a portion of a circle (13 is substantially circular; see Meiri Annotated Fig. 2).
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Regarding Claim 34, Meiri discloses the device of Claim 33. Meiri further discloses wherein the device is an imaging device (Fig. 3, 16 is an endoscope; Col. 2, Lines 17-19).
Regarding Claim 35, Meiri discloses the device of Claim 33. Meiri further discloses wherein the structure comprises a first key portion (a proximal row of 17; see Fig. 1) and a second key portion (a distal row of 17; see Fig. 1), the second key portion being spaced apart from the first key portion along a longitudinal axis of the elongate flexible shaft (see Fig. 1).
Regarding Claim 36, Meiri discloses the device of Claim 33. Meiri further discloses wherein the portion of the inner surface includes at least three flat surfaces and an outer profile of the structure (Annotated Meiri Fig. 2, 14; Col. 2, Lines 14-16) includes two non-adjacent surfaces (B and D; see Annotated Meiri Fig. 2) configured to slide along two of the at least three flat surfaces of the portion of the inner surface.
Regarding Claim 37, Meiri discloses the device of Claim 33. Meiri further discloses wherein:
the portion of the inner surface of the wall includes four flat surfaces; and
an outer profile of the structure (Annotated Meiri Fig. 2, 14; Col. 2, Lines 14-16) includes at least four surfaces (B, C, D and E; see Annotated Meiri Fig. 2), including two non-adjacent surfaces (B and D; see Annotated Meiri Fig. 2), configured to slide along and engage with the four flat surfaces of the portion of the inner surface.
Regarding Claim 38, Meiri discloses the device of Claim 33. Meiri further discloses wherein:
the portion of the inner surface includes a first curved surface extending between two of at least three flat surfaces; and
an outer profile of the structure (Annotated Meiri Fig. 2, 14; Col. 2, Lines 14-16) includes a second curved surface (C; see Annotated Meiri Fig. 2) arranged between two non-adjacent surfaces (B and D; see Annotated Meiri Fig. 2).
Regarding Claim 43, Meiri discloses the device of Claim 33. Meiri further discloses wherein the structure is coupled to the outer surface of the elongate flexible shaft by a bonding material (Col. 2, 20-25).
Regarding Claim 44, Meiri discloses the device of Claim 33. Meiri further discloses wherein the structure is an elongate flexible structure that bends with the elongate flexible shaft (see Fig. 3).
Regarding Claim 45, Meiri discloses a device (Fig. 3, an endoscopic device comprising 10 and 16; Col. 2, Lines 11-18) comprising:
an elongate flexible shaft (Fig. 3, 16 wherein 16 is flexible; Col. 2, Lines 17-19 & Col. 3, Lines 14-15) configured to be slideably inserted within a main lumen of a catheter; and
a structure (Fig. 1, 10; Col. 2, Lines 11-12) coupled to an outer surface (Fig. 4, 21; Col. 3, Lines 50-60) of the elongate flexible shaft (see Figs. 3 & 4),
wherein the structure is configured to engage with a plurality of flat surfaces comprising a portion of an inner surface of a wall of the main lumen to prevent rotation of the elongate flexible shaft within the main lumen,
wherein the portion of the inner surface includes at least three flat surfaces and an outer profile of the structure (Annotated Meiri Fig. 2, 14; Col. 2, Lines 14-16) includes two non-adjacent surfaces (B and D; see Annotated Meiri Fig. 2) configured to slide along two of the at least three flat surfaces of the portion of the inner surface,
wherein the outer profile of the structure includes a recessed surface between the two non-adjacent surfaces (C; see Annotated Meiri Fig. 2),
the recessed surface of the outer profile of the structure and the inner surface of the catheter forming a fluid channel.
Regarding Claim 46, Meiri discloses the device of Claim 45. Meiri further discloses wherein the device is an imaging device (Fig. 3, 16 is an endoscope; Col. 2, Lines 17-19).
Regarding Claim 47, Meiri discloses the device of Claim 45. Meiri further discloses wherein the structure comprises a first key portion (a proximal row of 17; see Fig. 1) and a second key portion (a distal row of 17; see Fig. 1), the second key portion being spaced apart from the first key portion along a longitudinal axis of the elongate flexible shaft (see Fig. 1).
Regarding Claim 48, Meiri discloses the device of Claim 45. Meiri further discloses wherein the portion of the inner surface includes at least three flat surfaces and an outer profile of the structure (Annotated Meiri Fig. 2, 14; Col. 2, Lines 14-16) includes two non-adjacent surfaces (B and D; see Annotated Meiri Fig. 2) configured to slide along two of the at least three flat surfaces of the portion of the inner surface.
Regarding Claim 49, Meiri discloses a device (Fig. 3, an endoscopic device comprising 10 and 16; Col. 2, Lines 11-18) comprising:
an elongate flexible shaft (Fig. 3, 16 wherein 16 is flexible; Col. 2, Lines 17-19 & Col. 3, Lines 14-15) configured to be slideably inserted within a main lumen of a catheter; and
a structure (Fig. 1, 10; Col. 2, Lines 11-12) coupled to an outer surface (Fig. 4, 21; Col. 3, Lines 50-60) of the elongate flexible shaft (see Figs. 3 & 4),
wherein the structure is configured to engage with a plurality of flat surfaces comprising a portion of an inner surface of a wall of the main lumen to prevent rotation of the elongate flexible shaft within the main lumen,
wherein the structure includes a U-shaped inner wall (Fig. 4, 13 wherein a semi-circular portion of 13 is U-shaped; Col. 2, Lines 13-16) that engages with a portion of the outer surface of the elongate flexible shaft (see Fig. 4).
Regarding Claim 50, Meiri discloses the device of Claim 49. Meiri further discloses wherein the device is an imaging device (Fig. 3, 16 is an endoscope; Col. 2, Lines 17-19).
Regarding Claim 51, Meiri discloses the device of Claim 49. Meiri further discloses wherein the structure comprises a first key portion (a proximal row of 17; see Fig. 1) and a second key portion (a distal row of 17; see Fig. 1), the second key portion being spaced apart from the first key portion along a longitudinal axis of the elongate flexible shaft (see Fig. 1).
Regarding Claim 52, Meiri discloses the device of Claim 49. Meiri further discloses wherein the portion of the inner surface includes at least three flat surfaces and an outer profile of the structure (Annotated Meiri Fig. 2, 14; Col. 2, Lines 14-16) includes two non-adjacent surfaces (B and D; see Annotated Meiri Fig. 2) configured to slide along two of the at least three flat surfaces of the portion of the inner surface.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 39-42 are rejected under 35 U.S.C. 103 as being unpatentable over Meiri et al. (hereinafter "Meiri") (U.S. 4,207,872) in view of Ito et al. (hereinafter "Ito") (US 2008/0269560).
Regarding Claims 39-42, Meiri discloses the device of Claim 33. Meiri fails to explicitly disclose an imaging coupler coupled to the elongate flexible shaft for coupling the device to the catheter, wherein the imaging coupler is removable from the elongate flexible shaft; wherein the imaging coupler is disposable after a single use; wherein the imaging coupler includes a cable adapter for coupling the imaging coupler to an imaging cable; and wherein the cable adapter includes a leak test port.
However, Ito teaches a device (Fig. 1, 21; [0045]) comprising:
an elongate flexible shaft (Fig. 1, 23; [0045]);
an imaging coupler (Fig. 1, 22; [0045]) coupled to the elongate flexible shaft ([0045]) for coupling the device to the catheter;
wherein the imaging coupler is removable from the elongate flexible shaft (Fig. 3, 51 of 22 is detachable; [0057]);
wherein the imaging coupler is disposable after a single use (22 is capable of being discarded after a single use);
wherein the imaging coupler includes a cable adapter (Fig. 3, 50; [0057]) for coupling the imaging coupler to an imaging cable (Fig. 1, 24; [0088]); and
wherein the cable adapter includes a leak test port (Fig. 3, 54; [0059]).
The advantage of the imaging coupler is to permit the images signals captured by the endoscope to be displayed on a video display (Ito; [0048]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the conventional endoscope as disclosed by Meiri, to include the imaging coupler taught by Ito, to permit the images signals captured by the endoscope to be displayed on a video display (Ito; [0048]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 33-45 & 48-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-14 of U.S. Patent No. 12,268,361.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current application limit a broader version of '361 and thus are anticipated by '361.
Claims 46-47 & 50-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 13-14 of U.S. Patent No. 12,268,361 in view of Meiri et al. (hereinafter "Meiri") (U.S. 4,207,872).
Claim 13 of ‘361 discloses all the limitations of instant Claims 46-47 except for wherein the device is an imaging device; and wherein the structure comprises a first key portion and a second key portion, the second key portion being spaced apart from the first key portion along a longitudinal axis of the elongate flexible shaft.
Regarding Claims 46-47, Meiri discloses a device (Fig. 3, an endoscopic device comprising 10 and 16; Col. 2, Lines 11-18) comprising:
an elongate flexible shaft (Fig. 3, 16 wherein 16 is flexible; Col. 2, Lines 17-19 & Col. 3, Lines 14-15) configured to be slideably inserted within a main lumen of a catheter; and
a structure (Fig. 1, 10; Col. 2, Lines 11-12) coupled to an outer surface (Fig. 4, 21; Col. 3, Lines 50-60) of the elongate flexible shaft (see Figs. 3 & 4),
wherein the structure is configured to engage with a plurality of flat surfaces comprising a portion of an inner surface of a wall of the main lumen to prevent rotation of the elongate flexible shaft within the main lumen,
wherein the portion of the inner surface includes at least three flat surfaces and an outer profile of the structure (Annotated Meiri Fig. 2, 14; Col. 2, Lines 14-16) includes two non-adjacent surfaces (B and D; see Annotated Meiri Fig. 2) configured to slide along two of the at least three flat surfaces of the portion of the inner surface,
wherein the outer profile of the structure includes a recessed surface between the two non-adjacent surfaces (C; see Annotated Meiri Fig. 2),
the recessed surface of the outer profile of the structure and the inner surface of the catheter forming a fluid channel;
wherein the device is an imaging device (Fig. 3, 16 is an endoscope; Col. 2, Lines 17-19); and
wherein the structure comprises a first key portion (a proximal row of 17; see Fig. 1) and a second key portion (a distal row of 17; see Fig. 1), the second key portion being spaced apart from the first key portion along a longitudinal axis of the elongate flexible shaft (see Fig. 1).
The advantage of the device being an imaging device and the structure having key portions is to examine an interior wall of colon and help advance the endoscope though a passag.
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the device and as disclosed by '361, to make the device an imaging device and include key portions on the structure, respectively, as taught by Meiri, to examine an interior wall of colon and help advance the endoscope though a passage, respectively, (Meiri; Col. 1, Lines 6-9 & Lines 50-53).
Claim 14 of ‘361 discloses all the limitation of instant Claims 50-52 except for wherein the device is an imaging device; wherein the structure comprises a first key portion and a second key portion, the second key portion being spaced apart from the first key portion along a longitudinal axis of the elongate flexible shaft; and wherein the portion of the inner surface includes at least three flat surfaces and an outer profile of the structure includes two non-adjacent surfaces configured to slide along two of the at least three flat surfaces of the portion of the inner surface.
Regarding Claims 50-52, Meiri discloses a device (Fig. 3, an endoscopic device comprising 10 and 16; Col. 2, Lines 11-18) comprising:
an elongate flexible shaft (Fig. 3, 16 wherein 16 is flexible; Col. 2, Lines 17-19 & Col. 3, Lines 14-15) configured to be slideably inserted within a main lumen of a catheter; and
a structure (Fig. 1, 10; Col. 2, Lines 11-12) coupled to an outer surface (Fig. 4, 21; Col. 3, Lines 50-60) of the elongate flexible shaft (see Figs. 3 & 4),
wherein the structure is configured to engage with a plurality of flat surfaces comprising a portion of an inner surface of a wall of the main lumen to prevent rotation of the elongate flexible shaft within the main lumen,
wherein the structure includes a U-shaped inner wall (Fig. 4, 13 wherein a semi-circular portion of 13 is U-shaped; Col. 2, Lines 13-16) that engages with a portion of the outer surface of the elongate flexible shaft (see Fig. 4);
wherein the device is an imaging device (Fig. 3, 16 is an endoscope; Col. 2, Lines 17-19);
wherein the structure comprises a first key portion (a proximal row of 17; see Fig. 1) and a second key portion (a distal row of 17; see Fig. 1), the second key portion being spaced apart from the first key portion along a longitudinal axis of the elongate flexible shaft (see Fig. 1); and
wherein the portion of the inner surface includes at least three flat surfaces and an outer profile of the structure (Annotated Meiri Fig. 2, 14; Col. 2, Lines 14-16) includes two non-adjacent surfaces (B and D; see Annotated Meiri Fig. 2) configured to slide along two of the at least three flat surfaces of the portion of the inner surface.
The advantage of the device being an imaging device and the structure having key portions is to examine an interior wall of colon and help advance the endoscope though a passage, respectively, (Meiri; Col. 1, Lines 6-9 & Lines 50-53).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the device and modify the structure as disclosed by '361, to make the device an imaging device and include key portions on the structure, respectively, as taught by Meiri, to examine an interior wall of colon and help advance the endoscope though a passage, respectively, (Meiri; Col. 1, Lines 6-9 & Lines 50-53).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Axon (US 2019/0183328) teaches a medical scope accessory.
St. George (US 2018/0814885) teaches a sheath for an endoscope.
Rottenberg et al. (US 2018/0153380) teaches an endoscope sleeve with wings.
Spenser (US 2012/0197083) teaches a method and apparatus for endoscope advancement.
Carrillo Jr. et al. (US 2007/0244356) teaches an elongated medical device having an improved distal profile.
Martone et al. (US 2007/0142709) teaches a sheath with a channel for an endoscope.
Bonnet et al. (US 2005/0267448) teaches an endoscope with a shank having a cross-section of a polygon.
Furnish (US 2003/0125719) teaches a multi-fiber catheter probe arrangement.
Bacich et al. (U.S. 5,279,280) teaches an endoscope with a grooved outer surface.
Patel (U.S. 4,577,621) teaches an endoscope having novel proximate and distal portions.
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
Prosecution Insights