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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosures of the prior-filed applications, Provisional Application No. 62/553,057, and Application Nos. PCT/US2018/049234, 16/796,589, 17/214,496 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claim 3 recites “the instrument comprises an endoscope”. This limitation in view of claim 1, which recites “rotating the instrument with respect to the everting balloon” would result in the method of rotating an endoscope with respect to the everting balloon.
Claim 5 recites “the instrument comprises an IUD inserter”. This limitation in view of claim 1, which recites “rotating the instrument with respect to the everting balloon” would result in the method of rotating an IUD inserter with respect to the everting balloon.
Claim 11 recites “rotating the IUD inserter with respect to the everting balloon.”
Claim 17 recites “the instrument comprises an endoscope”. This limitation in view of claim 16, which recites “rotating the instrument with respect to the everting balloon” would result in the method of rotating an endoscope with respect to the everting balloon.
Claim 19 recites “the instrument comprises an IUD inserter”. This limitation in view of claim 16, which recites “rotating the instrument with respect to the everting balloon” would result in the method of rotating an IUD inserter with respect to the everting balloon.
The rotating of the instruments as claimed in claims 3, 5, 11, 17, and 19 was not described in the specification of the priority documents in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the priority application was filed, had possession of the claimed invention.
The only recitations of rotating an instrument in the specification, in application 17/214,496 are in paragraphs [0089], [0096], [0099] and [0105] as copied below.
Paragraph [0089]- “Once everted the everting catheter system 2 can allow the operator to manually push, rotate, or actuate the biopsy mechanism for tissue collection.”
Paragraph [0096]- “The brush can be manually manipulated by the physician either forward and back, or rotated, or both motions simultaneously. […] For the example of endometrial biopsy, the physician will want to rotate and pump the brush forward and backward slightly to increase the amount of endometrium within or on the bristles 72 of the brush.”
Paragraph [0099]- “The physician can manually manipulate the knob 58 of the cytology brush 68 to rotate or advance and retract the brush from the distal end of the everted balloon.”
Paragraph [0105]- “The shaver can may be manipulated (e.g., advanced, retracted, and rotated)”
There is no description in the Specification nor depiction in the Drawings of a method including rotating an endoscope or an IUD inserter with respect to the everting balloon.
Accordingly claims 3, 5, 11-15, 17, and 19 are not entitled to the benefit of the prior filed applications.
Drawings
The drawings are objected to because:
Figure 8B shows the everting balloon with no separation between it and the brush 68, the brush appears to be a part of the distal end of the balloon. The examiner recommends adding a line between the end of the everting balloon and the brush to show the separation, for example as depicted in Fig 8E. The examiner has annotated Fig 8D with a line to show how this could look.;
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Figure 8D shows the cytology brush 68 fully protruding beyond the everting balloon, with bristles ending at the proximal end of the brush outside of the everting balloon. This does not appear to be consistent with the specification. The examiner notes Figure 8D is intended to show the biopsy brush slightly protruding from the everted balloon as described in [0034] and [0094], this indicates that some of the biopsy brush should still be enveloped by the balloon which is not clearly shown in Figure 8D;
Additionally, Figure 8D shows a radially outward protruding flange at the end of the everting balloon 12, this does not appear consistent with how the everting balloon would be shaped;
Figure 8C shows the cytology brush 68 with bristles that do not appear to be flattened or compressed as described, the bristles appear to be in the same configuration as in Figures 8D and 8E.
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 mechanical implement of claims 10 and 15 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.
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: “mechanical implement” in claims 10 and 15. Mechanical implement is interpreted to be a sharp surface using paragraph [0021]: (e.g., scissors, a knife edge, scalpel or other blade), and [0083]: "The mechanical implement can be a sharp surface made from metal or plastic".
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 § 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.
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.
Claim(s) 1-4, 8, 10, 16-18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bacich et al. (US 2015/0133727 A1) in view of Lowery et al. (US 5,300,023 A), Reydel et al. (US 2001/0044595 A1), and Obradovic (US 2017/0266416 A1).
Regarding claim 1, Bacich et al. discloses a method for accessing a body cavity or lumen in a body comprising: inserting an everting catheter system (Figs 1A-1E) into the body ([0063] system is used to traverse a vessel), wherein the everting catheter system comprises an inner catheter (8 Figs 1A-1E) defining an inner lumen (10 Figs 1A-1E), an outer catheter (4 Figs 1A-1E), and an everting balloon (6 Figs 1A-1 E, Fig 1A shows balloon in inverted configuration, Fig 1E shows balloon in everted configuration) defining a balloon lumen (12 Figs 1A-1E), and wherein the inner catheter is in the balloon lumen (Figs 1A-1E, see inner catheter 8 within lumen 12); deploying the everting balloon out of a distal end of the everting catheter system and into the body cavity or lumen (Figs 1A-1E show everting balloon 6 deploying from catheter system 2); inserting an instrument through the inner lumen (26 Fig 1E, [0074]); and tearing the everting balloon [0117].
Bacich et al. does not teach wherein deploying comprises positioning the inner catheter in the body cavity or lumen in a first profile that is smaller than a second profile, wherein the inner catheter has an expandable portion and a non-expandable portion positioned proximally from the expandable portion, wherein the inner catheter is pleated or folded longitudinally along the inner catheter and within the expandable portion when the inner catheter is in the first profile; and wherein the inner catheter has the second profile around the instrument when the instrument is inserted in the inner lumen; and rotating the instrument with respect to the everting balloon.
Lowery et al. teaches rotating the instrument with respect to the everting balloon (Col 6 lines 32-34). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the method of Bacich et al. to include rotating the instrument with respect to the everting balloon as taught by Lowery et al. to “more desirably position” the instrument during use (Col 6 lines 35-37).
Reydel et al. teaches an everting catheter sleeve system with an inner catheter (15 Fig 4), an outer catheter (12 Fig 4), and an everting sheath (13 Fig 4) to introduce medical devices into bodily passages. Reydel et al. further teaches the system wherein deploying comprises positioning the inner catheter in the body cavity or lumen in a first profile that is smaller than a second profile ([0015] “once it is introduced into the body[…]a larger device […] can be introduced therethrough as the inner member expands to accommodate its passageway”, See pleated profile of inner catheter 15 Fig. 31, [0075] inner catheter (called inner member) has a first, unexpanded diameter), wherein the inner catheter is pleated or folded longitudinally along the inner catheter and within the expandable portion when the inner catheter is in the first profile (See pleat 99 Fig 31, [0075] inner catheter is folded when in first, unexpanded diameter). Reydel et al. further teaches the system wherein when the instrument is in the inner lumen, the inner catheter is in the second profile around the instrument ([0075) when the instrument Is pushed through the inner catheter, the inner catheter assumes its larger, second diameter). It would have been obvious to one of ordinary skill at the time of effective filing to include a pleat or fold in the inner catheter of Bacich et al. and for the method of modified Bacich et al. to include the profile limitations as taught by Reydel et al. to allow the inner lumen to expand in the presence of a large instrument inserted through its lumen but maintain a small profile without the presence of the instrument. Thus, insertion of the system can be performed in a small profile to prevent risk of puncturing or damaging the target body cavity or body lumen.
Obradovic teaches a catheter (1 Fig 1) has an expandable portion (5 Fig 1) and a non-expandable portion (4 Fig 1) positioned proximally from the expandable portion ([0026] “The insertion tube 3 itself is divided into a proximal portion 4 with fixed diameter and a distal portion 5 which is of variable diameter”), wherein the catheter has expansion elements longitudinally along the catheter and within the expandable portion ([0028] “Incisions 11 represent the first incisions extending from the proximal end of the distal portion 5 to just before the distal end of the distal portion 5.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the inner catheter of modified Bacich et al. to include the expandable and non-expandable portions as taught by Obradovic to provide structure to securely attach the inner catheter to a rigid proximal hub and to provide a larger opening for more easily inserting an instrument.
Regarding claim 2, modified Bacich et al. teaches the method of claim 1. Reydel further teaches the method wherein the inner catheter is radially unexpanded in the first profile (15 Fig 31) and radially expanded in the second profile ([0075] inner catheter (referred to as inner member) radially expands from a first, unexpanded diameter to a larger, second diameter to allow passage of a device).
Regarding claim 3, modified Bacich et al. teaches the method of claim 1. Bacich et al. further teaches wherein the instrument comprises an endoscope [0029].
Regarding claim 4, modified Bacich et al. teaches the method of claim 1. Bacich et al. further teaches wherein the instrument comprises a cytology brush ([0029] a sampling brush is a cytology brush).
Regarding claim 8, modified Bacich et al. teaches the method of claim 1. Bacich et al. teaches the everting balloon is torn at an intentional weakness in a wall of the everting balloon [0118]. Bacich et al. teaches the everting balloon can be torn when a device introduced into the everting balloon causes the everting balloon diameter to expand beyond the strain limit for the everting balloon ([0117] the dilating balloon 62 inflates in the everting balloon Figs 3A-3B). However, modified Bacich et al. does not explicitly teach the method wherein when the inner catheter is in the second profile, the everting balloon is torn.
Reydel et al. teaches the system wherein when the instrument is in the inner lumen, the inner catheter is in the second profile around the instrument, the second profile being larger than the first profile ([0075] when the instrument is pushed through the inner catheter, the inner catheter assumes its larger, second diameter). It would have been obvious to a person having ordinary skill in the art for the method of modified Bacich et al. to include wherein when the inner catheter is in the second profile, the everting balloon is torn to allow further advancement or expansion of the inner catheter for the insertion and use of a larger instrument. The use of a larger instrument would thus allow for treatment or diagnosis of the target body cavity or lumen.
Regarding claim 10, modified Bacich et al. teaches the method of claim 8. Bacich et al. further teaches wherein the tearing of the everting balloon comprises using a mechanical implement ([0118] “torn by a mechanical instrument”, “a sharp implement”, as described in the 112f interpretation above, Mechanical implement is interpreted to be a sharp surface).
Regarding claim 16, Bacich et al. discloses a method for accessing a body cavity or lumen in a body comprising: inserting an everting catheter system (Figs 1A-1E) into the body ([0063] system is used to traverse a vessel), wherein the everting catheter system comprises an inner catheter (8 Figs 1A-1E) defining an inner lumen (10 Figs 1A-1E), an outer catheter (4 Figs 1A-1E), and an everting balloon (6 Figs 1A-1 E, Fig 1A shows balloon in inverted configuration, Fig 1E shows balloon in everted configuration) defining a balloon lumen (12 Figs 1A-1E), and wherein the inner catheter is in the balloon lumen (Figs 1A-1E, see inner catheter 8 within lumen 12); deploying the everting balloon out of a distal end of the everting catheter system and into the body cavity or lumen (Figs 1A-1E show everting balloon 6 deploying from catheter system 2); inserting an instrument through the inner lumen (26 Fig 1E, [0074]).
Bacich et al. does not teach the method wherein deploying comprises positioning the inner catheter in the body cavity or lumen in a first profile that is smaller than a second profile, wherein the inner catheter has an expandable portion and a non-expandable portion positioned proximally from the expandable portion, wherein the inner catheter is pleated or folded longitudinally along the inner catheter and within the expandable portion when the inner catheter is in the first profile; wherein the inner catheter is radially unexpanded in the first profile and radially expanded in the second profile; and rotating the instrument with respect to the everting balloon.
Lowery et al. teaches rotating the instrument with respect to the everting balloon (Col 6 lines 32-34). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the method of Bacich et al. to include rotating the instrument with respect to the everting balloon as taught by Lowery et al. to “more desirably position” the instrument during use (Col 6 lines 35-37).
Reydel et al. teaches an everting catheter sleeve system with an inner catheter (15 Fig 4), an outer catheter (12 Fig 4), and an everting sheath (13 Fig 4) to introduce medical devices into bodily passages. Reydel et al. further teaches the system wherein deploying comprises positioning the inner catheter in the body cavity or lumen in a first profile that is smaller than a second profile ([0015] “once it is introduced into the body[…]a larger device […] can be introduced therethrough as the inner member expands to accommodate its passageway”, See pleated profile of inner catheter 15 Fig. 31, [0075] inner catheter (called inner member) has a first, unexpanded diameter), wherein the inner catheter is pleated or folded longitudinally along the inner catheter and within the expandable portion when the inner catheter is in the first profile (See pleat 99 Fig 31, [0075] inner catheter is folded when in first, unexpanded diameter), wherein the inner catheter is radially unexpanded in the first profile (15 Fig 31) and radially expanded in the second profile ([0075] inner catheter (referred to as inner member) radially expands from a first, unexpanded diameter to a larger, second diameter to allow passage of a device). It would have been obvious to one of ordinary skill at the time of effective filing to include a pleat or fold in the inner catheter of Bacich et al. and for the method of Bacich et al. to include the profile limitations as taught by Reydel et al. to allow the inner lumen to expand in the presence of a large instrument inserted through its lumen but maintain a small profile without the presence of the instrument. Thus, insertion of the system can be performed in a small profile to prevent risk of puncturing or damaging the target body cavity or body lumen.
Obradovic teaches a catheter (1 Fig 1) has an expandable portion (5 Fig 1) and a non-expandable portion (4 Fig 1) positioned proximally from the expandable portion ([0026] “The insertion tube 3 itself is divided into a proximal portion 4 with fixed diameter and a distal portion 5 which is of variable diameter”), wherein the catheter has expansion elements longitudinally along the catheter and within the expandable portion ([0028] “Incisions 11 represent the first incisions extending from the proximal end of the distal portion 5 to just before the distal end of the distal portion 5.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the inner catheter of modified Bacich et al. to include the expandable and non-expandable portions as taught by Obradovic to provide structure to securely attach the inner catheter to a rigid proximal hub and to provide a larger opening for more easily inserting an instrument.
Regarding claim 17, modified Bacich et al. teaches the method of claim 16. Bacich et al. further teaches wherein the instrument comprises an endoscope [0029].
Regarding claim 18, modified Bacich et al. teaches the method of claim 16. Bacich et al. further teaches wherein the instrument comprises a cytology brush ([0029] a sampling brush is a cytology brush).
Regarding claim 20, modified Bacich et al. teaches the method of claim 16. Bacich et al. teaches the everting balloon is torn at an intentional weakness in a wall of the everting balloon [0118]. Bacich et al. teaches the everting balloon can be torn when a device introduced into the everting balloon causes the everting balloon diameter to expand beyond the strain limit for the everting balloon ([0117] the dilating balloon 62 inflates in the everting balloon Figs 3A-3B).
However, modified Bacich et al. does not explicitly teach the method wherein when the inner catheter is in the second profile, the everting balloon is torn.
Reydel et al. teaches the system wherein when the instrument is in the inner lumen, the inner catheter is in the second profile around the instrument, the second profile being larger than the first profile ([0075] when the instrument is pushed through the inner catheter, the inner catheter assumes its larger, second diameter). It would have been obvious to a person having ordinary skill in the art for the method of modified Bacich et al. to include wherein when the inner catheter is in the second profile, the everting balloon is torn to allow further advancement or expansion of the inner catheter for the insertion and use of a larger instrument. The use of a larger instrument would thus allow for treatment or diagnosis of the target body cavity or lumen.
Claim(s) 5, 11-13, 15, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bacich et al. (US 2015/0133727 A1) in view of Lowery et al. (US 5,300,023 A), Reydel et al. (US 2001/0044595 A1), Obradovic (US 2017/0266416 A1), and Tal et al. (US 2015/0107598 A1).
Regarding claim 5, modified Bacich et al. teaches the method of claim 5. Bacich et al. teaches wherein the instrument comprises “Devices, tools, instrumentation, endoscopes, drugs, therapeutic agents, sampling devices (brushes, biopsy, and aspiration mechanisms)” [0029] however, is silent to wherein the instrument comprises an IUD inserter.
Tal et al. teaches an instrument for insertion into a body cavity (U Fig 2A) wherein the instrument comprises an IUD inserter (12 Fig 2B). It would have been obvious to one of ordinary skill at the time of effective filing for the instrument of modified Bacich et al. to comprise an IUD inserter to facilitate insertion of an IUD into a uterus (Abstract) to provide long-acting, reversible contraception [0002].
Regarding claim 11, Bacich et al. discloses a method for accessing a body cavity or lumen in a body comprising: inserting an everting catheter system (Figs 1A-1E) into the body ([0063] system is used to traverse a vessel), wherein the everting catheter system comprises an inner catheter (8 Figs 1A-1E) defining an inner lumen (10 Figs 1A-1E), an outer catheter (4 Figs 1A-1E), and an everting balloon (6 Figs 1A-1 E, Fig 1A shows balloon in inverted configuration, Fig 1E shows balloon in everted configuration) defining a balloon lumen (12 Figs 1A-1E), and wherein the inner catheter is in the balloon lumen (Figs 1A-1E, see inner catheter 8 within lumen 12); deploying the everting balloon out of a distal end of the everting catheter system and into the body cavity or lumen (Figs 1A-1E show everting balloon 6 deploying from catheter system 2); inserting an instrument through the inner lumen (26 Fig 1E, [0074]).
Bacich et al. does not teach the method wherein deploying comprises positioning the inner catheter in the body cavity or lumen in a first profile that is smaller than a second profile, wherein the inner catheter has an expandable portion and a non-expandable portion positioned proximally from the expandable portion, wherein the inner catheter is pleated or folded longitudinally along the inner catheter and within the expandable portion when the inner catheter is in the first profile. Bacich et al. teaches wherein the instrument comprises “Devices, tools, instrumentation, endoscopes, drugs, therapeutic agents, sampling devices (brushes, biopsy, and aspiration mechanisms)” [0029] however, Bacich et al. is silent to wherein the instrument comprises an IUD inserter; and rotating the IUD inserter with respect to the everting balloon.
Lowery et al. teaches rotating the instrument with respect to the everting balloon (Col 6 lines 32-34). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the method of Bacich et al. to include rotating the instrument with respect to the everting balloon as taught by Lowery et al. to “more desirably position” the instrument during use (Col 6 lines 35-37).
Reydel et al. teaches an everting catheter sleeve system with an inner catheter (15 Fig 4), an outer catheter (12 Fig 4), and an everting sheath (13 Fig 4) to introduce medical devices into bodily passages. Reydel et al. further teaches the system wherein deploying comprises positioning the inner catheter in the body cavity or lumen in a first profile that is smaller than a second profile ([0015] “once it is introduced into the body[…]a larger device […] can be introduced therethrough as the inner member expands to accommodate its passageway”, See pleated profile of inner catheter 15 Fig. 31, [0075] inner catheter (called inner member) has a first, unexpanded diameter), wherein the inner catheter is pleated or folded longitudinally along the inner catheter and within the expandable portion when the inner catheter is in the first profile (See pleat 99 Fig 31, [0075] inner catheter is folded when in first, unexpanded diameter). It would have been obvious to one of ordinary skill at the time of effective filing to include a pleat or fold in the inner catheter of Bacich et al. and for the method of Bacich et al. to include the profile limitations as taught by Reydel et al. to allow the inner lumen to expand in the presence of a large instrument inserted through its lumen but maintain a small profile without the presence of the instrument. Thus, insertion of the system can be performed in a small profile to prevent risk of puncturing or damaging the target body cavity or body lumen.
Obradovic teaches a catheter (1 Fig 1) has an expandable portion (5 Fig 1) and a non-expandable portion (4 Fig 1) positioned proximally from the expandable portion ([0026] “The insertion tube 3 itself is divided into a proximal portion 4 with fixed diameter and a distal portion 5 which is of variable diameter”), wherein the catheter has expansion elements longitudinally along the catheter and within the expandable portion ([0028] “Incisions 11 represent the first incisions extending from the proximal end of the distal portion 5 to just before the distal end of the distal portion 5.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the inner catheter of modified Bacich et al. to include the expandable and non-expandable portions as taught by Obradovic to provide structure to securely attach the inner catheter to a rigid proximal hub and to provide a larger opening for more easily inserting an instrument.
Tal et al. teaches an instrument for insertion into a body cavity (U Fig 2A) wherein the instrument comprises an IUD inserter (12 Fig 2B). It would have been obvious to one of ordinary skill at the time of effective filing for the instrument of modified Bacich et al. to comprise an IUD inserter to facilitate insertion of an IUD into a uterus (Abstract) to provide long-acting, reversible contraception [0002].
Regarding claim 12, modified Bacich et al. teaches the method of claim 11. Reydel further teaches the method wherein the inner catheter is radially unexpanded in the first profile (15 Fig 31) and radially expanded in the second profile ([0075] inner catheter (referred to as inner member) radially expands from a first, unexpanded diameter to a larger, second diameter to allow passage of a device).
Regarding claim 13, modified Bacich et al. teaches the method of claim 11. Bacich et al. teaches the everting balloon is torn at an intentional weakness in a wall of the everting balloon [0118]. Bacich et al. teaches the everting balloon can be torn when a device introduced into the everting balloon causes the everting balloon diameter to expand beyond the strain limit for the everting balloon ([0117] the dilating balloon 62 inflates in the everting balloon Figs 3A-3B). However, modified Bacich et al. does not explicitly teach the method wherein when the inner catheter is in the second profile, the everting balloon is torn.
Reydel et al. teaches the system wherein when the instrument is in the inner lumen, the inner catheter is in the second profile around the instrument, the second profile being larger than the first profile ([0075] when the instrument is pushed through the inner catheter, the inner catheter assumes its larger, second diameter). It would have been obvious to a person having ordinary skill in the art for the method of modified Bacich et al. to include wherein when the inner catheter is in the second profile, the everting balloon is torn to allow further advancement or expansion of the inner catheter for the insertion and use of a larger instrument. The use of a larger instrument would thus allow for treatment or diagnosis of the target body cavity or lumen.
Regarding claim 15, modified Bacich et al. teaches the method of claim 12. Bacich et al. further teaches wherein the tearing of the everting balloon comprises using a mechanical implement ([0118] “torn by a mechanical instrument”, “a sharp implement”, as described in the 112f interpretation above, Mechanical implement is interpreted to be a sharp surface).
Regarding claim 19, modified Bacich et al. teaches the method of claim 16. Bacich et al. teaches wherein the instrument comprises “Devices, tools, instrumentation, endoscopes, drugs, therapeutic agents, sampling devices (brushes, biopsy, and aspiration mechanisms)” [0029] however, is silent to wherein the instrument comprises an IUD inserter.
Tal et al. teaches an instrument for insertion into a body cavity (U Fig 2A) wherein the instrument comprises an IUD inserter (12 Fig 2B). It would have been obvious to one of ordinary skill at the time of effective filing for the instrument of modified Bacich et al. to comprise an IUD inserter to facilitate insertion of an IUD into a uterus (Abstract) to provide long-acting, reversible contraception [0002].
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bacich et al. (US 2015/0133727 A1) in view of Lowery et al. (US 5,300,023 A), Reydel et al. (US 2001/0044595 A1), Obradovic (US 2017/0266416 A1), and Roy et al. (US 2014/0128732 A1).
Regarding claim 6, modified Bacich et al. teaches the method of claim 1. However, modified Bacich et al. is silent to wherein the instrument comprises a shaver.
Roy et al. teaches an instrument advanced within a lumen, wherein the instrument comprises a shaver ([0039] “mechanical shavers”). It would have been obvious to one of ordinary skill at the time of effective filing for the instrument of modified Bacich et al. to comprise a shaver as taught by Roy et al. because such a modification is the result of a simple substitution of one known element (sampling device- Bacich et al. [0029]) for another (mechanical shaver) to achieve a predictable result (provide a device that can sample tissue).
Claim(s) 7, 9, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bacich et al. (US 2015/0133727 A1) in view of Lowery et al. (US 5,300,023 A), Reydel et al. (US 2001/0044595 A1), Obradovic (US 2017/0266416 A1), and Bacich ‘889 (US 5,749,889 A).
Regarding claim 7, modified Bacich et al. teaches the method of claim 1. However, modified Bacich et al. is silent to wherein the instrument comprises an aspiration-type biopsy device.
Bacich ‘889 teaches an instrument advanced within a lumen, wherein the instrument comprises an aspiration-type biopsy device (214 Fig 10, Col 17 Lines 40-43). It would have been obvious to one of ordinary skill at the time of effective filing for the instrument of modified Bacich et al. to comprise an aspiration type biopsy device as taught by Bacich ‘889 since such a modification is the result of a simple substitution of one known element (sampling device- Bacich et al. [0029]) for another (aspiration-type biopsy device) to achieve a predictable result (provide a device that can sample tissue).
Regarding claim 9, modified Bacich et al. teaches the method of claim 8. Bacich et al. teaches that the weakening of the balloon can be a mechanical indentation or seam [0118]. However, modified Bacich et al. does not specifically teach that the intentional weakness comprises a perforation.
Bacich ‘889 teaches an intentional weakness in a membrane comprises perforations (Col 5 Lines 13-15). It would have been obvious to one of ordinary skill at the time of effective filing for the intentional weakness of modified Bacich et al. to comprise a perforation as taught by Bacich ’889 since such a modification is the result of a simple substitution of one known element (mechanical indentation) for another (perforation) to achieve a predictable result (intentional area of weakness).
Regarding claim 21, modified Bacich et al. teaches the method of claim 20. Bacich et al. teaches that the weakening of the balloon can be a mechanical indentation or seam [0118]. However, modified Bacich et al. does not specifically teach that the intentional weakness comprises a perforation.
Bacich ‘889 teaches an intentional weakness in a membrane comprises perforations (Col 5 Lines 13-15). It would have been obvious to one of ordinary skill at the time of effective filing for the intentional weakness of modified Bacich et al. to comprise a perforation as taught by Bacich ’889 since such a modification is the result of a simple substitution of one known element (mechanical indentation) for another (perforation) to achieve a predictable result (intentional area of weakness).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bacich et al. (US 2015/0133727 A1) in view of Lowery et al. (US 5,300,023 A), Reydel et al. (US 2001/0044595 A1), Obradovic (US 2017/0266416 A1), Tal et al. (US 2015/0107598 A1), and Bacich ‘889 (US 5,749,889 A).
Regarding claim 14, modified Bacich et al. teaches the method of claim 12. Bacich et al. teaches that the weakening of the balloon can be a mechanical indentation or seam [0118]. However, modified Bacich et al. does not specifically teach that the intentional weakness comprises a perforation.
Bacich ‘889 teaches an intentional weakness in a membrane comprises perforations (Col 5 Lines 13-15). It would have been obvious to one of ordinary skill at the time of effective filing for the intentional weakness of modified Bacich et al. to comprise a perforation as taught by Bacich ’889 since such a modification is the result of a simple substitution of one known element (mechanical indentation) for another (perforation) to achieve a predictable result (intentional area of weakness).
Conclusion
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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