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 .
Election/Restrictions
Claims 18-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/19/2025.
Applicant’s election without traverse of Group I, Species A, claims 1-17 in the reply filed on 8/19/2025 is acknowledged.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “the anus” in lines 1-2 which should read “an anus”, “said distal end” in line 9 which should read “said distal end portion”, and “said proximal end” in line 10 which should read “said proximal end portion”. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: Claim 2 recites “an outer flexible sheath” in line 4 which should read “a flexible outer sheath” for consistency purposes i.e. “said outer sheath” and “said sheath” in later claims. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: Claim 7 recites “said sheath” in lines 3 and 4 which should read “said outer sheath” and “said rim” in line 5 which should read “said circumferential rim section”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: Claim 12 recites “the anus” in lines 1-2 which should read “an anus”, “an outer flexible sheath” in line 6 which should read “a flexible outer sheath”, and “said sheath” in line 7 which should read “said outer sheath”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: Claim 15 recites “said sheath” in lines 2 and 4 which should read “said outer sheath”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: Claim 16 recites “the anal sphincter” which should read “an anal sphincter”. 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: an expansion mechanism in claims 1 and 6.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim 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 2-11 and 13-17 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.
Claims 2-11 and 13-17 recite the limitation "The recto-anal sequenced expander set" in line 1, respectively. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "said outer sheath" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "said outer sheath" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "said outer sheath" in lines 3-5 and 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the expansion of said outer sheath" in lines 2-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the amount of pressure" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "said outer sheath" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "said insert member" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "said insert member" in lines 3 and 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the expansion of said outer sheath" in lines 2-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the amount of pressure" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Newton (US 1,826,284).
Regarding claim 1, Newton discloses a recto-anal sequenced expander (Fig. 1) for relaxing muscles surrounding an anus and anal canal (column 1, lines 1-5), comprising: (a) an elongated anal insertion member (dilator 5; Fig. 1) having a distal end portion (towards reference number 27) for penetrating the anus and an opposing proximal end portion (towards holding portion 7), at least said distal end portion of said insertion member having a wall structure of sufficient rigidity to permit penetration through the anus to the anal canal (column 1, lines 1-5); and (b) said insertion member having an expansion mechanism (interpreted under 112(f) as a gaseous substance, a liquid substance, a semi-liquid substance, and a mechanical actuator and equivalents thereof and Newton discloses atmospheric air is used to expand the dilator; column 2, lines 75-80) incorporated therein which operatively expands said insertion member radially outward in a sequential and progressive manner from an area adjacent said distal end toward an area adjacent said proximal end of said insertion member (Figs. 2-3).
Regarding claim 5, Newton discloses wherein said expansion mechanism is a member selected from the group consisting of a gaseous substance, a liquid substance, a semi-liquid substance, and a mechanical actuator (as air is a gaseous substance; column 2, lines 75-80).
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.
Claim(s) 2-4, 8-9 and 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Newton (US 1,826,284) in view of Isham (US 8,080,031 B2).
Regarding claim 2, Newton discloses wherein said insertion member (5) is comprised of an elongated tubular member (inner supporting stem or base member 4) having an open proximal end (opening at the proximal end of 4 that allows air to flow through; Figs. 5-6) which is enclosed within an outer flexible sheath (outer portion 27).
Newton fails to disclose the elongated tubular member having a closed distal end and a perforated sidewall structure extending therebetween. Instead, fluid (air) dilates the outer sheath through an open distal end.
However, Isham teaches a recto-anal expander (Figs. 1-5) comprising an elongated tubular member (shaft 12) having a closed distal end (Fig. 5), an open proximal end (open end of 12 through which fluid fills the balloon), and a perforated sidewall structure (plurality of holes 48) extending therebetween which is enclosed within an outer flexible sheath (balloon 14) to facilitate complete extraction of fluid from the balloon as well as assure that the holes allow fluid to continue to flow even if one becomes clogged (columns 6-7, lines 67, 1-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elongated tubular member of Newton to have a closed distal end and a perforated sidewall structure extending therebetween as taught by Isham in order to allow fluid to pass from an interior of the elongated tubular member to the interior of the outer sheath in a more uniform manner and to allow fluid to continue to flow even if one of the perforations becomes clogged.
Regarding claim 3, modified Newton discloses wherein said expansion mechanism is comprised of a fluid (as air is a fluid; column 2, lines 75-80 of Newton) and said open proximal end of said tubular member (4 of Newton) provides an input port (opening surrounding bushing 13 and cage 15; Figs. 5-6 of Newton) for the introduction of said fluid (air) into said tubular member (4 of Newton) and through said perforated sidewall structure (holes 48 of Isham) to said outer sheath (27).
Regarding claim 4, modified Newton discloses the invention as claimed above, and Newton further discloses wherein said outer sheath (27) is constructed of alternating sidewall sections having varying degrees of material flexibility (due to ribs 26 and varying thickness of the outer portion 27; Fig. 3).
Regarding claim 8, Newton discloses wherein said insertion member (5) includes an outer surrounding flexible sheath (outer portion 27) which is affixed in sealed relation to said proximal end portion of said insertion member (as disk 6 of 4 is sealed to rear base portion 7 of 27), and said proximal end portion thereof is constructed to facilitate the introduction of an expansion fluid (air) into said insertion member for passage to said outer sheath (Figs. 1-3).
Newton fails to disclose wherein the expansion fluid passes through a plurality of openings extending through a sidewall of said insertion member.
However, Isham teaches a recto-anal expander (Figs. 1-5) comprising an elongated tubular member (shaft 12) having a closed distal end (Fig. 5), an open proximal end (open end of 12 through which fluid fills the balloon), and a perforated sidewall structure (plurality of holes 48) extending therebetween which is enclosed within an outer flexible sheath (balloon 14) to facilitate complete extraction of fluid from the balloon as well as assure that the holes allow fluid to continue to flow even if one becomes clogged (columns 6-7, lines 67, 1-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elongated tubular member of Newton to have a closed distal end and a perforated sidewall structure extending therebetween so that fluid is passed through a plurality of openings extending through a sidewall of said insertion member as taught by Isham in order to allow fluid to pass from an interior of the elongated tubular member to the interior of the outer sheath in a more uniform manner and to allow fluid to continue to flow even if one of the perforations becomes clogged.
Regarding claim 9, modified Newton discloses the invention as claimed above, and Newton further discloses wherein said insertion member (5) includes a first handle member (disk 6) formed adjacent said proximal end portion which protrudes outwardly therefrom (Figs. 2-3), and said outer sheath (27) includes a second handle member (rear base portion 7) cooperatively shaped to mate with said first handle member (6) in sealed relation thereto (Figs. 2-3).
Regarding claim 11, Newton discloses wherein said insertion member (5) is comprised of an elongated tubular member (4) with an input port (opening surrounding bushing 13 and cage 15; Figs. 5-6) for the introduction of an expansion fluid (air) and a perforation (at 22) therein extending to an outer surrounding flexible sheath (27), said outer sheath being constructed with sections of varying material flexibility to facilitate sequential progressive expansion thereof by said expansion fluid (due to ribs 26 and varying thickness of the outer portion 27; Fig. 3).
Newton fails to disclose more than one perforation.
However, Isham teaches a recto-anal expander (Figs. 1-5) comprising an elongated tubular member (shaft 12) having a closed distal end (Fig. 5), an open proximal end (open end of 12 through which fluid fills the balloon), and a perforated sidewall structure (plurality of holes 48) extending therebetween which is enclosed within an outer flexible sheath (balloon 14) to facilitate complete extraction of fluid from the balloon as well as assure that the holes allow fluid to continue to flow even if one becomes clogged (columns 6-7, lines 67, 1-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elongated tubular member of Newton to have a closed distal end and a perforated sidewall structure extending therebetween so that fluid is passed through a plurality of openings extending through a sidewall of said insertion member as taught by Isham in order to allow fluid to pass from an interior of the elongated tubular member to the interior of the outer sheath in a more uniform manner and to allow fluid to continue to flow even if one of the perforations becomes clogged.
Regarding claim 12, Newton discloses a recto-anal sequenced expander (Fig. 1) for relaxing muscles surrounding the anus and anal canal (column 1, lines 1-5), comprising:(a) a tubular insertion member (inner support or base member 4), an open proximal end (Fig. 5), said distal end being tapered (at 24) to permit penetration through the anus and into the anal canal (Figs. 2-3); (b) an outer flexible sheath (outer portion 27) surrounding a substantial portion of said insertion member between a distal end and said proximal end thereof (Figs. 2-3), said outer sheath having an imperforate wall structure (solid outer portion) and being sealed around said a sidewall structure (wall of 4) of said insertion member (at 6 and 7); (c) an input valve (valve 10) connected to said proximal end of said insertion member for connection to a fluid supply source (bulb 3); and (d) said wall structure of said outer sheath (27) being constructed to balloon outwardly around said insertion member (4) progressively from said distal end of said insertion member toward said proximal end upon the introduction of a fluid (air) from said fluid supply source through said input valve (Figs. 2-3; column 4, lines 98-101).
Newton fails to disclose the tubular insertion member with a closed distal end, and a perforated sidewall structure extending between the closed distal end and the open proximal end.
However, Isham teaches a recto-anal expander (Figs. 1-5) comprising an elongated tubular member (shaft 12) having a closed distal end (Fig. 5), an open proximal end (open end of 12 through which fluid fills the balloon), and a perforated sidewall structure (plurality of holes 48) extending therebetween which is enclosed within an outer flexible sheath (balloon 14) to facilitate complete extraction of fluid from the balloon as well as assure that the holes allow fluid to continue to flow even if one becomes clogged (columns 6-7, lines 67, 1-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elongated tubular member of Newton to have a closed distal end and a perforated sidewall structure extending between the closed distal end and the open proximal end so that fluid is passed through a plurality of openings extending through a sidewall of said insertion member as taught by Isham in order to allow fluid to pass from an interior of the elongated tubular member to the interior of the outer sheath in a more uniform manner and to allow fluid to continue to flow even if one of the perforations becomes clogged.
Regarding claim 13, modified Newton discloses the invention as claimed, and Newton further discloses wherein said wall structure of said outer sheath (27) has multiple wall sections of varying degrees of material flexibility to facilitate sequential expansion of said wall sections progressively from said distal end of said insertion member toward said proximal end (due to ribs 26 and varying thickness of the outer portion 27; Fig. 3).
Regarding claim 14, modified Newton discloses the invention as claimed, and Newton further discloses wherein said wall structure of said outer sheath has multiple wall sections of varying degrees of material flexibility extending between said distal end and said proximal end of said insertion member which facilitate expansion of said wall sections at different rates (due to ribs 26 and varying thickness of the outer portion 27; Fig. 3).
Regarding claim 15, modified Newton discloses the invention as claimed, and Newton further discloses wherein one of said wall sections of said outer sheath (27) located between said distal end and said proximal end of said insertion member (4) is formed of a material having a lower elastic modulus (wall section that does not include ribs 26) than adjacent said wall sections of said sheath, thus permitting greater and more rapid expansion thereof to prevent against inadvertent expulsion of the expander from the anus.
Claim(s) 6-7 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Newton (US 1,826,284) in view of Isham (US 8,080,031 B2), as applied to claims 2 and 12 above, and further in view of Lottick (US 4,686,985).
Regarding claims 6-7, modified Newton fails to disclose wherein said expansion mechanism and said outer sheath cooperatively interact to form a circumferentially expanded rim section intermediately located between said proximal end portion and said distal end portion of said insertion member which helps to prevent inadvertent expulsion of the expander from the anal canal, wherein said expansion mechanism interacts with said outer sheath to cause an initial expansion of said distal end portion of said sheath and said circumferential rim section thereof, followed be a progressive expansion of said sheath therebetween from said distal end portion toward said rim.
However, Lottick teaches a recto-anal expander/insertion member (Fig. 8) comprising an elongated tubular member (annular structure 74) having a closed distal end (Fig. 8), an open proximal end (Fig. 8), and a perforated sidewall structure (passages 68, 70, 72) extending therebetween which is enclosed within an outer flexible sheath (chambers 62, 64, 66), and an expansion mechanism (inflation fluid), wherein said expansion mechanism and said outer sheath cooperatively interact to form a circumferentially expanded rim section (64) intermediately located between said proximal end portion and said distal end portion of said insertion member (Fig. 8) which helps to prevent inadvertent expulsion of the expander from the anal canal (as chamber 64 is positioned within the sphincter muscles; column 6, lines 50-54).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the expander of modified Newton to include a circumferentially expanded rim section intermediately located between said proximal end portion and said distal end portion as taught by Lottick in order to further secure the expander within the sphincter. It is noted that the modification would cause the intermediate section of the outer sheath of Newton to expand to the shape taught by Lottick, not add a separate chamber. Therefore, the modification would cause said expansion mechanism to interact with said outer sheath to cause an initial expansion of said distal end portion of said sheath and said circumferential rim section thereof, followed be a progressive expansion of said sheath therebetween from said distal end portion toward said rim (due to the ribs 26 causing slower expansion of modified Newton which would be proximal to the circumferential rim of modified Newton).
Regarding claim 16, modified Newton discloses the invention as claimed above, and Newton further discloses wherein said wall structure of said outer sheath (27) has a first annular wall section located adjacent said distal end of said insertion member (Fig. 3) which is adapted to expand progressively toward said proximal end of said insertion member upon the introduction of said fluid therein (Figs. 2-3), and a second annular wall section spaced proximally from said first wall section (Fig. 3), said second wall section being constructed to expand more rapidly than adjacent wall sections of said outer sheath thereto (as the wall of 27 between ribs will expand more rapidly that the portions containing ribs 26), but fails to disclose forming a circumferential rim to bear against the anal sphincter and prevent inadvertent expulsion of the expander from the anus.
However, Lottick teaches a recto-anal expander/insertion member (Fig. 8) comprising an elongated tubular member (annular structure 74) having a closed distal end (Fig. 8), an open proximal end (Fig. 8), and a perforated sidewall structure (passages 68, 70, 72) extending therebetween which is enclosed within an outer flexible sheath (chambers 62, 64, 66), and an expansion mechanism (inflation fluid), wherein said expansion mechanism and said outer sheath cooperatively interact to form a circumferentially expanded rim section (64) intermediately located between said proximal end portion and said distal end portion of said insertion member (Fig. 8) which helps to prevent inadvertent expulsion of the expander from the anal canal (as chamber 64 is positioned within the sphincter muscles; column 6, lines 50-54).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the expander of modified Newton to include a circumferentially expanded rim section intermediately located between said proximal end portion and said distal end portion as taught by Lottick in order to further secure the expander within the sphincter. It is noted that the modification would cause the intermediate section of the outer sheath of Newton to expand to the shape taught by Lottick, not add a separate chamber. Therefore, the modification would cause said expansion mechanism to interact with said outer sheath to cause an initial expansion of said distal end portion of said sheath and said circumferential rim section thereof, followed be a progressive expansion of said sheath therebetween from said distal end portion toward said rim (due to the ribs 26 causing slower expansion of modified Newton which would be proximal to the circumferential rim of modified Newton) and cause the circumferential rim to bear against the anal sphincter and prevent inadvertent expulsion of the expander from the anus (based on the placement of the circumferential rim as taught by Lottick).
Claim(s) 10 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Newton (US 1,826,284) in view of Isham (US 8,080,031 B2), as applied to claims 8 and 12 above, and further in view of Walsh et al. (US 3,799,170).
Regarding claims 10 and 17, modified Newton fails to disclose a control device for effecting at least one of a group consisting of (i) measuring the expansion of said outer sheath; (ii) displaying the expansion of said outer sheath; (iii) recording the expansion of said outer sheath; (iv) controlling expansion and reversion of said outer sheath; (v) cycling expansion and reversion of said outer sheath over time;(vi) incorporating an integrated timer for controlling expansion and reversion of said outer sheath; (vii) measuring the amount of pressure exerted upon said outer sheath; (viii) inducing vibration to the expander; and (ix) remotely controlling the expander through wireless communication.
However, Walsh teaches a dilator (10; Fig. 1) comprising an elongated tubular member (rod or tube 12) having a distal end, an open proximal end, and a perforated sidewall structure (openings 14) extending therebetween which is enclosed within an outer flexible sheath (thin, flexible and expansible covering 15), including a control device (at least gauge 38) for effecting measuring the expansion of said outer sheath (as hydraulic pressure line 36 is adapted with a valve 37 and gauge 38 for the measurement and control of the pressure within the disposable sound 10; Fig. 6; column 4, lines 16-22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the expander of modified Newton to include the gauge as taught by Walsh in order to effectively measure the expansion of the outer sheath and control the amount of pressure/expansion to the outer sheath for smoother adaptability to a patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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/SARAH A LONG/Primary Examiner, Art Unit 3771