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 .
Response to Arguments
The previous objection of claims 1 and 37 due to minor informalities has been withdrawn in light of applicant’s amendments made 7/07/2026.
The previous rejection of claim(s) 3, 11-13, 18 and 26-28 over 35 U.S.C. 112(b) as being indefinite has been overcome in light of the amendments made to claim(s) 1, 11, 13 and 18 on 7/07/2026.
The rejection of claims 1, 10-13, 18, 26-28, 31, 37 and 41 under 35 U.S.C. 102(a)(1) as being anticipated by Nagel (US 2,400,251) has been withdrawn in light of applicant’s amendment made 7/07/2026. Specifically, Nagel does not teach wherein the quick release coupling is a luer slip coupling, a luer lock coupling or a bayonet coupling.
Applicant’s arguments with respect to claims 1, 10-13, 18, 26-32, 37 and 41 have been considered but are moot because the new ground of rejection does not rely on any reference in the prior art rejection of record for any teaching or matter specifically challenged in the argument. However, as discussed below, the newly added reference Werschmidt et al. (US 5,620,427) teaches said limitation.
Claim Objections
Claim 26 is objected to because of the following informalities: Claim 26 recites “the quick release coupling” in lines 1-2 which should read “the second quick release coupling”. Appropriate correction is required.
Claim 32 is objected to because of the following informalities: Claim 32 recites “the apparatus” in line 2 which should read “the handheld gynecological apparatus” for consistency purposes. 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 engaging portion in claims and 32 and a vacuum generating mechanism in claims 1 and 31-32.
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.
Claim(s) 1, 10-13, 18, 26-28, 31, 37 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nagel (US 2,400,251) in view of Werschmidt et al. (US 5,620,427).
Regarding claim 1, Nagel discloses a handheld gynecological apparatus for cervix handling (Fig. 1), comprising: a body member (handle 48) having a proximal end and a distal end (Fig. 1); a rod member (elbow 50) having a proximal end and a distal end (Fig. 1), the rod member (50) defining a lumen (bore 52) and being configured to be fluidly connected to the distal end of the body member (at threaded bore 62; Figs. 1, 4); a suction head (cervical cup 14 as suction is applied via adaptor 54 which may go through 14 when 36 is removed; Fig. 3; column 2, lines 22-39) having an engaging portion (interpreted under 112(f) as a closed loop edge ([0246]) and Nagel discloses a distal closed loop edge 28) configured to engage at least a portion of a cervix of a patient (Fig. 1), the suction head being fluidly connected to the distal end of the rod member (50) and having a cross-section that is larger than a cross-section of the rod member (Figs. 1, 3); and a vacuum generating mechanism (interpreted under 112(f) as a vacuum pump and equivalents thereof and Nagel discloses a suction apparatus, which is equivalent structure to a vacuum pump; column 2, lines 35-39) configured to generate a vacuum within at least a portion of the gynecological apparatus, wherein a first member (rod) and at least one second member (body member or suction head) of the gynecological apparatus are connectable to each other by a quick release coupling (threaded connection between 14 and 50 or threaded connection between 50 and 48) configured for manually coupling and uncoupling the first member and the at least one second member to each other (as threads may be screwed into or out of one another), and wherein the first member is the rod member (50) and the at least one second member is one of the body member (48) and the suction head (14), and wherein the quick release coupling has an engaging section (proximal end of male portion of threaded section) configured to abut at least one stop surface (proximal end of female portion of threaded section) to limit rotation of the first member and/or the at least one second member relative to each other as the first member and the at least one second member are being coupled with each other (Figs. 1, 3-4).
Nagel fails to disclose wherein the quick release coupling is a luer slip coupling, a luer lock coupling or a bayonet coupling, and wherein the quick release coupling comprises a first tapered section arranged on the first member and a second tapered section arranged on the at least one second member, wherein the first tapered section and the second tapered section are mated to each other such that the first tapered section and the second tapered section can be pressed together to couple the first member and the at least one second member to each other, and wherein the luer lock coupling additionally comprises at least one threaded section arranged on the first or the at least one second member and at least one counter element arranged on the other of the first and the at least one second member, the at least one counter element being configured to be screwed into the at least one threaded section to couple the first member and the at least one second member to each other.
However, Werschmidt teaches a quick release coupling (Fig. 2) for a medical device for attaching a fluid supply line (column 4, lines 49-51) configured for manually coupling and uncoupling a first member (luer component 70) and at least one second member (hub 24 and luer component 26) to each other, wherein the quick release coupling is a luer lock coupling (luer-lock connector 20), wherein the quick release coupling has an engaging section (proximal end face of 70 near 76 in Fig. 2) configured to abut at least one stop surface (exterior step 86; Figs. 2; 8a) to limit rotation of the first member and/or the at least one second member relative to each other as the first member and the at least one second member are being coupled with each other (Fig. 2), wherein the quick release coupling comprises a first tapered section (tapered wall of inner lumen 78; Fig. 2; column 6, lines 4-7) arranged on the first member (72) and a second tapered section (tapered nose 30) arranged on the at least one second member (28), wherein the first tapered section and the second tapered section are mated to each other such that the first tapered section and the second tapered section can be pressed together to couple the first member and the at least one second member to each other (Fig. 2), and wherein the luer lock coupling additionally comprises at least one threaded section (internal threads 48) arranged on the first or the at least one second member (on hub 24 of 28) and at least one counter element (external thread segments 76) arranged on the other of the first (on 72) and the at least one second member, the at least one counter element (76) being configured to be screwed into the at least one threaded section (48) to couple the first member and the at least one second member to each other (Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute for the quick release coupling of Nagel the luer lock coupling quick release coupling taught by Werschmidt because the substitution of one known element for another would have yielded the predictable result of quickly releasing and coupling the first and at least one second members together.
Regarding claim 10, Nagel modified discloses wherein the quick release coupling is configured to provide a fluid-tight seal between the first member and the at least one second member (the tapered nose 30 and inner lumen 78 are forced into frictional fluid-sealing engagement by rotation of the hub 24; column 6, lines 15-18 of Werschmidt).
Regarding claim 11, Nagel modified discloses a least one alignment mark (protrusions of the male threaded coupling elements 76 and recesses of the female threaded coupling elements 48 of Werschmidt) configured to indicate a starting orientation and/or a final orientation of at least one of the components of the handheld gynecological apparatus relative to another component of the handheld gynecological apparatus prior to and/or upon completion of the coupling of the first member with the at least one second member via the quick release coupling (as the user sees the threading and aligns them together to screw the pieces together).
Regarding claim 12, Nagel modified discloses wherein at least one first alignment mark is provided on the first member (72 includes external thread 76 of Werschmidt) and at least one second alignment mark is provided on the at least one second member (24 includes internal threads 48 of Werschmidt).
Regarding claim 13, Nagel modified discloses wherein the at least one first alignment mark is aligned with the at least one second alignment mark in a starting orientation and/or a final orientation (as the internal and external threads of Werschmidt are aligned) of at least one of the components of the handheld gynecological apparatus relative to another component of the handheld gynecological apparatus prior to and/or upon completion of the coupling of the first member with the at least one second member via the quick release coupling (Fig. 2 of Werschmidt), wherein the at least one first and/or second alignment mark is printed onto the first and second member, respectively, and/or wherein the at least one first and/or second alignment mark is formed as a recess or projection (recesses in the internal threads 48 and projections in the external threads 76 of Werschmidt).
Regarding claim 18, Nagel modified discloses the invention as claimed above, and Nagel further discloses wherein the first member (50) is connectable to a third member (other of 14 or 48) of the gynecological apparatus by a second quick release coupling (threaded coupling) configured for manually coupling and uncoupling the first member and the third member to each other (Figs. 1, 3-4), wherein the third member is the other one of the body member (48) and the suction head (14), and wherein the second quick release coupling is a luer slip coupling, a luer lock coupling, a bayonet coupling, a threaded coupling (threaded coupling; Figs. 1, 3-4) or a snap fit coupling, and wherein the luer slip coupling and the luer lock coupling each comprise a first tapered section arranged on the first member and a second tapered section arranged on the third member, wherein the first tapered section and the second tapered section are mated to each other such that the first tapered section and the second tapered section can be pressed together to couple the first member and the third member to each other, and wherein the luer lock coupling additionally comprises at least one threaded section arranged on the first or the third member and at least one counter element arranged on the other of the first and the third member, the at least one counter element being configured to screw into the at least one threaded section to couple the first member and the third member to each other (because the threaded coupling is choses, additional limitations to the luer slip coupling and the luer lock coupling are moot), and/or wherein the second quick release coupling has at least one protrusion (shank 60) formed on the first member (50) or the third member (shank 56) and the other of the first member and the third member has at least one engaging section (bore 62 or bore 58), and wherein the protrusion and the engaging section are configured such that the protrusion can pass the engaging section as the first member and the third member are being connected and such that the protrusion can engage the engaging section after the protrusion has passed the engaging section to lock the first member and third member in position relative to each other (by threading), and wherein the engaging section comprises at least one opening (bore) through which the protrusion (shank) can pass as the first member and the third member are being connected, and/or wherein the first member and/or the third member is/are configured to be rotated relative to each other once the protrusion has passed the respective engaging section such that the protrusion can engage the engaging section to lock the first member and the third member in position relative to each other (by the threaded sections being screwed together).
Regarding claim 26, Nagel modified discloses the invention as claimed above, and Nagel further discloses wherein the second quick release coupling has at least one stop surface (proximal end of thread bores) configured to limit rotation of the first member and/or the third member relative to each other as the first member and the third member are being coupled with each other (as the threaded shanks are limited by the threaded bores).
Regarding claim 27, Nagel modified discloses a plurality of protrusions (external thread segments 76 of Werschmidt), wherein at least two protrusions of the plurality of protrusions are arranged diametrically opposite from each other (Fig. 2 of Werschmidt).
Regarding claim 28, Nagel modified discloses the invention as claimed above, and Nagel further discloses wherein the second quick release coupling is configured to provide a fluid-tight seal between the first member and the third member (because the device is used for suctioning purposes, the threaded sections must be sealed in order for the device to maintain a vacuum).
Regarding claim 31, Nagel modified discloses the invention as claimed above, and Nagel further discloses wherein the vacuum generating mechanism is at least partially integrated within the body member (via adaptor 54; column 2, lines 35-39).
Regarding claim 37, Nagel modified discloses the invention as claimed above, and Nagel further discloses wherein the rod member (50) is substantially rigid (as 50 maintains a bent shape), and wherein a longitudinal axis of the rod member (50) and a longitudinal axis of the body member (48) coincide with each other (as the two provide a fluid path to one another; Figs. 1, 3-4), and wherein the rod member and/or the body member are substantially hollow cylindrical (Figs. 1, 3-4), and/or wherein the gynecological apparatus has a total length extending in the direction of the longitudinal axis of the rod member and wherein the total length is 60 cm or less.
Regarding claim 41, Nagel modified discloses the invention as claimed above, and Nagel further discloses wherein the suction head (14) defines a suction chamber (within cup 14) fluidly connected to the lumen of the rod member (Fig. 3), the suction chamber being delimited by a concave wall (concavity 20), with respect to a distal direction (Fig. 3), and/or wherein an edge of the engaging portion of the suction head has a C shape, and wherein the edge forms a closed loop (Figs. 1-3) comprising at least a first edge portion (at posterior wall 28) and a second edge portion (at anterior wall 30), and wherein the first edge portion and the second edge portion do not lie in a common plane (Fig. 3).
Claim(s) 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nagel (US 2,400,251) in view of Werschmidt et al. (US 5,620,427), as applied to claim 1 above, and further in view of Finci et al. (US 2017/0325843 A1).
Regarding claims 29-30, Nagel modified discloses the invention as claimed above, and further discloses a vacuum generating mechanism (suction apparatus; column 2, lines 35-39) but fails to explicitly disclose wherein the vacuum generating mechanism is a vacuum pump driven by a drive mechanism and/or is a pneumatically driven, electrically driven or manually driven vacuum pump.
However, Finci teaches a handheld gynecological apparatus (apparatus 2; Fig. 1) for cervix handling (abstract), comprising: a rod member (hollow rod 20), a suction head (suction chamber 10) having an engaging portion (within 10) configured to engage at least a portion of a cervix of a patient (abstract), the suction head being fluidly connected to the distal end of the rod member (Fig. 2) and having a cross-section that is larger than a cross-section of the rod member (Figs. 1-2); and a vacuum generating mechanism (pump; [0059]) configured to generate a vacuum within at least a portion of the gynecological apparatus ([0059]), wherein the vacuum generating mechanism is a vacuum pump (pump) driven by a drive mechanism (reciprocal sliding manually or via an electrical motor; [059]) and/or is a pneumatically driven, electrically driven or manually driven vacuum pump (as the pump may be manually driven or electrically driven via a motor; [0059]).
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 vacuum generating mechanism of modified Nagel to be a vacuum pump driven by a drive mechanism that is electrically driven or manually driven as taught by Finci. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded the predictable result of providing suction to through the apparatus.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nagel (US 2,400,251) in view of Werschmidt et al. (US 5,620,427), as applied to claim 1 above, and further in view of Essig et al. (US 5,279,548) in view of Khurana et al. (US 2017/0196593 A1) in view of Newell et al. (US 2022/0241139 A1).
Regarding claim 32, Nagel modified fails to disclose at least one filter arranged within the apparatus between the vacuum generating mechanism and the engaging portion of the suction head, wherein the at least filter is arranged in the rod member, the suction head, or the body member and the at least one filter is anti-bacterial and/or hydrophobic, and further comprising a plurality of filters, wherein a first filter of the plurality of filters is arranged in the rod member and a second filter of the plurality of filters is arranged in the body member.
However, Essig teaches a handheld apparatus (surgical instrument 10; Fig. 1) comprising a rod member (inner tubular member 14) and a suction head (membrane 26 in which tissue may be captured by suctioning from the proximal end of the membrane; column 2, lines 15-20) and a filter (screen or filter) may be arranged within the apparatus between a vacuum generating mechanism (suction source) and the suction head (26), wherein the filter is arranged in the rod member (as the screen or filter may be provided in the upper or distal end of inner tubular member 14; column 4, lines 20-22) for the purpose of preventing passage of any tissue segments of significant size (column 4, lines 18-22).
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 rod member of modified Nagel to include a filter as taught by Essig in order to prevent passage of any tissue segments of significant size.
Khurana teaches a handheld gynecological apparatus (Fig. 12) with a filter (filter 444; Figs. 15-16) arranged in a body member (reservoir assembly 440 of handle 430; Fig. 12) for the purpose of stopping fluid from entering the reusable portion of the medical device.
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 body member of modified Nagel to include a filter as taught by Khurana in order to make a portion of the body member reusable and to stop fluid from entering the reusable portion of the body member.
Modified Nagel fails to disclose the filters being anti-bacterial and/or hydrophobic.
However, Newell teaches hydrophobic filters may be used to block contaminates from reaching a vacuum pump ([0024]).
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 filters of modified Nagel to be hydrophobic as taught by Newell, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
