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 .
DETAILED ACTION
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-15, drawn to a male incontinence threshold device, classified in A61F2250/007.
II. Claims 16-20, drawn to a method of using/installing a male incontinence device, classified in A61F2/0054.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the Invention I is present as a clamping device with O-rings for creating a clamping pressure. The Invention I being a clamp could be used in materially different ways such as for clamping for a tourniquet of a finger by applying a circumference force therein, or could be used paper bag clip by clamping paper bag ends together. The overall construction of claims 1-15 is a clamp that could be used for a wide variety of uses.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
there is a search and examination burden as the inventions have acquired a separate status in the art in view of their material distinctness and separate classifications.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Francis Tinny, attorney of record, on 12/19/2025 a provisional election was made without traverse to prosecute the invention of Invention I, claims 1-15. Affirmation of this election must be made by applicant in replying to this Office action. Claims 16-20 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function.
Such claim limitation(s) is/are: “means of convolutions” in claim 1 (this limitation appears to be using “means” a description of function wherein the adjustment experiences convolutions, which is assumed to be turning the adjustment nut).
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Drawings
The drawings are objected to because the use of text should be removed from the drawings, any text in drawings should instead be present within the specification describing the drawings. 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.
Figure 6 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated (Bottom half of Figure 6 is labelled “Typical Clamp” thus appearing to be prior art). See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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.
Specification
The disclosure is objected to because of the following informalities:
Remove the header of “CLAIMS” at the bottom of the specification
Please update the formatting for readability in regards to proper paragraph indentation use
Appropriate correction is required.
The spacing of the lines of the specification is such as to make reading difficult. New application papers with lines 1 1/2 or double spaced (see 37 CFR 1.52(b)(2)) on good quality paper are required.
Claim Objections
Claim 1 objected to because of the following informalities: “O-ring groves” should be “O-ring grooves”. Appropriate correction is required.
Claim 9 objected to because of the following informalities: “moves away from to the upper member” should be “moves away from the upper member”. Appropriate correction is required.
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 1-15 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “O-rings which elastically hold the upper and lower members in place”, “O-ring groves located in the upper and lower members to hold the O-rings in place”, and “an O-ring which is stretched over an O-ring groove in the adjustment nut to hold the adjustment nut in place”, wherein the second recitation of “an O-ring” and “an O-ring groove” causes the claim to become indefinite as this second recitation makes it unclear if these are different or the same O-rings and O-ring grooves previously recited or a new structure.
Claim 1 recites “an adjustment nut which is positioned in and rotates in the upper member and wherein the threaded rod is threaded through”, and then further recites “an adjustment nut is turned by means of convolutions around the circumference of the adjustment nut used to turn the adjustment nut relative to the threaded rod”. This second recitation is indefinite for more than one reason. Firstly, “an adjustment nut” is recited again wherein it is unclear if this is a new adjustment nut or the same previously recited adjustment nut. Secondly, the recitation that the adjustment nut is turning around a circumference of itself which is used to turn the adjustment nut is confusing as an adjustment nut cannot act on itself nor can it surround itself, thus Examiner is not certain what is being claimed herein. Examiner will assume that the second limitation should be read as simply the adjustment nut may be turned around the threaded rod, else Examiner is not sure what the limitation is meaning.
Claim 1 recites “a threaded rod in which the pressure disc is molded onto the end of the threaded rod” and then “a button snapped onto the end of the threaded rod which prevents the button from separating from the threaded rod and helps to pull the upper and lower members apart”, wherein each of these recites “the end of the threaded rod” wherein it is unclear if this is referring to the same end of the threaded rod of different ends as it unclear how same structures could be at the same point therein. There is also insufficient antecedent basis for this limitation of “the end of the threaded rod” in the claim.
Claim 1 recites the limitation "the right and left sides of the lower member" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation " the left and right vertical outside surfaces of the upper member". There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites “the catches” in line 12 (and further use of plural catches through the claim). There is insufficient antecedent basis for this limitation in the claim, as the previous line does not sufficiently provide for their being plural catches as there could be a singular catch structure that is on right and left sides at once.
Claim 1 recites the limitation "the right and left gaps" in the last line. There is insufficient antecedent basis for this limitation in the claim. It is unclear to what the gaps could be referring to as well regarding claim mapping, Examiner will interpret this to be gaps formed by the upper and lower members.
Claim 1 recites the limitation "channels located in the lower member" and “channels in the upper member”, wherein as written herein causes lack of clarity on if these are the same channel structure extending between the lower and upper members or wholly separate different channel structures.
Claim 2 recites the limitation "the force and pressure” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the markings on the scales" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Firstly, there is no previously recited “markings” and secondly claim 1 provides a singular “scale” and not a plural scale.
Claim 3 recites the limitation "the distance" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "an inserted penis" in lines 1. Claim 1 also recites “to enclose a penis of a user”, wherein it is unclear if this is a different or same penis in claim 4 in comparison to the one in claim 1.
Claim 4 recites the limitation "the pressure" and “the force” (unclear if related to “a sum of forces”). There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the left and right gaps" (see 112b above where claim 1 has “the left and right gaps” as well, but Examiner is still unclear what they are). There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 5, the term “gentle pressure” in claim 5 is a relative term which renders the claim indefinite. The term “gentle” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus claim 5 is indefinite as the pressure in the functional language is rendered indefinite by “gentle”.
Claim 5 recites the limitation "the thumb and forefinger" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the center of" and “the same plane”. There is insufficient antecedent basis for these limitations in the claim.
Claim 8 recites the limitation "the nut”. There is insufficient antecedent basis for these limitations in the claim (unclear if referring to “the adjustment nut” in claim 1).
Claim 9 recites the limitation "the nut”. There is insufficient antecedent basis for these limitations in the claim (unclear if referring to “the adjustment nut” in claim 1).
Claim 10 recites the limitation "the top end of the threaded rod”. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation “latches located in the upper member engage catches attached to the lower member”. It is unclear if these are the same latches and catches presented within claim 1 or different new latches and catches.
Claim 11 recites the limitation “the hold-open channel”. There is insufficient antecedent basis for this limitation in the claim. Examiner is unsure which channel in claim 1 this could be referring.
Claim 12 recites the limitation " the inside surface of the lower member” and “the center of the lower member”. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation “the pressure area”. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation “the diameter of the pressure disc”. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 14, the term “sufficient length” in claim 14 is a relative term which renders the claim indefinite. The term “sufficient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The length being restricted is completely indefinite. Furthermore, claim 14’s whole recitation of: “wherein the diameter of the pressure disc and depth of the lower member results in a restriction of sufficient length to prevent soft interior penis material from flowing upstream when the device is being pulled off” is thus completely indefinite as the structure of the diameter of the pressure disc and depth of the lower member is indefinite which is essentially the entire ultimate structure of the claim. Examiner further is completely uncertain on what structure the functional language is providing as the instant specification does not provide further clarification on what diameter or depth is needed to provide the functional language herein. For examining purposes, claim 14 will be met as rejected through the presence of the pressure disc and lower member likely implicitly being capable of this function.
Claims 6-7, 15 are rejected as being dependent on rejected claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 12-13 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 12 recites “a radiused concave "V" shape in the inside surface of the lower member allows the penis inserted between the lower and upper members to remain in the center of the lower member as pressure is applied”, wherein the present language appears to be positively reciting the penis as being inserted within the invention. Thus, encompassing a human organism.
Claim 13 recites “the pressure area of the pressure disc fully engages the penis”, wherein this uses language positively claiming the penis as the invention appears to be directly engaging the human body part. Thus, encompassing a human organism.
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) 1-6 and 8-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jung (US 20220346925 A1) in view of Hale (US 5336157 A) in view of Bialick (US 3203421 A) in view of Curhan (US 20190145455 A1) in view of Pacey (US 20190314129 A1).
Regarding claim 1, Jung discloses a male urinary incontinence threshold device (title) (Fig. 3-6) comprising:
an upper member 110/330/332 (Fig. 3-6);
a lower member 120 (Fig. 3-6) having a curved surface 200 wherein the upper 110/330/332 and lower 120 members are dimensioned to enclose a penis of a user (Fig. 3-6);
vertical guides 331 attached to the upper member 110/330/110 which allow the upper 110/330/332 and lower 120 member to be oriented with respect to each other (Fig. 4-6, see wherein the two vertical guides 331 extend through the channels 322 in the lower member);
channels 322 located in the lower member 120 (Fig. 4-5, [0102]) which engage the vertical guides 331 and allow the upper 110/330/332 and lower 120 members to move up and down vertically parallel to each other (Fig. 4-5, wherein the vertical guides 331 extend through the channel 322);
a catch 321 on the right and left sides of the lower member 120 (Fig. 4-5, there are catches 321 that are positioned on the left and right sides of the lower member 120 [0102]);
channels in the upper member 110/330/332 to allow the catches 321 to slide vertically (Fig. 4-5, there are channels formed by the space between pieces 330 and 110 of the upper member, that enable the catches 321 with the lower piece as a whole to slide vertically in relation to the upper member 110/330/332 when in an adjustable mode [0102]);
latches 312 in the upper member 110/330/332 which engages with the ends of the right and left catches 321 to maintain the upper 110/330/332 and lower 120 members in a hold-open position (Fig. 4-5, and [0097]);
diagonal corners 310 located in the upper 110/330/332 and lower 120 members which when diagonally squeezed allow the left and right latches 312 to be disengaged from the catches 321 (Fig. 4-5, wherein the pressing buttons 310 are diagonal in shape at corners of the device therein wherein when pressed disengages the latches from the catches for movement therein [0097-0102]).
However, Jung does not disclose:
O-rings which elastically hold the upper and lower members in place;
O-ring grooves located in the upper and lower members to hold the O-rings in place;
a pressure disc;
a threaded rod in which the pressure disc is molded onto the end of the threaded rod;
a button snapped onto the end of the threaded rod which prevents the button from separating from the threaded rod and helps to pull the upper and lower members apart;
an adjustment nut which is positioned in and rotates in the upper member and wherein the threaded rod is threaded through;
an adjustment nut is turned by means of convolutions around the circumference of the adjustment nut used to turn the adjustment nut relative to the threaded rod;
an O-ring which is stretched over an O-ring groove in the adjustment nut to hold the adjustment nut in place;
a scale molded onto both the left and right vertical outside surfaces of the upper member which indicates the distance opening of the left and right gaps, respectively.
However, Hale teaches an analogous incontinence clamp (title) with analogous upper and lower members 7 (Fig. 2-3), wherein Hale further comprises O-rings 8 which elastically hold the upper and lower members 7 in place (Fig. 2-3 and Col. 2 lines 15-33, wherein there are circular elastic bands 8, thus being “O-rings” that elastically holds the upper and lower members 7 together to create clamping force), O-ring grooves 3 located in the upper and lower members 7 to hold the O-rings 8 in place (Col. 2 lines 27-31, notches 3 being provided on both upper and lower members as seen in Fig. 2-3, wherein ref. 5 should be the notches, for placement of O-rings).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided O-rings and O-ring grooves to the upper and lower members of Jung in order to enable a consistent clamping pressure to be formed on the urethra (Hale Col. 2 lines 30-34).
However, Jung in view of Hale does not disclose:
a pressure disc;
a threaded rod in which the pressure disc is molded onto the end of the threaded rod;
a button snapped onto the end of the threaded rod which prevents the button from separating from the threaded rod and helps to pull the upper and lower members apart;
an adjustment nut which is positioned in and rotates in the upper member and wherein the threaded rod is threaded through;
an adjustment nut is turned by means of convolutions around the circumference of the adjustment nut used to turn the adjustment nut relative to the threaded rod;
an O-ring which is stretched over an O-ring groove in the adjustment nut to hold the adjustment nut in place;
a scale molded onto both the left and right vertical outside surfaces of the upper member which indicates the distance opening of the left and right gaps, respectively.
However, Bialick teaches an analogous incontinence clamp device (title) (Fig. 1-7) having an analogous upper member 11 (Fig. 1) and an analogous lower member 12 (Fig. 1), wherein the clamp comprises:
a pressure disc 23 (Fig. 1 and Col. 2 lines 34-51, the element 23 being a pressure device and being disc like in shape);
a threaded rod 28 in which the pressure disc 23 is molded onto the end of the threaded rod 28 (Fig. 3 and Col. 2 lines 34-51, the end of the threaded rod 28 is molded with pressure disc 23);
a button 31 snapped onto the end of the threaded rod 28 which prevents the button 31 from separating from the threaded rod 28 and helps to pull the upper and lower members 11/12 apart (Fig. 1-3 and Col. 2 lines 34-69, wherein the upper end of the threaded rod 28 mates into jack screw/adjustment nut 27, which then has a further upper end provided with a “snapped” on button 31, thus the button 31 being snapped onto the end of the threaded rod via intervening structures therein, the button capable of being pulled to provide separation force between the upper and lower members when they are not locked together);
an adjustment nut 27 which is positioned in and rotates in the upper member 11 and wherein the threaded rod 29 is threaded through (Fig. 3 and Col. 2 lines 34-51);
an adjustment nut 27 is turned by means of convolutions around the circumference of the adjustment nut 27 used to turn the adjustment nut 27 relative to the threaded rod 28 (see 112b above, wherein as stated in Col. 2 lines 34-51 the adjustment nut 27 rotates around the threaded rod 28, and nut 27 being in threaded communication with threaded rod 28 is further capable of being turned relative each other).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the structures of Bialick in its upper member 11 to the analogous upper member 110/330/332 of Jung in order to provide adjustable pressure exerting means to the analogous incontinence clamping device for quick adjustment of pressure that is also precise and easily used (Bialick Col. 1 lines 30-52).
Jung in view of Hale and Bialick does not disclose an O-ring which is stretched over an O-ring groove in the adjustment nut to hold the adjustment nut in place;
a scale molded onto both the left and right vertical outside surfaces of the upper member which indicates the distance opening of the left and right gaps, respectively.
However, Curhan teaches an analogous nut/fastener 200 (Fig. 2A-2C) wherein the nut 200 comprises an O-ring 202 (Fig. 2b and [0072]) which is stretched over an O-ring groove 208 (Fig. 2C and [0079}) in the adjustment nut 200 to hold the adjustment nut in place ([0070-0072] the sealing ring 202 seals the opening of the nut/fastener at which it mates thus also further holding the fastener in place).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the adjustment nut 27 of Bialick as combined with an O-ring which is stretched over an O-ring groove in the adjustment nut to hold the adjustment nut in place as taught by Curhan in order to seal foreign material from getting into the clamp (Curhan [0070-0072]).
Jung in view of Hale and Bialick and Curhan does not disclose a scale molded onto both the left and right vertical outside surfaces of the upper member which indicates the distance opening of the left and right gaps, respectively.
However, Pacey teaches an analogous urinary clamp/sphincter (Fig. 1-23) comprising an analogous upper member 12 (Fig. 2) and an analogous lower member 14 (Fig. 2) for clamping around a penis (Fig. 1), wherein the upper member 12 further includes a strap 16 which analogously enables the clamping and closure of space between the upper and lower members (Fig. 1-23), wherein the upper member 12 has scale 65 molded onto its outside surface therein and the strap 16 has scales 63 molded on its outside surface therein, wherein the markings 63 on the strap may extend on both the left and right sides of the invention as so does the strap 16 extend vertically on both the left and right sides as seen in Fig. 1-2, thus providing a scale 63/65 molded onto both the left and right vertical outside surfaces of the upper member 12/16 which indicates the distance opening of the left and right gaps (see [0073-0074] the indicia indicate how much pressure is applied which implicitly correlates with the distance thus between the upper and lower members).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided a scale molded onto both the left and right vertical outside surfaces of the upper member which indicates the distance opening of the left and right gaps, respectively as taught by Pacey to the invention of Jung as combined in order to enable the user to understand the pressure being applied to the user (Pacey [0073-0074]).
Regarding claim 2, Jung in view of Hale and Bialick and Curhan and Pacey disclose the invention of claim 1 above.
Jung in view of Hale and Bialick and Curhan and Pacey as combined further teaches wherein the scale 63/65 (of Pacey) on each side of the upper member 110/330/332 (of Jung as combined) which shows how far the upper 110/330/332 and lower 120 members (of Jung) are separated (see combination in claim 1 above, wherein the markings/scale 63/65 of Pacey enables the user to understand the pressure being applied by the members 12/14 being correlated to the distance between the two when placed around the member), is equal to how much the O-rings (of Hale) are stretched which can be correlated with the force and pressure being applied to the penis inserted into the device (see combination with Hale Col. 2 lines26-34 above, wherein invention has O-rings around the upper and lower members for applying force and pressure, the markings from Pacey which provide the user with understanding of consistent pressure applied from the device, see Pacey [0074], may be thus correlated between each other as combined) (Examiner notes that there does not appear to be any implicit structure within this claim for the device and is purely functional language that Examiner has described as being present via the currently presented combination of prior art).
Regarding claim 3, Jung in view of Hale and Bialick and Curhan and Pacey disclose the invention of claim 1 above.
Jung in view of Hale and Bialick and Curhan and Pacey is silent on the distance between the markings on the scales is 0.100 inches.
However, Pacey further teaches the distance between the markings 63 on the scales 63/65 is 1 centimeter (Pacey [0073], being 0.39 inches).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided a distance of 0.100 inches as Pacey teaches having a spacing between scale markings of 0.39 inches (wherein this spacing size is very close to the claimed size) and it has been held as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05., thus choosing 0.100 inches would be obvious to one of ordinary skill in the art based on Pacey.
Regarding claim 4, Jung in view of Hale and Bialick and Curhan and Pacey disclose the invention of claim 1 above.
Jung in view of Hale and Bialick and Curhan and Pacey discloses wherein the pressure being applied to an inserted penis is equal to a sum of forces generated by the O-rings 8 (see Hale above for O-rings used to add pressure) used to hold the upper and lower members in place divided by the projected area of the pressure disc 23 (see Bialick above) where the force is directly proportional to the average of the left and right gaps (the present claim is further purely functional language wherein the pressure applied in the presented combined device may be of the combined factors of the O-rings 8 of Hale and the pressure disc 23 of Bialick, and wherein based on the instant specification the “gaps” refer simply to a distance between the upper and lower members of the clamp, all of these apply pressure as combined, there is no apparent structure actually present in the claim).
Regarding claim 5, Jung in view of Hale and Bialick and Curhan and Pacey disclose the invention of claim 1 above.
Jung as combined discloses that simulates that when gentle pressure is applied to the penis of a user between the thumb and forefinger, urine flow is stopped (Jung [0110] pressure is applied in the space 130 as shown in Fig. 3 which would be analogous to the pressure applied by a finger and thumb to stop urine flow, see [0002]).
Regarding claim 6, Jung in view of Hale and Bialick and Curhan and Pacey disclose the invention of claim 1 above.
Jung as combined is silent on being formed of a rigid polymer.
However, Bialick teaches being formed of a rigid polymer (Col. 3 lines 11-20, stiff plastic material for the upper and lower members 11/12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have formed the upper and lower members of Jung of a rigid polymer as taught by Bialick in order to ensure little pressure is translated to the components of the invention and less flexing (Bialick Col. 3 lines 11-20), thus the “device is formed of a rigid polymer”).
Regarding claim 8, Jung in view of Hale and Bialick and Curhan and Pacey disclose the invention of claim 1 above.
Bialick further teaches wherein the threaded rod 28 that passes through the nut 27 is constrained to rotate perpendicular to, at the center of, and in the same plane as the upper member 11 (Bialick Fig. 3 shows the threaded rod being constrained perpendicular, at the center of, and in the same place as the upper member 11).
Regarding claim 9, Jung in view of Hale and Bialick and Curhan and Pacey disclose the invention of claim 1 above.
Bialick further teaches wherein when the nut 27 is turned clockwise relative to the button 31 the pressure disc 23 moves away from the upper member 11 (Fig. 3, nut 27 may be turned clockwise relative to the button 31 such that then the nut 27 would extend further downward via the default clockwise turning of a thread forming a downward “tightening” action, thus moving the pressure disc 23 away from the upper member 11).
Regarding claim 10, Jung in view of Hale and Bialick and Curhan and Pacey disclose the invention of claim 1 above.
Bialick further teaches wherein the button 31 located at the top end of the threaded rod 28 is used to pull the upper 11 and lower 12 members apart (Fig. 1-3, when upper and lower members 11/12 are unlocked, the button 31 is capable of being pulled such that members 11 and 12 would pull apart).
Regarding claim 11, Jung in view of Hale and Bialick and Curhan and Pacey disclose the invention of claim 1 above.
Jung further discloses wherein when the upper and lower members 110/120 are separated by a predetermined distance 130 (Fig. 3),
latches 312 (Fig. 4) located in the upper member 110 engage catches 321 attached to the lower member 120 that slide within the hold-open channel (Fig. 4-5, there are channels formed by the space between pieces 330 and 110 of the upper member, that enable the catches 321 with the lower piece as a whole to slide vertically in relation to the upper member 110/330/332 when in an adjustable mode [0102]) to enable the device to assume a hold-open position (Fig. 4-5, and [0097]) and subsequently the latches 312 can be released by alternately applying a diagonal force to the upper right and lower left corners and the upper left and lower right corners of the device (Fig. 4-5, wherein the pressing buttons 310 are diagonal in shape at corners of the device therein wherein when pressed disengages the latches from the catches for movement therein [0097-0102], wherein this may be performed by applying a diagonal force on one of the buttons and on the side at a lower opposite corner when using fingers to form force therein).
Regarding claim 12, Jung in view of Hale and Bialick and Curhan and Pacey disclose the invention of claim 1 above.
Jung further discloses wherein a radiused concave "V" shape 200 (Fig. 5, this can be called an upside-down V shape, wherein the inner side of the curved shape is concave) in the inside surface of the lower member 120 (Fig. 5) allows the penis inserted between the lower 120 and upper 110 members to remain in the center of the lower member 120 as pressure is applied (Fig. 5, see wherein this applies a strong central pressure at a center therein thus keeping the penis in the center).
Regarding claim 13, Jung in view of Hale and Bialick and Curhan and Pacey disclose the invention of claim 1 above.
Bialick further teaches wherein the pressure area of the pressure disc 23 fully engages the penis (Fig. 1).
Regarding claim 14, Jung in view of Hale and Bialick and Curhan and Pacey disclose the invention of claim 1 above.
Bialick further teaches wherein the diameter of the pressure disc 23 and depth of the lower member 12/21 results in a restriction of sufficient length to prevent soft interior penis material from flowing upstream when the device is being pulled off (see 112b above) (Bialick Fig. 1-3, the pressure disc 23 and lower member 12/21 is capable of restricting the penis as seen in Fig. 1, and based on 112b would be of length relative to some size of penis to prevent soft penis material from flowing upstream in order to ensure the clamp functions as desired).
Regarding claim 15, Jung in view of Hale and Bialick and Curhan and Pacey disclose the invention of claim 1 above.
Bialick further teaches wherein the end of the threaded rod 28 is molded onto the pressure disc 23 prevents the pressure disc 23 from rotating relative to the threaded rod 23 (Fig. 3 and Col. 2 lines 34-51, pressure element 23 is attached to the threaded rod 23, wherein the element 23 is also molded to pins 25, thus element 23 cannot rotate).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jung (US 20220346925 A1) in view of Hale (US 5336157 A) in view of Bialick (US 3203421 A) in view of Curhan (US 20190145455 A1) in view of Pacey (US 20190314129 A1), in further view of Chadwick (US 5571125 A).
Regarding claim 7, Jung in view of Hale and Bialick and Curhan and Pacey disclose the invention of claim 6 above.
Jung as combined is silent on wherein the rigid polymer is polypropylene.
However, Chadwick teaches an analogous urinary incontinence clamp 10 (title, abstract, Fig. 1) wherein almost all of the clamp is formed of polypropylene (Col. 4 lines 29-32).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have chosen a rigid polymer of being polypropylene for Jung as combined as taught by Chadwick in order to provide lower manufacturing costs (Chadwick Col. 4 lines 29-32).
Conclusion
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/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786