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 .
Status of Claims
2. Claims 1-19 are pending and currently under consideration for patentability under 37 CFR 1.104.
Information Disclosure Statement
The information disclosure statement filed February 7, 2025, fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. For example, there is no concise explanation of the relevance of CH 396311 or CN 103689822. It has been placed in the application file, but the information referred to therein has not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 5 (“https:// www.amazon.com/Motherlove-Certified-Organic-Cracked-Nursing/dp/B00007CQ726/&tag= diapersnet-20”). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following feature(s) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
A perimeter of the skirt adjacent the tissue contacting surface is shorter than a perimeter of the skirt adjacent the shell (claim 13) has not been shown.
Figures 6K-6L are objected to because the figures appear to be photographs or photocopies of photographs. Examiner notes that photographs or photocopies of photographs are not ordinarily permitted in utility applications unless they are the only practicable medium for illustrating the claimed invention. See MPEP § 608.02 (V). Examiner respectively notes that MPEP § 608.02 (V) states “the photographs must be of sufficient quality so that all details in the photographs are reproducible in the printed patent." Examiner respectively notes the details of the photographs in 6K-6L are unclear due to the quality of the photographs in the printed patent.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
It is noted that while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function (see MPEP 2114). “Apparatus claims cover what a device is, not what a device does” (MPEP 2114(II)). In the instant case, the claims recite intended uses and/or functional language (such as “tissue expanded by a distracting force … the skirt is non-fixedly attached to the skin of the patient and slides laterally outwardly during application of the distracting force” (claim 1), “the skirt increasingly spreads under increasing pressure in the shell” (claim 2) …”to generate a scaffold for grafting materials” (claim 19), etc.). In these instances where the claims recite intended use or functional language, as long as the prior art structure is capable of performing the claimed function(s), it will be considered to read on the claimed function(s).
Claim Interpretation - 35 USC § 112(f)
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.
Claim Objections
Claims 4-5, 10, and 17 are objected to because of the following informalities:
Claim 4, line 3 recites “skin contact surface” and the Examiner suggests --the skin contact surface area-- to clarify the antecedent basis in claim 1, line 3.
Claim 5, line 2 recites “shore AA” and the Examiner suggests --Shore AA--.
Claim 10, line 3 recites “mmHG” and the Examiner suggests --mmHg-- to conform with claim 9 and claim 10, line 2.
Claim 17, line 1 recites “sell” which appears to be a typographical error. Examiner suggests --shell--.
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 5, 7, 9, 13, 15, and 18-19 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.
Claim 5, line 2 recites “in the Shore 00 range less than 10-15 in the shore AA” which is confusing because it is unclear whether “less than 10-15” is referring to the Shore 00 range or the Shore AA. Additionally, it is unclear whether “AA” is a typographical error. Furthermore, it is unclear whether values such as 11-14 are included by the phrase “less than 10-15.” Examiner suggests --less than 10-- or --less than 15--.
Claim 7, lines 1-2 recite “the tissue contact surface area” which lacks antecedent basis. Claim 1 previously recites “a skin contact surface area” (line 2).
Claim 7, lines 1-2 recite “increases the tissue contact surface area by at least a multiple of three” and it is unclear what this increase is relative to. What is the original tissue contact surface area?
Claim 9, line 1 recites “vacuum pressure can be applied” which is confusing because it is unclear whether the claim actually requires this limitation due to the word “can.” Examiner suggests --vacuum pressure is configured to be applied-- to clarify.
Claim 13, lines 1-2 recite “the tissue contacting surface” which lacks antecedent basis. Claim 1 previously recites “a skin contact surface area” (line 2).
Claim 18, lines 1-2 recite “the tissue expander maintains the tissue in an expanded state” which is confusing because this is appears to be a method step. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011). MPEP 2173.05(p)(II). The Examiner suggests --the tissue expander is configured to maintain the tissue in an expanded state--.
Claim 19, lines 1-2 recite “the tissue expander temporarily stretches the tissue” which is confusing because this is appears to be a method step. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011). MPEP 2173.05(p)(II). The Examiner suggests --the tissue expander is configured to temporarily stretch the tissue to generate a scaffold for grafting materials--.
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 1-19 are 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 1, line 3 recites “providing a skin contact surface area against a skin of a patient” which recites a human. The Examiner suggests --providing a skin contact surface configured to be against a skin of a patient--.
Claim 1, lines 5-6 recite “the skirt is non-fixedly attached to the skin of the patient” which recites a human. The Examiner suggests --the skirt is configured to be non-fixedly attached to the skin of the patient--.
Claim 10, lines 1-2 recite “the increased skin contacting surface area reduces the counter pressure on the skin” which recites a human. The Examiner suggests --the increased skin contacting surface area is configured to reduce the counter pressure on the skin--.
Claim 18, lines 1-2 recite “wherein the tissue expander maintains the tissue in an expanded state” which recites a human. The Examiner suggests --wherein the tissue expander is configured to maintain the tissue in an expanded state--.
Claim 19, lines 1-2 recite “wherein the tissue expander temporarily stretches the tissue to generate a scaffold for grafting materials” which recites a human. The Examiner suggests --wherein the tissue expander is configured to temporarily stretch the tissue to generate a scaffold for grafting materials--.
The remaining claims are rejected based on their dependence on a rejected base claim.
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 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.
Claims 1, 4, 6, and 18-19 are rejected under 35 U.S.C. 103 as being obvious over Freyre et al. (2005/0245850).
Regarding claim 1, Freyre discloses a tissue expander (Fig. 1) configured to be worn by a user (see Fig. 1) comprising a shell (dome 12, Fig. 1), the shell having an aperture formed within the shell (aperture between shell 12 and the skin, see Figs. 2-4) to receive tissue expanded by a distracting force (a vacuum force is applied for soft tissue enlargement, see Figs. 2-4, see lines 3-4 of [0033] and see the first sentence of [0051]), the shell (12) having a skirt (rim 14 and gasket 46, Figs. 2-4) extending therefrom providing a skin contact surface area against a skin of a patient (skirt 14, 46 is shown to have a surface area able to contact the patient in Figs. 2-4), the aperture defining an aperture surface area (the surface area associated with the interior of shell 12), and wherein the skirt (14, 46) is non-fixedly attached to the skin of the patient and slides laterally outwardly during application of the distracting force while worn by the user (the skirt is able to slide relative to the skin due to the petroleum jelly layer and Freyre states the skin tissue protrudes into the dome, see lines 8-12 of [0053], lines 4-9 of [0055], and lines 1-11 of [0056]. Because the skin tissue protrudes into the dome, the skirt is configured to slide laterally outwardly with relative to the skin. Additionally, Freyre discloses the cushion 46 “may itself be made of materials which exhibit a sufficiently ‘sticky’ surface property so as to in and of itself provide this ‘sticky’ function … such as silicone, hydrogels, and many other low durometer synthetic rubbers and gels” see lines 4-11 of [0059] and lines 4-9 of [0055]. The use of an inherently “sticky” cushion such as silicone, hydrogel, or low durometer synthetic rubber with the petroleum jelly layer is a non-fixed and non-adhesive skirt).
Freyre does not specifically state the skin contact surface area of the skirt (14, 46) is greater than the aperture surface area of the shell (12). However, it is noted that Freyre states that the surface area of the skirt may at least be equal to the normal area of the dome opening (see the first sentence of [0054]), and Freyre states that distributing the shear forces over a larger area will improve user comfort (see the last sentence of [0056]) and avoid tissue damage (see the second sentence of the Abstract).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the relative surface area of the skirt and shell of Freyre to have a larger skin contact surface area because this will provide an expected result of distributing the shear forces over a larger area to improve user comfort and avoid tissue damage, and since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 4, the modified Freyre device discloses wherein the skirt (14, 46) is composed of synthetic rubber (silicone, lines 6-8 of [0055]) and has a lubricating layer (petroleum jelly, see lines 8-9 of [0055]) on a bottom surface to glide over the skin (the petroleum jelly layer will allow the rim surface to glide over the skin), thereby reducing shear stress between the skirt and skin contact surface (Freyre discloses that petroleum jelly may be used to supplement the skin-contacting element to improve patient comfort, see lines 4-9 of [0055]. The petroleum jelly will reduce shear stress at least to some degree).
Regarding claim 6, the modified Freyre device discloses wherein the skirt (14, 46) is less hard than the shell (the shell 12 is stated to be “a generally rigid dome capable of withstanding a pressure differential” in the first sentence of the Abstract, and the skirt 14 is stated to be a “flexible rim material provides a cushion to improve the user’s comfort” in the last sentence of [0056] and may be made “a silicone gel cushion or other soft, conforming type material” in lines 6-8 of [0055]. A soft, flexible, cushioning rim that may be made of silicone is less hard than a generally rigid dome).
Regarding claim 18, the modified Freyre device discloses wherein the tissue expander (Fig. 1) maintains the tissue in an expanded state (the claim does not require the tissue to be “maintained” for any particular amount of time, and this is a device claim rather than a method claim so the prior art merely needs to be capable of maintaining the tissue in an expanded state for some amount of time. Freyre discloses maintaining vacuum on the tissue on a continuous basis, see the second sentence of [0052] and the tissue is maintained in an expanded state as treatment continues, see lines 9-18 of [0053]).
Regarding claim 19, the modified Freyre device discloses wherein the tissue expander (Fig. 1) temporarily stretches the tissue (through application of the vacuum suction, see Figs. 2-4 and para. [0053]) to generate a scaffold for grafting materials (this is a recitation of intended use, and the prior art apparatus does not need to disclose generating a scaffold to read on the claim. Instead, it merely needs to be capable of temporarily stretching the tissue).
Claims 2-3, 5, and 7-14 are rejected under 35 U.S.C. 103 as being unpatentable over Freyre et al. (2005/0245850) in view of Adelman (6,558,314).
Regarding claim 2, Freyre discloses wherein the shell (12) has an opening (connection for conduit 50, Fig. 1) in communication with an external vacuum source (vacuum pump assembly 16 with vacuum pump 20, Fig. 1) to apply a vacuum within the shell and impart the distracting force (see lines 3-5 of [0033]) to expand the tissue (soft tissue enlargement, see Figs. 3-4 and see the first sentence of [0051]). Freyre does not specifically state the skirt (14) increasingly spreads under increasing pressure in the shell.
Adelman teaches a related tissue suction device (Fig. 1-3A; Figs. 19-27b) comprising a shell (upper portion 264, Fig. 19-27b) that is harder than a skirt (skirt-like member 266, Fig. 26; see col. 15, lines 15-23 and col. 3, lines 13-21, portion 264 is a semi-rigid elastomer of Shore A 30 to 70 and skirt member 266 is a compliant material of Shore A 5 to 10), the skirt (266) increasingly spreads under increasing pressure in the shell (see Fig. 27b and col. 15, lines 57-63, the lower edge of the skirt 266 angles spreads outwardly when vacuum pressure is applied) and increases the skin contact surface area of the skirt (see Fig. 27b and see col. 15, lines 57-63), thereby promoting an effective seal and distributes the coupling force to reduce potential tissue trauma (see col. 15, lines 60-62 and col. 3, lines 35-40).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shell and skirt of Freyre to have the shell be relatively harder than the skirt, and the skirt increasingly spreads under increasing pressure in the shell as taught by Adelman because this provides an expected result of promoting an effective seal upon application of vacuum and distributes the coupling force to reduce potential tissue trauma (see col. 15, lines 60-62 and col. 3, lines 35-40 of Adelman).
Regarding claim 3, the modified Freyre/Adelman device as currently combined discloses wherein the opening receives a tubing (conduit 50, Fig. 1 of Freyre) but is silent regarding the flexible tubing being connected at one end to the external vacuum source and connected at an other end to the shell.
However, Freyre teaches an additional embodiment (Fig. 10-11) in which the shell(s) (domes 110, Fig. 10) each have an opening (opening 116, Fig. 10) receiving tubing (tubing 118, Fig. 10) connected at one end to the external vacuum source (portable vacuum pump 120, Fig. 10; see [0061]) and connected at an other end to the shell (at opening 116, see Fig. 10). Freyre does not specifically state the tubing (118) is flexible, but it is shown to bend to fit between the shells (Fig. 10) and flexible tubing to transmit air pressure is well known in the art, such as plastic tubing. It is noted that 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.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tubing of Freyre/Adelman to be flexible tubing connected at one end to a portable external vacuum source and connected at an other end to the shell as taught by Freyre’s Fig. 10 embodiment because this would provide an expected result of allowing the tubing to be flexible to fit between the pair of domes and easily connect to an external vacuum pump that would improve portability of the device.
Regarding claim 5, Freyre discloses wherein the skirt is composed of rubber (silicone, lines 6-8 of [0055]), but is silent regarding the rubber being low durometer and in the Shore OO range less than 10-15 in the shore AA.
Adelman teaches a related tissue suction device (Fig. 1-3A; Figs. 19-27b) comprising a shell (upper portion 264, Fig. 19-27b) that is harder than a skirt (skirt-like member 266, Fig. 26), wherein the skirt is composed of rubber of low durometer and in the Shore 00 range less than 10 in the Shore AA (see col. 15, lines 15-23 and col. 3, lines 13-21, portion 264 is a semi-rigid elastomer of Shore A 30 to 70 and skirt member 266 is a compliant material of Shore A 5 to 10), the skirt (266) increasingly spreads under increasing pressure in the shell (see Fig. 27b and col. 15, lines 57-63, the lower edge of the skirt 266 angles spreads outwardly when vacuum pressure is applied) and increases the skin contact surface area of the skirt (see Fig. 27b and see col. 15, lines 57-63), thereby promoting an effective seal and distributes the coupling force to reduce potential tissue trauma (see col. 15, lines 60-62 and col. 3, lines 35-40).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shell and skirt of Freyre to have the shell be relatively harder than the skirt, with the skirt formed of low durometer rubber in the Shore OO range less than 10-15 in the shore AA skirt increasingly spreads under increasing pressure in the shell as taught by Adelman because this provides an expected result of promoting an effective seal upon application of vacuum and distributes the coupling force to reduce potential tissue trauma (see col. 15, lines 60-62 and col. 3, lines 35-40 of Adelman).
Regarding claim 7, Freyre is silent regarding the skirt increasing the tissue contact surface area by at least a multiple of three as pressure increases. However, it is noted that Freyre states that distributing the shear forces over a larger area will improve user comfort and avoid tissue damage (see the last sentence of [0056] and the second sentence of the Abstract).
Adelman teaches a related tissue suction device (Fig. 1-3A; Figs. 19-27b) comprising a shell (upper portion 264, Fig. 19-27b) that is harder than a skirt (skirt-like member 266, Fig. 26; see col. 15, lines 15-23 and col. 3, lines 13-21, portion 264 is a semi-rigid elastomer of Shore A 30 to 70 and skirt member 266 is a compliant material of Shore A 5 to 10), the skirt (266) increasingly spreads under increasing pressure in the shell (see Figs. 27a-27b and col. 15, lines 57-63, the lower edge of the skirt 266 angles spreads outwardly when vacuum pressure is applied. The skin contact surface area in Fig. 27a is a relatively small area 278 but in Fig. 27b the surface between 278 and 276 is configured to contact the skin) and increases the skin contact surface area of the skirt (see Figs. 27a-27b and see col. 15, lines 57-63. See also col. 3, lines 35-40), thereby promoting an effective seal and distributes the coupling force to reduce potential tissue trauma (see col. 15, lines 60-62 and col. 3, lines 35-40).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shell and skirt of Freyre to have the shell be relatively harder than the skirt, and the skirt increasingly spreads under increasing pressure in the shell as taught by Adelman because this provides an expected result of promoting an effective seal upon application of vacuum and distributes the coupling force to reduce potential tissue trauma (see col. 15, lines 60-62 and col. 3, lines 35-40 of Adelman) and improving user comfort (as suggested by Freyre).
The modified Freyre/Adelman device does not specifically state that the increased tissue contact area is at least a multiple of three. However, it is reiterated that both Freyre and Adelman suggest providing an increased tissue contact area to improve the seal and reduce tissue damage (see Fig 27b, col. 15, lines 57-63, and col. 3, lines 35-40 of Adelman, and Freyre states distributing the shear forces over a larger area will improve user comfort and avoid tissue damage, see the last sentence of [0056] and the second sentence of the Abstract).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the increased skin contact surface area of Freyre/Adelman to be at least a multiple of three, since it has been held that where the general conditions of a claim are disclosed in the prior art (Freyre suggests distributing shear forces over a larger area will improve user comfort and avoid tissue damage from skin contact pressure, and Adelman discloses providing an increased tissue contact area to improve the seal and reduce tissue damage), discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05.
Regarding claim 8, Freyre is silent regarding wherein the skirt under pressure deflects outwardly to increase the skin contact surface area to approximately three times the aperture surface area.
Adelman teaches a related tissue suction device (Fig. 1-3A; Figs. 19-27b) comprising a shell (upper portion 264, Fig. 19-27b) that is harder than a skirt (skirt-like member 266, Fig. 26; see col. 15, lines 15-23 and col. 3, lines 13-21, portion 264 is a semi-rigid elastomer of Shore A 30 to 70 and skirt member 266 is a compliant material of Shore A 5 to 10), the skirt (266) under pressure deflects outwardly (see Figs. 27a-27b and see col. 15, lines 57-63, the lower edge 278 of the skirt 266 is pivoted outwardly when vacuum pressure is applied) to increase the skin contact surface area of the skirt (see Fig. 27b and see col. 15, lines 57-63), thereby promoting an effective seal and distributes the coupling force to reduce potential tissue trauma (see col. 15, lines 60-62 and col. 3, lines 35-40).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shell and skirt of Freyre to have the shell be relatively harder than the skirt, and the skirt under pressure deflects outwardly to increase the skin contact surface area as taught by Adelman because this provides an expected result of promoting an effective seal upon application of vacuum and distributes the coupling force to reduce potential tissue trauma (see col. 15, lines 60-62 and col. 3, lines 35-40 of Adelman).
The modified Freyre/Adelman device does not specifically state the increased tissue contact area is approximately three times the aperture surface area. However, it is noted that both Freyre and Adelman suggest providing an increased tissue contact area to improve the seal and reduce tissue damage (see Fig 27b, col. 15, lines 57-63, and col. 3, lines 35-40 of Adelman, and Freyre states distributing the shear forces over a larger area will improve user comfort and avoid tissue damage, see the last sentence of [0056] and the second sentence of the Abstract).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the increased skin contact surface area of Freyre/Adelman to be approximately three times the aperture surface area, since it has been held that where the general conditions of a claim are disclosed in the prior art (Freyre suggests distributing shear forces over a larger area will improve user comfort and avoid tissue damage from skin contact pressure, and Adelman discloses providing an increased tissue contact area to improve the seal and reduce tissue damage), discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05.
Regarding claim 9, the modified Freyre/Adelman device as currently combined does not specifically state vacuum pressure can be applied for bursts over 60mmHg.
However, Freyre additionally states that pressures of 70 mmHg can be provided in intermittent bursts without causing tissue damage (see the last two sentences of [0017], the first two sentences of [0019]), and the intermittent high pressure would provide expected results of increased amount of suction to enlarge tissue (see lines 11-18 of [0021]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tissue expander of Freyre/Adelman to be capable of receiving bursts of vacuum pressure over 60 mmHg as further taught by Freyre so the doctor is able to provide brief periods of enhanced suction to safely increase the degree of tissue enlargement.
Regarding claim 10, the modified Freyre/Adelman device discloses wherein the increased skin contacting surface area reduces the counter pressure on the skin (Freyre states distributing the shear forces over a larger area will improve user comfort and avoid tissue damage, see the last sentence of [0056] and the second sentence of the Abstract; Adelman states that the increased surface area will distribute the coupling force to reduce potential tissue trauma, see col. 15, lines 60-62 and col. 3, lines 35-40 of Adelman), but does not specifically state reducing from a pressure above 20mmHg to a pressure about 20mmHG.
However, 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 size of the skin contacting surface area of Freyre/Adelman to reduce counter pressure to about 20 mmHg, since it has been held since it has been held that where the general conditions of a claim are disclosed in the prior art (Freyre suggests distributing shear forces over a larger area will improve user comfort and avoid tissue damage from skin contact pressure, and Adelman states that the increased surface area will distribute the coupling force to reduce potential tissue trauma), discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05.
Regarding claim 11, Freyre is silent regarding wherein an angle of the skirt shifts under increasing pressure from an inward oblique angle to an outward obtuse angle.
Adelman teaches a related tissue suction device (Fig. 1-3A; Figs. 19-27b) comprising a shell (upper portion 264, Fig. 19-27b) that is harder than a skirt (skirt-like member 266, Fig. 26; see col. 15, lines 15-23 and col. 3, lines 13-21, portion 264 is a semi-rigid elastomer of Shore A 30 to 70 and skirt member 266 is a compliant material of Shore A 5 to 10), the skirt (266) shifts under increasing pressure (vacuum pressure) from an oblique angle to an outward obtuse angle (see Figs. 26-27b and see col. 15, lines 57-63, the lower edge of the skirt 266 angles downwardly and laterally outwardly when vacuum pressure is applied), and increases the skin contact surface area of the skirt (see Fig. 27b and see col. 15, lines 57-63), thereby promoting an effective seal and distributes the coupling force to reduce potential tissue trauma (see col. 15, lines 60-62 and col. 3, lines 35-40).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shell and skirt of Freyre to have the shell be relatively harder than the skirt, and the skirt shift under increasing pressure from an oblique angle to an outward obtuse angle as taught by Adelman because this provides an expected result of promoting an effective seal upon application of vacuum and distributes the coupling force to reduce potential tissue trauma (see col. 15, lines 60-62 and col. 3, lines 35-40 of Adelman).
The modified device does not specifically disclose the oblique angle being an inward angle.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the starting shape of the skirt of Freyre/Adelman to be slightly concave and thus have an inward oblique angle, since a slightly concave shape would be a minor change from the curved wall of the skirt in Fig. 27a of Adelman and this shape is merely one of numerous shapes or configurations a person having ordinary skill in the art would find obvious for the purpose of providing a sealing skirt to conform to the curvature of a breast. See MPEP 2144.04(IV)(B).
Regarding claim 12, Freyre is silent regarding the skirt angling inwardly with respect to the shell.
Adelman teaches a related tissue suction device (Fig. 1-3A; Figs. 19-27b) comprising a shell (upper portion 264, Fig. 19-27b) that is harder than a skirt (skirt-like member 266, Fig. 26; see col. 15, lines 15-23 and col. 3, lines 13-21, portion 264 is a semi-rigid elastomer of Shore A 30 to 70 and skirt member 266 is a compliant material of Shore A 5 to 10), the skirt (266) pivots under vacuum pressure (see Figs. 26-27b and see col. 15, lines 57-63, the lower edge of the skirt 266 angles downwardly and laterally outwardly when vacuum pressure is applied), and increases the skin contact surface area of the skirt (see Fig. 27b and see col. 15, lines 57-63), thereby promoting an effective seal and distributes the coupling force to reduce potential tissue trauma (see col. 15, lines 60-62 and col. 3, lines 35-40). The skirt angles inwardly with respect to the shell (at least point 276 in Figs. 26-27a is angled inwardly with respect to the shell 264).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shell and skirt of Freyre to have the shell be relatively harder than the skirt, and the skirt pivots under vacuum pressure and angles inwardly with respect to the shell as taught by Adelman because this provides an expected result of promoting an effective seal upon application of vacuum and distributes the coupling force to reduce potential tissue trauma (see col. 15, lines 60-62 and col. 3, lines 35-40 of Adelman).
Regarding claim 13, Freyre is silent regarding a perimeter of the skirt adjacent the tissue contacting surface being shorter than a perimeter of the skirt adjacent the shell.
Adelman teaches a related tissue suction device (Fig. 1-3A; Figs. 19-27b) comprising a shell (upper portion 264, Fig. 19-27b) that is harder than a skirt (skirt-like member 266, Fig. 26; see col. 15, lines 15-23 and col. 3, lines 13-21, portion 264 is a semi-rigid elastomer of Shore A 30 to 70 and skirt member 266 is a compliant material of Shore A 5 to 10), the skirt (266) pivots under vacuum pressure (see Figs. 26-27b and see col. 15, lines 57-63, the lower edge of the skirt 266 angles downwardly and laterally outwardly when vacuum pressure is applied), and increases the skin contact surface area of the skirt (see Fig. 27b and see col. 15, lines 57-63), thereby promoting an effective seal and distributes the coupling force to reduce potential tissue trauma (see col. 15, lines 60-62 and col. 3, lines 35-40). A perimeter of the skirt adjacent the skin contact surface (such as the perimeter at point 276, which is adjacent skin contact surface 274, see Fig. 27a) is less than a perimeter of the skirt adjacent the shell (such as the perimeter at the point adjacent the lead line of 274 in Fig. 27a).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shell and skirt of Freyre to have the shell be relatively harder than the skirt, and the skirt has a perimeter adjacent the skin contact surface that is less than a perimeter of the skirt adjacent the shell, and pivots under vacuum pressure and angles inwardly with respect to the shell as taught by Adelman because this provides an expected result of promoting an effective seal upon application of vacuum and distributes the coupling force to reduce potential tissue trauma (see col. 15, lines 60-62 and col. 3, lines 35-40 of Adelman).
Regarding claim 14, Freyre is silent regarding wherein the skirt has a lateral side longer than a medial side.
Adelman teaches a related tissue suction device (Fig. 1-3A; Figs. 19-27b) comprising a shell (upper portion 264, Fig. 19-27b) that is harder than a skirt (skirt-like member 266, Fig. 26; see col. 15, lines 15-23 and col. 3, lines 13-21, portion 264 is a semi-rigid elastomer of Shore A 30 to 70 and skirt member 266 is a compliant material of Shore A 5 to 10), the skirt (266) pivots under vacuum pressure (see Figs. 26-27b and see col. 15, lines 57-63, the lower edge of the skirt 266 angles downwardly and laterally outwardly when vacuum pressure is applied), and increases the skin contact surface area of the skirt (see Fig. 27b and see col. 15, lines 57-63), thereby promoting an effective seal and distributes the coupling force to reduce potential tissue trauma (see col. 15, lines 60-62 and col. 3, lines 35-40). The skirt has a lateral side longer than a medial side (see lateral side 1, medial side 2, in annotated Figure A below).
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Annotated Figure A (from Fig. 27a of Adelman): the skirt has a lateral side (1) that is longer than the medial side (2), where the medial side is the portion of the skirt that extends inward.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shell and skirt of Freyre to have the shell be relatively harder than the skirt, and the skirt pivots under vacuum pressure and angles inwardly, with the lateral side being longer than a medial side as taught by Adelman because this provides an expected result of promoting an effective seal upon application of vacuum and distributes the coupling force to reduce potential tissue trauma (see col. 15, lines 60-62 and col. 3, lines 35-40 of Adelman).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Freyre et al. (2005/0245850) in view of Reaves (3,382,867).
Regarding claim 15, Freyre is silent regarding wherein the shell is removably connectable to the skirt such that shells of varying size can be selectively connected to the rim.
Reaves teaches a related vacuum-based tissue expanding device (Figs. 1-2) comprising a shell (cup 12 and peripheral edge 42, Fig. 1) being removably connectable to the skirt (sealing pad 52, Fig. 2) to allow different sized shells be attached (see col. 3, lines 54-71, the sealing pad 52 is removably restrained in the edge 42 of the shell 12 and thus different sizes and shapes of edge portions 42 can be provided to fit more closely to the contour of the regions of the breast in accordance with the sizing established by the brassiere industry. For example, providing five body sizes that will allow utilization of the device by a majority of women).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shell and skirt of Freyre to have the shell removably connectable to a skirt to have the shells of varying sizes to be selectively connected as taught by Reaves so that different size shells can be provided that will be able to be used by a majority of women (see col. 3, lines 65-71 of Reaves).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Freyre et al. (2005/0245850) in view of Aarestad et al. (2014/0144450).
Regarding claim 16, Freyre is silent regarding wherein the shell has a circumferential groove to receive a band to secure the skirt and shell.
Aarestad teaches a related negative pressure tissue treatment device (Fig. 12; see the last sentence of [0045]) having a shell (“dome” in Fig. 2) and a skirt (“flange” in Fig. 2; see also Fig. 14, Fig. 17A-17B) that provides a low friction region configured to provide local movement of the skirt (flange) relative to the skin surface (see the last six lines of [0019]). The shell (“dome”) has a circumferential groove to receive a band to secure the skirt and shell in a replaceable fashion (see Fig. 2, the dome has a groove immediately prior to its distal circular cross-section. The groove is where the flange meets the dome to secure the skirt and shell, see the last sentence of [0048]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shell and skirt of Freyre to include a circumferential groove to receive a band to secure the skirt and shell in a replaceable fashion as taught by Aarestad because the detachability of the skirt from the shell would allow the user to reversibly detach/attach different skirts to replace used or damaged skirts.
Regarding claim 17, Freyre is silent regarding wherein the shell and skirt are attached in a tongue and groove fashion, and a circumferential band provides an air-tight securement.
Aarestad teaches a related negative pressure tissue treatment device (Fig. 12; see the last sentence of [0045]) having a shell (“dome” in Fig. 2) and a skirt (“flange” in Fig. 2; see also Fig. 14, Fig. 17A-17B) that provides a low friction region configured to provide local movement of the skirt (flange) relative to the skin surface (see the last six lines of [0019]). The shell (“dome”) and skirt (“flange” are attached in a reversible tongue and groove fashion (see Fig. 2, there is a groove that receives a circular cross-section portion of the shell that is considered a tongue, see the last sentence of [0048]) with a circumferential band that provides an air-tight securement (the circular cross-section portion of the dome that is inserted into the “flange” in Fig. 2 is a circumferential band and it provides air-tight securement, see lines 6-7 of [0039]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shell and skirt of Freyre to be detachably attached in a tongue and groove fashion as taught by Aarestad because the detachability of the skirt from the shell would allow the user to reversibly detach/attach different skirts to replace used or damaged skirts.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,547,155.
Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 1-19 are broader than claims 1-17 of U.S. Patent No. 11,547,155. For example, instant claim 1 does not include the limitations “wherein the rim is asymmetric and has a narrower skirt medially and a more curved inward skirt laterally to provide a lateral side with deeper concavity and a length longer than a medial side.” Instant claim 1 includes an additional limitation such as “the skin contact surface area of the skirt is greater than the aperture surface area of the shell” but this limitation is disclosed/rendered obvious by the prior art of record such as Freyre et al. (2005/0245850), Adelman (6,558,314), Reaves (3,382,867), and Aarestad et al. (2014/0144450) as described above in the 35 U.S.C. 103 rejection(s).
Conclusion
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/CHRISTOPHER E MILLER/ Examiner, Art Unit 3785
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