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 .
In light of the amendments to the claims filed 08/04/2025 in which claims 1, 4-5, and 14 were amended and claims 16-18 were added, claims 1-18 are pending in the instant application and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/IB2021/057056 filed 08/02/2021 which claims priority IT/102020000019474 filed 08/06/2020.
Claims 1-18 receive priority to the prior-filed application, filed on 08/06/2020.
Response to Arguments
Claim Rejections under 35 U.S.C. 112(b)
The previous claim rejections under 35 U.S.C. 112(b) are withdrawn in view of the amendments to the claims.
Claim Rejections under 35 U.S.C. 102(a)(1) and 103
Applicant's arguments filed 08/04/2025 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding amended claim 1, applicant asserts on pg. 6 that Connor fails to disclose the newly amended limitations.
In response to the applicant’s argument, the examiner acknowledges the applicant’s argument and respectfully notes that Connor was not used in the previous Office Action filed 04/04/2025 to read on the amended limitations at issue. However, as explained in the rejection of the claims below, Connor does read on the newly amended limitations.
Regarding claim 1, applicant asserts on pg. 6 that Connor fails to disclose devices actuated with a person’s fingers, that the priming force of the system can be relatively high, and that the access opening for the priming tool is restricted in size and designed to limit pivoting or angulation of the priming tool.
In response to the applicant’s argument, the examiner acknowledges the applicant’s argument and respectfully notes that the applicant is arguing a functional limitation. MPEP 2114(II) states, “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)”. Connor discloses all of the structural limitations of independent claim 1, specifically a rear opening at the second end of the longitudinal housing, and therefore, Connor can be utilized in the manner as claimed. Further, on the disclosure of Connor that the priming force of the system can be relatively high/excessive, this disclosure seems to be directed to an embodiment which utilizes a spring drive, which is not the embodiment relied upon in the Office Action.
The amendments to the claims have necessitated new grounds of rejection.
Claim Interpretation
Claim 1 recites the limitation “wherein the cylindrical support is arranged on a longitudinal axis of the housing…another end connected to the housing” in ln. 21-23. The “housing” in these limitations is considered the “longitudinal housing” previously recited in the claim.
The Examiner recognizes claim 15 as a "product-by-process" claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113). As a product claim, Examiner has determined claim 15 to require the central disc of the circular membrane to comprise the following structural elements in addition to those in the claims from which they depend: two half-discs. In the prior art rejection in this Office action, Examiner considers claim 15 to be met when a reference teaches these structural limitations.
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 and 18 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 recites the limitation “a single constant-force spring mounted on a cylindrical support” in ln. 2. This limitation is indefinite in that it is unclear whether the constant-force spring and the cylindrical support in claim 5 are the same as those recited in claim 1, which claim 5 is dependent upon. For the sake of compact prosecution, the examiner is treating the claim as though it reads “the single constant-force spring mounted on the cylindrical support”.
Claim 18 recites the limitation “wherein the rear cover” in ln. 1. There is insufficient antecedent basis for this limitation in the claim. For the sake of compact prosecution, the examiner is treating the claim as though it reads “wherein a rear cover”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6-9, and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US/2014/0276498 A1 to Connor.
Regarding claim 1, Connor discloses a negative pressure device (Fig. 23B, suction apparatus 2200) for treating a wound (para. 0056-0057) and removing fluid from said wound (para. 0005), the device comprising:
a longitudinal housing (Fig. 23B, longitudinal housing 2210) having a first end configured to be connected to the wound (para. 0004 ln. 16-30; Fig. 23B, first end 2213) and a second end opposite the first end (Fig. 23B, second end 2214 opposite first end 2213), wherein the longitudinal housing is a structure in a single piece, hollow and cylindrical (Fig. 23B-24A showing longitudinal housing 2210 in a single piece structure, hollow, and cylindrical),
a piston inside the housing (para. 0145; Fig. 24A showing piston assembly 2260 inside longitudinal housing 2210; Fig. 30, piston assembly 2260 comprising piston seal 2910 and piston 2920), the piston being slidable in the housing to generate a negative pressure (para. 0131 ln. 1-26),
a constant-force mechanism configured to be loaded and operated by the piston (para. 0131 ln. 1-26; para. 0147 ln. 40-46, the system may utilize one spring; Fig. 24B, constant force spring 2300; Fig. 30, constant force spring 2950), wherein said constant-force mechanism is fixed at the second end of the longitudinal housing and to the piston and is arranged inside the housing (Fig. 30 showing constant force spring 2950 fixed to bushing 2830; para. 0130 ln. 6-8; para. 0144 ln. 1-10; para. 0147 ln. 40-46), and
a valve system for drawing air out of the housing when the piston slides towards the first end of the housing (para. 0141; Fig. 32D, check valve 3214) and for bringing wound fluid into the housing when the piston slides towards the second end of the housing (para. 0004 ln. 16-30; para. 0140; Fig. 32A-32B, connector 3200 comprising check valve 3202),
wherein the constant-force mechanism is entirely contained inside the longitudinal housing where the piston slides (Fig. 23B-24D showing constant force spring 2300 entirely contained in longitudinal housing 2210) and the second end of the longitudinal housing comprises a rear opening configured to allow the insertion of one or more fingers of an individual's hand into the rear opening and to allow the one or more fingers to engage the piston and manually slide the piston and load the constant-force mechanism (Fig. 23A showing longitudinal housing 2210 comprising rear opening 2216 and spring assembly 2270 that connects to the rear opening of longitudinal housing 2210; Fig. 28B showing 2824 central opening of 2270 spring assembly configured to permit passage of priming device to access and displace piston assembly 2260; para. 0144),
wherein the constant-force mechanism comprises a constant-force spring mounted on a cylindrical support that is connected to the piston (Fig. 30 showing constant force spring 2950 mounted on 2830 cylindrical bushing that is indirectly connected to piston assembly 2260 through the constant force spring 2950; alternatively, Fig. 30 showing cylindrical bushing 2830 in contact with support 2944 of piston assembly 2260; para. 0147),
wherein the cylindrical support is arranged on a longitudinal axis of the longitudinal housing (Fig. 23B, spring assembly 2270 comprising cylindrical bushing 2830 arranged on the long axis of longitudinal housing 2210),
wherein the constant-force spring has one end fixed to the cylindrical support (Fig. 30 showing constant force spring 2950 fixed to cylindrical bushing 2830; para. 0130 ln. 6-8; para. 0144 ln. 1-10), and another end connected to the housing (Fig. 30 showing distal region 2952 of constant force spring 2950 coupled to piston assembly 2260 by retaining structures 2942; para. 0145, piston seal 2910 of piston assembly 2260 in direct contact with interior of longitudinal housing 2210; para. 0147; end of constant force spring is therefore indirectly connected to the housing through a direct coupling to piston assembly 2260 and a direct connection between piston assembly 2260 and longitudinal housing 2210).
Regarding claim 2, Connor discloses the invention of claim 1, Connor further discloses: wherein the housing comprises a rear cover curved at the second end and partially covering the back of the device (para. 0129 ln. 7-12, notches 2370 allow for connection of rear cover 2230 such that rear cover 2230 covers part of the back of suction apparatus 2200; Fig. 23B, rear cover 2230 comprising a curved end face).
Regarding claim 3, Connor discloses the invention of claim 2, Connor further discloses: wherein the rear cover comprises a fixing element for fixing the constant-force mechanism to the housing (Fig. 30 showing constant force springs 2950 fixed to bushings 2830; para. 0130 ln. 6-8; para. 0144 ln. 1-10).
Regarding claim 4, Connor discloses the invention of claim 1, Connor further discloses: wherein the constant-force mechanism comprises at least one constant-force spring fixed to the piston in a laminar manner (Fig. 30, two flat constant force springs 2950 fixed to piston 2920 of piston assembly 2260; para. 0144 ln. 6-10; para. 0147 ln. 7-29); which is capable of being activated by the pressure exerted by one or more fingers of a single user inserted into the rear opening and pressing on the piston (Fig. 23B showing longitudinal housing 2210 comprising a rear opening and spring assembly 2270 that connects to the rear opening of longitudinal housing 2210; Fig. 28B showing 2824 central opening of 2270 spring assembly configured to permit passage of priming device to access and displace piston assembly 2260; para. 0131 ln. 1-16; para. 0144).
Regarding claim 6, Connor discloses the invention of claim 1, Connor further discloses: wherein the piston comprises a main body with a first surface defining a pressure chamber with the first end of the housing (para. 0131 ln. 30-39; para. 0145-0146; Fig. 30 showing piston 2920 of piston assembly with first surface comprising piston seal 2910) and the constant-force mechanism is confined, at least partially, in an inner region of said main body of the piston (para. 0147 ln. 7-29; Fig. 30 showing constant force spring 2950 wound around support 2944 and fixed).
Regarding claim 7, Connor discloses the invention of claim 6, Connor further discloses: wherein the main body of the piston comprises a second surface used to manually load the constant-force mechanism (para. 0148 ln. 16-37; Fig. 31B showing second surface 3130 of piston 2920 in contact with priming tool 2290).
Regarding claim 8, Connor discloses the invention of claim 1, Connor further discloses: wherein the valve system is placed at the first end of the longitudinal housing (para. 0140 ln. 1-8; Fig. 32D, check valve 3214 placed at first end of longitudinal housing 2210; Fig. 32A-32B, connector 3200 comprising check valve 3202).
Regarding claim 9, Connor discloses the invention of claim 1, Connor further discloses: wherein the valve system comprises two one-way valves (para. 0140 ln. 16-19; para. 0141 ln. 18-24; Fig. 32D, check valve 3214; Fig. 32A-32B, connector 3200 comprising check valve 3202).
Regarding claim 17, Connor discloses the invention of claim 1, Connor further discloses: wherein the piston includes a void through which the constant-force spring extends, and the void is radially offset from the longitudinal axis (Fig. 29C-30, void 2940 in 2260 piston assembly through which constant-force spring 2950 extends; longitudinal axis extends through cylindrical bushing 2830 such that void 2940 is radially offset).
Regarding claim 18, Connor discloses the invention of claim 17, Connor further discloses: wherein a rear cover (Fig. 23A, rear cover 2230) includes an opening (Fig. 23A, rear cover opening 2232) and the rear opening of the housing is defined at least partially by the profile of the rear cover (Fig. 23A, rear opening 2216 defined by rear cover 2230 by connection of rear cover 2230 to longitudinal housing 2210) and the constant-force spring curves away from the opening in the rear cover so that the constant-force spring does not interfere with insertion of the one or more fingers into the rear opening (Fig. 23A, rear cover opening 2232 at the central-most portion of rear cover 2230; Fig. 30, constant-force spring 2950 curves outward from the center of the system on cylindrical bushing 2830 and on support 2944).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Connor as applied above, and further in view of WO/2019/190721 A1 to Locke.
Regarding claim 5, Connor discloses the invention of claim 2, Connor further discloses: wherein the constant-force mechanism comprises the single constant-force spring mounted on the cylindrical support (para. 0144 ln. 1-10; para. 0147 ln. 40-46, the system may utilize one spring; Fig. 30 showing constant force spring 2950 mounted on cylindrical bushing 2830), wherein the spring is formed by a band which is capable of being wound around said cylindrical support, in which one end of the band is fixed to the cylindrical support (Fig. 30 showing constant force spring 2950 as a band fixed/coupled through some coupling mechanism to cylindrical bushing 2830; para. 0130 ln. 6-8; para. 0144 ln. 1-10).
Connor differs from the instantly claimed invention in that Connor fails to explicitly disclose wherein the spring is a metallic band.
Locke teaches an air pump substantially similar to Connor that utilizes a spring steel constant force spring (para. 0086; Fig. 12 showing constant force springs 502).
Locke is considered to be analogous to the instantly claimed invention in that Locke discloses a manual air pump. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the constant force spring of Connor that allows for creation of negative pressure within the air pump, for the spring steel constant force spring of Locke since these mechanisms perform the same function of providing constant force in the creation of negative pressure within an air pump. Simply substituting one constant force spring for another would yield the predicable result of providing constant force in the creation of negative pressure within an air pump. See MPEP 2143.
Claims 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Connor as applied above, and further in view of U.S. Patent no. 1,416,771 A to Babson.
Regarding claim 10, Connor discloses the invention of claim 1; however, Connor differs from the instantly claimed invention in that Connor fails to disclose wherein the valve system comprises a cover element fixable to the first end of the longitudinal housing and a circular membrane positioned between the cover element and the first end of the longitudinal housing.
Connor discloses that other one-way valve mechanisms may be used instead of a duckbill valve, including ball check valves, diaphragm check valves, tilting disc check valves, and the like (para. 0140 ln. 16-19) and that the first and second check valves may have the same or different check valve mechanisms (para. 0141 ln. 18-24). Babson teaches a valve system for a pump (Fig. 1) that comprises a cover element fixable to a front part at a first end of a longitudinal housing (Fig. 1 showing cover element 3 fastened by bolts 4 to front part 2 of first end of longitudinal housing 1) and a circular membrane positioned between the cover element and the first end of the longitudinal housing (col. 3 ln. 5-12; Fig. 1 showing plate positioned between cover element 3 and front part 2 of first end of longitudinal housing 1; Fig. 2 showing circular plate).
Babson is considered to be analogous to the instantly claimed invention in that Babson discloses an air pump comprising a valve system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the valve system at the first end of the longitudinal housing of Connor that allows for drawing air out of the housing through one valve and bringing wound fluid into the housing through another valve, for the valve system at the first end of the longitudinal housing of Babson since these mechanisms perform the same function of allowing for input and output from the valves to occur non-simultaneously. Simply substituting one valve system for another would yield the predicable result of allowing for input into one valve to occur non-simultaneously with output from the other valve. See MPEP 2143. Further, the valve system of Babson provides the advantage of simplifying the valve construction and providing a combined valve and gasket to form an air tight closure that holds the valve centralized and in proper relation to the ports (col. 1 ln. 9-26).
Regarding claim 11, the combination of Connor and Babson suggests the invention of claim 10, the combination further suggests: wherein the cover element comprises a first opening for the entry of wound fluid and a second opening for the exit of air (Connor: para. 0140 ln. 8-14, 3202 valve comprising opening for entry of wound fluid; para. 0142 ln. 9-12, 3214 valve comprising opening for exit of fluids; Babson: Fig. 1, cover element 3 comprising first opening 10 for entry of fluid and second opening 13 for exit of fluid).
Regarding claim 12, the combination of Connor and Babson suggests the invention of claim 11, the combination further suggests: wherein the longitudinal housing comprises a front portion at the first end, wherein said front portion comprises an inlet hole at the first opening of the cover element and an outlet hole at the second opening of the cover element (Babson: Fig. 1 showing longitudinal housing 1 comprising front portion 2 comprising inlet hole 12 at first opening 10 of cover element 3 and outlet hole 11 at second opening 13 of cover element 3).
Regarding claim 13, the combination of Connor and Babson suggests the invention of claim 10, the combination further suggests: wherein the circular membrane consists of a central disc element and a circumferential element concentric with the disc element and positioned externally thereto (Babson: Fig. 3 showing circular plate consisting of inner portion 18 as a central disk element and circumferential element 16 concentric with inner portion 18), wherein the circumferential element acts as a gasket and is fixed between the cover element and the longitudinal housing (Babson: col. 3 ln. 5-12; Fig. 1 showing circumferential element 16 fixed between cover element 3 and first portion 2 of longitudinal housing 1).
Regarding claim 14, the combination of Connor and Babson suggests the invention of claim 10, the combination further suggests: wherein the longitudinal housing comprises a front part at the first end, wherein said front part has a pointed profile and comprises two surfaces defining a tip and which are configured to be alternately contacted with a half of the circular membrane following the sliding of the piston inside the longitudinal housing (Babson: Fig. 1 showing longitudinal housing 1 comprising front portion 2 at first end which has a pointed profile on the side of the plate at recess 22 and comprises two surfaces on the side of the plate, the first being the surface of front end 2 at recess 22 and the second being the surface of front end 2 at recess 24, that define a pointed tip, which are configured to be alternately connected to a half of the plate following the sliding of a piston in longitudinal housing 1; col. 4 ln. 69-98).
Regarding claim 15, the combination of Connor and Babson suggests the invention of claim 13, the combination further suggests: wherein the front portion of the housing comprises an outer central edge (Babson: Fig. 3, outer central edge considered area directly below recess 22 on the side of the plate), the cover element comprises an inner central edge (Babson: Fig. 3, inner central edge considered area directly above recess 24 on the side of the plate) and the central disc of the circular membrane is divided into two half-discs following the crushing of said central disc between said outer central edge and said inner central edge (Babson: Fig. 3 showing central disc 18 of plate divided into two half-discs 19; Fig. 1 showing plate crushed between central edges of front portion 2 and cover element 3).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Connor as applied above.
Regarding claim 16, Connor discloses the invention of claim 1, Connor further discloses: wherein the constant force mechanism comprises two constant-force springs that are each mounted on a separate one of two cylindrical supports (Fig. 30 showing constant force springs 2950 fixed to cylindrical bushings 2830) and that the constant force mechanism can comprise one or more constant-force springs (para. 0147); however, Connor differs from the instantly claimed invention in that Connor fails to disclose a second constant-force spring mounted on a cylindrical support that is spaced apart along the longitudinal axis.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to have duplicated the constant-force springs and cylindrical supports to include a second spring mounted along the longitudinal axis since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Furthermore, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781