DETAILED ACTION
This is a Final rejection for Application 18/149,053 filed December 30, 2022. Claims 1-7 are currently pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The examiner acknowledges the new drawings filed June 3, 2025. The drawing objection indicated in the action filed March 3, 2025 is withdrawn.
The examiner acknowledges the amendments to the specification filed June 3, 2025. The specification objection indicated in the action filed March 3, 2025 is withdrawn.
The examiner acknowledges the amendments to the claims. The claim objections for claims 1-2, 4 and 6-7 are withdrawn however, the claim objection of claim 5 has not been overcome. Additional claim objections are presented below.
The amendments to the claims do not overcome the 112(b) rejections of claims 2-3 and 6-7. The 112(b) rejections are maintained. Additional 112(b) rejections are presented below.
Claims 1, 2 and 4 are amended to be independent claims and to include limitations not previously presented. Therefore, new grounds of rejection are presented below in response to the amendments.
The examiner acknowledges the terminal disclaimer filed June 3, 2025. Therefore, the nonstatutory double patenting rejection indicated in the action filed March 3, 2025 is withdrawn.
Response to Arguments
Applicant's arguments filed June 3, 2025 have been fully considered but they are not persuasive.
Applicant argues that “[t]he bands [of Cottrell and South] are out the outside of the cover and are not self-encased as the present invention (Fancher 18/149,053) and do not form an inward "ledge" as the present invention.”
This argument is not persuasive as Cottrell and South are not being used in the combination to teach the encasement; this feature is already taught in Fancher. Cottrell and South are used to teach multiple additional elastic bands.
Applicant argues that “the omission of the property "slip" is not a standard procedure, nor recommended, as it would cause the material to adhere to itself, rendering it useless for forming anything.”
This argument is unpersuasive as while properties of polymeric materials can be manipulated, Fancher uses a polyethylene film and Dedo describes a polyethylene film with inherent anti-slip properties found in analogous art. Therefore, the limitation is obvious since it is directly disclosed in the prior art.
Applicant argues that “[t]he multi-layered end seal mentioned in Fancher US 2004/0199974 is not descriptive nor does it show how the seal is made. The end seal is unique in the medical field for covers such as the present invention, and would not have been known to a skilled artisan.”
Applicant does not provide evidence as to how the seal of Fancher is different from the claimed seal of the present invention. As previously presented, Fancher provides sufficient evidence to imply a multi-layered seal by folding the material of the covering and heat sealing the layers, thereby forming a multi-layered seal.
Claim Objections
Claim 1 is objected to because of the following informalities:
“the edge of the opening” in lines 3-4 should recite “an edge of an opening in the open end” as the edge and opening are a part of the open end, though not already recited.
“the first and second bands” in line 8 should recite ”the one elastic and second elastic bands” since the first band is not already recited but refers to the one elastic band.
“said covering presenting a space between parallel encased bands” in line 10 is already recited in line 9 so it is unnecessary to repeat this recitation.
Claim 2 is objected to because of the following informalities:
“the edge of the opening” in line 2 should recite “an edge of an opening in the one open end” as the edge and opening are a part of the open end, though not already recited.
“the first band” in line 3 should recite “the one elastic band” since the first band is not already recited but refers to the one elastic band.
“one open end” in line 4 should recite “the one open end” since one open end is already claimed in line 1.
“a sealed distal end” in line 6 should recite “the one closed end” since a closed end is already claimed in line 3.
“said covering to present with one open end consisting of one or more encased elastic bands, placed parallel to each other and a distance apart to accommodate the insertion of absorbent material” in lines 7-9 and 11-13 are unnecessary since they repeat the recitation in lines 4-6.
“as viewed in the drawings” in lines 15-16 should be removed as the claims may not refer to the drawings.
Claim 4 is objected to because of the following informalities:
“said covering that is comprised of” in line 3 should recite “said covering is comprised of” for proper grammar.
Claim 5 is objected to because of the following informalities:
“Said covering of Claim 4 that is a reusable, and disposable” in line 1 should recite “Said covering of Claim 4 is reusable and disposable” for proper grammar.
Claim 7 is objected to because of the following informalities:
“elasticized open end and a multi-layer seal” in line 1 should recite “the elasticized open end and the multi-layer seal” since they are both already recited in claim 2.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-3 and 6-7 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.
Regarding claim 2:
“the structure” in line 1 lacks antecedent basis as it is unclear what the structure is. This may be overcome with language such as “the covering”.
“a multi-layered folded and heat sealed enclosed distal end to accommodate a limb ending, such as a foot” in lines 9-10 is rejected since the claim already recites that the covering has a sealed distal end so it is unclear which limitation Applicant intends to claim. Additionally, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
“the distal end comprising abbreviated fingertip and thumb tip pockets to accommodate only the digital endings or tips of a hand in such a manner as to create a webbing between the digits as viewed in the drawings and the appearance of a hybrid version of a glove and mitten” in lines 14-17 is rejected since the claim already recites that the covering has a sealed distal end so it is unclear which limitation Applicant intends to claim.
Regarding claim 3:
“the structure” in line 1 lacks antecedent basis as it is unclear what the structure is. This may be overcome with language such as “the covering”.
Regarding claim 7:
“said multi-layer seal being no wider than half the diameter of the device width” in line 3 is rejected as not only is the diameter, the width, and the device not previously recited, the phrase “diameter of the device width” is redundant and confusing. This rejection can be overcome with language such as “said multi-layer seal being no wider than half a diameter of the covering”.
Claim 6 is rejected for depending from claim 2 and not curing the deficiencies thereof.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 2, 6 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2004/0199974 (Fancher).
Regarding claim 2, Fancher discloses a covering (Fancher discloses in [0025]-[0040] that the depicted inventions are variations of each other. Therefore, the examiner is interpreting the features presented by Fancher to be combinable except where otherwise stated.)
wherein the structure has one open end with one elastic band encased at the edge of the opening and an additional elastic band or bands encased a distance parallel to the first band and one closed end ([0033] – “FIG. 7 is another variation of the same device, used for knees (no. 16). Each figure shown on this page indicates a double elastic (no. 12) design, used for added protection”; figures 6-8 are all shown in the drawings to comprise one elastic band encased at an edge of an open end and an additional elastic band encased a distance parallel from that band, and a figures 6 and 8 show a closed end.);
said covering to present with one open end consisting of one or more encased elastic bands, placed parallel to each other and a distance apart to accommodate the insertion of absorbent material and a sealed distal end (Figs. 6 and 8 show one open end consisting of one or more encased elastic bands placed parallel to each other and a distance apart and are capable of accommodating the insertion of absorbent material. Figs. 6 and 8 also show a sealed distal end.);
said covering to present with one open end consisting of one or more encased elastic bands, placed parallel to each other and a distance apart to accommodate the insertion of absorbent material with a multi-layered folded and heat sealed enclosed distal end to accommodate a limb ending, such as a foot (Figs. 6 and 8 show one open end consisting of one or more encased elastic bands placed parallel to each other and a distance apart and are capable of accommodating the insertion of absorbent material. Figs. 6 and 8 also show a sealed distal end. [0032] - The distal end overlaps itself such that it forms multiple layers, and by heat sealing the multiple layers, a multi-layer seal is formed. The examiner also notes that Fig. 6 of the drawings filed 01 March 2024 of the present application contains the multi-layer seal according to Pg. 9 of the specification filed 30 December 2022 and Fig. 6 has all of the same features shown as Fig. 8 of US 2004/0199974. Below is a side-by-side comparison.);
said covering to present with one open end consisting of one or more encased elastic bands, placed parallel to each other and a distance apart to accommodate the insertion of absorbent material and the distal end comprising abbreviated fingertip and thumb tip pockets to accommodate only the digital endings or tips of a hand in such a manner as to create a webbing between the digits as viewed in the drawings and the appearance of a hybrid version of a glove and mitten (Figs. 1-3 and 5b show an embodiment with abbreviated fingertip and thumb tip pockets and a webbing between the digits.).
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Fig. 6 of the present Fig. 8 of
Application US 2004/0199974
Regarding claim 6, Fancher discloses said covering of Claim 2, comprising an elasticized open end and a sealed distal portion comprising abbreviated fingertip and thumb tip pockets (Figs. 1-3 and 5b show an embodiment with abbreviated fingertip and thumb tip pockets.).
Regarding claim 7, Fancher discloses said covering of Claim 2, elasticized open end and a multi-layer seal forming the distal end (Figs. 6 and 8 show a sealed distal end. [0032] - The distal end overlaps itself such that it forms multiple layers, and by heat sealing the multiple layers, a multi-layer seal is formed.);
said multi-layer seal being no wider than half the diameter of the device width (The multi-layer seal forms a point due to its rounded appearance and therefore is no wider than half the diameter since the multi-layer seal is at a point. See Fig. 8.);
said multi-layer seal that produces a narrowed ending to accommodate the digital end of a foot (The multi-layer seal forms a point due to its rounded appearance and therefore is a narrowed ending to accommodate the digital end of a foot. See Fig. 8.);
said multi-layer seal that, when device the covering is inflated, presents a rounded appearance (The distal end of the protective covering is folded in a manner that will create a rounded appearance. See [0032]. When inflated, the rounded appearance will remain due to the protective covering being tubular.);
said multi-layer seal that provides for flat folding and packaging (The distal end of the protective covering is capable of flat folding and packaging. This is evident by Fig. 5 where the protective covering is folded flat. See [0029].).
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.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0199974 (Fancher) in view of US 2021/0069035 (Cottrell) and US 2001/0041853 (South et al.).
Regarding claim 1, Fancher discloses a covering for the torso, arm or leg or mid areas of same (Fancher discloses a protective covering for the torso, arm or leg or mid areas of same. See Fig. 1 which shows one of the embodiments.),
with single or multiple encased elastic closures at each open end (Elastic band 12 is encased in the folded over edge. See [0044].);
said covering having an open end with one elastic band encased at the edge of the opening (Elastic band 12 is shown to be positioned at an open end of the protective covering. See Fig. 1 and the abstract.).
The variation of Fancher in Fig. 1 does not disclose said covering having a second elastic band encased a distance parallel to the first band at the open end; said covering having multiple additional elastic bands, encased a distance parallel to the first and second bands and to each other; said covering presenting a space between the parallel encased bands.
However, the variation in Fig. 8 shows a second elastic band 12 a distance parallel to the first band at the open end.
Cottrell discloses a cover 101 that is analogous to the protective covering of Fancher. The cover 101 has an elastic band 123 encased a distance parallel to the first and second bands 123. See Fig. 5 where the bands 123 are encased. Additionally, [0038] discloses that the bands can be located in any surface or layer of the cover 101 and that bands 123 may be on internal surfaces, external surfaces or between surfaces of cover 101.
South discloses a sleeve portion 12 that is analogous to the protective covering of Fancher and the assembly 100b of Cottrell. The sleeve portion has multiple intermediate bands 40 a distance parallel from the band 13 at the open end 12a.
The proposed combination is to add a second elastic band 12 parallel to the first band at the open end of the variation in Fig. 1 and to add an encased elastic band 123 of Cottrell to the protective covering of Fancher as an intermediate band as taught by South and to duplicate the added elastic band 123 of Cottrell such that there are two intermediate bands as taught by South.
It would have been obvious to an artisan of ordinary skill before the effective filing date to add a second elastic band 12 parallel to the first band at the open end of the variation in Fig. 1 as taught by Fancher in the variation in Fig. 8. A skilled artisan would have been motivated to do so because Fancher teaches that a double band design allows for added protection by allowing the casing of the inner band to serve as a ledge for seepage ([0015]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to protective body coverings.
It would have been obvious to an artisan of ordinary skill before the effective filing date to add an encased elastic band 123 of Cottrell to the protective covering of Fancher as an intermediate band as taught by South and to duplicate the added elastic band 123 of Cottrell such that there are two intermediate bands as taught by South. A skilled artisan would have been motivated to do so because Cottrell teaches that the bands secure the appendage cover to the appendage ([0039]) and South teaches that the user can cut the cover 101 immediately above a select intermediate band to shorten the cover to fit about a particular size cast ([0025]-[0026]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to protective body coverings.
As a result of the combination, Fancher in view of Cottrell and South discloses said covering having a second elastic band encased a distance parallel to the first band at the open end (The protective covering has a second elastic band 12 encased a distance parallel to the first band at the open end.);
said covering having multiple additional elastic bands, encased a distance parallel to the first and second bands and to each other (The combination comprises multiple additional elastic bands, encased a distance parallel to the first and second bands and to each other.);
said covering presenting a space between the parallel encased bands (The elastic bands 12 are separated by a space. See [0015] and Fig. 8.);
said covering presenting a space between parallel encased bands to accommodate the insertion of absorbent material ([0015] – “Located at the open edge of the device, each piece contains either a single band, mostly for arm or long term wear items, or double bands placed parallel and separated by a space, mostly for the leg items”; the space is capable of accommodating the insertion of absorbent material.).
Regarding claim 3, Fancher in view of Cottrell and South discloses said covering of Claim 1.
Fancher in view of Cottrell and South as modified above does not disclose wherein the structure has two open ends, each end comprising of one or more encased elastic bands, placed parallel to each other and a distance apart to accommodate the insertion of absorbent material.
However, The variation in Fig. 5a of Fancher discloses wherein the protective covering has two open ends.
The proposed combination is to modify the variation in Fig. 1 of Fancher to include a second open end as taught by the variation in Fig. 5a of Fancher.
It would have been obvious to an artisan of ordinary skill before the effective filing date to modify the variation in Fig. 1 of Fancher to include a second open end as taught by the variation in Fig. 5a of Fancher. A skilled artisan would have been motivated to do so because Fancher teaches that the variation in Fig. 5a allows for the device to isolate the elbow and leave the hand free ([0030]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to protective body coverings.
As a result of the combination, Fancher in view of Cottrell and South discloses wherein the structure has two open ends, each end comprising of one or more encased elastic bands, placed parallel to each other and a distance apart to accommodate the insertion of absorbent material (The protective covering comprises two open ends, each comprising one or more encased elastic bands placed parallel to each other and a distance apart.).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0199974 (Fancher) in view of US 2021/0069035 (Cottrell), US 5,643,183 (Hill), US 2003/0065357 (Dedo et al.) and US 2017/0335086 (Leano et al.).
Regarding claim 4, Fancher discloses a covering, for the torso, arm, leg or mid- areas of same (Abstract – “A disposable, yet re-usable, clear plastic protective covering, preferably clear, but not limited in color or clarity, designed to enclose articles or areas of the body in an air tight, thus waterproof environment and fitted to the body”.),
which is comprised of moisture resistant polymeric material ([0020] – “This present invention includes the use of a water-resistant plastic material, such as polyethylene film”);
said polymeric material comprising stretchable properties ([0009] – “This invention is made from polyethylene sheeting with thickness of approximately, but not limited to, 1.5 mil, providing durability, strength and stretchability as well as affordability.”);
said polymeric material that is approximately 1.5 mil or greater in thickness ([0009] – “This invention is made from polyethylene sheeting with thickness of approximately, but not limited to, 1.5 mil, providing durability, strength and stretchability as well as affordability.”).
Fancher does not disclose said covering that is comprised of seamless extruded tubular material of consistent diameter; said polymeric material comprising non-slip properties; said polymeric material comprising anti-microbial properties.
However, Cottrell discloses an appendage cover assembly formed of a cover body that is seamless and waterproof. See the abstract. [0005] – “Other appendage covers use a waterproof material, but the formation of the cover includes a seam that runs lengthwise along the cover or about its bottom end. Seams for a protective cover present a mode of failure since the seam may fail during manufacturing or during use, thus permitting external contaminants to enter within the cover. Furthermore, having a seam running along the protective cover presents a source of physical irritation for the user as the seam may protrude outward from the cover and catch on objects in passing, or the seam is oriented in a fashion that is noticeable by the user when external pressure is applied to the protective cover”; [0006] – “It is desired to make a seamless and waterproof bandage cover that does not add unwanted pressure to local injuries on an appendage.”
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the covering of Fancher to be made seamless as taught by Cottrell. A skilled artisan would have been motivated to do so because Cottrell teaches that seams are undesired since they present a mode of failure and may present a source of physical irritation ([0005]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to appendage covers.
Hill discloses a waterproof cover that is analogous to the protective covering of Fancher. The waterproof cover uses a single diameter to cover for a wide range of arm and leg diameters. See Col. 1, Lns. 47-51 of Hill.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the tubular material of the protective covering of Fancher to use a single diameter throughout as taught by Hill. A skilled artisan would have been motivated to do so because Hill teaches that a single diameter cover for a wide range of leg or arm diameters thereby eliminates requirements for many different models for differently sized extremities (Col. 1, Lns. 47-51). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to protective body coverings.
Dedo discloses a tourniquet padding comprising a cover sheet having anti-slip properties. [0093] – “Examples of suitable polymer resins having inherent anti-slip properties for cling use include polyethylene and polyethylene-containing films”; [0092] – “the cover sheet 14a comprises a polymeric film layer having anti-slip (cling) properties, strength, and elongation and memory properties such that the film layer will cling to skin and prevent slippage of a tourniquet disposed on the tourniquet padding during use on an extremity of a patient.”
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the material of the protective covering of Fancher to have non-slip properties as taught by Dedo. A skilled artisan would have been motivated to do so because Dedo teaches that the cling properties prevent slippage of the device on the patient. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to appendage covers.
Leano discloses a polymer composition made of polyethylene with an anti-microbial agent additive. See [0069] of Leano.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to add an anti-microbial agent to the polyethylene material of Fancher as taught by Leano. A skilled artisan would have been motivated to do so because anti-microbial agents prevent infections of the user by reducing the growth of microbials on the anti-microbial material. A skilled artisan would have a reasonable expectation of success given that Fancher and Leano are drawn to polyethylene compositions.
As a result of the modifications, Fancher in view of Cottrell, Hill, Dedo and Leano teaches said covering that is comprised of seamless extruded tubular material of consistent diameter (The covering of Fancher is modified by the teachings of Cottrell to be seamless and modified by the teachings of Hill to have a consistent diameter. The recitation “extruded” is considered a product-by-process limitation. 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(I).);
said polymeric material comprising non-slip properties (The covering of Fancher is modified by the teachings of Dedo to have non-slip properties.);
said polymeric material comprising anti-microbial properties (The covering of Fancher is modified by the teachings of Leano to comprise anti-microbial properties.).
Regarding claim 5, Fancher in view of Cottrell, Hill, Dedo and Leano teaches said covering of Claim 4 that is a reusable, and disposable (The protective covering is reusable and disposable. See [0022].);
said covering that is intended to be worn throughout the duration of treatment and recovery, yet cost effective and affordably replaceable (The protective covering is intended to be worn throughout the duration of treatment and recovery and is cost effective and affordably replaceable. See [0009].).
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 Seth Brown whose telephone number is (571)272-5642. The examiner can normally be reached 8:00 AM – 11:00 AM or 1:00 PM – 3:00 PM ET.
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/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786