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 .
Election/Restrictions
Applicant's election with traverse of Invention Group I (claims 1-21 and 26) in the reply filed on 06/25/2026 is acknowledged.
Applicant's election with traverse of Species Group A (Figures 1A-D, 2, 3A-D) in the reply filed on 06/25/2026 is acknowledged.
The traversal is on the ground(s) that the alleged multiple embodiments are actually a single inventive concept which should be allowed to be continued in this application (Applicant’s Remarks, page 6). Applicant argues that independent claim 1 is not anticipated nor obvious in view of the cited U.S. Patent Application 2009/0260639) (“Hsu”) (Applicant’s Remarks, pages 6-7).
This is not found persuasive because as set forth in the Requirement for Restriction/Election of 02/27/2026, Groups I and II and Species A, B, C, D and E lack unity of invention because even though the invention and species of these groups require the technical features of an elevation apparatus to elevate a bony prominence on a user comprising: a permeable skin-compatible adhesive layer; an absorbent layer for absorbing wound exudate; a hydrophobic layer above the absorbent layer, these technical features are not special technical features as they do not make a contribution over the prior art of Hsu. Examiner did not address whether Hsu anticipates claim 1 only that in view of Hsu the shared technical features of the groups of inventions and the species are not special technical features as they are disclosed by Hsu.
The requirement is still deemed proper and is therefore made FINAL.
In the reply filed on 06/25/2026, Applicant failed to identify the claims readable on the elected species. Applicant elected Species Group A (Figures 1A-D, 2, 3A-D) in the reply filed on 06/25/2026 which species pertains to the sacrum.
Examiner hereby selects claims 1-5, 11-13, 18, 20-21, and 26 as claims readable on the elected species (elevation apparatus for a sacrum).
Claims 6-10, 14-16, 17, 19, 22-25 are hereby withdrawn from consideration. Claims 1-5, 11-13, 18, 20-21 and 26 are being examined herewith.
Response to Amendment
The amendment to the claims filed on 6/25/2026 is acknowledged. In the amendment, claims 5, 16 and 26 are amended.
Claim Objections
The claims are objected to because in the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
The claims are objected to because the lines are crowded too closely together, making reading difficult. Substitute claims with lines one and one-half or double spaced on good quality paper are required. See 37 CFR 1.52(b).
Claim 21 is objected to because of the following informalities: Claim 21 includes the pronoun “its” which is unclear as it does not indicate whether “packaging” had been previously introduced in the claim. It is suggested that the claim be amended to recite –taking the elevation apparatus from packaging--. 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 4, 11, 13 and 18 is 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 4 recites wherein the absorbent layer either has the permeable skin-compatible adhesive layer therein is a foam or is set between the permeable skin-compatible adhesive layer and the hydrophobic layer.
This claim is indefinite as it is unclear what Applicant is trying to claim as the language of “is a foam” does not make sense in the claim. For the purposes of examination the claim will be interpreted as -- wherein the absorbent layer either has the permeable skin-compatible adhesive layer therein or is set between the permeable skin-compatible adhesive layer and the hydrophobic layer--.
Claim 11 recites the limitation "a second prefilled air bladder both creating one aperture" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, it will be interpreted as –a second prefilled air bladder, both prefilled air bladders creating one aperture--.
The term “and the like” in claim 13 is a relative term which renders the claim indefinite. The term “and the like” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination the term will be interpreted as being deleted.
The term “about” in claim 18 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination the limitation will be interpreted as --2 inches to 10 inches--..
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.
Claim(s) 1, 4-5, 11-12, 18 and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi (US 2013/0174856) in view of Andrews (US 5914125).
Regarding claim 1, Choi discloses an elevation apparatus (14) (Fig. 2, capable of intended use; [0033]) to elevate a bony prominence on a user (capable of intended use; [0033], relieve pressure from bony protuberances pf the body contacted against an underlying surface; [0042], pods 28 have an height range; [0035]; [0021], sacrum is capable of being elevated relative to other body parts), comprising; an absorbent layer (26) ([0024], [0051], pad has a breathable layer that is porous and can be made from materials such as cotton; [0038], [0045], outer pad in contact with the patient; [0045], pad 26 still flexible enough for conforming over or around the patient’s body; NOTE: as outer pad is positioned over the patient’s body and has a porous cover such as cotton it is capable of intended use); a layer (22) above the absorbent layer (Fig. 3; it is above the absorbent layer 26 depending on orientation of the device); and at least one prefilled air bladder (28) ([0040], each of the pods may be filled with a gas such as air, nitrogen etc.) connected to the layer (Fig. 3) including at least one aperture (spaces between pods 28 [at least one prefilled air bladder) configured for placement over the bony prominence being elevated ([0035]; sacrum, capable of intended use).
Choi does not disclose a permeable skin-compatible adhesive layer and that the layer is a hydrophobic layer.
Andrews teaches an analogous elevation apparatus (30) (Fig. 3, Fig. 4) (col. 4, line 62 to col. 5, line 2; an island dressing is capable of elevating the body part to which it is applied; capable of intended use; col. 11, lines 10 to 26) comprising a permeable skin-compatible adhesive layer (38) (col. 11, lines 10 to 26), an analogous absorbent layer (40, 32, 34) (col. 11, lines 10 to 26) and a hydrophobic layer (36) (analogous to the backing/shell layer 22 of Choi; col. 4, line 62 to col. 5, line 2, the backing layer is thin, waterproof thus it is hydrophobic) above the absorbent layer (Fig. 3, Fig. 4).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide a permeable skin-compatible adhesive layer to the elevation apparatus of Choi by providing the permeable skin-compatible layer to the absorbent layer as taught by Andrews in order to provide an improved device that adheres the apparatus to a patient (Andrews, col. 11, lines 10-26) and to provide that the layer of Choi is a hydrophobic layer, as taught by Andrews, in order to provide an improved device that allows a patient to wash or shower while wearing the apparatus (Andrews, col. 4, line 62 to col. 5, line 5).
Regarding claim 4, Choi in view of Andrews discloses the invention as described above with regard to claim 1.
The combination further discloses wherein the absorbent layer either has the permeable skin-compatible adhesive layer therein is a foam or is set between the permeable skin-compatible adhesive layer and the hydrophobic layer (In the combination the absorbent layer is disposed between the shell 22 [which shell 22 of Choi in the combination with Andrews is taught to be a hydrophobic layer] and the skin-compatible permeable adhesive layer (In the combination the skin-compatible permeable adhesive is applied to the absorbent layer and thus the absorbent layer is set between the permeable skin-compatible adhesive layer and the hydrophobic layer).
Regarding claim 5, Choi in view of Andrews discloses the invention as described with regard to claim 1.
Choi further discloses wherein the bony prominence is selected from the group consisting of a heel, metatarsal, ankle, elbow, hip, shoulder, blade or sacrum ([0008], [0021]; [0035]; sacrum).
Regarding claim 11, Choi in view of Andrews discloses the invention as described above with regard to claim 1.
Choi further discloses a second prefilled air bladder (28) ([0038], a second one of the fluid filled pods; [0040], each of the pods filled with a gas such as air) both creating one aperture (opening between the pods 28 seen in Fig. 2) and the two prefilled air bladders and one aperture are configured to be placed over a sacrum bone of a user ([0038]; [0037], assembly 14 placed against the region of the body requiring support such as the sacrum SA).
Regarding claim 12, Choi in view of Andrews discloses the invention as described above with regard to claim 1.
Choi further discloses wherein the shape of the elevation apparatus is selected from the group consisting of circle, square, rectangle, heart (Fig. 2 shows rounded side lobes of the backing 22 which in the combination is hydrophobic and thus it is in the shape of a heart in that the heart shape of Applicant’s specification shown in Figs. 1-3 has rounded side lobes), rounded square, rounded rectangle (Fig. 2 shows a central rectangle shape between the sides with rounded ends) , "T" shape, "U" shape, "V" shape and combinations thereof (Fig. 2 shows the device has a V-shape and can also be considered to be a rounded rectangle in the middle of the device at the section where pods/pads 24 and 28 are; also ).
Regarding claim 18, Choi in view of Andrews discloses the invention as described above with regard to claim 1.
Choi further discloses wherein the bony prominence is a sacrum bone, further comprising a second air bladder and the hydrophobic layer is in the shape of a heart (Fig. 2 shows rounded side lobes of the backing 22 which in the combination is hydrophobic and thus it is in the shape of a heart in that the heart shape of Applicant’s specification shown in Figs. 1-3 has rounded side lobes) or rounded heart, square or circle having a length and width of about 2 inches to about 10 inches.
Choi discloses the claimed invention except for the hydrophobic layer is in the shape having a length and width of about 2 inches to about 10 inches.
It would It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to provide that the shape of the hydrophobic layer is having a length and width of about 2 inches to about 10 inches for the purpose of providing support to the region of the body upon which the assembly is secured (Choi, [0019]) as applicant appears to have placed no criticality on the claimed range (at page 17 Applicant indicates the shape of the hydrophobic layer may be dependent on the size of the sacrum bone and some ranges are about 3-15 inches for adult in width, preferably about 5-10 includes and about 3-15 inches long, preferably about 5-10 includes long), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 20, Choi in view of Andrews discloses the invention as described above with regard to claim 1.
Choi further discloses further comprising a second air bladder in connection with the first prefilled air bladder (28) ([0038], a second one of the fluid filled pods; [0040], each of the pods filled with a gas such as air; Fig. 2 shows it adjacent to the first bladder 28 and connected via pod 24, and pad 26).
Regarding claim 21, Choi in view of Andrews discloses the invention as described above with regard to claim 1.
Andrews further teaches further comprising a protective layer (42, 44) (col. 11, lines 10-26) over the permeable skin-compatible adhesive layer (col. 11, lines 10-26, exposed adhesive protected by removable panels 42, 44), wherein the protective layer is comprised of a film, polymer, paper (col. 11, lines 10-26 low-adherent film or silicone-coated release paper) or combinations thereof.
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the permeable skin-compatible adhesive layer of the elevation apparatus of Choi in view of Andrews is further comprising a protective layer (over the permeable skin-compatible adhesive layer, wherein the protective layer is comprised of a film, polymer, paper or combinations thereof, in order to provide an improved elevation apparatus that protects the adhesive layer before application (Andrews, col. 11, lines 10-26).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi (US 2013/0174856) in view of Andrews (US 5914125) as applied to claim 1 above and further in view of Ravikumar (US 2009/0124944).
Regarding claim 2, Choi in view of Andrews discloses the invention as described above.
The combination does not disclose wherein the absorbent layer is foam or sponge.
Ravikumar teaches an analogous elevation apparatus (Figs. 4A-4C) ([0017], pre-filled air bladder; capable of intended use of elevating a limb; [0046]) having an analogous absorbent layer ([0017], foam is analogous to the pad of Choi which is absorbent as described above) for absorbing wound exudate ([0017], absorbent foam, sponge or dressing formed as a unit with the pre-filled air bladder; [0048]; [0049]), wherein the absorbent layer is foam or sponge ([0017]; [0048]) and an analogous air bladder (238) ([0048]).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the absorbent layer of Choi in view of Andrews is foam, as taught by Ravikumar, in order to provide an improved elevation apparatus that aids in wicking exudate from the wound or ulcer (Ravikumar, [0049]).
Regarding claim 3, Choi in view of Andrews and in further view of Ravikumar discloses the invention as described above with regard to claim 2.
Ravikumar further teaches wherein the absorbent layer is selected from an open cell foam ([0049], open cell foam), closed cell foam, partial open and closed cell foam, silicone foam, and combinations thereof.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi (US 2013/0174856) in view of Andrews (US 5914125) as applied to claim 1 above, and further in view of Sakotic (US 2020/0121515), in view of Hansen (US 2021/0205138), and in view of Buglino (US 6011194).
Regarding claim 13, Choi in view of Andrews discloses the invention as described above with regard to claim 1.
The combination fails to disclose further comprising medication, silver, zinc oxide, antibiotics, pain killers and the like impregnated into the permeable skin-compatible adhesive layer.
Sakotic teaches a dressing ([0044]) having analogous absorbent layer for absorbing a wound exudate (wound dressing, [0044]) and an analogous skin adhesive layer ([0054], adhesive composition) where the analogous skin adhesive layer is comprising medication ([0054]), antibiotics ([0054]), pain killers ([0054], analgesic which is medication and a pain killer) impregnated into the analogous adhesive ([0054]; the recitation of impregnated has been treated as a product-by-process recitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulations of the recited steps, only to the structure implied by the steps. Thus, even though Sakotic is silent as to the process used to provide the medication, pain killers, the apparatus disclosed is the same as that claimed).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the elevation apparatus of Choi in view of Andrews is further comprising medication, antibiotics, pain killers impregnated into the permeable skin-compatible adhesive layer, as taught by Sakotic, in order to provide an improved elevation apparatus that provides pain relief (Sakotic [0054], analgesic provides pain relief).
Choi in view of Andrews and in further view of Sakotic discloses the invention as described above.
The combination fails to disclose further comprising, silver, zinc oxide, impregnated into the permeable skin-compatible adhesive layer.
Hansen teaches a dressing ([0040] to [0042) having an analogous adhesive layer ([0042]) and is further comprising silver ([0042]) impregnated into the analogous adhesive layer (the recitation of impregnated has been treated as a product-by-process recitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulations of the recited steps, only to the structure implied by the steps. Thus, even though Hansen is silent as to the process used to provide the medication, pain killers, the apparatus disclosed is the same as that claimed).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the elevation apparatus of Choi/Andrews/Sakotic is further comprising silver impregnated into the permeable skin-compatible adhesive layer as taught by Hansen in order to provide an improved elevation apparatus that provides antimicrobial properties (Hansen, [0042]).
Choi in view of Andrews, in view of Sakotic and in further view of Hansen discloses the invention as described above.
The combination fails to disclose further comprising, zinc oxide, impregnated into the permeable skin-compatible adhesive layer.
Buglino teaches a dressing with an analogous adhesive layer (col. 4, lines 27-33) and is comprising zinc oxide impregnated in the analogous adhesive layer (col. 4, lines 27-33, the adhesive of the dressing may include zinc oxide; the recitation of impregnated has been treated as a product-by-process recitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulations of the recited steps, only to the structure implied by the steps. Thus, even though Buglino is silent as to the process used to provide the medication, pain killers, the apparatus disclosed is the same as that claimed).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the elevation apparatus of Choi/Andrews/Sakotic/Hansen is further comprising zinc oxide impregnated into the permeable skin-compatible adhesive layer as taught by Buglino in order to provide an improved elevation apparatus that provides wound care (Buglino, col. 4, lines 27-33).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi (US 2013/0174856) in view of Hansson (US 2020/0383836) and in further view of Andrews (US 5914125).
Regarding claim 26, Choi discloses a method of elevating a bony prominence of a user ([0033], relieve pressure from bony protuberances of the body contacted against an underlying surface; [0042], pods 28 have an height range; [0035]; [0021], sacrum is capable of being elevated relative to other body parts), comprising: the elevation apparatus including at least one prefilled air bladder (28) ([0040], each of the pods may be filled with a gas such as air, nitrogen etc.), a layer (22) (Fig. 3), an absorbent layer (26) ([0024], [0051], pad has a breathable layer that is porous and can be made from materials such as cotton; [0038], [0045], outer pad in contact with the patient; [0045], pad 26 still flexible enough for conforming over or around the patient’s body; NOTE: as outer pad is positioned over the patient’s body and has a porous cover such as cotton it is capable of absorbing); and placing the at least one prefilled air bladder and absorbent layer for absorbing wound exudate over the bony prominence ([0011], securing the portable support assembly [apparatus] directly to the region of the body to be supported…wherein the redistributed pressure load is exerted upon the body surrounding the supported region).
Choi does not disclose taking an elevation apparatus from its packaging, a hydrophobic layer, and a permeable skin-compatible adhesive layer with a protective layer on the permeable skin-compatible adhesive laver; removing the protective layer comprised of film, polymer, paper or combination thereof thereby activating the permeable skin-compatible adhesive layer below the protective layer on the elevation apparatus; and pressing on the elevation apparatus so that the bony prominence is in contact with the permeable skin-compatible adhesive layer.
Hansson teaches an analogous elevation apparatus (300) ([0080], dressing applied to the skin in the sacrum region which elevates the sacrum) and taking an elevation apparatus from its packaging ([0087]; standard packaging may be used to sterilize the product and for storage, thus it is implicit that the packaging is removed before use).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the method of elevating a bony prominence of a user of Choi, is comprising taking an elevation apparatus from its packaging as taught by Hansson in order to provide an improved method that facilitates storage and sterilization of the elevation apparatus before use (Hansson, [0087]).
Choi in view of Hansson discloses the invention as described above.
The combination does not disclose a hydrophobic layer, and a permeable skin-compatible adhesive layer with a protective layer on the permeable skin-compatible adhesive laver; removing the protective layer comprised of film, polymer, paper or combination thereof thereby activating the permeable skin-compatible adhesive layer below the protective layer on the elevation apparatus; and pressing on the elevation apparatus so that the bony prominence is in contact with the permeable skin-compatible adhesive layer.
Andrews teaches an analogous method of elevating a bony prominence of a user (col. 4, line 62 to col. 5, line 2; an island dressing is capable of elevating the body part to which it is applied; col. 11, lines 10 to 26, comprising an analogous elevation apparatus (30) (Fig. 3, Fig. 4) (col. 4, line 62 to col. 5, line 2; an island dressing is capable of elevating the body part to which it is applied; capable of intended use of elevating; col. 11, lines 10 to 26) comprising a hydrophobic layer (36) (analogous to the backing/shell layer 22 of Choi; col. 4, line 62 to col. 5, line 2, the backing layer is thin, waterproof thus it is hydrophobic), a permeable skin-compatible adhesive layer (38) (col. 11, lines 10 to 26), an analogous absorbent layer (40, 32, 34) (col. 11, lines 10 to 26) with a protective layer (42, 44) (col. 11, lines 10-26) on the permeable skin-compatible adhesive layer (col. 11, lines 10-26, exposed adhesive protected by removable panels 42, 44), removing the protective layer comprised of film, polymer, paper or combination thereof thereby activating the permeable skin-compatible adhesive layer below the protective layer on the elevation apparatus (col. 11, lines 10-26); and placing the analogous elevation apparatus over the bony prominence and pressing on the elevation apparatus so that the bony prominence is in contact with the permeable skin-compatible adhesive layer (col. 11, lines 10-26; NOTE: the adhesive serves to adhere the dressing to a patient and thus it is implicit that pressing on the elevation apparatus occurs so that the bony prominence is in contact with the skin-compatible adhesive).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the method of elevating a bony prominence of Choi in view of Hansson is comprising a hydrophobic layer, as taught by Andrews, in order to provide an improved method that allows a patient to wash or shower while wearing the apparatus (Andrews, col. 4, line 62 to col. 5, line 5), is comprising a permeable skin-compatible adhesive layer with a protective layer, removing the protective layer comprised of film, polymer, paper or combination thereof thereby activating the permeable skin-compatible adhesive layer below the protective layer on the elevation apparatus; and pressing on the elevation apparatus so that the bony prominence is in contact with the permeable skin-compatible adhesive layer as taught by Andrews, in order to provide an improved method that adheres the apparatus to a patient (Andrews, col. 11, lines 10-26) and that protects the adhesive layer before application (Andrews, col. 11, lines 10-26).
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1 is provisionally rejected on the ground of nonstatutory double patenting as
being unpatentable over claim 21 of copending Application No. 19331657 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are a narrower recitation of the invention than that of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 of the instant application recites: An elevation apparatus to elevate a bony prominence on a user, comprising:a permeable skin-compatible adhesive layer; an absorbent layer for absorbing wound exudate; a hydrophobic layer above the absorbent layer; andat least one prefilled air bladder connected to the hydrophobic layer including at least one aperture configured for placement over the bony prominence being elevated.
Claim 21 of the reference application recites: An elevation and wound dressing apparatus to elevate a bony prominence on a user, comprising: a permeable skin-compatible adhesive layer; an inner hydrophilic layer; an absorbent layer for absorbing wound exudate; a hydrophobic layer above the absorbent layer; and at least one inflatable air bladder capable of inflation via an inflation port and a inflation means, the at least one inflatable air bladder connected to the hydrophobic layer including at least one aperture configured for placement over the bony prominence being elevated
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 1 of the current application and claim 21 of the reference application lies in the fact that the reference application claims includes more elements and is thus more specific. Thus, the invention of claim 21 of the reference application is in effect a “species” of the “generic” invention of current application claim 1. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the current application is anticipated by claim 21 of the reference application, it is not patentably distinct from claim 21 of the reference application.
Claims 2 is provisionally rejected on the ground of nonstatutory double patenting as
being unpatentable over claim 22 of copending Application No. 19331657 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are a narrower recitation of the invention than that of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 2 of the instant application recites: wherein the absorbent layer is a foam or sponge.
Claim 22 of the reference application recites: wherein the absorbent layer is selected from the group consisting of a foam, sponge, an open cell foam, closed cell foam, partial open and closed cell foam, silicone foam, cotton, pulp, cellulose, cellulose derivatives, polymers, high molecular water absorbent polymers, thermoplastic resin, cellulosic fiber, acrylic (salt) polymer, foam, woven or nonwoven material selected from the group consisting of rayon, polyester, polyurethane, polyolefin, orlon, hydrogel polymeric material, and combinations thereof.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 2 of the current application and claim 22 of the reference application lies in the fact that the reference application claims includes more elements and is thus more specific. Thus, the invention of claim 22 of the reference application is in effect a “species” of the “generic” invention of current application claim 2. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 2 of the current application is anticipated by claim 22 of the reference application, it is not patentably distinct from claim 22 of the reference application.
Claims 3 is provisionally rejected on the ground of nonstatutory double patenting as
being unpatentable over claim 22 of copending Application No. 19331657 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are a narrower recitation of the invention than that of the reference application.
Claim 3 of the present application recites: wherein the absorbent layer is selected from an open cell foam, closed cell foam, partial open and closed cell foam, silicone foam, and combinations thereof.
For the recitation of claim 22, see above with regard to claim 2.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 3 of the current application and claim 22 of the reference application lies in the fact that the reference application claims includes more elements and is thus more specific. Thus, the invention of claim 22 of the reference application is in effect a “species” of the “generic” invention of current application claim 3. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 3 of the current application is anticipated by claim 22 of the reference application, it is not patentably distinct from claim 22 of the reference application.
Regarding claims 4, the limitations therein are substantially recited in claim 23 of the
reference application.
Claims 5 is provisionally rejected on the ground of nonstatutory double patenting as
being unpatentable over claim 24 of copending Application No. 19331657 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are a narrower recitation of the invention than that of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 5 of the instant application recites: wherein the bony prominence is selected from the group consisting of a heel, metatarsal, ankle, elbow, hip, shoulder, lade or sacrum.
Claim 24 of the reference application recites: wherein the bony prominence is selected from the group consisting of heel, metatarsal, ankle, elbow, hip, shoulder blade, sacrum, elbow, wrist, finger, thumb or combinations thereof.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 5 of the current application and claim 24 of the reference application lies in the fact that the reference application claims includes more elements and is thus more specific. Thus, the invention of claim 24 of the reference application is in effect a “species” of the “generic” invention of current application claim 24. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 5 of the current application is anticipated by claim 24 of the reference application, it is not patentably distinct from claim 24 of the reference application.
Claims 1-2, 5, 11-12 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 10 and 18-19 of copending Application No. 19331657 in view of Andrews (US 5914125) and in further view of Choi (US 2013/0174856).
Regarding claim 1, the limitations recited therein are substantially recited in claim 1 of the reference application where the outerwaterproof layer is interpreted as a hydrophobic layer.
Claim 1 of the reference application does not disclose a permeable skin-compatible adhesive layer and at least one aperture configured for placement over the bony prominence being elevated.
Andrews teaches an analogous elevation apparatus (30) (Fig. 3, Fig. 4) (col. 4, line 62 to col. 5, line 2; an island dressing is capable of elevating the body part to which it is applied; capable of intended use; col. 11, lines 10 to 26) comprising a permeable skin-compatible adhesive layer (38) (col. 11, lines 10 to 26), an analogous absorbent layer (40, 32, 34) (col. 11, lines 10 to 26) and a hydrophobic layer (36) (analogous to the backing/shell layer 22 of Choi; col. 4, line 62 to col. 5, line 2, the backing layer is thin, waterproof thus it is hydrophobic) above the absorbent layer (Fig. 3, Fig. 4).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide a permeable skin-compatible adhesive layer to the elevation apparatus of claim 1 by providing the permeable skin-compatible layer to the absorbent layer as taught by Andrews in order to provide an improved device that adheres the apparatus to a patient (Andrews, col. 11, lines 10-26) and to provide that the layer of Choi is a hydrophobic layer, as taught by Andrews, in order to provide an improved device that allows a patient to wash or shower while wearing the apparatus (Andrews, col. 4, line 62 to col. 5, line 5).
Claim 1 in view of Andrews discloses the invention as described above.
Claim 1 in view of Andrews does not disclose at least one aperture configured for placement over the bony prominence.
Choi teaches an analogous elevation apparatus (14) (Fig. 2, capable of intended use) to elevate a bony prominence on a user (capable of intended use; [0042], pods 28 have an height range; [0035]; [0023], sacrum is capable of being elevated relative to other body parts), comprising; an analogous absorbent layer (26) ([0024], has a breathable layer that is porous and can be made from materials such as cotton; [0038], [0045], outer pad in contact with the patient; [0045], pad 26 still flexible enough for conforming over or around the patient’s body; NOTE: as outer pad is positioned over the patient’s body and has a porous cover such as cotton it is capable of intended use); an analogous outer layer (22) above the absorbent layer (Fig. 3; it is above the absorbent layer 26 depending on orientation of the device); and at least one analogous prefilled air bladder (28) ([0040], each of the pods may be filled with a gas such as air, nitrogen etc.) connected to the layer (Fig. 3) including at least one aperture (spaces between pods 28 [at least one prefilled air bladder) configured for placement over the bony prominence being elevated ([0035]; sacrum, capable of intended use).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide at least one aperture configured for placement over the bony prominence to the elevation apparatus of claim 1 in view of Andrews, as taught by Choi, in order to provide an improved elevation apparatus that has more than one air bladder spaced apart (Choi, [0040]).
Regarding claim 2, the limitations are substantially recited in claim 3 of the reference application.
Regarding claim 5, the limitations are substantially recited in claim 10 of the reference patent.
Regarding claim 11, the limitations are substantially recited in claim 18 of the reference patent.
Regarding claim 12, the limitations are substantially recited in claim 19 of the reference patent.
Regarding claim 20, the limitations are substantially recited in claim 18 of the reference patent.
Conclusion
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/G.M./Examiner, Art Unit 3786
/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786
