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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it includes legal phraseology (i.e. “comprise”; “comprises”). Correction is required. See MPEP § 608.01(b).
Claim Objections
Claims 1, 8, 14, 16 and 20 are objected to because of the following informalities which require appropriate correction:
In claim 1 line 3: “the treatment” should be “treatment”.
In claim 1 line 4: “the development” should be “development”.
In claim 8, lines 1-3 should be amended to recite: “an adhesive configured such that the piece of material is adherable and removable from adherence to skin of a user when the piece…”.
In claim 14 line 4: “the treatment” should be “treatment”.
In claim 16 lines 1-2: the words “the positioning on” should be removed.
In claim 20 lines 1-2: the words “the positioning on” should be removed.
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 10, 12-13, 18 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites the limitation "the height" in line 1. There is insufficient antecedent basis for this limitation in the claim.
In claims 12-13 and 18-19 there exists an inconsistency between the language in the preamble and that of the body of each claim, thus making the scope of the claims unclear. In independent claim 1, in the preamble, line 1, applicant recites an “article of manufacture” with an area susceptible to the development of a bedsore being only functionally recited thus indicating that the claim is directed to the subcombination, a device. However, in each of claims 12-13 and 18-19, applicant positively recites and further limits the area susceptible to the development of a bedsore, i.e. by reciting that the area “comprises a bony prominence or a pressure point” (claims 12 and 18) or “is located on the back of the head, a shoulder, an elbow, a hip, the lower back, an inner knee, or a heel” (claims 13 and 19), thus indicating that the combination, device and area susceptible to the development of a bedsore, is being claimed. As such, it is unclear whether applicant intends to claim the subcombination or combination. Since claiming the combination of the device and the area susceptible to the development of a bedsore makes such claim(s) directed to non-statutory subject matter, applicant should amend the claims so as to remove all positive recitations of the area susceptible to the development of a bedsore. As such, the claim(s) would be directed to the subcombination, the device, and will be considered as such for examination purposes.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-2, 8-9 and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hu et al (US2010/0174250).
With respect to claim 1, Hu discloses an article of manufacture (dressing 100; fig 1) comprising:
a piece of material (base layer 108) having a perimeter side (outer edge 116 of dressing 100), a first surface (upper surface 112), a second surface (lower surface 110), and one or more openings (opening 120), the piece of material (108) forming a medical pad (base 108 forms the dressing 100 which is used for reduced pressure wound therapy {RPWT} as described in para [0040]) configured to allow the treatment and healing of bedsores and to prevent the development of bedsores (the dressing 100 is configured for RPWT and thus inherently is configured to reduce pressure to treat or prevent pressure sores; see also para [0002;0034-0036]) wherein: the piece of material is sized and shaped to position on a bedsore or an area susceptible to the development of a bedsore (the dressing is configured to reduce pressure points in the sacral region - para [0035]; pressure sores develop on the body in areas such as the sacral region of bed-ridden patients); the perimeter side (116) defines the perimeter of the piece of material (as shown in fig 1) extending between the first and second surfaces (as shown in fig 1); the first and second surfaces (112/110) extend opposite to each other between the perimeter side (as shown in fig 1) in a concave shaped portion (region 106; fig 1) such that the first surface (112) extends concave toward the second surface and the second surface extends concave away from the first surface (as shown in fig 1 at region 106), wherein the concave shaped portion (106) is sized and shaped to position over a bedsore or an area susceptible to the development of a bedsore (the fold sealing region 106 is configured to fit along skin at the intergluteal cleft – para [0041]; bedridden patients can develop pressure sores in the sacral region); the one or more openings (120) extend between and through the first and second surfaces (the opening provides fluid communication between a vacuum source and a wound bed that is covered by the dressing and thus inherently extends though the first/second surfaces of the dressing; see para [0036]); the one or more openings (120) are sized and shaped to allow air and vapor to pass through the one or more openings such that a bedsore or an area susceptible to the development of a bedsore can breathe while covered by the piece of material (the opening provides fluid communication between a vacuum source and a wound bed that is covered by the dressing and thus inherently allows air/vapor to pass though; see para [0036]); and the piece of material (108) comprises a silicone material or a silicone gel material (the dressing layers can comprise silicone material – para [0063]).
With respect to claim 2, Hu discloses the invention as claimed (see rejection of claim 1) and Hu also discloses that the perimeter side is rectangular shaped (as shown in fig 1).
With respect to claim 8, Hu discloses the invention as claimed (see rejection of claim 1) and Hu also discloses that the piece of material (108) further comprises an adhesive (para [0041]) such that the piece of material is adhereable and removable from adherence to a user's skin when the piece of material is positioned on a bedsore or an area susceptible to the development of a bedsore (the adhesive creates an airtight seal with the skin in the intergluteal cleft – para[0041]; pressure sores can form in bed ridden patients in the sacral region; the adhesive is used to attach the dressing to the user’s skin but is interpreted as being removable since it is not configured for permanent attachment to the body).
With respect to claim 9, Hu discloses the invention as claimed (see rejection of claim 1) and Hu also discloses that the piece of material is further sized and shaped to provide shock absorption that protects a bedsore or an area susceptible to the development of a bedsore from external force when the piece of material is positioned on the bedsore or the area susceptible to the development of a bedsore (para [0076]).
With respect to claim 12, Hu discloses the invention as claimed (see rejection of claim 1) and Hu also discloses that an area susceptible to the development of a bedsore comprises a bony prominence or a pressure point (pressure sores can develop at pressure points in the sacral region – para [0002]).
With respect to claim 13, Hu discloses the invention as claimed (see rejection of claim 1) and Hu also discloses that an area susceptible to the development of a bedsore is located on the back of an elbow, an inner knee, or a heel (pressure sores can develop at pressure points at the heel, knee and elbow – para [0002]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hu et al (US2010/0174250) in view of Jung et al (US 2011/0165221).
With respect to claim 3, Hu discloses the invention as claimed (see rejection of claim 2) but does not explicitly disclose that the piece of material has a length and a width of about 5 inches and a thickness between the first surface and the second surface of about 0.4 inches.
Jung teaches a wound dressing for use on wounds such as ulcers and bed sores (para [0002]) comprising a body having dimensions that are dictated by the size of the wounds for which it is applicable which include a length and width between 10mm-250mm (which includes the claimed length/width of 5 inches which is approximately 127mm) and a thickness of between 2-100mm (which includes the claimed thickness of 0.4 inches which is approximately 10mm). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the piece of material on the device of Hu having a length and a width of about 5 inches and a thickness between the first surface and the second surface of about 0.4 inches as taught by Jung since such a modification would have involved a mere change in the size of a component which is generally recognized as being within the level of ordinary skill in the art.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hu et al (US2010/0174250) in view of Wang (CN 202982403 U; machine translation).
With respect to claim 4, Hu discloses the invention as claimed (see rejection of claim 2) but does not disclose that the piece of material weighs about 150 grams.
Wang teaches a wound dressing which is configured for use on bedsores (para [0074]) which has a gram weight of between 100-300g/100cm2 (para [0011]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the device of Hu with a piece of material that weighs about 150grams as taught by Wang since discovering an optimum value of a result effective variable involves only routine skill in the art.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hu et al (US2010/0174250).
With respect to claim 5, Hu discloses the invention as claimed (see rejection of claim 1) but does not explicitly disclose in the embodiment of fig 1 that the perimeter side is elliptical shaped. Hu does, however, teach with respect to the embodiment of fig 3B that the layers forming the dressing can be not just generally rectangular but can be elliptical (para [0060]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention to have formed the device of figure 1 of Hu having an elliptical shape as taught with respect to the embodiment of figure 3B in order to provide a shape that best accommodates the anatomical contour of the area to be treated on the body.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hu et al (US2010/0174250) in view of Jung et al (US 2011/0165221).
With respect to claim 6, Hu discloses the invention substantially as claimed (see rejection of claim 5) but does not explicitly disclose that the piece of material has a width of about 5 inches and a thickness between the first surface and the second surface of about 0.4 inches.
Jung teaches a wound dressing for use on wounds such as ulcers and bed sores (para [0002]) comprising a body having dimensions that are dictated by the size of the wounds for which it is applicable which include a width between 10mm-250mm (which includes the claimed width of 5 inches which is approximately 127mm) and a thickness of between 2-100mm (which includes the claimed thickness of 0.4 inches which is approximately 10mm). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the piece of material on the device of Hu having a width of about 5 inches and a thickness between the first surface and the second surface of about 0.4 inches as taught by Jung since such a modification would have involved a mere change in the size of a component which is generally recognized as being within the level of ordinary skill in the art.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hu et al (US2010/0174250) in view of Wang (CN 202982403 U; machine translation).
With respect to claim 7, Hu discloses the invention substantially as claimed (see rejection of claim 5) but does not disclose that the piece of material weighs about 100 grams.
Wang teaches a wound dressing which is configured for use on bedsores (para [0074]) which has a gram weight of between 100-300g/100cm2 (para [0011]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the device of Hu with a piece of material that weighs about 100grams as taught by Wang since discovering an optimum value of a result effective variable involves only routine skill in the art.
Claims 1-2, 11, 14 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mack (US 2017/0056251) in view of Hu et al (US2010/0174250).
With respect to claim 1, Mack discloses an article of manufacture (disc 200; figs 5-8) comprising: a piece of material (the disc is formed from material – para [0013]) having a perimeter side (the device has an outer edge defining a perimeter as shown in figs 5-8), a first surface and a second surface (identified in the annotated fig 8 below), and one or more openings (holes 5), the piece of material forming a medical pad configured to allow the treatment and healing of bedsores and to prevent the development of bedsores (para [0021]) wherein: the piece of material is sized and shaped to position on a bedsore or an area susceptible to the development of a bedsore (para [0021]); the perimeter side defines the perimeter of the piece of material (as shown in figs 5-8) extending between the first and second surfaces (as shown in fig 8); the first and second surfaces extend opposite to each other between the perimeter side (as shown in fig 8) in a concave shaped portion (conical dome 2) such that the first surface extends concave toward the second surface and the second surface extends concave away from the first surface (as shown in annotated fig 8), wherein the concave shaped portion (2) is sized and shaped to position over a bedsore or an area susceptible to the development of a bedsore (para [0021;0054]); the one or more openings (holes 5) extend between and through the first and second surfaces (as shown in fig 8); the one or more openings (5) are sized and shaped to allow air and vapor to pass through the one or more openings such that a bedsore or an area susceptible to the development of a bedsore can breathe while covered by the piece of material (para [0058]; use on bedsores is discussed in para [0021]).
ANNOTATED FIG 8 of Mack (US 2017/0056251)
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Mack does not, however, disclose that the piece of material comprises a silicone material or a silicone gel material.
Hu, however ,teaches an article of manufacture (dressing 100; fig 1) comprising:
a piece of material (base layer 108) having a perimeter side (outer edge 116 of dressing 100), a first surface (upper surface 112), a second surface (lower surface 110), and one or more openings (opening 120), the piece of material (108) forming a medical pad (base 108 forms the dressing 100 which is used for reduced pressure wound therapy {RPWT} as described in para [0040]) configured to allow the treatment and healing of bedsores and to prevent the development of bedsores (the dressing 100 is configured for RPWT and thus inherently is configured to reduce pressure to treat or prevent pressure sores; see also para [0002;0034-0036]) wherein: the piece of material is sized and shaped to position on a bedsore or an area susceptible to the development of a bedsore (the dressing is configured to reduce pressure points in the sacral region - para [0035]; pressure sores develop on the body in areas such as the sacral region of bed-ridden patients); the perimeter side (116) defines the perimeter of the piece of material (as shown in fig 1) extending between the first and second surfaces (as shown in fig 1); the first and second surfaces (112/110) extend opposite to each other between the perimeter side (as shown in fig 1) in a concave shaped portion (region 106; fig 1) such that the first surface (112) extends concave toward the second surface and the second surface extends concave away from the first surface (as shown in fig 1 at region 106), wherein the concave shaped portion (106) is sized and shaped to position over a bedsore or an area susceptible to the development of a bedsore (the fold sealing region 106 is configured to fit along skin at the intergluteal cleft – para [0041]; bedridden patients can develop pressure sores in the sacral region); the one or more openings (120) extend between and through the first and second surfaces (the opening provides fluid communication between a vacuum source and a wound bed that is covered by the dressing and thus inherently extends though the first/second surfaces of the dressing; see para [0036]); the one or more openings (120) are sized and shaped to allow air and vapor to pass through the one or more openings such that a bedsore or an area susceptible to the development of a bedsore can breathe while covered by the piece of material (the opening provides fluid communication between a vacuum source and a wound bed that is covered by the dressing and thus inherently allows air/vapor to pass though; see para [0036]); and the piece of material (108) comprises a silicone material or a silicone gel material (the dressing layers can comprise silicone material – para [0063]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used a silicone or silicone gel material as taught by Hu for the piece of material on the device of Mack in order to allow the device to form a seal with various anatomical contours of the body (Hu para [0063]) and, furthermore, because it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
With respect to claim 2, Mack in view of Hu discloses the invention as claimed (see rejection of claim 1) and Hu also teaches that the perimeter side is rectangular shaped (as shown in fig 1). Mack also teaches in a different embodiment, shown in fig 26, that the perimeter side can be rectangular shaped. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the article of Mack in view of Hu such that the perimeter side is rectangular shaped since applicant has not disclosed that such a design solves any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a piece of material for positioning on a bedsore.
With respect to claim 11, Mack in view of Hu discloses the invention substantially as claimed (see rejection of claim 1) but does not explicitly disclose that the one or more openings are about 3.6 millimeters wide. Mack does, however, teach that the one or more openings have a hole diameter of about 0.0625 inches but that larger holes can be provided (para [0058]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have provided larger openings in the article of Mack in view of Hu such that the openings are about 3.6mm wide since Mack specifically teaches forming the device with larger holes and such a modification would have involved a mere change in the size of a component which is generally recognized as being within the level of ordinary skill in the art.
With respect to claim 14, Mack in view of Hu discloses the article substantially as claimed (see rejection of claim 1) and Mack also discloses a method of using the article comprising positioning the piece of material on a bedsore such that the first surface faces toward the bedsore and the concave shaped portion positions over the bedsore such that the piece of material covers the bedsore and allows the treatment and healing of the bedsore (para [0021;0054;0060]; fig 22).
With respect to claim 16, Mack in view of Hu discloses the method substantially as claimed (see rejection of claim 14) and Mack also discloses removing the piece of material from the positioning on the bedsore (para [0090-0091] disclose method steps which include removing the disc from a treatment site).
With respect to claim 17, Mack in view of Hu discloses the article substantially as claimed (see rejection of claim 1) and Mack also discloses a method of using the article comprising positioning the piece of material on an area susceptible to the development of a bedsore such that the first surface faces toward the area and the concave shaped portion positions over the area such that the piece of material covers the area and prevents the development of a bedsore on the area (para [0021;0054;0060]; fig 22).
With respect to claim 18, Mack in view of Hu discloses the method substantially as claimed (see rejection of claim 17) and Mack also discloses that the area susceptible to the development of a bedsore comprises a pressure point (“irritation point” – para [0054]).
With respect to claim 19, Mack in view of Hu discloses the method substantially as claimed (see rejection of claim 17) and Mack also discloses that the device is designed to fit various areas of the human body for treating bedsores on those areas (para [0021]). Mack does not, however, explicitly disclose that such areas are located on the back of the head, a shoulder, an elbow, a hip, the lower back, an inner knee, or a heel. Hu, however, teaches application of the device to an area susceptible to the development of a bedsore which is located on an elbow, an inner knee, or a heel (pressure sores can develop at pressure points at the heel, knee and elbow – para [0002]). Furthermore, it would be understood by one having ordinary skill in the art that a bed-ridden patient would be susceptible to developing bedsores on areas such as, specifically, the heels, due to the pressure applied to the area from lying in bed in i.e. a supine position with the heels against the mattress for a prolonged period of time. Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used the method of Mack in view of Hu to treat areas located on an elbow, knee or heel as taught by Hu since Mack specifically discloses use of the device for treating bedsores on various areas of the body and it would have been known by those having ordinary skill in the art that areas such as the heels are an area of the body that is highly susceptible to the development of pressure sores in bed-ridden patients and thus, would be in need of treatment/prevention of such sores.
With respect to claim 20, Mack in view of Hu discloses the method substantially as claimed (see rejection of claim 17) and Mack also discloses removing the piece of material from the positioning on the area susceptible to the development of a bedsore (para [0090-0091] disclose method steps which include removing the disc from a treatment site).
Claims 3 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Mack (US 2017/0056251) in view of Hu et al (US2010/0174250) and further in view of Jung et al (US 2011/0165221).
With respect to claim 3, Mack in view of Hu discloses the invention as claimed (see rejection of claim 2) but does not explicitly disclose that the piece of material has a length and a width of about 5 inches and a thickness between the first surface and the second surface of about 0.4 inches.
Jung teaches a wound dressing for use on wounds such as ulcers and bed sores (para [0002]) comprising a body having dimensions that are dictated by the size of the wounds for which it is applicable which include a length and width between 10mm-250mm (which includes the claimed length/width of 5 inches which is approximately 127mm) and a thickness of between 2-100mm (which includes the claimed thickness of 0.4 inches which is approximately 10mm). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the piece of material on the device of Mack in view of Hu having a length and a width of about 5 inches and a thickness between the first surface and the second surface of about 0.4 inches as taught by Jung since such a modification would have involved a mere change in the size of a component which is generally recognized as being within the level of ordinary skill in the art.
With respect to claim 10, Mack in view of Hu discloses the invention as claimed (see rejection of claim 1) and Mack also discloses that the concave shaped portion (dome 2) has a height that is approximately the same as the thickness of the disc (para [0054]). Mack does not, however, disclose that the height (or thickness) is about 2 inches.
Jung teaches a wound dressing for use on wounds such as ulcers and bed sores (para [0002]) comprising a body having dimensions that are dictated by the size of the wounds for which it is applicable which include a thickness of between 2-100mm (which includes a thickness value of 2 inches which is approximately 51mm). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the piece of material on the device of Mack in view of Hu having a thickness between the first surface and the second surface of about 2 inches as taught by Jung since such a modification would have involved a mere change in the size of a component which is generally recognized as being within the level of ordinary skill in the art. Also, if the thickness is about 2 inches, it would have been obvious to one having ordinary skill in the art, at the time of the invention, to form the concave shaped portion of the device of Mack in view of Hu having a height that is about 2 inches since Mack explicitly discloses that the height of the dome 2 is approximately the same as the thickness of the disc. Furthermore, one having ordinary skill in the art would have been motivated to modify the concave shaped portion of Mack in view of Hu to have a height that is about 2 inches since discovering an optimum value of a result effective variable involves only routine skill in the art.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mack (US 2017/0056251) in view of Hu et al (US2010/0174250) and further in view of Wang (CN 202982403 U; machine translation).
With respect to claim 4, Mack in view of Hu discloses the invention substantially as claimed (see rejection of claim 2) but does not disclose that the piece of material weighs about 150 grams.
Wang teaches a wound dressing which is configured for use on bedsores (para [0074]) which has a gram weight of between 100-300g/100cm2 (para [0011]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the device of Hu with a piece of material that weighs about 150grams as taught by Wang since discovering an optimum value of a result effective variable involves only routine skill in the art.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mack (US 2017/0056251) in view of Hu et al (US2010/0174250) and further in view of Mumby (RU-2615075-C2; machine translation).
With respect to claim 15, Mack in view of Hu discloses the method substantially as claimed (see rejection of claim 14) but does not explicitly disclose that the bedsore is covered with a dressing and the piece of material is positioned on the bedsore over the dressing.
Mumby, however, teaches a method for producing a wound dressing, comprising: providing a shielding layer for distributing the pressure applied to the wound dressing over an area larger than the area of applied pressure; and providing a cover layer adjacent to and above the shielding layer on the surface of the wound dressing not facing the wound (“sixth aspect” of the invention described in page 3 of the translation). Thus, Mumby teaches covering a wound with a dressing (shielding layer) and positioning a piece of material (cover layer) over the dressing. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the method of Mack in view of Hu to include the step of covering a bedsore with a dressing and positioning the piece of material of Mack in view of Hu over the dressing as taught in the method in Mumby in order to protect the treatment site from direct contact with the piece of material.
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 1-4 and 8-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12076214 (hereinafter referred to as the ‘214 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the present application and claim 1 of the ‘214 patent differ in that the patented claims include more elements than the claims in the present application and, therefore, are more narrow and specific. Thus, claim 1 of the ‘214 Patent is in effect a “species” of the broader, “generic” invention recited in claim 1 of the present application. It has been held that a generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Thus, claim 1 of the present application is anticipated by claim 1 of the ‘214 patent and, therefore, is not patentably distinct from claim 1 of the ‘214 patent.
All of the limitations of claim 2 can be found in claim 1 of the ‘214 Patent; All of the limitations of claim 3 can be found in claim 9 of the ‘214 Patent; All of the limitations of claim 4 can be found in claim 10 of the ‘214 Patent; All of the limitations of claim 8 can be found in claim 11 of the ‘214 Patent; All of the limitations of claim 9 can be found in claim 12 of the ‘214 Patent; All of the limitations of claim 10 can be found in claim 13 of the ‘214 Patent; All of the limitations of claim 11 can be found in claim 14 of the ‘214 Patent; All of the limitations of claim 12 can be found in claim 15 of the ‘214 Patent; All of the limitations of claim 13 can be found in claim 16 of the ‘214 Patent; All of the limitations of claim 14 can be found in claim 6 of the ‘214 Patent; All of the limitations of claim 15 can be found in claim 7 of the ‘214 Patent; All of the limitations of claim 16 can be found in claim 8 of the ‘214 Patent; All of the limitations of claim 17 can be found in claim 2 of the ‘214 Patent; All of the limitations of claim 18 can be found in claim 3 of the ‘214 Patent; All of the limitations of claim 19 can be found in claim 4 of the ‘214 Patent; All of the limitations of claim 20 can be found in claim 5 of the ‘214 Patent.
Conclusion
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786