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 without traverse of Species I in the reply filed on 5/27/2026 is acknowledged. Claims 1, 2, 4, 14-15, 21, 29, 31, 35, 39-41, 47, 54-55, 66-68, and 77 are examined while claim 13 is withdrawn.
Claim Objections
Claim 14 objected to because of the following informalities: “the pulling force” should be “the pulling force on the tissue site” in line 3. Appropriate correction is required.
Claim 15 objected to because of the following informalities: “the shape of the tissue site” should be “[[the]] a shape of the tissue site” in line 2. Appropriate correction is required.
Claim 47 objected to because of the following informalities: “the pulling force” should be “the pulling force on the tissue site” in line 3. Appropriate correction is required.
Claim 77 objected to because of the following informalities: “the pulling force” should be “the pulling force on the tissue site” in line 3. 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 1, 4, 14, 21, 29, 35, 39, 47, 54-55, 66-67, and 77 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. Claims 2, 15, and 31 are rejected due to their dependency on claim 1, claims 40-41 are rejected due to their dependency on claim 35, and claim 68 is rejected due to their dependency on claim 67.
The limitation “unloaded state” and “loaded state” in claim 1 is unclear. Examiner is unsure how the first layer itself has an unloaded state and loaded state without any other structure or material involved in the claim. Examiner examined this claim as best understood.
The limitation “first layer comprises a biasing element configured to radially pull on the tissue site” in claim 4 is unclear. Examiner is unsure what the biasing element is in the first layer that is capable of radially pulling on the tissue site. There is not enough information in the specification on how the first layer is interacting with the tissue site. Examiner examined this claim as best understood.
The limitation “wherein the first layer is configured to exert a pulling force on the tissue site” in claim 14 is unclear. Examiner is unsure how the first layer is capable of pulling on the tissue site. There is not enough information in the specification on how the first layer is interacting with the tissue site. Examiner examined this claim as best understood.
The term “about” in claim 21 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. Examiner proposes to remove the term “about” to improve clarity.
The term “about” in claim 29 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. Examiner proposes to remove the term “about” to improve clarity.
The limitation “unloaded state” and “loaded state” in claim 35 is unclear. Examiner is unsure how the spring layer itself has an unloaded state and loaded state without any other structure or material involved in the claim. Examiner examined this claim as best understood.
The limitation “wherein the spring member is configured to radially pull on the tissue site” in claim 39 is unclear. Examiner is unsure on how the spring member is capable of radially pulling on the tissue site. There is not enough information in the specification on how the spring member is interacting with the tissue site. Examiner examined this claim as best understood.
The limitation “wherein the spring member is configured to exert a pulling force on the tissue site” in claim 47 is unclear. Examiner is unsure how the spring member is capable of pulling on the tissue site. There is not enough information in the specification on how the first layer is interacting with the tissue site. Examiner examined this claim as best understood.
The term “about” in claim 54 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. Examiner proposes to remove the term “about” to improve clarity.
The term “about” in claim 55 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. Examiner proposes to remove the term “about” to improve clarity.
Claim 66 recites the limitation "the second layer" in line 2. There is insufficient antecedent basis for this limitation in the claim.
The limitation “unloaded state” and “loaded state” in claim 67 is unclear. Examiner is unsure how the first layer itself has an unloaded state and loaded state without any other structure or material involved in the claim. Furthermore, examiner is unclear on what is applying the external force onto the first layer. Examiner examined this claim as best understood.
The limitation “wherein the first layer is configured to exert a pulling force on the tissue site” in claim 77 is unclear. Examiner is unsure how the first layer is capable of pulling on the tissue site. There is not enough information in the specification on how the first layer is interacting with the tissue site. Examiner examined this claim as best understood.
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.
Claims 1-2, 4, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Locke (US 20200000643 A1).
Regarding claim 1, Locke discloses an apparatus (114 – figure 7C, tissue interface: paragraph 0085) configured to increase fluid flow through a tissue site (the apparatus [114] comprises fluid restrictions configured to permit fluid flow: paragraph 0013-0016), the apparatus (114) comprising: a first layer (A – see annotated figure 1, a layer made of a liquid-impermeable, elastomeric material which comprises one or more fluid restrictions [220 – figure 7C] that consist of elastic passages: paragraph 0062/0066-0068/0085) configured to at least partially encircle the tissue site (the first layer [A] can be formed into a hollow cylinder and be adjacent to the tissue site [see examiner further notes below]; additionally, the apparatus [114] comprising the first layer [A] can vary in geometry and dimensions depending on a particular application or anatomy: paragraph 0034/0047/0055/0072/0085), the first layer (A) having an unloaded state and a loaded state (the first layer [A] comprises fluid restrictions [220] that are made of elastic passage and can reduce liquid flow if unstrained [unloaded state], and can expand or open in response to a pressure gradient [loaded state, such as under negative pressure which pulls on the tissue site]: paragraph 0016/0021/0062/0067-0068); a second layer (205 – figure 7C, a layer that comprises or consist of a manifold: paragraph 0058-0059/0085) coupled to the first layer (A) (figure 7B/see annotated figure 1, the first layer [A] and third layer [B – see annotated figure 1] are coupled to the second layer [205] via welding: paragraph 0084-0085), a third layer (B – see annotated figure 1, another layer made of a liquid-impermeable, elastomeric material which comprises one or more fluid restrictions [220 – figure 7C] that consist of an elastic passage: paragraph 0062/0066-0068/0085) coupled to the second layer (205) opposite the first layer (A) (see annotated figure 1, the third layer [B] is coupled to the second layer [205] opposite the first layer [A] via welding: paragraph 0084-0085), the third layer (B) configured to be coupled to the tissue site (see annotated figure 1, the apparatus [114] comprising the third layer [B] is adapted to contact the tissue site [can partially or fully contact and partially or fully fill a wound]; additionally, the apparatus [114] comprising the third layer [B] can vary in geometry and dimensions depending on a particular application or anatomy: paragraph 0034/0047/0055/0072/0085).
Examiner further notes: A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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Annotated figure 1: tissue interface of Locke
Regarding claim 2, Locke discloses the invention as discussed in claim 1. Locke further discloses wherein the first layer (A) has an arc-shaped cross section with a central angle of at least 180 degrees (C – see annotated figure 1, a central angle) when the first layer (A) is in the unloaded state (see annotated figure 1, the central angle [C] excludes the triangle piece; from the first end [D – see annotated figure 1] to the second end [E – see annotated figure 1] arc, the central angle [C] is greater than 180 degrees, which reads on the claimed range).
Regarding claim 4, Locke discloses the invention as discussed in claim 1. Locke further discloses wherein the first layer (A) comprises a biasing element (220 – figure 7C, plurality of fluid restrictions: paragraph 0085) configured to radially pull on the tissue site to increase lymphatic flow through the tissue site (the first layer [A] comprises a biasing element [220] that are made of elastic passages and can reduce liquid flow if unstrained [unloaded state], and can expand or open in response to a pressure gradient [loaded state, such as under negative pressure which pulls on the tissue site] to increase liquid flow: paragraph 0016/0021/0062/0067-0068).
Examiner further notes: A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 15, Locke discloses the invention as discussed in claim 1. Locke et al. further discloses wherein the second layer (205) comprises a conformable material configured to conform to the shape of the tissue site (the second layer [205] can be a porous material such as open-cell foam [reticulated foam], which is capable of conforming to the shape of the tissue site: paragraph 0056/0060).
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.
Claims 14 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Locke (US 20200000643 A1).
Regarding claim 14, Locke discloses the invention as discussed in claim 1. Locke further discloses wherein the first layer (A) is configured to exert a pulling force on the tissue site (the first layer [A] comprises a biasing element [220] that are made of elastic passages and can reduce liquid flow if unstrained [unloaded state], and can expand or open in response to a pressure gradient [loaded state, such as under negative pressure which pulls on the tissue site] to increase liquid flow: paragraph 0016/0021/0062/0067-0068).
Examiner further notes: A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
However, Locke fails to disclose wherein the third layer has a bond strength at least 30% greater than the pulling force.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the third layer to have a bond strength of at least 30% greater than the pulling force to enable extended wear while undergoing negative-pressure therapy (paragraph 0006/0023, Locke), 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. Further, applicant places no criticality on the range claimed, indicating simply that the peel strength (bond strength) of the third layer is 30% greater than the pulling force of the first layer (written specification: paragraph 0056).
Regarding claim 21, Locke discloses the invention as discussed in claim 1. Locke further discloses wherein the second layer (205) has a thickness of about 2 to about 4 millimeters (the second layer [205] may have a thickness of about 5 to about 8 millimeters: paragraph 0083).
It would have been prima facie obvious to one of ordinary skills in the art before the filing date to have modified the thickness of the second layer from about 5-8 millimeters to about 2-4mm for a specific need of a desired therapy and to a desired conformability (paragraph 0056, Locke) even though the claimed ranges or amounts do not overlap with the prior art (please see MPEP 2144.05 I., “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)”). Further, applicant places no criticality on the range claimed, indicating simply that the thickness of the second layer in some embodiments may be in a range of about 2 millimeters to 4 millimeters, less than 2 millimeters, or greater than 4 millimeters (written specification: paragraph 0032).
Claims 29 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Locke (US 20200000643 A1) in view of Munro et al. (US 20190000677 A1), with extrinsic evidenced provided by “BioBright.blog” for the rejection of claim 31.
Regarding claim 29, Locke discloses the invention as discussed in claim 1.
However, Locke fails to disclose wherein the third layer comprises an adhesive having a peel strength in a range of about 10 N to about 20 N.
Munro teaches wherein an analogous third layer (203 – figure 2, a supporting film that provides structural support and can be made of a fabric layer which can comprise of a polymeric film [such as polyurethane]: paragraph 0110/0137) comprises an adhesive (204 – figure 2, an adhesive comprising silicone, a hydrocolloid, a polyurethane, an acrylic polymer, a rubber adhesive and a hydrogel: paragraph 0137) having a peel strength in a range of about 10 N to about 20 N (the adhesive [204] has a peel strength of 10N/25mm, when measured in a 180° peel strength test on steel after 20 minutes adhesion, e.g. a test as described in ASTM D3330 [similar to instant applications test mentioned in paragraph 0041]: paragraph 0104).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the third layer of Locke et al. with an adhesive having a peel strength in a range of about 10N to about 20N as taught by Munro in order to provide an improved third layer that allows for an enhanced bond between the skin of the user and the apparatus (paragraph 0085, Munro). Further, applicant places no criticality on the range claimed, indicating simply that the adhesive peel strength “may be” within the claimed ranges (written specification: 0041).
Regarding claim 31, Locke in view of Munro discloses the invention as discussed in claim 29. Munro further discloses wherein the adhesive (204) has a peel strength that is configured to be reduced following an application of an alcohol to the adhesive (204) (since the adhesive can be made of silicone, the peel strength of the adhesive can be reduced following an application of an alcohol such as isopropyl [as evidenced in “BioBright.blog”]: paragraph 0137).
Claims 35, 39-41, 47, 54-55, 66-68, and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Bennett (US 6554786 B2) in view of Francis (US 20200107966 A1).
Regarding claim 35, Bennett discloses an apparatus (figure 1, a compression dressing: column 1, lines 58-67 & column 2, lines 1-16) configured to increase fluid flow through a tissue site (the apparatus [figure 1] is for the treatment of lymphoedema: column 1, lines 58-67), the apparatus (figure 1) comprising: a spring member (1 – figure 1, a two-way stretch material with a high modulus of elasticity: column 3, lines 3-15) configured to at least partially encircle the tissue site (the spring member [1] encircles the user’s arm: column 3, lines 47-66), the spring member (1) comprising: a curved wall (F – see annotated figure 2, a curved wall that goes around the user’s limb: column 3, lines 47-59); a first open end (G – see annotated figure 2, a first open end for the user’s hand: column 3, lines 16-22); a second open end (H – see annotated figure 2, a second open end); and an opening in the curved wall (I – see annotated figure 2, an opening in the curved wall) extending from the first open end (G) to the second open end (H) (the opening in the curved wall [I] is open before wrapping around the user’s limb: abstract), the opening (I) defining a first edge (5 – figure 1, tape sewn to the spring member: column 3, lines 23-30) and a second edge (8 – figure 1, the other half of the slide fastener that is sewn to a continuous edge of a tape of hooked material: column 3, lines 32-45) wherein the spring member (1) is configured to be in an unloaded state and a loaded state (the spring member [1] is highly elastic; in its unloaded state [original shape or tube shape {no limb within tube}, such as figures 1 and 2] there are no pressure applied, while in its loaded state, there is a compression force around the user’s limb: column 3, lines 47-67 & column 4, lines 1-3); wherein the spring member (1) is configured to be compressed from the unloaded state to the loaded state (the spring member [1] is highly elastic; in its unloaded state [original shape or tube shape {no limb within tube}, such as figures 1 and 2] there are no pressure applied while in its loaded state, there is a compression force around the user’s limb: column 3, lines 47-67 & column 4, lines 1-3); and wherein the spring member (1) is biased to the unloaded state (figure 1/figure 2, the spring member [1] is highly elastic and is biased to the unloaded state (original shape/tube shape) from the loaded state [deformed shape with limb in the tube shape] due to deformation/compression in the loaded state; the term “elastic” is defined as “easily resuming original size or shape after being stretched or otherwise deformed; flexible” by Elastic - definition of elastic by The Free Dictionary); a conformable layer coupled to the spring member (1) (the inner surface of the spring member [1] is clad [bonded] with a woven or knitted stretch fabric of natural or man-made fibers for comfort: column 3, lines 11-15).
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Annotated figure 2: apparatus of Bennett when unzipped
However, Bennett fails to disclose an adhesive layer coupled to the conformable layer opposite the spring member.
Francis teaches an adhesive layer (20 – figure 6B, an adhesive layer: paragraph 0075) coupled to an analogous conformable layer (16 – figure 6B, a third layer that may be an inner gauze dressing: paragraph 0071) opposite an analogous spring member (14 – figure 6B, a second layer that is made with bias weaved yarn; it is stretchable and elastic: paragraph 0077) (figure 6B, the adhesive layer [20] is opposite of the spring member [14]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the conformable layer of Bennett with an adhesive layer that is opposite of the spring member as taught by Francis in order to provide an improved apparatus to better secure the apparatus onto the user’s skin (paragraph 0075, Francis).
Regarding claim 39, Bennett in view of Francis discloses the invention as discussed in claim 35. Bennett further discloses wherein the spring member (1) is configured to radially pull on the tissue site to increase lymphatic flow through the tissue site (figure 1/figure 2, the spring member [1] is highly elastic and provides compression around a user’s limb in its loaded state; however, when the compression of the spring member [1] is decreased and rebounds [bias towards] to a unloaded state, the rebound indirectly lifts [radially pulls] the user’s limb which is capable of increasing lymphatic flow [see examiner further notes below]: column 3, lines 47-67 & column 4, lines 1-3).
Examiner further notes: A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 40, Bennett in view of Francis discloses the invention as discussed in claim 35. Bennett further discloses wherein compression of the spring member (1) brings the first edge (5) closer to the second edge (8) (figure 1/figure 2, as the user is wrapping the spring member [1] on to their limb, there is a compression force needed to bring the first edge [5] to the second edge [8] to enclose the spring member [1] around the user since the spring member [1]’s circumference is smaller than the limb’s circumference: column 3, lines 47-59).
Regarding claim 41, Bennett in view of Francis discloses the invention as discussed in claim 35. Bennett further discloses wherein the spring member (1) includes one or more apertures extending therethrough (the spring member [1] is perforated to make it breathable: column 3, lines 3-7).
Regarding claim 47, Bennett in view of Francis discloses the invention as discussed in claim 35. Bennett further discloses wherein the spring member (1) is configured to exert a pulling force on the tissue site (figure 1/figure 2, the spring member [1] is highly elastic and provides compression around a user’s limb in its loaded state; however, when the compression of the spring member [1] is decreased and rebounds [bias towards] to a unloaded state, the rebound indirectly lifts [pulls] the user’s limb: column 3, lines 47-67 & column 4, lines 1-3)
However, Bennett in view of Francis fails to explicitly disclose wherein the adhesive layer has a peel strength at least 30% greater than the pulling force.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the adhesive layer to have a peel strength at least 30% greater than the pulling force to enhance the bond between the apparatus and the user’s skin to prevent the apparatus from coming off (paragraph 0075, Francis), 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. Further, applicant places no criticality on the range claimed, indicating simply that the peel strength of the adhesive layer is “at least 30%” greater than the pulling force (written specification: paragraph 0056).
Regarding claim 54, Bennett in view of Francis discloses the invention as discussed in claim 35.
However, Bennett in view of Francis fails to explicitly disclose wherein the conformable layer has a thickness of about 2 to about 4 millimeters.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the conformable layer to have a thickness of about 2 to about 4 millimeters to provide comfort for the user during use (column 3, lines 9-15, Bennett), 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. Further, applicant places no criticality on the range claimed, indicating simply that the thickness of the conformable layer in some embodiments may be in a range of about 2 millimeters to 4 millimeters, less than 2 millimeters, or greater than 4 millimeters (written specification: paragraph 0032).
Regarding claim 55, Bennett in view of Francis discloses the invention as discussed in claim 35.
However, Bennett in view of Francis fails to explicitly disclose wherein the conformable layer has a tear strength of about 20 N and the adhesive layer has a peel strength in a range of about 10 N to about 20 N.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the conformable layer to have a tear strength of about 20N to ensure structural integrity (column 3, lines 9-15, Bennett), 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. Further, applicant places no criticality on the range claimed, indicating simply that the tear strength of the conformable layer in some embodiments may have a tear strength of at least 2.5 pounds per inch or 20N (written specification: paragraph 0031).
Furthermore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the adhesive layer to have a peel strength in a range of about 10N to about 20N to enhance the bond between the apparatus and the user’s skin to prevent the apparatus from coming off (paragraph 0075, Francis), 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. Further, applicant places no criticality on the range claimed, indicating simply that the peel strength of the adhesive layer in some embodiments may have a peel strength of about 5N to about 20N or 10N (written specification: paragraph 0041).
Regarding claim 66, Bennett in view of Francis discloses the invention as discussed in claim 35. Francis further teaches wherein the adhesive layer (20) is printed on the second layer (16) (figure 6A/figure 6B, the adhesive layer [20] is printed on [adhesive is applied onto] the second layer; the adhesive layer [20] is coated radially by known coating techniques [see examiner further notes below]: paragraph 0079).
Examiner further notes: As to claim 66, the limitation, “wherein the adhesive layer is printed on the second layer” is drawn to an article of manufacture, and therefore the limitation is considered to be a product-by-process limitation that is given patentable weight only for the structural limitations imparted to the final product by the process. When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps (emphasis added). Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “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.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, it is noted that the adhesive layer of Francis, et al. appear to be substantially identical to the adhesive layer claimed, although produce by a different process, therefore the burden is upon the applicant to come forward with evidence establishing an unobvious difference between the two. In re Marosi, 218 USPQ 289 (Fed. Cir. 1983).
Regarding claim 67, Bennett discloses a method of treating a tissue site (the apparatus [figure 1/figure 2] is for the treatment of lymphoedema: column 1, lines 58-67), the method comprising: inserting the tissue site into an apparatus (figure 1, a compression dressing: column 1, lines 58-67 & column 2, lines 1-16), the apparatus (figure 1) comprising: a first layer (1 – figure 1, a two-way stretch material with a high modulus of elasticity: column 3, lines 3-15) configured to at least partially encircle the tissue site (the spring member [1] encircles the user’s arm: column 3, lines 47-66), the first layer (1) having an unloaded state and a loaded state (the spring member [1] is highly elastic and has an unloaded state where there is no pressure applied and a loaded state where there is a compression force around the user’s limb: column 3, lines 47-67 & column 4, lines 1-3); wherein the spring member (1) is configured to be compressed from the unloaded state to the loaded state (the spring member [1] is highly elastic; in its unloaded state [original shape or tube shape {no limb within tube}, such as figures 1 and 2], there are no pressure applied while in its loaded state, there is a compression force around the user’s limb: column 3, lines 47-67 & column 4, lines 1-3); a second layer (the inner surface of the spring member [1] is clad [bonded] with a woven or knitted stretch fabric of natural or man-made fibers for comfort: column 3, lines 11-15) coupled to the first layer (1) (the second layer [2] is clad [bonded] with the first layer [1]), placing an external force on the first layer (1) to place the first layer in the loaded state (figure 1/figure 2, as the user is wrapping the spring member [1] on to their limb, there is a compression force needed to bring the first edge [5 – figure 1] to the second edge [8 – figure 1] to enclose the spring member [1] around the user since the spring member [1]’s circumference is smaller than the limb’s circumference; once closed via slide fastener [9 – figure 1], the first layer [1] is in a loaded state that provides compression onto the user’s limb: column 3, lines 47-67 & column 4, lines 1-3); and removing the external force from the first layer (1) (the user would unzip the edges [5/8] via the slide fastener [9], which would remove the compression force applied from the spring member [1]: column 3, lines 47-67 & column 4, lines 1-3); wherein the first layer (1) tends to return from the loaded state to the unloaded state (the spring member [1] is highly elastic and is biased to the unloaded state (original shape/tube shape) from the loaded state [deformed shape with limb in the tube shape] due to deformation/compression in the loaded state; the term “elastic” is defined as “easily resuming original size or shape after being stretched or otherwise deformed; flexible” by Elastic - definition of elastic by The Free Dictionary) to radially pull on the tissue site to increase lymphatic flow through the tissue site (figure 1/figure 2, the spring member [1] is highly elastic and provides compression around a user’s limb in its loaded state; however, when the compression of the spring member [1] is decreased and rebounds [bias towards] to a unloaded state, the rebound indirectly lifts [radially pulls] the user’s limb which is capable of increasing lymphatic flow: column 3, lines 47-67 & column 4, lines 1-3).
However, Bennett fails to disclose a third layer coupled to the second layer opposite the first layer; coupling the apparatus to the tissue site using the third layer.
Francis teaches a third layer (20 – figure 6B, an adhesive layer: paragraph 0075) coupled to an analogous second layer (16 – figure 6B, a third layer that may be an inner gauze dressing: paragraph 0071) opposite an analogous first layer (14 – figure 6B, a second layer that is made with bias weaved yarn; it is stretchable and elastic: paragraph 0077) (figure 6B, the adhesive layer [20] is opposite of the spring member [14]); coupling an analogous apparatus (figure 6B) to the tissue site using the third layer (20) (the third layer [20] is an adhesive that contacts the skin: paragraph 0075).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the second layer of Bennett with a third layer that is opposite of the first layer that couples the apparatus to the tissue site using the third layer as taught by Francis in order to provide an improved apparatus to better secure the apparatus onto the user’s skin (paragraph 0075, Francis).
Regarding claim 68, Bennett in view of Francis discloses the method as discussed in claim 67. Bennett further discloses wherein the first layer (1) has an arc-shaped cross section of at least 180 degrees when the first layer (1) is in the unloaded state (figure 2, when the apparatus [figure 1/figure 2] is in its tubular form [unloaded state, without limb], the central angle [J – see annotated figure 3]; from the first end [K – see annotated figure 3] to the second end [L – see annotated figure 3] arc, the central angle [J] is at least 180 degrees).
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Annotated figure 3: apparatus of Bennett revealing the arc-shaped cross section
Regarding claim 77, Bennett in view of Francis discloses the method as discussed in claim 67. Bennett further discloses wherein the first layer (1) is configured to exert a pulling force on the tissue site ((figure 1/figure 2, the spring member [1] is highly elastic and provides compression around a user’s limb in its loaded state; however, when the compression of the spring member [1] is decreased and rebounds [bias towards] to a unloaded state, the rebound indirectly lifts [pulls] the user’s limb: column 3, lines 47-67 & column 4, lines 1-3)
However, Bennett in view of Francis fails to disclose wherein the third layer has a peel strength at least 30% greater than the pulling force.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the adhesive layer to have a peel strength at least 30% greater than the pulling force to enhance the bond between the apparatus and the user’s skin to prevent the apparatus from coming off (paragraph 0075, Francis), 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. Further, applicant places no criticality on the range claimed, indicating simply that the peel strength of the adhesive layer is “at least 30%” greater than the pulling force (written specification: paragraph 0056).
Conclusion
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/ANDREW JUN-WAI MOK/Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786
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