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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/21/2026 has been entered.
Status of Claims
Claims 1, 3-15, 19-21 and 23-25 are pending and currently under consideration for patentability.
Claims 1, 7, 21, 23 and 24 are newly amended.
Response to Amendment
The examiner accepts claim amendments regarding the previous claim objections. The claim objections are therefore withdrawn.
Response to Arguments
Applicant's arguments filed 1/21/2026 have been fully considered but they are not persuasive.
The applicant further claims Rodzewicz does not disclose a skin-contact layer that extends beyond the corresponding first ply layer of the compress shell, the figure 2a clearly shows that the external layers extend beyond first and second ply.
The applicant further claims the present claims require that the compress has a different modulus of elasticity in the longitude direction and transverse direction and that the core of the compress contains a nonwoven material. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (page 16 of applicants specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
The applicant further argues that one skilled in the art would not have been motivated to incorporate an additional backing layer from Ahsani into the article of Rodzewicz given that Rodzewicz already contained a backing layer used in conjunction with a skin contact layer in substantially the same manner as used in Ahsani. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the prior art references have different structures and uses with the addition backing layers. Since the backing layers of Ahsani have an improved purpose (to hold more fluid) the combination is obvious.
Regarding Claim 4 and 6, and the applicant’s argument that Rodzewicz fails to teach a hydrophilic material, the examiner disagrees. As mentioned a hydrophilic material is widely known to be a material that attracts water. This does not need to be a chemical property, but instead be a physical property. Paragraph [0034] cites “The apertures serve to improve the absorption of fluid into the pad without compromising the tight fit to the skin provided by the adhesive first layer.” Thus aiding in the fluid being attracted to the body contact layer, therefor hydrophilic.
Regarding Claim 8 and 9, and the applicants argument that nothing in paragraph [0081] or elsewhere in Leppanen describes the weld seam as being anything other than a continuous seam, the examiner disagrees. The examiner has interpreted continuous to mean a visually discontinuous seem. The seems is visually discontinuous as cited by the applicant in the arguments.
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.
Claim(s) 1-7,11-19, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable Rodzewicz (US 20200383839 A1) in view of Ahsani (US 20180133066 A1 ).
Regarding Claim 1, Rodzewicz teaches a medical article (200) (figure 2) for prophylaxis (paragraph [0007]) of the development and/or worsening of decubitus ulcers (abstract), comprising:
a compress (paragraph [0062]),
wherein the compress includes a proximal surface and a distal surface (figure 2a) and comprises a core (202) and a shell (201 +203) surrounding the core (202), wherein the core (202) includes a proximal surface and a distal surface and comprises a nonwoven material (paragraph [0075]) comprising of fibers and absorbent particles (paragraph [0102]), and
a skin-contact layer (207) comprising an adhesive configured to secure the outer ply layer and/or the compress to a subject's skin (paragraph [0028]),
wherein the skin-contact layer projects beyond the compress (figure 2a),
wherein the outer ply layer and the skin-contact layer are coextensive and form a first edge region that surrounds the compress on all sides (figure 2a)
wherein the shell comprises a first ply layer (203) composed of a liquid-permeable material (apertures, paragraph [0034]) and arranged on the proximal surface of the core and a second ply layer (201) composed of a liquid impermeable layer (paragraph [0122]) arranged on the distal surface of the core (figure 2A),
wherein the compress has a longitudinal direction having a first modulus of elasticity and a transverse direction having a second modulus of elasticity and the first modulus of elasticity is greater than the second modulus of elasticity (figures 2a-2c) (paragraphs [0071]-[0077].
And wherein the first ply layer (203) of the shell projects beyond the proximal surface of the core on all sides and the second ply layer (201) of the shell projects beyond the distal surface of the core on all sides (figure 2a), and wherein the first ply layer (203) of the shell and the second ply layer of the shell form a second edge region which surrounds the core on all sides (figure 2a), wherein the first ply layer (203) of the shell and the second ply layer (201) of the shell are joined to one another with a connection in the second edge region (figure 2a) (paragraph [0062]).
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The claimed phrase “welding” is being treated as a product by process limitation that is a material that results from the process of being welded. As set forth in MPEP 2113, “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 in 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). Examiner notes since there was no evidence provided by the applicant that the process of welding imparts a structural difference onto the end product of the claimed invention that is not present in the prior art, the limitation “welding” is being given very little patentable weight.
Rudzewicz fails to teach an outer ply layer disposed over at least the core of the compress and extending beyond a periphery of the core. In the same field of endeavor, Ahsani teaches a wound pad wherein the outer ply layer (2) and shell (12) are separate structure (paragraph [0100]) and an outer ply layer (2) disposed over at least the core (3) of the compress and extending beyond a periphery of the core (4) (figure 1 and 2).
Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Rodzewicz to have an addition outer ply layer , similar to Ahsani, so that more fluid may be retained and distributed (paragraph [0100]).
Regarding Claim 2, Rodzewicz in view of Ahsani teaches the medical article of claim 1. The combination further teaches wherein the first ply layer (203) of the shell projects beyond the proximal surface of the core (202) on all sides and the second ply layer (201) of the shell projects beyond the distal surface of the core (202) on all sides (figure 2A), and wherein the first ply layer of the shell and the second ply layer of the shell each form an edge region (204) which surrounds the core on all sides, wherein the first ply layer of the shell and the second ply layer of the shell are joined to one another in said edge region (figure 2A).
Regarding Claim 3, Rodzewicz in view of Ahsani teaches the medical article of claim 1. Rodzewicz fails to teach wherein the core has an absorption capacity of from 100 g/100 cm2 to 5000 g/100 cm2. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the core has an absorption capacity of from 100 g/100 cm2 to 5000 g/100 cm2 since this claimed dimension of the absorbance capacity is non critical. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see paragraphs 00XX of applicants specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding Claim 4, Rodzewicz in view of Ahsani teaches the medical article of claim 2. Rodzewicz further teaches wherein the first ply layer (203) of the shell comprises a first material having hydrophilic properties (apertures absorb fluid, paragraph [0034]) and in that the second ply layer (201) of the shell comprises a second material having hydrophobic properties (paragraph [0062]).
Regarding Claim 5, Rodzewicz in view of Ahsani teaches the medical article of claim 2. Rodzewicz further teaches wherein both the first ply layer (203) and the second ply layer (201) of the shell each comprise a material having thermoplastic properties (paragraph [0078]).
Regarding Claim 6, Rodzewicz in view of Ahsani teaches the medical article of claim 5. Rodzewicz further teaches wherein the second ply layer (201) of the shell comprises a thermoplastic material having hydrophobic properties (paragraph [0078]) and the first ply layer (203) of the shell comprises a thermoplastic material (paragraph [0078]) which is the same material as that of the second ply layer (201) of the shell and has been treated in a chemical and/or physical process such that it has hydrophilic properties (apertures absorb fluid, paragraph [0035]).
Regarding Claim 7, Rodzewicz in view of Ahsani teaches the medical article of claim 5. Rodzewicz further teaches wherein the first ply layer of the shell and the second ply layer of the shell have been joined to one another in a thermal process thereby forming the weld connection to one another (paragraph [0062] and [0083]).
Claim 7 is being treated as a product by process limitation. As set forth in MPEP 2113, “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 in 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). Examiner notes since there was no evidence provided by the applicant that the process of wherein the first ply layer of the shell and the second ply layer of the shell have been joined to one another in a thermal process and therefore have a weld connection to one another imparts a structural difference onto the end product of the claimed invention that is not present in the prior art, the limitation “welding the first and second ply layer together” is being given very little patentable weight.
Regarding Claim 11, Rodzewicz in view of Ahsani teaches the medical article of claim 1. Rodzewicz further teaches wherein the skin-contact layer adhesive to skin to be treated comprises a ply layer of a skin-friendly silicone adhesive (paragraph [0032]).
Regarding Claim 12, Rodzewicz in view of Ahsani teaches the medical article of claim 1. Rodzewicz further teaches wherein the skin-contact layer has openings, the total open area of which is between 10% and 25% of the total surface area of the skin-contact layer (paragraph [0092]).
Regarding Claim 13, Rodzewicz in view of Ahsani teaches the medical article of claim 1. Rodzewicz further teaches wherein the skin-contact layer has openings having a substantially circular shape, the average diameter of which is between 0.2 mm to 3.0 mm (paragraph [0093]).
Regarding Claim 14, Rodzewicz in view of Ahsani teaches the medical article of claim 1. Rodzewicz further teaches wherein the outer ply layer comprises a water vapor-permeable and substantially liquid-impermeable film material (paragraph [0122]).
Regarding Claim 15, Rodzewicz in view of Ahsani teaches the medical article of claim 1. Rodzewicz further teaches wherein the proximal surface of the outer ply layer comprises a coating containing a pressure-sensitive adhesive (paragraph [0021]).
Regarding Claim 16, Rodzewicz in view of Ahsani teaches the medical article of claim 1. Rodzewicz further teaches wherein the skin-contact layer is coextensive with the outer ply layer (figure 2A).
Regarding Claim 19, Rodzewicz teaches a method for production of a medical device for prophylaxis of the development and/or worsening of decubitus ulcers comprising employing the medical article of claim1 (paragraph [0027]).
Regarding Claim 21, Rodzewicz in view of Ahsani teaches the medical article of claim 1. Rodzewicz further teaches wherein the edge region of the outer ply layer (204) extends beyond and surrounds the shell (201 +203).
Regarding Claim 22, Rodzewicz in view of Ahsani teaches the medical article of claim 2. Rodzewicz further teaches wherein the edge region of the outer ply layer (204) extends beyond and surrounds the edge region of the first ply layer and the second ply layer of the shell (201+203)(figure 2A).
Regarding Claim 23, Rodzewicz teaches a medical article (200), comprising;
a compress and a skin-contact layer including a silicone adhesive (paragraph [0032]), the compress comprising a core (202) and a shell surrounding the core (202), the shell including a first ply layer (201)comprising a liquid- permeable material and being adjacent to the skin-contact layer and a second ply layer (203) comprising a liquid-impermeable material, the first ply layer (201) and the second ply layer (203) forming an edge region of the shell extending beyond and surrounding the core (202), the first ply layer (201) and the second ply layer (203) being joined together with a connection in the edge region; and
an outer ply layer (204) disposed over the compress and extending beyond the edge region of the shell (figure 2A); and
a skin-contact layer (207)comprising an adhesive for securing the outer ply layer and/or the compress to a subject's skin (paragraph [0028]);
wherein the first ply layer of the shell comprises polypropylene and/or polypropylene fibers (paragraph [0078]),
wherein the skin-contact layer projects beyond the edge region of the shell (figure 2a),
wherein the outer ply layer (203) and the skin-contact layer form a border area that surrounds the compress on all sides (figure 2a);
The claimed phrase “welding” is being treated as a product by process limitation that is a material that results from the process of being welded. As set forth in MPEP 2113, “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 in 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). Examiner notes since there was no evidence provided by the applicant that the process of welding imparts a structural difference onto the end product of the claimed invention that is not present in the prior art, the limitation “welding” is being given very little patentable weight.
Regarding Claim 25, Rodzewicz in view of Ahsani teaches the medical article of claim 1. Rodzewicz in view of Ahsani fail to teach wherein the medical article is characterized by a compressibility of 2.0 mm to 5.0 mm under a load of 150 N in a dry state. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to a compressibility of 2.0 mm to 5.0 mm under a load of 150 N in a dry state in order to fit the particular procedure being done since this claimed dimension of the compressibility is non-critical . Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (page 16 of applicants specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable Rodzewicz (US 20200383839 A1) in view of Ahsani (US 20180133066 A1 ) in view of Leppänen (US 20190328579 A1).
Regarding Claim 8, Rodzewicz in view of Ahsani teaches the medical article of claim 7. Rodzewicz further teaches lamination via welding (paragraph [0083]) however fails to teach wherein the weld connection comprises at least one discontinuous weld line.
Leppänen teaches a medical dressing wherein the weld connection comprises at least one discontinuous weld line (60) (figure 4A)(paragraph [0081]).
Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the welding of Rodzewicz so that the weld connection comprises at least one discontinuous weld line similar to Leppänen so that the welding may be entirely along a seam.
Regarding Claim 9, Rodzewicz in view of Ahsani and Leppänen teaches the medical article of claim 8. Rodzewicz further teaches lamination via welding (paragraph [0083]) however fails to teach, wherein the weld connection comprises four to six parallel discontinuous weld lines. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the weld connection wherein the weld connection comprises four to six parallel discontinuous weld lines since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In addition, adding more weld connection lines would allow for a more secure absorbent article.
Regarding Claim 10, Rodzewicz in view of Leppänen teaches the medical article of claim 8. Rodzewicz fails to explicitly teach wherein the at least one discontinuous weld line is oriented parallel to the machine direction in the production process however one of ordinary skill in the art knows that this is often an implicit feature with machine welding. It would have been an obvious matter of design choice to wherein the at least one discontinuous weld line is oriented parallel to the machine direction in the production process since applicant has not disclosed that process solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with a perpendicular line (as cited in applicant’s specification).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable Rodzewicz (US 20200383839 A1) in view of Ahsani (US 20180133066 A1 ) in view of Love (US 20180256412 A).
Regarding Claim 20, Rodzewicz in view of Ahsani teaches the medical article of claim 1. Rodzewicz fails to teach wherein the absorbent core further comprises a diffusion layer at least disposed between the first ply layer and the proximal surface of the absorbent core.
Love teaches a treatment for ulcers wherein the absorbent core (116) further comprises a diffusion layer (paragraph [0072]) at least disposed between the first ply layer and the proximal surface of the absorbent core (116) (paragraph [0072]).
Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the medical article of Rodzewicz to include a diffusion layer similar to Love as in many instances it can be advantageous to allow moisture vapor to permeate through the base layer (Love, paragraph [0072]).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable Rodzewicz (US 20200383839 A1) in view of Ahsani (US 20180133066 A1 ) in view of Houbin (US 20200214909 A1).
Regarding Claim 24, Rodzewicz in view of Ahsani teaches the medical article of claim 1. Rodzewicz fails to teach wherein the compress is anisotropic and is characterized by an anisotropy ratio between the longitudinal direction having the first modulus of elasticity and the transverse direction having the second modulus of elasticity of from 1.5 to 20.0. Houbin teaches an absorbent article wherein the compress (12) is anisotropic and is characterized by an anisotropy ratio between the longitudinal direction having the first modulus of elasticity and the transverse direction having the second modulus of elasticity of from 1.5 to 20.0 (paragraph [0054]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the article of Rodzewicz teach wherein the compress is anisotropic and is characterized by an anisotropy of from 1.5 to 20.0, similar to Houbin, so that the fluid travels in the intended direction and pattern (as motivated by Houbin, paragraph [0054])
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781