DETAILED ACTION
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 claims 1-3, 6-7, 10, 15, 19-20, 25, 27-32, 37-38, and 47 in the reply filed on 13 January 2026 is acknowledged.
Information Disclosure Statement
The information disclosure statements filed 14 August 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "102" and "216" have both been used to designate “the membrane”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “first side” and “second side” of claims 1, 19, 37-38, and 47, the “first backing material” of claims 1, 10, 15, 25, 38, and 47, the “second backing material” of claims 1, 7, 10, 15, 19-20, 25, 27-30, 38, and 47, “one translucent layer” of claim 2, “liquid preservation medium” of claim 3, “a pore size” and “a second pore size” of claim 10, “a preservation media” of claim 38, and “a first portion of said portion of said intact membrane” of claim 47 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: A “first backing material” and “second backing material” are referenced in the claim set but not found in the specification.
Claim Objections
Claim 7 is objected to because of the following informalities: claim 7 states “one physical characteristic being that said primary backing material having a first color and said second backing material having a second color”, rather than “one physical characteristic being that said primary backing material has a first color and said second backing material has a second color” or comprises. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: claim 10 states “a pore size” rather than “a first pore size” similar to the “second pore size” stated later in the claim. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: claim 15 states “one physical characteristic being that first backing material having a different hydrophilic property” rather than “one physical characteristic being that first backing material has a different hydrophilic property” or comprises. Appropriate correction is required.
Claim 25 is objected to because of the following informalities: claim 15 states “one physical characteristic being that said first backing material having a first texture and said second backing material having a second texture” rather than “one physical characteristic being that said first backing material has a first texture and said second backing material has a second texture” or comprises. Appropriate correction is required.
Claim 47 is objected to because of the following informalities: claim 47 refers to “a treatment area” in line 17 which instead should state “said treatment area” since “a treatment area” has previously been stated in the claim. 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 1-3, 6-7, 10, 15, 19-20, 25, 27-32, 37-38, and 47 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 1, 19-20, 27-32, 37-38, and 47 recite the limitation "said intact membrane tissue" or “said intact amniotic membrane tissue” rather than “said portion of intact membrane tissue” or “said portion of intact amniotic membrane tissue”. There is insufficient antecedent basis for these limitations in the claim. Further, the claims refer to both “said portion of said intact membrane tissue” and “said intact membrane tissue” which causes confusion as to whether the entire membrane tissue is being claimed, or just a particular region of the membrane tissue. Further clarification is required. Claims 2-3, 6-7, 10, 15, and 25, are rejected by dependency.
The term “approximately” in claims 1, 38, and 47 is a relative term which renders the claim indefinite. The term “approximately” 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. It is unclear what qualifies as “approximately as large as said planar area”. Claims 2-3, 6-7, 10, 15, 19-20, 25, 27-32, and 37 are rejected by dependency.
Claims 1, 10, 15, 25, 38, and 47 refer to a “first backing material” that is not found in the Drawings or Specification. It is unclear to Examiner what exactly this “first backing material” is relative to the “primary backing material”. Examiner has found within [0026] of Applicant’s Specification that “the backings may be a thin polymer sheet, mesh, or other material that may be bendable and flexible, but generally stiffer than the tissue” which may be what Applicant is trying to define by “first backing material”, however it remains unclear how the “first backing material” relates to the “primary backing material”. Further clarification is required. Claims 2-3, 6-7, 19-20, 27-32, and 37 are rejected by dependency.
Claims 1, 7, 10, 15, 19-20, 25, 27-30, 38, and 47 refer to a “second backing material” that is not found in the Drawings or Specification. It is unclear to Examiner what exactly this “second backing material” is relative to the “secondary backing material”. Examiner has found within [0026] of Applicant’s Specification that “the backings may be a thin polymer sheet, mesh, or other material that may be bendable and flexible, but generally stiffer than the tissue” which may be what Applicant is trying to define by “second backing material”, however it remains unclear how the “second backing material” relates to the “secondary backing material”. Further clarification is required. Claims 2-3, 6, 31-32, and 37 are rejected by dependency.
Claim 6 recites the limitation "said package" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 27-30 refer to the “second backing material being sized to overlay less than _% of said planar area of said intact membrane tissue”, however it is unclear how the second backing material “overlay[s]” the intact membrane tissue. Examiner is unsure whether this “overlay[ing]” is referring to when the membrane product is within the envelope or when the membrane product is applied to a patient, or something else entirely. Further clarification is required.
Claims 31-32 refer to “said portion of said intact membrane tissue overlying at least _% of said planar area of said intact membrane tissue”. It is unclear whether these claims are attempting to state the intact membrane tissue is folded over itself or is sized in a certain way. There is no support in the Applicant’s Specification to further define this limitation. Further clarification is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 7, 10, 15, 19-20, 25, 37-38, and 47 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Young (US 2013/0289724 A1).
Regarding claim 1, Young teaches
A membrane product comprising: a transportation and storage assembly comprising (wound dressing is assembled in a package [0021]):
a portion of intact membrane tissue (Fig. 1A, allograft 1), said intact membrane tissue having a first side (Fig. 1D, area of wound dressing above allograft 1 when placed on wound) and a second side (Fig. 1D, area of wound dressing comprising allograft 1),
said second side being applied to a patient during treatment (Fig. 1D, side comprising allograft 1 is placed within boundaries of a wound [0040]),
said intact membrane tissue further having a planar area (Fig. 1C);
a primary backing material supporting said portion of intact membrane tissue on said first side (Fig. 1D, support layer 3),
said primary backing material having a first backing material (Fig. 1D, support layer 3 comprises polymeric elastic film [0048]);
said primary backing material having a surface area at least approximately as large as said planar area (Fig. 1D, support layer 3 covers both base sheet 2 and allograft 1);
a secondary backing material supporting said portion of intact membrane (Fig. 1B, base sheet 2),
said secondary backing material having a second backing material (Fig. 1B, base sheet 2 may comprise surgical fabric mesh or any medical grade polymer [0046]);
said secondary backing material being smaller than said intact membrane tissue on at least one dimension (Fig. 1B, base sheet 2 comprises a smaller width than allograft 1) and
having at least a portion of said secondary backing material extending past said intact membrane tissue on at least one dimension (Fig. 1C-D, base sheet 2 extends beyond area of allograft 1);
said first backing material having at least one different physical characteristic than said second backing material (Fig. 1D, support layer 3 is more rigid than base layer 2 [0048]).
Regarding claim 2, Young teaches
a planar envelope comprising at least one translucent layer into which said transportation and storage assembly is sealed (wound dressing may be assembled in a package such as a laminated peel pouch, paper peel pouch, or sealed with a laminated cover [0059]).
Regarding claim 7, Young teaches
said at least one physical characteristic being that said primary backing material having a first color and said second backing material having a second color (Fig. 1D, support layer 3 is transparent (i.e., clear) [0048] and base sheet 2 comprises PTFE (i.e., generally white or opaque) [0046]).
Regarding claim 10, Young teaches
said at least one physical characteristic being that first backing material having a pore size and said second backing material having a second pore size (Fig. 1D, support layer 3 resists the passage of microbes but is permeable to moisture [0048] and base sheet 2 comprises porous polyethylene [0046]).
Regarding claim 15, Young teaches
said at least one physical characteristic being that first backing material having a different hydrophilic property than said second backing material (Fig. 1D, support layer 3 is permeable to moisture [0048] and base sheet 2 comprises PTFE (i.e., hydrophobic) [0046]).
Regarding claim 19, Young teaches
said second backing material being placed against said second side of said intact membrane tissue (Fig. 1D, base sheet 2 is attached to area of wound dressing comprising allograft 1).
Regarding claim 20, Young teaches
said second backing material being placed between said primary backing material and said intact membrane tissue (Fig. 1D, base sheet 2 is between support layer 3 and allograft 1).
Regarding claim 25, Young teaches
said at least one physical characteristic being that said first backing material having a first texture and said second backing material having a second texture (Fig. 1B, base sheet 2 comprises surgical fabric mesh [0046] and support layer 3 comprises polymeric elastic film [0048] (i.e., different materials comprising different textures).
Regarding claim 37, Young teaches
said secondary backing material being placed against said second side of said portion of intact membrane tissue (Fig. 1D, base sheet 2 is attached to area of wound dressing comprising allograft 1).
Regarding claim 38, Young teaches
An amniotic membrane product comprising: a transportation and storage assembly comprising (wound dressing is assembled in a package [0021]):
a portion of intact amniotic membrane tissue (Fig. 1A, allograft 1 comprises at least one layer of human amnion and chorion tissues [0014]),
said intact amniotic membrane tissue having a first side (Fig. 1D, area of wound dressing above allograft 1 when placed on wound) and a second side (Fig. 1D, area of wound dressing comprising allograft 1),
said second side being applied to a patient during treatment (Fig. 1D, side comprising allograft 1 is placed within boundaries of a wound [0040]),
said intact amniotic membrane tissue further having a planar area (Fig. 1C);
a primary backing material supporting said portion of intact membrane tissue on said first side (Fig. 1D, support layer 3),
said primary backing material having a first backing material (Fig. 1D, support layer 3 comprises polymeric elastic film [0048]);
said primary backing material having a surface area at least approximately as large as said planar area (Fig. 1D, support layer 3 covers both base sheet 2 and allograft 1);
a secondary backing material supporting said portion of intact membrane (Fig. 1B, base sheet 2),
said secondary backing material having a second backing material (Fig. 1B, base sheet 2 may comprise surgical fabric mesh or any medical grade polymer [0046]);
said secondary backing material being smaller than said intact membrane tissue on at least one dimension (Fig. 1B, base sheet 2 comprises a smaller width than allograft 1) and
having at least a portion of said secondary backing material extending past said intact membrane tissue on at least one dimension (Fig. 1C-D, base sheet 2 extends beyond area of allograft 1);
said first backing material having at least one different physical characteristic than said second backing material (Fig. 1D, support layer 3 is more rigid than base layer 2 [0048]);
a preservation media derived from amniotic fluid (wound dressing kit further comprises amniotic fluid [0084]).
Regarding claim 47, Young teaches
A method of treatment comprising: receiving a tissue assembly comprising: a portion of intact membrane tissue (Fig. 1A, allograft 1),
said intact membrane tissue having a first side (Fig. 1D, area of wound dressing above allograft 1 when placed on wound) and a second side (Fig. 1D, area of wound dressing comprising allograft 1),
said second side being applied to a patient during treatment (Fig. 1D, side comprising allograft 1 is placed within boundaries of a wound [0040]),
said intact membrane tissue further having a planar area (Fig. 1C);
a primary backing material supporting said portion of intact membrane tissue on said first side (Fig. 1D, support layer 3),
said primary backing material having a first backing material (support layer 3 is individually wrapped before assembled (i.e., each piece of the wound dressing comprises a wrapping material) [0059]);
said primary backing material having a surface area at least approximately as large as said planar area (Fig. 1D, support layer 3 covers both base sheet 2 and allograft 1);
a secondary backing material supporting said portion of intact membrane tissue on said second side (Fig. 1B, base sheet 2),
said secondary backing material having a second backing material (base sheet 2 is individually wrapped before assembled (i.e., each piece of the wound dressing comprises a wrapping material) [0059]);
said secondary backing material being smaller than said intact membrane tissue on at least one dimension (Fig. 1B, base sheet 2 comprises a smaller width than allograft 1) and
having at least a portion of said secondary backing material extending past said intact membrane tissue on at least one dimension (Fig. 1C-D, base sheet 2 extends beyond area of allograft 1);
placing said tissue assembly on a treatment area such that at least a first portion of said portion of said intact membrane tissue is against a treatment area (Fig. 1A, allograft 1 is placed inside the boundaries of a wound [0024]);
removing said primary backing material from said portion of intact membrane tissue (the allograft 1, base sheet 2, and support layer 3 are assembled together in one package such as a laminated peel pouch, paper peel pouch, or sealed with a laminated cover, and further that each piece of the wound dressing (i.e., allograft, base sheet, and support layer) can each be individually wrapped before they are assembled together (i.e., each wrap would need to be removed before adhering the wound dressing to the patient) [0059]);
holding said intact membrane tissue to said treatment area (Fig. 1C, base sheet 2 comprises an adhesive which sticks allograft 1 to the skin surrounding the wound [0025]), and
removing said secondary backing material to apply said portion of intact membrane tissue to said treatment area (the allograft 1, base sheet 2, and support layer 3 are assembled together in one package such as a laminated peel pouch, paper peel pouch, or sealed with a laminated cover, and further that each piece of the wound dressing (i.e., allograft, base sheet, and support layer) can each be individually wrapped before they are assembled together (i.e., each wrap would need to be removed before adhering the wound dressing to the patient) [0059]).
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.
Claims 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Young (US 2013/0289724 A1) in view of Bordano (US 2008/0254471 A1), “Bordano”.
Regarding claim 3, Young teaches a transportation and storage assembly (wound dressing is assembled in a package [0021]) but fails to teach a liquid preservation medium.
Bordano teaches a sterile collection package comprising a liquid preservation medium in which said transportation and storage assembly is immersed when encapsulated in said planar envelope (Fig. 1, tissue container 10 has fluid added before or after tissue is placed within [0058]). Bordano discloses that the tissue container can be pre-filled during manufacturing with a certain volume of fluid so as to prevent the walls of the container from sticking together [0043]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the transportation and storage assembly taught by Young with the liquid preservation medium taught by Bordano in order to avoid compromising the assembly during storage or transport.
Regarding claim 6, Young teaches said package (wound dressing is assembled in a package [0021]) but fails to teach said package comprising a syringe port.
Bordano teaches a sterile collection package wherein said package comprises a syringe port (Fig. 1, tissue container 10 comprises connector 20 and tubing 40 which may include syringe port 47 [0044]). Bordano discloses that the tissue container can be pre-filled during manufacturing with a certain volume of fluid so as to prevent the walls of the container from sticking together [0043]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the transportation and storage assembly taught by Young with the liquid preservation medium taught by Bordano in order to avoid compromising the assembly during storage or transport.
Claims 27-32 are rejected under 35 U.S.C. 103 as being unpatentable over Young (US 2013/0289724 A1).
Regarding claim 27, Young teaches said second backing material being sized to overlay less than 10% of said planar area of said intact membrane tissue (Fig. 1C, base sheet 2 comprises a central opening therethrough which has a dimension that is smaller than the dimension of the allograft so that base sheet 2 adheres to the skin around the wound and the periphery of the allograft [0040]), but is silent as to the specific percentage of area the second backing material takes up. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the percentage of area the second backing material takes up, since these are result effective variables that contribute to the overall mechanical properties of the prosthesis, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering an optimum value of a result effective variable involves only routine skill in the art. MPEP 2144.05.
Regarding claim 28, Young teaches said second backing material being sized to overlay less than 25% of said planar area of said intact membrane tissue (Fig. 1C, base sheet 2 comprises a central opening therethrough which has a dimension that is smaller than the dimension of the allograft so that base sheet 2 adheres to the skin around the wound and the periphery of the allograft [0040]). but is silent as to the specific percentage of area the second backing material takes up. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the percentage of area the second backing material takes up, since these are result effective variables that contribute to the overall mechanical properties of the prosthesis, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering an optimum value of a result effective variable involves only routine skill in the art. MPEP 2144.05.
Regarding claim 29, Young teaches said second backing material being sized to overlay less than 50% of said planar area of said intact membrane tissue (Fig. 1C, base sheet 2 comprises a central opening therethrough which has a dimension that is smaller than the dimension of the allograft so that base sheet 2 adheres to the skin around the wound and the periphery of the allograft [0040]). but is silent as to the specific percentage of area the second backing material takes up. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the percentage of area the second backing material takes up, since these are result effective variables that contribute to the overall mechanical properties of the prosthesis, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering an optimum value of a result effective variable involves only routine skill in the art. MPEP 2144.05.
Regarding claim 30, Young teaches said second backing material being sized to overlay less than 75% of said planar area of said intact membrane tissue (Fig. 1C, base sheet 2 comprises a central opening therethrough which has a dimension that is smaller than the dimension of the allograft so that base sheet 2 adheres to the skin around the wound and the periphery of the allograft [0040]). but is silent as to the specific percentage of area the second backing material takes up. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the percentage of area the second backing material takes up, since these are result effective variables that contribute to the overall mechanical properties of the prosthesis, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering an optimum value of a result effective variable involves only routine skill in the art. MPEP 2144.05.
Regarding claim 31, Young teaches said portion of said intact membrane tissue overlying at least 75% of said planar area of said intact membrane tissue (Fig. 1C, base sheet 2 comprises a central opening therethrough which has a dimension that is smaller than the dimension of the allograft (shown by dashed line) so that base sheet 2 adheres to the skin around the wound and the periphery of the allograft [0040]), but is silent as to the specific percentage of planar area the intact membrane tissue takes up. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the percentage of planar area the intact membrane tissue takes up, since these are result effective variables that contribute to the overall mechanical properties of the prosthesis, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering an optimum value of a result effective variable involves only routine skill in the art. MPEP 2144.05.
Regarding claim 32, Young teaches said portion of said intact membrane tissue overlying at least 90% of said planar area of said intact membrane tissue (Fig. 1C, base sheet 2 comprises a central opening therethrough which has a dimension that is smaller than the dimension of the allograft (shown by dashed line) so that base sheet 2 adheres to the skin around the wound and the periphery of the allograft [0040]), but is silent as to the specific percentage of planar area the intact membrane tissue takes up. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the percentage of planar area the intact membrane tissue takes up, since these are result effective variables that contribute to the overall mechanical properties of the prosthesis, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering an optimum value of a result effective variable involves only routine skill in the art. MPEP 2144.05.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2019/0276215, EP 3587095, EP 2768747, EP 2641564, EP 2561829.
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/G.G.R./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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