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 .
Status of Claims
Claims 1-25 are pending in the present application. None are amended.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “116a” has been used to designate both the perforations in Fig. 3A and one set of perforations Fig. 4A.
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 third and fourth groups of central openings of the second plurality of peripheral openings, as recited in claims 19-22, 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. 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.
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 1-25 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.
The term “maximize” in claims 1 and 13 is a relative term which renders the claim indefinite. The term “maximize” 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. Rather, Applicant discloses a wide range of size/shape configurations purported to “maximize” features of the instant invention (¶ 44 of Applicant’s specification) without indicating how said features all actually achieve “optimization” of adhesion/permeability despite their different configurations. Further, Applicant does not describe what levels of adhesion/permeability would be considered “maximized” and what would not. As such, the metes and bounds of Applicant’s claims cannot be determined.
Similarly, the term “minimize” in claim 23 is a relative term which renders the claim indefinite. The term “minimize” 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. Rather, Applicant discloses a wide range of size/shape configurations purported to achieve the optimization of features of the instant invention (¶ 44 of Applicant’s specification) without indicating how said features all actually achieve “optimization” of adhesion/permeability despite their different configurations.
In an effort to promote compact prosecution, the limitations of being “configured to maximize” and “to minimize” for certain features is interpreted as being met by the prior art disclosing the structural features as claimed.
Claims 2-12, 14-22, and 24-25 are rejected via their dependency on claim 1.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 10-11 and 21-22 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10 recites that the second pattern is the same as the first pattern. It is unclear how two patterns that are the same would distinct from a single pattern. Claim 10 depends off of claim 8, which already establishes a single, first pattern. Claim 10 also appears to negate the limitations of having two patterns as recited in its parent claim 9. Thus, claim 10 appears to be equivalent to claim 8, and not further narrowing with respect to claim 9.
Similarly, claim 11 recites that the second pattern is different than the first pattern. As previously stated, it is unclear how two patterns that are the same would distinct from a single pattern. Thus, it is unclear how comprising two patterns as in claim 9 would not comprise two different patterns.
Claims 21-22 mirror the language of claims 10-11.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-6, 8-11, 13, 15-16, 19-23, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cotton (WO 2015/173547 A1).
Regarding claim 1, Cotton discloses a bandage (Figs. 2-3 and 7-8; Abstract) comprising:
a top film (film 611);
an absorbent layer positioned below the top film (absorbent body 612);
an adhesive layer provided below the absorbent layer (skin contact layer 615);
wherein the adhesive layer includes:
a layer of adhesive provided on a bottom surface of the adhesive layer (page 37, 2nd paragraph describes the acrylic adhesive which is exposed by removing the underside backing);
at least one central opening provided in a central portion of the adhesive layer (larger perforations 621; best seen in Fig. 8) having a first size and a first shape (page 9, 1st paragraph and page 24, 3rd-4th paragraph describe the perforations may be different sizes and shapes; also see pages 35-36); and
at least one peripheral opening provided in a peripheral portion of the adhesive layer (smaller perforations 622), the at least one peripheral opening having a second size and a second shape (page 9, 1st paragraph and page 24, 3rd-4th paragraph describe the perforations may be different sizes and shapes; also see pages 35-36).
Further, the limitations of the sizes and shapes of the openings being “configured to maximize fluid passage into the absorbent layer” and “configured to maximize adhesion of the adhesive layer to a user’s skin” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, openings in the adhesive layer of Cotton has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. the larger openings of Cotton are designed to allow exudate to pass through while the smaller openings are configured to not substantially impair retention of the dressing to the skin as described on page 36).
Regarding claim 2, Cotton further discloses the absorbent layer comprises an upper layer adhered to the top film and a lower layer adhered to the adhesive layer (absorbent body 612 is made up of an upper layer of super absorbent material 614 and a lower layer of polyurethane foam 613; page 35, 2nd paragraph describes how the film 611 is affixed to the top of the absorbent body 612; Page 36, 2nd paragraph describes the contact layer 615 is also affixed via adhesive to absorbent body 612).
Regarding claim 3, Cotton further discloses the absorbent layer includes a superabsorbent layer (super absorbent material 614).
Regarding claim 4, Cotton further discloses the first size of the at least one central opening is larger than the second size of the at least one peripheral opening (page 24, 2nd paragraph, the central openings are described as larger perforations while the peripheral openings are described as smaller perforations; also see Fig. 8).
Regarding claim 5, Cotton further discloses the at least one central opening comprises a first plurality of openings (see Fig. 8; the last paragraph on page 35 describes the perforations as forming an array).
Regarding claim 6, Cotton further discloses each central opening of the first plurality of central openings has the first shape (see Fig. 8; page 9, 1st paragraph and page 24, 3rd-4th paragraph describe the perforations may be different sizes and shapes; also see pages 35-36).
Regarding claims 8 and 10, Cotton further discloses at least a first group of central openings of the first plurality of central openings are arranged the first pattern (Fig. 8; the last paragraph on page 35 describes the perforations as forming an array, a single array pattern being equivalent to having two of the same pattern).
Regarding claims 9 and 11, Cotton further discloses at least a second group of central openings of the first plurality of central openings are arranged in a second pattern (Fig. 8 shows the apertures being arranged in off-set rows, each row arrangement comprising a different pattern, as required by claim 11).
Regarding claim 13, Cotton further discloses the spacing between the first plurality of openings varies (Fig. 8 shows the apertures being arranged in off-set rows, thus the spacing varies particularly on the left and right columns).
Further, the limitations of the plurality of central opening varying ”to maximize fluid passage into the absorbent layer” is considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, openings in the adhesive layer of Cotton has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. the larger openings of Cotton are designed to allow exudate to pass through).
Regarding claim 15, Cotton further discloses the at least one peripheral opening comprises a second plurality of openings (see openings 622 in Fig. 8; the last paragraph on page 35 describes the perforations as forming an array).
Regarding claim 16, Cotton further teaches each of the peripheral openings of the second plurality of central openings has the second shape (Fig. 8, openings 622; page 9, 1st paragraph and page 24, 3rd-4th paragraph describe the perforation shapes; also see pages 35-36).
Regarding claims 19 and 21, Cotton further discloses at least a third group of central openings of the first plurality of central openings are arranged a third pattern (Fig. 8; the last paragraph on page 35 describes the perforations as forming an array, a single array pattern being equivalent to having two of the same pattern).
Regarding claims 20 and 22, Cotton further discloses at least a fourth group of central openings of the second plurality of peripheral openings are arranged in a fourth pattern (Fig. 8 shows the apertures being arranged in off-set rows, including those most centrally positioned, each row arrangement comprising a different pattern, as required by claim 11).
Regarding claim 23, Cotton further discloses the spacing between the second plurality of openings varies (Fig. 8 shows the apertures being arranged in off-set rows, thus the spacing varies particularly on the left and right columns).
Further, the limitations of the space between the second plurality of peripheral openings varies ”to minimize adhesion” is considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, openings in the adhesive layer of Cotton has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed.
Regarding claim 25, Cotton further discloses the adhesive layer includes a perforation free region positioned between the at least one central opening and the at least one peripheral opening that does not include any openings (Fig. 8 shows an area free of openings around the boarder of where the adhesive layer overlays absorbent layer 612).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Cotton, as applied to claim 5 above, and further in view of Kieswetter et al. (US 2021/0338490 A1).
Regarding claim 7, Cotton further teaches a first group of central openings of the first plurality of central openings have the first shape (Fig. 8).
Cotton does not explicitly teach a second group of central openings of the first plurality of central openings having a third shape different from the first shape.
However, Kieswetter teaches a wound dressing apparatus (Figs. 2 and 8; Abstract), thus being in the same field of endeavor, comprising a contact layer (fourth layer 804) comprising apertures with mixed shapes (¶s 79-81).
Thus, Kieswetter shows that having multiple groups of different shaped apertures is an equivalent structure known in the art. Therefore, because these two apertures shape arrangements were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute having at least two different shapes of apertures (i.e. having a first group of openings having a first shape and a second group of openings having third shape different from the first shape) for having all uniformly shaped central apertures.
Further, doing so would be within ordinary skill in the art as a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Also see MPEP 2144.04 (IV)(B) which relates to Changes in Shape. Further, Applicant has placed no criticality on the claimed shape arrangement (as it is only described as being in embodiments in ¶ 12).
Regarding claim 14, Cotton further teaches the at least one central opening may be different shapes (page 9, 1st paragraph and page 24, 3rd-4th paragraph describe the perforations may be different sizes and shapes; also see pages 35-36).
Cotton does not explicitly teach at least one of the central openings comprises a curved slot.
However, Kieswetter teaches a wound dressing apparatus (Figs. 2 and 8; Abstract), thus being in the same field of endeavor, comprising a contact layer (fourth layer 804) comprising apertures with many different shapes, including curbs (¶s 79-81).
Thus, Kieswetter shows that having different shaped (i.e. curves) apertures is an equivalent structure known in the art. Therefore, because these two shape arrangements were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute apertures shaped as curved slots for circular apertures.
Further, doing so would be within ordinary skill in the art as a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Also see MPEP 2144.04 (IV)(B) which relates to Changes in Shape. Further, Applicant has placed no criticality on the claimed shape arrangement (as Applicant discloses many different suitable shapes; ¶ 47 only indicates the slots or channels “may have a curved shape”).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Cotton, as applied to claim 5 above, and further in view of Locke et al. (US 2022/0249762 A1).
Regarding claim 12, Cotton substantially discloses the invention of claim 5. Cotton does not explicitly teach at least one central opening of the plurality of central openings is larger than at least one other central opening of the first plurality of central openings.
However, Locke teaches a wound dressing apparatus (Figs. 6 and 10; Abstract), thus being in the same field of endeavor, comprising a contact layer (fourth layer 605) comprising apertures with mixed sizes (¶s 113).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified central openings of Cotton such that at least one of the first plurality of central openings is larger than at least one other central opening of the first plurality of openings, as taught by Locke. Doing so would be advantageous in controlling bond strength and enhancing movement and proliferation of epithelial cells (¶s 113-114 of Locke).
Further, doing so would be within ordinary skill in the art as a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Also see MPEP 2144.04 (IV)(B) which relates to Changes in Shape. Further, Applicant has placed no criticality on the claimed shape arrangement (as Applicant discloses many size and shape configurations are suitable and ¶ 9 only indicates said size arrangement as being in embodiments).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Cotton, as applied to claim 15 above, and further in view of Kieswetter.
Regarding claim 17, Cotton further teaches a third group of peripheral openings of the second plurality of peripheral openings have the second shape (Fig. 8).
Cotton does not explicitly teach a fourth group of peripheral openings of the second plurality of peripheral openings having a fourth shape different from the second shape.
However, Kieswetter teaches a wound dressing apparatus (Figs. 2 and 8; Abstract), thus being in the same field of endeavor, comprising a contact layer (fourth layer 804) comprising apertures with mixed shapes (¶s 79-81).
Thus, Kieswetter shows that having multiple groups of different shaped apertures is an equivalent structure known in the art. Therefore, because these two aperture shape arrangements were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute having at least two different shapes of apertures (i.e. having a first group of openings having a first shape and a second group of openings having third shape different from the first shape) for having all uniformly shaped central apertures.
Further, doing so would be within ordinary skill in the art as a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Also see MPEP 2144.04 (IV)(B) which relates to Changes in Shape. Further, Applicant has placed no criticality on the claimed shape arrangement (as it is only described as being in embodiments in ¶ 22 and very generally in ¶ 44).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Cotton, as applied to claim 15 above, and further in view of Locke.
Regarding claim 18, Cotton substantially discloses the invention of claim 15. Cotton does not explicitly teach at least one peripheral opening of the second plurality of peripheral openings is larger than at least one other peripheral opening of the second plurality of peripheral openings.
However, Locke teaches a wound dressing apparatus (Figs. 6 and 10; Abstract), thus being in the same field of endeavor, comprising a contact layer (fourth layer 605) comprising apertures with mixed sizes (¶s 113).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified peripheral openings of Cotton such that at least one of the second plurality of peripheral openings is larger than at least one other peripheral opening of the second plurality of peripheral, as taught by Locke. Doing so would be advantageous in controlling bond strength and enhancing movement and proliferation of epithelial cells (¶s 113-114 of Locke).
Further, doing so would be within ordinary skill in the art as a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Also see MPEP 2144.04 (IV)(B) which relates to Changes in Shape. Further, Applicant has placed no criticality on the claimed shape arrangement (as Applicant discloses many size and shape configurations are suitable and ¶ 23 only indicates said size arrangement as being in embodiments).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Cotton, as applied to claim 11 above, and further in view of Kieswetter.
Regarding claim 24, Cotton further teaches the at least one peripheral opening may be different shapes (page 9, 1st paragraph and page 24, 3rd-4th paragraph describe the perforations may be different sizes and shapes; also see pages 35-36).
Cotton does not explicitly teach at least one of the peripheral openings comprises a curved slot.
Kieswetter teaches a wound dressing apparatus (Figs. 2 and 8; Abstract), thus being in the same field of endeavor, comprising a contact layer (fourth layer 804) comprising apertures with many different shapes, including curbs (¶s 79-81).
Thus, Kieswetter shows that having different shaped (i.e. curved) apertures is an equivalent structure known in the art. Therefore, because these two shape arrangements were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute apertures shaped as curved slots for circular apertures.
Further, doing so would be within ordinary skill in the art as a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Also see MPEP 2144.04 (IV)(B) which relates to Changes in Shape. Further, Applicant has placed no criticality on the claimed shape arrangement (as Applicant discloses many different suitable shapes; ¶ 47 only indicates the slots or channels “may have a curved shape”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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