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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: drawing does not include rear exterior (1A) mentioned in the description in [0029].
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.
Specification
The disclosure is objected to because of the following informalities:
“…may be a One of many… in para.[0007] needs to be corrected. A suggested correction is -- may be one of many --.
“agentand” in [0008] needs to be corrected. A suggested correction is –[[agentand]] agent and --.
“rear exterior (1A)” needs to be corrected. A suggested correction is -- rear exterior (1[[A]]B)--.
bonding or fabricated together with such known techniques as.” in [0043] page 9 needs to be corrected.
“receptable Layer 11 is the layer” in [0045] needs to be corrected. A suggested correction is -- receptable [[Layer]] layer 11 is the layer--.
“may not need to block As much as 30%” in [0046] needs to be corrected. A suggested correction is -- may not need to block [[As]] as much as 30%--.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Following claims are objected to because of the following informalities:
Claim 1 line 4 “the passage” needs to be corrected. A suggested correction is – [[the]] passage – in light of lack of any antecedent for this term in claim 1.
Claim 2 line 6 “the passage” needs to be corrected. A suggested correction is – [[the]] passage – in light of lack of any antecedent for this term in claim 2.
Claim 2 line 8 “system” needs to be corrected. A suggested correction is –the system—in light of its antecedent “a treatment delivery system” in claim 2 line 1.
Claim 12 “the anatomical area and/or physiological pathway” needs to be corrected. A suggested correction is – [[the]] an anatomical area and/or physiological pathway-- in light of lack of any antecedent for this term in this claim or preceding claims.
Claim 18 lines 1-3 “wherein the system is intended to be located on the outer side of the wearable item oriented so as to expose an applied treatment towards the wearer's olfactory system” needs to be corrected. A suggested correction is – wherein the system is intended to be located on the outer side of the wearable item oriented [[so]] in a manner as to expose an applied treatment towards the wearer's olfactory system —to avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation proceeding “so as to”, is even required or not required.
Each of claims 3-22 line needs to be corrected to include a “,” between claim number and wherein verbiage. For example amend claim 3 line 1 “The wearable article of claim 2 wherein” to -- The wearable article of claim 2, wherein--. Similar amendments is suggested for claims 4-22.
Claim 9 line 1 “The treatment delivery system of claim 2” needs to be corrected to -- The wearable article , wherein--.
Claim 21 is objected to for including acronyms/abbreviations. At least first occurrence of each acronym/abbreviation should be spelled out in full.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 1-22 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 in line 5 recite the limitation "the treatment". There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if claim 1 line 5 “the treatment” is the same as, different than or in addition to claim 1 line 3 “a treatment agent”.
Claim 2 in line 6 recites the limitation “the treatment”. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if claim 2 line 6 “the treatment” is the same as, different than or in addition to claim 2 line 3 “a treatment agent”.
Claim 20 in recites “a treatment agent” which renders this claim unclear. More specifically, it is unclear as to whether claim 20 “a treatment agent” is the same as, different than or in addition to “a treatment agent” recited in claim 2 line 3.
Claim 8 in line 2 recites “a wearable article” which renders this claim unclear. More specifically, it is unclear as to whether claim 8 line 2 “a wearable article” is the same as, different than or in addition to that recited in claim 1 line 1 and if different in what way the two differ.
Claim 18 in line 2 recite the limitation " the wearable item ". There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if claim 18 line 2 “the wearable item” is the same as, different than or in addition to claim 1 line 1 “a wearable article” and if different in what way the two differ.
Claim 19 contains the trademark/trade name “Neoshell™ fabric from Polartec” which renders this claim indefinite as the term “Neoshell™ fabric from Polartec” fails to particularly point out and distinctly define the structure of the invention. More specifically, where a trademark or trade name such as “Noeshell” is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe backing layer fabric and, accordingly, the identification/description is indefinite.
Claim 21 recites “waterproof rating is at least 5,000 mm” which renders this claim unclear. More specifically, it is unclear as to waterproof rating of what preceding element in claim 21 and/or base claim 1 is being referenced as at least 5,000 mm. Additionally, it is unclear as to whether some combined metric is being used to refer to the waterproof rating of the whole system rather than subcomponents making up the system.
Claim 22 recites “breathability score (RET) is 20 or less” which renders this claim unclear. More specifically, it is unclear as to breathability score of what preceding element in claim 21 and/or base claim 1 is being references as 20 or less. Additionally, it is unclear as to whether some combined metric is being used to refer to the breathability score of the whole system rather than subcomponents making up the system.
Dependent claims 3-22 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 3-22 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification para. [0023], [0034], [0036], [0038], [0054], [0079], [0082], [0087], [0096], [0105-0110].
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
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 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 of this title, 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 1-5, 8-18, 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Brown; Timothy (Pub. No.: US 20130012892 A1, hereinafter referred to as "Brown”).
As per independent Claim 1, Brown discloses a treatment delivery system for integration with a wearable article (Brown in at least abstract, fig. 1-3, [0001], [0005-0006], [0009], [0014-0026], [0028-0030], [0032] for example discloses relevant subject-matter. More specifically, Brown in fig. 1-2, abstract, [0001], [0005], [0014-0015] for example discloses treatment delivery system (fig. 2, [0005]) for integration with a wearable article (fig. 1). See at least Brown abstract “article of clothing is provided for topically delivering a pharmaceutical composition to a wearer of the article of clothing. The clothing typically includes at least three layers, an optional outer surface layer, a middle layer, and an inner layer. A pharmaceutical composition is applied to the inner layer. The middle layer prevents the pharmaceutical composition from passing from the inner layer to the outer surface layer…wherein a pharmaceutical composition is applied to the inner layer of an article of clothing and the clothing is worn by a person”; [0001] “an article of clothing having multiple layers comprising a pharmaceutical composition that is topically applied to a user”), the system comprising
a pliable assembly of layers (Brown in at least fig. 2, [0005], [0015], [0017], [0024], for example discloses a pliable assembly of layers. See at least Brown [0005] “an article of clothing suitable for applying a pharmaceutical composition … comprises typically at least three layers), comprising
a receptacle layer having a surface for containing a treatment agent and arranged to orient against a wearer's skin or outside the wearable article (Brown in at least fig. 2, [0005], [0015], [0020-0021], [0025-0026], [0028] for example discloses a receptacle layer/inner layer 16 having a surface for containing a treatment agent and arranged to orient against a wearer's skin or outside the wearable article. See at least Brown [0005] “an article of clothing suitable for applying a pharmaceutical composition … comprises typically at least three layers… an inner layer to which the pharmaceutical composition is applied or coated”; [0015] “A pharmaceutical composition typically containing one or more active ingredients and one or more carrier materials is applied to, coated on… inner layer 16. ”);
a coupled backing layer for selectively blocking the passage of the treatment (Brown in at least fig. 2, [0005], [0015], [0018-0019], [0023] for example discloses a coupled backing layer/middle layer 14 for selectively blocking the passage of the treatment. See at least Brown [0015] “Middle layer 14 comprises a breathable barrier 18 to prevent the pharmaceutical composition from passing from inner layer 16 to the outer surface layer 12.”),
the delivery system being configured to map to a selected anatomical area and/or physiological system of an intended wearer (Brown in at least abstract, fig. 2, [0014-0015], [0017], [0020-0022], [0025-0026] for example discloses delivery system being configured to map to a selected anatomical area and/or physiological system of an intended wearer. See Brown [0014] “Articles of clothing suitable for applying a pharmaceutical composition… any articles of clothing. Articles of clothing include, for example, but are not limited to, t-shirts, sweatshirts, any long-sleeved shirt, any short-sleeved shirt, gloves, hats, pants, smocks, gowns, caps, hair nets, shorts or socks.”; [0020] “Pharmaceutical application area 20 can be any area on inner layer 16 where, when worn by a user, comes in contact with the desired area of pharmaceutical application on the user's body”; [0021] “pharmaceutical preparation may include, in addition to one or more active ingredient pharmaceuticals, one or more carrier materials. The carrier material can be used to promote distribution of the active pharmaceutical on the internal clothing layer and can also promote topical delivery of the pharmaceutical by contact with the skin as a result of the internal clothing layer contacting the skin.”; [0022] “When the article of clothing remains in contact with the wearer, the pharmaceutical composition is topically delivered to the area of the wearer's body that is in contact with the pharmaceutical.”; [0026] “article of clothing is worn in order to allow for topical delivery of the pharmaceutical composition from the inner layer of the article of clothing to the desired area of the body.”); and
wherein the receptacle layer's surface comprises a material suitable for delivering treatment agent to the wearer’s skin (Brown in at least [0016-0017] for example discloses the receptacle layer's 16 surface comprises a material suitable for delivering treatment agent to the wearer’s skin. See at least Brown [0016] “inner layer 16 can be made of any suitable material as desired… Inner layer 16 may be suitably constructed and may also be selected to facilitate application of the pharmaceutical to a wearer's skin, and could also be selected from relatively liquid impermeable materials that could be perforated if desired”)
Brown does not necessarily require a material selected from (1) knit or woven fibers, (2) hydrophilic fibers, or (3) spun superfine fibers feature in the applied embodiment.
However, Brown discloses alternate embodiments that disclose wherein the receptacle layer's surface comprises a material selected from (1) knit or woven fibers, (2) hydrophilic fibers, or (3) spun superfine fibers (Brown in at least [0016-0017] for example discloses the receptacle layer's surface comprises any suitable material and enumerated (1) knit or woven fibers, (2) hydrophilic fibers, or (3) spun superfine fibers as some suitable materials. See at least Brown [0016] “inner layer 16 can be made of any suitable material as desired. … natural or synthetic, including but not limited to cotton, rayon, nylon, wool and combinations thereof…Inner layer 16 may be suitably constructed and may also be selected to facilitate application of the pharmaceutical to a wearer's skin, and could also be selected from relatively liquid impermeable materials that could be perforated if desired”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the receptacle layer's surface material used in the treatment delivery system for integration with a wearable article as taught by Brown, such that the receptacle layer's surface comprises a material selected from (1) knit or woven fibers, (2) hydrophilic fibers, or (3) spun superfine fibers, as also taught by Brown as a matter of mere design choice (also see MPEP 2144.04). A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of offering desired design choices for uses while also facilitating application of the pharmaceutical to a wearer's skin (Brown, [0016])
As per independent Claim 2, Brown discloses a wearable article, comprising a treatment delivery system (Brown in at least abstract, fig. 1-3, [0001], [0005-0006], [0009], [0014-0026], [0028-0030], [0032] for example discloses relevant subject-matter. More specifically, Brown in fig. 1-2, abstract, [0001], [0005], [0014-0015] for example discloses wearable article (fig.1, [0014]), comprising a treatment delivery system (fig. 2, [0005]). See at least Brown abstract “article of clothing is provided for topically delivering a pharmaceutical composition to a wearer of the article of clothing. The clothing typically includes at least three layers, an optional outer surface layer, a middle layer, and an inner layer. A pharmaceutical composition is applied to the inner layer. The middle layer prevents the pharmaceutical composition from passing from the inner layer to the outer surface layer…wherein a pharmaceutical composition is applied to the inner layer of an article of clothing and the clothing is worn by a person”; [0001] “an article of clothing having multiple layers comprising a pharmaceutical composition that is topically applied to a user”), the system comprising,
a pliable assembly of layers (Brown in at least fig. 2, [0005], [0015], [0017], [0024], for example discloses a pliable assembly of layers. See at least Brown [0005] “an article of clothing suitable for applying a pharmaceutical composition … comprises typically at least three layers), comprising:
a receptacle layer having a surface for containing a treatment agent and intended to orient against a wearer's skin or outside the article (Brown in at least fig. 2, [0005], [0015], [0020-0021], [0025-0026], [0028] for example discloses a receptacle layer/inner layer 16 having a surface for containing a treatment agent and intended to orient against a wearer's skin or outside the article. See at least Brown [0005] “an article of clothing suitable for applying a pharmaceutical composition … comprises typically at least three layers… an optional outer surface layer, an inner layer to which the pharmaceutical composition is applied or coated; and a middle layer comprising …a breathable barrier to prevent or restrict liquid or solid pharmaceutical preparation material from passing from the inner layer to the outer surface layer. Note that if the optional outer surface layer is not present, the "inner layer" may actually then be the outer layer as will be readily understood by one skilled in the art”; [0015] “A pharmaceutical composition typically containing one or more active ingredients and one or more carrier materials is applied to, coated on… inner layer 16. ”);
a base layer (Brown in at least fig. 2, [0005], [0014-0017], for example discloses a base layer represented by wearable article 10 clothing material and outer layer 12. See at least Brown [0005] “article of clothing comprises typically at least three layers: an optional outer surface layer, an inner layer to which the pharmaceutical composition is applied or coated; and a middle layer comprising …a breathable barrier to prevent or restrict liquid or solid pharmaceutical preparation material from passing from the inner layer to the outer surface layer.”; [0014] “Articles of clothing suitable for applying a pharmaceutical composition”; [0016] “Outer surface layer 12 … can be made of any suitable material as desired…outer layer 12 will be any type of clothing material, e.g., natural or synthetic, including but not limited to cotton, rayon, nylon, wool and combinations thereof, for example”; [0017] “Layers 12, 14 and 16 are formed into a suitable article of clothing as desired”);
a backing layer for selectively blocking the passage of the treatment, the backing layer being disposed behind the receptacle layer (Brown in at least fig. 2, [0005], [0015], [0018-0019], [0023] for example discloses a backing layer/middle layer 14 for selectively blocking the passage of the treatment, the backing layer being disposed behind the receptacle layer 16 as seen in fig. 2. See at least Brown [0005] “article of clothing comprises typically at least three layers… an inner layer to which the pharmaceutical composition is applied or coated; and a middle layer comprising a solid, liquid and gas barrier or a breathable barrier to prevent or restrict liquid or solid pharmaceutical preparation material from passing from the inner layer to the outer surface layer”; [0015] “Middle layer 14 comprises a breathable barrier 18 to prevent the pharmaceutical composition from passing from inner layer 16 to the outer surface layer 12.”); and
wherein system is configured to map to a selected anatomical areas and/or physiological system of an intended wearer (Brown in at least abstract, fig. 2, [0014-0015], [0017], [0020-0022], [0025-0026] for example discloses wherein system is configured to map to a selected anatomical areas and/or physiological system of an intended wearer. See Brown [0014] “Articles of clothing suitable for applying a pharmaceutical composition… any articles of clothing. Articles of clothing include, for example, but are not limited to, t-shirts, sweatshirts, any long-sleeved shirt, any short-sleeved shirt, gloves, hats, pants, smocks, gowns, caps, hair nets, shorts or socks.”; [0020] “Pharmaceutical application area 20 can be any area on inner layer 16 where, when worn by a user, comes in contact with the desired area of pharmaceutical application on the user's body”; [0021] “pharmaceutical preparation may include, in addition to one or more active ingredient pharmaceuticals, one or more carrier materials. The carrier material can be used to promote distribution of the active pharmaceutical on the internal clothing layer and can also promote topical delivery of the pharmaceutical by contact with the skin as a result of the internal clothing layer contacting the skin.”; [0022] “When the article of clothing remains in contact with the wearer, the pharmaceutical composition is topically delivered to the area of the wearer's body that is in contact with the pharmaceutical.”; [0026] “article of clothing is worn in order to allow for topical delivery of the pharmaceutical composition from the inner layer of the article of clothing to the desired area of the body.”).
Brown does not necessarily require backing layer being disposed with the base layer feature in the applied embodiment.
However, Brown discloses alternate embodiments that disclose the backing layer being disposed behind the receptacle layer and with the base layer (Brown in at least abstract, fig. 2, [0005], [0016-0017] for example discloses backing layer 14 being disposed behind the receptacle layer 16 and with the base layer portion 12 of the base layer represented by wearable article 10 clothing material and outer layer 12. See at least Brown abstract “article of clothing is provided for topically delivering a pharmaceutical composition to a wearer of the article of clothing. The clothing typically includes at least three layers, an optional outer surface layer, a middle layer, and an inner layer”; [0005] “article of clothing comprises typically at least three layers: an optional outer surface layer, an inner layer to which the pharmaceutical composition is applied or coated; and a middle layer comprising …a breathable barrier to prevent or restrict liquid or solid pharmaceutical preparation material from passing from the inner layer to the outer surface layer.”; [0016] “Outer surface layer 12 … can be made of any suitable material as desired…outer layer 12 will be any type of clothing material, e.g., natural or synthetic, including but not limited to cotton, rayon, nylon, wool and combinations thereof, for example”; [0017] “Layers 12, 14 and 16 are formed into a suitable article of clothing as desired”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the backing layer arrangement with the base layer used in the wearable article, comprising a treatment delivery system as taught by Brown, such that the backing layer being disposed behind the receptacle layer and with the base layer, as also taught by Brown. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of concealing the underlying treatment layer facilitating outdoor use of the article of clothing, thereby enabling an efficient, practical method for topically delivering a pharmaceutical to a user as needed or desired (Brown, [0004]).
As per dependent Claim 3, Brown as a whole further discloses wearable article of claim 2 wherein the backing layer comprises a membrane (Applicants in [0062] disclose “Waterproof breathable (WBR) membranes, like GORE-TEX, are an example of common waterproof fabrics” and [0071] “waterproof breathable (WBR) membranes are commercially available and include the trademark GORE-TEX® of W.L. Gore & Associates, Inc.” in [0073] “traditional ePTFE's like GORE-TEX” i.e. Applicant admits GORE-TEX is a membrane and is well-known prior art. Brown in [0018-0019] for example discloses backing layer/breathable barrier 18 comprises a thermo-mechanically expanded polytetrafluoroethylene or other fluoropolymers… and polyvinylidene fluoride. Such materials are commonly commercially available, including the trademark GORE-TEX.RTM” which reads on backing layer comprises a membrane as recited).
As per dependent Claim 4, Brown as a whole further discloses wearable article wherein the membrane comprises a layer comprising a hydrophobic layer (Brown in at least [0018-0019] for example discloses GORE-TEX.RTM breathable barrier 18/membrane comprises a layer comprising a hydrophobic layer as breathable barrier 18 is disclosed as preventing liquid water from passing from inner layer 16 to outer surface layer 12 and vice versa and preventing any liquid or bulk solid pharmaceutical composition from migrating from inner layer 16 to outer surface layer 12. See at least Brown [0018] “Breathable barrier 18 … prevents air and liquid water from passing from inner layer 16 to outer surface layer 12 and vice versa. Breathable barrier 18 prevents any liquid or bulk solid pharmaceutical composition from migrating from inner layer 16 to outer surface layer 12. Typically, breathable barrier 18 comprises a thermo-mechanically expanded polytetrafluoroethylene or other fluoropolymers… and polyvinylidene fluoride. Such materials are commonly commercially available, including the trademark GORE-TEX.RTM. of W.L. Gore & Associates, Inc.”).
As per dependent Claim 5, Brown as a whole further discloses wearable article wherein the receptacle layer comprises a hydrophilic layer (Brown in at least [0016] for example discloses the receptacle layer 16 comprises a hydrophilic layer such as any type of clothing material, natural or synthetic, including but not limited to cotton. See at least Brown [0016] “inner layer 16 can be made of any suitable material as desired…any type of clothing material, e.g., natural or synthetic, including but not limited to cotton… Inner layer 16 may be suitably constructed and may also be selected to facilitate application of the pharmaceutical to a wearer's skin”).
As per dependent Claim 8, Brown as a whole further discloses treatment delivery system wherein the system includes a bonding section for bonding the system to a base layer of a wearable article, wherein the bonding section is disposed along at least one edge of the system, the bonding section being an adhesive or thermal bonding material or a stitchable edge (Brown in at least fig. 1, [0014], [0017] for example discloses the system includes a bonding section for bonding the system to a base layer of a wearable article, wherein the bonding section is disposed along at least one edge of the system, the bonding section being an adhesive. See at least Brown [0014] “Articles of clothing suitable for applying a pharmaceutical composition… any articles of clothing…include, for example, but are not limited to, t-shirts, sweatshirts, any long-sleeved shirt, any short-sleeved shirt, gloves, hats, pants, smocks, gowns, caps, hair nets, shorts or socks.”; [0017] “Layers 12, 14 and 16 are formed into a suitable article of clothing as desired and, for example, in accordance with commonly known techniques including sewing and adhesive attachment, for example.”).
As per dependent Claim 9, Brown as a whole further discloses treatment delivery system wherein the receptacle layer comprises a knit, woven, non-woven textile, or any combination thereof (Brown in at least [0016] for example discloses the receptacle layer comprises a knit, woven, non-woven textile, or any combination thereof. See at least Brown [0016] “inner layer 16 can be made of any suitable material as desired. … natural or synthetic, including but not limited to cotton, rayon, nylon, wool and combinations thereof…Inner layer 16 may be suitably constructed and may also be selected to facilitate application of the pharmaceutical to a wearer's skin, and could also be selected from relatively liquid impermeable materials that could be perforated if desired”).
As per dependent Claim 10, Brown as a whole further discloses wearable article wherein the article comprises a garment (Brown in at least fig. 1, [0014]. See at least Brown [0014] “Articles of clothing suitable for applying a pharmaceutical composition… any articles of clothing…include, for example, but are not limited to, t-shirts, sweatshirts, any long-sleeved shirt, any short-sleeved shirt, gloves, hats, pants, smocks, gowns, caps, hair nets, shorts or socks.”;).
As per dependent Claim 11, Brown as a whole further discloses wearable article wherein the article comprises a sleeve or wrap for covering a selected area of the anatomy or physiology (Brown in at least fig. 1, [0014], t-shirt comprises a sleeve. Also see fig. 3 which shows shirt with wrap 40 on sleeve embodiment 32’. See at least Brown [0014] “Articles of clothing suitable for applying a pharmaceutical composition… any articles of clothing…include, for example, but are not limited to, t-shirts, sweatshirts, any long-sleeved shirt, any short-sleeved shirt, gloves, hats, pants, smocks, gowns, caps, hair nets, shorts or socks.”;).
As per dependent Claim 12, Brown as a whole further discloses system wherein the system maps along the anatomical area and/or physiological pathway of the spine, neck, and/or back region (Brown in at least fig. 1, [0014], t-shirt maps spine, neck, and/or back region. See at least Brown [0014] “Articles of clothing suitable for applying a pharmaceutical composition… any articles of clothing…include, for example, but are not limited to, t-shirts, sweatshirts, any long-sleeved shirt, any short-sleeved shirt, gloves, hats, pants, smocks, gowns, caps, hair nets, shorts or socks.”;).
As per dependent Claim 13, Brown as a whole further discloses system wherein the system maps along an anatomical area and/or physiological pathway comprising a finger, hand and/or arm region(Brown in at least fig. 1, [0014], shirt maps arm region while gloves map a finger, hand and/or arm region. See at least Brown [0014] “Articles of clothing suitable for applying a pharmaceutical composition… any articles of clothing…include, for example, but are not limited to, t-shirts, sweatshirts, any long-sleeved shirt, any short-sleeved shirt, gloves, hats, pants, smocks, gowns, caps, hair nets, shorts or socks.”;).
As per dependent Claim 14, Brown as a whole further discloses system wherein the system maps along an anatomical area and/or physiological pathway comprising hips, abdomen and/or pelvic region(Brown in at least fig. 1, [0014], pants and shorts map hips, abdomen and/or pelvic region. See at least Brown [0014] “Articles of clothing suitable for applying a pharmaceutical composition… any articles of clothing…include, for example, but are not limited to, t-shirts, sweatshirts, any long-sleeved shirt, any short-sleeved shirt, gloves, hats, pants, smocks, gowns, caps, hair nets, shorts or socks.”;).
As per dependent Claim 15, Brown as a whole further discloses system wherein the system maps along an anatomical area and/or physiological pathway comprising a shoulder, brachial plexus, collarbone and/or shoulder blade region (Brown in at least fig. 1, [0014], [0020], shirt maps a shoulder (fig. 1), brachial plexus, collarbone and/or shoulder blade region. See at least Brown [0014] “Articles of clothing suitable for applying a pharmaceutical composition… any articles of clothing…include, for example, but are not limited to, t-shirts, sweatshirts, any long-sleeved shirt, any short-sleeved shirt, gloves, hats, pants, smocks, gowns, caps, hair nets, shorts or socks.”;[0020]” Pharmaceutical application area 20 can be any area on inner layer 16 where, when worn by a user, comes in contact with the desired area of pharmaceutical application on the user's body. As shown in FIG. 1, pharmaceutical application area 20 is located on a shoulder area 22 of t-shirt 10.”).
As per dependent Claim 16, Brown as a whole further discloses system wherein the system maps along an anatomical area and/or physiological pathway comprising toes, foot, and leg region (Brown in at least fig. 1, [0014], socks, pants map toes, foot, and leg region. See at least Brown [0014] “Articles of clothing suitable for applying a pharmaceutical composition… any articles of clothing…include, for example, but are not limited to, t-shirts, sweatshirts, any long-sleeved shirt, any short-sleeved shirt, gloves, hats, pants, smocks, gowns, caps, hair nets, shorts or socks.”;).
As per dependent Claim 17, Brown as a whole further discloses system wherein the system maps along an anatomical area and/or physiological pathway comprising the skull and/or jaw region (Brown in at least fig. 1, [0014], hats, caps, hair nets map the skull and/or jaw region. See at least Brown [0014] “Articles of clothing suitable for applying a pharmaceutical composition… any articles of clothing…include, for example, but are not limited to, t-shirts, sweatshirts, any long-sleeved shirt, any short-sleeved shirt, gloves, hats, pants, smocks, gowns, caps, hair nets, shorts or socks.”;).
As per dependent Claim 18, Brown as a whole further discloses system wherein the system is intended to be located on the outer side of the wearable item oriented so as to expose an applied treatment towards the wearer's olfactory system (This limitation is being interpreted as intended use/functional limitation as detailed in MPEP 2111.04 which states inter alia that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. Brown in at least [0005], [0020], [0028] discloses an embodiment wherein the system is intended to be located on the outer side of the wearable item oriented so as to expose an applied treatment towards the wearer's olfactory system. See at least Brown [0005] “an article of clothing suitable for applying a pharmaceutical composition…comprises typically at least three layers: an optional outer surface layer, an inner layer to which the pharmaceutical composition is applied or coated; and a middle layer …Note that if the optional outer surface layer is not present, the "inner layer" may actually then be the outer layer as will be readily understood by one skilled in the art… pharmaceutical composition comprises any pharmaceutical that can be topically delivered and typically will include at least one active ingredient and a carrier material and other inactive ingredients as desired and which are well known to those skilled in the art.”; [0028] “The pharmaceutical composition can be any pharmaceutical composition suitable for topical delivery to an individual and may be a drug or nutraceutical…Examples of appropriate pharmaceutical compositions include, for example, ointments, salves, gels, oils, and/or muscle treatments”).
As per dependent Claim 20, Brown as a whole further discloses system wherein the system further comprises a treatment agent applied to the receptacle layer (Brown in at least [0005], [0020], [0028] for example discloses a treatment agent applied to the receptacle layer. See at least Brown [0005] “pharmaceutical composition comprises any pharmaceutical that can be topically delivered and typically will include at least one active ingredient and a carrier material and other inactive ingredients as desired and which are well known to those skilled in the art”; [0020] “Inner layer 16 has a pharmaceutical composition applied to it. The pharmaceutical composition can be any pharmaceutical that is suitable for topical delivery to a person. Examples of pharmaceutical compositions suitable for topical delivery to a person, typically with a carrier and at least one active ingredient include, for example, ointments, salves, gels, oils, and/or muscle treatments. Examples of suitable types of drugs or active pharmaceuticals include, but are not limited to corticosteroids, immunosuppressants, antihistamines, anesthetics, retinoids, sex hormones, pediculicides, rubifacients, antifungals, antibacterial, antiparasitic and antiviral agents. The pharmaceutical composition is applied to at least a portion of inner layer 16”; [0028] “pharmaceutical composition can be any pharmaceutical composition suitable for topical delivery to an individual and may be a drug or nutraceutical, for example. Examples of appropriate pharmaceutical compositions include, for example, ointments, salves, gels, oils, and/or muscle treatments”;).
As per dependent Claim 21, Brown as a whole further discloses system wherein the waterproof rating is at least 5,000 mm (This limitation is being interpreted in light of instant application specification [0067]. Based on disclosed waterproof rating scale, Brown disclosure in [0005], [0018-0019], [0023] reads on subject-matter as now explicitly, positively and specifically recited by the Applicants. See at least Brown [0018] “Breathable barrier 18 …prevents … liquid water from passing from inner layer 16 to outer surface layer 12 and vice versa. Breathable barrier 18 prevents any liquid … pharmaceutical composition from migrating from inner layer 16 to outer surface layer 12. Typically, breathable barrier 18 comprises a thermo-mechanically expanded polytetrafluoroethylene or other fluoropolymers, including, but not limited to perfluoroalkoxy polymer, fluorinated ethylene-propylene, polyvinylfluoride, polyethylenetetrafluoroethylene, polyethylenechlorotrifluoroethylene, and polyvinylidene fluoride. Such materials are commonly commercially available, including the trademark GORE-TEX.RTM. of W.L. Gore & Associates, Inc.”; [0005] “a middle layer comprising a …liquid … barrier … to prevent or restrict liquid … pharmaceutical preparation material from passing from the inner layer to the outer surface layer.”; [0019] “Middle layer 14 can alternatively be a barrier or substantial barrier to … liquid … Any suitable material for this purpose can be used and the material may be, for example, polyethylene film.”; [0023] “By …preventing liquids such as water … from passing from inner layer 16 to outer surface layer 12, breathable barrier 18 prevents the pharmaceutical composition from passing in that manner from inner layer 16 to outer surface layer 12… efficient utilization of the pharmaceutical preparation and prevents contact with exterior items that the wearer may contact, such as … other clothing that may be worn over the article of clothing, for example.”).
As per dependent Claim 22, Brown as a whole further discloses system wherein the breathability score (RET) is 20 or less (This limitation is being interpreted in light of instant application specification [0068]. Based on disclosed breathability score scale, Brown disclosure in [0005], [0018], [0023] reads on subject-matter as now explicitly, positively and specifically recited by the Applicants. See at least Brown [0018] “Breathable barrier 18 allows the transmission of air and water vapor from outer surface layer 12 to inner layer 16 and vice versa… breathable barrier 18 comprises a thermo-mechanically expanded polytetrafluoroethylene or other fluoropolymers, including, but not limited to perfluoroalkoxy polymer, fluorinated ethylene-propylene, polyvinylfluoride, polyethylenetetrafluoroethylene, polyethylenechlorotrifluoroethylene, and polyvinylidene fluoride. Such materials are commonly commercially available, including the trademark GORE-TEX.RTM. of W.L. Gore & Associates, Inc”; [0023] “By allowing the transmission of air and water vapor from outer surface layer 12 to inner layer 16”).
Claims 6-7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Brown in view of Gladish et al. (Pub. No.: US 20170254005 A1, hereinafter referred to as “Gladish”).
As per dependent Claim 6, Brown discloses wearable article of claim 3 (see claim 3 analysis).
Brown does not explicitly disclose polyurethane-based fiber feature.
However, in an analogous textile for apparel field of endeavor, Gladish discloses a wearable article (Gladish in at least abstract, abstract, [0002], [0013-0014], [0019], [0021], [0040-0041], [0043], [0045], [0048], [0075], [0083], [0125-0135] for example discloses relevant subject-matter. More specifically, Gladish in at least abstract, [0021], [0040], [0045], [0074] for example discloses wearable textile. See at least [0021] “materials made of fiber webs of fibers or agglomerations of fibers…used in a variety of applications, including garments and apparel… etc.”; [0045] “articles incorporating superfine fibers created by jet extrusion, the articles consisting of garments and apparel, e.g., jackets and pants; footwear, e.g., shoes and socks; headwear, e.g., soft caps and brimmed or visored hats, and facemasks…etc.”;)
wherein the membrane comprises a polyurethane-based fiber (Gladish in at least [0021], [0074-0075] for example discloses the membrane comprises a polyurethane-based fiber. See at least [0075] “membrane, either deposited directly on the fabric, or material, or laminated on the material, may also be used in softshell constructions…Collectively, these factors influence the breathability and durability of the nanofiber membrane…Fiber-forming materials of use for softshell and waterproof breathable applications include PFTE dispersions, polyurethanes, nylons, polyesters, bio-based materials”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the membrane used in the wearable article, comprising a treatment delivery system as taught by Brown, in a manner that membrane comprises a polyurethane-based fiber, as taught by Gladish. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of constructing wearable articles having a predetermined/desired degree of durability, waterproofness, windproofness and breathability (Gladish, [0013], [0019], [0040], [0045], [0075]).
As per dependent Claim 7, Brown discloses wearable article of claim 4 (see claim 4 analysis)
Brown does not explicitly disclose super fine jet extruded fibers feature.
However, in an analogous textile for apparel field of endeavor, Gladish discloses wearable article (Gladish in at least abstract, [0002], [0013-0014], [0019], [0021], [0040-0041], [0043], [0045], [0048], [0075], [0083], [0125-0135] for example discloses relevant subject-matter. More specifically, Gladish in at least abstract, [0021], [0040], [0074] for example discloses wearable textile. See at least [0021] “materials made of fiber webs of fibers or agglomerations of fibers…used in a variety of applications, including garments and apparel… etc.”)
wherein the membrane comprises super fine jet extruded fibers (Gladish in at least [0040-0041], [0043], [0045], [0048], for example discloses membrane comprises super fine jet extruded fibers. See at least [0045] “articles incorporating superfine fibers created by jet extrusion, the articles consisting of garments and apparel, e.g., jackets and pants; footwear, e.g., shoes and socks; headwear, e.g., soft caps and brimmed or visored hats, and facemasks…etc.”; [0048] “layer 3 may be created using any forcespinning or other jet extrusion”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify membrane used in the wearable article, comprising a treatment delivery system as taught by Brown, in a manner that membrane comprises super fine jet extruded fibers, as taught by Gladish. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of producing textile user end-products having predetermined/desired waterproof and breathable protection, as well as wind protection (Gladish, [0045], [0083]).
As per dependent Claim 19, Brown discloses system of claim 1 (see claim 1 analysis).
Brown does not explicitly disclose Neoshell™ fabric from Polartec feature.
However, in an analogous textile for apparel field of endeavor, Gladish discloses wearable textile (Gladish in at least abstract, [0002], [0013-0014], [0019], [0021], [0040-0041], [0043], [0045], [0048], [0075], [0083], [0125-0135] for example discloses relevant subject-matter. More specifically, Gladish in at least abstract, [0021], [0040], [0045], [0074] for example discloses wearable textile. See at least [0021] “materials made of fiber webs of fibers or agglomerations of fibers…used in a variety of applications, including garments and apparel… etc.”; [0045] “articles incorporating superfine fibers created by jet extrusion, the articles consisting of garments and apparel, e.g., jackets and pants; footwear, e.g., shoes and socks; headwear, e.g., soft caps and brimmed or visored hats, and facemasks…etc.”;)
wherein the backing/textile layer comprises Neoshell™ fabric from Polartec (Applicants in at least instant application specification as-filed at least [0063], [0073-0075] discloses recited subject-matter as well-known prior art. Gladish in at least [0014], [0021], [0074-0075] for example discloses textile layer comprises Neoshell™ fabric from Polartec. See at least Gladish [0014] “Among recent electrospun products is the high volume production of Polartec's NEOSHELL materials”; [0075] “membrane, either deposited directly on the fabric, or material, or laminated on the material, may also be used in softshell constructions…Collectively, these factors influence the breathability and durability of the nanofiber membrane…Fiber-forming materials of use for softshell and waterproof breathable applications include PFTE dispersions, polyurethanes, nylons, polyesters, bio-based materials”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the backing layer used in treatment delivery system for integration with a wearable article as taught by Brown, in a manner that backing layer comprises Neoshell™ fabric, as taught by Gladish. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of constructing wearable articles having a predetermined/desired degree of durability, waterproofness, windproofness and breathability (Gladish, [0013], [0019], [0040], [0045], [0075]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims.
Prior art US 20070135777 A1 to Greene et al. for disclosing a therapeutic article that includes a permeable skin contact layer configured for wear against a user's skin similar to that disclosed and claimed. More specifically, a therapeutic article that includes a skin contact layer having a plurality of fibers forming a plurality of point-bearing surfaces configured for wear against a user's skin; a personal care composition disposed proximate the fibers; an external layer attached to the skin contact layer; and an intermediate layer interposed between the skin contact layer and the external layer, the intermediate layer being configured to activate the personal care composition, the external layer being configured to direct the activated personal care composition through the skin contact layer to treat the user.
Prior art US 20050033214 A1 to Cantor for disclosing component that article that includes fragrance/aromatic portions disposed within an adhesive portion wherein the article is adapted to be applied to a user's skin wound similar to that disclosed. More specifically, a bandage that includes a flexible backing layer having a rear surface, a pad portion attached to the rear surface of the backing layer, an adhesive portion disposed on the rear surface of the backing layer away from the central pad portion. The adhesive is used to adhere the bandage to the user's skin. Also included are fragrance/aromatic portions disposed within the adhesive portion and a release cover releasably secured to the adhesive portion, which when removed, allows for release of a scent associated with the fragrance portions.
Prior art US 20140052080 A1 to Gibson et al. for disclosing garments, including but not limited to shoes or gloves, for the application of medication or related substance to the foot or hand of a patient in need of such medication or related substance similar to that disclosed. More specifically, a disposable garment, such as a glove, a sock, or a shoe, for treating foot or hand inflammation or disease. In a preferred embodiment, the garment comprises a flexible outer cover that is nonporous and an inner layer closely adhered to the inside of the outer cover. The outer cover may preferably have a flexible closure at the level of the ankle or wrist, arranged such that liquids will be retained therein. The inner layer serves as a reservoir for a selected therapeutic product, and preferably comprises a bladder. Preferably, the bladder has a perforation, and may be disposed within the inner layer in a position allowing a user to apply pressure to bladder with his foot or hand. A therapeutic product in liquid form is stored within the reservoir, and is released upon application of pressure by the user's foot or hand.
Prior art US 4283011 A to Spector for disclosing aroma-dispensing stickers that are attachable to an article of clothing or any other surface similar to that disclosed. More specifically, scented sticker attachable to an article of clothing or other surface, the sticker including an applique sheet which is profiled to simulate the appearance of an odoriferous object such as a fruit or flower. Secured to the rear of the sheet is a shallow dish containing a pad saturated with a volatile scent whose odor simulates the characteristic natural odor of the object pictured by the sheet, the scent being emitted through perforations in the sheet. The base of the dish has a layer of pressure-sensitive adhesive thereon to facilitate attachment of the sticker.
Prior art US 4277024 A to Spector an aroma-dispensing tab that is stickable onto any surface similar to that disclosed. More specifically, aroma-dispensing tab that is stickable onto any surface, such as an article of apparel, to exude a pleasant fragrance or to function as an insect repellent. The tab is in the form of a sac constituted by a base having a perforated dome marginally secured thereto to define a vented chamber occupied by an absorbent pad saturated by a liquid scent. A layer of pressure-sensitive adhesive on the underside of the base makes it possible to attach the tab to any surface.
Prior art US 5395047 A to Pendergrass for disclosing repositionable device for delivery of volatile materials such as aromatics/ fragrance similar to that disclosed. More specifically, device for delivery of volatile materials comprising a volatile material delivery layer, a support layer and a repositionable adhesive layer..
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791