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 .
Response to Amendment
The amendment to claims 1, 15, 16, 17, 29-33, the cancellation of claims 13-14, and the addition of new claims 34-35 in the response filed on 04/01/2026 is acknowledged.
Claims 1-33 are now pending in the application.
Response to Arguments
Applicant’s arguments with respect to claims 1, 17, and 29 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
However, the Cramer (US 6096067) and Whitely US 10632011 references remain applicable in the below office action given that Cramer teaches various structural features of the front and back sheets and is now relied upon as a teaching reference.
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.
Claim 13 is 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.
Claim 13 recites the limitation "the outer center" in line 4. There is insufficient antecedent basis for this limitation in the claim. For purpose of compact prosecution, the Examiner is interpreting the term as –an outer center--. Furthermore, the term “outer center” is unclear and vague as there is no mention or explanation/definition of the term in the written specification such that one skilled in the art is able to understand what is meant by the term. As such, the term “outer center” is examines as best understood.
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.
Claim 16 is 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 16 depends from now cancelled claim 13. 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. For purpose of compact prosecution, the Examiner is interpreting claim 16 to depend directly from claim 1.
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 1-12, 16-30 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over MacWhinnie US 6261313 in view of Cramer US 6096067.
Regarding claim 1, MacWhinnie discloses a breast pack 110 (similar in structure to breast pack 10, just shaped differently) for delivering heat or cold therapy to a breast (col. 2, lines 47-67, col. 3, lines 1-7, 14-24, 48-67, col. 4, lines 1-5, 45-48, 63-67, col. 5, lines 1-5, 43-49, col. 6, lines 50-67, col. 7, lines 34-55, fig. 8), comprising a front sheet 11 formed as a first fabric, the first fabric having a first loft, a back sheet 12 formed as a second fabric, the second fabric having a second loft then the first loft (back sheet 12 is formed of a terry cloth like material that has a different loft than the first fabric of front sheet 11), wherein each of the front sheet 11 and the back sheet 12 comprises an open center 128 for receiving a nipple, and a plurality of radial channels 90,91,92 extending from the open center 128 (fig. 8, col. 7, lines 34-55), the front sheet 11 bonded (the edges of the heat pack are shown to be closed) to the back sheet 12 at a periphery of the breast pack 110, such that the front sheet 11 and the back sheet 12 define therebetween a volume 14, a gel contained within the volume 14 (col.3, lines 1-7, col. 4, lines 63-67 disclose gel material, col. 6, lines 50-67, see fig. 1, where 14 defines a chamber pocket between front sheet 11 and back sheet 12).
MacWhinnie does not expressly disclose a front sheet formed as a laminate including a first fluid-impervious layer and a first fabric, the first fabric having a first loft; a back sheet formed as a laminate including a second fluid-impervious layer and a second fabric, the second fabric having a second loft larger than the first loft. Although MacWhinnie discloses the edges of the front sheet and back sheet are closed and sealed at their edges to form the chamber, MacWhinnie does not explicitly disclose the front sheet bonded to the back sheet at a periphery of the breast pack.
Cramer teaches an analogous breast pack 10 (col. 1, lines 20-25, col. 9, lines 10-42, figs. 1-2) for delivering heat or cold therapy to a breast (the pack 10 is capable of being applied to a breast given that it is intended for relieving menstrual pain which is normally also felt in female breasts due to tenderness and swelling during their menstrual cycle thus rendering packing 10 as a breast pack), the analogous breast pack 10 comprising: a front sheet 22,26 formed as a laminate (laminated structure, col. 5, lines 40-67) including a first fluid-impervious layer 22 and a first fabric 26, the first fabric 26 having a first loft (32 gsm, col. 10, lines 12-24 evidences first loft of fabric 26 since gsm measures weight and density, directly influencing how thick, substantial, and lofty a fabric feels), a back sheet 20,30 formed as a laminate including a second fluid-impervious layer 20 and a second fabric 30, the second fabric 30 having a second loft larger than the first loft (63 gsm, col. 10, lines 25-35 evidences larger loft since higher gsm means more weight, density/thickness which), the front sheet 22,26 bonded to the back sheet 20,30 at a periphery of the breast pack 10 via 28,32 (the packing inherently has edges that define a periphery that is bonded together to create a volume, col. 9, lines 40-58), such that the front sheet 22,26 and the back sheet 20,30 define therebetween an analogous volume (housing/enveloping 16,18), an analogous gel 16,18 (18 contains silica gel, col. 8, lines 4-44) contained within the analogous volume (col. 5,l lines 38-67, col. 6, lines 1-67, figs. 1-2), for the purpose of providing continuous front sheets and back sheets that are continuous and exhibit specific thermophysical properties while still maintaining good overall drape characteristics such that the pack provides consistent, convenient, and comfortable thermal application and excellent conformity with the user’s body (col. 4, lines 7-8 et seq. 25-30).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have formed the front sheet 11 and back sheet 12 of MacWhinnie as a laminate including a first fluid-impervious layer and a first fabric, the first fabric having a first loft; a back sheet formed as a laminate including a second fluid-impervious layer and a second fabric, the second fabric having a second loft larger than the first loft and also have bonded the front sheet to the back sheet at a periphery of the pack as taught by Cramer in order to have provided an improved breast pack that has an improved front sheets and back sheets that are continuous and exhibit specific thermophysical properties while still maintaining good overall drape characteristics such that the pack provides consistent, convenient, and comfortable thermal application and excellent conformity with the user’s breast (Cramer, col. 4, lines 7-8 et seq. 25-30).
Regarding claim 2, MacWhinnie in view of Cramer discloses the invention a discussed above. MacWhinnie in view of Cramer further discloses wherein the first fluid-impervious layer 22 is plastic as taught by Cramer (col. 6, lines 5-46).
Regarding claim 3, MacWhinnie in view of Cramer r discloses the invention a discussed above. MacWhinnie in view of Cramer further discloses wherein the plastic is a thermoplastic film as taught by Cramer (col 6, lines 5-24).
Regarding claim 4, MacWhinnie in view of Cramer discloses the invention a discussed above. MacWhinnie in view of Cramer further discloses wherein the thermoplastic film is selected from the group consisting of polyvinyl chloride, polypropylene, polyethylene, polycarbonate, polyurethane, polyamide and compatible mixtures thereof as taught by Cramer (col. 6, lines 5-46).
Regarding claim 5, MacWhinnie in view of Cramer discloses the invention a discussed above. MacWhinnie in view of Cramer further discloses wherein the second fluid-impervious layer 20 is plastic as taught by Cramer (col. 6, lines 5-46).
Regarding claim 6, MacWhinnie in view of Cramer discloses the invention a discussed above. MacWhinnie in view of Cramer further discloses wherein the second fluid-impervious layer 20 is a thermoplastic film as taught by Cramer (col. 6, lines 5-24).
Regarding claim 7, MacWhinnie in view of Cramer discloses the invention a discussed above. MacWhinnie in view of Cramer further discloses wherein the thermoplastic film is selected from the group consisting of polyvinyl chloride, polypropylene, polyethylene, polycarbonate, polyurethane, polyamide and compatible mixtures thereof as taught by Cramer (col. 6, lines 5-46).
Regarding claim 8, MacWhinnie in view of Cramer discloses the invention a discussed above. MacWhinnie in view of Cramer further discloses wherein the first fabric 26 is a woven or nonwoven fabric composed of fibers selected from the group consisting of polyester, nylon, spandex, cotton, viscose, flax and blends thereof as taught by Cramer (col. 10, lines 12-25).
Regarding claim 9, MacWhinnie in view of Cramer discloses the invention a discussed above. MacWhinnie in view of Cramer further discloses wherein the first fabric 26 is mesh, knit, plush, canvas, linen, velvet or muslin as taught by Cramer (knitted col. 10, lines 12-25).
Regarding claim 10, MacWhinnie in view of Cramer discloses the invention a discussed above. MacWhinnie in view of Cramer further discloses wherein the second fabric 30 is a woven or nonwoven fabric composed of fibers selected from the group consisting of polyester, nylon, spandex, cotton, viscose, flax and blends thereof as taught by Cramer (col. 10, lines 25-36).
Regarding claim 11, MacWhinnie in view of Cramer discloses the invention a discussed above. MacWhinni further discloses the second fabric is a plush (a terry cloth material which could be a knitted). MacWhinnie in view of Cramer further discloses wherein the second fabric 30 is mesh, knit, plush, canvas, linen, velvet or muslin as taught by Cramer (knitted col. 10, lines 25-36).
Regarding claim 12, MacWhinnie in view of Cramer discloses the invention a discussed above. MacWhinnie in view of Cramer further discloses wherein the first fluid-impervious layer 22 is directly bonded to the second fluid-impervious layer 20 at the periphery 20,22 are thermally bonded together, see fig. 2 and col. 6, lines 25-46) as taught by Cramer.
Regarding claim 16, MacWhinnie in view of Cramer discloses the invention a discussed above. MacWhinnie further discloses the periphery of the breast pack 110 includes an outer periphery A (see annotated figure 8 below), and an angular segment 119 (defined by sides 115,116) extends from the outer center B to the outer periphery A.
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Regarding claim 17, MacWhinnie discloses a breast pack 110 (similar in structure to breast pack 10, just shaped differently) for delivering heat or cold therapy to a breast (col. 2, lines 47-67, col. 3, lines 1-7, 14-24, 48-67, col. 4, lines 1-5, 45-48, 63-67, col. 5, lines 1-5, 43-49, col. 6, lines 50-67, col. 7, lines 34-55, fig. 8), comprising a front sheet 11 formed as a first fabric, the first fabric having a first thermal conductance, a back sheet 12 formed as a second fabric, the second fabric having a second thermal conductance smaller than the first thermal conductance (back sheet 12 is formed of a terry cloth like material that has a different thermal conductance than the first fabric of front sheet 11), wherein each of the front sheet 11 and the back sheet 12 comprises an open center 128 for receiving a nipple, and a plurality of radial channels 90,91,92 extending from the open center 128 (fig. 8, col. 7, lines 34-55), the front sheet 11 bonded (the edges of the heat pack are shown to be closed) to the back sheet 12 at a periphery of the breast pack 110, such that the front sheet 11 and the back sheet 12 define therebetween a volume 14, a gel contained within the volume 14 (col.3, lines 1-7, col. 4, lines 63-67 disclose gel material, col. 6, lines 50-67, see fig. 1, where 14 defines a chamber pocket between front sheet 11 and back sheet 12).
MacWhinnie does not expressly disclose a front sheet formed as a laminate including a first fluid-impervious layer and a first fabric, the first fabric having a first thermal conductance; a back sheet formed as a laminate including a second fluid-impervious layer and a second fabric, the second fabric having a second thermal conductance smaller than the first thermal conductance. Although MacWhinnie discloses the edges of the front sheet and back sheet are closed and sealed at their edges to form the chamber, MacWhinnie does not explicitly disclose the front sheet bonded to the back sheet at a periphery of the breast pack.
Cramer teaches an analogous breast pack 10 (col. 1, lines 20-25, col. 9, lines 10-42, figs. 1-2) for delivering heat or cold therapy to a breast (the pack 10 is capable of being applied to a breast given that it is intended for relieving menstrual pain which is normally also felt in female breasts due to tenderness and swelling during their menstrual cycle thus rendering packing 10 as a breast pack), the analogous breast pack 10 comprising: a front sheet 22,26 formed as a laminate (laminated structure, col. 5, lines 40-67) including a first fluid-impervious layer 22 and a first fabric 26, the first fabric 26 having a first thermal conductance (32 gsm, col. 10, lines 12-24 evidences inherent first thermal conductance of fabric 26 since gsm measures weight and density, directly influencing how thick, substantial, and insulating a fabric is, higher gsm means heavier and better insulation/lower heat transfer while higher gsm fabrics are lighter more breathable), a back sheet 20,30 formed as a laminate including a second fluid-impervious layer 20 and a second fabric 30, the second fabric 30 having a second thermal conductance smaller than the first thermal conductance (63 gsm, col. 10, lines 25-35 evidences inherent smaller heat conductance since higher gsm means directly influencing how thick, substantial, and insulating a fabric is, higher gsm means heavier and better insulation/lower heat transfer while higher gsm fabrics are lighter more breathable so 63 gsm of fabric 30 has a smaller thermal conductance than the 32 gsm of fabric 26), the front sheet 22,26 bonded to the back sheet 20,30 at a periphery of the breast pack 10 via 28,32 (the packing inherently has edges that define a periphery that is bonded together to create a volume, col. 9, lines 40-58), such that the front sheet 22,26 and the back sheet 20,30 define therebetween an analogous volume (housing/enveloping 16,18), an analogous gel 16,18 (18 contains silica gel, col. 8, lines 4-44) contained within the analogous volume (col. 5,l lines 38-67, col. 6, lines 1-67, figs. 1-2), for the purpose of providing continuous front sheets and back sheets that are continuous and exhibit specific thermophysical properties while still maintaining good overall drape characteristics such that the pack provides consistent, convenient, and comfortable thermal application and excellent conformity with the user’s body (col. 4, lines 7-8 et seq. 25-30).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have formed the front sheet 11 and back sheet 12 of MacWhinnie as a laminate including a first fluid-impervious layer and a first fabric, the first fabric having a first loft; a back sheet formed as a laminate including a second fluid-impervious layer and a second fabric, the second fabric having a second loft larger than the first loft and also have bonded the front sheet to the back sheet at a periphery of the pack as taught by Cramer in order to have provided an improved breast pack that has an improved front sheets and back sheets that are continuous and exhibit specific thermophysical properties while still maintaining good overall drape characteristics such that the pack provides consistent, convenient, and comfortable thermal application and excellent conformity with the user’s breast (Cramer, col. 4, lines 7-8 et seq. 25-30).
Regarding claim 18, MacWhinnie in view of Cramer discloses the invention a discussed above. MacWhinnie in view of Cramer further discloses wherein the first fluid-impervious layer 22 is plastic as taught by Cramer (col. 6, lines 5-46).
Regarding claim 19, MacWhinnie in view of Cramer discloses the invention discussed above. MacWhinnie in view of Cramer further discloses wherein the plastic is a thermoplastic film as taught by Cramer (col 6, lines 5-24).
Regarding claim 20, MacWhinnie in view of Cramer discloses the invention a discussed above. MacWhinnie in view of Cramer further discloses wherein the thermoplastic film is selected from the group consisting of polyvinyl chloride, polypropylene, polyethylene, polycarbonate, polyurethane, polyamide and compatible mixtures thereof as taught by Cramer (col. 6, lines 5-46).
Regarding claim 21, MacWhinnie in view of Cramer discloses the invention as discussed above. MacWhinnie in view of Cramer further discloses wherein the second fluid-impervious layer 20 is plastic as taught by Cramer (col. 6, lines 5-46).
Regarding claim 22, MacWhinnie in view of Cramer discloses the invention a discussed above. MacWhinnie in view of Cramer further discloses wherein the second fluid-impervious layer 20 is a thermoplastic film as taught by Cramer (col. 6, lines 5-24).
Regarding claim 23, MacWhinnie in view of Cramer discloses the invention a discussed above. MacWhinnie in view of Cramer further discloses wherein the thermoplastic film is selected from the group consisting of polyvinyl chloride, polypropylene, polyethylene, polycarbonate, polyurethane, polyamide and compatible mixtures thereof as taught by Cramer (col. 6, lines 5-46).
Regarding claim 24, MacWhinnie in view of Cramer discloses the invention a discussed above. MacWhinnie in view of Cramer further discloses wherein the first fluid-impervious layer 22 is directly bonded to the second fluid-impervious layer 20 at the periphery 20,22 are thermally bonded together, as taught by Cramer (see fig. 2 and col. 6, lines 25-46).
Regarding claim 25, MacWhinnie in view of Cramer discloses the invention a discussed above. MacWhinnie in view of Cramer further discloses wherein the first fabric 26 is a woven or nonwoven fabric composed of fibers selected from the group consisting of polyester, nylon, spandex, cotton, viscose, flax and blends thereof as taught by Cramer (col. 10, lines 12-25).
Regarding claim 26, MacWhinnie in view of Cramer discloses the invention a discussed above. MacWhinnie in view of Cramer further discloses wherein the first fabric 26 is mesh, knit, plush, canvas, linen, velvet or muslin as taught by Cramer (knitted col. 10, lines 12-25).
Regarding claim 27, MacWhinnie in view of Cramer discloses the invention a discussed above. MacWhinnie in view of Cramer further discloses wherein the second fabric 30 is a woven or nonwoven fabric composed of fibers selected from the group consisting of polyester, nylon, spandex, cotton, viscose, flax and blends thereof as taught by Cramer (col. 10, lines 25-36).
Regarding claim 28, MacWhinnie in view of Cramer discloses the invention a discussed above. MacWhinnie discloses the second fabric 12 is plush (terry cloth). MacWhinnie in view of Cramer further discloses wherein the second fabric 30 is mesh, knit, plush, canvas, linen, velvet or muslin as taught by Cramer (knitted col. 10, lines 25-36).
Regarding claim 29, MacWhinnie discloses a method for delivering hot or cold therapy to a breast (col. 2, lines 47-67, col. 5, lines 30-49), the method comprising the steps of providing a breast pack 10,110 (fig. 8, 110 has a different shape then 10, but has the same general structure and formation), having a front sheet 11 and a back sheet 12, the front sheet 11 comprising a first fabric 11 and the back sheet 12 comprising a second fabric 12 (e.g. terry cloth), the first fabric 11 having a first loft and a first thermal conductance and the second fabric 12 having a second loft and a second thermal conductance (first and back sheets 11,12 are different since back sheet 12 also includes terry cloth, col. 6, lines 50-67, col. 7, lines 34-55) the first thermal conductance is different from the second thermal conductance, each of the front sheet 11 and the back sheet 12 comprises an open center 128 for receiving a nipple, and a plurality of radial channels 90,91,92 extending from the open center 128, heating or cooling the breast pack 10,110 (col. 5, lines 43-49), selecting one of the front sheet 11 and the back sheet 12 for application to the breast (back sheet 12 is placed against breast, col. 7, lines 43-55), and applying the selected one of the front sheet 11 and the back sheet 12 (back sheet 12) to the breast.
MacWhinnie does not explicitly disclose the front sheet comprising a first fabric and the back sheet comprising a second fabric, the first fabric having a first loft and a first thermal conductance and the second fabric having a second loft and a second thermal conductance, wherein the first loft is different from the second loft, the first thermal conductance is different from the second different from the second thermal conductance.
Cramer teaches an analogous method for delivering hot therapy to a body part comprising the steps of providing an analogous breast pack 10 (col. 1, lines 20-25, col. 9, lines 10-42, figs. 1-2, the pack 10 is capable of being applied to a breast given that it is intended for relieving menstrual pain which is normally also felt in female breasts due to tenderness and swelling during their menstrual cycle thus rendering packing 10 as a breast pack) having an analogous front sheet 26 and a back sheet 30, the front sheet 26 comprising a first fabric (col. 9, lines 15-35, col. 10, lines 12-24, fig. 2) and the back sheet 30 comprising a second fabric 30 (col. 9, lines 15-35, col. 10, lines 25-36), the first fabric having a first loft and a first thermal conductance (32 gsm) and the second fabric 30 having a second loft and a second thermal conductance (63 gsm), wherein the first loft is different from the second loft, the first thermal conductance is different from the second thermal conductance (col. 10, lines 12-36, (32 gsm, col. 10, lines 12-24 evidences inherent first thermal conductance of fabric 26 since gsm measures weight and density, directly influencing how thick, lofty, substantial, and insulating a fabric is, higher gsm means heavier and better insulation/lower heat transfer/conductivity while lower gsm fabrics are lighter more breathable than 63 gsm, col. 10, lines 25-35 evidences inherent smaller heat conductance since higher gsm means directly influencing how thick, lofty, substantial, and insulating a fabric is, higher gsm means heavier and better insulation/lower heat transfer/conductivity while lower gsm fabrics are lighter more breathable, so 63 gsm of fabric 30 has a smaller thermal conductance than the 32 gsm of fabric 26), providing a front sheet that is more light weight and less heat conducting then the back sheet which is non-irritating and yet more insulating for better heat retention than the front sheet (col. 10, lines 12-35).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the step of providing the front sheet 14 and back sheet 14 of Vasconcellos with providing the first fabric having a first loft and a first thermal conductance and the second fabric having a second loft and a second thermal conductance, wherein the first loft is different from the second loft, the first thermal conductance is different from the second different from the second thermal conductance as taught by Cramer in order to have provided an improved step of providing a breast pack that has a front sheet that is more light weight and less heat conducting then the back sheet which is non-irritating and yet more insulating for better heat retention than the front sheet (Cramer, col. 10, lines 12-35).
Regarding claim 30, MacWhinnie in view of Cramer discloses the invention as discussed above. MacWhinnie in view of Cramer further discloses the second loft (63 gsm) is greater than the first loft (32 gsm) as taught by Cramer (col. 10, lines 12-36). MacWhinnie further discloses the method including the further steps of: cooling the breast pack (col. 5, lines 43-50) and applying the back sheet 12 to the breast (col. 7, lines 43-55) to discourage engorgement (this is an intended use that occurs from cooling the tissue breast).
Regarding claim 33, MacWhinnie in view of Cramer discloses the invention as discussed above. MacWhinnie in view of Cramer further discloses the first thermal conductance (32 gsm) is greater than the second thermal conductance (63 gsm) as taught by Cramer (col. 10, lines 12-36). MacWhinnie further discloses the method including the further steps of: cooling the breast pack (col. 5, lines 43-50) and applying the back sheet 12 to the breast (col. 7, lines 43-55) to discourage engorgement (this is an intended use that occurs from cooling the tissue breast).
Claims 29 and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over MacWhinnie US 6261313 in view of Cramer US 6096067 further in view of Whitely US 10632011.
Regarding claim 29, MacWhinnie discloses a method for delivering hot or cold therapy to a breast (col. 2, lines 47-67, col. 5, lines 30-49), the method comprising the steps of providing a breast pack 10,110 (fig. 8, 110 has a different shape then 10, but has the same general structure and formation), having a front sheet 11 and a back sheet 12, the front sheet 11 comprising a first fabric 11 and the back sheet 12 comprising a second fabric 12 (e.g. terry cloth), the first fabric 11 having a first loft and a first thermal conductance and the second fabric 12 having a second loft and a second thermal conductance (first and back sheets 11,12 are different since back sheet 12 also includes terry cloth, col. 6, lines 50-67, col. 7, lines 34-55) the first thermal conductance is different from the second thermal conductance, each of the front sheet 11 and the back sheet 12 comprises an open center 128 for receiving a nipple, and a plurality of radial channels 90,91,92 extending from the open center 128, heating or cooling the breast pack 10,110 (col. 5, lines 43-49), selecting one of the front sheet 11 and the back sheet 12 for application to the breast (back sheet 12 is placed against breast, col. 7, lines 43-55), and applying the selected one of the front sheet 11 and the back sheet 12 (back sheet 12) to the breast.
MacWhinnie does not explicitly disclose the front sheet comprising a first fabric and the back sheet comprising a second fabric, the first fabric having a first loft and a first thermal conductance and the second fabric having a second loft and a second thermal conductance, wherein the first loft is different from the second loft, the first thermal conductance is different from the second different from the second thermal conductance.
Cramer teaches an analogous method for delivering hot therapy to a body part comprising the steps of providing an analogous breast pack 10 (col. 1, lines 20-25, col. 9, lines 10-42, figs. 1-2, the pack 10 is capable of being applied to a breast given that it is intended for relieving menstrual pain which is normally also felt in female breasts due to tenderness and swelling during their menstrual cycle thus rendering packing 10 as a breast pack) having an analogous front sheet 26 and a back sheet 30, the front sheet 26 comprising a first fabric (col. 9, lines 15-35, col. 10, lines 12-24, fig. 2) and the back sheet 30 comprising a second fabric 30 (col. 9, lines 15-35, col. 10, lines 25-36), the first fabric having a first loft and a first thermal conductance (32 gsm) and the second fabric 30 having a second loft and a second thermal conductance (63 gsm), wherein the first loft is different from the second loft, the first thermal conductance is different from the second thermal conductance (col. 10, lines 12-36, (32 gsm, col. 10, lines 12-24 evidences inherent first thermal conductance of fabric 26 since gsm measures weight and density, directly influencing how thick, lofty, substantial, and insulating a fabric is, higher gsm means heavier and better insulation/lower heat transfer/conductivity while lower gsm fabrics are lighter more breathable than 63 gsm, col. 10, lines 25-35 evidences inherent smaller heat conductance since higher gsm means directly influencing how thick, lofty, substantial, and insulating a fabric is, higher gsm means heavier and better insulation/lower heat transfer/conductivity while lower gsm fabrics are lighter more breathable, so 63 gsm of fabric 30 has a smaller thermal conductance than the 32 gsm of fabric 26), providing a front sheet that is more light weight and less heat conducting then the back sheet which is non-irritating and yet more insulating for better heat retention than the front sheet (col. 10, lines 12-35).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the step of providing the front sheet 14 and back sheet 14 of Vasconcellos with providing the first fabric having a first loft and a first thermal conductance and the second fabric having a second loft and a second thermal conductance, wherein the first loft is different from the second loft, the first thermal conductance is different from the second different from the second thermal conductance as taught by Cramer in order to have provided an improved step of providing a breast pack that has a front sheet that is more light weight and less heat conducting then the back sheet which is non-irritating and yet more insulating for better heat retention than the front sheet (Cramer, col. 10, lines 12-35).
MacWhinnie in view of Cramer discloses the invention as discussed above. MacWhinnie in view of Cramer does not disclose selecting one of the front sheet and the back sheet for application to the breast; and applying the selected one of the front sheet and the back sheet to the breast.
Whitely teaches an analogous method for delivering hot or cold therapy to a body part (col. 4, lines 8-18), comprising the steps of providing an analogous pack 10 having an analogous front sheet 12,16 comprising an analogous first fabric (layer 16 can include fibers, fabrics col. 2, lines 40-50) and an analogous back sheet 18,24, the front sheet 12,16 comprising an analogous first fabric and the back sheet 18,24 comprising a second fabric 24 (col. 3, lines 24-67), heating or cooling the pack 10 (col. 4, lines 8-18), selecting one of the front sheet and the back sheet 18,24 for application to the body (col. 3, lines 29-40), and applying the selected one of the front sheet 12,16 and the back sheet 18,2 to the body part (col. 4, lines 8-18), providing a method of heating or cooling a pack using a heating device or cooled in a freezer or cooling device for a suitable amount of time and applying the insulative layer to the body part in need of thermal therapy while allowing the user to flip the packing if the thermal therapeutic effect is insufficient and to continue the thermal therapy as needed (col. 4, lines 8-18).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the method of delivering hot or cold therapy to a breast of MacWhinnie in view of Cramer with the steps of selecting one of the front sheet and the back sheet for application to the breast; and applying the selected one of the front sheet and the back sheet to the breast in order to have provided an improved method of delivering a desired and customized amount of hot or cold therapy to a breast by heating or cooling a pack using a heating device or cooled in a freezer or cooling device for a suitable amount of time and applying the insulative layer to the body part in need of thermal therapy while allowing the user to flip the packing if the thermal therapeutic effect is insufficient and to continue the thermal therapy as needed (Whitely, col. 4, lines 8-18).
Regarding claim 31, MacWhinnie in view of Cramer discloses the invention as discussed above. MacWhinnie in view of Cramer further discloses the second loft (63 gsm) is greater than the first loft (32 gsm) as taught by Cramer (col. 10, lines 12-36), the method including the further steps of: heating the breast pack (microwave or similar device, col. 4, 8-18) and applying the back sheet 18 to the breast to discourage engorgement (col. 4, lines 8-18) as taught by Whitely.
Regarding claim 32, MacWhinnie in view of Cramer discloses the invention as discussed above. MacWhinnie in view of Cramer further discloses the first thermal conductance (32 gsm) is greater than the second thermal conductance (63 gsm) as taught by Cramer (col. 10, lines 12-36), the method including the further steps of: heating the breast pack (microwave or similar device, col. 4, 8-18) and applying the front sheet 16 to the breast to discourage engorgement (when flipped to 16, col. 4, lines 8-18) as taught by Whitely.
Claims 15 and 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over MacWhinnie US 6261313 in view of Cramer US 6096067 further in view of Enderby US 2015/0351956.
MacWhinnie in view of Cramer discloses the invention as discussed above.
Although MacWhinnie discloses the shape of the front sheet and back sheet is bilaterally symmetrical around a vertical axis (see annotated fig. 8 above), MacWhinnie in view of Cramer do not explicitly disclose each of the front sheet and the back sheet comprises a teardrop shape bilaterally symmetrical around a vertical axis.
Enderby teaches an analogous breast pack 5610 (see figs. 2, 37, and fig. 56) for delivering heat or cold therapy to a breast (see fig. 1), wherein each of an analogous front sheet 215 and back sheet 225 comprise a teardrop shape (215 and 225 are teardrop shaped as are 5610, [0093]) bilaterally symmetrical around a vertical axis (see fig. 56, the teardrop shape is bilaterally symmetrical around a central vertical/longitudinal axis of the band/strap), providing a shape that is comfortable and aesthetically pleasing while allowing sufficient surface area for providing therapy and soothing to the breast (Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the shape of the front sheet and back sheet of McWhinnie in view of Cramer with the teardrop shape of each of the front sheet and the back sheet that are bilaterally symmetrical around a vertical axis as taught by Enderby in order to have provided an improved breast pack that has an improved shape that is comfortable and aesthetically pleasing while allowing sufficient surface area for providing therapy and soothing to the breast ([0042] and Abstract). In the written specification, it appears Applicant has not imparted any criticality to the teardrop shape of the breast pack providing any unpredictable result as such, Applicant is reminded that changes in shape are not patentable and are a matter of design choice, since it has been held that In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786
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