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 .
Response to Amendment
The amendment filed 7/20/26 has been entered. Claims 12, 15, 16, 18, 21-24 remain pending in the application. Applicant’s amendments to the (Specification, Drawings, and Claims) have not overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 4/22/26.
Claim Objections
Claim(s) 12, 24 is/are objected to because of the following informalities:
The term “surgical drainage or incision point” in Claim 12 Line 20 (and again in Claim 24 Line 4) needs review for how it relates to “surgical area” beginning in Claim 12 Line 9; currently, the term is interpreted as “surgical drainage or incision point of the surgical area”
Claim 24 Lines 2-3 delete “fabric body comprises a plurality of the absorption areas” and substitute –at least one absorption area is a plurality of absorption areas—for clear antecedent basis
Disagreement with any of the aforementioned may warrant at least a 112(b) indefiniteness rejection without constituting a new rejection
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim(s) 21 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The term “the stretchable fabric being configured to create a compressive force at the at least one absorption area sufficient to hold the absorption pad against the surgical area” in Claim 21 is considered new matter. There is no antecedent basis in the specification, nor is the term “sufficient” defined by the claim—as such, the term encompasses new matter. Specification [0012] supports a compressive force, and the stretch fabric is further mentioned in [0021] and [0026], but is not recited as having some degree of sufficiency to hold as recited. Examiner recommends deleting the term especially as it is merely functional, and/or utilizing the language in [0012] (“configured to reduce movement”).
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(s) 12, 15, 16, 18, 21-24 is/are rejected under U.S.C. 112(b).
The term “absorption pad” and “absorbent element” beginning in Claim 12 is unclear and therefore renders the claim indefinite. It is unclear whether the Claim intends for the term to be positive or functionally claimed. The first instance of the term is in Claim 12 Lines 11-12 “the at least one absorption area being configured to hold a replaceable absorption pad as an absorbent element” indicates the terms as being functionally claimed. However, Claim 12 Lines 15-16 “the inside layer is disposed between the absorption pad and the patient’s skin at the surgical area seems positively claim the absorption pad. It is unclear whether this was inadvertently done, especially as the recitation further positively claims the patient’s skin which is a U.S.C. 101 rejection. If the recitation is functional, Lines 15-16 should recite “configured to be disposed.” If the term is meant to be positive, the claim should clearly define “post-surgical garment comprising:…a replaceable absorption pad…the at least one absorption area being configured to hold the replaceable absorption pad.” For the purposes of applying art and providing rejections, two different rejections are given—one in which the pad/element is functiona, one in which the pad/element is positively claimed; see claim interpretation.
The term "sufficient" in claim 21 “sufficient to hold the absorption pad against the surgical area” is a relative term which renders the claim indefinite. The term "sufficient" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, the metes and bounds are unclear. For the purposes of applying art and providing rejections, the recitation of Claim 21 is considered met inasmuch as the fabric body comprises a stretchable fabric and is capable of a force at the at least one absorption area.
The term “arms…of the patient” in Claim 23 is unclear and therefore renders the claim indefinite. It is unclear how the term relates to “arm region” in Claim 12 Line 22. For the purposes of applying art and providing rejections, the terms are considered the same.
The term “legs of the patient” in Claim 23 is unclear and therefore renders the claim indefinite. It is unclear how the term relates to “leg region” in Claim 12 Line 22. For the purposes of applying art and providing rejections, the terms are considered the same.
The term “surgical drainage or incision points” in Claim 24 Line 4 is unclear and therefore renders the claim indefinite. It is unclear how the term differs from “surgical drainage or incision point” of Claim 12 Line 20. For the purposes of applying art and providing rejections, two different rejections are given—one in which the points merely have to be different from one another; another in which the points have to be at least two different ones in the group listed in Claim 12; see claim interpretation.
The term “each of the plurality of absorption areas being accessible through a respective opening formed in the outside layer” in Claim 24 is unclear and therefore renders the claim indefinite. It is unclear how these respective openings differ from “at least one opening” in Claim 12 Line 5. For the purposes of applying art and providing rejections, it is recommended that Claim 24 be deleted and only recite “wherein the at least one absorption area is a plurality of absorption areas” as recommended above in the claim objections, as the rest of the recitation is essentially redundant with Claim 12 Lines 5-8.
Dependent claims are rejected at the least for depending on rejected claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 12, 15, 16, 18, 21-24 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the following terms, to the best of the examiner’s understanding, is directed to a human organism and therefore is not patent eligible subject matter. Claims directed to or encompassing a human organism is excluded from eligibility before the Supreme Court. See MPEP 2105.
Claim 12 Lines 15-16 “the inside layer is disposed between the absorption pad and the patient’s skin at the surgical area” seems to positively claim patient skin and surgical area; examiner recommends “configured to be disposed”
Dependent claims are rejected at the least for depending on rejected claims.
Claim Interpretation
For FIRST and/or SECOND rejections:
The term “absorption pad” or “absorbent element(s)” is functionally claimed in Claims 12, 16, 21 due to Claim 12 functionally reciting “the at least one absorption area being configured to hold …absorption pad as an absorbent element” and/or the dependencies thereon.
The term “absorbent element(s)” seems to be positively claimed in Claim 13 due to Claim 13 positively reciting that the garment further comprises an absorbent element, and/or the dependencies thereon.
The term “foam insert” seems to be positively claimed in Claim 16.
The term “different surgical drainage or incision points” in Claim 24 is considered to be different from one another.
For THIRD rejection:
The term “absorption pad” or “absorbent element(s)” is interpreted as being positively claimed in Claims 12, 24 for compact prosecution.
The term “different surgical drainage or incision points” in Claim 24 is considered to be different selections in the Markush of Claim 24.
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.
FIRST REJECTION: as best understood in light of the 112(b) rejections--Claim(s) 12, 15, 18, 21, 22, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Caden (USPN 10786016) in view of Barg (USPN 3398749).
Regarding Claim 12, Caden teaches a post-surgical garment (it is noted that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations; however, see Figs. 1B, 5; title "moisture absorbing anti-leak undergarments"; Caden teaches the garment which meets the structural limitations in the claims and performs the functions as recited such as being capable of being utilized post-surgical), comprising:
a fabric body (see Fig. 5; Col. 6 Lines 26-28 "undergarment 10, at least the front section 14 of the body 12 is provided with a multi-layer construction 30"; Col. 6 Lines 33-37 "construction 30 includes a first layer 32 fabricate from a soft, pliable material…and provide a wicking effect drawing moisture from the wearer's chest area...first layer 32 may comprise a knit fabric"; Col. 6 Lines 53-58 "second layer 38 which is disposed adjacent the first layer...having prescribed moisture absorption properties...fabricated from...an absorbent foam"; Col. 7 Lines 9-10 "third layer 40 may comprise a breathable, elastic polyurethane film", wherein at least 32 being a knit fabric makes a fabric body),
the fabric body having a size configured to cover at least a portion of a patient's torso, a limb, or both (see Figs. 1B; Caden teaches the fabric body with size which meets the structural limitations in the claims and performs the functions as recited such as being capable of covering at least a portion of a patient’s torso in light of Fig. 1B; as another interpretation, abstract "undergarments that …are uniquely constructed to absorb fluids, such as those associated with sweat and lactation, in either prescribed areas of the undergarment or throughout the totality thereof"; Col. 1 Lines 34-36 "undergarments can include…men's undershirts…underwear"; Caden teaches the fabric body which meets the structural limitations in the claims and performs the functions as recited such as being capable of covering at least a portion of a patient’s torso with an undershirt, in light of the recitation),
the fabric body comprising an inside layer (32) and an outside layer (38) disposed outwardly of the inside layer (see Fig. 5; Col. 6 Lines 26-28, 33-37, 53-58; Col. 7 Lines 9-10; Col. 7 Lines 41-43 "at least portions of the first and second layers 32, 38 collectively define at least one pocket 44"; wherein at least layers 32, 38 are inside/outside relative to one another);
at least one opening formed in the fabric body (see Fig. 1B; Col. 7 Line 67-Col. 8 Line 6 "As seen in FIG. 1B, the undergarment 10 is provided with a pair of elongate slots or slits 48 within respective ones of the cup portions 16, each of which provides access to the interior of a respective one of the pockets 44 to allow for the advancement of the absorption layer 46 into its associated pocket 44, and removal of the absorption layer 46 from therewithin"; wherein the opening is in the fabric body inasmuch as the fabric body is not fully enclosed); and
at least one absorption area positioned within the fabric body between the inside layer and the outside layer and being accessible through the at least one opening (see Fig. 1B; Col. 6 Lines 53-58 for second layer 38 of fabric body absorbent and therefore creating an absorption area with Col. 7 Line 67-Col. 8 Line 6; nevertheless, see also for the area being for absorption-- Col. 7 Lines 41-46 "in the undergarment 10, at least portions of the first and second layers 32, 38 collectively define at least one pocket 44 therebetween which is sized and configured to removably accommodate an ancillary absorption layer 46 adapted to supplement the moisture absorption properties of the second layer 38"; Col. 7 Lines 52-53 "each ancillary absorption layer 46 takes the form of a generally circular absorption pad"; Col. 7 Lines 41-43 "at least portions of the first and second layers 32, 38 collectively define at least one pocket 44"; Caden teaches the pocket of the absorbent fabric body with an opening which meets the structural limitations in the claims and performs the functions as recited such as being capable of being accessible as recited, and for absorption in light of the pad recitations);
the at least one absorption area being defined by the inside layer (32) of the fabric body that is configured to be in direct contact with the patient's skin at a surgical area, the inside layer being porous to permit post-surgical fluid through from the surgical area (see Fig. 5; Col. 6 Lines 27-28 "the front section 14 of the body 12 is provided with a multi-layer construction 30"; Col. 6 Lines 33-37 "construction 30 includes a first layer 32 fabricate from a soft, pliable material…and provide a wicking effect drawing moisture from the wearer's chest area...first layer 32 may comprise a knit fabric"; wherein the wicking indicates porosity; for defined-- Col. 7 Lines 41-43 "at least portions of the first and second layers 32, 38 collectively define at least one pocket 44"; Caden teaches the inside layer which meets the structural limitations in the claims and performs the functions as recited such as being capable of being in direct contact at a surgical area, especially in light of Fig. 5 showing 32 at the skin, and to permit post-surgical fluid as recited),
the at least one absorption area being configured to hold a replaceable absorption pad as an absorbent element removably received within the at least one absorption area through the at least one opening (see claim interpretation; Caden teaches the at least one absorption area which meets the structural limitations in the claims and performs the functions as recited such as being capable of holding a replaceable absorption pad as absorbent element removably received as recited, especially in light of Fig. 1B; Col. 7 Lines 41-46 "in the undergarment 10, at least portions of the first and second layers 32, 38 collectively define at least one pocket 44 therebetween which is sized and configured to removably accommodate an ancillary absorption layer 46 adapted to supplement the moisture absorption properties of the second layer 38"; Col. 7 Lines 52-53 "each ancillary absorption layer 46 takes the form of a generally circular absorption pad");
wherein the inside layer extends continuously across the at least one absorption area such that the inside layer is disposed between the absorption pad and the patient’s skin at the surgical area of the fabric body, wherein the absorbent element is configured to absorb fluid from the surgical area of the patient (see Fig. 1A wherein the at least one absorption area is where pads 46 are located; especially in light of Fig. 5 and Col. 7 Lines 41-46, in order for 46 to be ancillary to the inside layer absorption, the inside layer would extend across 46, and Figs. 1A, 5 shows continuity of the inside layer; Caden teaches the inside layer of the fabric body which meets the structural limitations in the claims and performs the functions as recited such as being capable of having an absorption pad located between skin and inside layer and absorbing fluid from a surgical area as recited, especially in light of Col. 7 Lines 41-46),
wherein the at least one absorption area is configured to be located at a position corresponding to a surgical drainage or incision point, selected from the group consisting of: an abdominal region around a belly button and lower left and lower right quadrants, a thoracic region, an arm region around a posterior elbow, and a leg region around a medial knee or medial thigh (Caden teaches the at least one absorption area which meets the structural limitations in the claims and performs the functions as recited such as being capable of being at a thoracic region, especially in light of abstract "undergarments that …are uniquely constructed to absorb fluids, such as those associated with sweat and lactation, in either prescribed areas of the undergarment or throughout the totality thereof" and Col. 5 Lines 51-52 “undergarment 10 is a bra”), and
wherein the at least one opening is positioned such that the absorbent element is inserted into, and removable from, the at least one absorption area while the garment remains worn by the patient (see Fig. 1B; Caden teaches the at least one opening which meets the structural limitations in the claims and performs the functions as recited such as being capable of replacing the absorbent element while the garment is worn, especially in light of Col. 7 Lines 41-46).
Caden does not explicitly teach at least one opening formed in the outside layer of the fabric body, and therefore:
the at least one absorption area positioned within the fabric body between the inside layer and the outside layer and being accessible from an exterior of the garment through the at least one opening,
wherein the at least one opening is positioned in the outside layer such that the absorbent element is inserted into, and removable from, the at least one absorption area from the exterior of the garment while the garment remains worn by the patient.
However, Caden already teaches that the at least opening is of a breast cup.
Barg teaches the at least one opening of a breast cup is formed in the outside layer of the body (see Figs. 1, 3; Col. 2 Lines 10-19 "two outwardly disposed breast cups 19 and 19' on the front of the body portion 10…each is constructed of two sections 28, 29 which are joined…by…zipper 20...and thereby seal the outer sections of the pockets 27 so formed in breast cups 19 and 19'"; wherein Fig. 3 shows pocket formed in inside/outside layers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Caden’s opening to be in the outside layer as taught by Barg for easy accessibility to the receptacle (Col. 1 Lines 13-15).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that modified Caden teaches the at least one absorption area positioned within the fabric body between the inside layer and the outside layer and being accessible from an exterior of the garment through the at least one opening (via Barg, the at least one opening of Caden is now on the exterior of the garment on the outside layer),
wherein the at least one opening is positioned in the outside layer such that the absorbent element is inserted into, and removable from, the at least one absorption area from the exterior of the garment while the garment remains worn by the patient (modified Caden teaches the at least one opening on the exterior of the garment which meets the structural limitations in the claims and performs the functions as recited such as being capable of inserting and removing the absorbent element as recited).
Regarding Claim 15, modified Caden teaches all the claimed limitations as discussed above in Claim 12.
Caden further teaches wherein the absorbent element has a size and shape that correlates to a size and shape of the at least one absorption area (see claim interpretation; as best understood in light of the 112(b) rejections—see Fig. 1B; Col. 7 Lines 41-46 wherein sized indicates shaped; Col. 7 Lines 52-53).
Regarding Claim 18, modified Caden teaches all the claimed limitations as discussed above in Claim 12.
Modified Caden further teaches wherein the at least one opening comprises a slit, flap, elastic opening, zipper, or hook-and-loop closure (Caden Col. 7 Line 67-Col. 8 Line 6 "As seen in FIG. 1B, the undergarment 10 is provided with a pair of elongate slots or slits 48 within respective ones of the cup portions 16, each of which provides access to the interior of a respective one of the pockets 44 to allow for the advancement of the absorption layer 46 into its associated pocket 44, and removal of the absorption layer 46 from therewithin"; nevertheless, Barg teaches the zipper and slit, see rejection of Claim 12).
Regarding Claim 21, modified Caden teaches all the claimed limitations as discussed above in Claim 12.
Caden further teaches wherein the fabric body comprises a stretchable fabric, the stretchable fabric being configured to create a compressive force at the at least one absorption area sufficient to hold the absorption pad against the surgical area (Col. 7 Lines 9-10 "third layer 40 may comprise a breathable, elastic polyurethane film" wherein the elastic layer is of the fabric body and therefore the fabric body is stretchable; and/or Col. 6 Line 37 “first layer 32 may comprise a knit fabric", wherein knits are inherently stretchable; Caden teaches the stretch fabric which meets the structural limitations in the claims and performs the functions as recited such as being capable of creating the compressive force as recited, especially as the fabric is related to the at least one absorption area, see Fig. 5; Col. 7 Lines 41-52).
Regarding Claim 22, modified Caden teaches all the claimed limitations as discussed above in Claim 12.
Caden further teaches wherein the fabric body comprises an antimicrobial material (Col. 3 Lines 49-52 "desirable that the undergarments provide…antimicrobial management…the present disclosure addresses these particular needs").
Regarding Claim 24, modified Caden teaches all the claimed limitations as discussed above in Claim 12.
Modified Caden further teaches wherein the fabric body comprises a plurality of the absorption areas located at spaced-apart positions corresponding to different surgical drainage or incision points, each of the plurality of absorption areas being accessible through a respective opening formed in the outside layer (assuming the points merely have to be different from one another; Caden teaches at least two absorption areas in Fig. 1A, 1B where 46 is located on the left/right and therefore different and spaced-apart positions which meets the structural limitations in the claims and performs the functions as recited such as being capable of corresponding to different points as recited; modified Caden teaches the absorption areas being accessible through an opening of the outside layer via Barg).
As best understood in light of the 112(b) rejections--Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Caden (USPN 10786016) in view of Barg (USPN 3398749), as applied to the FIRST REJECTION above, in view of Watabe et al (JP 2007/215822), herein Watabe.
Regarding Claim 16, modified Caden teaches all the claimed limitations as discussed above in Claim 12.
Caden does not explicitly teach a foam insert receivable within the at least one absorption area in addition to the absorption pad, the foam insert being configured to provide compression to the surgical area.
However, Caden does teach that the absorbent pad at the surgical site is already a foam insert (for foam-- Col. 7 Lines 59-63 "absorption layer 46 (e.g., pad) may be fabricated from materials having prescribed moisture absorption properties, including but not limited to those described above in relation to the second layer 38"; Col. 6 Lines 56-58 "second layer 38 is fabricated from a liquid or moisture absorbing material (e.g.,...absorbent foam..."; for insert-- Col. 7 Lines 41-46).
Watabe teaches stacking two absorption pad inserts (see Fig. 1; [0017] "absorbent pads (30) and (31)…stacked together…facilitates the replacement of the small pad (31) that directly touches the affected area, and also allows the large pad (30) to absorb any leakage from the small pad (31)").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Caden to have two foam inserts as taught by Watabe in order to ensure absorption ([0017]) in the same art of endeavor as absorbent garments.
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that modified Caden teaches foam insert receivable within the at least one absorption area in addition to the absorption pad, the foam insert being configured to provide compression to the surgical area (modified Caden teaches an addition to the original foam insert/absorption pad/element which meets the structural limitations in the claims and performs the functions as recited such as being capable of providing compression as recited).
SECOND REJECTION: as best understood in light of the 112(b) rejections--Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Caden (USPN 10786016) in view of Barg (USPN 3398749), Kurihara (US Publication 2021/0289863), and Chatfield (USPN 2639708).
Regarding Claim 23 (which is Claims 12, 23)-- Caden teaches a post-surgical garment (it is noted that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations; however, see Figs. 1B, 5; title "moisture absorbing anti-leak undergarments"; Caden teaches the garment which meets the structural limitations in the claims and performs the functions as recited such as being capable of being utilized post-surgical), comprising:
a fabric body (see Fig. 5; Col. 6 Lines 26-28 "undergarment 10, at least the front section 14 of the body 12 is provided with a multi-layer construction 30"; Col. 6 Lines 33-37 "construction 30 includes a first layer 32 fabricate from a soft, pliable material…and provide a wicking effect drawing moisture from the wearer's chest area...first layer 32 may comprise a knit fabric"; Col. 6 Lines 53-58 "second layer 38 which is disposed adjacent the first layer...having prescribed moisture absorption properties...fabricated from...an absorbent foam"; Col. 7 Lines 9-10 "third layer 40 may comprise a breathable, elastic polyurethane film", wherein at least 32 being a knit fabric makes a fabric body),
the fabric body having a size configured to cover at least a portion of a patient's torso, a limb, or both (see Figs. 1B; Caden teaches the fabric body with size which meets the structural limitations in the claims and performs the functions as recited such as being capable of covering at least a portion of a patient’s torso in light of Fig. 1B; as another interpretation, abstract "undergarments that …are uniquely constructed to absorb fluids, such as those associated with sweat and lactation, in either prescribed areas of the undergarment or throughout the totality thereof"; Col. 1 Lines 34-36 "undergarments can include…men's undershirts…underwear"; Caden teaches the fabric body which meets the structural limitations in the claims and performs the functions as recited such as being capable of covering at least a portion of a patient’s torso with an undershirt, in light of the recitation),
the fabric body comprising an inside layer (32) and an outside layer (38) disposed outwardly of the inside layer (see Fig. 5; Col. 6 Lines 26-28, 33-37, 53-58; Col. 7 Lines 9-10; Col. 7 Lines 41-43 "at least portions of the first and second layers 32, 38 collectively define at least one pocket 44"; wherein at least layers 32, 38 are inside/outside relative to one another);
at least one opening formed in the fabric body (see Fig. 1B; Col. 7 Line 67-Col. 8 Line 6 "As seen in FIG. 1B, the undergarment 10 is provided with a pair of elongate slots or slits 48 within respective ones of the cup portions 16, each of which provides access to the interior of a respective one of the pockets 44 to allow for the advancement of the absorption layer 46 into its associated pocket 44, and removal of the absorption layer 46 from therewithin"; wherein the opening is in the fabric body inasmuch as the fabric body is not fully enclosed); and
at least one absorption area positioned within the fabric body between the inside layer and the outside layer and being accessible through the at least one opening (see Fig. 1B; Col. 6 Lines 53-58 for second layer 38 of fabric body absorbent and therefore creating an absorption area with Col. 7 Line 67-Col. 8 Line 6; nevertheless, see also for the area being for absorption-- Col. 7 Lines 41-46 "in the undergarment 10, at least portions of the first and second layers 32, 38 collectively define at least one pocket 44 therebetween which is sized and configured to removably accommodate an ancillary absorption layer 46 adapted to supplement the moisture absorption properties of the second layer 38"; Col. 7 Lines 52-53 "each ancillary absorption layer 46 takes the form of a generally circular absorption pad"; Col. 7 Lines 41-43 "at least portions of the first and second layers 32, 38 collectively define at least one pocket 44"; Caden teaches the pocket of the absorbent fabric body with an opening which meets the structural limitations in the claims and performs the functions as recited such as being capable of being accessible as recited, and for absorption in light of the pad recitations);
the at least one absorption area being defined by the inside layer (32) of the fabric body that is configured to be in direct contact with the patient's skin at a surgical area, the inside layer being porous to permit post-surgical fluid through from the surgical area (see Fig. 5; Col. 6 Lines 27-28 "the front section 14 of the body 12 is provided with a multi-layer construction 30"; Col. 6 Lines 33-37 "construction 30 includes a first layer 32 fabricate from a soft, pliable material…and provide a wicking effect drawing moisture from the wearer's chest area...first layer 32 may comprise a knit fabric"; wherein the wicking indicates porosity; for defined-- Col. 7 Lines 41-43 "at least portions of the first and second layers 32, 38 collectively define at least one pocket 44"; Caden teaches the inside layer which meets the structural limitations in the claims and performs the functions as recited such as being capable of being in direct contact at a surgical area, especially in light of Fig. 5 showing 32 at the skin, and to permit post-surgical fluid as recited),
the at least one absorption area being configured to hold a replaceable absorption pad as an absorbent element removably received within the at least one absorption area through the at least one opening (see claim interpretation; Caden teaches the at least one absorption area which meets the structural limitations in the claims and performs the functions as recited such as being capable of holding a replaceable absorption pad as absorbent element removably received as recited, especially in light of Fig. 1B; Col. 7 Lines 41-46 "in the undergarment 10, at least portions of the first and second layers 32, 38 collectively define at least one pocket 44 therebetween which is sized and configured to removably accommodate an ancillary absorption layer 46 adapted to supplement the moisture absorption properties of the second layer 38"; Col. 7 Lines 52-53 "each ancillary absorption layer 46 takes the form of a generally circular absorption pad");
wherein the inside layer extends continuously across the at least one absorption area such that the inside layer is disposed between the absorption pad and the patient’s skin at the surgical area of the fabric body, wherein the absorbent element is configured to absorb fluid from the surgical area of the patient (see Fig. 1A wherein the at least one absorption area is where pads 46 are located; especially in light of Fig. 5 and Col. 7 Lines 41-46, in order for 46 to be ancillary to the inside layer absorption, the inside layer would extend across 46, and Figs. 1A, 5 shows continuity of the inside layer; Caden teaches the inside layer of the fabric body which meets the structural limitations in the claims and performs the functions as recited such as being capable of having an absorption pad located between skin and inside layer and absorbing fluid from a surgical area as recited, especially in light of Col. 7 Lines 41-46),
wherein the at least one opening is positioned such that the absorbent element is inserted into, and removable from, the at least one absorption area while the garment remains worn by the patient (see Fig. 1B; Caden teaches the at least one opening which meets the structural limitations in the claims and performs the functions as recited such as being capable of replacing the absorbent element while the garment is worn, especially in light of Col. 7 Lines 41-46).
Caden does not explicitly teach at least one opening formed in the outside layer of the fabric body, and therefore:
the at least one absorption area positioned within the fabric body between the inside layer and the outside layer and being accessible from an exterior of the garment through the at least one opening,
wherein the at least one opening is positioned in the outside layer such that the absorbent element is inserted into, and removable from, the at least one absorption area from the exterior of the garment while the garment remains worn by the patient.
However, Caden already teaches that the at least opening is of a breast cup.
Barg teaches the at least one opening of a breast cup is formed in the outside layer of the body (see Figs. 1, 3; Col. 2 Lines 10-19 "two outwardly disposed breast cups 19 and 19' on the front of the body portion 10…each is constructed of two sections 28, 29 which are joined…by…zipper 20...and thereby seal the outer sections of the pockets 27 so formed in breast cups 19 and 19'"; wherein Fig. 3 shows pocket formed in inside/outside layers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Caden’s opening to be in the outside layer as taught by Barg for easy accessibility to the receptacle (Col. 1 Lines 13-15).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that modified Caden teaches the at least one absorption area positioned within the fabric body between the inside layer and the outside layer and being accessible from an exterior of the garment through the at least one opening (via Barg, the at least one opening of Caden is now on the exterior of the garment on the outside layer),
wherein the at least one opening is positioned in the outside layer such that the absorbent element is inserted into, and removable from, the at least one absorption area from the exterior of the garment while the garment remains worn by the patient (modified Caden teaches the at least one opening on the exterior of the garment which meets the structural limitations in the claims and performs the functions as recited such as being capable of inserting and removing the absorbent element as recited).
Caden does not explicitly teach wherein the at least one absorption area is configured to be located at a position corresponding to a surgical drainage or incision point, selected from the group consisting of: an abdominal region around a belly button and lower left and lower right quadrants, an arm region around a posterior elbow, and a leg region around a medial knee or medial thigh.
However, Caden teaches that the at least one absorption area is in areas of sweat in undergarments, such as men’s undershirts, underwear (abstract "undergarments that …are uniquely constructed to absorb fluids, such as those associated with sweat and lactation, in either prescribed areas of the undergarment or throughout the totality thereof"; Col. 1 Lines 34-36 "undergarments can include…men's undershirts…underwear”).
Kurihara teaches the at least one absorption area is in at least one area of sweat in a garment with a pad (see Fig. 1; [0042] "underarm sweat pad 1…includes…back surface sheet 2…a liquid-permeable front surface sheet 3…and an absorbent body 4 interposed between both the sheets"; [0043] "pad 1 is used by being attached to an inside of an axillary portion of a garment ,and is worn with the front surface sheet 3 facing a skin side and the back surface sheet 2 facing a garment side").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Caden's undershirt garment with the location of the at least one absorption area of Kurihara in order to absorb sweat at desired locations ([0042], [0043], abstract), especially as Caden already indicates doing so (abstract).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that modified Caden teaches wherein the at least one absorption area is configured to be located at a position corresponding to a surgical drainage or incision point, selected from the group consisting of: an abdominal region around a belly button and lower left and lower right quadrants, an arm region around a posterior elbow, and a leg region around a medial knee or medial thigh (Caden’s undershirt garment has an underarm pad from Kurihara which meets the structural limitations in the claims and performs the functions as recited such as being capable of being at an arm region around a posterior elbow).
Caden also does not explicitly teach wherein the garment is configured to extend across the torso, arms, and legs of the patient.
However, as aforementioned, Caden’s garment is an undergarment, such as men’s undershirts, underwear (abstract "undergarments that …are uniquely constructed to absorb fluids, such as those associated with sweat and lactation, in either prescribed areas of the undergarment or throughout the totality thereof"; Col. 1 Lines 34-36 "undergarments can include…men's undershirts…underwear”).
Chatfield teaches wherein the men’s undergarment is configured to extend across the torso, arms, and legs of the patient (see Fig. 4 for extent across torso, arms, legs; Col. 1 Lines 1-4 "invention relates to...men's undergarments”; Chatfield teaches the garment which meets the structural limitations in the claims and performs the functions as recited such as being capable of being for a patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Caden’s men’s undergarments to extend as taught by Chatfield as aesthetic design choice (Col. 1 Lines 27-29), such as for warmth or modesty.
THIRD REJECTION: as best understood in light of the 112(b) rejections--Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown (USPN 12193529) in view of Gilford et al (USPN 5052052), herein Gilford, and O’Neill (USPN 4015294).
Regarding Claim 24 (which is Claims 12, 24), Brown teaches a post-surgical garment (it is noted that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations; however, see Figs. 1B, 2B; Col. 3 Lines 27-36 "torso protection apparatus 100…may be protective clothing worn over the torso with a front 101…and a covered back 120…the back 120 may include a plurality of specifically and diversely shaped protective pads 122 within pad housings 121 covering a majority of a wearer's back torso"; Brown teaches the clothing which meets the structural limitations in the claims and performs the functions as recited such as being capable of being post-surgical), comprising:
a body (Col. 7 Lines 10-11 "material used in the apparel 100 may be stretchable"),
the body having a size configured to cover at least a portion of a patient's torso, a limb, or both (see Fig. 1B for back torso; see Fig. 4 for limb such as arm);
the body comprising an inside layer and an outside layer disposed outwardly of the inside layer (Col. 7 Lines 12-17 "pad housings 121 may include stretchable pocket seams 211 creating openings that may expand for insertion and removal of the protective pads 122, but contract after insertion…the interior housing material may be webbing and the outer housing enclosure may be material such as spandex"; Col. 7 Lines 20-21 "pads may be enclosed in two types of stretchable mesh material");
at least one opening formed in the outside layer of the body (see Fig. 1B; Col. 7 Lines 12-15"pad housings 121 may include stretchable pocket seams…creating openings"); and
at least one absorption area positioned within the body between the inside layer and the outside layer and being accessible from an exterior of the garment through the at least one opening (the at least one area being the interior of at least one housing 121; see Fig. 1B; Col. 7 Lines 12-15"pad housings 121 may include stretchable pocket seams 211 creating openings"; Brown teaches the at least one area between inside/outer layer with at least one opening on the outside layer which meets the structural limitations in the claims and performs the functions as recited such as being capable of being accessible from an exterior as recited, wherein such an area is capable of being for absorption by mere existence, such from impact, furthermore in light of Col. 7 Lines 28-29 "protective pads 122 may be made from foam" which is known in the art of capable of absorbing, such as from impact),
the at least one absorption area being defined by an inside layer of the body that is configured to be in direct contact with a patient's skin at a surgical area, the inside layer being porous to permit post-surgical fluid through from the surgical area (Col. 7 Line 16 "interior housing material may be webbing", wherein webbing indicates porosity; Brown teaches the inside layer webbing which meets the structural limitations in the claims and performs the functions as recited such as being capable of being in direct contact and permitting post-surgical fluid as recited),
the at least one absorption area being configured to hold a replaceable absorption pad as an absorbent element (Brown teaches the at least one absorption area which meets the structural limitations in the claims and performs the functions as recited such as being capable of holding the recited, especially in light of Col. 7 Lines 7-9 "the pad housing 121 may be uniquely sized and shaped to removably accommodate the unique size and shape of the protective pad 122"; Col. 7 Lines 28-29 "protective pads 122 may be made from foam", wherein the foam is capable of being absorbent, such as from impact),
removably received within the at least one absorption area through the at least one opening (Brown teaches the at least one absorption area with at least one opening which meets the structural limitations in the claims and performs the functions as recited such as being capable of removably receiving the pad, especially in light of Col. 7 Lines 12-17 "pad housings 121 may include stretchable pocket seams 211 creating openings that may expand for insertion and removal of the protective pads 122, but contract after insertion…the interior housing material may be webbing and the outer housing enclosure may be material such as spandex"),
wherein the inside layer extends continuously across the at least one absorption area such that the inside layer is disposed between the absorption pad and the patient's skin at the surgical area (Col. 7 Lines 12-17; inside layer forms the at least one absorption area and extends continuously based on Fig. 1B which meets the structural limitations in the claims and performs the functions as recited such as being capable of having the inside layer disposed between as recited, especially in light of Col. 7 Lines 12-17),
wherein the at least one absorption area is configured to be located at a position corresponding to surgical drainage or incision point, selected from the group consisting of: an abdominal region around a belly button and lower left and lower right quadrants, a thoracic region, an arm region around a posterior elbow, and a leg region around a medial knee or medial thigh (see Figs. 1B, 2B wherein spine is of the thoracic region; Col. 4 Lines 7-8 "medial spine guard 204…upper spine guard 202"; Col. 4 Line 24 "main spine guard 206"; see Figs. 1B, 2B wherein kidneys are of the abdominal region around a belly button and lower left/right quadrants, inasmuch as the term "around" has been defined, see extrinsic evidence Biology Insights NPL; Col. 4 Lines 24-25 "pair of kidney guards 207a, 207b"; Brown teaches the spine guard and kidney guards which meets the structural limitations in the claims and performs the functions as recited such as being capable of being located at a thoracic region and an abdominal region as recited, especially in light of the recitations),
wherein the at least one opening is positioned in the outside layer such that the absorbent element is inserted into, and removable from, the at least one absorption area from the exterior of the garment while the garment remains worn by the patient (see Figs. 1B, 2B; Col. 7 Lines 12-17 "pad housings 121 may include stretchable pocket seams 211 creating openings that may expand for insertion and removal of the protective pads 122, but contract after insertion…the interior housing material may be webbing and the outer housing enclosure may be material such as spandex"; Brown teaches the at least one opening in the outside layer with an at least one absorption area which meets the structural limitations in the claims and performs the functions as recited such as being capable of inserting and removing the element from the exterior while garment is worn as recited),
wherein the body comprises a plurality of the absorption areas located at spaced-apart positions corresponding to different surgical drainage or incision points, each of the plurality of absorption areas being accessible through a respective opening formed in the outside layer (see aforementioned where the spine guard and the kidney guards correspond to different points, each in an absorption area with an opening which meets the structural limitations in the claims and performs the functions as recited such as being capable of being for surgical or incision and capable of being accessible as recited).
Brown does not explicitly teach that the body is fabric.
However, Brown already taught that the body is stretchable material (Col. 7 Lines 10-11).
Gilford teaches a fabric body of stretchable material (Col. 4 Lines 9-12 "protective suits of this invention are preferably made of light-weight washable stretch fabric, e.g. polyester. The compressible inserts are preferably formed of foamed material"; abstract "protective [suit] to protect ...against injuries...which has...pockets designed to hold removable compressible padding inserts at areas susceptible to...injuries").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brown’s stretch material to be fabric as taught by Gilford as a known effective arrangement in a protective padded apparel and/or based on material availability.
Brown does not explicitly teach wherein the absorbent element is configured to absorb fluid from the surgical area of the patient.
However, Brown already taught that the padding/absorbent element is foam (Col. 7 Lines 28-29).
O’Neill teaches an open-cell foam/padding (see Fig. 1; Col. 3 Lines 1-2 "padding means 14 are preferably an open-cell foam material"; Col. 3 Lines 6-10 "open-cell foam padding …provides a comfortable fit…but also aids in...impact protection…temperature insulation").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brown's foam to be open-cell as taught by O'Neill as a known foam material for protection.
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that modified Brown teaches wherein the absorbent element is configured to absorb fluid from the surgical area of the patient (see extrinsic evidence Bainbridge et al USPN 5920915, wherein it is known in the art that open-cell foam is capable of absorbing moisture; modified Brown teaches the open-cell absorbent element which meets the structural limitations in the claims and performs the functions as recited such as being capable of absorbing fluid as recited),
and therefore furthermore how the at least one area is an absorption area (furthermore as the at least one area houses an absorbent element).
Response to Arguments
Applicant’s arguments with respect to claims 12, 15, 16, 18, 21-24 have been considered but are moot because of the new grounds of rejection necessitated by amendment. Therefore, see aforementioned rejections for the argued missing limitations. Nevertheless, for clarification--
Pertaining to remarks beginning on page 6 that Caden has four layers and therefore the pocket is not defined between the outer layers and only between the first/second layers 32, 38—examiner respectively disagrees. First, the claims do not claim that the pocket is between outer layers, let alone outermost layers; the claim only recites that the pocket is between the inside layer and the outside layer. Layer 32, 38 are inside/outside layers relative to one another, and based on person’s perspective of the garment. Even if the claims were amended to read that the pocket is between outermost layers, the claim is a comprising claim, and the pocket is still between the fourth and first layers, as being between the second/first layer would still be between the fourth and first layers.
Pertaining to remarks on page 7 that Caden does not disclose an opening through layers and therefore Caden cannot be utilized—examiner respectfully disagrees. The claims do not claim that the opening is through a layer, merely in a layer. Under broadest reasonable interpretation, the opening can be interpreted as being in a layer inasmuch as it is of a layer.
As such, Caden still teaches that the opening is in/of the outside layer, and is between the inside/outer layer. Nevertheless, for compact prosecution, new art has been presented.
Pertaining to remarks on page 7, remarks refer to differences being more than intended use and therefore allowable—examiner respectfully disagrees. Nowhere in the rejection was the term “intended use” utilized, especially as Caden was not modified for at least Claim 12 in the previous rejection of 4/22/26.
Pertaining to remarks on page 8 for Claim 12 that Caden reciting men’s undershirts/underwear does not indicate the absorption area being capable of being located at at least abdominal region and lower left/right quadrants—examiner respectfully disagrees. It is noted that the garment will fit differently sized wearers in different manners and an intended relative position of the at least one absorption area to the wearer's abdominal and lower left/right quadrants, or other anatomy, is functional and not patentably significant. Also, the remarks do not take into account the recitation of the abstract, where the at least one absorption area is for sweat tailored throughout the garment; men’s undershirts/underwear with areas for sweat is capable of being at the region and quadrants recited. Nevertheless, for compact prosecution, new art is presented herein. Furthermore, it is noted that the amendments also recite a thoracic region which Caden’s brassiere would also teach without men’s undershirts/underwear.
Pertaining to remarks on page 8 for Claim 21 that the stretch fabric body requires a compressive force and is not taught by Caden—examiner respectfully disagrees. As aforementioned, the recitation is functional; inasmuch as Caden teaches a stretch fabric, especially relative to an absorption area, the recitation is met. Claims would have to structurally differentiate from the prior art for further weight to be given to the function; in other words, if there is additional structure contributing to the compression function, the additional structure should be claimed.
It is further noted that the remarks seem to argue as if the pad is positively claimed, where, at least in Claim 12, the pad is not positively claimed, as has been indicated in the Claim Interpretation section since the office action of 11/19/25. In order to positively claim the pad, Claim 12 should clearly recite the garment comprising the pad, and not functionally configured to hold the pad. Claim 13 is currently interpreting the pad as positive for compact prosecution, and as best understood, an attempt at writing the structure positively. See claim interpretation.
Pertaining to remarks on page 8 for Claim 24 that Caden does not teach pockets at spaced apart positions for different points because both are at the same anatomical structure—examiner respectfully disagrees. Remarks desire a narrower interpretation of the limitation that is not required by the current claim limitation under broadest reasonable interpretation. Inasmuch as the pockets are clearly separate elements/structures, the pockets are spaced apart, and are configured for different points of the wearer (ex. left/right breast). Especially in light of the indefiniteness rejections, this narrower interpretation is not required. Nevertheless, for compact prosecution, the third rejection has been provided. It is noted that the Brown reference can be utilized in a rejection for all the claims in future prosecution.
Pertaining to remarks on page 9 that Watabe does not teach the recitation—examiner respectfully disagrees. Examiner clarifies-- Caden already teaches a foam insert absorbent pad, and merely does not teach at least two of them. Watabe teaches at least two absorbent pads, and provides the motivation for doing so. The motivation has not been addressed in the remarks.
Pertaining to remarks on page 9 that Caden does not teach a foam insert for compression—examiner respectfully disagrees. Similarly as aforementioned—the compression is functional. Modified Caden teaches an additional foam insert which meets the structural limitations in the claims and performs the functions as recited such as being capable of compression. Claims would have to structurally differentiate from the prior art for further weight to be given to the function; in other words, if there is additional structure contributing to the compression function, the additional structure should be claimed.
Pertaining to remarks on page 9 for Claim 16 that Watabe teaches away from the layer arrangement as Watabe is not between the pad and wound—examiner respectfully disagrees. First, teaching away is not applicable to Watabe, as teaching away pertains to a first reference teaching away from being modified by a second reference. Furthermore, the remarks misconstrue the rejection. Watabe is only utilized to teach that it is known to have two absorption pads together, and is not being utilized for any pocket recitations. To argue pocket recitations is piecemeal, as the recitation was already met by Caden. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Additionally, utilizing Watabe does not require further modifying with Watabe’s layers; the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Pertaining to remarks on page 9 for Claim 23 that the motivation to modify with Chatfield is not found within Chatfield and therefore is improper—examiner respectfully disagrees. Applicant may argue that the combination of two or more references is “hindsight” because “express” motivation to combine the references is lacking. However, there is no requirement that an “express, written motivation to combine must appear in prior art references before a finding of obviousness.” See Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1276, 69 USPQ2d 1686, 1690 (Fed. Cir. 2004). See MPEP 2141 and 2143 for guidance regarding establishment of a prima facie case of obviousness. In other words, motivations may rely on examiner’s own reasoning (see MPEP 2143), such as common sense or ordinary ingenuity.
Pertaining to remarks on page 9 that Chatfield is not relevant to the rejection of Claim 23 as it is not a brassiere like Caden—examiner respectfully disagrees. The rejection indicated that Caden teaches men’s undershirt/underwear, wherein Chatfield is men’s undergarments, and therefore in the same art of endeavor, wherein Chatfield teaches that Caden’s garments have the extent recited.
Conclusion
The prior art made of record and not relied upon but is considered pertinent to applicant's disclosure and can be used to formulate a rejection if necessary: Hoffmann (US Publication 2004/0221354) directed to sweat absorbent pads near posterior elbow; de Jorio (USPN 2258209), Seller (USPN 2953133) directed to outer-layer opening pocket on a brassiere; Michelle (US Publication 2019/0281905) directed to full body protective padded garment.
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 extension fee 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 date of this final action.
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/GRACE HUANG/Primary Examiner, Art Unit 3732
Prosecution Insights